Food and Nutrition Service
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Navy Department
Presidential Documents
Centers for Disease Control and Prevention
Children and Families Administration
Food and Drug Administration
Health Resources and Services Administration
Indian Health Service
Indian Health Service
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
Transportation Security Administration
U.S. Customs and Border Protection
National Park Service
Employment and Training Administration
Federal Aviation Administration
National Highway Traffic Safety Administration
Surface Transportation Board
Transportation Security Administration
Thrift Supervision Office
Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
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Federal Aviation Administration (FAA), DOT.
Final rule; correction.
This action corrects the geographic coordinates of a final rule that was published in the
Effective December 17, 2009. The Director of the Federal Register approves this incorporation by reference action under 1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
Scott Enander, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321–7716.
On October 16, 2009, the FAA published in the
Accordingly, pursuant to the authority delegated to me, the geographic coordinates for the Class D and Class E airspace areas at New Orleans NAS, Alvin Callender Field, LA, as published in the
By removing “(Lat. 29°49′31″ N., long. 90°02′06″ W.) and substituting (Lat. 29°49′38″N., long. 90°01′36″ W.)
By removing “(Lat. 29°49′31″ N., long. 90°02′06″ W.) and substituting (Lat. 29°49′38″ N., long. 90°01′36″ W.)
Federal Aviation Administration (FAA), DOT.
Final rule.
This action amends Class E airspace at Mankato, MN. Additional controlled airspace is necessary to accommodate Area Navigation (RNAV) Standard Instrument Approach Procedures (SIAP) at Mankato Regional Airport, Mankato, MN. The FAA is taking this action to enhance the safety and management of Instrument Flight Rule (IFR) operations at Mankato Regional Airport.
Effective 0901 UTC, February 11, 2010. The Director of the Federal Register approves this incorporation by reference action under 1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
Scott Enander, Central Service Center, Operations Support Group, Federal Aviation Administration, Southwest Region, 2601 Meacham Blvd., Fort Worth, TX 76137; telephone (817) 321–7716.
On September 3, 2009, the FAA published in the
This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by amending Class E airspace at Mankato, MN, adding additional controlled airspace extending upward from 700 feet above the surface for SIAPs at Mankato Regional Airport, Mankato, MN, for the safety and management of IFR operations.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action”
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it amends controlled airspace at Mankato Regional Airport, Mankato, MN.
Airspace, Incorporation by reference, Navigation (air).
49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959–1963 Comp., p. 389.
Within a 4.2-mile radius of Mankato Regional Airport and within 1.8 miles each side of the Mankato VOR/DME 167° radial extending from the 4.2-mile radius to 7 miles south of the VOR/DME; and within 2.7 miles each side of the Mankato VOR/DME 326° radial extending from the 4.2-mile radius to 7 miles northwest of the VOR/DME. This Class E airspace is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
That airspace extending upward from 700 feet above the surface within a 7-mile radius of Mankato Regional Airport, and within 2 miles each side of the 047° bearing from the airport extending from the 7-mile radius to 8 miles northeast of the airport; and within 4 miles each side of the 020° bearing from the airport extending from the 7-mile radius to 11 miles north of the airport; and within a 6-mile radius of the point in space serving Immanuel-St. Joseph's Hospital.
National Aeronautics and Space Administration.
Final rule.
NASA is amending its regulations by removing a subpart concerning authority and delegations to take certain actions relating to patents and other intellectual property rights. The NASA General Counsel establishes Agency-wide legal policies and procedures in conjunction and coordination with the various Center Chief Counsels and determines best methods and practices for providing legal advice, assistance, and functional guidance inherent in rendering legal services.
Robert F. Rotella, Office of the General Counsel, NASA Headquarters, telephone (202) 358–2066, fax (202) 358–4341.
NASA Policy Directive NPD 2000.1F, “Authority to Take Certain Actions for The General Counsel,” serves as the delegation from, and governs such delegated authority by, the General Counsel to the various designated Agency counsel to carry out such duties and responsibilities. NPD 2000.1 provides greater implementation details of the delegation as compared to 14 CFR part 1245, subpart 5. Accordingly, 14 CFR part 1245, subpart 5 is superfluous and can be eliminated.
Authority delegations (Government agencies), inventions and patents.
42 U.S.C. 2457
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander Fifth Coast Guard District has issued a temporary deviation from the regulations governing the operation of the Tacony-Palmyra Bridge (Route 73), across the Delaware River, mile 107.2 between the townships of Tacony, PA and Palmyra, NJ. The deviation is necessary to facilitate the resurfacing of the bridge roadway. This deviation reduces the vertical clearance of the bridge in the closed position by three feet and restricts operation of the draw span.
This deviation is effective from 9 p.m. on November 16, 2009, until 5 a.m. on December 23, 2009.
Documents mentioned in this preamble as being available in the docket are part of docket USCG–2009–0976 and are available online by going to
If you have questions on this rule, call or e-mail Terrance Knowles, Environmental Protection Specialist, Fifth Coast Guard District; telephone 757–398–6587, e-mail
The Burlington County Bridge Commission, who owns and operates this bascule drawbridge, has requested a temporary deviation from the current operating regulations set out in 33 CFR 117.5 and 117.716(b) to facilitate the resurfacing of the bridge roadway.
The Tacony-Palmyra Bridge (Route 73) at mile 107.2, across the Delaware River, between Tacony, PA and Palmyra, NJ, has a vertical clearance in the closed position to vessels of 53 feet above mean high water (MHW). This clearance will be reduced for safety netting by approximately three feet to 50 feet above MHW.
Under this temporary deviation, the resurfacing repairs will restrict the operation of the draw span on the following dates and times:
Closed-to-navigation each day from 9 p.m. to 5 a.m., from 9 p.m. on November 16, 2009 to 5 a.m. on November 24, 2009; and from 9 p.m. on November 30, 2009 to 5 a.m. on December 23, 2009; except vessel openings will be provided with at least four hours advance notice given to the bridge operator at (856) 829–3002 or via marine radio on Channel 13. The drawbridge will open in the event of an emergency. Vessels that can pass under the bridge without a bridge opening may do so at all times. There are no alternate routes for vessels transiting this section of the Delaware River.
The Coast Guard has coordinated the restrictions with the Delaware River Pilots Association and will inform the other users of the waterways through our Local and Broadcast Notices to Mariners of the closure periods for the bridge so that vessels can arrange their transits to minimize any impact caused by the temporary deviation.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Coast Guard, DHS.
Notice of temporary deviation from regulations.
The Commander, Eleventh Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the California Route 160 Drawbridge across Three Mile Slough, mile 0.1, near Rio Vista, CA. The deviation is necessary to allow Caltrans to conduct drawbridge maintenance. This deviation allows the bridge to remain in the closed-to-navigation position during the maintenance period.
This deviation is effective from 8 a.m. on November 18, 2009 through 4 p.m. on November 20, 2009.
Documents mentioned in this preamble as being available in the docket are part of docket USCG–2009–0967 and are available online by going to
If you have questions on this rule, call or e-mail David H. Sulouff, Chief, Bridge Section, Eleventh Coast Guard District; telephone 510–437–3516, e-mail
Caltrans requested a time extension to the temporary change to the operation of the California Route 160 Drawbridge, mile 0.1, Three Mile Slough, near Rio Vista, CA. Reference docket USCG–2009–0896. The drawbridge navigation span provides a vertical clearance of 12 feet above Mean High Water in the closed-to-navigation position. The drawbridge opens on signal as required by 33 CFR 117.5. Navigation on the waterway is commercial and recreational.
The drawbridge will be secured in the closed-to-navigation position from 8 a.m. through 4 p.m. Monday through Friday, from November 18, 2009 through November 20, 2009, to allow Caltrans to replace the industrial staircase leading to the control house. At all other times during this period, and on November 11, 2009, Veterans Day Holiday, the drawbridge will open on signal as required by 33 CFR 117.5. This temporary deviation has been coordinated with commercial and recreational waterway users. There is no anticipated levee maintenance during this deviation period. No objections to the proposed temporary deviation were raised.
Vessels that can transit the drawbridge, while in the closed-to-navigation position, may continue to do so at any time.
In the event of an emergency the drawbridge can be opened with 4 hours advance notice.
In accordance with 33 CFR 117.35(e), the drawbridge must return to its regular operating schedule immediately at the end of the designated time period. This deviation from the operating regulations is authorized under 33 CFR 117.35.
Department of Veterans Affairs.
Final rule.
The Department of Veterans Affairs (VA) is amending its Servicemembers' Group Life Insurance (SGLI) regulations in order to implement sec. 402 of the Veterans' Benefits Improvement Act of 2008. Section 402 of the Veterans' Benefits Improvement Act of 2008 extended SGLI dependent coverage to an insured member's stillborn child. This final rule defines the term “member's stillborn child.”
Greg Hosmer, Senior Attorney-Advisor, Department of Veterans Affairs Regional Office and Insurance Center (310/290B), P.O. Box 8079, Philadelphia, Pennsylvania 19101, (215) 842–2000, ext 4280. (This is not a toll free number.)
The Veterans' Survivor Benefits Improvements Act of 2001, Public Law 107–14, established a program of family insurance coverage under Servicemembers' Group Life Insurance (SGLI) through which the dependents of SGLI-insured service members could also be insured. Section 4 of Public Law 107–14 amended section 1965 of title 38, United States Code (U.S.C.), which defines various terms for SGLI purposes, to define the term “insurable dependent” as a member's spouse or a member's child (as defined in 38 U.S.C. 101(4)(A)). Section 101(4)(A) defines the term “child” in part as an unmarried person who: (1) Is under the age of 18 years; (2) became permanently incapable of self support before attaining the age of 18; or (3) after attaining the age of 18 and until completion of education or training (but not after attaining the age of 23) is pursuing a course of instruction at an approved educational institution. Under Public Law 107–14, stillborn children were not eligible for coverage under SGLI as insurable dependents. Effective October 10, 2008, section 402 of the Veterans' Benefits Improvement Act of 2008, Public Law 110–389, amended 38 U.S.C. 1965(10) to include a service member's stillborn child as an insurable dependent under the SGLI program.
We are adding to 38 CFR 9.1 a new paragraph (k) to define the term “member's stillborn child” as a member's natural child whose death occurs before expulsion, extraction, or delivery and: (1) Whose fetal weight is 350 grams or more; or (2) if the fetal weight is unknown, whose duration in utero was 20 or more completed weeks of gestation, calculated from the date the last normal menstrual period began to the date of expulsion, extraction, or delivery. Our definition of the term excludes a fetus or child extracted for purposes of an abortion.
Our definition is consistent with Congressional intent that VA issue regulations that define the term “stillborn child” consistently with the 1992 recommended reporting requirements of the Model State Vital Statistics Act and Regulations (Model Act) as drafted by the Centers for Disease Control and Prevention's National Center for Health Statistics. S. Rep. No. 110–449, at 41 (2008); Joint Explanatory Statement on Amendment to Senate Bill, S. 3023, as Amended, 154 Cong. Rec. S10,445, S10,452 (daily ed. Oct. 2, 2008). Congress did not intend the term “stillborn child” to cover the deaths of fetuses or children at any gestational age or under every circumstance. S. Rep. No. 110–449, at 41. The Model Act recommends a state reporting requirement of fetal deaths involving fetuses weighing 350 grams or more, or if weight is unknown, of 20 completed weeks or more of gestation, calculated from the date the last normal menstrual period began to the date of delivery. Model Act section 15. The Model Act defines “fetal death” to mean “death prior to the complete expulsion or extraction from its mother of a product of human conception, irrespective of the duration of pregnancy and which is not an induced termination of pregnancy. The death is indicated by the fact that[,] after such expulsion or extraction, the fetus does not breathe or show any other evidence of life, such as beating of the heart, pulsation of the umbilical cord, or definite movement of voluntary muscles. Heartbeats are to be distinguished from transient cardiac contractions; respirations are to be distinguished from fleeting respiratory efforts or gasps.” Model Act section (1)(b). We do not include in § 9.1(k) the portion of the Model Act definition that describes what indicates death because a child who is not stillborn but later dies, is already a dependent covered under SGLI. Therefore, nuanced distinctions are unnecessary. Pursuant to Congressional intent, our definition fully complies with the Model Act.
Because this final rule merely interprets a statutory term, it is an interpretive rule exempt from the prior notice-and-comment and delayed-effective-date requirements of 5 U.S.C. 553(b).
The Unfunded Mandates Reform Act of 1995 requires, at 2 U.S.C. 1532, that agencies prepare an assessment of anticipated costs and benefits before issuing any rule that may result in an expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100 million or more (adjusted annually for inflation) in any one year. This rule would have no such effect on State, local, and tribal governments, or the private sector.
This final rule contains no provisions constituting a collection of information under the Paperwork Reduction Act (44 U.S.C. 3501
Executive Order 12866 directs agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Executive Order classifies as a “significant regulatory action,” requiring review by the Office of Management and Budget (OMB) unless OMB waives such review, any regulatory action that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or
VA has examined the interagency, economic, legal, and policy implications of this final rule and has determined that it is not a significant regulatory action under the Executive Order because it merely interprets existing law and does not raise any novel legal or policy issues and will have little to no effect on the economy.
The Secretary hereby certifies that this final rule will not have a significant economic impact on a substantial number of small entities as they are defined in the Regulatory Flexibility Act, 5 U.S.C. 601
The catalog of Federal Domestic Assistance Program number and the title for this regulation is 64.103, Life Insurance for Veterans.
Life insurance, Military personnel, Veterans.
38 U.S.C. 501, 1965–1980A, unless otherwise noted.
(k)(1) The term
(i) Whose death occurs before expulsion, extraction, or delivery; and
(ii) Whose—
(A) Fetal weight is 350 grams or more; or
(B) Ff fetal weight is unknown, duration in utero is 20 completed weeks of gestation or more, calculated from the date the last normal menstrual period began to the date of expulsion, extraction, or delivery.
(2) The term does not include any fetus or child extracted for purposes of an abortion.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; reallocation.
NMFS is reallocating the projected unused amount of halibut prohibited species catch (PSC) from rockfish cooperatives in the Central Gulf of Alaska (GOA) Rockfish Pilot Program to vessels using trawl gear in the GOA. This action is necessary to provide the opportunity to vessels using trawl gear to harvest available GOA groundfish total allowable catch (TAC) under existing PSC limits.
Effective 1200 hrs, Alaska local time (A.l.t.), November 15, 2009, through 2400 hrs, A.l.t., December 31, 2009.
Steve Whitney, 907–586–7269.
NMFS manages the groundfish fishery in the GOA according to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP) prepared by the North Pacific Fishery Management Council under authority of the Magnuson-Stevens Fishery Conservation and Management Act. Regulations governing fishing by U.S. vessels in accordance with the FMP appear at subpart H of 50 CFR part 600 and 50 CFR part 679.
The 2009 allocation of halibut PSC to vessels using trawl gear in the GOA is 2,000 metric tons (mt) as established by the final 2009 and 2010 harvest specifications for groundfish in the GOA (74 FR 7333, February 17, 2009). Under § 679.81(c)(1), 170 mt of halibut PSC is allocated to catcher/processor and catcher vessel rockfish cooperatives in the Central GOA. The website at
As of November 9, 2009, the Administrator, Alaska Region, NMFS (Regional Administrator), has determined that rockfish cooperatives in the Central GOA have not used 139 mt of the allocation. Therefore, in accordance with § 679.21(d)(5)(iii)(B)(
Therefore, the harvest specifications for halibut PSC are revised as follows: 31 mt to rockfish cooperatives in the Central GOA and 1,969 mt to vessels using trawl gear.
This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA (AA), finds good cause to waive the requirement to provide prior notice and opportunity for public comment pursuant to the authority set forth at 5 U.S.C. 553(b)(B) as such requirement is impracticable and contrary to the public interest. This requirement is impracticable and contrary to the public interest as it would prevent NMFS from responding to the most recent fisheries data in a timely fashion and would delay the reallocation of projected unused amounts of halibut PSC in the GOA. NMFS was unable to publish a notice providing time for public comment because the most recent, relevant data only became available as of November 9, 2009.
The AA also finds good cause to waive the 30-day delay in the effective date of this action under 5 U.S.C. 553(d)(3). This finding is based upon the reasons provided above for waiver of prior notice and opportunity for public comment.
16 U.S.C. 1801
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for the products listed above that would supersede an existing AD. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
The heating capability of several Angle Of Attack (AOA) transducer heating elements removed from in-service aircraft have been found to be below the minimum requirement. Also, it was discovered that a large number of AOA transducers repaired in an approved maintenance facility were not calibrated accurately.
Inaccurate calibration of the AOA transducer and/or degraded AOA transducer heating elements can result in early or late activation of the stall warning, stick shaker and stick pusher by the Stall Protection Computer (SPC).
We must receive comments on this proposed AD by January 4, 2010.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Bombardier, Inc., 400 Côte-Vertu Road West, Dorval, Québec H4S 1Y9, Canada; telephone 514–855–5000; fax 514–855–7401; e-mail
You may examine the AD docket on the Internet at
Wing Chan, Aerospace Engineer, Systems and Flight Test Branch, ANE–172, FAA, New York Aircraft Certification Office, 1600 Stewart Avenue, Suite 410, Westbury, New York 11590; telephone (516) 228–7311; fax (516) 794–5531.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We have lengthened the 30-day comment period for proposed ADs that address MCAI originated by aviation authorities of other countries to provide adequate time for interested parties to submit comments. The comment period for these proposed ADs is now typically 45 days, which is consistent with the comment period for domestic transport ADs.
We will post all comments we receive, without change, to
On February 5, 2009, we issued AD 2009–04–11, Amendment 39–15817 (74 FR 7789, February 20, 2009). That AD required actions intended to address an unsafe condition on the products listed above.
Note 1 of AD 2009–04–11 stated that we were differing from Canadian Airworthiness Directive CF–2008–35, dated December 22, 2008, by not including or requiring certain actions that have planned compliance times that would allow enough time to provide notice and opportunity for prior public comment on the merits of those actions. We were considering further rulemaking at that time to address the unsafe condition. Since then, we have determined that further rulemaking is necessary and are proposing to mandate a one-time inspection of certain angle of attack (AOA) transducers, replacement of transducers having certain serial numbers, repetitive inspections of the inrush current for certain AOA transducers, and replacement of inaccurately calibrated AOA transducers.
Bombardier has issued Service Bulletin 601R–27–154, dated December 1, 2008. The actions described in this service information are intended to
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.
We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD.
Based on the service information, we estimate that this proposed AD would affect about 613 products of U.S. registry.
The actions that are required by AD 2009–04–11 and retained in this proposed AD take about 1 work-hour per product, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the currently required actions is $80 per product.
We estimate that it would take about 1 work-hour per product to comply with the new basic requirements of this proposed AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $49,040, or $80 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing Amendment 39–15817 (74 FR 7789, February 20, 2009) and adding the following new AD:
(a) We must receive comments by January 4, 2010.
(b) The proposed AD supersedes AD 2009–04–11, Amendment 39–15817.
(c) This AD applies to Bombardier Model CL–600–2B19 (Regional Jet Series 100 & 440) airplanes, serial numbers 7003 and subsequent, certificated in any category, that are equipped with Thales angle of attack (AOA) transducers having part number (P/N) 45150340 or C16258AA.
(d) Air Transport Association (ATA) of America Code 27: Flight controls.
(e) The mandatory continued airworthiness information (MCAI) states:
The heating capability of several Angle Of Attack (AOA) transducer heating elements removed from in-service aircraft have been found to be below the minimum requirement. Also, it was discovered that a large number of AOA transducers repaired in an approved maintenance facility were not calibrated accurately.
Inaccurate calibration of the AOA transducer and/or degraded AOA transducer heating elements can result in early or late activation of the stall warning, stick shaker and stick pusher by the Stall Protection Computer (SPC).
This [Canadian] directive mandates a periodic inspection of the inrush current to verify the AOA heating capability and replacement of the inaccurately calibrated AOA transducers.
(f) Unless already done, do the following actions:
(1) For airplanes equipped with a transducer having accumulated more than 7,500 total flight hours as of March 9, 2009 (the effective date of AD 2009–04–11): Within 250 flight hours after March 9, 2009, measure the inrush current of both AOA transducers in accordance with Part A of the Accomplishment Instructions of Bombardier Service Bulletin 601R–27–153, Revision A, dated December 16, 2008.
(i) If both AOA transducers are found to have an inrush current of 1.60 amps or more, repeat the measurement thereafter at intervals not to exceed the applicable interval specified in Table 1 of this AD. Do the measurement in accordance with Part A of the Accomplishment Instructions of Bombardier Service Bulletin 601R–27–153, Revision A, dated December 16, 2008.
(ii) If one AOA transducer is found to have an inrush current below 1.60 amps, and the other AOA transducer is found to have an inrush current of 1.60 amps or more: Do the actions required by paragraphs (f)(1)(ii)(A) and (f)(1)(ii)(B) of this AD.
(A) For the AOA transducer having an inrush current of 1.60 amps or more: Repeat the measurement thereafter at intervals not to exceed the applicable interval specified in Table 1 of this AD. Do the measurement in accordance with Part A of the Accomplishment Instructions of Bombardier Service Bulletin 601R–27–153, Revision A, dated December 16, 2008.
(B) For the AOA transducer having an inrush current below 1.60 amps (“degraded” transducer): Within 1,000 flight hours after March 9, 2009, replace that transducer in accordance with Part C of the Accomplishment Instructions of Bombardier Service Bulletin 601R–27–153, Revision A, dated December 16, 2008. At the applicable time specified in Table 1 of this AD if the degraded transducer was replaced with a serviceable transducer, or within 2,000 flight hours after replacement if the degraded transducer was replaced with a new transducer, do the measurement for that replacement transducer and repeat the measurements thereafter at intervals not to exceed the applicable interval specified in Table 1 of this AD. Do the measurement in accordance with Part A of the Accomplishment Instructions of Bombardier Service Bulletin 601R–27–153, Revision A, dated December 16, 2008.
(iii) If both AOA transducers are found to have an inrush current below 1.60 amps, do the action specified in paragraph (f)(1)(iii)(A) or (f)(1)(iii)(B) of this AD.
(A) Before further flight, replace one of the degraded AOA transducers with a new or serviceable transducer; and replace the other degraded transducer with a new or serviceable transducer within 1,000 flight hours after the measurement required by paragraph (f)(1) of this AD; in accordance with Part C of the Accomplishment Instructions of Bombardier Service Bulletin 601R–27–153, Revision A, dated December 16, 2008. At the applicable time specified in Table 1 of this AD, if the degraded transducer was replaced with a serviceable transducer; or within 2,000 flight hours after replacement if the degraded transducer was replaced with a new transducer: Do the measurement for that replacement transducer and repeat the measurement thereafter at intervals not to exceed the applicable interval specified in Table 1 of this AD. Do the measurements in accordance with Part A of the Accomplishment Instructions of Bombardier Service Bulletin 601R–27–153, Revision A, dated December 16, 2008.
(B) Within 1,000 flight hours after the measurement required by paragraph (f) of this AD, replace both degraded AOA transducers with new or serviceable transducers in accordance with Part C of the Accomplishment Instructions of Bombardier Service Bulletin 601R–27–153, Revision A, dated December 16, 2008. Until the replacement is done, dispatch with two degraded AOA transducers is allowed, provided that the applicable Limitations section of the airplane flight manual (AFM) is revised to include the following statement or a copy of this AD is inserted into the applicable Limitations section of the AFM.
“Dispatch is allowed if:
(a) Operations are not conducted in visible moisture (including standing water and slush) in any form,
(b) Operations are not conducted in known or forecast icing conditions,
(c) Both Ice Detection Systems are operative; and,
(d) Operations are conducted in day VMC conditions only.”
(2) If, during any repetitive measurement required by paragraphs (f)(1)(i), (f)(1)(ii), and (f)(1)(iii) of this AD, any AOA transducer is found to have an inrush current below 1.60 amps, before further flight, replace that transducer in accordance with Part C of the Accomplishment Instructions of Bombardier Service Bulletin 601R–27–153, Revision A, dated December 16, 2008. At the applicable time specified in Table 1 of this AD, if the degraded transducer was replaced with a serviceable transducer; or within 2,000 flight hours after replacement if the degraded transducer was replaced with a new transducer: Do the measurement for that replacement transducer as specified in paragraph (f)(1)(ii)(B) of this AD and repeat the measurement thereafter at intervals not to exceed the applicable interval specified in Table 1 of this AD.
(3) Actions done before March 9, 2009, in accordance with Bombardier Service Bulletin 601R–27–153, dated October 17, 2008, are acceptable for compliance with the corresponding requirements of paragraphs (f)(1) and (f)(2) of this AD.
(g) Unless already done, do the following actions.
(1) For airplanes equipped with a transducer having accumulated 7,500 or fewer flight hours as of March 9, 2009, except transducers that have been measured in accordance with paragraph (f)(1) of this AD: Do the actions specified in paragraph (f)(1) of this AD before the transducer accumulates 7,500 total flight hours, or within 500 flight hours after the effective date of this AD, whichever occurs later.
(2) Within 900 flight hours after the effective date of this AD, inspect AOA transducers having P/N 45150340 or C16258AA to determine the serial numbers.
(i) If the serial number is not identified in paragraph 1.A.(1) of Bombardier Service Bulletin 601R–27–154, dated December 1, 2008, no further action is required by this paragraph.
(ii) If the part number and serial number are identified in one of the tables in paragraph 1.A.(1) of Bombardier Service Bulletin 601R–27–154, dated December 1, 2008, and have the suffix “A,” no further action is required by this paragraph.
Bombardier Service Bulletin 601R–27–154, dated December 1, 2008, references Thales Avionics Service Bulletins 45150340–31–004 and C16258A–27–002, both dated November 28, 2008, as additional sources of information for part and serial number information.
(iii) If the part number and serial number are identified in a table in paragraph 1.A.(1) of Bombardier Service Bulletin 601R–27–154, dated December 1, 2008, before further flight, replace the AOA transducer with a new or serviceable transducer, in accordance with the Accomplishment Instructions of Bombardier Service Bulletin 601R–27–154, dated December 1, 2008.
(3) As of the effective date of this AD, no person may install a replacement AOA transducer having P/N 45150340 or P/N C16258AA with a serial number identified in paragraph 1.A.(1) of Bombardier Service Bulletin 601R–27–154, dated December 1, 2008, unless the serial number has the suffix “A.”
This AD differs from the MCAI and/or service information as follows: No Differences.
(h) The following provisions also apply to this AD:
(1)
(2)
(3)
(i) Refer to MCAI Canadian Airworthiness Directive CF–2008–35, dated December 22, 2008; Bombardier Service Bulletin 601R–27–154, dated December 1, 2008; and Bombardier Service Bulletin 601R–27–153, Revision A, dated December 16, 2008; for related information.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to adopt a new airworthiness directive (AD) for the products listed above that would supersede an existing AD. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
Following the occurrence of cracks on the MLG [main landing gear] rib 5 RH [right-hand] and LH [left-hand] attachment fitting lower flanges, DGAC [Direction Générale de l'Aviation Civile] France AD 2003–318(B) [parallel to part of FAA AD 2006–12–13] was issued to require repetitive inspections and, as terminating action * * *[.]
Subsequently, new cases of cracks were discovered during scheduled maintenance checks by operators of A300B4 and A300–600 type aeroplanes on which the terminating action * * * [was] embodied. This condition, if not corrected, could affect the structural integrity of those aeroplanes.
We must receive comments on this proposed AD by January 4, 2010.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Airbus SAS—EAW (Airworthiness Office), 1 Rond Point Maurice Bellonte, 31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61 93 44 51; e-mail:
You may examine the AD docket on the Internet at
Dan Rodina, Aerospace Engineer, International Branch, ANM–116, Transport Airplane Directorate, FAA, 1601 Lind Avenue, SW., Renton, Washington 98057–3356; telephone (425) 227–2125; fax (425) 227–1149.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We have lengthened the 30-day comment period for proposed ADs that address MCAI originated by aviation authorities of other countries to provide adequate time for interested parties to submit comments. The comment period for these proposed ADs is now typically 45 days, which is consistent with the comment period for domestic transport ADs.
We will post all comments we receive, without change, to
On May 31, 2006, we issued AD 2006–12–13, Amendment 39–14639 (71 FR 33994, June 13, 2006). That AD required actions intended to address an unsafe condition on the products listed above.
Since we issued AD 2006–12–13, the European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European
Following the occurrence of cracks on the MLG [main landing gear] rib 5 RH [right-hand] and LH [left-hand] attachment fitting lower flanges, DGAC [Direction Générale de l'Aviation Civile] France AD 2003–318(B) [parallel to part of FAA AD 2006–12–13] was issued to require repetitive inspections and, as terminating action, the embodiment of Airbus Service Bulletins (SB) A300–57–0235 and A300–57–6088 * * *.
Subsequently, new cases of cracks were discovered during scheduled maintenance checks by operators of A300B4 and A300–600 type aeroplanes on which the terminating action SBs were embodied. This condition, if not corrected, could affect the structural integrity of those aeroplanes.
To address and correct this condition, Airbus developed an inspection programme for aeroplanes modified in accordance with SB A300–57–0235 or A300–57–6088. This inspection programme was required to be implemented by DGAC France AD F–2005–113, original issue and later revision 1 [parallel to part of FAA AD 2006–12–13].
A new EASA AD 2008–0111, superseding DGAC France AD F–2005–113R1, was issued to reduce the applicability. For aeroplanes already compliant with DGAC France AD F–2005–113R1, no further action was required.
Since EASA AD 2008–0111 issuance, Airbus reviewed the inspection programmes of SB A300–57A0246 and SB A300–57A6101 to introduce repetitive inspections including a new inspection technique for holes 47 and 54 and to reduce inspections threshold and intervals from 700 Flight Cycles (FC) to 400 FC until a revised terminating action is made available.
Airbus has issued Mandatory Service Bulletin A300–57A0246, including Appendixes 1 and 2, Revision 03, dated March 11, 2009; and Mandatory Service Bulletin A300–57A6101, including Appendixes 1 and 2, Revision 03, dated March 11, 2009. The actions described in this service information are intended to correct the unsafe condition identified in the MCAI.
This proposed AD would retain certain requirements of AD 2006–12–13. Since AD 2006–12–13 was issued, the AD format has been revised, and certain paragraphs have been rearranged. As a result, the corresponding paragraph identifiers have changed in this proposed AD, as listed in the following table:
We have also revised paragraph (i) of this NPRM to clarify the compliance times for airplanes that have not had the modification required by paragraph (i) of this NPRM accomplished before July 18, 2006. We added the phrase, “Except as required by paragraph (l) of this AD,” to paragraph (i) of this NPRM. We have determined that this change will neither increase the economic burden on any operator nor increase the scope of the AD.
We have also revised paragraph (o) of this AD to specify that no reporting is required.
This product has been approved by the aviation authority of another country, and is approved for operation in the United States. Pursuant to our bilateral agreement with the State of Design Authority, we have been notified of the unsafe condition described in the MCAI and service information referenced above. We are proposing this AD because we evaluated all pertinent information and determined an unsafe condition exists and is likely to exist or develop on other products of the same type design.
We have reviewed the MCAI and related service information and, in general, agree with their substance. But we might have found it necessary to use different words from those in the MCAI to ensure the AD is clear for U.S. operators and is enforceable. In making these changes, we do not intend to differ substantively from the information provided in the MCAI and related service information.
We might also have proposed different actions in this AD from those in the MCAI in order to follow FAA policies. Any such differences are highlighted in a NOTE within the proposed AD.
Based on the service information, we estimate that this proposed AD would affect about 155 products of U.S. registry.
The actions that are required by AD 2006–12–13 and retained in this proposed AD take about 76 work-hours per product, at an average labor rate of $80 per work hour. Required parts cost about $10,270 per product. Based on these figures, the estimated cost of the currently required actions is $16,350 per product.
We estimate that it would take about 3 work-hours per product to comply with the new basic requirements of this proposed AD. The average labor rate is $80 per work-hour. Based on these figures, we estimate the cost of the proposed AD on U.S. operators to be $37,200, or $240 per product.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify this proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative,
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing Amendment 39–14639 (71 FR 33994, June 13, 2006) and adding the following new AD:
(a) We must receive comments by January 4, 2010.
(b) The proposed AD supersedes AD 2006–12–13, Amendment 39–14639.
(c) This AD applies to the airplanes, certificated in any category, identified in paragraph (c)(1) and (c)(2) of this AD; except airplanes on which Airbus Modification 11912 or 11932 has been installed.
(1) Airbus Model A300 B2–1C, B2K–3C, B2–203, B4–2C, B4–103, and B4–203 airplanes.
(2) Airbus Model A300 B4–601, B4–603, B4–620, B4–622, B4–605R, B4–622R, and F4–605R airplanes.
(d) Air Transport Association (ATA) of America Code 57: Wings.
(e) The mandatory continuing airworthiness information (MCAI) states:
Following the occurrence of cracks on the MLG [main landing gear] rib 5 RH [right-hand] and LH [left-hand] attachment fitting lower flanges, DGAC [Direction Générale de l'Aviation Civile] France AD 2003–318(B) [parallel to part of FAA AD 2006–12–13] was issued to require repetitive inspections and, as terminating action, the embodiment of Airbus Service Bulletins (SB) A300–57–0235 and A300–57–6088 * * *.
Subsequently, new cases of cracks were discovered during scheduled maintenance checks by operators of A300B4 and A300–600 type aeroplanes on which the terminating action SB's were embodied. This condition, if not corrected, could affect the structural integrity of those aeroplanes.
To address and correct this condition, Airbus developed an inspection programme for aeroplanes modified in accordance with SB A300–57–0235 or A300–57–6088. This inspection programme was required to be implemented by DGAC France AD F–2005–113, original issue and later revision 1 [parallel to part of FAA AD 2006–12–13].
A new EASA [European Aviation Safety Agency] AD 2008–0111, superseding DGAC France AD F–2005–113R1, was issued to reduce the applicability. For aeroplanes already compliant with DGAC France AD F–2005–113R1, no further action was required.
Since EASA AD 2008–0111 issuance, Airbus reviewed the inspection programmes of SB A300–57A0246 and SB A300–57A6101 to introduce repetitive inspections including a new inspection technique for holes 47 and 54 and to reduce inspections threshold and intervals from 700 Flight Cycles (FC) to 400 FC until a revised terminating action is made available.
Required actions include contacting Airbus for repair instructions, if necessary, and doing the repair.
(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(g) Perform a detailed inspection and a high-frequency eddy current (HFEC) inspection to detect cracks in Gear Rib 5 of the main landing gear (MLG) attachment fittings at the lower flange, in accordance with the Accomplishment Instructions of any applicable service bulletin listed in Table 1 and Table 2 of this AD, at the time specified in paragraph (g)(1) or (g)(2) of this AD. After April 12, 2000 (the effective date of AD 2000–05–07, amendment 39–11616), only the service bulletins listed in Table 2 of this AD may be used. Repeat the inspections thereafter at intervals not to exceed 1,500 flight cycles, until the actions specified in paragraph (i), (j), or (l) of this AD are accomplished.
(1) For airplanes that have accumulated 20,000 or more total flight cycles as of March 9, 1998 (the effective date of AD 98–03–06, amendment 39–10298): Inspect within 500 flight cycles after March 9, 1998.
(2) For airplanes that have accumulated less than 20,000 total flight cycles as of March 9, 1998: Inspect prior to the accumulation of 18,000 total flight cycles, or within 1,500 flight cycles after March 9, 1998, whichever occurs later.
For the purposes of this AD, a detailed inspection is defined as: “An
Accomplishment of the initial detailed and HFEC inspections in accordance with Airbus Service Bulletin A300–57A0234 or A300–57A6087, both dated August 5, 1997, as applicable, is considered acceptable for compliance with the initial inspections required by paragraph (g) of this AD.
(h) If any crack is detected during any inspection required by paragraph (g) of this AD, prior to further flight, accomplish the requirements of paragraph (h)(1) or (h)(2) of this AD, as applicable.
(1) If a crack is detected at one hole only, and the crack does not extend out of the spotface of the hole, repair in accordance with the Accomplishment Instructions of the applicable service bulletin in Table 2 of this AD.
(2) If a crack is detected at more than one hole, or if any crack at any hole extends out of the spotface of the hole, repair in accordance with a method approved by the Manager, International Branch, ANM–116, Transport Airplane Directorate, FAA, or the European Aviation Safety Agency (EASA) (or its delegated agent).
(i) Except as required by paragraph (l) of this AD, prior to the accumulation of 21,000 total flight cycles, or within 2 years after October 20, 1999 (the effective date of AD 99–19–26, amendment 39–11313), whichever occurs later: Modify Gear Rib 5 of the MLG attachment fittings at the lower flange in accordance with the Accomplishment Instructions of the applicable service bulletin in Table 3 of this AD. After July 18, 2006 (the effective date of AD 2006–12–13), only Revision 04 of Airbus Service Bulletin A300–57–6088, and Revisions 04 and 05 of Airbus Service Bulletin A300–57–0235 may be used. Accomplishment of this modification constitutes terminating action for the repetitive inspection requirements of paragraphs (g) and (j) of this AD.
Accomplishment of the modification required by paragraph (i) of this AD prior to April 12, 2000, in accordance with Airbus Service Bulletin A300–57–6088 or A300–57–0235, both dated August 5, 1998; as applicable; is acceptable for compliance with the requirements of that paragraph.
(j) For airplanes on which the modification specified in paragraph (i) or (l) of this AD has not been done before July 18, 2006 (the effective date of AD 2006–12–13, amendment 39–14639), perform a detailed and an HFEC inspection to detect cracks of the lower flange of Gear Rib 5 of the MLG at holes 43, 47, 48, 49, 50, 52, and 54, in accordance with the applicable service bulletin listed in Table 4 of this AD. Perform the inspections at the applicable time specified in paragraph (j)(1), (j)(2), (j)(3), or (j(4) of this AD. Repeat the inspections thereafter at intervals not to exceed 700 flight cycles until the terminating modification required by paragraph (l) of this AD is accomplished. Accomplishment of the inspections per paragraph (j) of this AD terminates the inspection requirements of paragraph (g) of this AD.
(1) For Model A300 B2–1A, B2–1C, B2K–3C, B2–203, B4–2C, B4–103, and B4–203 airplanes; Model A300 B4–601, B4–603, B4–620, B4–622, B4–605R, B4–622R, F4–605R, F4–622R, and C4–605R Variant F airplanes; and Model C4–605R Variant F airplanes that have accumulated 18,000 or more total flight cycles as of July 18, 2006: Within 700 flight cycles after July 18, 2006.
(2) For Model A300 B2–1A, B2–1C, B2K–3C, and B2–203 airplanes that have accumulated less than 18,000 total flight cycles as of July 18, 2006: Prior to the accumulation of 18,000 total flight cycles, or within 700 flight cycles after July 18, 2006, whichever occurs later.
(3) For Model A300 B4–2C, B4–103, and B4–203 airplanes that have accumulated less than 18,000 total flight cycles as of July 18, 2006: Prior to the accumulation of 14,500 total flight cycles, or within 700 flight cycles after July 18, 2006, whichever occurs later.
(4) For Model A300 B4–601, B4–603, B4–620, B4–622, B4–605R, B4–622R, F4–605R, F4–622R, and C4–605R Variant F airplanes that have accumulated less than 18,000 total flight cycles as of July 18, 2006: Prior to the accumulation of 11,600 total flight cycles, or within 700 flight cycles after July 18, 2006, whichever occurs later.
(k) If any crack is detected during any inspection required by paragraph (j) of this AD, prior to further flight, accomplish the requirements of paragraphs (k)(1) and (k)(2) of this AD, as applicable.
(1) If a crack is detected at only one hole, and the crack does not extend out of the
(2) If a crack is detected at more than one hole, or if any crack at any hole extends out of the spotface of the hole, repair in accordance with a method approved by the Manager, International Branch, ANM–116, or the EASA (or its delegated agent).
(l) For airplanes on which the terminating modification in paragraph (i) of this AD has not been accomplished before July 18, 2006: At the earlier of the times specified in paragraphs (l)(1) and (l)(2) of this AD, modify Gear Rib 5 of the MLG attachment fittings at the lower flange. Except as provided by paragraph (m) of this AD, do the modification in accordance with the applicable service bulletin in Table 5 of this AD. This action terminates the repetitive inspections requirements of paragraphs (g) and (j) of this AD.
(1) Prior to the accumulation of 21,000 total flight cycles, or within 2 years after October 20, 1999, whichever is later.
(2) Within 16 months after July 18, 2006.
(m) Where the applicable service bulletin in paragraph (l) of this AD specifies to contact Airbus for modification instructions; or if there is a previously installed repair at any of the affected fastener holes; or if a crack is found when accomplishing the modification: Prior to further flight, modify in accordance with a method approved by the Manager, International Branch, ANM–116, or the EASA (or its delegated agent).
(n) Actions accomplished before July 18, 2006, in accordance with the service bulletins listed in Table 6 of this AD, are considered acceptable for compliance with the corresponding action specified in paragraphs (g) through (m) of this AD.
(o) Although the service bulletins identified in Tables 1, 2, 3, 4, 5, and 6 of this AD specify to submit certain information to the manufacturer, this AD does not include such a requirement.
(p) Unless already done, do the following actions.
(1) At the applicable time specified in paragraph (p)(2) of this AD, perform a detailed inspection for cracking at the locations specified in paragraphs (p)(1)(i), (p)(1)(ii), and (p)(1)(iii) of this AD, in accordance with the Accomplishment Instructions of Airbus Mandatory Service Bulletin A300–57A0246, Revision 03, dated March 11, 2009; or Airbus Mandatory Service Bulletin A300–57A6101, Revision 03, dated March 11, 2009, as applicable.
(i) The bottom flange and vertical web in the area between the wing rear spar/gear rib 5 attachment and the forward reaction-rod pick-up lug.
(ii) On the inboard side, around the fastener holes at locations 43, 47 to 50, 52, and 54.
(iii) On the outboard side, the lower flange, the vertical web and around the fastener holes at locations 43, 47 to 50, 52 and 54.
(2) Do the inspection required by paragraph (p)(1) of this AD at the later of the times in paragraphs (p)(2)(i) and (p)(2)(ii) of this AD.
(i) Within 400 flight cycles after the accomplishment of the actions required by paragraph (i) or (l) of this AD, as applicable.
(ii) Within 400 flight cycles or 4 months after the effective date of this AD, whichever occurs first.
(3) If no cracking is detected during the inspection required by paragraph (p)(1) of this AD, before further flight, perform a fluorescent penetrant inspection (FPI) at holes location 47 and 54, in the right-hand and left-hand MLG rib 5 attachment fitting lower flange, in accordance with the Accomplishment Instructions of Airbus Mandatory Service Bulletin A300–57A0246, Revision 03, dated March 11, 2009; or Airbus Mandatory Service Bulletin A300–57A6101, Revision 03, dated March 11, 2009; as applicable.
(4) Thereafter, at intervals not to exceed 400 flight cycles, repeat the detailed and FPI inspections, in accordance with the Accomplishment Instructions of Airbus Mandatory Service Bulletin A300–57A0246, Revision 03, dated March 11, 2009; or Airbus Mandatory Service Bulletin A300–57A6101, Revision 03, dated March 11, 2009; as applicable.
(5) If any crack is detected during any of the inspections required by paragraphs (p)(1), (p)(3), and (p)(4) of this AD, before further flight, contact Airbus for a repair solution, and do the repair.
This AD differs from the MCAI and/or service information as follows: No differences.
(q) The following provisions also apply to this AD:
(1)
(2)
(r) Refer to MCAI EASA Airworthiness Directive 2009–0081, dated April 6, 2009, and the service information in Table 7 of this AD.
Federal Aviation Administration (FAA), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
The FAA proposes to supersede an existing airworthiness directive (AD) that applies to certain Boeing Model 747 series airplanes. The existing AD currently requires repetitive inspections to detect cracking in certain fuselage skin lap joints, and repair if necessary. This proposed AD would expand the inspection area in the existing AD, add a modification of certain lap joints, and add certain post-repair inspections of the lap joints. Accomplishing the modification would end the repetitive inspections required by the existing AD for the length of lap joint that is modified. This proposed AD results from a structural review of affected skin lap joints for widespread fatigue damage. We are proposing this AD to prevent fatigue cracking in certain lap joints, which could result in rapid depressurization of the airplane.
We must receive comments on this proposed AD by January 4, 2010.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this proposed AD, contact Boeing Commercial Airplanes,
You may examine the AD docket on the Internet at
Ivan Li, Aerospace Engineer, Airframe Branch, ANM–120S, FAA, Seattle Aircraft Certification Office, 1601 Lind Avenue, SW., Renton, Washington 98057–3356; telephone (425) 917–6437; fax (425) 917–6590.
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On May 31, 1994, we issued AD 94–12–04, Amendment 39–8932 (59 FR 30277, June 13, 1994), for certain Boeing Model 747 series airplanes. That AD requires repetitive inspections to detect cracking in certain fuselage skin lap joints, and repair, if necessary. That AD was prompted by the results of extensive pressure fatigue tests conducted by the manufacturer. We issued that AD to detect and repair fatigue cracking in certain lap joints, which will ensure safe operation of airplanes that have exceeded their economic design goal.
Since we issued AD 94–12–04, the manufacturer has conducted a structural review of affected skin lap joints for widespread fatigue damage, and has identified additional inspection and modification requirements. It was determined that it is necessary to inspect lap joints with an upper skin thickness of 0.09 inch in addition to the areas inspected in accordance with the existing AD. For Model 747SP airplanes, the skin lap joints in Section 44 are also included in those inspections. It was determined that lap joints in Sections 41 and 42 with an upper skin thickness of 0.071 inch or less should be modified; and post-repair inspections are necessary.
We have reviewed Boeing Alert Service Bulletin 747–53A2367, Revision 2, dated October 30, 2008 (“Revision 2 of the service bulletin”); and Boeing Service Bulletin 747–53A2367, Revision 3, dated January 15, 2009 (“Revision 3 of the service bulletin”). We referred to Boeing Service Bulletin 747–53–2367, dated December 18, 1991 (“the original issue of the service bulletin”); and Boeing Service Bulletin 747–53–2367, Revision 1, dated January 27, 1994 (“Revision 1 of the service bulletin”); as the appropriate sources of service information for accomplishing the actions required by AD 94–12–04.
Revisions 2 and 3 of the service bulletin retain the procedures described in the original issue of the service bulletin and Revision 1 of the service bulletin; however, those revisions add procedures for a new inspection area (Area 2) in Sections 41, 42, 44, and 46. Revisions 2 and 3 of the service bulletin also add procedures for a modification of the lap joints in Sections 41 and 42 for Groups 1, 2, 4, 5, and 7 through 10 airplanes. For airplanes on which any crack is found during the external surface high frequency eddy current (HFEC) inspection, the related investigative action is doing an open-hole HFEC inspection before further flight for further cracking; and for airplanes on which any crack is found, during that inspection, the corrective action is repairing the crack before further flight.
The compliance time for accomplishing the new Area 2 inspections is before the accumulation of 22,000 total flight cycles, or within 3,000 flight cycles after the last HFEC inspection of the area (as specified in the Boeing Model 747 Supplemental Structural Inspection Document), or within 1,000 flight cycles from the date on Revision 2 of the service bulletin, whichever occurs latest.
The compliance time for accomplishing the inspections in Section 41 at stringer 6 for Groups 2, 4, 8, and 9 airplanes not affected by Boeing Service Bulletin 747–53–2253 is within 10,000 flight cycles after doublers are installed per Boeing Service Bulletin 747–53–2272. These requirements are specified in AD 2008–10–15, Amendment 39–15522 (73 FR 29042, May 20, 2008).
For areas on which a lap joint repair was installed and the repair doubler is greater than or equal to 40 inches long, Revision 3 of the service bulletin describes procedures for repetitive internal surface HFEC inspections for cracks. The compliance time for accomplishing the initial inspection is within 15,000 flight cycles after the repair was installed.
Revision 3 of the service bulletin specifies repeating the applicable inspection at intervals not to exceed 3,000 flight cycles, or at intervals not to exceed 1,500 flight cycles for airplanes that have accumulated 30,000 total flight cycles or more. For Group 7, 8, and 9 airplanes, the inspections of the lap joints in Section 46 at stringer 4 left, between body stations 1720 and 1740, and between body stations 1960 and 1980, are repeated at intervals not to exceed 1,500 flight cycles.
For all airplanes, the compliance time for accomplishing the lap joint modification is before the accumulation of 30,000 total flight cycles, or within 3,000 flight cycles from the date of Revision 2 of the service bulletin, whichever is later. Accomplishing this modification eliminates the need for the repetitive inspections for the length of lap joint that is modified.
Revision 3 of the service bulletin also specifies that no lap joint modification instructions are included for Groups 3 and 6 airplanes and recommends contacting Boeing for modification instructions.
We have evaluated all pertinent information and identified an unsafe condition that is likely to develop on other airplanes of the same type design. For this reason, we are proposing this AD, which would supersede AD 94–12–04 and would retain the requirements of the existing AD. This proposed AD would also require accomplishing the actions specified in the service information described previously, except as discussed under “Differences Between the Proposed AD and Service Information.”
Revision 3 of the service bulletin specifies to contact the manufacturer for instructions on how to repair or modify certain conditions, but this proposed AD would require those conditions be done in one of the following ways:
• Using a method that we approve; or
• Using data that meet the certification basis of the airplane, and that have been approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization whom we have authorized to make those findings.
Revision 3 of the service bulletin recommends that the modification be done before the accumulation of 30,000 total flight cycles or within 3,000 flight cycles after the release date of Revision 2 of the service bulletin, “whichever is earlier.” However, the manufacturer has informed us that an error was made in that compliance time and it should specify “whichever occurs later.” The correct compliance time is specified in paragraph (j) of this AD.
This proposed AD would retain all requirements of AD 94–12–04. Since that AD was issued, the AD format has been revised, and certain paragraphs have been rearranged. As a result, the corresponding paragraph identifiers have changed in this proposed AD, as listed in the following table:
We have also revised paragraph (g)(2)(i) of this AD (paragraph (c)(1) of AD 94–12–04) to remove reference to Chapter 53–30–03 of the Boeing 747 Structural Repair Manual (SRM). Instead, that paragraph instructs operators to contact the FAA for repair instructions. We have also added a new Note 1 to specify that guidance on repairing any subject cracking can be found in Chapter 53–30–03 of the Boeing 747 SRM.
There are about 209 airplanes of the affected design in the worldwide fleet. This proposed AD would affect about 69 airplanes of U.S. registry.
The actions that are required by AD 94–12–04 and retained in this proposed AD take about 14 work hours per airplane, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the currently required actions is $1,120 per airplane, per inspection cycle.
The new proposed Area 2 inspections would take about 477 work hours per airplane, depending on airplane configuration, at an average labor rate of $80 per work hour. Based on these figures, the estimated cost of the new actions specified in this proposed AD for U.S. operators is between $38,160 and $2,633,040, or between $2,400 and $3,840 per airplane, per inspection cycle.
The new proposed modification would take about 171 work hours per airplane, at an average labor rate of $80 per work hour. Required parts cost per airplane would be minimal. Based on these figures, the estimated cost of the new actions specified in this proposed AD for U.S. operators is $943,920, or $13,680, per airplane.
Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, Section 106, describes the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the Agency's authority.
We are issuing this rulemaking under the authority described in Subtitle VII, Part A, Subpart III, Section 44701, “General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.
For the reasons discussed above, I certify that the proposed regulation:
1. Is not a “significant regulatory action” under Executive Order 12866;
2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979); and
3. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
We prepared a regulatory evaluation of the estimated costs to comply with this proposed AD and placed it in the AD docket.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing Amendment 39–8932 (59 FR 30277, June 13, 1994) and adding the following new AD:
(a) The FAA must receive comments on this AD action by January 4, 2010.
(b) This AD supersedes AD 94–12–04, Amendment 39–8932.
(c) This AD applies Boeing Model 747–100, 747–100B, 747–100B SUD, 747–200B, 747–300, 747SR, and 747SP series airplanes, certificated in any category, as identified in Boeing Service Bulletin 747–53A2367, Revision 3, dated January 15, 2009.
(d) Air Transport Association (ATA) of America Code 53: Fuselage.
(e) This AD results from a structural review of affected skin lap joints for widespread fatigue damage. The Federal Aviation Administration is issuing this AD to prevent fatigue cracking in certain lap joints which could result in rapid depressurization of the airplane.
(f) You are responsible for having the actions required by this AD performed within the compliance times specified, unless the actions have already been done.
(g) For airplanes identified in Boeing Service Bulletin 747–53–2367, dated December 18, 1991: Prior to the accumulation of 22,000 full pressure flight cycles (or, if the external skin panel of an affected lap joint has been replaced, prior to the accumulation of 22,000 full pressure flight cycles since skin replacement), or within 1,000 landings after July 13, 1994 (the effective date of AD 94–12–04), whichever occurs later, perform an external surface high frequency eddy current (HFEC) inspection of the skin around the upper row of fasteners, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 747–53–2367, dated December 18, 1991; Revision 1, dated January 27, 1994; Boeing Alert Service Bulletin 747–53A2367, Revision 2, dated October 30, 2008; or Boeing Service Bulletin 747–53A2367, Revision 3, dated January 15, 2009. As of the effective date of this AD, only Revision 3 of the service bulletin may be used.
(1) If no crack is found, repeat the inspection thereafter at intervals not to exceed 3,000 full pressure flight cycles until the inspections required by paragraph (h) of this AD are done.
(2) If any crack is found, accomplish paragraphs (g)(2)(i) and (g)(2)(ii) of this AD.
(i) Prior to further flight, perform an open hole HFEC inspection to detect cracking in the upper row fastener holes between the adjacent frames, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 747–53–2367, dated December 18, 1991; Revision 1, dated January 27, 1994; Boeing Alert Service Bulletin 747–53A2367, Revision 2, dated October 30, 2008; or Boeing Service Bulletin 747–53A2367, Revision 3, dated January 15, 2009. Prior to further flight, repair any crack found, in accordance with a method approved by the
Guidance on repairing cracking can be found in Chapter 53–30–03 of the Boeing 747 Structural Repair Manual.
(ii) Repeat the inspection required by paragraph (g) of this AD thereafter at intervals not to exceed 3,000 full pressure flight cycles until the inspections required by paragraph (h) of this AD are done.
(h) For all airplanes: Do initial and repetitive HFEC inspections for cracks of lap joints in Sections 41, 42, 44, and 46, by doing all the actions, including all applicable related investigative and corrective actions, specified in the Accomplishment Instructions of Boeing Service Bulletin 747–53A2367, Revision 3, dated January 15, 2009, except as provided by paragraph (l) of this AD. Do the inspections at the applicable times specified in paragraph 1.E. of Boeing Service Bulletin 747–53A2367, Revision 3, dated January 15, 2009, except as required by paragraph (k) of this AD. Do all applicable related investigative and corrective actions before further flight. Accomplishing the inspections required by this paragraph ends the repetitive inspections required by paragraph (g) of this AD. Do the actions required by paragraph (h) of this AD until the modification required by paragraph (j) of this AD is done.
(i) For areas on which a lap joint repair was installed and the repair doubler is greater than or equal to 40 inches long: Do initial and repetitive internal HFEC inspections for cracks, as required by paragraph (h) of this AD, by doing all the applicable actions, including applicable corrective actions, specified in the Accomplishment Instructions of Boeing Service Bulletin 747–53A2367, Revision 3, dated January 15, 2009, except as provided by paragraph (l) of this AD. Do the inspection and corrective actions at the times specified in paragraph 1.E. of Boeing Service Bulletin 747–53A2367, Revision 3, dated January 15, 2009, except as required by paragraph (k) of this AD.
(j) Before the accumulation of 30,000 total flight cycles or within 3,000 flight cycles after the effective date of this AD, whichever occurs later: Modify the applicable lap joints in Sections 41 and 42 by doing all the actions specified in the Accomplishment Instructions of Boeing Service Bulletin 747–53A2367, Revision 3, dated January 15, 2009, except as required by paragraph (l) of this AD. Accomplishing this modification terminates the repetitive inspection requirements of this AD for the length of lap joint that is modified.
(k) Where Boeing Service Bulletin 747–53A2367, Revision 3, dated January 15, 2009, specifies compliance times “from the date on the original issue of this service bulletin [12/18/91],” and “from the date on Revision 2 of this service bulletin [10/30/08],” this AD requires compliance within the specified compliance time after the effective date of this AD.
(l) Where Boeing Service Bulletin 747–53A2367, Revision 3, dated January 15, 2009, specifies to contact Boeing for repair or modification instructions: Before further flight, repair or modify using a method approved in accordance with the procedures specified in paragraph (m) of this AD.
(m)(1) The Manager, Seattle ACO, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. Send information to ATTN: Ivan Li, Aerospace Engineer, Airframe Branch, ANM–120S, FAA, Seattle ACO, 1601 Lind Avenue, SW., Renton, Washington 98057–3356; telephone (425) 917–6437; fax (425) 917–6590. Or, e-mail information to
(2) To request a different method of compliance or a different compliance time for this AD, follow the procedures in 14 CFR 39.19. Before using any approved AMOC on any airplane to which the AMOC applies, notify your principal maintenance inspector (PMI) or principal avionics inspector (PAI), as appropriate, or lacking a principal inspector, your local Flight Standards District Office. The AMOC approval letter must specifically reference this AD.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD, if it is approved by an Authorized Representative for the Boeing Commercial Airplanes Delegation Option Authorization Organization who has been authorized by the Manager, Seattle ACO, to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane, and the approval must specifically refer to this AD.
(4) AMOCs approved previously in accordance with AD 94–12–04 are approved as alternative methods of compliance with the corresponding requirements of this AD.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace at Monterey Peninsula Airport, Monterey, CA. Additional controlled airspace is necessary to accommodate aircraft using a new Area Navigation (RNAV) Required Navigation Performance (RNP) Standard Instrument Approach Procedure (SIAP) at Monterey Peninsula Airport. The FAA is proposing this action to enhance the safety and management of aircraft operations at Monterey Peninsula Airport, Monterey, CA.
Comments must be received on or before January 4, 2010.
Send comments on this proposal to the U.S. Department of Transportation, Docket Operations, M–30, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590. Telephone (202) 366–9826. You must identify FAA Docket No. FAA–2009–1030; Airspace Docket No. 09–AWP–8, at the beginning of your comments. You may also submit comments through the Internet at
Eldon Taylor, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue, SW., Renton, WA 98057; telephone (425) 203–4537.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA 2009–1030 and Airspace Docket No. 09–AWP–8) and be submitted in triplicate to the Docket Management System (see
Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA–2009–1030 and Airspace Docket No. 09–AWP–8”. The
All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (see the
Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking, (202) 267–9677, for a copy of Advisory Circular No. 11–2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace designated as surface areas at Monterey Peninsula Airport, Monterey, CA. Controlled airspace is necessary to accommodate aircraft using the new RNAV (RNP) SIAP at Monterey Peninsula Airport. This action would enhance the safety and management of aircraft operations at Monterey Peninsula Airport, Monterey, CA.
Class E airspace designations are published in paragraph 6002, of FAA Order 7400.9T, signed August 27, 2009, and effective September 15, 2009, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in this Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation; (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes the authority for the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish additional controlled airspace at Monterey Peninsula Airport, Monterey, CA.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
1. The authority citation for 14 CFR part 71 continues to read as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR 71.1 of the FAA Order 7400.9T, Airspace Designations and Reporting Points, signed August 27, 2009, and effective September 15, 2009 is amended as follows:
Within a 5-mile radius of the Monterey Peninsula Airport, and within 3 miles each side of the localizer east course extending from the 5-mile radius of Monterey Peninsula Airport to 10 miles east of the Runway 28R landing threshold, and within 3 miles each side of the localizer east course extending from the 10-mile arc to 15.2 miles east of the Runway 28R landing threshold. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective dates and times will thereafter be continuously published in the Airport/Facility Directory.
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to establish Class E airspace at Bryce Canyon Airport, Bryce Canyon, UT. Controlled airspace is necessary to accommodate aircraft using a new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedure (SIAP) at Bryce Canyon Airport, Bryce Canyon, UT. The FAA is proposing this action to enhance the safety and management of Instrument Flight Rules (IFR) aircraft operations at Bryce Canyon Airport.
Comments must be received on or before January 4, 2010.
Send comments on this proposal to the U.S. Department of
Eldon Taylor, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue, SW., Renton, WA 98057; telephone (425) 203–4537.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA 2009–1011 and Airspace Docket No. 09–ANM–19) and be submitted in triplicate to the Docket Management System (
Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA–2009–1011 and Airspace Docket No. 09–ANM–19”. The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (
Persons interested in being placed on a mailing list for future NPRM's should contact the FAA's Office of Rulemaking, (202) 267–9677, for a copy of Advisory Circular No. 11–2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) part 71 by establishing Class E airspace extending upward from 700 feet above the surface at Bryce Canyon Airport, Bryce Canyon, UT. Controlled airspace is necessary to accommodate aircraft using the new RNAV (GPS) SIAP at Bryce Canyon Airport. This action would enhance the safety and management of (IFR) operations at Bryce Canyon Airport, Bryce Canyon, UT.
Class E airspace designations are published in paragraph 6005 of FAA Order 7400.9T, signed August 27, 2009, and effective September 15, 2009, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designation listed in this document will be published subsequently in this Order.
The FAA has determined that this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation; (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified that this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle I, Section 106, describes the authority for the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it would establish controlled airspace at Bryce Canyon Airport, Bryce Canyon, UT.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
1. The authority citation for 14 CFR part 71 continues to read as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR 71.1 of the FAA Order 7400.9T, Airspace Designations and Reporting Points, signed August 27, 2009, and effective September 15, 2009 is amended as follows:
That airspace extending upward from 700 feet above the surface within 8 miles each side of the 047° and 227° bearing from the airport, extending 18 miles northeast and 15.9 miles southwest of the airport.
Postal Service
Proposed rule.
The Postal Service is revising the
We must receive your comments on or before December 18, 2009.
Mail or deliver written comments to the Manager, Mailing Standards, U.S. Postal Service, 475 L'Enfant Plaza SW., Room 3436, Washington DC 20260–3436. You may inspect and photocopy all written comments at USPS Headquarters Library, 475 L'Enfant Plaza SW., 11th Floor N, Washington DC, between 9 a.m. and 4 p.m., Monday through Friday.
C. Scot Atkins, 703–280–7841 or Carol A. Lunkins, 202–268–7262.
This proposed rule includes mailing standards for postage printed using IBI postage meters and PC Postage® products including postage generated from Click-N-Ship® service. These technologies provide convenience and ease of use for printing and payment of postage. However, sufficient revenue assurance procedures and practices must be implemented to ensure all required postage is paid.
Postage meters and PC Postage products are collectively identified as “postage evidencing systems.” A postage evidencing system is a device or system of components a customer uses to print evidence that postage required for a mailing has been paid. Postage evidencing systems print indicia, such as meter imprints or IBI, to indicate postage payment. Mailers print indicia directly on a mailpiece or on a label that is affixed to a mailpiece.
Postage meters are devices that allow download, storage, and accounting of postage through the device. Meters print indicia that may be IBI or non-IBI, to indicate postage payment. IBI are digitally generated indicia that include a two-dimensional barcode. PC Postage products are software-based and Internet-based solutions for managing postage accounts and postage payment. Mailers purchase postage using a computer and print indicia using desktop or label printers. PC Postage products print IBI indicating postage payment and may print directly onto mailpieces, shipping labels, and USPS-approved customized labels. PC Postage products are offered by USPS and USPS-approved commercial providers.
IBI postage meters and PC Postage products, available from authorized providers, allow customers to set up and manage postage accounts via a secure host site, purchase postage via a credit card or automated clearing house (ACH) transaction, and print postage on envelopes, shipping labels, or customized labels for all mail classes except Periodicals and Bound Printed Matter.
The Postal Service will use mail processing equipment and ancillary information systems to detect and capture data for mailpieces with unpaid or shortpaid IBI postage from postage evidencing systems. The Postal Service will analyze this data to ensure its validity and confirm whether sufficient postage was paid. In cases where deficient postage is confirmed, the Postal Service will notify the respective PC Postage or postage meter provider to take corrective measures to recover the appropriate postage.
IBI printed either on a shipping label or directly on a mailpiece are to be used as originally printed and are not to be counterfeited, replicated, duplicated, falsified, or otherwise modified. In addition, the IBI postage affixed to a mailpiece must be equal to or greater than the amount due for the applicable price category and associated criteria such as weight, shape, and zone. Counterfeiting, replicating, duplicating, falsifying, or otherwise modifying IBI and not affixing the applicable amount of postage result in a loss of revenue for the Postal Service, because postage is not paid for the pieces mailed. This deficiency not only affects the Postal Service but our customers as well because rising costs may result in price adjustments.
USPS® may deny a customer use of a postage evidencing system in the event of failure to comply with rules and regulations contained in the DMM, submission of false or fictitious information, and entering a series of unpaid or shortpaid mailpieces and/or packages in the mailstream.
As part of the Postal Service's ongoing effort to increase effectiveness, enhance financial control, and reduce costs, an automated process will be implemented by using mail processing equipment and ancillary information systems to detect and capture unpaid and shortpaid IBI postage on mailpieces, including pieces with postage generated from Click-N-Ship service. This automated process will supplement and enhance our current manual process.
Mailpieces with unpaid IBI postage are those for which postage is not paid due to the use of counterfeited, replicated, duplicated, falsified, or otherwise modified IBI.
Mailpieces with shortpaid postage are those for which the total of the postage affixed to a mailpiece is not equal to or greater than the amount due for the applicable price category and associated criteria such as weight, shape, and zone.
The Postal Service will analyze captured data to verify its validity and use this information to identify cases where unpaid or shortpaid IBI postage exist. Any mailpiece identified with an unpaid or shortpaid IBI may be subject to the following actions: Collection of the unpaid or shortpaid postage, debit from the customer's account, revocation of the customer's account privileges, and/or civil and criminal fines and penalties pursuant to existing federal law. Customers will work with their PC Postage or postage meter providers to address shortpaid and unpaid IBI postage disputes and appeals. The PC Postage or postage meter provider will work with the Postal Service to resolve such appeals.
Although we are exempt from the notice and comment requirements of the Administrative Procedure Act [5 U.S.C of 553(b), (c)] regarding proposed rulemaking by 39 U.S.C. 410 (a), we invite public comments on the following proposed revisions to
Administrative practice and procedure, Postal Service.
Accordingly, 39 CFR part 111 is proposed to be amended as follows:
1. The authority citation for 39 CFR part 111 continues to read as follows:
5 U.S.C. 552(a); 39 U.S.C. 101, 401, 403, 404, 414, 416, 3001–3011, 3201–3219, 3403–3406, 3621, 3622, 3626, 3632, 3633, and 5001.
2. Revise the following sections of
* * * The primary characteristics of postage meters and PC Postage products are described below.
b. PC Postage products are software-based and Internet-based solutions for managing postage accounts and postage payment. Mailers purchase postage using a computer and print indicia using desktop or label printers. PC Postage products print information-based indicia (IBI) indicating postage payment and may print directly onto mailpieces, shipping labels, and USPS-approved customized labels. PC Postage products are offered by the USPS and USPS-approved commercial providers. PC Postage products are typically offered by providers through subscription service agreements. Some components of PC Postage systems may be purchased as authorized by the USPS.
USPS may deny use of a postage evidencing system in the event of failure to comply with rules and regulations contained in the DMM, submission of false or fictitious information, and for entering a series of unpaid or shortpaid mailpieces and/or packages in the mailstream. The customer must make the postage evidencing system and transaction records available and surrender the system to the provider, the USPS, or the USPS agent when notified to do so.
The value of the postage indicia on each mailpiece must be equal to or greater than the amount due for the applicable price category and associated criteria such as weight, shape, and zone or another amount permitted by mailing standards to qualify for existing prices. * * *
Mailpieces bearing shortpaid information-based indicia (IBI) postage are those for which the postage indicated in the IBI is not equal to or greater than the postage for the applicable price category and associated criteria such as weight, shape, and zone. Mailpieces bearing shortpaid IBI postage are treated as having insufficient postage (see 8.1.8). Customers who repeatedly deposit mail with shortpaid postage will be subject to revocation of the privilege to use a postage evidencing system.
Mailpieces bearing unpaid information-based indicia (IBI) are those for which postage is not paid due to the use of counterfeited, replicated, duplicated, falsified, or otherwise modified IBI. Counterfeited, replicated, duplicated, falsified, or otherwise modified IBI are not acceptable as payment of postage and are treated as omitted postage (see 8.2.3). Customers who repeatedly deposit mail with forms of nonpayment will be subject to revocation of the privilege to use a postage evidencing system.
Except Express Mail, Registered Mail, nonmachinable First-Class Mail, and mail paid with information-based indicia (IBI), all other mail that is received at either the office of mailing or office of address without enough postage is marked to show the total (rounded off) deficiency of postage and fees due.* * *
The total of the postage affixed to a mailpiece must be equal to or greater than the amount due for the applicable price category and associated criteria such as weight, shape, and zone. When USPS determines during any phase of processing that mailpieces bearing an information-based indicia (IBI) are shortpaid mailpieces, the Postal Service will notify the respective PC Postage or postage meter provider to take necessary actions to recover revenue loss for the total amount of postage due from the customer's PC Postage or postage meter account. The customer may appeal the decision through the PC Postage or postage meter provider. If the customer repeatedly deposits mailings with shortpaid postage, the PC Postage or postage meter account privileges may be revoked and/or the customer may be subject to the applicable civil and criminal fines and penalties pursuant to existing Federal law.
Except mail paid with information-based indicia, mail of any class and/or indicating extra services that is received at either the office of mailing or office of address without postage is endorsed “Returned for Postage” and is returned to the sender without an attempt at delivery. * * *
The total of the postage affixed to a mailpiece must be equal to or greater than the amount due for the applicable price category and associated criteria such as weight, shape, and zone. When the USPS determines during any phase of processing that mailpieces bearing an information-based indicia (IBI) are unpaid due to the use of counterfeited, replicated, duplicated, falsified, or otherwise modified IBI, the USPS will notify the PC Postage or postage meter provider to take necessary actions to reclaim revenue loss for the total amount of omitted postage. The customer may appeal the decision through their PC Postage or postage meter provider. The PC Postage or postage meter account may be revoked and/or the customer may be subject to applicable civil and criminal fines and penalties pursuant to existing Federal law.
We will publish an appropriate amendment to 39 CFR part 111 to reflect these changes if our proposal is adopted.
Environmental Protection Agency (EPA).
Notice of data availability (NODA) and request for comment.
The EPA is providing notice that it has placed in the docket for the proposed rulemaking concerning California's June 5, 2009 Motor Vehicle Inspection and Maintenance (I/M) program submittal additional modeling data relevant to the proposed rulemaking, published on August 19, 2009. The August 19, 2009 notice established a 30-day comment period on EPA's proposal, which ended on September 18, 2009. EPA is reopening the comment period to end on December 2, 2009. The purpose of this notice is to provide the public an opportunity to review and comment on the additional modeling data, which were described in the proposed rulemaking notice and are further described below.
Readers should note that only comments about the new modeling data discussed in this document and related issues will be considered during the comment period. Issues related to the August 19, 2009 proposed rule that are not directly affected by the data referenced in this Notice of Data Availability are not open for further comment.
EPA will accept comments on the modeling data and related issues until December 2, 2009.
Submit your comments, identified by Docket ID No. EPA–R09–OAR–2009–0470, by one of the following methods:
1.
2.
3.
Jeffrey Buss, EPA Region IX, (415) 947–4152,
Throughout this document, the terms “we”, “us”, and “our” refer to EPA.
On August 19, 2009 (74 FR 41818), EPA proposed to approve state implementation plan (SIP) revisions submitted by the California Air Resources Board (CARB) on June 5, 2009 relating to the State's basic and enhanced vehicle I/M program (“2009 I/M Revision”) contingent upon California's submittal of revisions to the enhanced program performance standard evaluations to address a different attainment year for the Western Mojave Desert 8-hour ozone nonattainment area and to address California's base-year program performance.
As explained in the August 19, 2009 proposal, these revisions to California's enhanced program performance standard evaluation were necessary for two reasons. First, the submitted performance modeling evaluation for the Western Mojave Desert 8-hour ozone nonattainment area was based on the State's choice of 2020 as the horizon year, based on the attainment deadline for 8-hour ozone nonattainment areas classified as “severe-17.”
Second, CARB did not provide base year modeling evaluations for the six areas in the State that are subject to the enhanced I/M requirements in 40 CFR part 51, subpart S. The six areas are the South Coast Air Basin, San Joaquin Valley, Western Mojave Desert, Sacramento Metro, Coachella Valley, and Ventura County. We noted that a base year modeling run is required to allow for a more definitive conclusion that the California enhanced I/M program obtained the same or lower emission levels as the EPA model program by January 1, 2002, and that the program will maintain this level of emission reduction (or better) through the applicable 8-hour ozone attainment deadlines, as required by 40 CFR 51.351(f). Based on our preliminary modeling analyses and evaluation of the data provided in CARB's submittal, however, we noted that we expect these revised modeling evaluations will satisfy the regulatory requirements. 74 FR 41818–41823. In our proposed rule, we indicated that we would notify the public of any additional information that is provided to address these issues. Publication of this NODA is intended to serve this purpose.
On October 28, 2009, CARB submitted the revised enhanced I/M performance modeling analyses described above. We placed the analyses in the docket on October 29, 2009. Specifically, CARB submitted (1) revised enhanced program performance standard evaluations for the Western Mojave Desert area based on a horizon year of 2018, and (2) 2002 base year performance modeling evaluations for the six areas in the State that are subject to the enhanced I/M requirements in 40 CFR part 51, subpart S (the South Coast Air Basin, San Joaquin Valley, Western Mojave Desert, Sacramento Metro, Coachella Valley, and Ventura County). We find that selection of year 2018 by California as the “year before the attainment year” for Western Mojave Desert for enhanced performance modeling purposes is acceptable on the presumption that CARB will amend its voluntary reclassification request from “severe-17” to “severe-15.” We interpret section 181(b)(3) to allow for voluntary reclassification by a state to the latter, but not the former.
We have also reviewed the submitted modeling data and find that the inputs to the MOBILE6.2 model accurately reflect the California I/M program. Based on the modeling results for Western Mojave Desert submitted on October 28, 2009, together with the performance standard modeling results contained in the 2009 I/M Revision, we believe that California has now demonstrated that the California I/M program would achieve greater percent emissions reductions (relative to the no I/M scenario) for VOC and NO
Moreover, the modeling results for the California I/M program in 2002 show that the California program achieved greater percent emissions reductions (relative to the no I/M scenario) for VOC and NO
Environmental Protection Agency (EPA).
Proposed rule.
Oregon has applied to EPA for final authorization of certain changes to its hazardous waste program under the Resource Conservation and Recovery Act, as amended (RCRA). EPA has reviewed Oregon's application and has preliminarily determined that these changes satisfy all requirements needed to qualify for final authorization, and is proposing to authorize the State's changes.
Comments on this proposed rule must be received by December 18, 2009.
Submit your comments, identified by Docket ID No. EPA–R10–RCRA–2009–0766, by one of the following methods:
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Nina Kocourek, U.S. Environmental Protection Agency, Region 10, Office of Air, Waste & Toxics (AWT–122), 1200 Sixth Avenue, Suite 900, Seattle, Washington 98101, phone number: (206) 553–6502, e-mail:
States which have received final authorization from EPA under RCRA section 3006(b), 42 U.S.C. 6926(b), must maintain a hazardous waste program that is equivalent to, consistent with, and no less stringent than the Federal program. As the Federal program changes, States must change their programs and ask EPA to authorize the changes. Changes to State programs may be necessary when Federal or State statutory or regulatory authority is modified or when certain other changes occur. Most commonly, States must change their programs because of changes to EPA's regulations codified in Title 40 of the Code of Federal Regulations (CFR) parts 124, 260 through 268, 270, 273, and 279.
EPA has preliminarily determined that Oregon's application to revise its authorized program meets all of the statutory and regulatory requirements established by RCRA. Therefore, we are proposing to grant Oregon final authorization to operate its hazardous waste program with the changes described in the authorization application. Oregon will have responsibility for permitting Treatment, Storage, and Disposal Facilities (TSDFs) within its borders, except in Indian country (18 U.S.C. 1151), and for carrying out the aspects of the RCRA program described in its revised program application, subject to the limitations of the Hazardous and Solid Waste Amendments of 1984 (HSWA). New Federal requirements and prohibitions imposed by Federal regulations that EPA promulgates under the authority of HSWA, and which are not less stringent than existing requirements, take effect in authorized States before the States are authorized for the requirements. Thus, EPA will implement those requirements and prohibitions in Oregon, including issuing permits, until the State is granted authorization to do so.
If Oregon is authorized for these changes, a facility in Oregon subject to RCRA will have to comply with the authorized State requirements in lieu of the corresponding Federal requirements in order to comply with RCRA. Additionally, such persons will have to comply with any applicable Federal requirements, such as, for example, HSWA regulations issued by EPA for which the State has not received authorization, and RCRA requirements that are not supplanted by authorized State-issued requirements. Oregon continues to have enforcement responsibilities under its State hazardous waste management program for violations of this program, but EPA retains its authority under RCRA sections 3007, 3008, 3013, and 7003, which includes, among others, the authority to:
• Conduct inspections; require monitoring, tests, analyses, or reports;
• Enforce RCRA requirements; suspend, terminate, modify or revoke permits; and
• Take enforcement actions regardless of whether the State has taken its own actions.
The action to approve these revisions would not impose additional requirements on the regulated community because the regulations for which Oregon will be authorized are already effective under State law and are not changed by the act of authorization.
If EPA receives comments on this action, we will address those comments in a later final rule. You may not have another opportunity to comment. If you want to comment on this authorization, you must do so at this time.
Oregon initially received final authorization on January 30, 1986, effective January 31, 1986 (51 FR 3779), to implement the RCRA hazardous waste management program. EPA granted authorization for changes to Oregon's program on March 30, 1990, effective on May 29, 1990 (55 FR 11909); August 5, 1994, effective October 4, 1994 (59 FR 39967); June 16, 1995, effective August 15, 1995 (60 FR 31642); October 10, 1995, effective December 7, 1995 (60 FR 52629); September 10, 2002, effective September 10, 2002 (67 FR 57337); and June 26, 2006 effective June 26, 2006 (71 FR 36216) .
EPA is proposing to authorize revisions to Oregon's authorized program described in Oregon's official program revision application, submitted to EPA on October 21, 2009 and deemed complete by EPA on October 26, 2009. EPA has made a preliminary determination that Oregon's hazardous waste program revisions, as described in this proposed rule, satisfy the requirements necessary to qualify for final authorization. The following table identifies equivalent and more stringent State regulatory analogues to the Federal regulations for those regulatory revisions for which Oregon is seeking authorization. The referenced analogous State authorities were legally adopted and effective as of June 25, 2009.
This section discusses differences between the revisions Oregon proposed to its authorized program and the Federal regulations. EPA's preliminary determination is that the State does have more stringent requirements related to the Federal Burden Reduction Rule (70 FR 16862, April 4, 2006).
In 1999, EPA initiated a new Federal program, National Environmental Performance Track. This was a voluntary program designed to recognize facilities that had a sustained record of compliance and implemented high quality environmental management systems. EPA provided exclusive regulatory and administrative benefits to the Performance Track member facilities. The State of Oregon did not participate in the Federal National Environmental Performance Track Program. In May 2009, EPA terminated the Federal National Performance Track Program (74 FR 22742, May 14, 2009); therefore there are no current Federal Performance Track member facilities. However, EPA did not remove the Federal rules applicable to the Performance Track member facilities from its regulations, and if EPA's Performance Track Program were reinstated these Federal rules would continue to be applicable to future member facilities.
The State incorporated by reference the Federal Burden Reduction Rule (70 FR 16862, April 4, 2006), which included special allowances to lower priorities on routine inspections for Performance Track member facilities. The State also adopted rules which deleted those portions of the rule that referenced Federal Performance Track member facilities. The effect of deleting those references is that the State's rules do not allow any special or administrative benefits for Performance Track member facilities. Therefore, the State's rules found at OAR 340–104–0021(1), (2) and (3); OAR 340–105–0140(1), (2), (3), (4) and (5) are more stringent than those corresponding Federal counterparts found at 40 CFR 264.15(b)(4) and (5); 40 CFR 264.174; 40 CFR 264.195(e)(1); 40 CFR 265.15(b)(4) and (5); 40 CFR 265.174; 40 CFR 265.195(d); and 40 CFR 265.201(e).
Oregon will continue to issue permits for all the provisions for which it is authorized and administer the permits it issues. If EPA issued permits prior to authorizing Oregon for these revisions, these permits would continue in force until the effective date of the State's issuance or denial of a State hazardous waste permit, at which time EPA would modify the existing EPA permit to expire at an earlier date, terminate the existing EPA permit for cause, or allow the existing EPA permit to otherwise expire by its terms, except for those facilities located in Indian Country. EPA will not issue new permits or new portions of permits for provisions for which Oregon is authorized after the effective date of this authorization. EPA will continue to implement and issue permits for HSWA requirements for which Oregon is not yet authorized.
Codification is the process of placing the State's statutes and regulations that comprise the State's authorized hazardous waste program into the Code of Federal Regulations. This is done by referencing the authorized State rules in 40 CFR part 272. EPA is reserving the amendment of 40 CFR part 272, Subpart MM for codification to a later date.
Oregon is not authorized to carry out its hazardous waste program in Indian country, as defined in 18 U.S.C. 1151. Indian country includes: (1) All lands within the exterior boundaries of Indian reservations within or abutting the State of Oregon; (2) Any land held in trust by the U.S. for an Indian tribe; and (3) Any other land, whether on or off an Indian reservation, that qualifies as Indian country. Therefore, this action has no effect on Indian country. EPA will continue to implement and administer the RCRA program on these lands.
This proposed rule seeks to revise the State of Oregon's authorized hazardous waste program pursuant to section 3006
Under Executive Order 12866 (58 FR 51735, October 4, 1993), the Agency must determine whether the regulatory action is “significant”, and therefore subject to OMB review and the requirements of the Executive Order. The Executive Order defines “significant regulatory action” as one that is likely to result in a rule that may: (1) Have an annual effect on the economy of $100 million or more, or adversely affect in a material way, the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities; (2) create a serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. EPA has determined that this proposed rule is not a “significant regulatory action” under the terms of Executive Order 12866 and is therefore not subject to OMB review.
This proposed action does not impose an information collection burden under the provisions of the Paperwork Reduction Act, 44 U.S.C. 3501
Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing, and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.
An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in Title 40 of the CFR are listed in 40 CFR part 9.
The Regulatory Flexibility Act (RFA) generally requires Federal agencies to prepare a regulatory flexibility analysis of any rule subject to notice and comment rulemaking requirements under the Administrative Procedure Act or any other statute unless the agency certifies that the rule will not have a significant economic impact on a substantial number of small entities. Small entities include small businesses, small organizations, and small governmental jurisdictions. For purposes of assessing the impacts of today's proposed rule on small entities, small entity is defined as: (1) A small business defined by the Small Business Administration's size regulations at 13 CFR 121.201; (2) a small governmental jurisdiction that is a government of a city, county, town, school district, or special district with a population of less than 50,000; and (3) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field. As part of the State's rule development process, the State of Oregon prepared a “Department of Environmental Quality (DEQ) Chapter 340, Proposed Rulemaking Statement of Need and Fiscal and Economic Impact” which included an analysis on impacts to small businesses. The State concluded that there are no economic or fiscal impacts resulting from DEQ's proposed rulemaking. See the Oregon Environmental Quality Commission Agenda, dated June 19, 2009, Action Item N—Hazardous Waste Omnibus Rulemaking, Attachment E, for the DEQ “Impact to Small Business Analysis”
Title II of the Unfunded Mandates Reform Act (UMRA) of 1995 (Pub. L. 104–4) establishes requirements for Federal agencies to assess the effects of their regulatory actions on State, local, and tribal governments and the private sector. Under section 202 of the UMRA, EPA generally must prepare a written statement, including a cost-benefit analysis, for proposed and final rules with “Federal mandates” that may result in expenditures and final rules with “Federal mandates” that may result in expenditures to State, local, and tribal governments, in the aggregate, or to the private sector, of $100 million or more in any one year. Before promulgating an EPA rule for which a written statement is needed section 205 of the UMRA generally requires EPA to identify and consider a reasonable number of regulatory alternatives and adopt the least costly, most cost-effective or least burdensome alternative that achieves the objectives of the rule. The provisions of section 205 do not apply when they are inconsistent with applicable law. Moreover, section 205 allows EPA to adopt an alternative other than the least costly, most cost-effective, or least burdensome alternative if the Administrator publishes with the rule an explanation why the alternative was not adopted. Before EPA establishes any regulatory requirements that may significantly or uniquely affect small governments, including tribal governments, it must have developed under section 203 of the UMRA a small government agency plan. The plan must provide for notifying potentially affected small governments, enabling officials of affected small governments to have meaningful and timely input in the development of EPA regulatory proposals with significant Federal intergovernmental mandates, and informing, educating, and advising small governments on compliance with the regulatory requirements. Today's proposed rule contains no Federal mandates (under the regulatory provisions of Title II of the UMRA) for State, local, or tribal governments or the private sector. It imposes no new enforceable duty on any State, local or tribal governments or the private sector. Similarly, EPA has also determined that this proposed rule contains no regulatory requirements that might significantly or uniquely affect small government entities. Thus, today's proposed rule is not subject to the
This proposed rule does not have federalism implications. It will not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This rule proposes to authorize pre-existing State rules. Thus, Executive Order 13132 does not apply to this proposed rule. In the spirit of Executive Order 13132, and consistent with EPA policy to promote communications between EPA and State and local governments, EPA specifically solicits comment on this proposed rule from State and local officials.
Executive Order 13175, entitled “Consultation and Coordination with Indian Tribal Governments” (59 FR 22951, November 9, 2000), requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” This proposed rule does not have tribal implications, as specified in Executive Order 13175 because EPA retains its authority over Indian Country. Thus, Executive Order 13175 does not apply to this proposed rule. EPA specifically solicits additional comment on this proposed rule from tribal officials.
EPA interprets EO 13045 (62 F.R. 19885, April 23, 1997) as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5–501 of the EO has the potential to influence the regulation. This action is not subject to EO 13045 because it approves a State program.
This proposed rule is not subject to Executive Order 13211, “Actions Concerning Regulations that Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001) because it is not a “significant regulatory action” as defined under Executive Order 12866.
Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (“NTTAA”), Public Law 104–113, 12(d) (15 U.S.C. 272), directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
Executive Order (EO) 12898 (59 FR 7629, February 16, 1994) establishes Federal executive policy on environmental justice. Its main provision directs Federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. EPA has determined that this proposed rule will not have disproportionately high and adverse human health or environmental effects on minority or low-income populations. This proposed rule does not affect the level of protection provided to human health or the environment because this rule proposes to authorize pre-existing State rules which are equivalent to, and no less stringent than existing Federal requirements.
Environmental protection, Administrative practice and procedure, Confidential business information, Hazardous materials transportation, Hazardous waste, Indians—lands, Intergovernmental relations, Penalties, Reporting and recordkeeping requirements.
This proposed action is issued under the authority of sections 2002(a), 3006 and 7004(b) of the Solid Waste Disposal Act, as amended, 42 U.S.C. 6912(a), 6926, 6974(b).
National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (HHS).
Notice of proposed rulemaking; notice of public meeting.
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), will hold a public meeting concerning the proposed rule that was published in the
You may submit comments, identified by RIN: 0920–AA33, by any of the following methods:
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Jonathan V. Szalajda, NIOSH, National Personal Protective Technology Laboratory (NPPTL), Post Office Box 18070, 626 Cochrans Mill Road, Pittsburgh, Pennsylvania 15236, telephone (412) 386–5200, facsimile (412) 386–4089, e-mail
The Department of Health and Human Services published a proposed rule on the Total Inward Leakage Requirements for Respirators on Friday, October 30, 2009 (74 FR 56141).
NIOSH will hold a public meeting on the proposed rule at the following time and location: December 3, 2009, beginning at 8:30 a.m. EST and ending at 4 p.m. EST, or after the last public commenter has spoken, whichever is earlier, at the Marriot Inn and Conference Center UMUC, 3501 University Boulevard E., Adelphi, MD 20783.
Requests to make presentations at the public meeting should be mailed to the NIOSH Docket Office, Robert A. Taft Laboratories, MS–C34, 4676 Columbia Parkway, Cincinnati, OH 45226. Requests may also be submitted by telephone (513) 533–8611, facsimile (513) 533–8285, or e-mailed to
All requests to present should contain the name, address, telephone number and relevant business affiliations of the presenter, and the approximate time requested for the presentation. Oral presentations should be limited to 15 minutes.
After reviewing the requests for presentations, NIOSH will notify the presenter that his/her presentation is scheduled. If a participant is not present when his/her presentation is scheduled to begin, the remaining participants will be heard in order. After the last scheduled speaker is heard, participants who missed their assigned times may be allowed to speak limited by time available. Attendees who wish to speak but did not submit a request for the opportunity to make a presentation may be given this opportunity after the scheduled speakers are heard, at the discretion of the presiding officer and limited by time available.
This meeting will also be using Audio/LiveMeeting Conferencing, remote access capabilities where interested parties may listen in and review the presentations over the internet simultaneously. Parties remotely accessing the meeting will have the opportunity to comment during the open comment period. To register to use this capability, please contact the National Personal Protective Technology Laboratory (NPPTL), Policy and Standards Development Branch, Post Office Box 18070, 626 Cochrans Mill Road, Pittsburgh, PA 15236, telephone (412) 386–5200, facsimile (412) 386–4089. This option will be available to participants on a first come, first serve basis and is limited to the first 50 participants.
Coast Guard, DHS.
Notice of public meetings; request for comments.
The Coast Guard announces a series of public meetings to receive comments on a notice of proposed rulemaking (NPRM) entitled “Implementation of the 1995 Amendments to the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978” that published in the
Public meetings will be held on the following dates:
• Tuesday, December 1, 2009, in Miami, FL from 9 a.m. until noon;
• Wednesday, December 2, 2009, in NY from 9 a.m. until noon;
• Wednesday, December 9, 2009, in New Orleans, LA from 9 a.m. until noon;
• Friday, December 11, 2009, in Seattle, WA from 9 a.m. until noon;
• Wednesday, January 20, 2010, in Washington, DC from 10 a.m. until 1 p.m.
The public meetings will be held at the following locations:
• Tuesday, December 1, 2009, at the Marriott Miami Airport Hotel, 1201 NW LeJeune Road, Miami, FL 33126 from 9 a.m. until noon;
• Wednesday, December 2, 2009, at the Marriott New York LaGuardia Airport Hotel, 102–05 Ditmars Blvd, East Elmhurst, NY 11369 from 9 a.m. until noon;
• Wednesday, December 9, 2009, at the Renaissance Arts Hotel, 700 Tchoupitoulas Street, New Orleans, LA 70130 from 9 a.m. until noon;
• Friday, December 11, 2009, at the Marriott Seattle Airport Hotel, 3201 South 176th Street, Seattle, WA 98188 from 9 a.m. until noon;
• Wednesday, January 20, 2010, at United States Coast Guard Headquarters Building, Room 2415, 2100 Second Street, SW., Washington, DC 20593 from 10 a.m. until 1 p.m.
You may submit written comments identified by docket number USCG–2004–17914 before or after the meetings using any one of the following methods:
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(2)
(3)
(4)
To avoid duplication, please use only one of these four methods. Our online docket for this rulemaking is available on the Internet at
If you have questions on this proposed rulemaking, call or e-mail Mr. Mark Gould, Maritime Personnel Qualifications Division, U.S. Coast Guard, telephone 202–372–1409, e-mail:
The Coast Guard published a notice of proposed rulemaking (NPRM) in the
In the NPRM, we seek to more fully incorporate the requirements of the International Convention on Standards of Training, Certification and Watchkeeping for Seafarers, 1978, as amended (STCW Convention), as well as the Seafarer's Training, Certification and Watchkeeping Code (STCW Code) in the requirements for the credentialing of United States merchant mariners.
You may view the NPRM in our online docket, in addition to supporting documents prepared by the Coast Guard, and comments submitted thus far by going to
We encourage you to participate in this rulemaking by submitting comments either orally at the meetings or in writing. If you bring written comments to the meetings, you may submit them to Coast Guard personnel specified at the meeting to receive written comments. These comments will be submitted to our online public docket. All comments received will be posted without change to
Anyone can search the electronic form of comments received into any of our dockets by the name of the individual submitting the comment (or signing the comment, if submitted on behalf of an association, business, labor union, etc.). You may review a Privacy Act notice regarding our public dockets in the January 17, 2008, issue of the
For information on facilities or services for individuals with disabilities or to request special assistance at the public meetings, contact Mr. Mark Gould at the telephone number or e-mail address indicated under the
National Highway Traffic Safety Administration (NHTSA), DOT.
Notice of initial determination.
The State of Texas has petitioned for approval of alternate requirements to certain requirements under Federal odometer law. NHTSA has initially determined that Texas's alternate requirements satisfy Federal odometer law, with limited exceptions. Accordingly, NHTSA has preliminarily decided to grant Texas's petition, on the condition that before NHTSA makes a final determination, Texas amends its program to meet all the requirements of Federal odometer law or demonstrates that it meets the requirements of Federal law. This notice is not a final agency action.
Comments are due no later than December 18, 2009.
You may submit comments [identified by DOT Docket ID Number NHTSA–2008–0116] by any of the following methods:
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Andrew DiMarsico, Office of the Chief Counsel, National Highway Traffic Safety Administration, 1200 New Jersey Avenue, SE., Washington, DC 20590 (
Federal odometer law, which is largely based on the Motor Vehicle Information and Cost Savings Act (Cost Savings Act)
TIMA's requirements respecting the disclosure of motor vehicle mileage when vehicles are transferred or leased apply in a State unless the State has in effect alternative requirements approved by NHTSA. A State may petition NHTSA for the approval of alternate odometer disclosure requirements that apply in lieu of the Federal odometer requirements.
Seeking to implement an electronic vehicle title transfer system, the State of Texas has petitioned for approval of alternate odometer disclosure requirements under TIMA. The Texas Department of Transportation proposes a paperless electronic title transfer scheme. Texas' program is similar to the Commonwealth of Virginia's alternate odometer disclosure program, which, after notice and comment, NHTSA approved on January 2, 2009. 74 FR 643, 650 (January 7, 2009). Similar to Virginia's, Texas's proposal does not implicate the provisions of federal odometer law related to leased vehicles, disclosures by power of attorney where the title is held by a lien holder, or transactions involving at least one out-of-State party.
As discussed below, NHTSA's initial assessment is that the Texas program satisfies the requirements for approval under Federal odometer law, if Texas amends its program to or shows that its program provides for a transferee to obtain a paper title that complies with the requirements of TIMA,
NHTSA recently reviewed the statutory background of Federal odometer law in its consideration and approval of Virginia's petition for alternate odometer disclosure requirements.
In 1972, Congress enacted the Cost Savings Act, among other things, to prohibit tampering of odometers on motor vehicles and to establish certain safeguards for the protection of purchasers with respect to the sale of motor vehicles having altered or reset odometers.
(a) Not later than 90 days after the date of enactment of this Act, the Secretary shall prescribe rules requiring any transferor to give the following written disclosure to the transferee in connection with the transfer of ownership of a motor vehicle:
(1) Disclosure of the cumulative mileage registered on the odometer.
(2) Disclosure that the actual mileage is unknown, if the odometer reading is known to the transferor to be different from the number of miles the vehicle has actually traveled.
Such rules shall prescribe the manner in which information shall be disclosed under this section and in which such information shall be retained.
(b) It shall be a violation of this section for any transferor to violate any rules under this section or to knowingly give a false statement to a transferee in making any disclosure required by such rules.
A major shortcoming of the odometer provisions of the Cost Savings Act was that they did not require that the odometer disclosure statement be on the title. In a number of States, they were on separate documents that could be altered easily or discarded and did not travel with the title.
Congress enacted TIMA in 1986 to address the Cost Savings Act's shortcomings. It amended the Cost Savings Act to prohibit States from licensing vehicles after transfers of ownership unless the new owner (transferee) submitted a title from the seller (transferor) containing the seller's signed and dated statement of the vehicle's mileage, as previously required by the Cost Savings Act.
TIMA added a provision to the Cost Savings Act, allowing States to have alternate requirements to those required under TIMA respecting the disclosure of mileage, with the approval of the Secretary of Transportation. It amended Section 408 of the Cost Savings Act as follows:
(f)(1) The requirements of subsections (d) and (e)(1) respecting the disclosure of motor vehicle mileage when motor vehicles are transferred or leased shall apply in a State unless the State has in effect alternate motor vehicle mileage disclosure requirements approved by the Secretary. The Secretary may promulgate regulations establishing procedures for the consideration and approval of such alternate requirements.
(2) The Secretary shall approve alternate motor vehicle mileage disclosure requirements submitted by a State unless the Secretary determines that such requirements are not consistent with the purpose of the disclosure required by subsection (d) or (e), as the case may be.
In 1988, Congress amended section 408(d) of the Cost Savings Act to permit the use of a secure power of attorney in circumstances where the title was held by a lienholder. The Secretary was required to publish a rule to implement the provision.
In 1994, in the course of the recodification of various laws pertaining to the Department of Transportation, the Cost Savings Act, as amended, was repealed, reenacted and recodified without substantive change.
As discussed above, the Cost Savings Act, as amended by TIMA in 1986, contains a specific provision on approval of State alternate odometer disclosure programs. Subsection 408(f)(2) of the Cost Savings Act (recodified in 1994 to 49 U.S.C. 32705(d)) provides that NHTSA “shall approve alternate motor vehicle mileage disclosure requirements submitted by a State unless [NHTSA] determines that such requirements are not consistent with the purpose of the disclosure required by subsection (d) or (e) as the case may be.” (Subsections 408(d), (e) of the Cost Savings Act were recodified to 49 U.S.C. 32705(b) and (c)). In light of this provision, we now turn to our interpretation of the purposes of these subsections, as germane to Texas's petition.
Our Final Determination granting Virginia's petition for alternate odometer disclosure requirements, after notice and comment, identified the purposes of TIMA germane to petitions for approval of certain alternate odometer disclosure requirements.
One purpose of TIMA was to assure that the form of the odometer disclosure precluded odometer fraud. 74 FR 647. To prevent odometer fraud facilitated by disclosure statements that were separate from titles, TIMA required mileage disclosures to be on a secure vehicle title instead of a separate document. These titles also had to contain space for the seller's attested mileage disclosure and a new disclosure by the purchaser when the vehicle was sold again. This discouraged mileage alterations on titles and limited opportunities for obtaining new titles with lower mileage than the actual mileage.
A second purpose of TIMA was to prevent odometer fraud by processes and mechanisms making the disclosure of an odometer's mileage on the title a condition of the application for a title, and a requirement for the title issued by the State. 74 FR 647. This provision was intended to eliminate or significantly reduce abuses associated with lack of control of the titling process.
Third, TIMA sought to prevent alterations of disclosures on titles and to preclude counterfeit titles through secure processes. 74 FR 648. In furtherance of these purposes, in the context of paper titles, under TIMA, the title must be set forth by means of a secure printing process or protected by “other secure process.”
Another purpose was to create a record of the mileage on vehicles and a paper trail. 74 FR 648. The underlying purposes of this record and paper trail were to enable consumers to be better informed and provide a mechanism through which odometer tampering can be traced and violators prosecuted. TIMA's requirement that new applications for titles include the prior owner's signed mileage disclosure statement on his or her title creates a permanent record that is easily checked by subsequent owners or law enforcement officials. This record provides critical snapshots of the vehicle's mileage at every transfer, which are the fundamental links of this paper trail.
Finally, the general purpose of TIMA was to protect consumers by assuring that they received valid representations of the vehicle's actual mileage at the time of transfer based on odometer disclosures.
Because it seeks to implement an electronic title transfer system, Texas petitions for approval of alternate odometer disclosure requirements. The scope of its petition is limited; Texas does not request alternate disclosure requirements for leased vehicles, disclosures of odometer statements by power of attorney, such as for vehicles subject to a lien, or transactions involving at least one out-of-State party.
Texas proposes maintaining electronic records of titles in the Texas Department of Transportation (TxDOT), Division of Vehicle Title and Registration (VTR) computer system. According to Texas's petition, the “title” will reside as an electronic record with the TxDOT, but that “hard” copies of the title can be generated if needed.
The petition also states that the proposed system would require sellers to accurately disclose vehicle mileage and allow buyers to record, view and acknowledge receipt of the disclosure through a secure on-line transaction
A purchaser or seller cannot access the proposed electronic title system unless the purchaser's or seller's identity, and status as a Texas resident, holding a valid Texas driver's license or identification card, is authenticated by TOAS. Therefore, the Texas petition asserts that out-of-state parties would be unable to initiate an electronic title transfer in an on-line transaction with TxDOT.
Under Texas's proposal, completing a motor vehicle sale would require that the seller (transferor) and the purchaser (transferee) perform several steps. First, the seller's identity must be authenticated using TOAS. Once authenticated, the seller can access the TxDOT VTR Registration and Titles System (VTR system). The seller then selects a “transfer of ownership” transaction and enters the Vehicle Identification Number (VIN). The vehicle's information is automatically populated on the screen. The transferor is prompted to enter the vehicle sales price and odometer reading.
The transaction would remain in “pending” status until the transferee logs on to complete the transfer of ownership transaction. Meanwhile, the VTR system would automatically check the odometer reading entered by the transferor against VTR odometer records. If the odometer reading entered by the transferor is lower than in the State's records, the transaction will be immediately rejected.
Once transferees log on to TexasOnline and are authenticated, TOAS will transfer them to the TxDOT VTR system where they can select “vehicle transfer of ownership” and enter the unique transaction number obtained from the transferor. The transferee must enter the correct transaction number to continue. Once access is obtained, the transferee would verify the sales price and odometer reading entered by the transferor. If all the data entered by the transferor is verified and acknowledged as correct by the transferee, ownership of the vehicle would pass to the transferee and an electronic title record would be established by the VTR system. The VTR system would then contact the transferor and request that the transferor's original paper title be mailed to the VTR for destruction.
If the transferee does not agree with the information entered by the transferor, then the VTR system will reject the transaction. The transferor will have the opportunity to correct the sales price and odometer reading for the rejected transaction. The transferee would then re-verify the information to ensure the accuracy. A second discrepancy would result in cancellation of the electronic transaction.
Texas's petition states that the same process, along with additional safeguards, will be used in dealer assignments and reassignments of vehicle ownership. According to Texas, such safeguards include requiring the dealership to notify VTR of the employees authorized to do titling activities for the dealership.
Texas's petition asserts that its proposed alternate odometer disclosure is consistent with Federal odometer law. As advanced by TxDOT, Texas's alternative ensures that a fraudulent odometer disclosure can readily be detected and reliably traced to a particular individual by providing a means for TxDOT to validate and authenticate the individuals through the electronic signatures of both parties. As described above, the parties' electronic signatures are established and their identities authenticated through the four TOAD data elements, Texas driver's license, driver's license audit number, date of birth and last four digits of social security number. TOAS then verifies the identity of the transferor and transferee through the submission of the required information. To conduct any transaction, both the transferor and transferee will have to authenticate their identity by submitting the correct data elements.
Texas also asserts that its proposal provides a level of security equivalent to that of a disclosure on a secure title document and provides an on-line authentication for identity management solution in lieu of an actual signature on the title. Furthermore, Texas states that the electronic odometer disclosure provided by the transferor will be available to the transferee at the time ownership of the vehicle is transferred.
The Texas petition maintains that the electronic record and signature components of the proposal comport with the Electronic Signatures in Global and National Commerce Act (E-Sign), 15 U.S.C. 7001
Under TIMA, NHTSA “shall approve alternate motor vehicle mileage disclosure requirements submitted by a State unless [NHTSA] determines that such requirements are not consistent with the purpose of the disclosure required by subsection (d) or (e) as the case may be.” The purposes are discussed above, as is the Texas alternative. We now provide our initial assessment whether Texas's proposal
One purpose is to assure that the form of the odometer disclosure precludes odometer fraud. In this regard, NHTSA has initially determined that Texas's proposed alternate disclosure requirements satisfy this purpose. Under Texas's proposal, it appears that the “title” will reside as an electronic record with the TxDOT, but a hard copy of the title will be generated upon request. Texas's proposed system will, therefore, continue to have the odometer disclosure on the virtual “title” itself, as required by TIMA, and not as a separate document. As to TIMA's requirement that the title contain a space for the transferor to disclose the vehicle's mileage, NHTSA does not believe the proposed Texas electronic title is inconsistent with the space requirement. The agency, however, expects that hard copies of these electronic titles will provide a separate space for owners to execute a proper odometer disclosure in keeping with TIMA and current practice.
Another purpose of TIMA is to prevent odometer fraud by processes and mechanisms making the disclosure of an odometer's mileage on the title a condition of the application for a title and a requirement for the title issued by the State. NHTSA has initially determined that Texas's proposed process satisfies this purpose. The proposed on-line title transfer process requires disclosure of odometer information before the transaction can be completed. If the transaction is successful, the VTR system will retain an electronic title, which includes a record of the transaction and the odometer disclosure information. Once the transaction is complete, transferors are instructed to mail the existing title to the VTR for destruction.
Another purpose of TIMA is to prevent alterations of disclosures on titles and to preclude counterfeit titles through secure processes. The agency has initially determined that VTR's alternate disclosure requirements appear to be as secure as current paper titles. Electronic recording of odometer readings and disclosures decreases the likelihood of any subsequent odometer disclosure being altered by erasures or other methods. As we understand Texas's proposal, once the transaction is completed, the VTR system stores an electronic version of the title until the transferee requests it.
Under the VTR system, all subsequent transfers may be performed through the on-line process. Each time an on-line transfer occurs, the VTR system stores the electronic version of the title, and issues a paper title only upon request. Since the title remains in electronic form under State care and custody, the likelihood of an individual altering, tampering or counterfeiting the title is significantly decreased. These electronic records are maintained in a secure environment and any attempted alteration would be detected by the system. Finally, if a transferee requests a paper title, the VTR will issue a paper title, but the Texas submission does not state that the paper title will comply with TIMA requirements, which it must.
Another purpose of TIMA is to create a record of the mileage on vehicles and a paper trail. The underlying purposes of this record trail are to enable consumers to be better informed and provide a mechanism through which odometer tampering can be traced and violators prosecuted. In NHTSA's preliminary view, the proposed electronic title transfer system will create a scheme of records equivalent to the current “paper trail” now assisting law enforcement in identifying and prosecuting odometer fraud. Under the Texas proposal, creation of a paper trail starts with the establishment of the electronic signatures of the parties. Due to the system's procedures for validating and authenticating the electronic signature of each individual through TOAS and TOAD, the electronic signatures of the transferor and transferee are reliable, readily detectable and can easily be linked to particular individuals.
Finally, TIMA's overall purpose is to protect consumers by assuring that they receive valid representations of the vehicle's actual mileage at the time of transfer based on odometer disclosures. Here, Texas's proposed alternate disclosure requirements include several characteristics that would assure that representations of a vehicle's actual mileage would be as valid as those found in current paper title transfers, with one exception. These characteristics include identity and residency authentication, an automatic system check of the reported mileage against previously reported mileage, and transferee verification of the data reported by the transferor.
For the foregoing reasons, NHTSA preliminarily grants Texas's proposed alternate disclosure requirements on the condition that Texas amends its program to enable transferees to obtain a paper copy of the title that meets the requirements of TIMA, requires dealers to retain a copy of all odometer disclosures that they issue and receive, and requires disclosure of the brand, or demonstrates that these requirements are met. This is not a final agency action. NHTSA invites public comments within the scope of this notice. Should NHTSA decide to issue a final grant of Texas' petition, it would likely reserve the right to rescind that grant in the event that information acquired after
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National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Proposed rule.
The National Marine Fisheries Service (NMFS) publishes its proposed Annual Determination (AD) for 2010, pursuant to its authority under the Endangered Species Act (ESA). Through this proposed AD, NMFS would identify commercial fisheries operating in state and Federal waters in the Atlantic Ocean, Gulf of Mexico, and Pacific Ocean that would be required to take observers upon NMFS' request. The purpose of observing identified fisheries is to learn more about sea turtle interactions in a given fishery, evaluate existing measures to reduce or prevent sea turtle takes, and to determine whether additional measures to address prohibited sea turtle takes may be necessary. Fisheries identified through this process would remain on the AD, and therefore required to carry observers upon NMFS' request, for 5 years.
Comments must be received by December 18, 2009.
Send comments on the proposed rule by any one of the following methods.
(1) Electronic Submissions: Submit all electronic comments through the Federal eRulemaking portal:
(2) Facsimile: (301) 713–0376, Attention: 2010 Sea Turtle Annual Determination.
(3) Mail: Chief, Marine Mammal and Sea Turtle Conservation Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Silver Spring, MD 20910.
Instructions: All comments received are a part of the public record and will generally be posted to
Send comments on the information collection requirements or any other aspects of the collection of information to the Chief of the Marine Mammal and Sea Turtle Conservation Division, Office of Protected Resources, at the
See
Kristy Long, Office of Protected Resources, 301–713–2322; Ellen Keane, Northeast Region, 978–282–8476; Dennis Klemm, Southeast Region, 727–824–5312; Elizabeth Petras, Southwest
Information regarding the Marine Mammal Protection Act (MMPA) List of Fisheries (LOF) may be obtained at
NMFS, Northeast Region, 55 Great Republic Drive, Gloucester, MA 01930–2298;
NMFS, Southeast Region, 263 13th Avenue South, St. Petersburg, FL 33701;
NMFS, Southwest Region, 501 W. Ocean Blvd., Suite 4200, Long Beach, CA 90802–4213; or
NMFS, Pacific Islands Region, Protected Resources, 1601 Kapiolani Boulevard, Suite 1100, Honolulu, HI 96814–4700.
Under the ESA, 16 U.S.C. 1531
Incidental take, or bycatch, in fishing gear is one of the main sources of sea turtle injury and mortality nationwide. Section 9 of the ESA prohibits the take (including harassing, harming, pursuing, hunting, shooting, wounding, killing, trapping, capturing, or collecting or attempting to engage in any such conduct), including incidental take, of endangered sea turtles. Pursuant to section 4(d) of the ESA, NMFS has issued regulations extending the prohibition of take, with exceptions, to threatened sea turtles (50 CFR 223.205 and 223.206). Section 11 of the ESA authorizes the issuance of regulations to enforce the take prohibitions. NMFS may grant exceptions to the take prohibitions with an incidental take statement or an incidental take permit issued pursuant to ESA section 7 or 10, respectively. To do so, NMFS must determine that the activity that will result in incidental take is not likely to jeopardize the continued existence of the affected listed species. In some cases, NMFS has been able to make this determination because the fishery is conducted with modified gear or modified fishing practices that NMFS has been able to evaluate. However, for some Federal fisheries and most state fisheries, NMFS has not granted an exception primarily because we lack information about fishery-turtle interactions. Therefore, any incidental take of sea turtles in those fisheries is unlawful as it has not been exempted from the ESA prohibition on take.
The most effective way for NMFS to learn more about sea turtle-fishery interactions in order to minimize or prevent take is to place observers aboard fishing vessels. In 2007, NMFS issued a regulation (50 CFR 222.402) to establish procedures through which each year NMFS will identify, pursuant to specified criteria and after notice and opportunity for comment, those fisheries in which the agency intends to place observers (72 FR 43176, August 3, 2007). These regulations specify that NMFS may place observers on U.S. fishing vessels, either recreational or commercial, operating in U.S. territorial waters, the U.S. exclusive economic zone (EEZ), or on the high seas, or on vessels that are otherwise subject to the jurisdiction of the U.S.
NMFS and/or interested cooperating entities will pay the direct costs for vessels to carry observers. These include observer salary and insurance costs. NMFS may also evaluate other potential direct costs, should they arise. Once selected, a fishery will be eligible to be observed for five years without further action by NMFS. This will enable NMFS to develop an appropriate sampling protocol to investigate whether, how, when, where, and under what conditions incidental takes are occurring; to evaluate whether existing measures are minimizing or preventing takes; and to determine whether additional measures are needed to implement ESA take prohibitions and conserve turtles.
Pursuant to 50 CFR 222.402, the Assistant Administrator for Fisheries, NOAA (AA), in consultation with Regional Administrators and Fisheries Science Center Directors, develops a proposed annual determination identifying which fisheries are required to carry observers, if requested, to monitor potential interactions with sea turtles. NMFS provides an opportunity for public comment on any proposed determination. The determination is based on the best available scientific, commercial, or other information regarding sea turtle-fishery interactions; sea turtle distribution; sea turtle strandings; fishing techniques, gears used, target species, seasons and areas fished; or qualitative data from logbooks or fisher reports. Specifically, this determination is based on the extent to which:
(1) The fishery operates in the same waters and at the same time as sea turtles are present;
(2) The fishery operates at the same time or prior to elevated sea turtle strandings; or
(3) The fishery uses a gear or technique that is known or likely to result in incidental take of sea turtles based on documented or reported takes in the same or similar fisheries; and
(4) NMFS intends to monitor the fishery and anticipates that it will have the funds to do so.
The AA uses the most recent version of the annually published MMPA List of Fisheries (LOF) as the comprehensive list of commercial fisheries for consideration. The LOF includes all known state and Federal commercial fisheries that occur in U.S. waters. The classification scheme used for fisheries on the LOF would not be relevant to this process. Unlike the LOF process, an annual determination may also include recreational fisheries likely to interact with sea turtles on the basis of the best available information.
NMFS consulted with appropriate state and Federal fisheries officials and other entities to identify which fisheries, both commercial and recreational, should be considered in the annual determination. Although the comments and recommendations provided to NMFS by states were based upon the best available information on their fisheries, NMFS received more
The AD is not an exhaustive or comprehensive list of all fisheries with documented or suspected takes of sea turtles; there are additional fisheries that NMFS remains concerned about. For these additional fisheries, NMFS may already be addressing incidental take through another mechanism (e.g., rulemaking to implement modifications to fishing gear and/or practices) or will consider adding them to future annual determinations based on the four previously noted criteria (50 CFR 222.402(a)).
Notice of the final determination will be published in the
The design of any observer program for fisheries identified through the AD process, including how observers would be allocated to individual vessels, would vary among fisheries, fishing sectors, gear types, and geographic regions and would ultimately be determined by the individual NMFS Regional Office, Science Center, and/or observer program. During the program design, NMFS would be guided by the following standards for distributing and placing observers among fisheries identified in the AD and vessels in those particular fisheries:
(1) The requirements to obtain the best available scientific information;
(2) The requirement that observers be assigned fairly and equitably among fisheries and among vessels in a fishery;
(3) The requirement that no individual person or vessel, or group of persons or vessels, be subject to inappropriate, excessive observer coverage; and
(4) The need to minimize costs and avoid duplication, where practicable.
Vessels where the facilities for accommodating an observer or carrying out observer functions are so inadequate or unsafe (due to size or quality of equipment, for example) that the health or safety of the observer or the safe operation of the vessel would be jeopardized, would not be required to take observers under this proposed rule. Nonetheless, per Magnuson-Stevens Fishery Conservation and Management Act (MSA) regulations for observers (50 CFR 600.746), a vessel that would otherwise be required to carry an observer, but is inadequate or unsafe for purposes of carrying an observer and for allowing operation of normal observer functions, is prohibited from fishing without observer coverage. However, observation techniques using alternative platforms apart from the fishing vessel, but still requiring the cooperation of fishermen, may be employed in such instances as appropriate. Failure to comply with the requirements under this rule may result in civil or criminal penalties under the ESA.
Observer programs designed or carried out in accordance with 50 CFR 222.404 would be required to be consistent with existing observer-related NOAA policies and regulations, such as those under the Fair Labor and Standards Act (29 U.S.C. 201
Fisheries not included on the 2010 AD may still be observed under a different authority than the ESA (e.g., MMPA, MSA).
Additional information on observer programs in commercial fisheries can be found on the NMFS National Observer Program's website:
Sea turtle species found in waters of the Atlantic Ocean and Gulf of Mexico include green, hawksbill, Kemp's ridley, leatherback, and loggerhead turtles. The waters off the U.S. East Coast represent important residential, migrating, and foraging habitat for several of these species. Further, the Southeastern U.S. is a major sea turtle nesting area for loggerheads and, to a lesser extent, green and leatherback turtles.
Four species, green, Kemp's ridley, leatherback, and loggerhead turtles, occur seasonally in southern New England and mid-Atlantic continental shelf waters north of Cape Hatteras, North Carolina. The occurrence of these species in these waters is temperature dependent. In general, turtles move up the coast from southern wintering areas as water temperatures warm in the spring. The trend is reversed in the fall as water temperatures decrease. By December, turtles have passed Cape Hatteras, returning to more southern waters for the winter. Hard-shelled species are typically observed as far north as Cape Cod, Massachusetts, whereas more cold-tolerant leatherbacks are observed farther north in northern Gulf of Maine waters in the summer and fall.
Green turtles are found in inshore and nearshore waters from Texas to Massachusetts, the U.S. Virgin Islands, and Puerto Rico. While foraging and developmental habitats also occur in the wider Caribbean, important feeding areas in Florida include the Indian River Lagoon, the Florida Keys, Florida Bay, Homosassa, Crystal River, Cedar Key, and St. Joseph Bay. The bays and sounds of North Carolina also provide important foraging habitat for green turtles, which can occur in those areas in relatively high densities.
In the Atlantic, hawksbills are most common in Puerto Rico and its associated islands and in the U.S. Virgin Islands. In the continental U.S., the species is recorded from all the Gulf States and along the east coast as far north as Massachusetts, but sightings north of Florida are rare. Hawksbills are observed in Florida on the reefs off Palm Beach, Broward, Miami-Dade, and Monroe Counties. Texas is the only other U.S. state where hawksbills are sighted with any regularity.
Kemp's ridleys are distributed throughout waters of the Gulf of Mexico and U.S. Atlantic coast, from Florida to New England. The major nesting area for Kemp's ridleys is in Tamaulipas, Mexico, but some nesting also occurs along the Texas coast.
The second largest nesting aggregation of loggerheads in the world occurs in the southeastern U.S. Loggerheads occur throughout the Atlantic and Gulf of
Adult leatherbacks are capable of tolerating a wide range of water temperatures, and have been sighted along the entire continental coast of the United States as far north as the Gulf of Maine and south to Puerto Rico, the U.S. Virgin Islands, and into the Gulf of Mexico. The central east coast of Florida represents a small, but growing, nesting area for leatherbacks in the western North Atlantic.
Leatherback sea turtles are found consistently off the U.S. west coast, usually north of Point Conception, California. Green turtles, loggerhead, and olive ridley sea turtles are rarely observed in the west coast EEZ, but records show that all species have stranded in California and the Pacific Northwest. Leatherbacks are known to migrate to central and northern California from their natal beaches in the Western Pacific to feed on jellyfish. During aerial surveys conducted since the early 1990s, leatherbacks were most often spotted off Point Reyes, south of Point Arena, in the Gulf of the Farallons, and in Monterey Bay. Leatherback turtles usually appear in Monterey Bay and California coastal waters during August and September and move offshore in October and November. Other observed areas of summer leatherback concentration include northern California and the waters off Washington through northern Oregon, offshore from the Columbia River plume.
Green, loggerhead, and olive ridley sea turtles are generally found in waters temperatures above 18 C, which is warmer than the waters off most of California, Oregon, and Washington. Two small populations of green turtles occur in the southern California Bight utilizing the warm water outflows from power plants in San Diego Bay and Alamitos Bay in Long Beach, California. In the eastern Pacific, loggerheads have been reported as far north as Alaska, and as far south as Chile. Occasional sightings are reported from the coasts of Washington and Oregon, but most records are of juveniles off the coast of California. Based upon limited observer records, loggerheads travel into the southern California Bight during El Nino events (or warm water conditions similar to an El Nino). The majority of fishery interactions with loggerheads during El Nino conditions have occurred during the summer. Olive ridleys have been recorded stranded all along the U.S. west coast. Olive ridleys are believed to use warm water currents along the west coast for foraging. The general distribution of olive ridleys along the U.S. west coast is unknown at this time.
Sea turtles occur throughout the Pacific Islands Region including the State of Hawaii and the U.S. territories of Guam, American Samoa, and the Commonwealth of the Northern Mariana Islands (CNMI). Green and hawksbill turtles are most common in nearshore waters while leatherbacks, loggerheads, and olive ridleys occur in offshore pelagic waters. Stock structure and population dynamics for some species in this region are poorly understood.
NMFS reviewed data collected by the Sea Turtle Stranding and Salvage Network (STSSN) between 2003 and 2007 to identify stranding trends and inform development of this proposed rule. Cold stunned, captive-reared, and post-hatchling turtles were not included in the data reviewed.
Between 2003 and 2007, the STSSN along the U.S. Atlantic and Gulf coasts collectively documented strandings of six species: loggerhead, Kemp's ridley, green, leatherback, hawksbill, and olive ridley turtles, with loggerheads consistently representing the highest number of strandings. For the purposes of this review, the U.S. Atlantic and Gulf of Mexico coastline is divided into three regions: (1) Gulf, including all Gulf of Mexico waters from TX through the FL gulf coast, (2) Southeast Atlantic, including U.S. Atlantic waters from FL east coast through NC, and (3) Northeast Atlantic, including all U.S. Atlantic waters from VA through ME. Of the three regions, the Southeast Atlantic consistently records the highest level of strandings during any given month, each year. In each region, as well as collectively, loggerhead sea turtles represent the highest number of annual strandings, followed by Kemp's ridley and leatherback turtles in the Atlantic and green turtles in the Gulf.
Based on the data reviewed, strandings have occurred in each month of the year, in all three regions; however, distinct trends are notable within each region. In the Gulf and Southeast Atlantic regions, strandings consistently occur in every month of the year. In the Gulf region, the highest concentration of strandings occurs from March to August, with a notable peak in April and May. In the Southeast Atlantic region, the highest concentration of strandings occurs from March to November, with a notable peak in May and June. In the Northeast Atlantic region, strandings predominately occur between May and November of each year, with the highest concentration of strandings between June and September; strandings are not regularly observed in the winter and early spring.
On the U.S. West Coast, strandings are infrequent compared to the Atlantic and Gulf of Mexico coasts predominantly due to oceanographic features (e.g., currents) and species abundance and distribution. Between 2003 and 2007, the STSSN in California documented strandings of three species: green, leatherback, and olive ridley turtles. Green turtles represent the highest number of strandings. Strandings were documented in all months except April; data indicate a peak in strandings between July and October.
In Oregon and Washington, very few strandings were recorded between 2003 and 2007. Green, loggerhead, and olive ridley turtle strandings were recorded from December to March, with no strandings documented from April through November. Prior to 2003, stranded leatherback turtles were recorded in Oregon and Washington.
In the Pacific Islands region, strandings occur throughout the year, primarily green turtles and secondarily hawksbills in Hawaii, Guam, American Samoa, and CNMI.
NMFS is proposing to include 19 fisheries (17 in the Atlantic Ocean and Gulf of Mexico and 2 in the Pacific Ocean) on the 2010 AD. These 19 fisheries, described below and listed in Table 1, represent several gear types, including trawl, gillnet, trap/pot, and pound net/weir/seine.
As described above, the most recent LOF is used as the universe of commercial fisheries included on the AD. The fishery name, definition, and number of vessels/persons specified on the AD are taken from the most recent final LOF. Additionally, the fishery descriptions below include a particular fishery's current classification on the MMPA LOF (i.e., Category I, II, or III); Category I and II fisheries are required to carry observers if requested by NMFS. As noted previously, NMFS also has authority to observe fisheries in Federal waters under the MSA, under which NMFS has collected sea turtle bycatch information.
Interactions with trawl fisheries are of a particular concern for sea turtles, since forced submergence in any type of restrictive gear could lead to lack of oxygen and subsequent death by drowning. Metabolic changes that can
Trawls that are not outfitted with turtle excluder devices (TEDs) may result in forced submergence. Currently, only trawl fisheries capable of catching shrimp and operating south of Cape Charles, VA, and in the Gulf of Mexico as well as trawl fisheries targeting summer flounder south of Cape Charles, VA, are required to use TEDs.
NMFS' Strategy for Sea Turtle Conservation and Recovery in Relation to Atlantic Ocean and Gulf of Mexico Fisheries (“Strategy”), a gear-based approach to addressing sea turtle bycatch, has identified trawl gear as a priority given our knowledge of the level of bycatch in this gear and the availability of technology that allows sea turtles to escape the trawl net, minimizing injury and mortality. The Strategy is currently evaluating mitigation measures for trawl fisheries that overlap with sea turtles. Several fisheries that NMFS proposes to include on the 2010 AD may be considered for sea turtle conservation measures under the Strategy in a future rulemaking to implement the prohibition of take and to help conserve and recover sea turtles.
Several states included trawl fisheries in their responses to NMFS' request for information and recommendations for the 2010 AD. Massachusetts noted that summer flounder trawlers are known to interact with sea turtles. New York recommended considering bottom otter trawl fisheries given that this is one of the top gear types in terms of pounds landed in Long Island Sound, Peconic Bay, and along the South Shore. New Jersey suggested focusing observer coverage in areas where trawl gear overlaps with sea turtle observations. Maryland reported that interactions between bottom otter trawl gear as well as beam trawl gear and sea turtles are possible in the Atlantic Ocean (0–3 miles (0–4.8 km)) and there have been reports of sea turtles captured in trawl gear. North Carolina ranked trawls operating in ocean waters as their top priority based on NMFS' four criteria. South Carolina noted that both trynets and whelk trawls are of concern. Georgia, Florida, and Alabama all noted trawl fisheries as well. Mississippi highlighted skimmer trawls in their response to NMFS' request for recommendations. Therefore, based on the information provided by states and the best available scientific information, NMFS proposes to include the following trawl fisheries on the 2010 AD.
The Atlantic shellfish bottom trawl fishery (estimated 972 vessels/persons) encompasses the calico scallop trawl, crab trawl, Georgia/South Carolina/Maryland whelk trawl, Gulf of Maine/Mid-Atlantic sea scallop trawl, and Gulf of Maine northern shrimp trawl (71 FR 2006, January 4, 2006). This fishery extends from Maine through Florida. The fishery is managed through Federal and interstate fishery management plans (FMPs).
This fishery is classified as Category III on the MMPA LOF; however, portions of the fishery have been observed at low levels under MSA authority and by the Georgia Department of Natural Resources (GA DNR).
Since 2004, 16 sea turtle takes were reported by NMFS trained observers in the Atlantic sea scallop trawl fishery. Takes of sea turtles in scallop trawl gear have been observed during the months from June through October. One of the 16 sea turtles captured in scallop trawl gear was decomposed indicating it was not killed as a result of the scallop trawl gear in which it was observed. Fourteen of the non-decomposed turtles were loggerhead sea turtles, while one was not identified to species.
In addition, loggerhead sea turtle bycatch in the mid-Atlantic sea scallop trawl fishery, one component of the Atlantic shellfish bottom trawl fishery, was estimated for 2004 and 2005. The average annual bycatch estimates of loggerhead sea turtles in 2004 and 2005 in mid-Atlantic sea scallop trawl gear ranged from 81 to 191 turtles, depending on the estimation methodology used (Murray 2007). GA DNR conducted a limited observer program in the trawl fishery targeting whelk in the late 1990s; 7 turtles (3 Kemp's ridleys, 2 greens, and 2 loggerheads) were taken in 28 observed tows. NMFS is particularly interested in observing this fishery in waters off of Massachusetts and south as sea turtles more commonly occur in this area.
NMFS proposes to include this fishery on the 2010 AD based on documented interactions with sea turtles in this and other bottom trawl fisheries and the need to obtain more information on the interactions in this fishery.
Bottom otter trawl nets include a variety of net types, including flynets, which are high profile trawls. The “Mid-Atlantic bottom trawl fishery” as described in this proposed AD includes both the mid-Atlantic bottom trawl fishery and the mid-Atlantic flynet fishery as defined on the LOF.
The Mid-Atlantic bottom trawl fishery (estimated >1,000 vessels/persons), as defined on the LOF, uses bottom trawl gear to target species including, but not limited to, bluefish, croaker, monkfish, summer flounder (fluke), winter flounder, silver hake (whiting), spiny dogfish, smooth dogfish, scup, and black sea bass. The fishery occurs year-round from Cape Cod, MA, to Cape Hatteras, NC, in waters west of 72 30' W. long. and north of a line extending due east from the North Carolina/South Carolina border. The gear is managed by several state and Federal FMPs.
The Mid-Atlantic flynet fishery (estimated 21 vessels/persons), as defined on the LOF, is a multi-species fishery composed of nearshore and offshore components that operate along the east coast of the mid-Atlantic United States. Flynets typically range from 80–120 ft (24–36.6 m) in headrope length, with wing mesh sizes of 16–64 in (41–163 cm), following a slow 3:1 taper to smaller mesh sizes in the body, extension, and codend sections of the net. The nearshore fishery operates from October to April inside of 30 fathoms (180 ft; 55 m) from New Jersey to North Carolina. This nearshore fishery targets Atlantic croaker, weakfish, butterfish, harvestfish, bluefish, menhaden, striped bass, kingfish species, and other finfish species. Flynet fishing is no longer permitted in Federal waters south of Cape Hatteras to a line extending from the NC/SC border in order to protect weakfish stocks. The offshore component operates from November to April outside of 30 fathoms (180 ft; 55 m) from the Hudson Canyon off New York, south to Hatteras Canyon off North Carolina. These deeper water fisheries target bluefish, Atlantic mackerel,
The Mid-Atlantic bottom trawl fishery and the Mid-Atlantic flynet fishery are currently classified as Category II on the MMPA LOF, which authorizes NMFS to observe these fisheries for marine mammal interactions, and to collect information on sea turtles should a take occur on an observed trip. Between 2003 and 2007, observer coverage as reported in the Marine Mammal Stock Assessment Report (SAR) ranged from a low of 1% to a high of 18.61% depending on target species; see Appendix III of the draft 2009 SAR for additional details (NMFS, 2009). It should be noted that the mid-Atlantic
Since 2003, NMFS has documented 50 sea turtle takes (excluding severely decomposed animals) in bottom otter trawl gear in the mid-Atlantic. These takes occurred primarily between October and February, but takes were also reported May through September. In 2007, the observer program created new codes to document the different net types used, including flynets. Seven of the takes were recorded on trips where flynets were indicated as the specific net type used. Loggerhead turtles were the predominant species observed taken, but leatherback turtles were also documented. An estimate of the average annual bycatch of loggerhead sea turtles in mid-Atlantic bottom otter trawl gear during 1996–2004 was completed in 2006. The analysis defined the mid-Atlantic as the region from the shoreline below 41° 30' N./66° W. to the southern extent of the NEFSC observer data collection, around 35° 00' N. lat. and 75° 30' W. long. Estimated average annual bycatch of loggerhead turtles in mid-Atlantic bottom otter trawl gear during 1996–2004 was 616 animals (Murray, 2008).
NMFS proposes to include this fishery on the 2010 AD to more adequately observe this gear type where and when it overlaps with sea turtle distribution.
The Mid-Atlantic mid-water trawl fishery (estimated 620 vessels/persons) primarily targets Atlantic mackerel, chub mackerel, and miscellaneous other pelagic species. This fishery consists of both single and pair trawls, which are designed, capable, or used to fish for pelagic species with no portion of the gear designed to be operated in contact with the bottom. The fishery for Atlantic mackerel occurs primarily from southern New England through the mid-Atlantic from January to March and in the Gulf of Maine during the summer and fall (May to December).
The Mid-Atlantic mid-water trawl fishery is currently classified as Category II on the MMPA LOF, which authorizes NMFS to observe this fishery for marine mammal interactions, and to collect information on sea turtles should a take occur on an observed trip. During 2003–2007, estimated observer coverage year-round in this fishery was 3.5%, 12.16%, 8.4%, 8.9%, and 3.85%, respectively (NMFS 2009); no sea turtle takes were observed.
NMFS proposes to include this fishery on the 2010 AD to more adequately observe this gear type in areas and during times where it overlaps with sea turtle distribution.
The Southeastern U.S. Atlantic, Gulf of Mexico shrimp trawl fishery (estimated >18,000 vessels/persons) targets shrimp using various types of trawls; NMFS would focus on the component of the fishery that uses skimmer trawls for the 2010 AD. Skimmer trawls are used primarily in inshore/inland shallow waters (typically less than 20 ft (6.1 m)) to target shrimp. The skimmer trawl has a rigid “L”-shaped or triangular metal frame with the inboard portion of the frame attached to the vessel and the outboard portion attached to a skid that runs along the seabed.
Skimmer trawl use increased in response to TED requirements for shrimp bottom otter trawls. Skimmer trawls currently have no TED requirement but are subject to tow time limits of 55 minutes from April 1 to October 31 and 75 minutes from November 1 to March 31. Skimmer trawls are used in North Carolina, Florida (Gulf Coast), Mississippi, and Louisiana. There are documented takes of sea turtles in skimmer trawls in North Carolina, and anecdotal reports elsewhere. In North Carolina, there were 150–200+ active vessels per year from 2000–2002 and in Louisiana, skimmer trawls accounted for 37% of the shrimp catch and 63% of the total shrimp trawling effort from 1999–2004. Louisiana skimmer trawl effort averaged about 60,750 trips per year over that period, ranging from about 81,700 trips in year 2000 to 49,000 trips in year 2004. No effort information is available for Mississippi and Florida.
Skimmer trawl effort overlaps with sea turtle distribution, and as noted above, takes have been reported. Although subject to tow times, the magnitude and impact of turtle takes in this fishery are not understood, and no observer program currently exists for this portion of the shrimp fishery. Given the extent this gear is used, NMFS thinks it is important to better understand these interactions.
NMFS is considering including skimmer trawls under the Atlantic Ocean and Gulf of Mexico Sea Turtle Strategy, which may result in a regulation to require TEDs or other protections for sea turtles for all trawl gears as appropriate. Observer coverage to understand the scope and impact of turtle takes by this gear will also be needed to make well informed management decision on what actions may be necessary to manage this fishery to minimize and prevent sea turtle takes and further sea turtle conservation and recovery.
The Southeastern U.S. Atlantic, Gulf of Mexico shrimp trawl fishery is classified as Category III on the MMPA LOF, but mandatory observer coverage under MSA authority began in 2007. The fishery is currently observed at approximately 1% of total fishery effort. NMFS is proposing to include the Southeastern U.S. Atlantic, Gulf of Mexico shrimp trawl fishery, to focus observer coverage in the component of the fishery that uses skimmer trawls, on the 2010 AD.
Sea turtles are vulnerable to entanglement and drowning in gillnets, especially when the gear is left untended. The main risk to sea turtles from capture in gillnet is forced submergence. Entanglement in gillnets can also result in severe abrasions on entangled turtles. Large mesh gillnets (e.g., 10–12 in. (25.4–30.5 cm) stretched mesh) have been documented as effective at capturing sea turtles. Additionally, sea turtles have been documented as entangled in smaller mesh gillnets.
Several states (i.e., CA, NY, NJ, DE, MD, VA, NC, AL) recommended including gillnet fisheries on the 2010 AD. California recommended two small mesh gillnet fisheries. New York recommended considering sink gillnets and runaround gillnets, particularly those operating off the South Shore and Peconic Bay. During the time sea turtles are present in New York waters, gillnets are one of the top gear types in terms of pounds landed along the South Shore. New Jersey recommended observing gillnet fisheries operating in areas that overlap with sea turtle sightings. Delaware identified gillnet gear as a concern based on the potential for interactions. Maryland noted that potential for sea turtle takes exists in gillnet fisheries operating within coastal bays and tidal tributaries, but no takes have been documented. Virginia noted that there are state regulations for gillnets in an effort to conserve and protect sea turtles in their waters. North Carolina ranked large mesh commercial gillnets operating in estuarine waters as a top concern. Alabama noted gillnets in their response to NMFS' request for recommendations. In addition, NMFS' Strategy for Sea Turtle Conservation and Recovery in Relation to Atlantic Ocean and Gulf of Mexico Fisheries has identified gillnet gear as a high priority.
The CA halibut, white seabass, and other species set gillnet fishery (estimated 58 vessels/persons) targets halibut, white seabass, and other species from the U.S.-Mexico border north to Monterey Bay using 200 fathom (1,200 ft; 366 m) gillnet with a stretch mesh size of 8.5 in (31.6 cm). Net soak duration is typically 8–10, 19–24, or 44–49 hours at a depth ranging from 15–50 fathoms (90–300 ft; 27–91 m) with most sets from 15–35 fathoms (90–210 ft; 27–64 m). No more than 1500 fathoms (9,000 ft; 2,743 m) of gill or trammel net may be fished in combination for CA halibut and angel shark. Fishing occurs year-round, with effort generally increasing during summer months and declining during last the 3 months of the year. The central CA portion of the fishery from Point Arguello to Point Reyes has been closed since September, 2002, following a ban on gillnets inshore of 60 fathoms (360 ft; 110 m). Set gill nets have been prohibited in state waters south of Point Arguello and within 70 fathoms (420 ft; 128 m) or one mile (1.6 km), whichever is less, around the Channel Islands since 1990. The California Department of Fish and Game (CDFG) manages the fishery as a limited entry fishery with gear restrictions and area closures.
This fishery is classified as Category II on the MMPA LOF, which authorizes NMFS to observe this fishery in state waters for marine mammal interactions, and to collect information on sea turtles should a take occur on an observed trip. This fishery was observed at about 17.8% in 2007 and 5% in 2008. No sea turtle takes were observed during 2007 or 2008. NMFS proposes to include this fishery on the 2010 AD because it operates in the same waters that turtles are known to occur and this gear type is known to result in the incidental take of sea turtles based on documented takes in similar fisheries.
The CA yellowtail, barracuda, and white seabass drift gillnet fishery (24 vessels/persons) targets primarily yellowtail and white seabass, and secondarily barracuda, with target species typically determined by market demand on a short-term basis. Drift gillnets are up to 6,000 ft (1,829 m) long and are set at the surface. The mesh size depends on target species and is typically 6.0–6.5 in (15–16.5 cm). When targeting yellowtail and barracuda, the mesh size must be ≥3.5 in (9 cm); when targeting white seabass, the mesh size must be ≥6 in (15.2 cm). From June 16 to March 14 not more than 20 percent, by number, of a load of fish may be white seabass with a total length of 28 in (71 cm). A maximum of ten white seabass per load may be taken, if taken in gillnet or trammel nets with meshes from 3.5–6.0 in (9–15 cm) in length. The fishery operates year-round, primarily south of Point Conception with some effort around San Clemente Island and San Nicolas Island. This fishery is a limited entry fishery with various gear restrictions and area closures managed by the California Department of Fish and Game (CDFG).
This fishery is classified as Category II on the MMPA LOF, which authorizes NMFS to observe this fishery for marine mammal interactions, and to collect information on sea turtles should a take occur on an observed trip. This fishery was observed in 2003 and 2004, with 10.4% and 11.0% coverage, respectively. No sea turtle takes were observed during 2003 or 2004. NMFS proposes to include this fishery on the 2010 AD because it operates in the same waters that turtles are known to occur and this gear type is known to result in the incidental take of sea turtles based on documented takes in similar fisheries.
The Chesapeake Bay inshore gillnet fishery (estimated 45 vessels/persons) targets menhaden and croaker using gillnet gear with mesh sizes ranging from 2.75–5 in (7–12.7 cm), depending on the target species. The fishery operates between the Chesapeake Bay/Bridge Tunnel and the mainland. The fishery is managed under the Interstate FMPs for Atlantic Menhaden and Atlantic Croaker.
This fishery is classified as Category II on the MMPA LOF, which authorizes NMFS to observe this fishery in state waters for marine mammal interactions, and to collect information on sea turtles should a take occur on an observed trip. NMFS has previously observed this fishery at extremely low levels. NMFS proposes to include this fishery on the 2010 AD because sea turtles are known to occur in the same areas where the fishery operates, takes have been previously documented in similar gear, and the fishery operates during a period of high sea turtle strandings.
The Long Island Sound inshore gillnet fishery (estimated 20 vessels/persons) includes all gillnet fisheries setting nets west of a line from the north fork of the eastern end of Long Island, NY (Orient Point to Plum Island to Fishers Island) to Watch Hill, RI (59 FR 43703, August 25, 1994). Target species include, but are not limited to bluefish, striped bass, weakfish, and summer flounder.
This fishery is classified as Category III on the MMPA LOF and NMFS has not previously required vessels operating in this fishery to carry an observer. NMFS has previously observed this fishery at extremely low levels; no sea turtle takes were observed. NMFS proposes to include this fishery in the 2010 AD because sea turtles are known to occur in the same areas where the fishery operates and takes have been documented in similar gear types.
The Mid-Atlantic gillnet fishery (estimated 7,596 vessels/persons) targets monkfish, spiny dogfish, smooth dogfish, bluefish, weakfish, menhaden, spot, croaker, striped bass, large and small coastal sharks, Spanish mackerel, king mackerel, American shad, black drum, skate spp., yellow perch, white perch, herring, scup, kingfish, spotted seatrout, and butterfish. The fishery uses drift and sink gillnets, including nets set in a sink, stab, set, strike, or drift fashion, with some unanchored drift or sink nets used to target specific species. The dominant material is monofilament twine with stretched mesh sizes from 2.5–12 in (6.4–30.5 cm), and string lengths from 150–8,400 ft. (46–2,560 m). This fishery operates year-round west of a line drawn at 72° 30' W. long. south to 36° 33.03' N. lat. and east to the eastern edge of the EEZ and north of the North Carolina/South Carolina border, not including waters where inshore gillnet fisheries (i.e., Chesapeake Bay, North Carolina, Long Island Sound inshore gillnet fisheries) operate in bays, estuaries, and rivers. This fishery includes any residual large pelagic driftnet effort in the mid-Atlantic and any shark and dogfish gillnet effort in the mid-Atlantic zone described. The fishing effort is prosecuted right off the beach (6 ft [1.8 m]) or in nearshore coastal waters to offshore waters (250 ft [76 m]).
Gear in this fishery is managed by several Federal FMPs and Interstate FMPs managed by the Atlantic States Marine Fisheries Commission (ASMFC). Fisheries are primarily managed by TACs; individual trip limits (quotas); effort caps (limited number of days at
This fishery is classified as Category I on the MMPA LOF, which authorizes NMFS to observe this fishery in state and federal waters for marine mammal interactions, and to collect information on sea turtles should a take occur on an observed trip. During 2003–2007, estimated observer coverage year-round in this fishery was 1%, 2%, 3%, 4%, and 6%, respectively (NMFS, 2009). Since 2003, 12 takes (excluding severely decomposed animals) of loggerhead, leatherback, green, and Kemp's ridley turtles were documented by observers between May and December. From 1995–2006, the average annual bycatch estimate of loggerheads in U.S. mid-Atlantic sink gillnet gear was 350 turtles (Murray 2009). The mid-Atlantic was defined in this analysis as west of 70° W. long. from the shoreline of Cape Cod southward to the southern limit of the observer data collection program (approximately 33° N. lat.), extending westward to the coastline (Murray, 2009). NMFS proposes to include this fishery on the 2010 AD to focus observer coverage during times and in areas where sea turtles are known to occur.
The Northeast sink gillnet fishery (estimated >6,455 vessels/persons) targets Atlantic cod, haddock, pollock, yellowtail flounder, winter flounder, witch flounder, American plaice, windowpane flounder, spiny dogfish, monkfish, silver hake, red hake, white hake, ocean pout, skate spp, mackerel, redfish, and shad. This fishery uses sink gillnet gear, which is anchored gillnet (bottom-tending net) gear fished in the lower one-third of the water column. The dominant material is monofilament twine with stretched mesh sizes from 6–12 in (15–30.5 cm) and string lengths from 600–10,500 ft (183–3,200 m), depending on the target species. Large mesh (10–14 in [25–35.6 cm]) sink gillnets, either tied down or set upright without floats using a polyfoam core floatline, are used when targeting monkfish. The fishery operates from the U.S.-Canada border to Long Island, NY, at 72° 30' W. long. south to 36° 33.03' N. lat. (corresponding with the Virginia/North Carolina border) and east to the eastern edge of the EEZ, including the Gulf of Maine, Georges Bank, and Southern New England, and excluding Long Island Sound or other waters where gillnet fisheries are classified as Category III on the MMPA LOF. Fishing effort occurs year-round, peaking from May to July primarily on continental shelf regions in depths from 30–750 ft (9–228.6 m), with some nets deeper than 800 ft (244 m).
This fishery is managed by the Northeast Multispecies (Groundfish) FMP. This fishery is also managed by the Atlantic Large Whale Take Reduction Plan (ALWTRP) and the Harbor Porpoise Take Reduction Plan (HPTRP) to reduce the risk of entanglement of right, humpback, and fin whales, and harbor porpoises, respectively. The fishery is primarily managed through TAC limits; individual trip limits (quotas); effort caps (limited number of days at sea per vessel); time and area closures; and gear restrictions.
This fishery is classified as Category I on the MMPA LOF, which authorizes NMFS to observe this fishery in state and Federal waters for marine mammal interactions and to collect information on sea turtles should a take occur on an observed trip. During 2003–2007, estimated observer coverage year-round in this fishery was 3%, 6%, 7%, 4%, 7%, respectively (NMFS, 2009). Five sea turtle takes were observed during this time. NMFS proposes to include this fishery on the 2010 AD to focus observer coverage during times and in areas where sea turtles are known to occur, particularly in waters off Massachusetts and waters south of this area.
The NC inshore gillnet fishery (94 vessels/persons) targets species including, but not limited to, southern flounder, weakfish, bluefish, Atlantic croaker, striped mullet, spotted seatrout, Spanish mackerel, striped bass, spot, red drum, black drum, and shad. This fishery includes any fishing effort using any type of gillnet gear, including set (float and sink), drift, and runaround gillnet for any target species inshore of the COLREGS lines in North Carolina. This fishery is managed under state and ASMFC interstate FMPs, applying net and mesh size regulations, and seasonal area closures in the Pamlico Sound Gillnet Restricted Area (PSGNRA).
Gillnet fisheries operating in inshore and inland waters of North Carolina are currently not observed except in a limited area. An ESA section 10(a)(1)(B) permit requires monitoring the Pamlico Sound summer flounder gillnet fishery. However, extensive gillnet activity occurs throughout the inshore and inland waters of North Carolina (e.g., Core Sound/Cape Fear area, Roanoke and Albemarle Sounds); effort in some areas has never been observed, but other areas have had limited coverage, which was authorized under the MMPA (this fishery is listed as Category II on the MMPA LOF). Gillnet activity overlaps spatially with areas utilized by sea turtles, often at relatively high densities. Additionally, the likelihood of significant injury or mortality to sea turtles when taken by this gear is high. NMFS recently conducted a limited observer program in the southern flounder gillnet fishery in Core Sound, which was previously unobserved. Several sea turtles (green, Kemp's ridley, and loggerhead) were observed taken in the fishery. Take levels were highly variable, but generally high, with many observed trips taking no sea turtles, and other trips having as many as five takes. A more extensive, longer-term observer program is needed to adequately assess the extent and impact of the all components of the inshore North Carolina gillnet fishery on sea turtles. Therefore, NMFS is proposing to include this fishery on the 2010 AD.
The Southeast Atlantic gillnet fishery (779 estimated vessels/persons) targets finfish including, but not limited to, king mackerel, Spanish mackerel, whiting, bluefish, pompano, spot, croaker, little tunny, bonita, jack crevalle, cobia, and striped mullet. This fishery does not include gillnet effort targeting sharks as part of the Southeastern U.S. Atlantic shark gillnet fishery. This fishery uses gillnets set in sink, stab, set, or strike fashion. The fishery operates in waters south of a line extending due east from the North Carolina-South Carolina border and south and east of the fishery management council demarcation line between the Atlantic Ocean and the Gulf of Mexico. The majority of fishing effort occurs in Federal waters since South Carolina, Georgia, and Florida prohibit the use of gillnets, with limited exceptions, in state waters.
Fishing for king mackerel, Spanish mackerel, cobia, cero, and little tunny in Federal waters is managed under the Coastal Migratory Pelagic Resources FMP. None of the other target species are Federally-managed under the MSA. In state waters, state and ASMFC Interstate FMPs apply.
This fishery is classified as Category II on the MMPA LOF, which authorizes NMFS to observe this fishery in state and federal waters for marine mammal interactions, and to collect information on sea turtles should a take occur on an observed trip. NMFS has previously observed this fishery at moderate levels, primarily focused on target catch and bycatch species other than sea turtles. NMFS proposes to include this fishery on the 2010 to focus observer coverage during times and in areas where sea turtles are known to occur.
Turtles are known to become entangled in the end lines (also called vertical lines) of trap/pot gear and there have been anecdotal reports that sea turtles may interact with the trap/pot itself. Turtles entangled in trap/pot gear may drown or suffer injuries (and potential subsequent mortality) due to constriction by the rope or line. Takes of both leatherback and hard-shelled sea turtles have been documented in this gear type. NMFS Northeast Region established the Northeast Atlantic Sea Turtle Disentanglement Network (STDN) in 2002 to respond to entanglements in vertical lines associated with trap/pot gear.
Several states included trap/pot fisheries in their responses to NMFS' request for information and recommendations for the 2010 AD. Massachusetts listed pots (lobster, fish, whelk) as a gear type known to interact with sea turtles. New York recommended that fish, lobster, and crab pots be considered. Maryland ranked the commercial crab pot fishery that operates April through December as having a high possibility for interacting with sea turtles and a greater possibility for injury compared to other gear types in Maryland state waters. Maryland also ranked several other commercial pot fisheries (e.g., conch and fish) with a lower potential to interact with sea turtles. Maryland noted reports of sea turtles getting their heads caught in the gear while eating bait out of the trap/pot. Delaware included conch and blue crab trap/pot fisheries as having potential interactions with sea turtles where effort overlaps with sea turtle distribution. Both South Carolina and Florida included trap/pot fisheries in their recommendations and noted the potential for using an alternative platform program to observe this gear type.
Therefore, NMFS proposes to include the following four trap/pot fisheries, focusing on those fisheries or components of fisheries operating south of Massachusetts, as sea turtles more commonly occur in this area, on the 2010 AD.
The Atlantic blue crab trap/pot fishery (estimated >16,000 vessels/persons) targets blue crab using pots baited with fish or poultry typically set in rows in shallow water. The pot position is marked by either a floating or sinking buoy line attached to a surface buoy. The fishery occurs year-round from the south shore of Long Island at 72 30' W. long. in the Atlantic and east of the fishery management demarcation line between the Atlantic Ocean and the Gulf of Mexico (50 CFR 600.105), including state waters. The fishery is managed under state FMPs.
This fishery is classified as Category II on the MMPA LOF, which authorizes NMFS to observe this fishery for marine mammal interactions, and to collect information on sea turtles should a take occur on an observed trip. NMFS has not observed this fishery, but has documented 3 sea turtle takes in blue crab trap/pot gear in Virginia during the months of May and June. One of the events involved a leatherback and two involved loggerheads (STDN, unpublished data). NMFS proposes to include this fishery on the 2010 AD to target observer coverage more specifically to obtain information on sea turtle bycatch and how sea turtles may be interacting with trap/pot gear.
The Atlantic mixed species trap/pot fishery (unknown number of vessels/persons) targets species including, but not limited to, hagfish, shrimp, conch/whelk, red crab, Jonah crab, rock crab, black sea bass, scup, tautog, cod, haddock, pollock, redfish (ocean perch), white hake, spot, skate, catfish, and stone crab. This fishery as defined on the MMPA LOF also includes American eel as a target species; however, there is also a Category III American eel trap/pot fishery listed on the LOF. Therefore, NMFS does not consider American eel to be a target species in the Atlantic mixed species trap/pot fishery and will correct this oversight in a future LOF. The fishery includes all trap/pot operations from the Maine-Canada border south through the waters east of the fishery management demarcation line between the Atlantic Ocean and the Gulf of Mexico (50 CFR 600.105), but does not include the following trap/pot fisheries (as defined on the MMPA LOF): Northeast/Mid-Atlantic American lobster trap/pot; Atlantic blue crab trap/pot; Florida spiny lobster trap/pot; Southeastern U.S. Atlantic, Gulf of Mexico stone crab trap/pot; U.S. Mid-Atlantic eel trap/pot fisheries; and the Southeastern U.S. Atlantic, Gulf of Mexico golden crab fishery (68 FR 1421, January 10, 2003). The fishery is managed under various Interstate and Federal FMPs.
This fishery is classified as Category II on the MMPA LOF, which authorizes NMFS to observe this fishery in state and Federal waters for marine mammal interactions, and to collect information on sea turtles should a take occur on an observed trip. NMFS has previously observed this fishery at extremely low levels; no sea turtle takes have been documented by fishery observers. However, the NMFS STDN has documented 9 leatherback entanglements in trap/pot gear targeting sea bass in Massachusetts during the month of August from 2003 to 2008 (STDN, unpublished data). From 2003–2008, the STDN documented 1 green, 4 loggerhead, and 8 leatherback turtle takes in trap/pot gear targeting whelk in MA, VA, and NJ during May, June, July, August, and October.
NMFS is proposing to include this fishery in the 2010 AD to target observer coverage more specifically to obtain information on sea turtle interactions and how sea turtles may be interacting with trap/pot gear, particularly in waters off of Massachusetts and waters south of this area, as sea turtles more commonly occur in these areas.
The Northeast/Mid-Atlantic American lobster trap/pot fishery (estimated 13,000 vessels/persons) targets American lobster primarily with traps, while 2–3 percent of the target species is taken by mobile gear (trawls and dredges). The fishery operates in inshore and offshore waters from Maine to New Jersey and may extend as far south as Cape Hatteras, NC. Approximately 80 percent of American lobster is harvested from state waters; therefore, the ASMFC has the primary regulatory role. The fishery is managed in state waters under the ASMFC Interstate FMP and in Federal waters under the Atlantic Coastal Fisheries Cooperative Management Act.
This fishery is classified as Category I on the MMPA LOF, which authorizes NMFS to observe this fishery in state and Federal waters for marine mammal interactions, and to collect information on sea turtles should a take occur on an observed trip. NMFS has previously observed this fishery at extremely low levels; no sea turtle takes have been observed. However, NMFS STDN has documented 27 leatherback turtle entanglements in this fishery operating in ME, MA, and RI. These entanglements have occurred between June and October (STDN, unpublished data).
NMFS is proposing to include this fishery in the 2010 AD to target observer coverage more specifically to obtain information on sea turtle bycatch and how sea turtles may be interacting with trap/pot gear, particularly in waters off of Massachusetts and waters south of this area, as sea turtles more commonly occur in these areas.
Pound net, weir, and seine fisheries may use mesh similar to that used in gillnets, but the gear is prosecuted differently from traditional gillnets. For example, pound net leaders have a mesh component similar to a gillnet; sea turtles have been documented entangled in pound net leaders. Pound net leaders in the Virginia portion of the Chesapeake Bay are subject to requirements designed to reduce sea turtle bycatch. Purse seines and weirs also have the potential to entangle and drown sea turtles.
Several states included pound net/weir/seine fisheries in their responses to NMFS' request for information and recommendations for the 2010 AD. Massachusetts listed pound nets/weirs as a gear type known to interact with sea turtles. Maryland noted that sea turtles have been documented alive and uninjured in the pounds, but none have been documented in pound net leaders. Virginia recognized both historical observations of interactions in this fishery as well as current regulations in the fishery (69 FR 24997, May 5, 2004; 71 FR 36024, June 23, 2006). North Carolina noted pound nets operating in estuarine waters in their recommendations.
Therefore, based on the information provided by states and the best available scientific information, NMFS proposes to include the following four pound net/weir/seine fisheries on the 2010 AD.
The Mid-Atlantic haul/beach seine fishery (estimated >221 vessels/persons) targets striped bass, mullet, spot, weakfish, sea trout, bluefish, kingfish, and harvest fish using seines with one end secured (e.g., swipe nets and long seines) and seines secured at both ends or those anchored to the beach and hauled up on the beach. The beach seine system also uses a bunt and a wash net that are attached to the beach and extend into the surf. The beach seines soak for less than 2 hours. The fishery occurs in waters west of 72° 30' W. long. and north of a line extending due east from the North Carolina-South Carolina border. Fishing on the Outer Banks, NC, occurs primarily in the spring (April to June) and fall (October to December). In the Chesapeake Bay, this gear has been historically fished in the southwest portion of the Bay with some effort in the northwest portion. Effort begins to increase in early May, peaks in early/mid-June, and continues into July. During this time, based on historical data from Virginia, approximately 100 haul seine trips occur.
The fishery is managed under the Interstate FMPs for Bluefish and for Atlantic Striped Bass of the Atlantic Coast from Maine through North Carolina, and is subject to Bottlenose Dolphin Take Reduction Plan implementing regulations.
This fishery is classified as Category II on the MMPA LOF, which authorizes NMFS to observe this fishery for marine mammal interactions, and to collect information on sea turtles should a take occur on an observed trip. NMFS has previously observed this fishery at low levels; no sea turtle takes have been observed. NMFS proposes to include this fishery on the 2010 AD based on suspected interactions with sea turtles given the nature of the gear and fishing methodology in addition to effort overlapping with sea turtle distribution. In the Chesapeake Bay, the fishery operates at the same time as historically elevated sea turtle strandings.
The Mid-Atlantic menhaden purse seine fishery (22 estimated vessels/persons) targets menhaden and thread herring using purse seine gear. Most sets occur within 3 mi (4.8 km) of shore with the majority of the effort occurring off North Carolina from November to January, and moving northward during warmer months to southern New England. The fishery is managed under the Interstate FMP for Atlantic Menhaden. In the Chesapeake Bay, this fishery operates to a limited extent during a period of high sea turtle strandings (May and June).
This fishery is classified as Category II on the MMPA LOF, which authorizes NMFS to observe this fishery for marine mammal interactions, and to collect information on sea turtles should a take occur on an observed trip. NMFS recently began observing the fishery at low levels. NMFS proposes to include this fishery on the 2010 AD to focus observer coverage in times and areas of sea turtle distribution and learn more about the interactions between this fishery and sea turtles.
The Virginia pound net fishery (estimated 41 vessels/persons) targets species including, but not limited to, croaker, menhaden, mackerel, weakfish, and spot, using stationary gear in nearshore Virginia waters, primarily in the Chesapeake Bay and its tributaries. Pound net gear includes a leader posted perpendicular to the shoreline and extending outward to the “heart,” which funnels the fish into the pound, where the catch accumulates. This fishery includes all pound net effort in Virginia State waters, including waters inside the Chesapeake Bay. The fishery is managed under Interstate FMPs for Atlantic Croaker and Spot.
The Virginia pound net fishery is currently classified as Category II on the MMPA LOF, which authorizes NMFS to observe this fishery for marine mammal interactions, and to collect information on sea turtles should a take occur on an observed trip. Loggerhead, Kemp's ridley, leatherback, and green turtles have been observed taken in this fishery. Between 2002 and 2004, approximately 2,650 surveys of leaders were completed in the Virginia pound net fishery; 27 takes of sea turtles were recorded during the survey.
NMFS currently requires the use of a modified pound net leader in certain areas of the VA Chesapeake Bay to reduce entanglements of sea turtles in this gear type (71 FR 36024, June 23, 2006). This fishery operates at the same time as historically elevated sea turtle strandings. NMFS proposes to include this fishery on the 2010 AD to assess interactions between pound net gear and sea turtles and to evaluate the effectiveness of the modified gear. Because some vessels in this fishery may be too small to carry observers, NMFS would consider observing the fishery using both traditional methods as well as an alternative platform.
The Mid-Atlantic mixed species stop seine/weir/pound net fishery (estimated 751 vessels/persons) targets several species, including, but not limited to, weakfish, striped bass, shark, catfish, menhaden, flounder, gizzard shad, and white perch. The fishery uses fixed or staked net gear (pound net, weir, staked trap) from Nantucket Sound to Chesapeake Bay (60 FR 31681, June 16, 1995); the Virginia pound net and the NC roe mullet stop net fisheries are not included as part of this fishery.
This fishery is classified as Category III on the MMPA LOF and has never been observed. However, sea turtle takes have been documented in pound net gear in NY, MD, VA, and NC by NMFS, STSSN, and other researchers. NMFS proposes to include this fishery on the 2010 to better understand the nature
The Chief Counsel for Regulation of the Department of Commerce certified to the Chief Counsel for Advocacy of the Small Business Administration that this rule would not have a significant economic impact on a substantial number of small entities. The factual basis leading to the certification is set forth below.
NMFS has estimated that approximately 65,940 vessels participating in 19 fisheries listed in Table 1 would be eligible to carry an observer if requested. However, NMFS would only request a fraction of the total number of participants to carry an observer based on the sampling protocol identified for each fishery by regional observer programs. As noted throughout this proposed rule, NMFS would select vessels and focus coverage in times and areas where fishing effort overlaps with sea turtle distribution. Due to the unpredictability of fishing effort, NMFS cannot determine the specific number of vessels that would be requested to carry an observer.
If a vessel is requested to carry an observer, fishers will not incur any direct economic costs associated with carrying that observer. Potential indirect costs to individual fishers required to take observers may include: lost space on deck for catch, lost bunk space, and lost fishing time due to time needed to process bycatch data. For effective monitoring, however, observers will rotate among a limited number of vessels in a fishery at any given time and each vessel within an observed fishery has an equal probability of being requested to accommodate an observer. Therefore, the potential indirect costs to individual fishers are expected to be minimal because observer coverage would only be required for a small percentage of an individual's total annual fishing time. In addition, 50 CFR 222.404(b) states that an observer will not be placed on a vessel if the facilities for quartering an observer or performing observer functions are inadequate or unsafe, thereby exempting vessels too small to accommodate an observer from this requirement. As a result of this certification, an initial regulatory flexibility analysis is not required and was not prepared.
This proposed rule would amend an existing collection-of-information that was approved by the Office of Management and Budget (OMB) under OMB control number 0648–0593. This requirement will be submitted to OMB for approval. This proposed rule would add an estimated 853 participants and an estimated maximum 60 burden hours to the associated information collection.
Public comment is sought regarding: whether this proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the burden estimate; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the collection of information, including through the use of automated collection techniques or other forms of information technology. Send comments on these or any other aspects of the collection of information to (enter office name) at the
Notwithstanding any other provision of the law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the requirements of the Paperwork Reduction Act, unless that collection of information displays a currently valid OMB Control Number.
This proposed rule has been determined to be not significant for the purposes of Executive Order 12866.
An environmental assessment (EA) was prepared under the National Environmental Policy Act (NEPA) for regulations to implement this observer requirement in 50 CFR part 222, subpart D. The EA concluded that implementing these regulations would not have a significant impact on the human environment. This proposed rule would not make any significant change in the management of fisheries included on the AD, and therefore, this proposed rule would not change the analysis or conclusion of the EA. If NMFS takes a management action, for example, requiring fishing gear modifications such as TEDs, NMFS would first prepare an environmental document as
This proposed rule would not affect species listed as threatened or endangered under the Endangered Species Act (ESA) or their associated critical habitat. The impacts of numerous fisheries have been analyzed in various biological opinions, and this proposed rule would not affect the conclusions of those opinions. The inclusion of fisheries on the AD is not considered to be a management action that would adversely affect threatened or endangered species. If NMFS takes a management action, for example, requiring modifications to fishing gear and/or practices, NMFS would review the action for potential adverse affects to listed species under the ESA.
This proposed rule would have no adverse impacts on sea turtles and may have a positive impact on sea turtles by improving knowledge of sea turtles and the fisheries interacting with sea turtles through information collected from observer programs.
This proposed rule would not affect the land or water uses or natural resources of the coastal zone, as specified under section 307 of the Coastal Zone Management Act.
Lutcavage, M. E. and P.L. Lutz. 1997. Diving Physiology. In: P.L. Lutz and J. Musick (eds.) The Biology of Sea Turtles. ERC Press, Boca Raton, F.L. 432 pp.
Murray K.T. 2008. Estimated average annual bycatch of loggerhead sea turtles (
Murray K.T. 2007. Estimated bycatch of loggerhead sea turtles (
Murray, K.T. 2009. Characteristics and magnitude of sea turtle bycatch in US mid-Atlantic gillnet gear. Endangered Species Research 8:211–224.
National Marine Fisheries Service. 2009. Draft 2009 Marine Mammal Stock Assessment Reports for the Atlantic Ocean and Gulf of Mexico.
Food and Nutrition Service (FNS), USDA.
Notice.
In accordance with the Paperwork Reduction Act of 1995, this notice invites the general public and other public agencies to comment on this proposed information collection. This is a revision of a currently approved collection for the Senior Farmers' Market Nutrition Program (SFMNP).
Written comments must be received on or before January 19, 2010.
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions that were used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on those who are to respond, including use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Comments may be sent to: Sandra Clark, Chief, Policy and Program Development Branch, Food and Nutrition Service, U.S. Department of Agriculture, 3101 Park Center Drive, Room 528, Alexandria, VA 22302. Comments may also be submitted via fax to the attention of Margarita Ray at 703–305–2746 or via e-mail to
All written comments will be open for public inspection at the office of the Food and Nutrition Service during regular business hours (8:30 a.m. to 5 p.m. Monday through Friday) at 3101 Park Center Drive, Room 522, Alexandria, Virginia 22302.
All responses to this notice will be summarized and included in the request for Office of Management and Budget approval. All comments will be a matter of public record.
Requests for additional information or copies of this information collection should be directed to Sandra Clark, Chief, Policy and Program Development Branch at 703–305–2746.
USDA published a final rulemaking on the SFMNP on December 6, 2006 (71 FR 74618), that contained an estimated information collection burden based on the rule's requirements for program operation and administration. The initial SFMNP information collection burden was approved by the Office of Management and Budget (OMB) for 3 years, effective January, 2007, under RIN 0584–0541. The Department is now soliciting comments on the accuracy and reasonableness of this estimated burden since the original SFMNP rulemaking.
The estimated time of response varies from 15 minutes to 40 hours depending on respondent group.
The estimated time of response varies from 15 minutes to 40 hours depending on respondent group.
Import Administration, International Trade Administration, Department of Commerce.
November 18, 2009.
Dennis McClure or George McMahon at (202) 482–5973 and (202) 482–1167, respectively; AD/CVD Operations, Office 3, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230.
On April 27, 2009, the Department of Commerce (the “Department”) initiated an administrative review of the antidumping duty order on brass sheet and strip from Germany with respect to Wieland–Werke AG (Wieland).
The period of review (POR) is March 1, 2008, through February 28, 2009. The preliminary results of this review are currently due no later than December 1, 2009.
Section 751(a)(3)(A) of the Tariff Act of 1930, as amended (the Act), requires the Department to make a preliminary determination within 245 days after the last day of the anniversary month of an order or finding for which a review is requested. Section 751(a)(3)(A) of the Act further states that if it is not practicable to complete the review within the time period specified, the administering authority may extend the 245–day period to issue its preliminary results by up to 120 days.
We determine that completion of the preliminary results of this review within the 245–day period is not practicable for the following reasons. This review requires the Department to gather and analyze a significant amount of information pertaining to the company's sales practices, manufacturing costs and corporate relationships, which is complicated due to the manner in which the inputs for making brass sheet and strip are purchased and the processes by which brass sheet and strip are sold. Furthermore, the respondent, Wieland, has proposed that the Department use an alternative cost methodology to account for the volatility in the material costs that affects our analysis and requires an examination of a significant amount of data. Given the number and complexity of issues in this case, and in accordance with section 751(a)(3)(A) of the Act, we are extending the time period for issuing the preliminary results of review by 120 days. Therefore, the preliminary results are now due no later than March 31, 2010. The final results continue to be due 120 days after the date of publication of the preliminary results.
We are issuing and publishing this notice in accordance with sections 751(a)(3)(A) and 777(i)(1) of the Act.
An application has been submitted to the Foreign-Trade Zones Board (the Board) by the Greater Metropolitan Area Foreign Trade Zone Commission (Minneapolis, Minnesota), grantee of FTZ 119, requesting special-purpose subzone status for the photo-electronic industrial sensor manufacturing facility of SICK, Inc. (SICK), located in Bloomington, Minnesota. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a–81u), and the regulations of the Board (15 CFR part 400). It was formally filed on November 10, 2009.
The SICK facility (300 employees/55,207 sq.ft./3.2 acres) is located at 6900 West 110th Street, Bloomington (Hennepin County), Minnesota. The facility is used to manufacture and distribute photo-electronic industrial automation sensors, safety systems, and automatic identification products (classified under HTSUS 8541.40) for the U.S. market and export. At full capacity the plant can manufacture up to 50,000 units annually. Activity under FTZ procedures would include manufacturing, testing, inspection, and packaging. Components to be purchased from abroad (representing about 30% of the value of the finished sensors) would include plates/sheets/film/foil of polycarbonates, fasteners, parts of circuit breakers, and electrical conductors (duty rate range: 2.6–8.5%). The application indicates that SICK would also admit foreign-origin photo-electronic sensors and related components to the proposed subzone for domestic distribution and export.
FTZ procedures could exempt SICK from customs duty payments on the foreign components used in export production. On domestic shipments, the company would be able to elect the duty rate that applies to finished photo-electronic sensors (free) for the foreign inputs noted above. Subzone status would further allow SICK to realize logistical benefits through the use of weekly customs entry procedures. Customs duties could possibly be deferred or reduced on foreign status production equipment. The application indicates that the savings from FTZ procedures would help improve the facility's international competitiveness.
In accordance with the Board's regulations, Pierre Duy of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the Board.
Public comment is invited from interested parties. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at the following address: Office of the Executive Secretary, Room 2111, U.S. Department of Commerce, 1401 Constitution Avenue, NW., Washington, DC 20230–0002. The closing period for receipt of comments is January 19, 2010. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to February 1, 2010.
A copy of the application will be available for public inspection at the Office of the Foreign-Trade Zones Board's Executive Secretary at the address listed above and in the “Reading Room” section of the Board's Web site, which is accessible via
An application has been submitted to the Foreign-Trade Zones Board (the Board) by the Cedar Rapids Airport Commission, grantee of FTZ 175, requesting special-purpose subzone status for the agricultural tractors, cabs, engines and components manufacturing facilities of Deere & Company (Deere), located in Waterloo, Iowa. The application was submitted pursuant to the provisions of the Foreign-Trade Zones Act, as amended (19 U.S.C. 81a-81u), and the regulations of the Board (15 CFR part 400). It was formally filed on November 12, 2009.
The Deere facilities (approximately 4,000 employees) consist of 6 sites on approximately 1,437.58 acres in Waterloo, Iowa:
FTZ procedures could exempt Deere from customs duty payments on the foreign components used in export production. The company anticipates that some 30 to 35 percent of the facilities' shipments will be exported. On its domestic sales, Deere would be able to choose the duty rates during customs entry procedures that apply to its finished products (duty rates range between free and 8.6%) for the foreign inputs noted above. FTZ designation would further allow Deere to realize scrap benefits and certain logistical benefits through the use of customs procedures. Customs duties also could possibly be deferred or reduced on foreign status production equipment. The request indicates that the savings from FTZ procedures would help improve the plant's international competitiveness.
In accordance with the Board's regulations, Diane Finver of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the Board.
Public comment is invited from interested parties. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is January 19, 2010. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to February 1, 2010.
A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 2111, U.S. Department of Commerce, 1401 Constitution Avenue, NW., Washington, DC 20230–0002, and in the “Reading Room” section of the Board's Web site, which is accessible via
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that Robert Pilley, Leighside, Bridge Road, Leighwoods, Bristol, BS8 3PB, United Kingdom, has applied in due form for a permit to conduct commercial/educational photography of bottlenose dolphins (
Written, telefaxed, or e-mail comments must be received on or before December 18, 2009.
The application and related documents are available for review upon written request or by appointment in the following offices:
Permits, Conservation and Education Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301)713–2289; fax (301)713–0376; and
Southeast Region, NMFS, 263 13th Avenue South, Saint Petersburg, Florida 33701; phone (727)824–5312; fax (727)824–5309.
Written comments or requests for a public hearing on this application
Comments may also be submitted by facsimile at (301)713–0376, provided the facsimile is confirmed by hard copy submitted by mail and postmarked no later than the closing date of the comment period.
Comments may also be submitted by e-mail. The mailbox address for providing e-mail comments is
Amy Hapeman or Carrie Hubard, (301)713–2289.
The subject permit is requested under the authority of section 104(c)(6) of the Marine Mammal Protection Act of 1972, as amended (16 U.S.C. 1361
Mr. Pilley requests a two-year photography permit to film bottlenose dolphin strand feeding events in the estuaries and creeks of Bull Creek and around Hilton Head, South Carolina. Filmmakers plan to use four filming platforms: a static remotely operated camera placed on the mudflats, a radio-controlled camera helicopter, a radio-controlled camera glider, and a radio-controlled camera boat. Up to 128 dolphins annually may be approached and filmed. Filming will occur over 14 days and be completed by November 2010. Footage will be used to create a 6–part television series,
In compliance with the National Environmental Policy Act of 1969 (42 U.S.C. 4321
Concurrent with the publication of this notice in the
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice; receipt of application.
Notice is hereby given that NMFS Southwest Fisheries Science Center, 3333 North Torrey Pines Court, La Jolla, CA 92037–1023, has applied in due form for a permit to take green (
Written, telefaxed, or e-mail comments must be received on or before December 18, 2009.
The application and related documents are available for review by selecting “Records Open for Public Comment” from the Features box on the Applications and Permits for Protected Species (APPS) home page,
Permits, Conservation and Education Division, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910; phone (301)713–2289; fax (301)713–0376; and
Southwest Region, NMFS, 501 West Ocean Blvd., Suite 4200, Long Beach, CA 90802–4213; phone (562)980–4001; fax (562)980–4018.
Written comments or requests for a public hearing on this application should be mailed to the Chief, Permits, Conservation and Education Division, F/PR1, Office of Protected Resources, NMFS, 1315 East-West Highway, Room 13705, Silver Spring, MD 20910. Those individuals requesting a hearing should set forth the specific reasons why a hearing on this particular request would be appropriate.
Comments may also be submitted by facsimile at (301)713–0376, provided the facsimile is confirmed by hard copy submitted by mail and postmarked no later than the closing date of the comment period.
Comments may also be submitted by e-mail. The mailbox address for providing e-mail comments is
Patrick Opay or Kate Swails, (301)713–2289.
The subject permit is requested under the authority of the Endangered Species Act of 1973, as amended (ESA; 16 U.S.C. 1531
The purpose of the proposed research project is to initiate a baseline study of the status of sea turtles in the San Gabriel River and Alamitos Bay in Long Beach, California. Researchers would also opportunistically take samples and potentially track sea turtles incidentally taken in coastal power plants off California and that strand live in the marine environment. The applicant would study abundance, size ranges, growth, sex ratio, health status, diving behavior, local movements, habitat use, migration routes, and contaminant levels. Researchers would track the movements of healthy turtles released off the coast of California to determine their movements locally and/or offshore. Researchers would annually capture, measure, weigh, photograph/video, flipper tag, passive integrated transponder tag (PIT), tissue biopsy, blood sample, scute scrape, lavage, ultrasound, oral swab, cloacal swab, inject tetracycline, and release up to 35 green, six loggerhead, and six olive ridley sea turtles during captures as part of the San Gabriel and Los Alamitos Bay California project. Fifteen of the 35 green sea turtles would have a sonic transmitter attached, five of the green sea turtles would have a satellite transmitter attached, five would have a sonic transmitter and camera attached, and five would have a sonic transmitter and time depth recorder attached. One of the loggerhead sea turtles and two of the olive ridley sea turtles would also have a satellite transmitter attached.
Researchers would also annually measure, weigh, photograph/video, flipper tag, PIT tag, tissue biopsy, blood sample, scute scrape, lavage, ultrasound, oral swab, cloacal swab, inject tetracycline, transport, and release up to ten green, one olive ridley, and three loggerhead sea turtles taken in power plant entrainments. Three of the loggerheads, the one olive ridley, and one of the loggerhead sea turtles would also have a satellite transmitter attached. Researchers would also have authority to salvage, necropsy, and sample animals that die as a result of entrainment.
Researches would also annually measure, weigh, photograph/video, flipper tag, PIT tag, tissue biopsy, blood sample, scute scrape, lavage, ultrasound, oral swab, cloacal swab, transport, and release up to four green, one olive ridley, one loggerhead, and two leatherback sea turtles that strand in the marine environment. One of the green, the olive ridley, and the loggerhead would have a satellite transmitter attached. The leatherbacks would have a camera attached. Researchers would also have authority to authority to salvage, necropsy, and sample animals that die as a result of stranding. The applicant requests a five year permit.
Import Administration, International Trade Administration, Department of Commerce.
Elfi Blum, AD/CVD Operations, Office 6, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington DC 20230; telephone: (202) 482–0197.
On August 25, 2009, the Department of Commerce (the Department) initiated an administrative review of the countervailing duty (CVD) order on PET Film from India covering one producer/exporter of subject merchandise, Jindal Poly Films Limited of India (Jindal), for the period January 1, 2008, through December 31, 2008.
The Department's regulations at 19 CFR 351.213(d)(1) provide that the Department will rescind an administrative review if the party that requested the review withdraws its request for review within 90 days of the date of publication of the notice of initiation of the requested review, or withdraws its request at a later date if the Department determines that it is reasonable to extend the time limit for withdrawing the request. Jindal submitted its request within the 90 day limit set by the regulations. Since no other parties requested a review of Jindal, the Department is rescinding, the administrative review of the countervailing duty order on PET Film from India for the period January 1, 2008, through December 31, 2008, for Jindal.
The Department will instruct U.S. Customs and Border Protection (CBP) to assess countervailing duties on all appropriate entries. Jindal shall be assessed countervailing duty rates equal to the cash deposit of the estimated countervailing duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department will issue appropriate assessment instructions directly to CBP within 15 days of publication of this notice.
This notice serves as a final reminder to importers for whom this review is being rescinded of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO materials or conversion to judicial protective order is hereby requested. Failure to comply with the regulations and terms of an APO is a violation which may be subject to sanctions.
This notice is issued and published in accordance with section 777(i)(1) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.213(d)(4).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The Gulf of Mexico Fishery Management Council will convene a meeting of its Ecosystem Scientific and Statistical Committee.
The Ecosystem and Statistical Committee meeting will begin at 1 p.m. on Monday, December 7, 2009 and conclude by 12 p.m. on Tuesday, December 8, 2009. The meeting will be webcast over the internet. A link to the webcast will be available on the Council's web site, http://www.gulfcouncil.org.
The meeting will be held at the Crowne Plaza, 5303 W. Kennedy Blvd., Tampa, FL 33609.
Dr. Karen Burns, Ecosystems Management Specialist, Gulf of Mexico Fishery Management Council; telephone: (813) 348–1630.
The Ecosystem and Statistical Committee will begin developing a conceptual framework for advancing an ecosystem approach for fishery management. They will also explore the use of ecological attributes in the Allowable Biological Catch Control Rule. There will also be an evaluation on the efficacy of various models and approaches to determine how recovering red snapper interact with vermilion snapper and groupers and future data and research needs for these models.
Copies of the agendas and other related materials can be obtained by calling (813) 348–1630 or can be downloaded from the Council's ftp site,
Although other non-emergency issues not on the agendas may come before the and Statistical Committee for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during these meetings. Actions of the and Statistical Committee will be restricted to those issues specifically identified in the agendas and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act, provided the public has been notified of the Council's intent to take action to address the emergency.
These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Tina O'Hern at the Council (see
Department of the Navy, DOD.
Notice.
The U.S. Naval Academy Board of Visitors will meet to make such inquiry, as the Board shall deem necessary into the state of morale and discipline, the curriculum, instruction, physical equipment, fiscal affairs, and academic methods of the Naval Academy. The executive session of this meeting from 11 a.m. to 12 p.m. on December 7, 2009, will include discussions of disciplinary matters, law enforcement investigations into allegations of criminal activity, and personnel-related issues at the Naval Academy, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. For this reason, the executive session of this meeting will be closed to the public.
The open sessions of the meeting will be held on Monday, December 7, 2009, from 8 a.m. to 11 a.m. The closed session of this meeting will be the executive session held from 11 a.m. to 12 p.m. on December 7, 2009.
The meeting will be held in the Bo Coppedge Room of Alumni Hall, U.S. Naval Academy, Annapolis, MD. The meeting will be handicap accessible.
Lieutenant Commander David S. Forman, USN, Executive Secretary to the Board of Visitors, Office of the Superintendent, U.S. Naval Academy, Annapolis, MD 21402–5000, (410) 293–1503.
This notice of meeting is provided per the Federal Advisory Committee Act, as amended (5 U.S.C. App.). The executive session of the meeting from 11 a.m. to 12 p.m. on December 7, 2009, will consist of discussions of law enforcement investigations into allegations of criminal activity, new and pending administrative/minor disciplinary infractions and nonjudicial punishments involving the Midshipmen attending the Naval Academy to include but not limited to individual honor/conduct violations within the Brigade, and personnel-related issues. The discussion of such information cannot be adequately segregated from other topics, which precludes opening the executive session of this meeting to the public. Accordingly, the Secretary of the Navy has determined in writing that the meeting shall be partially closed to the public because the discussions during the executive session from 11 a.m. to 12 p.m. will be concerned with matters coming under sections 552b(c)(5), (6), and (7) of title 5, United States Code.
These priorities are:
This priority is:
Applications that focus on language instruction in any of the following seventy-eight (78) languages selected from the U.S. Department of Education's list of Less Commonly Taught Languages (LCTLs):
Akan (Twi-Fante), Albanian, Amharic, Arabic (all dialects), Armenian, Azeri (Azerbaijani), Balochi, Bamanakan (Bamana, Bambara, Mandikan, Mandingo, Maninka, Dyula), Belarusian, Bengali (Bangla), Berber (all languages), Bosnian, Bulgarian, Burmese, Cebuano (Visayan), Chechen, Chinese (Cantonese), Chinese (Gan), Chinese (Mandarin), Chinese (Min), Chinese (Wu), Croatian, Dari, Dinka, Georgian, Gujarati, Hausa, Hebrew (Modern), Hindi, Igbo, Indonesian, Japanese, Javanese, Kannada, Kashmiri, Kazakh, Khmer (Cambodian), Kirghiz, Korean, Kurdish (Kurmanji), Kurdish (Sorani), Lao, Malay (Bahasa Melayu or Malaysian), Malayalam, Marathi, Mongolian, Nepali, Oromo, Panjabi, Pashto, Persian (Farsi), Polish, Portuguese (all varieties), Quechua, Romanian, Russian, Serbian, Sinhala (Sinhalese), Somali, Swahili, Tagalog, Tajik, Tamil, Telugu, Thai, Tibetan, Tigrigna, Turkish, Turkmen, Ukrainian, Urdu, Uyghur/Uigur, Uzbek, Vietnamese, Wolof, Xhosa, Yoruba, and Zulu.
20 U.S.C. 1130–1130b.
The regulations in 34 CFR part 86 apply to institutions of higher education only.
Also included on these Web sites and links are the specific recommendations the Secretary received from Federal agencies.
The Department is not bound by any estimates in this notice.
1.
2.
1.
If you use a telecommunications device for the deaf (TDD), call the Federal Relay Service (FRS), toll free, at 1–800–877–8339.
Individuals with disabilities can obtain a copy of the application package in an accessible format (
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• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides. Page numbers and an identifier may be outside of the 1” margin.
• Double space (no more than three lines per vertical inch) all text in the application narrative, except titles, headings, footnotes, quotations, references, captions, and all text in charts, tables, figures, and graphs. These items may be single-spaced. Charts, tables, figures, and graphs in the application narrative count toward the page limit.
• Use a font that is either 12 point or larger or no smaller than 10 pitch (characters per inch). However, you may use a 10 point font in charts, tables, figures, and graphs.
• Use one of the following fonts: Times New Roman, Courier, Courier New, or Arial. An application submitted in any other font (including Times Roman and Arial Narrow) will not be accepted.
The page limit does not apply to Part I, the Application for Federal Assistance face sheet (SF 424); the supplemental information form required by the Department of Education; Part II, the budget information summary form (ED Form 524); or Part IV, the assurances and certifications. The page limit also does not apply to a table of contents.
We will reject your application if you exceed the page limit.
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Applications for grants under this program must be submitted electronically using the Electronic Grant Application System (e-Application) accessible through the Department's e-Grants site. For information (including dates and times) about how to submit your application electronically, or in paper format by mail or hand delivery if you qualify for an exception to the electronic submission requirement, please refer to Section IV. 7.
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Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
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Applications for grants under the BIE Program—CFDA number 84.153A must be submitted electronically using e-Application, accessible through the Department's e-Grants Web site at:
We will reject your application if you submit it in paper format unless, as described elsewhere in this section, you qualify for one of the exceptions to the electronic submission requirement and submit, no later than two weeks before the application deadline date, a written statement to the Department that you qualify for one of these exceptions. Further information regarding calculation of the date that is two weeks before the application deadline date is provided later in this section under
While completing your electronic application, you will be entering data online that will be saved into a database. You may not e-mail an electronic copy of a grant application to us.
Please note the following:
• You must complete the electronic submission of your grant application by 4:30:00 p.m., Washington, DC time, on the application deadline date. E-Application will not accept an application for this program after 4:30:00 p.m., Washington, DC time, on the application deadline date. Therefore, we strongly recommend that you do not wait until the application deadline date to begin the application process.
• The hours of operation of the e-Grants Web site are 6:00 a.m. Monday until 7:00 p.m. Wednesday; and 6:00 a.m. Thursday until 8:00 p.m. Sunday, Washington, DC time. Please note that, because of maintenance, the system is unavailable between 8:00 p.m. on Sundays and 6:00 a.m. on Mondays, and between 7:00 p.m. on Wednesdays and 6:00 a.m. on Thursdays, Washington, DC time. Any modifications to these hours are posted on the e-Grants Web site.
• You will not receive additional point value because you submit your application in electronic format, nor will we penalize you if you qualify for an exception to the electronic submission requirement, as described elsewhere in this section, and submit your application in paper format.
• You must submit all documents electronically, including all information you typically provide on the following forms: The Application for Federal Assistance (SF 424), the Department of Education Supplemental Information for SF 424, Budget Information—Non-Construction Programs (ED 524), and all necessary assurances and certifications. You must attach any narrative sections of your application as files in a .DOC (document), .RTF (rich text), or .PDF (Portable Document) format. If you upload a file type other than the three file types specified in this paragraph or submit a password protected file, we will not review that material.
• Your electronic application must comply with any page limit requirements described in this notice.
• Prior to submitting your electronic application, you may wish to print a copy of it for your records.
• After you electronically submit your application, you will receive an automatic acknowledgment that will include a PR/Award number (an identifying number unique to your application).
• Within three working days after submitting your electronic application, fax a signed copy of the SF 424 to the Application Control Center after following these steps:
(1) Print SF 424 from e-Application.
(2) The applicant's Authorizing Representative must sign this form.
(3) Place the PR/Award number in the upper right hand corner of the hard-copy signature page of the SF 424.
(4) Fax the signed SF 424 to the Application Control Center at (202) 245–6272.
• We may request that you provide us original signatures on other forms at a later date.
(1) You are a registered user of e-Application and you have initiated an electronic application for this competition; and
(2)(a) E-Application is unavailable for 60 minutes or more between the hours of 8:30 a.m. and 3:30 p.m., Washington, DC time, on the application deadline date; or
(b) E-Application is unavailable for any period of time between 3:30 p.m. and 4:30:00 p.m., Washington, DC time, on the application deadline date.
We must acknowledge and confirm these periods of unavailability before granting you an extension. To request
• You do not have access to the Internet; or
• You do not have the capacity to upload large documents to e-Application; and
• No later than two weeks before the application deadline date (14 calendar days or, if the fourteenth calendar day before the application deadline date falls on a Federal holiday, the next business day following the Federal holiday), you mail or fax a written statement to the Department, explaining which of the two grounds for an exception prevents you from using the Internet to submit your application. If you mail your written statement to the Department, it must be postmarked no later than two weeks before the application deadline date. If you fax your written statement to the Department, we must receive the faxed statement no later than two weeks before the application deadline date.
Address and mail or fax your statement to: Tanyelle Richardson, Business and International Education Program, U.S. Department of Education, 1990 K Street, NW., room 6017, Washington, DC 20006–8521. FAX: (202) 502–7860.
Your paper application must be submitted in accordance with the mail or hand delivery instructions described in this notice.
b.
If you qualify for an exception to the electronic submission requirement, you may mail (through the U.S. Postal Service or a commercial carrier) your application to the Department. You must mail the original and two copies of your application, on or before the application deadline date, to the Department at the following address:
You must show proof of mailing consisting of one of the following:
(1) A legibly dated U.S. Postal Service postmark.
(2) A legible mail receipt with the date of mailing stamped by the U.S. Postal Service.
(3) A dated shipping label, invoice, or receipt from a commercial carrier.
(4) Any other proof of mailing acceptable to the Secretary of the U.S. Department of Education.
If you mail your application through the U.S. Postal Service, we do not accept either of the following as proof of mailing:
(1) A private metered postmark.
(2) A mail receipt that is not dated by the U.S. Postal Service.
If your application is postmarked after the application deadline date, we will not consider your application.
The U.S. Postal Service does not uniformly provide a dated postmark. Before relying on this method, you should check with your local post office.
c.
If you qualify for an exception to the electronic submission requirement, you (or a courier service) may deliver your paper application to the Department by hand. You must deliver the original and two copies of your application, by hand, on or before the application deadline date, to the Department at the following address:
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays.
If you mail or hand deliver your application to the Department—
(1) You must indicate on the envelope and—if not provided by the Department—in Item 11 of the SF 424 the CFDA number, including suffix letter, if any, of the competition under which you are submitting your application; and
(2) The Application Control Center will mail to you a notification of receipt of your grant application. If you do not receive this grant notification within 15 business days from the application deadline date, you should call the U.S. Department of Education Application Control Center at (202) 245–6288.
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If your application is not evaluated or not selected for funding, we notify you.
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We reference the regulations outlining the terms and conditions of an award in the
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The Department will use the following BIE measures to evaluate its success in meeting this objective:
The Department will use information provided by grantees in their performance reports submitted via IRIS as the source of data for these measures. Reporting screens for institutions can be viewed at:
If you use a TDD, call the FRS, toll free, at 1–800–877–8339.
The official version of this document is the document published in the
U.S. Department of Energy.
Notice.
The Department of Energy (DOE) invites public comment on a proposed collection of information that DOE is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995.
Comments regarding this proposed information collection must be received on or before January 19, 2010. If you anticipate difficulty in submitting comments within that period, contact the person listed in
Written comments may be sent to Johanna Zetterberg, U.S. Department of Energy, EE–2K/Forrestal Building, 1000 Independence Ave., SW., Washington, DC 20585 or by fax at 202–586–1233, or by e-mail at
Requests for additional information or copies of the information collection instrument and instructions should be directed to Jody Barringer at
The Energy Efficiency and Conservation Block Grant program is a newly established program authorized by the Energy Independence and Security Act of 2007 (Pub. L. 110–140) and funded under the American Recovery and Reinvestment Act (Pub. L. 111–5). The program provides grants to states, territories, local governments and Native American tribal governments to fund programs that reduce energy use and fossil fuel emissions and increase energy efficiency. The information collected will be used to track the recipients' activities, their progress in achieving program objectives, and funds expended (including expenditure rates). The information will also enable DOE to provide timely information on program activities and accomplishments to OMB, Congress and the public. The President's pledge of transparency and accountability in the expenditure of ARRA funds makes this information especially important.
Comments submitted in response to this notice will be summarized and/or included in the request for OMB approval of this information collection; they also will become a matter of public record.
Title V, Subtitle E of the Energy Independence and Security Act (EISA), Public Law 110–140.
Office of Electricity Delivery and Energy Reliability, DOE.
Notice of Application.
NorthPoint Energy Solutions Inc. (NorthPoint) has applied to renew its authority to transmit electric energy from the United States to Canada pursuant to section 202(e) of the Federal Power Act.
Comments, protests, or requests to intervene must be submitted on or before December 18, 2009.
Comments, protests or requests to intervene should be addressed as follows: Office of Electricity Delivery and Energy Reliability, Mail Code: OE–20, U.S. Department of Energy, 1000 Independence Avenue, SW., Washington, DC 20585–0350 (FAX 202–586–8008).
Ellen Russell (Program Office) 202–586–9624 or Michael Skinker (Program Attorney) 202–586–2793.
Exports of electricity from the United States to a foreign country are regulated by the Department of Energy (DOE) pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 7151(b), 7172(f)) and require authorization under section 202(e) of the FPA (16 U.S.C.824a(e)).
On April 8, 2003, DOE issued Order No. EA–275 authorizing NorthPoint to transmit electric energy from the United States to Canada as a power marketer using existing international electric transmission facilities for two years. On December 10, 2004, DOE issued Order No. EA–275–A, which renewed NorthPoint's authority for a five-year period, effective April 8, 2005. That authorization will expire on April 8, 2010. On November 2, 2009, NorthPoint filed an application with DOE to renew the export authority contained in Order No. EA–275–A and has requested a ten-year term.
The electric energy which NorthPoint proposes to export to Canada would be surplus energy purchased from electric utilities, Federal power marketing agencies and other entities within the United States. Each of the international transmission facilities to be utilized by NorthPoint has previously been authorized by a Presidential permit issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.
Comments on the NorthPoint application to export electric energy to Canada should be clearly marked with Docket No. EA–275–B. Additional copies are to be filed directly with Douglas F. John and Elizabeth A. Zembruski, John & Hengerer, 1730 Rhode Island Ave., NW., Suite 600, Washington, DC, 20036 and General Counsel of SaskPower—Law, Land and Regulatory Affairs, 2025 Victoria Ave., Regina, Saskatchewan, Canada S4P 0S1. A final decision will be made on this application after the environmental impacts have been evaluated pursuant to the National Environmental Policy Act of 1969, and a determination is made by DOE that the proposed action will not adversely impact on the reliability of the U.S. electric power supply system.
Copies of this application will be made available, upon request, for public inspection and copying at the address provided above, by accessing the program Web site at
Office of Electricity Delivery and Energy Reliability, DOE.
Notice of Application.
Under two separate applications, Constellation NewEnergy, Inc. (Constellation) has applied for authority to transmit electric energy from the United States to Mexico and from the United States to Canada pursuant to section 202(e) of the Federal Power Act.
Comments, protests, or requests to intervene must be submitted on or before December 18, 2009.
Comments, protests, or requests to intervene should be addressed as follows: Office of Electricity Delivery and Energy Reliability, Mail Code: OE–20, U.S. Department of Energy, 1000 Independence Avenue, SW., Washington, DC 20585–0350 (FAX 202–586–8008).
Ellen Russell (Program Office) 202–586–9624 or Michael Skinker (Program Attorney) 202–586–2793.
Exports of electricity from the United States to a foreign country are regulated by the Department of Energy (DOE) pursuant to sections 301(b) and 402(f) of the Department of Energy Organization Act (42 U.S.C. 7151(b), 7172(f)) and require authorization under section 202(e) of the FPA (16 U.S.C. 824a(e)).
On November 13, 2001, DOE issued Order No. EA–247 authorizing Constellation to transmit electric energy from the United States to Mexico as a power marketer for a two year period. DOE has twice renewed Constellation's authority to export. The most recent authorization, in Order No. EA–247–B, will expire on April 8, 2010. On October 27, 2009, Constellation applied to DOE to renew the authorization contained in Order No. EA–247–B for an additional five-year term.
On November 26, 2001, DOE issued Order No. EA–248 which authorized Constellation to transmit electric energy from the United States to Canada as a power marketer. That Order was also twice-renewed and will expire on April 8, 2010. On October 27, 2009, Constellation applied to DOE to renew the authorization contained in Order No. EA–247–B for an additional five-year term.
The electric energy which Constellation proposes to export to Mexico and Canada would be surplus energy purchased from electric utilities, Federal power marketing agencies and other entities within the United States. Each of the international transmission facilities to be utilized by Constellation has previously been authorized by a Presidential permit issued pursuant to Executive Order 10485, as amended, and are appropriate for open access transmission by third parties.
Comments on the Constellation application to export electric energy to Mexico should be clearly marked with Docket No. EA–247–C. Comments on the Constellation application to export electric energy to Canada should be clearly marked with Docket No. EA–248–C. Additional copies are to be filed directly with Joseph Donovan, Senior Counsel, Constellation Energy Resources, LLC on behalf of Constellation NewEnergy, Inc., 111 Market Place, Suite 500, Baltimore, MD 21202. A final decision will be made on this application after the environmental impacts have been evaluated pursuant to the National Environmental Policy Act of 1969, and a determination is made by DOE that the proposed action will not adversely impact on the reliability of the U.S. electric power supply system.
Copies of these applications will be made available, upon request, for public inspection and copying at the address provided above, by accessing the program Web site at
Environmental Protection Agency (EPA).
Notice.
There will be a 4–day meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review Draft Framework and Case Studies on Atrazine, Human Incidents, and the Agricultural Health Study: Incorporation of Epidemiology and Human Incident Data into Human Health Risk Assessment.
The meeting will be held on February 2 – 5, 2010, from approximately 8:30 a.m. to 5 p.m.
The meeting will be held at the Environmental Protection Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.
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Myrta R. Christian, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (202) 564–8498; fax number: (202) 564–8382; e-mail address:
This action is directed to the public in general. This action may, however, be of interest to persons who are or may be required to conduct testing of chemical substances under the Federal Food, Drug, and Cosmetic Act (FFDCA), FIFRA, and the Food Quality Protection Act of 1996 (FQPA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the DFO listed under
When submitting comments, remember to:
1. Identify the document by docket ID number and other identifying information (subject heading,
2. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
3. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
4. Describe any assumptions and provide any technical information and/or data that you used.
5. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
6. Provide specific examples to illustrate your concerns and suggest alternatives.
7. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
8. Make sure to submit your comments by the comment period deadline identified.
You may participate in this meeting by following the instructions in this unit. To ensure proper receipt by EPA, it is imperative that you identify docket ID number EPA–HQ–OPP–2009–0851 in the subject line on the first page of your request.
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The selection of scientists to serve on FIFRA SAP is based on the function of the panel and the expertise needed to address the Agency's charge to the panel. No interested scientists shall be ineligible to serve by reason of their membership on any other advisory committee to a Federal department or agency or their employment by a Federal department or agency except the EPA. Other factors considered during the selection process include availability of the potential panel member to fully participate in the panel's reviews, absence of any conflicts of interest or appearance of lack of impartiality, independence with respect to the matters under review, and lack of bias. Although financial conflicts of interest, the appearance of lack of impartiality, lack of independence, and bias may result in disqualification, the absence of such concerns does not assure that a candidate will be selected
FIFRA SAP members are subject to the provisions of 5 CFR part 2634, Executive Branch Financial Disclosure, as supplemented by the EPA in 5 CFR part 6401. In anticipation of this requirement, prospective candidates for service on the FIFRA SAP will be asked to submit confidential financial information which shall fully disclose, among other financial interests, the candidate's employment, stocks and bonds, and where applicable, sources of research support. The EPA will evaluate the candidates financial disclosure form to assess whether there are financial conflicts of interest, appearance of a lack of impartiality or any prior involvement with the development of the documents under consideration (including previous scientific peer review) before the candidate is considered further for service on FIFRA SAP. Those who are selected from the pool of prospective candidates will be asked to attend the public meetings and to participate in the discussion of key issues and assumptions at these meetings. In addition, they will be asked to review and to help finalize the meeting minutes. The list of FIFRA SAP members participating at this meeting will be posted on the FIFRA SAP website at
FIFRA SAP serves as the primary scientific peer review mechanism of EPA's Office of Prevention, Pesticides and Toxic Substances (OPPTS) and is structured to provide scientific advice, information and recommendations to the EPA Administrator on pesticides and pesticide-related issues as to the impact of regulatory actions on health and the environment. FIFRA SAP is a Federal advisory committee established in 1975 under FIFRA that operates in accordance with requirements of the Federal Advisory Committee Act. FIFRA SAP is composed of a permanent panel consisting of seven members who are appointed by the EPA Administrator from nominees provided by the National Institutes of Health and the National Science Foundation. FIFRA, as amended by FQPA, established a Science Review Board consisting of at least 60 scientists who are available to the SAP on an ad hoc basis to assist in reviews conducted by the SAP. As a peer review mechanism, FIFRA SAP provides comments, evaluations and recommendations to improve the effectiveness and quality of analyses made by Agency scientists. Members of FIFRA SAP are scientists who have sufficient professional qualifications, including training and experience, to provide expert advice and recommendation to the Agency.
Data from epidemiology studies and human incident reports contain valuable information about human exposure and response to pesticides. This information can contribute to a weight of evidence analysis in the characterization of human health risks. Epidemiology and incident data do, however, pose challenges with respect to characterizing human health risks. EPA is convening a meeting of the FIFRA Scientific Advisory Panel (SAP) to discuss science issues related to using epidemiology and human incident data in human health risk assessment. The Office of Pesticide Programs (OPP) will solicit comment on a draft framework for implementing such data into human health risk assessment in addition to several case studies that illustrate scientific issues to be addressed at the SAP meeting. OPP's draft framework describes a weight of the evidence evaluation that uses the best available science on mode of action, exposure, pharmacokinetics, animal and human data from both
A case study on the evaluation of several epidemiology studies concerning atrazine will be presented. These epidemiology studies are either ecologic or retrospective cohort studies in design. OPP, in collaboration with EPA's Office of Water and Office of Research and Development (ORD), will solicit comment on the strengths and weaknesses of these types of epidemiology studies in addition to advice on the appropriate way to use such studies in the atrazine human health risk assessment. This case study is also the first step in EPA's atrazine science re-evaluation plan as described to the November 3, 2009 FIFRA SAP previously
A case study is also included to illustrate an analysis of reported human incident cases using diazinon; a pesticide that has historically been used in residential settings.
Additionally, a case study concerning the collaborative work by scientists from OPP, ORD, and the National Cancer Institute (NCI) and the National Institute of Environmental Health Sciences (NIEHS) on the Agricultural Health Study (AHS) will be presented to: Compare the exposure algorithms used by OPP and the AHS, and; consider temporal relationships for multi-chemical exposure in the AHS. The purpose of on-going work to compare the OPP and AHS exposure algorithms is to better understand differences and similarities in the two approaches to estimating worker exposure. Evaluation of temporal relationships for multi-chemical exposure in the AHS will involve information on the timing of uses and combined uses of pesticides, with particular emphasis on pesticides which share the same mode of action. The Agency will solicit advice on types of evaluations conducted to date and those being proposed with the third case study.
The FIFRA SAP's advice will provide the Agency with input on approaches to integrate diverse types of experimental toxicology and epidemiology data. The SAP input will be considered in characterizing atrazine's human health risks which will be presented to the SAP in September 2010.
EPA's background paper, related supporting materials, charge/questions to FIFRA SAP, FIFRA SAP composition (i.e., members and ad hoc members for this meeting), and the meeting agenda will be available by early January. In addition, the Agency may provide additional background documents as the materials become available. You may obtain electronic copies of these documents, and certain other related documents that might be available electronically, at
FIFRA SAP will prepare meeting minutes summarizing its recommendations to the Agency approximately 90 days after the meeting. The meeting minutes will be posted on the FIFRA SAP website or may be obtained from the OPP Regulatory Public Docket at
Environmental protection, Pesticides and pests.
Environmental Protection Agency (EPA).
Notice.
This notice announces receipt of applications to register pesticide products containing new active ingredients not included in any currently registered products pursuant to the provisions of section 3(c)(4) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended.
Comments must be received on or before December 18, 2009.
Submit your comments, identified by docket identification (ID) number EPA–HQ–OPP–2009–0184, by one of the following methods:
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Tamue L. Gibson, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 305–9096; e-mail address:
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
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i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
EPA received applications as follows to register pesticide products containing active ingredients not included in any previously registered products pursuant to the provision of section 3(c)(4) of FIFRA. Notice of receipt of these applications does not imply a decision by the Agency on the applications.
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Environmental protection, Pesticides and pest.
Environmental Protection Agency (EPA).
Notice.
This notice announces EPA’s decision to modify certain provisions and risk mitigation measures that were specified in the 2005 Reregistration Eligibility Decision (RED) for the pesticide xylene, an aquatic herbicide used in irrigation canals. EPA conducted this reassessment of the xylene RED in response to comments received during the public comment period. Based on new information received, and in a continuing effort to mitigate risk, the Agency has made certain modifications to the xylene RED.
Tracy L. Perry, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–0128; fax number: (703) 308–7070; e-mail address:
This action is directed to the public in general, and may be of interest to a wide range of stakeholders including environmental, human health, farm worker and agricultural advocates; the chemical industry; pesticide users; and members of the public interested in the sale, distribution, or use of pesticides. Since others also may be interested, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
EPA has established a docket for this action under docket identification (ID) number EPA–HQ–OPP–2006–0145. Publicly available docket materials are available either in the electronic docket at
Section 4 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) directs EPA to reevaluate existing pesticides to ensure that they meet current scientific and regulatory standards. In 2005, EPA issued a RED for xylene under section 4(g)(2)(A) of FIFRA. In response to a notice of availability published in the
The xylene addendum includes: A summary of additional usage information provided by the Bureau of Reclamation and other stakeholders; a summary of the conclusions from revised human health risk assessments; Agency reconsideration of the need for removing the existing exemption from a tolerance; the addition of an ecological data requirement; revised ecological mitigation measures; and an updated Label Table, which summarizes specific labeling language required on product labels. Based on studies from the open literature and other information, the Agency has determined that crops irrigated with xylene-treated water may bear finite residues of xylene, albeit, at very low levels. Therefore, it is appropriate to retain the existing tolerance exemption for xylene to address any potential residues in food. The Agency has determined, based on additional usage information and revised assessments, that use of xylene does not present dermal risks of concern for occupational workers. As the potential for inhalation exposures to workers is uncertain at this time, given the lack of data, the Agency is requiring additional personal protective equipment (i.e., half-face respirator with an organic vapor-removing cartridge) for workers who apply or otherwise handle xylene. In order to mitigate potential
Section 4(g)(2) of FIFRA, as amended, directs that, after submission of all data concerning a pesticide active ingredient, “the Administrator shall determine whether pesticides containing such active ingredient are eligible for reregistration,” before calling in product specific data on individual end-use products and either reregistering products or taking other “appropriate regulatory action.”
Environmental protection, Pesticides and pests, xylene.
This notice is to inform the public that the Export-Import Bank of the United States has received an application to guarantee approximately $20 million in commercial bank financing for the export of approximately $22 million of U.S. iron ore mining equipment to Ukraine. The U.S. exports will enable the Ukrainian company to produce approximately 10 million metric tons of iron ore pellets per year during the 7-year repayment term of the loan. Available information indicates that this new Ukrainian iron ore production will be consumed in the Ukraine, Europe (Eastern, Western and Central), China, and India. Interested parties may submit comments on this transaction by e-mail to
The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501–3520. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.
Persons wishing to comments on this information collection should submit comments on January 19, 2010. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, you should advise the contact listed below as soon as possible.
Direct all PRA comments to Nicholas A. Fraser, Office of Management and Budget (OMB), via fax at (202) 395–5167, or via the Internet at Nicholas_A._Fraser@omb.eop.gov and to Judith B. Herman, Federal Communications Commission (FCC). To submit your PRA comments by e–mail send them to: PRA@fcc.gov.
Judith B. Herman, OMD, 202–418–0214. For additional information about the information collection(s) send an e–mail to
OMB Control No: 3060–XXXX.
Title: Sections 1.49 and 1.54, Forbearance Petition Filing Requirements.
Form No.: N/A.
Type of Review: New collection.
Respondents: Business or other for–profit.
Number of Respondents: 10 respondents; 10 responses.
Estimated Time Per Response: 640 hours.
Frequency of Response: On occasion reporting requirement, recordkeeping requirement and third party disclosure requirement.
Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. Sections 151, 154(i), 154(j), 155(c), 160, 201 and 303(r).
Total Annual Burden: 6,400 hours.
Total Annual Cost: N/A.
Privacy Act Impact Assessment: N/A.
Nature and Extent of Confidentiality: The Commission is not requesting that the respondents submit confidential information to the Commission. Respondents may, however, request confidential treatment for information they believe to be confidential under 47 CFR 0.459 of the Commission's rules.
Need and Uses: The Commission is requesting OMB approval of this new information collection request in order to obtain the full three year clearance from them. The Commission is estimating 6,400 total annual burden hours.
Under section 10 of the Communications Act of 1934, as amended, telecommunications carriers may petition the Commission to forbear from applying to a telecommunications carrier any statutory provision or Commission regulation. When a carrier petitions the Commission for forbearance, section 10 requires the Commission to make three determinations with regard to the need for the challenged provision or regulation. If the Commission fails to act within one year (extended by three additional months, if necessary) the petition is “deemed granted” by operation of law. These determinations require complex, fact–intensive analysis, e.g., “whether forbearance from enforcing the provision or regulation will promote competitive market conditions.”
Under the new filing procedures, the Commission requires that petitions for forbearance must be “complete as filed” and explain in detail what must be included in the forbearance petition. The Commission also incorporates by reference its rule, 47 CFR 1.49, which states the Commission's standard “specifications as to pleadings and documents.” Precise filing requirements are necessary because of section 10's strict time limit for Commission action. Also, commenters must be able to understand clearly the scope of the petition in order to comment on it. Finally, standard filing procedures inform petitioners precisely what the Commission expects from them in order to make the statutory determinations that the statute requires.
Federal Communications Commission.
Notice.
In this document, the Federal Communications Commission seeks to refresh the record in the proceeding regarding service rules for wireless Enhanced 911 (E911) Phase II location accuracy and reliability. The Public Notice seeks comment on whether, since the most recent activity in the docket, subsequent developments in the industry and technology may have affected parties' positions on the issues raised. The intended effect of this document is to provide an updated record for the Commission to fully consider what service rules concerning location accuracy and reliability might be adopted.
Comments are due November 20, 2009. Reply Comments are due December 4, 2009.
All filings must be addressed to: Marlene H. Dortch, Office of the Secretary, Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554. Parties must also serve one copy with the Commission's copy contractor, Best Copy and Printing, Inc. (BCPI), Portals II, 445 12th Street, SW., Room CY–B402, Washington, DC 20554, (202) 488–5300, or via e-mail to
David Siehl, Public Safety and Homeland Security Bureau, (202) 418–1313,
By this Public Notice, DA 09–2397, released November 6, 2009, the Public Safety and Homeland Security Bureau (Bureau) seeks to refresh the record in the above-referenced docket addressing location accuracy standards for wireless E911 calls. In light of the passage of time since the most recent activity in this docket, we seek comment on whether subsequent developments in the industry and technology may have affected parties' positions on the issues raised.
Recent developments in this proceeding include the vacatur and remand of the Commission's 2007 Report and Order in this proceeding, the submission by the Association of Public Safety Communications Officials-International (APCO), the National Emergency Number Association (NENA), Verizon Wireless, Sprint Nextel Corporation, and AT&T of written ex parte letters recommending new E911 accuracy requirements for both handset-based and network-based technologies in order to achieve E911 accuracy compliance at the county-level, the Bureau's September 2008 Public Notice seeking comment on these proposals, as well as the subsequent voluntary commitments by Verizon Wireless and Sprint Nextel to implement their proposed accuracy standards in connection with separate transactions approved by the Commission in 2008.
We also seek to refresh the record given that in response to the Bureau's September 2008 Public Notice, several parties proposed alternative timeframes for implementation of revised location accuracy standards, and approximately a year has passed since some of those proposals were made. For example, in addition to the timetables proposed by APCO, NENA, Verizon Wireless, Sprint, and AT&T, T–Mobile and the Rural Cellular Association suggested that several of the benchmarks proposed by AT&T should be extended by two years. We request that interested parties refresh the record on these proposed timeframes for implementation in light of the passage of time and any other relevant developments in the industry or economy.
Interested parties may file comments on the above-referenced petition on or before November 20, 2009, and reply comments may be filed on or before December 4, 2009. All comments should reference the appropriate petition(s) and PS Docket No. 07–114.
All comments may be filed using: (1) The Commission's Electronic Comment Filing System (ECFS), (2) the Federal Government's eRulemaking Portal, or (3) by filing paper copies. See Electronic Filing of Documents in Rulemaking Proceedings, 63 FR 24121 (1998).
• Electronic Filers: Statements in support of or in opposition to the Petition and replies to such statements may be filed electronically using the Internet by accessing the ECFS:
• For ECFS filers, in completing the transmittal screen, filers should include their full name, U.S. Postal Service mailing address, and the rulemaking number. Parties may also submit an electronic statement in support of or in opposition to the Petition and/or replies thereto by Internet e-mail. To get filing instructions, filers should send an e-mail to
•
Filings can be sent by hand or messenger delivery, by commercial overnight courier, or by first-class or overnight U.S. Postal Service mail (although the Commission continues to experience delays in receiving U.S. Postal Service mail). All filings must be addressed to: Marlene H. Dortch, Office of the Secretary, Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554. Parties must also serve one copy with the Commission's copy contractor, Best Copy and Printing, Inc. (BCPI), Portals II, 445 12th Street, SW., Room CY–B402, Washington, DC 20554, (202) 488–5300, or via e-mail to
• The Commission's contractor will receive hand-delivered or messenger-delivered paper filings for the Commission's Secretary at 236 Massachusetts Avenue, NE., Suite 110, Washington, DC 20002. The filing hours at this location are 8 a.m. to 7 p.m. All hand deliveries must be held together with rubber bands or fasteners. Any envelopes must be disposed of before entering the building.
• Commercial overnight mail (other than U.S. Postal Service Express Mail and Priority Mail) must be sent to 9300 East Hampton Drive, Capitol Heights, MD 20743.
• U.S. Postal Service first-class, Express, and Priority mail should be addressed to 445 12th Street, SW., Washington, DC 20554.
•
Documents submitted in PS Docket No. 07–114, including each petition, will be accessible via the Commission's ECFS (at:
These matters shall be treated as “permit-but-disclose” proceedings in accordance with the Commission's ex parte rules. Persons making oral ex parte presentations are reminded that memoranda summarizing such presentations must contain summaries of the substance of the presentations and not merely a listing of the subjects discussed. More than a one- or two-sentence description of the views and arguments presented generally is required. Other requirements pertaining to oral and written presentations are set forth in section 1.1206(b) of the Commission's rules.
This document contains proposed new information collection requirements. The Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and the Office of Management and Budget (OMB) to comment on the information collection requirements contained in this document as required by the Paperwork Reduction Act of 1995, Public Law 104–13. In addition, the Commission notes that pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107–198, see 44 U.S.C. 3506(c)(4), we previously sought specific comment on how the Commission might “further reduce the information collection burden for small business concerns with fewer than 25 employees.”
For further information regarding this proceeding, contact David Siehl, Public Safety and Homeland Security Bureau, (202) 418–1313,
Federal Deposit Insurance Corporation (FDIC).
Notice.
The FDIC, by its Board of Directors, has determined that insufficient assets exist in the receivership of IndyMac Bank, F.S.B., Pasadena, California and the receivership of IndyMac Federal Bank, FSB, Pasadena, California to make any distribution to general unsecured claims, and therefore such claims will recover nothing and have no value.
The Board made its determination on November 12, 2009.
If you have questions regarding this notice, contact Thomas P. Bolt, Counsel, Legal Division, (703) 562–2046 or
On July 11, 2008, IndyMac Bank, F.S.B., Pasadena, California (“IndyMac Bank”) (FIN # 10007) was closed by the Office of Thrift Supervision and the Federal Deposit Insurance Corporation (“FDIC”) was appointed as its receiver. In complying with its statutory duty to resolve the institution in the method that is least costly to the deposit insurance fund (see 12 U.S.C. 1823(c)(4)), the FDIC effected a pass-through receivership. Accordingly, the FDIC organized IndyMac Federal Bank, FSB, Pasadena, California (“IndyMac Federal”), a new federal savings bank for which the FDIC was appointed as conservator. IndyMac Bank's assets were transferred to IndyMac Federal under an agreement whereby the amount (if any) realized from the final resolution of IndyMac Federal after payment in full of IndyMac Federal's obligations was to be paid to the IndyMac Bank receivership. On March 19, 2009, IndyMac Federal was placed in receivership and substantially all of its assets were sold. The amount realized from the resolution of IndyMac Federal is insufficient to pay all of its liabilities, and therefore there will be no amount to pay to the IndyMac Bank receivership.
Section 11(d)(11)(A) of the FDI Act, 12 U.S.C. 1821(d)(11)(A), sets forth the order of priority for distribution of amounts realized from the liquidation or other resolution of an insured depository institution to pay claims. Under the statutory order of priority, administrative expenses and deposit liabilities must be paid in full before any distribution may be made to general unsecured creditors or any lower priority claims. The FDIC has determined that the assets of IndyMac Bank are insufficient to make any distribution on general unsecured claims and therefore, such claims, asserted or unasserted, will recover nothing and have no value. The FDIC has also determined that the assets of IndyMac Federal are insufficient to make any distribution on general unsecured claims and therefore, such claims, asserted or unasserted, will recover nothing and have no value.
By Order of the FDIC Board of Directors.
Federal Election Commission.
Tuesday, November 17, 2009, at 10 a.m.
999 E Street, NW., Washington, DC.
This meeting will be closed to the public.
Compliance matters pursuant to 2 U.S.C. 437g.
Audits conducted pursuant to 2 U.S.C. 437g, 438(b), and Title 26, U.S.C.
Matters concerning participation in civil actions or proceedings or arbitration.
Internal personnel rules and procedures or matters affecting a particular employee.
Judith Ingram, Press Officer, Telephone: (202) 694–1220.
Board of Governors of the Federal Reserve System.
11:30 a.m., Monday, November 23, 2009.
Marriner S. Eccles Federal Reserve Board Building, 20th and C Streets, N.W., Washington, D.C. 20551.
Closed.
1. Personnel actions (appointments, promotions, assignments, reassignments, and salary actions) involving individual Federal Reserve System employees.
2. Any items carried forward from a previously announced meeting.
Michelle Smith, Director, or Dave Skidmore, Assistant to the Board, Office of Board Members at 202–452–2955.
You may call 202–452–3206 beginning at approximately 5 p.m. two business days before the meeting for a recorded announcement of bank and bank holding company applications scheduled for the meeting; or you may contact the Board's Web site at
Board of Governors of the Federal Reserve System, November 13, 2009.
The Commission hereby gives notice of the filing of the following agreement under the Shipping Act of 1984. Interested parties may submit comments on the agreement to the Secretary, Federal Maritime Commission, Washington, DC 20573, within ten days of the date this notice appears in the
By Order of the Federal Maritime Commission.
Notice is hereby given that the following applicants have filed with the Federal Maritime Commission an application for license as a Non-Vessel-Operating Common Carrier and Ocean Freight Forwarder—Ocean Transportation Intermediary pursuant to section 19 of the Shipping Act of 1984 as amended (46 U.S.C. Chapter 409 and 46 CFR 515).
Persons knowing of any reason why the following applicants should not receive a license are requested to contact the Office of Transportation Intermediaries, Federal Maritime Commission, Washington, DC 20573.
The Federal Maritime Commission hereby gives notice that the following Ocean Transportation Intermediary licenses have been revoked pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. Chapter 409) and the regulations of the Commission pertaining to the licensing of Ocean Transportation Intermediaries, 46 CFR Part 515, effective on the corresponding date shown below:
Notice is hereby given that the following Ocean Transportation Intermediary license has been reissued by the Federal Maritime Commission pursuant to section 19 of the Shipping Act of 1984 (46 U.S.C. Chapter 409) and the regulations of the Commission pertaining to the licensing of Ocean Transportation Intermediaries, 46 CFR Part 515.
Section 7A of the Clayton Act, 15 U.S.C. 18a, as added by Title II of the Hart-Scott Rodino Antitrust Improvements Act of 1976, requires persons contemplating certain mergers or acquisitions to give the Federal Trade Commission and the Assistant Attorney General advance notice and to wait designated periods before consummation of such plans. Section 7A(b)(2) of the Act permits the agencies, in individual cases, to terminate this waiting period prior to its expiration and requires that notice of this action be published in the
The following transactions were granted early termination of the waiting period provided by law and the premerger notification rules. The grants were made by the Federal Trade Commission and the Assistant Attorney General for the Antitrust Division of the Department of Justice. Neither agency intends to take any action with respect to these proposed acquisitions during the applicable waiting period.
By Direction of the Commission.
Indian Health Service.
Notice.
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 day advance opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review.
The table below provides: Types of data collection instruments, Number of respondents, Response per respondent, Total annual responses, Average burden hour per response, and Total annual burden hours.
There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by December 18, 2009.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974, or e-mailed to
Liz Berbakos, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3792,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The statutory authority to collect this information is provided under sections 351 and 361 of the Public Health Service (PHS) Act (42 U.S.C. 262 and 264) and the provisions of the Federal Food, Drug, and Cosmetic Act that apply to drugs (21 U.S.C. 301
The human hepatitis viruses are not retroviruses, but several share with HIV the characteristic that they can be transmitted through body fluids, can establish persistent infections, and have long latency periods, e.g., approximately 30 years for Hepatitis C. In addition, the PHS guideline recommends that a record system be developed that allows easy, accurate, and rapid linkage of information among the specimen archive, the recipient's medical records, and the records of the source animal for 50 years. The development of such a record system is a one-time burden. Such a system is intended to cross-reference and locate relevant records of recipients, products, source animals, animal procurement centers, and nosocomial exposures. Respondents to this collection of information are the sponsors of clinical studies of investigational xenotransplantation products under investigational new drug applications (INDs) and xenotransplantation product procurement centers, referred to as source animal facilities. There are an estimated 12 respondents who are sponsors of INDs that include protocols for xenotransplantation in humans. Other respondents for this collection of information are an estimated 18 source animal facilities that provide source xenotransplantation product material to sponsors for use in human xenotransplantation procedures. These 18 source animal facilities keep medical records of the herds/colonies as well as the medical records of the individual source animal(s). The total annual reporting and recordkeeping burden is estimated to be approximately 156 hours. The burden estimates are based on FDA's records of xenotransplantation-related INDs and estimates of time required to complete the various reporting and recordkeeping tasks described in the guideline. FDA does not expect the level of clinical studies using xenotransplantation to increase significantly in the next few years.
In the
FDA estimates the burden of this collection of information as follows:
Because of the potential risk for cross-species transmission of pathogenic persistent virus, the guideline recommends that health records be retained for 50 years. Because these records are medical records, the retention of such records for up to 50 years is not information subject to the PRA (5 CFR 1320.3(h)(5)). Also, because of the limited number of clinical studies with small patient populations, the number of records is expected to be insignificant at this time. Information collections in this guideline not included in tables 1 through 4 of this document can be found under existing regulations and approved under the OMB control numbers as follows: (1) “Current Good Manufacturing Practice for Finished Pharmaceuticals,” 21 CFR 211.1 through 211.208, approved under OMB control number 0910–0139; (2) “Investigational New Drug Application,” 21 CFR 312.1 through 312.160, approved under OMB control number 0910–0014; and (3) information included in a license application, 21 CFR 601.2, approved under OMB control number 0910–0338. (Although it is possible that a xenotransplantation product may not be regulated as a biological product (e.g., it may be regulated as a medical device), FDA believes, based on its knowledge and experience with xenotransplantation, that any xenotransplantation product subject to FDA regulation within the next 3 years will most likely be regulated as a biological product.) However, FDA recognized that some of the information collections go beyond approved collections; assessments for these burdens are included in tables 1 through 4.
In table 5 of this document, FDA identifies those collection of information activities that are already encompassed by existing regulations or are consistent with voluntary standards which reflect industry's usual and customary business practice.
Periodically, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish a summary of information collection requests under OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. Chapter 35). To request a copy of these documents, call the SAMHSA Reports Clearance Officer on (240) 276–1243.
The Substance Abuse and Mental Health Services Administration's (SAMHSA) Center for Substance Abuse Treatment will conduct a data collection on the helpfulness of recovery support services for young people and their families after leaving substance abuse treatment. Specifically, the Recovery Services for Adolescents and Families (RSAF) project is evaluating a pilot test of the following recovery support services for young people and their families find the following recovery support services helpful: (1) Telephone/text message support; (2) a recovery-oriented social networking site; and (3) a family program. Approximately 200 adolescent respondents will be asked to complete 4 data collection forms (some repeated) during 5 interviews (baseline and 4 follow-ups) over a 12 month period after enrollment or discharge from treatment. Approximately 200 collateral respondents (
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The following table is a list of the hour burden of the information collection by form and by respondent:
Written
* Total Annualized Hour Burden = Total Responses × Hours per Response.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the
Submit written or electronic comments on the collection of information by January 19, 2010.
Submit electronic comments on the collection of information to
Denver Presley, Jr., Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3793.
Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Nutrition information is required on most packaged foods and this information must be provided in a specific format as defined in 21 CFR 101. 9. When FDA was determining which Nutrition Facts label format to require, the agency undertook consumer research to evaluate alternatives (Refs. 1, 2, and 3). More recently, FDA conducted qualitative consumer research on the format of the Nutrition Facts label on behalf of the agency's Obesity Working Group (OWG) (Ref. 4), which was formed in 2003 and tasked with outlining a plan to help confront the problem of obesity in the United States (Ref. 5). In addition to conducting consumer research, in response to the OWG plan FDA issued two Advance Notices of Proposed Rulemaking (ANPRM) requesting comments on format changes to the Nutrition Facts label. One ANPRM requested comments on whether and, if so, how to give greater emphasis to calories on the Nutrition Facts label (Ref. 6) and the other requested comments on whether and, if so, how to amend the agency's serving size regulations (Ref. 7). In 2007, FDA issued an ANPRM requesting comments on whether the agency should require that certain nutrients be added or removed from the Nutrition Facts label (Ref. 8).
FDA conducts consumer research under its broad statutory authority, set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (the act), to protect the public health by ensuring that foods are “safe, wholesome, sanitary, and properly labeled,” and in section 903(d)(2)(C) of the act, to conduct research relating to foods, drugs, cosmetics, and devices in carrying out the act.
FDA is proposing to conduct an experimental study to quantitatively assess consumer reactions to potential options for modifying the Nutrition Facts label format. The purpose of the study is to help enhance FDA's understanding of consumer comprehension and acceptance of modifications to the Nutrition Facts label format. The study is part of the agency's continuing effort to enable consumers to make informed dietary choices and construct healthful diets.
The proposed study will use a Web-based experiment to collect information from a sample of adult members in an online consumer panel established by a contractor. The study plans to randomly assign each of 3,600 participants to view Nutrition Facts labels from a set of Nutrition Facts labels that vary by the format, the type of food product, and the quality of nutritional attributes of the product. The study will focus on the following types of consumer reactions: (1) Judgments about a food product in terms of its nutritional attributes and overall healthfulness and (2) ability to use the Nutrition Facts label to, for example, calculate calories and estimate serving sizes needed to meet objectives. To help understand consumer reactions, the study will also collect information on participants' background, including but not limited to use of the Nutrition Facts label and health status.
The study results will be used to help the agency to understand whether modifications to the Nutrition Facts label format could help consumers to make informed food choices. The results of the experimental study will not be used to develop population estimates.
FDA estimates the burden of this collection of information as follows:
To help design and refine the questionnaire to be used for the experimental study, we plan to conduct cognitive interviews by screening 96 adult consumers in order to obtain 12 participants in the interviews. Each screening is expected to take 5 minutes (0.083 hours) and each cognitive interview is expected to take 1 hour. The total for cognitive interview activities is 20 hours (8 hours + 12 hours). Subsequently, we plan to conduct pretests of the questionnaire before it is administered in the study. We expect that 1,000 invitations, each taking 2 minutes (0.033 hours), will need to be sent to adult members of an online consumer panel to have 150 of them complete a 12-minute (0.20 hours) pretest. The total for the pretest activities is 63 hours (33 hours + 30 hours). For the experiment, we estimate that 24,000 invitations, each taking 2 minutes (0.033 hours), will need to be sent to adult members of an online consumer panel to have 3,600 of them complete a 12-minute (0.20 hours) questionnaire. The total for the experiment activities is 1,512 hours (792 hours + 720 hours). Thus, the total estimated burden is 1,595 hours. FDA's burden estimate is based on prior experience with research that is similar to this proposed study.
The following references have been placed on display in the Division of Dockets Management (see
1. Levy A., S. Fein, and R. Schucker, “Nutrition Labeling Formats: Performance and Preference,”
2. Levy A., S. Fein, and R. Schucker, “More Effective Nutrition Label Formats Are Not Necessarily Preferred,”
3. Levy A., S. Fein, and R. Schucker, “Performance Characteristics of Seven Nutrition Label Formats,”
4. Lando A. and J. Labiner-Wolfe, “Helping Consumers to Make More Healthful Food Choices: Consumer Views on Modifying Food Labels and Providing Point-of-Purchase Nutrition Information at Quick-Service Restaurants,”
5. U.S. Food and Drug Administration, Calories Count: Report of the Working Group on Obesity, 2004 (
6. 70 FR 17008, April 4, 2005.
7. 70 FR 17010, April 4, 2005.
8. 72 FR 62149, November 2, 2007.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Fax written comments on the collection of information by December 18, 2009.
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–6974, or e-mailed to
Liz Berbakos, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3792,
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
Under sections 735 and 736 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 379g and 379h), the Prescription Drug User Fee Act of 1992 (PDUFA) (Public Law 102–571), as amended by the Food and Drug Administration Modernization Act of 1997 (Public Law 105–115), the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which includes the Prescription Drug User Fee Amendments of 2002 (Public Law 107–188), and most recently by the Food and Drug Administration Amendments Act of 2007 (Public Law 110–85), FDA has the authority to assess and collect user fees for certain drug and biologics license applications and supplements. Under this authority, pharmaceutical companies pay a fee for certain new human drug applications, biologics license applications, or supplements submitted to the agency for review. Because the submission of user fees concurrently with applications and supplements is required, review of an application by FDA cannot begin until the fee is submitted. Form FDA 3397, the user fee cover sheet, is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to account for and track user fees. The form provides a cross-reference of the fee submitted for an application by using a unique number tracking system. The information collected is used by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of new drug applications, biologics license applications, and supplemental applications.
Respondents to this collection of information are new drug and biologics manufacturers. Based on FDA's database system for fiscal year (FY) 2008, there are an estimated 255 manufacturers of products subject to the user fee provisions of PDUFA. However, not all manufacturers will have any submissions, and some may have multiple submissions in a given year. The total number of annual responses is based on the number of submissions received by FDA in FY 2008. CDER received 3,107 annual responses that include the following submissions: 147 new drug applications; 13 biologics license applications; 1,813 manufacturing supplements; 987 labeling supplements; and 147 efficacy supplements. CBER received 810 annual responses that include the following submissions: 9 biologics license applications; 743 manufacturing supplements; 48 labeling supplements; and 10 efficacy supplements. Based on the previous submissions that were received, the rate of these submissions is not expected to change significantly in the next few years. The estimated hours per response are based on past FDA experience with the various submissions, and the average is 30 minutes.
FDA is revising Form FDA 3397 in the following ways: (1) By including an additional question regarding redemption of a priority review voucher; (2) by deleting the exclusion for certain applications submitted under section 505(b)(2) of the act (21 U.S.C. 355(b)(2)); and (3) by making several minor editorial changes.
In the
FDA estimates the burden of this collection of information as follows:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the
Submit written or electronic comments on the collection of information by January 19, 2010.
Submit electronic comments on the collection of information to:
Elizabeth Berbakos, Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3792.
Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
Under section 351 of the Public Health Service Act (PHS Act) (42 U.S.C. 262), all biological products, including human blood and blood components, offered for sale in interstate commerce must be licensed and meet standards, including those prescribed in the FDA regulations, designed to ensure the continued safety, purity, and potency of such products. In addition under section 361 of the PHS Act (42 U.S.C. 264), FDA may issue and enforce regulations necessary to prevent the introduction, transmission, or spread of communicable diseases between the States or possessions or from foreign countries into the States or possessions. Further, the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351) provides that drugs and devices (including human blood and blood components) are adulterated if they do not conform with current good manufacturing practice (CGMP) assuring that they meet the requirements of the act. Establishments manufacturing biological products including human blood and blood components must comply with the applicable CGMP regulations (parts 211, 606, and 820 (21 CFR parts 211, 606, and 820)) and current good tissue practice (CGTP) regulations (part 1271 (21 CFR part 1271)) as appropriate. FDA regards BPD reporting and HCT/P deviation reporting to be an essential tool in its directive to protect public health by establishing and maintaining surveillance programs that provide timely and useful information.
Section 600.14, in brief, requires the manufacturer who holds the biological product license, for other than human blood and blood components, and who had control over a distributed product when the deviation occurred, to report to the Center for Biologics Evaluation and Research (CBER) or to the Center for Drugs Evaluation and Research (CDER) as soon as possible but not to exceed 45 calendar days after acquiring information reasonably suggesting that a reportable event has occurred. Section 606.171, in brief, requires a licensed manufacturer of human blood and blood components, including Source Plasma; an unlicensed registered blood establishment; or a transfusion service who had control over a distributed product when the deviation occurred, to report to CBER as soon as possible but not to exceed 45 calendar days after acquiring information reasonably suggesting that a reportable event has occurred. Similarly § 1271.350(b), in brief, requires non-reproductive HCT/P establishments described in § 1271.10 to report to CBER all HCT/P deviations relating to a distributed HCT/P that relates to the core CGTP requirements, if the deviation occurred in the establishment's facility or in a facility that performed a manufacturing step for the establishment under contract, agreement or other arrangement. Form FDA 3486 is used to submit BPD reports and HCT/P deviation reports.
Respondents to this collection of information are the licensed manufacturers of biological products other than human blood and blood components, licensed manufacturers of blood and blood components including Source Plasma, unlicensed registered blood establishments, transfusion services, and establishments that manufacture non-reproductive HCT/Ps
CBER has developed an addendum to Form FDA 3486. The web-based addendum 3486A provides additional information when a BPD report has been reviewed by FDA and evaluated as a possible recall. The additional information requested includes information not contained in the Form FDA 3486 such as: (1) Distribution pattern, (2) method of consignee notification, (3) consignee(s) of products for further manufacture, (4) additional product information, (5) updated product disposition, and (6) industry recall contacts. This information is requested by CBER through e-mail notification to the submitter of the BPD report. This information is used by CBER for recall classification purposes. At this time Addendum 3486A is being used only for those BPD reports submitted under § 606.171. CBER estimates that 5 percent of the total BPD reports submitted to CBER under § 606.171 would need additional information submitted in the addendum. CBER further estimates that it would take between 10 to 20 minutes to complete the addendum. For calculation purposes, CBER is using 15 minutes.
Activities such as investigating, changing standard operating procedures or processes, and follow-up are currently required under 21 CFR parts 211, (approved under OMB control number 0910–0139), part 606 (approved under OMB control number 0910–0116), part 820 (approved under OMB control number 0910–0073), and part 1271 are approved under OMB Control No. 0910–0543 and, therefore, are not included in the burden calculation for the separate requirement of submitting a deviation report to FDA.
FDA estimates the burden of this collection of information as follows:
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the
Final Rule requires that the agency inform the potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number. This information is required to be stated in the 30-day
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the
Submit written or electronic comments on the collection of information by January 19, 2010.
Submit electronic comments on the collection of information to
Denver Presley Jr., Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3793.
Under the PRA (44 U.S.C. 3501–3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the
With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.
FDA communicates with consumers about food recalls directly, on its own Web site, and through various mass media channels, such as television and newspapers, during a foodborne illness outbreak or food recall. In these communications, FDA typically identifies the implicated food, the symptoms of the foodborne illness at issue, any subpopulations at elevated risk of infection or illness, and protective measures individuals can or should take. The purpose of these communications is to provide consumers with information so they can protect themselves from potential health risks associated with an outbreak or food recall. Consumers also get information about an outbreak or recall from other sources, including other federal and state agencies, industry, consumer groups, and the mass media,
Existing data show that many consumers do not take appropriate protective actions during a foodborne illness outbreak or food recall (Refs. 1 and 2). For example, 41 percent of U.S. consumers say they have never looked for any recalled product in their home (Ref. 2). Conversely, some consumers overreact to the announcement of a foodborne illness outbreak or food recall. In response to the 2006 fresh, bagged spinach recall which followed a multistate outbreak of
FDA conducts research and educational and public information programs relating to food safety under to its broad statutory authority, set forth in section 903(b)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393 (b)(2), to protect the public health by ensuring that foods are “safe, wholesome, sanitary, and properly labeled,” and in section 903(d)(2)(C), to conduct research relating to foods, drugs, cosmetics and devices in carrying out the act.
FDA plans to survey U.S. consumers using a web-based panel of U.S. households to collect information on consumers' “real time” knowledge, perceptions, beliefs, and self-reported behaviors for up to five foodborne illness outbreaks or food recalls a year. Moreover, because the information environment during certain foodborne illness outbreaks or food recalls evolves as new information emerges, the agency plans to field up to three waves of independent surveys per event (i.e., outbreak or recall). The surveys will query consumers on topics such as: (1) The products that are subject to the outbreak or recall; (2) the implicated pathogens; (3) the food vehicle of the outbreak or recall; and (4) how consumers can protect themselves. FDA plans to conduct the surveys soon after the onset of an outbreak or recall and whenever the agency suspects that: (1) Messages are not reaching consumers; and/or (2) consumers do not understand the messages; and/or (3) consumers are not taking appropriate actions in response to the messaging. Collecting information quickly during a foodborne illness outbreak or food recall is important because erroneous perceptions or misinterpreted information about an outbreak or recall can impede consumer adoption of recommended protective behaviors. Criteria for selecting a particular foodborne illness outbreak or food recall for a survey will include a qualitative assessment of the salience of some or all of the following: the geographical dispersion of the event, the number of illnesses or deaths associated with it, the relative familiarity of the food product, the complexity of consumer precaution instructions, and the presence of national media focus.
The agency will use the survey results to help adjust its communication strategies and messages for foodborne illness outbreaks or food recalls, when needed. The results will not be used to develop population estimates.
FDA estimates the burden of this collection of information as follows:
Approximately 30,000 respondents of a web-based consumer panel will be screened, (3 waves (independent surveys) for each of 5 incidents; 2,000 respondents per wave). We estimate that it will take a respondent 20 seconds (0.0055 hours) to complete the screening questions, for a total of 165 hours. We will conduct a pretest of the first survey with 40 respondents; we estimate that it will take a respondent 10 minutes (0.167 hours) to complete the pretest, for a total of 7 hours. Fifteen thousand (15,000) respondents will complete the surveys (3 waves (independent surveys) for each of 5 incidents; 1,000 respondents per wave). We estimate that it will take a respondent 10 minutes (0.167 hours) to complete the survey, for a total of 2,505 hours. Thus, the total estimated annual reporting burden is 2,677 hours. FDA's burden estimate is based on prior experience with consumer surveys that are similar to these.
The following references have been placed on display in the Division of Dockets Management (see
1. Cuite, C., S. Condry, M. Nucci, and W. Hallman, “Public Response to the Contaminated Spinach Recall of 2006,”Publication number RR–0107–013, New Brunswick, New Jersey: Rutgers, the State University of New Jersey, Food Policy Institute, 2007.
2. Hallman, W., C. Cuite, and N. Hooker, “Consumer Responses to Food Recalls: 2009 National Survey Report,” Publication number RR–0109–018, New Brunswick, New Jersey: Rutgers, the State University of New Jersey, Food Policy Institute, 2009.
3. Acheson, D., “Outbreak of Escherichia coli 0157 Infections Associated With Fresh Spinach—United States, August-September 2006,” 2007, (
Family and Youth Services Bureau, ACYF, ACF, HHS.
Notice to award one expansion supplement grant.
This notice announces the award of an expansion supplement grant to one grantee under the Family and Youth Services Bureau (FYSB)/Family Violence Prevention and Services Program. The expansion supplement award is made to the Pennsylvania Coalition Against Domestic Violence, Harrisburg, PA, a technical assistance provider, to support their capacity to provide technical support and training to State and local domestic violence advocates and social service agencies. These efforts will allow FYSB to support collaborative work to enhance the capacity of Temporary Assistance to Needy Families (TANF) and other Federal programs to provide assistance to eligible victims of domestic violence.
Marylouise Kelley, Ph.D., Director, Family Violence Prevention and Services Program, 1250 Maryland Avenue, SW., Suite 8216, Washington, DC 20024. Telephone: 202–104–5756 E-mail:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing that Sauflon Pharmaceuticals Ltd. has filed a petition proposing that the color additive regulations be amended to provide for the safe use of disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulfonate (CAS Reg. No. 70209–99–3) as a color additive in contact lenses.
Raphael A. Davy, Center for Food Safety and Applied Nutrition (HFS–265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740–3835, 301–436–1272.
Under the Federal Food, Drug, and Cosmetic Act (sec. 721(d)(1) (21 U.S.C. 379e(d)(1))), notice is given that a color additive petition (CAP 8C0287) has been filed by Sauflon Pharmaceuticals Ltd., 49–53 York St., Twickenham, Middlesex, TW1 3LP, United Kingdom. The petition proposes to amend the color additive regulations in 21 CFR part 73, subpart D,
The agency has determined under 21 CFR 25.32(l) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.
National Institutes of Health, Public Health Service, HHS.
Notice.
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852–3804; telephone: 301/496–7057; fax: 301/402–0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications.
1. M Kang, G Lisk, S Hollingworth, SM Baylor, SA Desai. Malaria parasites are rapidly killed by dantrolene derivatives specific for the plasmodial surface anion channel. Mol. Pharmacol. 2005 Jul;68(1):34–40.
2. SA Desai, SM Bezrukov, J Zimmerberg. A voltage-dependent channel involved in nutrient uptake by red blood cells infected with the malaria parasite. Nature. 2000 Aug 31;406(6799):1001–1005.
The present inventions provide methods for improved expression of multimeric proteins by engineering different ratios of the subunit expression units in a cell or upon expression from a multi-promoter plasmid having different strength promoters. The inventors have improved the levels and efficiency of expression of the IL–12 family of cytokines, which includes IL–12, IL–23, and IL–27, by adjusting the transcription and translation of the alpha and beta subunits that comprise the heterodimeric proteins. Optimal ratios of expression for the two (2) subunits were determined for IL–12, IL–23, and IL–27.
The Indian Health Service (IHS) estimated budget request for Fiscal Year (FY) 2010 includes $17,488,854 for the IHS Loan Repayment Program (LRP) for health professional educational loans (undergraduate and graduate) in return for full-time clinical service in Indian health programs.
This program announcement is subject to the appropriation of funds. This notice is being published early to coincide with the recruitment activity of the IHS, which competes with other Government and private health management organizations to employ qualified health professionals.
This program is authorized by Section 108 of the Indian Health Care Improvement Act (IHCIA) as amended, 25 U.S.C. 1601
The estimated amount available is approximately $17,488,854 to support approximately 391 competing awards averaging $44,740 per award for a two year contract. One year contract continuations will receive priority consideration in any award cycle. Applicants selected for participation in the FY 2010 program cycle will be expected to begin their service period no later than September 30, 2010.
Pursuant to Section 108(b), to be eligible to participate in the LRP, an individual must:
(1) (A) Be enrolled—
(i) In a course of study or program in an accredited institution, as determined by the Secretary, within any State and be scheduled to complete such course of study in the same year such individual applies to participate in such program; or
(ii) In an approved graduate training program in a health profession; or
(B) Have a degree in a health profession and a license to practice in a state; and
(2) (A) Be eligible for, or hold an appointment as a Commissioned Officer in the Regular or Reserve Corps of the Public Health Service (PHS); or
(B) Be eligible for selection for service in the Regular or Reserve Corps of the PHS; or
(C) Meet the professional standards for civil service employment in the IHS; or
(D) Be employed in an Indian health program without service obligation; and
(E) Submit to the Secretary an application for a contract to the LRP. The Secretary must approve the contract before the disbursement of loan repayments can be made to the participant. Participants will be required to fulfill their contract service agreements through full-time clinical practice at an Indian health program site determined by the Secretary. Loan
Any individual who owes an obligation for health professional service to the Federal Government, a State, or other entity is not eligible for the LRP unless the obligation will be completely satisfied before they begin service under this program.
Section 108 of the IHCIA, as amended by Public Laws 100–713 and 102–573, authorizes the IHS LRP and provides in pertinent part as follows:
“(a)(1) The Secretary, acting through the Service, shall establish a program to be known as the Indian Health Service Loan Repayment Program (hereinafter referred to as the “Loan Repayment Program”) in order to assure an adequate supply of trained health professionals necessary to maintain accreditation of, and provide health care services to Indians through, Indian health programs.”
Section 4(n) of the IHCIA, as amended by the Indian Health Care Improvement Technical Corrections Act of 1996, Public Law 104–313, provides that:
“Health Profession” means
For the purposes of this program, the term “Indian health program” is defined in Section 108(a)(2)(A), as follows:
(A) The term “Indian health program” means any health program or facility funded, in whole or in part, by the Service for the benefit of Indians and administered—
(i) Directly by the Service;
(ii) By any Indian Tribe or Tribal or Indian organization pursuant to a contract under—
(I) The Indian Self-Determination Act, or
(II) Section 23 of the Act of April 30, 1908, (25 U.S.C. 47), popularly known as the Buy Indian Act; or
(iii) By an urban Indian organization pursuant to Title V of this act.”
Section 108 of the IHCIA, as amended by Public Laws 100–713 and 102–573, authorizes the IHS to determine specific health professions for which IHS LRP contracts will be awarded. The list of priority health professions that follows is based upon the needs of the IHS as well as upon the needs of American Indians and Alaska Natives.
(a) Medicine: Allopathic and Osteopathic.
(b) Nurse: Associate, B.S., and M.S. Degree.
(c) Clinical Psychology: Ph.D. only.
(d) Social Work: Masters level only.
(e) Chemical Dependency Counseling: Baccalaureate and Masters level.
(f) Dentistry.
(g) Dental Hygiene.
(h) Pharmacy: B.S., Pharm.D.
(i) Optometry: O.D.
(j) Physician Assistant, Certified.
(k) Advanced Practice Nurses: Nurse Practitioner, Certified Nurse Midwife, Registered Nurse Anesthetist (Priority consideration will be given to Registered Nurse Anesthetists.).
(l) Podiatry: D.P.M.
(m) Physical Rehabilitation Services: Physical Therapy, Occupational Therapy, Speech-Language Pathology, and Audiology: M.S. and D.P.T.
(n) Diagnostic Radiology Technology: Certificate, Associate, and B.S.
(o) Medical Technology: Associate, and B.S.
(p) Public Health Nutritionist/Registered Dietitian.
(q) Engineering (Environmental): B.S. (Engineers must provide environmental engineering services to be eligible.).
(r) Environmental Health (Sanitarian): B.S.
(s) Health Records: R.H.I.T. and R.H.I.A.
(t) Respiratory Therapy.
(u) Ultrasonography.
Not applicable.
Interested individuals are reminded that the list of eligible health and allied health professions is effective for applicants for FY 2010. These priorities will remain in effect until superseded.
Application materials may be obtained online at
Applications must be submitted on the form entitled “Application for the Indian Health Service Loan Repayment Program,” identified with the Office of Management and Budget approval number of OMB #0917–0014, Expiration Date 02/29/2012.
Completed applications may be submitted to the IHS Loan Repayment Program, 801 Thompson Avenue, Suite 120, Rockville, Maryland 20852. Applications for the FY 2010 LRP will be accepted and evaluated monthly beginning January 15, 2010, and will continue to be accepted each month thereafter until all funds are exhausted for FY 2010. Subsequent monthly deadline dates are scheduled for Friday of the second full week of each month.
Applications shall be considered as meeting the deadline if they are either:
(a) Received on or before the deadline date; or
(b) Sent on or before the deadline date. (Applicants should request a legibly dated U.S. Postal Service postmark or obtain a legibly dated receipt from a commercial carrier or U.S. Postal Service. Private metered postmarks are not acceptable as proof of timely mailing.).
Applications received after the monthly closing date will be held for consideration in the next monthly funding cycle. Applicants who do not receive funding by September 30, 2010, will be notified in writing.
This program is not subject to review under Executive Order 12372.
Not applicable.
All applicants must sign and submit to the Secretary, a written contract agreeing to accept repayment of educational loans and to serve for the applicable period of obligated service in a priority site as determined by the Secretary, and submit a signed affidavit attesting to the fact that they have been informed of the relative merits of the U.S. PHS Commissioned Corps and the Civil Service as employment options.
The IHS has identified the positions in each Indian health program for which there is a need or vacancy and ranked those positions in order of priority by
(a) Historically critical shortages caused by frequent staff turnover;
(b) Current unmatched vacancies in a health profession discipline;
(c) Projected vacancies in a health profession discipline;
(d) Ensuring that the staffing needs of Indian health programs administered by an Indian Tribe or Tribal health organization receive consideration on an equal basis with programs that are administered directly by the Service; and
(e) Giving priority to vacancies in Indian health programs that have a need for health professionals to provide health care services as a result of individuals having breached LRP contracts entered into under this section.
Consistent with this priority ranking, in determining applications to be approved and contracts to accept, the IHS will give priority to applications made by American Indians and Alaska Natives and to individuals recruited through the efforts of Indian Tribes or Tribal or Indian organizations.
Loan repayment awards will be made only to those individuals serving at facilities which have a site score of 70 or above during the first and second quarters and the first month of the third quarter of FY 2010, if funding is available.
One or all of the following factors may be applicable to an applicant, and the applicant who has the most of these factors, all other criteria being equal, will be selected.
(a) An applicant's length of current employment in the IHS, Tribal, or urban program.
(b) Availability for service earlier than other applicants (first come, first served).
(c) Date the individual's application was received.
Not applicable.
Notice of awards will be mailed on the last working day of each month. Once the applicant is approved for participation in the LRP, the applicant will receive confirmation of his/her loan repayment award and the duty site at which he/she will serve his/her loan repayment obligation.
Applicants may sign contractual agreements with the Secretary for two years. The IHS may repay all, or a portion of the applicant's health profession educational loans (undergraduate and graduate) for tuition expenses and reasonable educational and living expenses in amounts up to $20,000 per year for each year of contracted service. Payments will be made annually to the participant for the purpose of repaying his/her outstanding health profession educational loans. Payment of health profession education loans will be made to the participant within 120 days, from the date the contract becomes effective. The effective date of the contract is calculated from the date it is signed by the Secretary or his/her delegate, or the IHS, Tribal, urban, or ABuy-Indian@ health center entry-on-duty date, whichever is more recent.
In addition to the loan payment, participants are provided tax assistance payments in an amount not less than 20 percent and not more than 39 percent of the participant's total amount of loan repayments made for the taxable year involved. The loan repayments and the tax assistance payments are taxable income and will be reported to the Internal Revenue Service (IRS). The tax assistance payment will be paid to the IRS directly on the participant's behalf. LRP award recipients should be aware that the IRS may place them in a higher tax bracket than they would otherwise have been prior to their award.
Any individual who enters this program and satisfactorily completes his or her obligated period of service may apply to extend his/her contract on a year-by-year basis, as determined by the IHS. Participants extending their contracts may receive up to the maximum amount of $20,000 per year plus an additional 20 percent for Federal withholding.
Please address inquiries to Ms. Jacqueline K. Santiago, Chief, IHS Loan Repayment Program, 801 Thompson Avenue, Suite 120, Rockville, Maryland 20852, Telephone: 301/443–3396 [between 8 a.m. and 5 p.m. (EST) Monday through Friday, except Federal holidays].
IHS Area Offices and Service Units that are financially able are authorized to provide additional funding to make awards to applicants in the LRP, but not to exceed $35,000 a year plus tax assistance. All additional funding must be made in accordance with the priority system outlined below. Health professions given priority for selection above the $20,000 threshold are those identified as meeting the criteria in 25 U.S.C. 1616a(g)(2)(A) which provides that the Secretary shall consider the extent to which each such determination:
(i) Affects the ability of the Secretary to maximize the number of contracts that can be provided under the LRP from the amounts appropriated for such contracts;
(ii) Provides an incentive to serve in Indian health programs with the greatest shortages of health professionals; and
(iii) Provides an incentive with respect to the health professional involved remaining in an Indian health program with such a health professional shortage, and continuing to provide primary health services, after the completion of the period of obligated service under the LRP.
Contracts may be awarded to those who are available for service no later than September 30, 2010, and must be in compliance with any limits in the appropriation and Section 108 of the IHCIA not to exceed the amount authorized in the IHS appropriation (up to $32,000,000 for FY 2010). In order to ensure compliance with the statutes, Area Offices or Service Units providing additional funding under this section are responsible for notifying the LRP of such payments before funding is offered to the LRP participant.
Should an IHS Area Office contribute to the LRP, those funds will be used for only those sites located in that Area. Those sites will retain their relative ranking from the national site-ranking list. For example, the Albuquerque Area Office identifies supplemental monies for dentists. Only the dental positions within the Albuquerque Area will be funded with the supplemental monies consistent with the national ranking and site index within that Area.
Should an IHS Service Unit contribute to the LRP, those funds will be used for only those sites located in that Service Unit. Those sites will retain their relative ranking from the national site-ranking list. For example, Chinle Service Unit identifies supplemental monies for pharmacists. The Chinle Service Unit consists of two facilities, namely the Chinle Comprehensive Health Care Facility and the Tsaile PHS Indian Health Center. The national ranking will be used for the Chinle Comprehensive Health Care Facility (Score = 44) and the Tsaile PHS Indian Health Center (Score = 46). With a score
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), notice is hereby given of the following meeting:
January 22, 2010, 8:30 a.m. to 3 p.m.
Proposed Agenda items are subject to change as priorities dictate. You can locate the Agenda, Committee Roster and Charter, presentations, and meeting materials at the home page of the Advisory Committee's Web site at
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the National Advisory Council for Biomedical Imaging and Bioengineering.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Muscular Dystrophy Coordinating Committee (MDCC).
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should inform the Contact Person listed below in advance of the meeting.
An agenda will be posted prior to the meeting on the MDCC Web site:
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting for the aforementioned committee:
Agenda items are subject to change as priorities dictate.
The Director, Management Analysis and Services Office, has been delegated the authority to sign
Food and Drug Administration, HHS.
Notice of public meeting.
The Food and Drug Administration (FDA) is announcing a meeting with sponsors of certain opioid drug products regarding the development of Risk Evaluation and Mitigation Strategies (REMS) for these products. Other members of the public are invited to attend and observe. The REMS is intended to ensure that the benefits of these drugs continue to outweigh certain risks. FDA has encouraged affected sponsors to work collectively to develop a proposed REMS. The purpose of this meeting is to hear from sponsors about the status of the development of a proposed REMS and their views regarding the specific features of the REMS for these products. To promote transparency of the REMS development process, other members of the public are invited to attend the meeting as observers. Additional opportunities for public input will be provided before FDA finalizes the elements of the REMS.
The meeting will be held on December 4, 2009, from 9 a.m. to 1 p.m. To ensure consideration at the meeting, submit comments by November 27, 2009. Register to attend the meeting by November 27, 2009. See section III of this document for information on how to register for the meeting.
The public meeting will be held at the Holiday Inn Washington-College Park, 10000 Baltimore Ave., College Park, MD 20740.
Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061. Rockville, MD 20852. Submit electronic comments to
A live webcast of this meeting will be viewable at
Theresa (Terry) Martin, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6196, Silver Spring, MD 20993, 301–796–3448, FAX: 301–847–8753, or
Patrick Frey, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6350, Silver Spring, MD 20993, 301–796–3844, FAX: 301–847–8443, e-mail:
On February 6, 2009, the Food and Drug Administration (FDA) sent letters to manufacturers of certain opioid drug products, indicating that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks. A table of opioid products that will be required to have REMS is available on the agency's Web site at
On March 3, 2009, FDA held a meeting with affected sponsors to discuss how the REMS could be designed to manage the risks while also minimizing burdens to the health care system. FDA presented a high-level overview, regulatory background, and the proposed elements of the REMS followed by questions and comments from the sponsors. At this meeting, FDA encouraged sponsors to work collectively to develop a proposed REMS. The FDA presentations and minutes from this meeting are available on the agency's Web site at
The purpose of this meeting is for FDA to hear from sponsors of long-acting opioids and extended-release opioid products on the development of the REMS for these products and their views about the specific features of the REMS. Other members of the public are invited to attend the meeting as observers. Because this is a meeting between FDA staff and the sponsors, only FDA staff will be permitted to question the sponsors at the meeting. However, interested persons who attend the public meeting will be given an opportunity to provide suggestions for questions for FDA staff to ask the sponsors, at FDA's sole discretion. Index cards will be provided for this purpose. There will be additional opportunities for public input before FDA finalizes the elements of the REMS.
If you need special accommodations because of disability, please contact Theresa (Terry) Martin (see
In addition, a live webcast of this meeting will be viewable at
In addition, any person may submit written or electronic comments to the Division of Dockets Management (see
Transcripts of the meeting will be available for review at the Division of Dockets Management and on the Internet at
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Anti-Infective Drugs Advisory Committee. This meeting was announced in the
Minh Doan, Center for Drug Evaluation and Research (HFD–21), Food and Drug Administration, 5600 Fishers Lane, (for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD 20857, 301–827–7001, FAX: 301–827–6776, e-mail:
In the
This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Advisory Committee to the Director, NIH.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and Waterfront Media. The purpose of the MOU is to extend the reach of FDA Consumer Health Information and to provide consumers with better information and timely content concerning public health and safety topics, including alerts of emerging safety issues and product recalls.
The agreement became effective October 14, 2009.
Jason Brodsky, Consumer Health Information Staff, Office of External Relations (HFI–40), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827–6251, e-mail:
In accordance with 21 CFR 20.108(c), which states that all written agreements and MOUs between FDA and others shall be published in the
Food and Drug Administration, HHS.
Notice; request for comments and scientific data and information; extension of comment period.
The Food and Drug Administration (FDA) is extending to January 25, 2010, the comment period for the notice entitled “Acrylamide in Food; Request for Comments and for Scientific Data and Information,” that appeared in the
Submit written or electronic comments by January 25, 2010.
Submit electronic comments and scientific data and information to
Lauren Posnick Robin, Center for Food Safety and Applied Nutrition (HFS–317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1639.
In the
The agency has received a request for a 60-day extension of the comment period for this notice. FDA has considered the request and is extending the comment period for the notice entitled “Acrylamide in Food; Request for Comments and for Scientific Data and Information,” until January 25, 2010. The agency believes that this extension allows adequate time for interested persons to submit comments without significantly delaying action by the agency.
Interested persons may submit to the Division of Dockets Management (see
U.S. Customs and Border Protection, Department of Homeland Security.
30-Day notice and request for comments; Revision of an existing information collection: 1651–0007.
U.S. Customs and Border Protection (CBP) of the Department of Homeland Security has submitted the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act: Application for Allowance in Duties. This is a proposed extension and revision of an information collection that was previously approved. CBP is proposing that this information collection be extended with no change to the burden hours. This document is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
Written comments should be received on or before December 18, 2009.
Interested persons are invited to submit written comments on the proposed information collection to the Office of Information and Regulatory Affairs, Office of Management and Budget. Comments should be addressed to the OMB Desk Officer for Customs and Border Protection, Department of Homeland Security, and sent via electronic mail to
U.S. Customs and Border Protection (CBP) encourages the general public and affected Federal agencies to submit written comments and suggestions on proposed and/or continuing information collection requests pursuant to the Paperwork Reduction Act (Pub. L. 104–13). Your comments should address one of the following four points:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency/component, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agencies/components estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collections of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological techniques or other forms of information.
If additional information is required contact: Tracey Denning, U.S. Customs and Border Protection, Office of Regulations and Rulings, 799 9th Street, NW., 7th Floor, Washington, DC 20229–1177, at 202–325–0265.
Coast Guard, DHS.
Notice.
The Coast Guard announces that a Certificate of Alternative Compliance was issued for the offshore supply vessel TERREL TIDE as required by 33 U.S.C. 1605(c) and 33 CFR 81.18.
The Certificate of Alternative Compliance was issued on October 15, 2009.
The docket for this notice is available for inspection or copying at the Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet by going to
If you have questions on this notice, call CWO2 David Mauldin, District Eight, Prevention Branch, U.S. Coast Guard, telephone 504–671–2153. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–366–9826.
The offshore supply vessel TERREL TIDE will be used for offshore supply operations. The horizontal distance between the forward and aft masthead lights may be 25′–9″. Placing the aft masthead light at the horizontal distance from the forward masthead light as required by Annex I, paragraph 3(a) of the 72 COLREGS, and Annex I, Section 84.05(a) of the Inland Rules Act, would result in an aft masthead light location directly over the cargo deck, where it would interfere with loading and unloading operations.
The Certificate of Alternative Compliance allows for the horizontal separation of the forward and aft masthead lights to deviate from the requirements of Annex I, paragraph 3(a) of 72 COLREGS, and Annex I, Section 84.05(a) of the Inland Rules Act.
This notice is issued under authority of 33 U.S.C. 1605(c), and 33 CFR 81.18.
Coast Guard, DHS.
Notice.
The Coast Guard announces that a Certificate of Alternative Compliance was issued for the offshore supply vessel GRANT CANDIES as required by 33 U.S.C. 1605(c) and 33 CFR 81.18.
The Certificate of Alternative Compliance was issued on October 28, 2009.
The docket for this notice is available for inspection or copying at the Docket Management Facility (M–30), U.S. Department of Transportation, West Building Ground Floor, Room W12–140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. You may also find this docket on the Internet by going to
If you have questions on this notice, call CWO2 David Mauldin, District Eight, Prevention Branch, U.S. Coast Guard, telephone 504–671–2153. If you have questions on viewing or submitting material to the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone 202–366–9826.
The offshore supply vessel GRANT CANDIES will be used for offshore supply operations. Full compliance with 72 COLREGS and Inland Rules Act will hinder the vessel's ability to maneuver within close proximity of offshore platforms and conduct helicopter operations. The forward masthead light may be located forward of the helideck 10.37 meters above the hull. Placing the forward masthead light at the height as required by Annex I, paragraph 2(a) of the 72 COLREGS would result in a masthead light location that would interfere with helideck operations.
In addition, the horizontal distance between the forward and aft masthead lights may be 32.845 meters. Placing the aft masthead light at the horizontal distance from the forward masthead light as required by Annex I, paragraph 3(a) of the 72 COLREGS would result in an aft masthead light location directly over the aft cargo deck where it would interfere with loading and unloading operations.
Furthermore, the sidelights may be placed 2.417 meters above the forward masthead light. Placing the sidelights lower than the forward masthead light as required by Annex I, paragraph 2(g) of 72 COLREGS and Annex I, paragraph 84.03(g) of the Inland Rules Act, would subject them to interference from the deck lights and obstruction by the helideck.
The Certificate of Alternative Compliance allows for the vertical placement of the forward masthead light to deviate from requirements set forth in Annex I, paragraph 2(a) of 72 COLREGS. In addition, the Certificate of Alternative Compliance allows for the horizontal separation of the forward and aft masthead lights to deviate from the requirements of Annex I, paragraph 3(a) of 72 COLREGS. Furthermore, the Certificate of Alternative Compliance allows for the placement of the sidelights to deviate from requirements set forth in Annex I, paragraph 2(g) of 72 COLREGS and Annex I, paragraph 84.03(g) of the Inland Rules Act.
This notice is issued under authority of 33 U.S.C. 1605(c), and 33 CFR 81.18.
Customs and Border Protection, Department of Homeland Security.
General notice.
This document provides notice to customs brokers that the annual fee of $138 that is assessed for each permit held by a broker, whether it may be an individual, partnership, association, or corporation, is due by January 25, 2010. Customs and Border Protection (CBP) announces this date of payment for 2010 in accordance with the Tax Reform Act of 1986.
Payment of the 2010 Customs Broker User Fee is due Monday, January 25, 2010.
Russell Morris, Broker Compliance Branch, Trade Policy and Programs, Office of International Trade, (202) 863–6543.
CBP Dec. 07–01 amended section 111.96 of title 19 of the Code of Federal Regulations (19 CFR 111.96) pursuant to the amendment of section 13031 of the Consolidated Omnibus Budget Reconciliation Act (COBRA) of 1985 (19 U.S.C. 58c) by section 892 of the American Jobs Creation Act of 2004, to establish that effective April 1, 2007, an annual user fee of $138 is to be assessed for each customs broker permit and national permit held by an individual, partnership, association, or corporation.
Customs and Border Protection (CBP) regulations provide that this fee is payable for each calendar year in each broker district where the broker was issued a permit to do business by the due date which is published in the
Section 1893 of the Tax Reform Act of 1986 (Pub. L. 99–514) provides that notices of the date on which the payment is due for each broker permit shall be published by the Secretary of the Treasury in the
This document notifies customs brokers that for calendar year 2010, the due date for payment of the user fee is January 25, 2010.
Coast Guard, DHS.
Notice of open teleconference meeting.
This notice announces a teleconference meeting of the National Offshore Safety Advisory Committee (NOSAC) to discuss items listed in the agenda as well as other items that NOSAC may consider. This meeting will be open to the public.
The teleconference call will take place on Thursday, December 8, 2009, from 2 p.m. to 4 p.m. EST. This meeting may close early if all business is finished. Written material and requests to make oral presentations should reach the Coast Guard on or before December 4, 2009. Requests to have a copy of your material distributed to each member of the committee should reach the Coast Guard on or before December 4, 2009.
The Committee will meet, via telephone conference, on December 8, 2009. Members of the public wishing to participate may contact CDR P.W. Clark at 202–372–1410 for call in information or they may participate in person by coming to Room 1303, U.S. Coast Guard Headquarters Building, 2100 Second Street, SW., Washington DC 20593. As there are a limited number of teleconference lines, public participation will be on a first come basis. Written comments should be sent to Commander P.W. Clark, Designated Federal Officer of NOSAC, Commandant (CG–5222), 2100 Second Street, SW., Washington, DC 20593–0001; or by fax to 202–372–1926. This notice is available on our online docket, USCG–2009-xxxx, at
Commander P.W. Clark, Designated Federal Officer of NOSAC, or Mr. Jim Magill, Assistant Designated Federal Officer, telephone 202–372–1414, fax 202–372–1926.
Public participation is welcome and the public may participate in person by coming to Room 1303, U.S. Coast Guard Headquarters Building, 2100 Second Street, SW., Washington DC 20593 or by contacting CDR P.W. Clark at 202–372–1410 for call in information. Notice of this meeting is given under the Federal Advisory Committee Act, 5 U.S.C. App. 2.
(1) Roll call of Committee members and the public participating in the teleconference.
(2) Approval of minutes from the November 5, 2009.
(3) Subcommittee's Final Report on proposals for MARPOL Annex II, A.673 standards for existing Offshore Supply Vessels (OSVs).
(4) Committee discussion and vote on Subcommittee's Final Report for MARPOL Annex II, A.673.
(5) Review of and possible NOSAC action to approve a recommendation to re-establish the Diving Subcommittee and discussion on a proposed task statement to study the matter of medical treatment of injured divers while working on the OCS.
(6) Review of background information and possible NOSAC action related to minimizing offshore lifts on the OCS.
(7) Period for Public Comment.
(8) Confirmation of the date/time for the next NOSAC Meeting (Thursday, April 8, 2009 in New Orleans).
This meeting is open to the public. Please note that the meeting may close early if all business is finished. At the
Minutes from the meeting will be available for the public review and copying 30 days following the teleconference meeting.
For information on facilities or services for individuals with disabilities or to request special assistance at the meeting, contact Mr. Jim Magill at 202–372–1414 as soon as possible.
Office of the Assistant Secretary for Public and Indian Housing, HUD.
Notice.
HUD announces the availability on its website of the applicant information, submission deadlines, funding criteria and other requirements for HUD's HOPE VI Main Street Grants program NOFA for FY2009. Approximately $4 million is made available through this NOFA by the Department of Housing and Urban Development Appropriations Act, 2009 (Pub. L. 111–8, approved March 11, 2009) for HUD's HOPE VI Main Street Grants program. The notice providing information regarding the application process, funding criteria and eligibility requirements is available on the Grants.gov Web site at:
Questions regarding specific program requirements should be directed to the agency contact identified in the program NOFA. Questions regarding the 2009 General Section should be directed to the Office of Departmental Grants Management and Oversight at 202–708–0667 (this is not a toll-free number) or the NOFA Information Center at 1–800–HUD–8929 (toll-free). Persons with hearing or speech impairments may access these numbers via TTY by calling the Federal Information Relay Service at 1–800–877–8339.
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice; technical correction.
On September 1, 2009, HUD posted its Notice of Funding Availability (NOFA) for Section 202 Supportive Housing for the Elderly for Fiscal Year 2009. The technical corrections to the NOFA are available on the Grants.gov Web site at
For questions concerning these technical corrections, please contact Alicia Anderson, Project Manager, Office of Housing Assistance and Grants Administration, Office of Housing, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; telephone 202–402–5787 (this is not a toll-free number); e-mail
Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD.
Notice; technical correction.
On September 1, 2009, HUD posted its Notice of Funding Availability (NOFA) for Section 811 Housing for Persons with Disabilities (Section 811 Program) for Fiscal Year 2009. The technical corrections to the NOFA are available on the Grants.gov Web site at
For questions concerning these technical corrections, please contact Marvis Hayward, Program Manager, Office of Housing Assistance and Grants Administration, Office of Housing, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; telephone 202–402–2255 (this is not a toll-free number); e-mail
Pursuant to (36 CFR 60.13(b,c)) and (36 CFR 63.5), this notice, through publication of the information included herein, is to apprise the public as well as governmental agencies, associations and all other organizations and individuals interested in historic preservation, of the properties added to, or determined eligible for listing in, the National Register of Historic Places from September 7 to September 11, 2009.
For further information, please contact Edson Beall via: United States Postal Service mail, at the National Register of Historic Places, 2280, National Park Service, 1849 C St., NW., Washington, DC 20240; in person (by appointment), 1201 Eye St., NW., 8th floor, Washington, DC 20005; by fax, 202–371–2229; by phone, 202–354–2255; or by e-mail,
Nominations for the following properties being considered for listing or related actions in the National Register were received by the National Park Service before October 31, 2009. Pursuant to § 60.13 of 36 CFR part 60 written comments concerning the significance of these properties under the National Register criteria for evaluation may be forwarded by United States Postal Service, to the National Register of Historic Places, National Park Service, 1849 C St., NW., 2280, Washington, DC 20240; by all other carriers, National Register of Historic Places, National Park Service, 1201 Eye St. NW., 8th floor, Washington, DC 20005; or by fax, 202–371–6447. Written or faxed comments should be submitted by December 3, 2009.
Request for REMOVAL has been made for the following resources:
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has determined that there is no violation of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), in the above-captioned investigation. The Commission has terminated the investigation.
Michael Liberman, Esq., Office of the General Counsel, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205–3116. Copies of non-confidential documents filed in connection with this investigation are or will be available for inspection during official business hours (8:45 a.m. to 5:15 p.m.) in the Office of the Secretary, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205–2000. General information concerning the Commission may also be obtained by accessing its Internet server at
This investigation was instituted on December 19, 2007, based on a complaint filed by FormFactor, Inc. (“FormFactor”) of Livermore, California. The complaint alleged violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain probe card assemblies, components thereof, and certain tested DRAM and NAND flash memory devices and products containing same by reason of infringement of certain claims of U.S. Patent Nos. 5,994,152 (“the '152 patent”); 6,509,751 (“the '751 patent”);
On December 5, 2008, respondents Phicom Corp. and Phiam Corp., (collectively, “Phicom”) jointly filed a motion for partial summary determination that claims 20 and 34 of the '648 patent are invalid as indefinite under 35 U.S.C. 112. On February 11, 2009, the ALJ granted the motion in an ID (Order No. 46). The ID determined that claims 20 and 34, and any asserted claims depending therefrom, are invalid. Complainant FormFactor filed a petition for review of Order No. 46, which Respondents and the Commission Investigative Attorney (“IA”) opposed. On March 11, 2009, the Commission determined to review Order No.46.
The evidentiary hearing in this investigation was held from February 24, 2009, through March 6, 2009. On June 29, 2009, the ALJ issued an Initial Determination on Violation of Section 337 and Recommended Determination on Remedy and Bond, finding no violation of section 337. All parties to this investigation, including the IA, filed timely petitions for review of various portions of the final ID, as well as timely responses to the petitions.
On September 17, 2009, the Commission determined to review the final ID in part, and issued a Notice to that effect. 74 FR 47822 (September 17, 2009). In the Notice, the Commission set a schedule for the filing of written submissions on the issues under review, including certain questions posed by the Commission, and on remedy, the public interest, and bonding. The parties have briefed, with initial and reply submissions, the issues under review and the issues of remedy, the public interest, and bonding.
On review, the Commission has determined as follows.
(1) With respect to the '751 patent:
(a) to reverse the ALJ's determination that Japanese Patent Application Publication H10–31034 to Amamiya
(b) to reverse in part the ID's conclusion that,
(2) With respect to the '152 patent:
(a) to strike the ID's statement “Since three bases for no violation of claim 21 have been determined, no analysis of the invalidity arguments related to anticipation and obviousness of the dependent claims will be made,”
(3) To affirm and adopt the ALJ's other findings contained in the final ID under review except insofar as they are inconsistent with the Commission Opinion to be issued later.
The Commission also determined to affirm ALJ Order No. 46 with certain modifications as will be detailed in the Commission's Opinion.
The Commission has determined that there is no violation of section 337 in this investigation, and has terminated the investigation.
The authority for the Commission's determination is contained in section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and sections 210.41–.42, 210.50 of the Commission's Rules of Practice and Procedure (19 CFR 210.41–.42, 210.50).
By order of the Commission.
The Department of Labor has submitted the following information collection request (ICR), utilizing emergency review procedures, to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104–13, 44 U.S.C. Chapter 35) and 5 CFR 1320.13. OMB approval has been requested by November 23, 2009. A copy of this ICR, with applicable supporting documentation; including among other things a description of the likely respondents, proposed frequency of response, and estimated total burden may be obtained from the RegInfo.gov Web site at
The OMB is particularly interested in comments which:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarify of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submissions of responses.
The U.S. Department of Labor's (DOL) Employment and Training Administration (ETA), in conjunction with the White House and IdeaScale, is launching the Jobs for America's Job Seekers Challenge. Using an online platform designed by IdeaScale, the Challenge will allow toolmakers and developers to present their free online job tools to workforce development experts and jobseekers for discussion, rating, and voting. The tools that receive the most votes will be shared broadly with the workforce investment system and jobseekers, and listed on government Web sites like
The Challenge will consist of three phases. Phase 1 will run from November 30, 2009 to December 18, 2009. In this phase, toolmakers and developers will submit information on their free online job search and job matching tools. These tools must be free to the job seeker, but can be licensed by the workforce system at the State or local level provided the companies offer a short-term demo or other platform that allows the tools to be reviewed free of charge. Submissions will be accepted from businesses, nonprofits organizations, entrepreneurs, and State and local workforce agencies. The tools will be organized into one or more of the following categories:
• General job boards, listing sites, and aggregators
• Niche job boards
• Career advancement tools
• Web based career exploration sites
• Web 2.0/social media sites specializing in job searches or job postings
• Other job tools
Phase 2 will run from January 4 to January 15, 2010. During this phase, workforce development experts and job seekers will review and vote on the submitted job search and matching tools. Reviewers will be encouraged to consider a tool's usability based on how effective the tool is in providing accurate results, how efficient it is in completing job search and matching tasks in a reasonable amount of time, and the level of satisfaction the user felt.
Phase 3 will begin on January 18, 2010. In this final phase, DOL, ETA, and the White House will communicate the top tools in each category with the entire workforce development community and job seekers through a variety of mediums, including:
(1) Posting an announcement of the top ranking tools on key Web sites including;
a. DOL.gov
b. Doleta.gov
c. White House OSTP blog
d. Workforce3one.org
e. Other sites
(2) Highlighting free tools on ETA's
(3) Hosting Webinars featuring the top ranking tools on Workforce3one.org;
(4) Utilizing other communication outlets such as national associations and Intergovernmental organizations like the National Association of State Workforce Agencies, the National Association of Workforce Boards, the National Governor's Association, the National Association of Counties, and the Association of Community Colleges.
As a result of the Challenge, the workforce development system will quickly boost its capacity to meet the job information needs of the significantly increased number of customers requiring service in the current economic recovery effort.
In today's tight employment market that has experienced a 10.2 percent unemployment rate that is the highest in 26 years, the publicly funded workforce investment system has a major responsibility to maximize unemployed workers' opportunities for rapid reemployment by quickly connecting them to the full scope of available jobs. We know the workforce system is working hard to connect workforce system customers to the best job search resources available. However, as a result of technological innovations, new job search tools have been launched and new tools are emerging daily that help job seekers find jobs and target their search to the most relevant employment opportunities.
Expedited or Emergency approval of this data collection will enable the Department of Labor (DOL), Employment and Training Administration (ETA), and the White House to respond aggressively to the record unemployment rates. Failure to start the Challenge and do the collection by November 30, 2009 would waste federal Recovery Act and State resources. Many States and local areas are individually searching for job matching and job search solutions to meet the significantly increased number of job seekers in need of assistance in One Stop Career Centers nationwide as a result of the historic downturn in the nation's economy.
Employment and Training Administration, Labor.
Notice.
The Employment and Training Administration is issuing this notice to announce the receipt of a “Certification of Non-Relocation and Market and Capacity Information Report” (Form 4279–2) for the following:
All interested parties may submit comments in writing no later than December 2, 2009. Copies of adverse comments received will be forwarded to the applicant noted above.
Address all comments concerning this notice to Anthony D. Dais, U.S. Department of Labor, Employment and Training Administration, 200 Constitution Avenue, NW., Room S–4231, Washington, DC 20210; or e-mail
Anthony D. Dais, at telephone number (202) 693–2784 (this is not a toll-free number).
Section 188 of the Consolidated Farm and Rural
Employment and Training Administration, Labor.
Notice.
The Employment and Training Administration is issuing this notice to announce the receipt of a “Certification of Non-Relocation and Market and Capacity Information Report” (Form 4279–2) for the following:
All interested parties may submit comments in writing no later than December 2, 2009. Copies of adverse comments received will be forwarded to the applicant noted above.
Address all comments concerning this notice to Anthony D. Dais, U.S. Department of Labor, Employment and Training Administration, 200 Constitution Avenue, NW., Room S–4231, Washington, DC 20210; or e-mail
Anthony D. Dais, at telephone number (202) 693–2784 (this is not a toll-free number).
Section 188 of the Consolidated Farm and Rural Development Act of 1972, as established under 29 CFR Part 75, authorizes the United States Department of Agriculture to make or guarantee loans or grants to finance industrial and business activities in rural areas. The Secretary of Labor must review the application for financial assistance for the purpose of certifying to the Secretary of Agriculture that the assistance is not calculated, or likely, to result in: (a) A transfer of any employment or business activity from one area to another by the loan applicant's business operation; or, (b) An increase in the production of goods, materials, services, or facilities in an area where there is not sufficient demand to employ the efficient capacity of existing competitive enterprises unless the financial assistance will not have an adverse impact on existing competitive enterprises in the area. The Employment and Training Administration within the Department of Labor is responsible for the review and certification process. Comments should address the two bases for certification and, if possible, provide data to assist in the analysis of these issues.
National Aeronautics and Space Administration.
Notice of meeting.
The National Aeronautics and Space Administration (NASA) announces a meeting of the Planetary Science Subcommittee of the NASA Advisory Council (NAC). This Subcommittee reports to the Science Committee of the NAC. The Meeting will be held for the purpose of soliciting from the scientific community and other person's scientific and technical information relevant to program planning.
Thursday, December 3, 2009, 8:30 a.m. to 5:30 p.m., and Friday, December 4, 2009, 8:30 a.m. to 12:30 p.m. MST.
University of Colorado, Laboratory for Atmospheric and Space Physics, Conference Room A200, 1234 Innovation Drive, Boulder, CO 80303.
Ms. Marian Norris, Science Mission Directorate, NASA Headquarters, Washington, DC 20546, (202) 358–4452, fax (202) 358–4118, or
The meeting will be open to the public up to the capacity of the room. The agenda for the meeting includes the following topics:
It is imperative that the meeting be held on these dates to accommodate the scheduling priorities of the key participants. Attendees will be requested to sign a register.
Nuclear Regulatory Commission.
Issuance of Environmental Assessment and Finding of No Significant Impact for Permit Amendment.
Orysia Masnyk Bailey, Health Physicist, Decommissioning Branch, Division of Nuclear Materials Safety, Region I, 475 Allendale Road, King of Prussia, Pennsylvania 19406; telephone (864) 427–1032; fax number (610) 680–3497; or by e-mail:
The U.S. Nuclear Regulatory Commission (NRC) is considering allowing the Department of the Navy (Navy) to issue an amendment to a materials permit in accordance with NRC Byproduct Materials License No. 45–23645–01NA. The NRC approval would authorize the Navy to release, for unrestricted use, Building 150 at the Naval Medical Research Center in Bethesda, Maryland. The Navy requested this action by letter July 11, 2008. The NRC has prepared an Environmental Assessment (EA) in support of this proposed action in accordance with the requirements of Title 10,
The proposed action would approve the Navy's July 11, 2008, request to release Building 150 at the Naval Medical Research Center (NMRC) in Bethesda, Maryland (the Facility) for unrestricted release. The Navy completed initial decommissioning of the Facility (excluding Building 150) in Bethesda, Maryland, in 2000. The NMRC was authorized to use licensed materials under Naval Radioactive Materials Permit 19–32398–41NP in accordance with the Navy's Master Materials License No. 45–23645–01NA. In the conduct of that initial decommissioning action the Navy requested authorization to postpone decommissioning activities at Building 150. Additionally, two underground storage tanks (USTs) were discovered during the decommissioning of the NMRC, and remediation of the USTs were added to the Navy's decommissioning work plan for Building 150.
Building 150 was constructed in the early 1950s as a facility for the irradiation of animals to determine the effects of ionizing radiation on the organ and cellular systems. The radiation source used for these studies consisted of 2,500 curies of cobalt-60 in ceramic slugs arranged in circles. AEC License No. 19–02891–03 was issued on October 2, 1957, authorizing the use of cobalt-60 for this research. License No. 19–02891–03 expired on March 31, 1963.
Building 150 is located on the grounds of the NMRC. The Facility consists of a 1,100 square foot building, with approximately one foot thick reinforced concrete walls. The building was divided into two radiation exposure rooms and a control room. The building is covered with a 10 inch thick overhead reinforced concrete slab. The control room is separated from the two radiation rooms by a 3 feet 10 inch thick radiation shield, constructed of reinforced barite concrete which is 45 pounds heavier per cubic foot then regular reinforced concrete. Radiation room 1, where the sources were stored, was further shielded by a 3 foot thick barite concrete wall.
Several minor contamination incidents occurred during routine maintenance between 1951 and 1962, probably caused by cracks in the ceramic slugs. In April 1962, one of the NMRC employees was found to be internally contaminated with cobalt-60 during routine internal personnel monitoring. Investigation disclosed that widespread contamination was present on the ground surrounding the building. The cause of the contamination was determined to be a failure of the source capsule seals. Building 150 and surrounding grounds were originally decommissioned in 1963. The sources were transferred by Atlantic Research Corporation, under AEC License No. 45–02808–02, to Oak Ridge National Laboratory. Building 150 internals, roof, ventilation equipment, and 4 to 6 inches of soil adjacent to the building were removed by Navy personnel and disposed of as radioactive waste. In 2002, following the initial decommissioning of the NMRC, the Navy initiated additional decommissioning of Building 150 and the underground storage tanks (UST). Remediation activities included removal of the USTs, removal of contaminated soil adjacent to Building 150, scabbling of concrete surfaces within Building 150, and removal of rubble and drain lines within the Facility.
The Navy is requesting approval of this permitting action because it has ceased conducting licensed activities at the Facility, and seeks the unrestricted use of its Facility and the termination of the permit. NRC is fulfilling its responsibilities under the Atomic Energy Act to make a timely decision on a proposed license amendment for decommissioning that ensures protection of the public health and safety.
The historical review of licensed activities conducted at the Facility shows that such activities involved use of the following radionuclides with half-lives greater than 120 days in unsealed form: cobalt-60. The Navy conducted a final status survey in January 2004. This survey covered the areas of use at the Facility. The Navy elected to demonstrate compliance with the radiological criteria for unrestricted release as specified in 10 CFR 20.1402 by using the screening approach described in NUREG–1757, “Consolidated NMSS Decommissioning Guidance,” Volume 2. The Licensee used the radionuclide-specific derived concentration guideline levels (DCGLs), developed there by the NRC, which comply with the dose criterion in 10 CFR 20.1402. These DCGLs define the maximum amount of residual radioactivity on building surfaces, equipment, and materials, and in soils, that will satisfy the NRC requirements in subpart E of 10 CFR part 20 for unrestricted release. The Navy's final status survey results were below these DCGLs and are in compliance with the As Low As Reasonably Achievable (ALARA) requirement of 10 CFR 20.1402. The NRC thus finds that the Navy's final status survey results are acceptable.
Based on its review the staff has determined that the affected environment and any environmental
The NRC staff finds that the proposed release of the Facility for unrestricted use and the termination of the Navy's materials permit is in compliance with 10 CFR 20.1402. Based on its review, the staff considered the impact of the residual radioactivity at the Facility and concluded that the proposed action will not have a significant effect on the quality of the human environment.
Due to the largely administrative nature of the proposed action, its environmental impacts are small. Therefore, the only alternative the staff considered is the no-action alternative, under which the staff would leave things as they are by simply denying the amendment request. This no-action alternative is not feasible because it conflicts with 10 CFR 30.36(d), requiring that decommissioning of byproduct material facilities be completed and approved by the NRC after licensed activities cease. The NRC's analysis of the Navy's final status survey data confirmed that the Facility meets the requirements of 10 CFR 20.1402 for unrestricted release and for permit termination. Additionally, denying the Navy's request to terminate its permit would result in no change in current environmental impacts. The environmental impacts of the proposed action and the no-action alternative are therefore similar, and the no-action alternative is accordingly not further considered.
The NRC staff has concluded that the proposed action is consistent with the NRC's unrestricted release criteria specified in 10 CFR 20.1402. Because the proposed action will not significantly impact the quality of the human environment, the NRC staff concludes that the proposed action is the preferred alternative.
NRC provided a draft of this Environmental Assessment to the Radiological Health Program in the Air and Radiation Management Administration of the Maryland Department of the Environment for review on August 13, 2009. On September 14, the State of Maryland responded by email. The State agreed with the conclusions of the EA, and otherwise had no comments.
The NRC staff has determined that the proposed action is of a procedural nature, and will not affect listed species or critical habitat. Therefore, no further consultation is required under Section 7 of the Endangered Species Act. The NRC staff has also determined that the proposed action is not the type of activity that has the potential to cause effects on historic properties. Therefore, no further consultation is required under Section 106 of the National Historic Preservation Act.
The NRC staff has prepared this EA in support of the proposed action. On the basis of this EA, the NRC finds that there are no significant environmental impacts from the proposed action, and that preparation of an environmental impact statement is not warranted. Accordingly, the NRC has determined that a Finding of No Significant Impact is appropriate.
Documents related to this action, including the application for license amendment and supporting documentation, are available electronically at the NRC's Electronic Reading Room at
1. NUREG–1757, “consolidated NMSS Decommissioning Guidance;”
2. Title 10,
3. Title 10,
4. NUREG–1496, “Generic Environmental Impact Statement in Support of Rulemaking on Radiological Criteria for License Termination of NRC-Licensed Nuclear Facilities;”
5. NRC License No. 45–23645–01NA inspection and licensing records;
6. NMRC Historical Site Assessment (HAS) Volume I of II, dated June 15, 1999 (ML082280739);
7. NMRC Historical Site Assessment (HAS) Volume II of II, dated June 15, 1999 (ML082280809);
8. NMRC Radiological Decontamination and Decommissioning (D&D) Plan, Revision 1, dated August 17,1999 (ML082280784 and ML082280814);
9. Radiological Decontamination and Decommissioning (D&D) Final Status Survey Report, dated April 2000 (ML082280117 and ML082280147);
10. Radiological Decontamination and Decommissioning (D&D) Final Status Survey Report, dated June 16, 2000 (ML082280738 and ML082280755);
11. Radiological Decontamination and Decommissioning (D&D) Final Status Survey Report, dated August 2000 (ML082280309, ML082280317, ML082280334, and ML082280287);
12. NRC letter dated February 29, 2000, “Decommissioning Plans for Naval Medical Research Center” (ML003687082);
13. Department of the Navy Letter dated July 6, 2005, “Decommissioning of the Former Naval Medical Research Center (NMRC), Bethesda, MD” (ML051940414);
14. Department of the Navy letter dated October 22, 2007, “Building 150 and Underground Storage Tank Decommissioning Project, National Naval Medical Center, Bethesda, MD” (ML073060430); and
15. Department of the Navy Letter dated July 11, 2008, “Naval Medical Research Center (NMRC), Bethesda Decommissioning Documentation” (ML082270292).
If you do not have access to ADAMS, or if there are problems in accessing the documents located in ADAMS, contact the NRC Public Document Room (PDR) Reference staff at 1–800–397–4209, 301–415–4737, or by e-mail to
For the Nuclear Regulatory Commission.
On September 18, 2009, NYSE Arca, Inc. (“NYSE Arca” or “Exchange”), through its wholly owned subsidiary, NYSE Arca Equities, Inc. (“NYSE Arca Equities”), filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
The Exchange proposes to list and trade the Shares of the Fund pursuant to NYSE Arca Equities Rule 8.600, which governs the listing of Managed Fund Shares.
The Fund's investment objective is long-term capital appreciation. It seeks to achieve its investment objective by investing at least 80% of its net assets (plus the amount of any borrowings for investment purposes) in common stocks and securities convertible into common stocks of issuers based in at least three different countries located outside the United States. The Fund will primarily hold securities of large capitalization companies
Creations and redemptions of Fund Shares will generally be in-kind, with a specified cash component. Authorized Participants or the investors on whose behalf the Authorized Participants are acting (“Investors”), however, may deliver in connection with creations or receive in connection with redemptions cash in lieu of one or more in-kind securities. Specifically, in connection with creations or redemptions, an Authorized Participant or Investor may transact in cash, in whole or in part, at the sole discretion of the Fund; provided, however, that the cash amount delivered or received shall not exceed 10% of the value of the in-kind creation or redemption basket, unless the Authorized Participant or Investor is subject to legal restrictions with respect to delivery or receipt of one or more securities in the in-kind creation or redemption basket, or the Fund is in a temporary defensive position. The creation unit size for the Fund will be 50,000 Shares.
Additional information regarding the Fund, the Shares, the Fund's investment objective (including other non-primary investments and investments permitted for temporary defensive purposes), investment strategies, policies, and restrictions, risks, fees and expenses, creations and redemptions of Shares, availability of information, trading rules and halts, and surveillance procedures, among other things, can be found in the Registration Statement and in the Notice, as applicable.
The Commission has carefully reviewed the proposed rule change and finds that it is consistent with the requirements of Section 6 of the Act
The Commission finds that the proposal to list and trade the Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the Act, which sets forth Congress' finding that it is in the public interest and appropriate for the protection of investors and the maintenance of fair and orderly markets to assure the availability to brokers, dealers and investors of information with respect to quotations for and transactions in securities. Quotation and last sale information for the Shares will be available via the Consolidated Tape Association (“CTA”) high-speed line, and the Exchange will disseminate the Portfolio Indicative Value (“PIV”) at least every 15 seconds during the Core Trading Session through the facilities of the CTA. In addition, the Fund will make available on its Web site on each business day before commencement of trading of the Core Trading Session the Disclosed Portfolio
The Commission further believes that the proposal to list and trade the Shares is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately and to prevent trading when a reasonable degree of transparency cannot be assured. The Commission notes that the Exchange will obtain a representation from the issuer of the Shares that the NAV per Share will be calculated daily and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time. Additionally, if it becomes aware that the NAV or the Disclosed Portfolio is not disseminated daily to all market participants at the same time, the Exchange will halt trading in the Shares until such information is available to all market participants. Further, if the PIV is not being disseminated as required, the Exchange may halt trading during the day in which the disruption occurs; if the interruption persists past the day in which it occurred, the Exchange will halt trading no later than the beginning of the trading day following the interruption.
The Exchange has represented that the Shares are equity securities subject to the Exchange's rules governing the trading of equity securities and will trade on the NYSE Arca Marketplace from 4 a.m. to 8 p.m. Eastern Time in accordance with NYSE Arca Equities Rule 7.34 (Opening, Core, and Late Trading Sessions). In support of this proposal, the Exchange has made representations, including:
(1) The Shares will conform to the initial and continued listing criteria under NYSE Arca Equities Rule 8.600.
(2) The Exchange intends to utilize its existing surveillance procedures applicable to derivative products (which include Managed Fund Shares) to monitor trading in the Shares. The Exchange's surveillance procedures are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws. The Exchange's current trading surveillance focuses on detecting securities trading outside their normal patterns. When such situations are detected, surveillance analysis follows and investigations are opened, where appropriate, to review the behavior of all relevant parties for all relevant trading violations. The Exchange may obtain information via the Intermarket Surveillance Group (“ISG”) from other exchanges that are members of ISG.
The Commission further notes that the Fund, as an investment company registered under the 1940 Act, is subject to the diversification standards included in Section 5(b)(1) of the 1940 Act. The Exchange represents that the Fund's fundamental policies, which may be changed only by a vote of the holders of a majority of the Fund's outstanding voting securities, are as follows: (1) Regarding diversification, the Fund may not invest more than 5% of its total assets (taken at market value) in securities of any one issuer, other than obligations issued by the U.S. Government, its agencies and instrumentalities, or purchase more than 10% of the voting securities of any one issuer, with respect to 75% of the Fund's total assets; and (2) regarding concentration, the Fund may not invest more than 25% of its total assets in the securities of companies primarily engaged in any one industry or group of industries provided that (a) this limitation does not apply to obligations issued or guaranteed by the U.S. Government, its agencies and instrumentalities, and (b) municipalities and their agencies and authorities are not deemed to be industries.
(3) Prior to the commencement of trading, the Exchange will inform its ETP Holders in an Information Bulletin of the special characteristics and risks associated with trading the Shares. Specifically, the Information Circular will discuss the following: (a) The procedures for purchases and redemptions of Shares and that Shares are not individually redeemable; (b) NYSE Arca Equities Rule 9.2(a), which imposes a duty of due diligence on its ETP Holders to learn the essential facts relating to every customer prior to trading the Shares; (c) the risks involved in trading the Shares during the Opening and Late Trading Sessions when an updated PIV will not be calculated or publicly disseminated; (d) how information regarding the PIV is disseminated; (e) the requirement that ETP Holders deliver a prospectus to
(4) The Fund will be in compliance with Rule 10A–3 under the Act.
For the foregoing reasons, the Commission finds that the proposed rule change is consistent with Section 6(b)(5) of the Act
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Pursuant to Section 19(b)(1)
CBOE proposes to amend certain of its rules to allow the Exchange to list options on the Mini-Russell 2000 Index (“RMN” or “Mini-RUT”), which is based on 1/10th the value of the Russell 2000 Index, at $1 strike intervals. The text of the rule proposal is available on the Exchange's Web site (
In its filing with the Commission, the self-regulatory organization included statements concerning the purpose of, and basis for, the proposed rule change and discussed any comments it received on the proposed rule change. The text of those statements may be examined at the places specified in Item IV below. The Exchange has prepared summaries, set forth in sections A, B, and C below, of the most significant parts of such statements.
This proposed rule change is based on a filing previously submitted by NASDAQ OMX PHLX, Inc. (“Phlx”) that was recently approved by the Commission.
The purpose of the proposed rule change is to amend Rule 24.9,
Strike price intervals for index options are set forth in Rules 5.5 and 24.9 at three levels: (1) Not less than $5.00 generally, (2) not less than $2.50 for index classes specifically listed in Rule 24.9.01(a), and (3) not less than $1 for certain other index classes set forth in Rule 24.9.01 (
The Exchange now proposes that the minimum strike price interval for RMN options will be $1 or greater, if the strike price is less than $200. The Exchange believes that $1 strike price intervals in this option series will provide investors with greater flexibility by allowing them to establish positions that are better tailored to meet their investment objectives.
For initial series, the Exchange would list at least two strike prices above and two strike prices below the current value of the RMN at or about the time a series is opened for trading on the Exchange. As part of this initial listing, the Exchange would list strike prices that are within 5 points from the closing value of the RMN on the preceding day.
As for additional series, the Exchange would be permitted to add additional series when the Exchange deems it necessary to maintain an orderly market, to meet customer demand or when the underlying RMN moves substantially from the initial exercise price or prices. To the extent that any additional strike prices are listed by the Exchange, such additional strike prices shall be within thirty percent (30%) above or below the closing value of the RMN. The Exchange would also be permitted to open additional strike prices that are more than 30% above or below the current RMN value provided that demonstrated customer interest exists for such series, as expressed by institutional, corporate or individual customers or their brokers. Market-Makers trading for their own account would not be considered when determining customer interest. In addition to the initial listed series, the Exchange may list up to sixty (60) additional series per expiration month for each series in Mini-RUT options. However, $1 strike price intervals may be listed on Mini-RUT options only where the strike price is below $200. In addition, the Exchange proposes that it shall not list LEAPS on Mini-RUT options at intervals less than $2.50.
The Exchange is also proposing to set forth a delisting policy with respect to Mini-RUT options. Specifically, the Exchange would, on a monthly basis, review series that are outside a range of five (5) strikes above and five (5) strikes
Notwithstanding the proposed delisting policy, customer requests to add strikes and/or maintain strikes in Mini-RUT options in series eligible for delisting shall be granted.
Further, in connection with the proposed delisting policy, if the Exchange identifies series for delisting, the Exchange shall notify other options exchanges with similar delisting policies regarding eligible series for listing, and shall work with such other exchanges to develop a uniform list of series to be delisted, so as to ensure uniform series delisting of multiply listed Mini-RUT options.
It is expected that the proposed delisting policy for Mini-RUT options will be adopted by other options exchanges that list and trade Mini-RUT options.
The Exchange also proposes to add new Interpretation and Policy .16 to Rule 5.5,
The Exchange is proposing to make some lettering and numbering changes to the Interpretations and Policies to Rules 5.5 and 24.9, which are being amended substantively by this filing. Specifically, the Exchange is proposing to re-number existing Interpretation and Policy .13 to Rule 5.5 as new Interpretation and Policy .15. The Exchange is proposing to make this change because the Exchange has two pending filings that have been formally submitted which overlap with the existing and proposed numbering to Rule 5.5.
Finally, the Exchange is proposing to reduce the minimum strike price intervals for LEAPS on Mini-NDX options from $5 to $2.50 in order to conform CBOE's listing ability with Phlx's.
The Exchange believes the proposed rule change is consistent with the Securities Exchange Act of 1934 (the “Act”)
The Exchange does not believe that the proposed rule change will impose any burden on competition that is not necessary or appropriate in furtherance of the purposes of the Act.
No written comments were solicited or received with respect to the proposed rule change.
Because the foregoing proposed rule change: (i) Does not significantly affect the protection of investors or the public interest; (ii) does not impose any significant burden on competition; and (iii) by its terms, does not become operative for 30 days from the date on which it was filed, or such shorter time as the Commission may designate, if consistent with the protection of investors and the public interest, it has become effective pursuant to Section 19(b)(3)(A) of the Act
The Exchange has requested that the Commission waive the 30-day operative delay and designate the proposed rule change immediately operative, so that the Exchange may, for competitive reasons, list Mini-RUT options at the same $1 strike price intervals currently listed by Phlx. The Commission believes such waiver is consistent with the protection of investors and the public interest.
At any time within 60 days of the filing of the proposed rule change, the Commission may summarily abrogate such rule change if it appears to the Commission that such action is necessary or appropriate in the public interest, for the protection of investors, or otherwise in furtherance of the purposes of the Act.
Interested persons are invited to submit written data, views, and arguments concerning the foregoing, including whether the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549–1090.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 27, 2009, NYSE Arca, Inc. (“NYSE Arca” or “Exchange”), through its wholly owned subsidiary, NYSE Arca Equities, Inc. (“NYSE Arca Equities”), filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”)
(i) PIMCO Enhanced Short Maturity Strategy Fund creation unit size will be reduced to 70,000 shares from 100,000 shares;
(ii) PIMCO Government Limited Maturity Strategy Fund creation unit size will be reduced to 90,000 shares from 100,000 shares; and
(iii) PIMCO Prime Limited Maturity Strategy Fund creation unit size will be reduced to 90,000 shares from 100,000 shares.
The creation unit sizes for each of the PIMCO Intermediate Municipal Bond Strategy Fund and the PIMCO Short Term Municipal Bond Strategy Fund will not change and will be 100,000 shares, respectively.
The Exchange proposes to list and trade the Shares pursuant to NYSE Arca Equities Rule 8.600, which governs the listing of Managed Fund Shares. Each of the Funds will be an actively managed exchange-traded fund. The Shares will be offered by the Trust.
The Exchange states that the Shares will be subject to the initial and continued listing criteria under NYSE Arca Equities Rule 8.600 applicable to Managed Fund Shares
Interested persons are invited to submit written data, views, and arguments concerning whether Amendment No. 1 to the proposed rule change is consistent with the Act. Comments may be submitted by any of the following methods:
• Use the Commission's Internet comment form (
• Send an e-mail to
• Send paper comments in triplicate to Elizabeth M. Murphy, Secretary, Securities and Exchange Commission, 100 F Street, NE., Washington, DC 20549–1090.
The Commission has carefully reviewed the proposed rule change and finds that it is consistent with the requirements of Section 6 of the Act
The Commission finds that the proposal to list and trade the Shares on the Exchange is consistent with Section 11A(a)(1)(C)(iii) of the Act,
The Commission further believes that the proposal is reasonably designed to promote fair disclosure of information that may be necessary to price the Shares appropriately and to prevent trading when a reasonable degree of transparency cannot be assured. The Commission notes that the Exchange will obtain a representation from the issuer that the NAV per Share will be calculated daily and that the NAV and the Disclosed Portfolio will be made available to all market participants at the same time.
The Exchange has represented that the Shares are equity securities subject to the Exchange's rules governing the trading of equity securities. In support of this proposal, the Exchange has made representations, including:
(1) The Shares will conform to the initial and continued listing criteria under NYSE Arca Equities Rule 8.600.
(2) The Exchange's surveillance procedures are adequate to properly monitor Exchange trading of the Shares in all trading sessions and to deter and detect violations of Exchange rules and applicable federal securities laws.
(3) Prior to the commencement of trading, the Exchange will inform its ETP Holders in an Information Bulletin of the special characteristics and risks associated with trading the Shares. Specifically, the Information Bulletin will discuss the following: (a) The procedures for purchases and redemptions of Shares and that Shares are not individually redeemable; (b) NYSE Arca Equities Rule 9.2(a), which imposes a duty of due diligence on its ETP Holders to learn the essential facts relating to every customer prior to trading the Shares; (c) the risks involved in trading the Shares during the Opening and Late Trading Sessions when an updated PIV will not be calculated or publicly disseminated; (d) how information regarding the PIV is disseminated; (e) the requirement that ETP Holders deliver a prospectus to investors purchasing newly issued Shares prior to or concurrently with the confirmation of a transaction; and (f) trading information.
(4) The Funds will be in compliance with Rule 10A–3 under the Act.
(5) The Funds will not invest in non-U.S. equity securities.
For the foregoing reasons, the Commission finds that the proposed rule change is consistent with the Act and the rules and regulations thereunder applicable to a national securities exchange.
The Commission finds good cause, pursuant to Section 19(b)(2) of the Act,
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 27, 2009, the New York Stock Exchange LLC (“NYSE” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1)
Currently, NYSE Rule 36 (Communications Between Exchange and Members' Offices) prohibits members and member organizations from establishing or maintaining any telephonic or electronic communication, including the usage of any portable or wireless communication devices (
Notwithstanding the rule's general prohibition on the use of portable or wireless communication devices, current Rule 36 permits Floor brokers to use Exchange authorized and issued portable phones on the Floor to
As noted in the foregoing paragraph, the restrictions on the use of portable or wireless communication devices in current Rule 36 relate to what is and is not permissible on the Exchange Floor. Under NYSE Rule 6, the term Floor is defined as “the trading Floor of the Exchange and the premises immediately adjacent thereto, such as the various entrances and lobbies of the 11 Wall Street, 18 New Street, 8 Broad Street, 12 Broad Street and 18 Broad Street Buildings, and also means the telephone facilities available in these locations.”
Recently, the Exchange adopted Rule 6A, setting forth a definition of Trading Floor that is distinct from the definition of Floor. Specifically, the Trading Floor is an area within the area of the “Floor” that is defined as “the restricted-access physical areas designated by the Exchange for the trading of securities, commonly known as the ‘Main Room’ and the ‘Garage.’ ”
The Exchange proposes to amend NYSE Rule 36 to permit the use of personal portable or wireless communication devices outside of the Exchange's Trading Floor and other restricted access areas, provided such usage is consistent with all other Exchange Rules and federal securities laws and rules thereunder. Floor brokers would still be limited to using only Exchange authorized and issued portable phones on the Exchange Trading Floor and DMMs would still only be permitted to use registered telephone lines and/or wired or wireless devices at their posts, and all such devices and communications would continue to be regulated by the Exchange.
The proposal would permit Exchange members and member firm employees to use personal portable or wireless communications devices in designated areas of the Exchange's buildings and facilities that fall within the technical definition of the Floor under Rule 6, but that are outside the Trading Floor, and other restricted access points (
The proposal would thus permit members and member firm employees to use their personal communications devices in the hallways, stairwells, lobbies or members-only areas of the Exchange premises that are adjacent to the Trading Floors of the Exchange, NYSE Amex Options and/or NYSE Amex Equities.
In its filing, the Exchange stated that the purpose of the proposal is to provide Exchange members and member firm employees with a reasonable and comfortable space inside the physical confines of the Exchange's buildings and facilities within which they may use their personal portable or wireless communication devices, without diminishing the ability to monitor and regulate their conduct.
In addition, noting that the proposed rule amendments specifically provide that the use of personal portable or wireless communication devices by Exchange members and member firm employees is subject to compliance with all other Exchange Rules and federal securities laws and rules thereunder, the Exchange represented that it will issue a Notice to Members that will, among other things, remind Exchange members and member firm employees of their obligations under the requirements of Securities Exchange Act Release Nos. 33–7288 and 34–37182, concerning the “Use of Electronic Media by Broker-Dealers, Transfer Agents, and Investment Advisers for Delivery of Information.”
The Exchange also proposed corresponding technical amendments to Rule 36.20.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange. Specifically, the Commission finds that the proposed rule change is consistent with Section 6(b)(5) of the Act,
The Exchange has proposed that members and member firm employees be permitted to use personal portable or wireless communication devices off the Exchange Trading Floor and outside of restricted access areas (
The Commission finds, however, that the proposal strikes a reasonable balance between the Exchange's interest in providing a convenient and comfortable space for Exchange members and member firm employees to use their personal portable communications devices inside Exchange buildings and its interest in minimizing the risk of misuse of such devices, which are not subject to the same surveillance as Exchange authorized and issued devices. In particular, the Commission notes the Exchange's representation that any time or place advantage to using personal portable communication devices outside restricted points of access to the Trading Floor is “significantly reduced by the fact that a Floor Broker or DMM has no line of sight and no ability to hear trading activity on the [Trading] Floor and the speed of electronic trading would likely render stale any information a DMM had prior to leaving his or her post on the Trading Floor.”
As noted above, the Commission expects that the Exchange will, in the exercise of its regulatory responsibilities, work to ensure that any line of sight to the Trading Floor that may exist does not allow access to Trading Floor information that may raise concerns.
The Commission notes that the Exchange retains jurisdiction over its members for their conduct in the new areas where the use of personal communication devices will now be permitted because these areas are still within the broader definition of Floor under NYSE Rule 6.
Based on the foregoing, the Commission therefore finds the proposal to be consistent with the Act. The Commission believes that the proposal to permit the use of personal communication devices in certain specified areas adjacent to the Trading Floor, while not without any risk, is tempered by the speed of electronic trading, the existence of access barriers between the Trading Floor and the areas where use of personal communication devices will now be permitted, and the fact that the Exchange retains jurisdiction over its members while they are in these areas. The Commission expects, however, that the Exchange will monitor compliance with the new rule and inform the Commission if it encounters difficulties in implementing and enforcing it or otherwise finds that the new rule raises regulatory concerns.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
On August 27, 2009, NYSE Amex LLC (“NYSE Amex” or “Exchange”) filed with the Securities and Exchange Commission (“Commission”), pursuant to Section 19(b)(1)
Currently, Rule 36—NYSE Amex Equities prohibits members and member organizations from establishing or maintaining any telephonic or electronic communication, including the usage of any portable or wireless communication devices (
Notwithstanding the general prohibition on the use of portable or wireless communication devices, current Rule 36—NYSE Amex Equities permits Floor brokers to use Exchange authorized and issued portable phones on the Floor to communicate with both member firms and non-members off the Floor, subject to certain restrictions.
As noted in the foregoing paragraph, the restrictions on the use of portable or wireless communication devices in current Rule 36—NYSE Amex Equities relate to what is and is not permissible on the Exchange Floor. Under Rule 6—NYSE Amex Equities, the term “Floor” is defined as having the same meaning given that term “under the Act.” The Exchange has issued interpretive guidance that the “Floor” includes the trading Floor of the Exchange and the premises immediately adjacent thereto, such as the various entrances and lobbies of the 11 Wall Street, 18 New Street, 8 Broad Street, 12 Broad Street and 18 Broad Street Buildings, the telephone facilities available in these locations, the areas outside the “Blue Line” (member and member organization booths adjacent to the trading Floor), and any area reserved primarily for members, including members' lounges and bathrooms.
Recently, the Exchange adopted Rule 6A—NYSE Amex Equities, setting forth a definition of “Trading Floor” that is distinct from the definition of Floor. Specifically, the Equities Trading Floor is an area within the area of the “Floor” and defined as “the restricted-access physical areas designated by the Exchange for the trading of securities, commonly known as the `Main Room' and the `Garage.'” As such, the Trading Floor's restricted access physical areas include the areas outside the Blue Line that include the member and member organization booths and/or trading desks. In accordance with Rule 6A—NYSE Amex Equities, the Equities Trading Floor does not, however, include the areas where NYSE Amex-listed options are traded, commonly known as the “Blue Room” and the “Extended Blue Room” (the “NYSE Amex Options Trading Floor”).
The Exchange proposes to amend Rule 36—NYSE Amex Equities to conform with proposed amendments to corresponding New York Stock Exchange (“NYSE”) Rule 36.
The proposal would permit members and member firm employees to use personal portable or wireless communications devices in designated areas of the Exchange's buildings and facilities that fall within the technical definition of the Floor under Rule 6, but that are outside the Trading Floor, and other restricted access points (
The proposal would thus permit members and member firm employees to use their personal communications devices in the in the hallways, stairwells, lobbies or members-only areas of the Exchange premises that are adjacent to the Equities and Options Trading Floors of the Exchange and the NYSE.
In its filing, the Exchange stated that the purpose of the proposal is to provide Exchange members and member firm employees with a reasonable and comfortable space inside the physical confines of the Exchange's buildings and facilities within which they may use their personal portable or wireless communication devices, without diminishing the ability to monitor and regulate their conduct.
In addition, noting that the proposed rule amendments specifically provide that the use of personal portable or wireless communication devices by Exchange members and member firm employees is subject to compliance with all other Exchange Rules and/or federal securities laws, the Exchange represented that it will issue a Notice to Members that will, among other things, remind Exchange members and member firm employees of their obligations under the requirements of Securities Exchange Act Release Nos. 33–7288 and 34–37182, concerning the “Use of Electronic Media by Broker-Dealers, Transfer Agents, and Investment Advisers for Delivery of Information.”
The Exchange also proposed to change Rule 36.23—NYSE Amex Equities to refer to NYSE Amex Options Rule 902NY to clarify that the Exchange's Options Rules permit NYSE Amex Options members to use personal communications devices on the NYSE Amex Options Trading Floor, but that such rule prohibits NYSE Amex Options members from using those devices on the Equities Trading Floor of the Exchange. The Exchange also proposed corresponding technical amendments to Rule 36.20—NYSE Amex Equities.
After careful review, the Commission finds that the proposed rule change is consistent with the requirements of the Act and the rules and regulations thereunder applicable to a national securities exchange. Specifically, the Commission finds that the proposed rule change is consistent with Section 6(b)(5) of the Act,
The Exchange has proposed that members and member firm employees be permitted to use personal portable or wireless communication devices off the Exchange Trading Floor and outside of restricted access areas (
The Commission finds, however, that the proposal strikes a reasonable balance between the Exchange's interest in providing a convenient and comfortable space for Exchange members and member firm employees to use their personal portable communications devices inside Exchange buildings and its interest in minimizing the risk of misuse of such devices, which are not subject to the same surveillance as Exchange authorized and issued devices. In particular, the Commission notes the Exchange's representation that any time or place advantage to using personal portable communication devices outside restricted points of access to the Trading Floor is “significantly reduced by the fact that a Floor Broker or DMM has no line of sight and no ability to hear trading activity on the [Trading] Floor and the speed of electronic trading would likely render stale any information a DMM had prior to leaving his or her post on the Trading Floor.”
The Commission notes that the Exchange retains jurisdiction over its members for their conduct in the new areas where the use of personal communication devices will now be permitted because these areas are still within the broader definition of Floor under Rule 6—NYSE Amex Equities.
The Commission further finds that the added reference in Rule 36.23 to NYSE Amex Options Rule 902NY is consistent with the Act because it ensures that Rule 36.23 references a rule that clarifies members' obligations. The Commission also finds the proposed technical changes to Rules 36.20 to be consistent with the Act.
Based on the foregoing, the Commission therefore finds the proposal to be consistent with the Act. The Commission believes that the proposal to permit the use of personal communication devices in certain specified areas adjacent to the Exchange's Equities Trading Floor, the NYSE Amex Options Trading Floor, and the NYSE Trading Floor, while not without any risk, is tempered by the speed of electronic trading, the existence of access barriers between such Trading Floors and the areas where use of personal communication devices will now be permitted, and the fact that the Exchange retains jurisdiction over its members while they are in these areas. The Commission expects, however, that the Exchange will monitor compliance with the new rule and inform the Commission if it encounters difficulties in implementing and enforcing it or otherwise finds that that the new rule raises regulatory concerns.
For the Commission, by the Division of Trading and Markets, pursuant to delegated authority.
Federal Aviation Administration (FAA), DOT.
Notice of RTCA Special Committee 206/EUROCAE WG 76 Plenary: AIS and MET Data Link Services meeting.
The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 206/EUROCAE WG 76 Plenary: AIS and MET Data Link Services.
The meeting will be held December 7–11, 2009 from 9 a.m. to 5 p.m.
The meeting will be held at Gilruth Center, Brazos Room, Space Center Blvd, Gate 5, Building 207, Houston, TX 77058, 281–483–0304; Contact Person: Tom Evans, (P) 757–864–2499, (C) 757–268–4852, (E)
RTCA Secretariat, 1828 L Street, NW., Suite 805, Washington, DC 20036; telephone (202) 833–9339; fax (202) 833–9434; Web site
Pursuant to section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463, 5 U.S.C., Appendix 2), notice is hereby given for a RTCA Special
Attendance is open to the interested public but limited to space availability. With the approval of the chairmen, members of the public may present oral statements at the meeting. Persons wishing to present statements or obtain information should contact the person listed in the
Federal Aviation Administration (FAA), DOT.
Notice.
The Federal Aviation Administration (FAA) announces its findings on the noise compatibility program update submitted by the Louisville Regional Airport Authority (LRAA).
On October 29, 2008, the LRAA submitted to the FAA Air Traffic Organization (ATO) a request with supporting documentation for an offset approach to Runway 17R at Louisville International Airport (SDF). This request was for a re-evaluation of noise abatement measure NA–7, and associated measures NA–2 and NA–3, submitted to the FAA for action in its 2003 NCP but were deferred.
The FAA ATO evaluated the offset approach procedure provided by LRAA. After considerable review and evaluation, the procedure was disapproved. The FAA ATO notified LRAA of its determination on April 3, 2009. Subsequent to ATO's determination, the FAA issued its Record of Approval (ROA) concerning the LRAA's NCP update on August 4, 2009, and disapproved noise abatement measures NA–2, NA–3, and NA–7.
In its evaluation, the FAA reviewed the proposal under 14 CFR part 150 and the Aviation Safety and Noise Abatement Act of 1979. Section 150.35 of Part 150 includes language stating that programs will be approved under this part if program measures relating to the use of flight procedures for noise control can be implemented within the period covered by the program and without reducing the level of aviation safety provided or adversely affecting the efficient use and management of the navigable airspace and air traffic control systems.
Stephen Wilson, Community Planner, Federal Aviation Administration, Memphis Airports District Office, 2862 Business Park Drive, Building G, Memphis, TN 38118. Documents reflecting this FAA action can be reviewed in person at this same location.
The FAA has reviewed Noise Abatement Measures (NA–2), (NA–3) and (NA–7) in accordance with 14 CFR Part 150. The ROA contains the FAA's decisions for 3 of the 7 NCP measures that were previously deferred under LRAA's 2003 NCP. The FAA has given its disapproval to the Runway 17R offset approach request at LRAA. All other portions of the previously issued ROA remain in effect.
The following is a brief overview of the request:
On October 29, 2008, the LRAA provided the FAA Air Traffic Organization with a letter and supporting documentation requesting an offset approach to Runway 17R at Louisville International Airport (SDF). This was additional information submitted for re-evaluation of previously submitted but deferred noise abatement measures NA–2, NA–3, and NA–7 in LRAA's 2003 NCP
Pursuant to a written supplemental trackage rights agreement dated January 1, 2009, BNSF Railway Company (BNSF) has agreed to amend the existing overhead trackage rights previously granted to Union Pacific Railroad Company (UP) over BNSF's Bieber line at Keddie, CA.
According to BNSF, the purpose of the proposed transaction is to amend the parties' existing agreement to accurately reflect the trackage rights received by UP under that agreement.
The transaction is scheduled to be consummated on December 2, 2009, the effective date of the exemption (30 days after the exemption was filed).
As a condition to this exemption, any employees affected by the trackage rights will be protected by the conditions imposed in
Pursuant to the Consolidated Appropriations Act, 2008, Public Law 110–161, section 193, 121 Stat. 1844 (2007), nothing in this decision authorizes the following activities at any solid waste rail transfer facility: collecting, storing, or transferring solid waste outside of its original shipping container; or separating or processing solid waste (including baling, crushing, compacting, and shredding). The term “solid waste” is defined in section 1004 of the Solid Waste Disposal Act, 42 U.S.C. 6903.
This notice is filed under 49 CFR 1180.2(d)(7). If the notice contains false or misleading information, the exemption is void
An original and 10 copies of all pleadings, referring to STB Finance Docket No. 35311, must be filed with the Surface Transportation Board, 395 E Street, SW., Washington, DC 20423–0001. In addition, a copy of each pleading must be served on Adrian L. Steel, Jr., Mayer Brown LLP, 1999 K Street, NW., Washington, DC 20006–1101.
Board decisions and notices are available on our Web site at
By the Board, Rachel D. Campbell, Director, Office of Proceedings.
Departmental Offices, Treasury.
Notice of request for public comment.
Section 504 of the Rehabilitation Act of 1973 requires that programs and activities conducted by federal agencies be accessible to individuals with disabilities. The Department of the Treasury invites the public to comment on any barriers to the accessibility of its conducted programs and activities by individuals with disabilities.
Comments should be received on or before December 30, 2009 to be assured of consideration.
Comments may be submitted via electronic mail at
Lydia E. Aponte at (202) 622–8335 (not a toll-free-call), or by e-mail to the above address.
Department of the Treasury.
Office of Thrift Supervision (OTS), Treasury.
Notice and request for comment.
The proposed information collection request (ICR) described below has been submitted to the Office of Management and Budget (OMB) for review and approval, as required by the Paperwork Reduction Act of 1995. OTS is soliciting public comments on the proposal.
Submit written comments on or before December 18, 2009. A copy of this ICR, with applicable supporting documentation, can be obtained from RegInfo.gov at:
Send comments, referring to the collection by title of the proposal or by OMB approval number, to OMB and OTS at these addresses: Office of Information and Regulatory Affairs, Attention: Desk Officer for OTS, U.S. Office of Management and Budget, 725—17th Street, NW., Room 10235, Washington, DC 20503, or by fax to (202) 395–6974; and Information Collection Comments, Chief Counsel's Office, Office of Thrift Supervision, 1700 G Street, NW., Washington, DC 20552, by fax to (202) 906–6518, or by e-mail to
For further information or to obtain a copy of the submission to OMB, please contact Ira L. Mills at,
OTS may not conduct or sponsor an information collection, and respondents are not required to respond to an information collection, unless the information collection displays a currently valid OMB control number. As part of the approval process, we invite comments on the following information collection.
Consumers use the privacy notice information to determine whether they want personal information disclosed to third parties that are not affiliated with the institution. Further, consumers use the opt-out notice mechanism to advise the institution of their wishes regarding disclosure of their personal information. Institutions use the opt-out information to determine the wishes of their consumers and to act appropriately.
Notice is hereby given that on November 9, 2009, the Office of Thrift Supervision approved the application of Northwest Savings Bank, Warren, Pennsylvania, to convert to the stock form of organization. Copies of the application are available for inspection by appointment (phone number: 202–906–5922 or e-mail
By the Office of Thrift Supervision.
Notice is hereby given that, pursuant to the authority contained in section 5(d)(2) of the Home Owners' Loan Act, the Office of Thrift Supervision (OTS) has duly appointed the Federal Deposit Insurance Corporation as sole Receiver for Home Federal Savings Bank, Detroit, Michigan (OTS No. 05171), on November 6, 2009.
By the Office of Thrift Supervision.
Veterans Benefits Administration, Department of Veterans Affairs.
Notice.
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the
Written comments and recommendations on the proposed collection of information should be received on or before January 19, 2010.
Submit written comments on the collection of information through the Federal Docket Management System (FDMS) at
Nancy J. Kessinger at (202) 461–9769 or FAX (202) 275–5947.
Under the PRA of 1995 (Pub. L. 104–13; 44 U.S.C. 3501–3521), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. This request for comment is being made pursuant to Section 3506(c)(2)(A) of the PRA.
With respect to the following collection of information, VBA invites comments on: (1) Whether the proposed collection of information is necessary for the proper performance of VBA's functions, including whether the information will have practical utility; (2) the accuracy of VBA's estimate of the burden of the proposed collection of
By direction of the Secretary.
Environmental Protection Agency (EPA).
Order.
In this order, EPA denies objections to, and requests for hearing on, a final rule revoking all pesticide tolerances for carbofuran under section 408(d) of the Federal Food, Drug, and Cosmetic Act (FFDCA). The objections and hearing requests were filed on June 30, 2009, by the National Corn Growers Association, National Sunflower Association, National Potato Council, and FMC Corporation (“Petitioners”).
This final order is effective November 18, 2009.
EPA has established a docket for this action under docket identification (ID) number EPA–HQ–OPP–2005–0162. To access the electronic docket, go to
Jude Andreasen, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–9342; e-mail address:
In this document EPA denies objections and hearing requests by the National Corn Growers Association, National Sunflower Association, National Potato Council, and FMC Corporation (“Petitioners”) concerning EPA's final rule revoking all pesticide tolerances for carbofuran. This action may also be of interest to agricultural producers, food manufacturers, or pesticide manufacturers. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under
In addition to accessing an electronic copy of this
The following is a list of acronyms used in this order:
Exposure to the pesticide carbofuran resulting from existing legal uses is unsafe—unsafe for the general
Pursuant to the procedures of the FFDCA, on June 29, 2009 objections to the final revocation rule were filed by the National Corn Growers Association, National Sunflower Association, National Potato Council, and FMC Corporation (“Petitioners”). The Petitioners also requested a hearing on their objections. Coupled with these objections, FMC filed on the same day yet another series of proposed amendments to its carbofuran registration. These proposed modifications contained new application and geographic restrictions as well as an unprecedented non-governmental scheme for preventing the use of carbofuran in any one area of the country above a small percentage of that area's agricultural acreage. The Petitioners relied on these proposed carbofuran registration amendments as central to, and inextricably intertwined with, their objection to EPA's prior determination in the final rule that carbofuran tolerances are unsafe. Specific challenges raised by the Petitioners involved EPA's decision on the appropriate level of the additional safety factor to protect infants and children, EPA's estimate of carbofuran levels in drinking water, EPA's consideration of the time needed to recover from exposure to carbofuran, and EPA's refusal to consider a human toxicity study conducted with carbofuran.
Today's order denies all of the Petitioners' objections and requests for hearing. A principal flaw in the Petitioners' objections is that they have objected to EPA's determination in the final rule on the safety of carbofuran based on the FIFRA registration amendments that FMC filed with EPA 45 days after the safety determination was made. As such, the Petitioners' objections are irrelevant, and thus immaterial, to the determination EPA made in the final rule. FMC has the statutory right under FIFRA to request amendment of its carbofuran registration. What Petitioners may not do is prolong the FFDCA tolerance revocation process by challenging EPA's safety determination based on proposed FIFRA registration changes not before EPA at the time of its final revocation decision.
It should be noted that EPA's decision on the carbofuran tolerances is not a determination on FMC's proposed registration amendments. FMC may continue to pursue these amendments and also the re-establishment of carbofuran tolerances in light of the amendments. Further, FMC may seek administrative review, and potentially an administrative hearing, with regard to any adverse decision issued by EPA on its proposed amendments. But that process must be played out in the future, a future in which any decision about the safety of carbofuran is made prior to the re-introduction of carbofuran residues in food and water, rather than concurrent with the continued exposure of infants and children to levels of carbofuran residues that EPA has found to be unsafe.
Despite the fact that a central aspect of the Petitioners' objections is based on a flawed conception of the objection process (
EPA is taking this action pursuant to the authority in FFDCA section 408(g)(2)(C), which requires the Agency to issue a final order resolving the objections to its final rule, issued pursuant to 408(b)(1)(b), 408(b)(2)(A), and 408(e)(1)(A). 21 U.S.C. 346a(b)(1)(b), (b)(2)(A), (e)(1)(A), (g)(2)(C).)
In this Unit, EPA provides background on the relevant statutes and regulations governing the Petitioners' objections and requests for hearing as well as on pertinent Agency policies and practices.
1.
EPA also regulates pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (“FIFRA”) (7 U.S.C. 136
2.
Consider, among other relevant factors—* * *
(vi) Available information concerning the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances, including dietary exposure under the tolerance and all other tolerances in effect for the pesticide chemical residue, and exposure from other non-occupational sources;
Risks to infants and children are given special consideration. Specifically, section 408(b)(2)(C) states that EPA:
Shall assess the risk of the pesticide chemical based on—* * *
(II) Available information concerning the special susceptibility of infants and children to the pesticide chemical residues, including neurological differences between infants and children and adults, and effects of in utero exposure to pesticide chemicals;
(21 U.S.C. 346a(b)(2)(C)(i)(II) and (III)). This provision also creates a presumptive additional safety factor for the protection of infants and children. Specifically, it directs that “[i]n the case of threshold effects, * * * an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children” (21 U.S.C. 346a(b)(2)(C)). EPA is permitted to “use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children” (Id.). The additional safety margin for infants and children is referred to throughout this order as the “children's safety factor.”
3.
In issuing a regulation on its own initiative, EPA must first publish a notice of proposed rulemaking, and must generally provide at least 60 days to allow the public to comment on the proposed regulation. After considering comments submitted during this comment period, EPA issues a final rule.
Once EPA issues a final rule, any person may file objections with EPA and, if desired, request an evidentiary hearing on those objections (21 U.S.C. 346a(g)(2)). Objections must specify “with particularity the provisions of the regulation * * * deemed objectionable and stating reasonable grounds therefore” (21 U.S.C. 346a(g)(2)(A); 40 CFR 178.25(a)). Objections and hearing requests must be filed within 60 days (Id.). The statute provides that EPA shall “hold a public evidentiary hearing if and to the extent the Administrator determines that such a public hearing is necessary to receive factual evidence relevant to material issues of fact raised by the objections” (21 U.S.C. 346a(g)(2)(B)). EPA regulations make clear that hearings will only be granted where it is shown that there is “a genuine and substantial issue of fact;” the requestor has identified evidence “which, if established, will resolve one or more of such issues in favor of the requestor,” and the issue is “determinative” with regard to the relief requested (40 CFR 178.32(b)). After consideration of any objections, EPA must issue a final order stating the action taken in response to each objection, including a determination as to whether any hearing is appropriate (21 U.S.C. 346a(g)(2)(C)). The final order also establishes any revisions to the final regulation EPA deems to be warranted based on the objections. Id. EPA's final order on the objections is subject to judicial review in the Court of Appeals, within 60 days of the publication of the order (21 U.S.C. 346a(h)(1)).
4.
The FQPA required that EPA reassess the safety of all pesticide tolerances existing at the time of its enactment. (21 U.S.C. 346a(q)). EPA was given 10 years to reassess the approximately 10,000 tolerances in existence in 1996. In this reassessment, EPA was required to review existing pesticide tolerances under the new “reasonable certainty that no harm will result” standard set forth in section 408(b)(2)(A)(i). (21 U.S.C. 346a(b)(2)(A)(i)). This reassessment was substantially completed by the August 3, 2006 deadline. Tolerance reassessment was generally handled in conjunction with a similar program involving reregistration of pesticides under FIFRA. (7 U.S.C. 136a–1). Reassessment and reregistration decisions were generally combined in a document labeled a Reregistration Eligibility Decision (RED).
EPA decisions regarding the use of human studies in pesticide regulatory decisions are governed by the Protection for Subjects in Human Research final rule (“Human Research rule”), which significantly strengthened and expanded protections for subjects of human research (71 FR 6138 (February 6, 2006)). The framework of the Human Research rule rests on the basic principle that EPA will not, in its actions, rely on data derived from unethical research. The rule divides studies involving intentional dosing of human subjects into two groups: “new” studies—those initiated after April 7, 2006 (the effective date of the rule)—and “old” studies—those initiated before April 7, 2006. The Human Research Rule forbids EPA from relying on data from any “new” study, unless EPA has adequate information to determine that the research was conducted in substantial compliance with the ethical requirements contained therein (40 CFR 26.1705). These ethical rules are derived primarily from the “Common Rule,” (40 CFR part 26), a rule setting ethical parameters for studies conducted or supported by the federal government. In addition to requiring informed consent and protection of the safety of the subjects, among other things, the rule specifies that “[r]isks to subjects [must be] reasonable in relation to * * * the importance of the knowledge that may reasonably be expected to result [from the study].” (40 CFR 26.1111(a)(2)). In other words, a study would be judged unethical if it did not have scientific value outweighing any risks to the test subjects.
As to “old” studies, the Human Research Rule forbids EPA from relying on such data if there is clear and convincing evidence that the conduct of the research was fundamentally unethical or significantly deficient with respect to the ethical standards prevailing at the time the research was conducted (40 CFR 26.1704). EPA has indicated that in evaluating “the ethical standards prevailing at the time the research was conducted” it will consider the Nuremburg Code, various editions of the Declaration of Helsinki, the Belmont Report, and the Common Rule, as among the standards that may be applicable to any particular study (71 FR at 6161). Further, reflecting the concern that scientifically invalid data are “always unethical,” (71 FR at 6160), the rule limits the human research that can be relied upon by EPA to “scientifically valid and relevant data” (40 CFR 26.1701).
Whether the data are “new” or “old,” the Human Research rule forbids EPA from relying on data from any study involving intentional exposure of pregnant women, fetuses, or children subject to a very limited exception (40 CFR 26.1703, 1706).
To aid EPA in making scientific and ethical determinations under the Human Research rule, the rule established an independent Human Studies Review Board (HSRB) to review both proposals for new research (new studies) and reports of completed human research (old studies) on which EPA proposes to rely (40 CFR 26.1603). The rule directs that the HSRB shall be comprised of non-EPA employees “who have expertise in fields appropriate for the scientific and ethical review of human research, including research ethics, biostatistics, and human toxicology” (40 CFR 26.1603(a)). If EPA decides to rely on the results from “old” research conducted to identify or measure a toxic effect, EPA must submit the results of its assessment to the HSRB for evaluation of the ethical and scientific merit of the research (40 CFR 26.1602(b)(2)).
EPA has established the HSRB as a federal advisory committee under the Federal Advisory Committee Act (FACA) to take advantage of “the benefits of the transparency and opportunities for public participation” that accompany a FACA committee (71 FR at 6156). The HSRB, as appointed by EPA, contains approximately 16 distinguished experts in the fields of bioethics, biostatistics, human health risk assessment and human toxicology, primarily from academia (Ref. 10).
EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. A short summary is provided below to aid the reader. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see
To assess the risk of a pesticide tolerance, EPA combines information on pesticide toxicity with information regarding the route, magnitude, and duration of exposure to the pesticide. The risk assessment process involves four distinct steps: (1) Identification of the toxicological hazards posed by a pesticide; (2) determination of the exposure “level of concern” for humans; (3) estimation of human exposure; and (4) characterization of human risk based on comparison of human exposure to the level of concern.
Once a pesticide's potential hazards are identified, EPA determines a toxicological level of concern for evaluating the risk posed by human exposure to the pesticide. In this step of the risk assessment process, EPA essentially evaluates the levels of exposure to the pesticide at which effects might occur. An important aspect of this determination is assessing the relationship between exposure (dose) and response (often referred to as the dose-response analysis). In evaluating a chemical's dietary risks EPA uses a reference dose (RfD) approach, which involves a number of considerations including:
• A ‘point of departure’ (PoD)—the value from a dose-response curve that is at the low end of the observable data and that is the dose that serves as the `starting point' in extrapolating a risk to the human population;
• An uncertainty factor to address the potential for a difference in toxic response between humans and animals used in toxicity tests (
• An uncertainty factor to address the potential for differences in sensitivity in the toxic response across the human population (
• The need for an additional safety factor to protect infants and children, as specified in FFDCA section 408(b)(2)(C).
EPA uses the chosen PoD to calculate a safe dose or RfD. The RfD is calculated by dividing the chosen PoD by all applicable safety or uncertainty factors. Typically in EPA risk assessments, a combination of safety or uncertainty factors providing at least a hundredfold (100X) margin of safety is used: 10X to account for interspecies extrapolation and 10X to account for intraspecies variability. Further, as required by FFDCA section 408(b)(2)(C), in evaluating the dietary risks for pesticide chemicals, an additional safety factor of 10X is presumptively applied to protect infants and children, unless reliable data support selection of a different
AChE inhibition is a disruption of the normal process in the body by which the nervous system chemically communicates with muscles and glands. Communication between nerve cells and a target cell (
AChE is an enzyme that breaks down acetylcholine and terminates its stimulating action in the synapse between nerve cells and target cells. When AChE is inhibited, acetylcholine builds up prolonging the stimulation of the target cell. This excessive stimulation potentially results in a broad range of adverse effects on many bodily functions including muscle cramping or paralysis, excessive glandular secretions, or effects on learning, memory, or other behavioral parameters. Depending on the degree of inhibition these effects can be serious, even fatal.
EPA's cholinesterase inhibition policy statement explains EPA's approach to evaluating the risks posed by AChE-inhibiting pesticides such as carbofuran (Ref. 78 at 10). The policy focuses on three types of effects associated with AChE-inhibiting pesticides that may be assessed in animal and human toxicological studies: (1) Physiological and behavioral/functional effects; (2) AChE inhibition in the central and peripheral nervous system; and (3) AChE inhibition in red blood cells and blood plasma. The policy discusses how such data should be integrated in deriving an acceptable dose (RfD/PAD) for a AChE-inhibiting pesticide.
After clinical signs or symptoms, AChE inhibition in the nervous system provides the next most important endpoint for evaluating AChE-inhibiting pesticides. Although AChE inhibition in the nervous system is not itself regarded as a direct adverse effect, it is “generally accepted as a key component of the mechanism of toxicity leading to adverse cholinergic effects” (Id. at 25). As such, the policy states that it should be treated as “direct evidence of potential adverse effects” and “data showing this response provide valuable information in assessing potential hazards posed by antiAChE pesticides” (Id.). Unfortunately, useful data measuring AChE inhibition in the peripheral nervous system tissues has only been relatively rarely captured by standard toxicology testing, particularly for the NMC compounds. For central nervous system effects, however, more recent neurotoxicity studies “have sought to characterize the time course of inhibition in * * * [the] brain, including brain regions, after acute and 90-day exposures” (Id. at 27).
AChE inhibition in the blood is one step further removed from the direct harmful consequences of AChE-inhibiting pesticides. According to the policy, inhibition of blood AChEs “is not an adverse effect, but may indicate a potential for adverse effects on the nervous system” (Id. at 28). The policy states that “[a]s a matter of science policy, blood AChE data are considered appropriate surrogate measures of potential effects on peripheral nervous system AChE activity in animals, for central nervous system (“CNS”) AChE activity in animals when CNS data are lacking and for both peripheral and central nervous system AChE in humans” (Id. at 29). The policy notes that “there is often a direct relationship between a greater magnitude of exposure [to a AChE-inhibiting pesticide] and an increase in incidence and severity of clinical signs and symptoms as well as blood AChE inhibition” (Id. at 30). Thus, the policy regards blood AChE data as “appropriate endpoints for derivation of reference doses or concentrations when considered in a weight-of-the-evidence analysis of the entire database * * *” (Id. at 29). Between AChE inhibition measured in red blood cell (“RBC”) or blood plasma, the policy states a preference for reliance on RBC AChE measurements because plasma is composed of a mixture of acetylcholinesterase and butyrylcholinesterase, and inhibition of the latter is less clearly tied to inhibition of acetylcholinesterase in the nervous system (Id. at 29, 32).
EPA has relied on a benchmark dose (BMD) approach for deriving the PoD from the available rat toxicity studies. A BMD is a point estimate along a dose-response curve that corresponds to a specific response level. For example, a BMD
In addition to the BMD, a confidence limit was also calculated. Confidence limits express the uncertainty in a BMD that may be due to sampling and/or
In the Agency's BMD analysis for carbofuran, EPA used a response level of 10% brain AChE inhibition; this value represents the estimated dose where AChE is inhibited by 10%, compared to untreated animals. For the last several years EPA has used the 10% value to regulate AChE inhibiting pesticides, including organophosphorous pesticides (OPs) and NMCs. For a variety of toxicological and statistical reasons, EPA chose 10% brain AChE inhibition as the response level for use in BMD calculations. EPA analyses have demonstrated that 10% is a level that can be reliably measured in the majority of rat toxicity studies; is generally at or near the limit of sensitivity for discerning a statistically significant decrease in AChE activity across the brain compartment; and is a response level close to the background (Refs. 34, 35).
Pursuant to section 408(b) of the FFDCA, EPA has evaluated carbofuran's dietary risks based on “aggregate exposure” to carbofuran. By “aggregate exposure,” EPA is referring to exposure to carbofuran by multiple pathways of exposure. EPA uses available data and standard analytical methods, together with assumptions designed to be protective of public health, to produce separate estimates of exposure for a highly exposed subgroup of the general population, for each potential pathway and route of exposure. For acute risks, EPA then calculates potential aggregate exposure and risk by using probabalistic
EPA relies on USDA's Continuing Survey of Food Intake by Individuals (CSFII) for information on food consumption by the US population as well as 32 subgroups based on age, gender, ethnicity, and region. The latest CSFII was conducted in 1994–1996 and 1998. The 1998 survey was a special survey required by the FQPA to supplement the number of children survey participants. DEEM–FCID also contains “recipes” that convert foods as consumed (
The DEEM–FCID computer program estimates exposure by combining data on human consumption amounts with residue values in food commodities. DEEM–FCID also compares exposure estimates to appropriate RfD or PAD values to estimate risk. EPA uses DEEM–FCID to estimate exposure for the general U.S. population as well as for 32 subgroups based on age, sex, ethnicity, and region. DEEM–FCID allows EPA to process extensive volumes of data on human consumption amounts and residue levels in making risk estimates. Matching consumption and residue data, as well as managing the thousands of repeated analyses of the consumption database conducted under probabilistic risk assessment techniques, requires the use of a computer.
For carbofuran's assessment, EPA used DEEM–FCID to calculate risk estimates based on a probabilistic distribution. DEEM–FCID combines the full range of residue values for each food with the full range of data on individual consumption amounts to create a distribution of exposure and risk levels. More specifically, DEEM–FCID creates this distribution by calculating an exposure value for each reported day of consumption per person (“person/day”) in CSFII, assuming that all foods potentially bearing the pesticide residue contain such residue at a value selected randomly from the exposure data sets. The exposure amounts for the thousands of person/days in the CSFII are then collected in a frequency distribution. EPA also uses DEEM–FCID to compute a distribution taking into account both the full range of data on consumption levels and the full range of data on potential residue levels in food. Combining consumption and residue levels into a distribution of potential exposures and risk requires use of probabilistic techniques.
The probabilistic technique that DEEM–FCID uses to combine differing levels of consumption and residues involves the following steps:
(1) Identification of any food(s) that could bear the residue in question for each person/day in the CSFII;
(2) Calculation of an exposure level for each of the thousands of person/days in the CSFII database, based on the foods identified in Step #1 by randomly selecting residue values for the foods from the residue database;
(3) Repetition of Step #2 one thousand times for each person/day; and
(4) Collection of all of the hundreds of thousands of potential exposures estimated in Steps ##2 and 3 in a frequency distribution.
The resulting probabilistic assessment presents a range of exposure/risk estimates.
Because of the limitations in most monitoring studies, EPA's standard approach is to use simulation water exposure models as the primary means to estimate pesticide exposure levels in drinking water. Modeling is a useful tool for characterizing vulnerable sites, and can be used to estimate peak pesticide water concentrations from infrequent, large rain events. EPA's computer models use detailed information on soil properties, crop characteristics, and weather patterns to estimate water concentrations in vulnerable locations where the pesticide could be used according to its label (69 FR 30042, 30058–30065 (May 26, 2004)). These models calculate estimated water concentrations of pesticides using laboratory data that describe how fast the pesticide breaks down to other chemicals and how it moves in the environment at these vulnerable locations. The modeling provides an estimate of pesticide concentrations in ground and surface water. Depending on the modeling algorithm (
EPA relies on models it has developed for estimating pesticide concentrations in both surface water and ground water. Typically EPA uses a two-tiered approach to modeling pesticide concentrations in surface and ground water. If the first tier model suggests that pesticide levels in water may be unacceptably high, a more refined model is used as a second tier assessment. The second tier model for surface water is actually a combination of two models: The Pesticide Root Zone Model (PRZM) and the Exposure Analysis Model System (EXAMS). The second tier model for ground water uses PRZM alone.
A detailed description of the models routinely used for exposure assessment is available from the EPA OPP Water Models Web site:
In modeling potential surface water concentrations, EPA attempts to model areas of the country that are vulnerable to surface water contamination rather than simply model “typical” concentrations occurring across the nation. Consequently, EPA models exposures occurring in small, highly agricultural watersheds in different growing areas throughout the country, over a 30-year period. The scenarios are designed to capture residue levels in drinking water from reservoirs with small watersheds with a large percentage of land use in agricultural production. EPA's models take into account that pesticide residues in water fluctuate daily, seasonally, and yearly as a result of the timing of pesticide applications, the vulnerability of the water supply to pesticide loading through runoff, spray drift and/or leaching, and changes in the weather. Concentrations are also affected by the method of application, the location and characteristics of the sites where a pesticide is used, the climate, and the type and degree of pest pressure.
EPA uses the output of daily concentration values from tier two modeling as an input to DEEM–FCID, which combines water concentrations with drinking water consumption information in the daily diet to generate a distribution of exposures from consumption of drinking water contaminated with pesticides. These results are then used to calculate a probabilistic assessment of the aggregate human exposure and risk from residues in food and drinking water.
EPA's standard acute dietary exposure assessment calculates total dietary exposure over a 24-hour period; that is consumption over 24 hours is summed and no account is taken of the fact that eating and drinking occasions may spread out exposures over a day. This total daily exposure generally provides reasonable estimates of the risks from acute dietary exposures, given the nature of most chemical endpoints. Due to the rapid recovery associated with carbofuran toxicity (AChE inhibition), 24-hour exposure periods may or may not be appropriate. To the extent that a day's eating or drinking occasions leading to high total daily exposure might be found close together in time, or to occur from a single eating event, minimal AChE recovery would occur between eating occasions (
Thus, rather than treating a full day's exposure as a one-time “bolus” dose, as is typically done in the Agency's assessments, the Eating Occasion analysis uses the actual time of eating or drinking occasion, and amounts consumed as reported by individuals to the USDA CSFII. The actual CSFII-recorded time of each eating event is used to “separate out” the exposures due to each eating occasion; in doing so, this “separation” allows the Agency to distinguish between each intake event and account for the fact that at least some partial recovery of AChE inhibition attributable to the first (earlier) exposure occurs before the second exposure event. For chemicals for which the toxic effect is rapidly reversible, the time between two (or more) exposure events permits partial to full recovery from the toxic effect from the first exposure and it is this “partial recovery” that is specifically accounted for by the Eating Occasion Analysis. More specifically, an estimated “persisting dose” from the first exposure event is added to the second exposure event to account for the partial recovery of AChE inhibition that occurs over the time between the first and second exposures. The `persisting dose' terminology, and this general approach were originally suggested by the FIFRA SAP in the context of assessing AChE inhibition from cumulative exposures to OP pesticides (Ref. 33).
Because probabilistic assessments generally are based on a realistic range of residue values to which the population may be exposed, EPA's starting point for estimating exposure and risk for such aggregate assessments is the 99.9th percentile of the population under evaluation, which represents one person out of every 1000 persons. When using a probabilistic method of estimating acute dietary exposure, EPA typically assumes that, when the 99.9th percentile of acute exposure is equal to or less than the aPAD, the level of concern for acute risk has not been exceeded. By contrast, where the analysis indicates that estimated exposure at the 99.9th percentile exceeds the aPAD, EPA would generally conduct one or more sensitivity analyses to determine the extent to which the estimated exposures at the high-end percentiles may be affected by unusually high food consumption or residue values. To the extent that one or a few values seem to “drive” the exposure estimates at the high end of exposure, EPA would consider whether these values are reasonable and should be used as the primary basis for regulatory decision making (Ref. 77).
In July 2006, EPA completed a refined acute probabilistic dietary risk assessment for carbofuran as part of the tolerance reassessment program under section 408(q) of the FFDCA and pesticide reregistration under section 4 of FIFRA. The assessment was conducted using Dietary Exposure Evaluation Model-Food Commodity Intake Database (DEEM–FCID
The tolerance reassessment and FIFRA reregistration process for carbofuran contained numerous opportunities for public participation. These included public comment periods on the preliminary ecological risk assessment (June–August 2005), the preliminary human health risk assessment (September–November 2005), the revised combined risk assessment (March–May 2006), and the interim Registration Eligibility Document (RED) (August–November 2006). EPA received over 200 comments (plus a letter campaign supporting carbofuran with 2,896 signatories) to the 2006 RED. FMC submitted extensive comments throughout the process (including, but not limited to, a comment of 62 pages plus 13 attachments totaling over 900 pages on August 23, 2005, a letter with 20 attachments on November 11, 2005, 46 pages of comments on January 26, 2006, 78 pages of comments on February 17, 2006, a 15-page letter with 8 attachments on May 22, 2006, over 200 pages on May 24, 2006, and other submissions. Following issuance of the RED in August 2006, FMC stated that they would be submitting new data to refute EPA's ecological and human health risk concerns, as well as EPA's benefits assessments. Twenty-three submissions with studies and analyses were submitted in 2007, all of which EPA reviewed. FMC submitted 175 pages of comments to the proposed tolerance revocations jointly with the NPC, NCGA, NCC, and NSA on 9/29/09. The Agency has also met numerous times with FMC, growers, and other stakeholders regarding carbofuran.
One particular aspect of the risk assessment process that involved substantial public participation opportunities was EPA's review of the human toxicology studies performed with carbofuran. In making a determination on whether these studies met the standards of the Human Research rule, EPA, as required, sought the advice of the HSRB. The HSRB review process includes the opportunity for the public both to submit written comments and to make an oral presentation to the HSRB. FMC gave both written and oral comments at the HSRB meeting, which was held May 2–4, 2006. FMC also submitted written comments on the final HSRB report on the meeting.
In January 2008, EPA published a draft Notice of Intent to Cancel (NOIC) all carbofuran registrations, based in part on carbofuran's dietary risks. As mandated by FIFRA, EPA solicited comments from the FIFRA Scientific Advisory Panel (SAP) on its draft NOIC.
Having considered the comments from the SAP, EPA initiated the process to revoke all carbofuran tolerances, publishing a proposed revocation on July 31, 2008 (73 FR 44,864 (July 31, 2008) (FRL–8378–8)). EPA proposed to revoke all of the existing tolerances for residues of carbofuran on the grounds that aggregate exposure from all uses of carbofuran fails to meet the FFDCA section 408 safety standard (Id). Based on the contribution from food alone, EPA calculated dietary exposures to carbofuran exceed EPA's level of concern for all of the more sensitive subpopulations of infants and children. At the 99.9th percentile, aggregate carbofuran dietary exposure from food and drinking water from contaminated ground water was estimated to range from 1100% of the aPAD for adults, to greater than 10,000% of the aPAD for infants, the population subgroup with the highest estimated dietary exposure (Ref. 12). Similarly, aggregate dietary exposures from food and drinking water from surface water, based on contamination from use on corn in Nebraska, ranged from 340% of the aPAD for adults, to 3,900% aPAD for infants. EPA also determined that, based on actual residue levels measured in food in commerce, individual children consuming typical amounts of a single food item received unsafe levels of carbofuran. For example, based on the level of residues detected on in the food supply, a child between 3–5 years, who consumed
EPA held a 60-day comment period on the proposed revocation rule. In the proposed rule, EPA made clear that if any person had concerns with EPA's proposed revocation, those concerns must be raised during the comment period to be preserved. Specifically, EPA stated:
In addition to submitting comments in response to this proposal, you may also submit an objection at the time of the final rule. If you anticipate that you may wish to file objections to the final rule, you must raise those issues in your comments on this proposal. EPA will treat as waived, any issue not originally raised in comments on this proposal. Similarly, if you fail to file an objection to the final rule within the time period specified, you will have waived the right to raise any issues resolved in the final rule. After the specified time, issues resolved in the final rule cannot be raised again in any subsequent proceedings on this rule.
The comment period for the proposed rule closed on September 29, 2008. During the comment period, the Petitioners submitted comments challenging particular aspects of EPA's risk assessment. For example, the Petitioners challenged the basis for EPA's 4X children's safety factor, and the method and assumptions on which EPA relied to estimate drinking water concentrations. In addition, the registrant, FMC Corporation, requested that EPA cancel the use on 22 of the crops on which it was registered, including many of the foods posing the highest risks to children. FMC also requested that EPA modify its labels to include a number of additional restrictions intended to mitigate the risks identified in EPA's risk assessment. For example, use was prohibited on much of the Eastern US to protect vulnerable sources of groundwater; use restrictions were imposed in other areas of the country, preventing use within set distances to prevent runoff into sources of surface water drinking water supplies.
On November 7, 2008, the Petitioners submitted additional information as a supplement to their September comments. Specifically, they submitted carbofuran use data that the Petitioners used in preparing its surface water assessments. The information consisted of a spreadsheet that contained all of the data provided to the Water Panel by FMC, and a document that explained the materials, methods, and procedures employed by the Panel to utilize this data.
On December 24, 2008, FMC submitted a petition requesting that EPA stay the effective date of the tolerance revocations, and that EPA consider additional information, including further risk mitigation measure that the registrant intended to implement, as well as additional analyses that the Petitioners' experts were developing.
On May 15, 2009, EPA published its final rule, based on a revised risk assessment that addressed the voluntary cancellations and label restrictions submitted by the close of the September 29 comment period. The only food uses that remained registered after the voluntary cancellations were sunflowers, corn, potatoes, and pumpkins. In response to the changes made on the labels, EPA revised its risk assessment to account for the reduced number of crops, the altered geographic restrictions, and the additional risk mitigation measures proposed as part of FMC's comments.
Having considered all comments received by the close of the comment period, and based on its revised analyses, EPA concluded that aggregate exposures from all remaining uses of carbofuran were still unsafe for infants and children, and that revocation of the remaining tolerances was warranted. The final rule explained that, although the recent cancellation of several registered uses reduced the dietary risks to children, EPA's analyses still showed that estimated exposures significantly exceed EPA's level of concern for children. For example, EPA determined that the estimated risks could be as high as 9,400% of the aPAD for infants. A detailed description of the risk assessment supporting the final rule follows.
There are three studies available that compare the effects of carbofuran on eleven-day-old rats (
The studies in juvenile rats show a consistent pattern that juvenile rats are more sensitive than adult rats to the effects of carbofuran. These effects include inhibition in AChE in addition to incidence of clinical signs of neurotoxicity such as tremors. This pattern has also been observed for other NMC pesticides, which exhibit the same mechanism of toxicity as carbofuran (Ref. 81). It is not unusual for juvenile rats, or indeed, for infants or young children, to be more sensitive to chemical exposures as metabolic detoxification processes in the young are still developing. Because juvenile rats, called ‘pups’ herein, are more sensitive than adult rats, data from pups provide the most relevant information for evaluating risk to infants and young children and are thus used to derive the PoD. In addition, typically (and this is the case for carbofuran) young children (ages 0–5 years) tend to be the age groups most exposed to carbofuran because they tend to ingest larger amounts of food and water per their body weight than do teenagers or adults. As such, the focus of EPA's analysis of carbofuran's dietary risk from residues in food and water is on young children (ages 0 to 5 years). Since these age groups experience the highest levels of dietary risk, protecting these groups against the effects of carbofuran will, in turn, also protect other age groups.
The Agency used a meta-analysis to calculate the BMD
For AChE-inhibiting pesticides, EPA generally evaluates the effects of the pesticide on both brain and RBC AChE. RBC AChE is used as a surrogate for effects on the PNS because data directly measuring effects on the PNS are difficult to obtain.
Using quality brain AChE data from the three studies (two FMC, one EPA–ORD) conducted with PND11 rats, in combination, provides data to describe both low and high doses. By combining the three studies in PND11 animals together in a meta-analysis, the entire dose-response range is covered. The results of the BMD analysis for PND11 pup brain AChE data provide a BMD
EPA, however, lacked adequate data on carbofuran's effects on RBC AChE. Two studies required from FMC were rejected as flawed. To account for the lack of data in the PNS and/or a surrogate (
The modified children's safety factor takes into account the greater sensitivity of the RBC AChE. The preferred approach to comparing the relative sensitivity of brain and RBC AChE inhibition would be to compare the BMD
Comparing RBC BMD
Using the BMDL
Exposure estimates for this assessment are drawn primarily from EPA's modeling. To conduct its modeling, EPA examined readily available data with respect to ground water and soil pH to evaluate the spatial variability of pH. Ground water pH values can span a wide range; this is especially true for shallow ground water systems, where local conditions can greatly affect the quality and characteristics of the water (higher or lower pHs compared to average values). The ground water simulations reflect variability in pH by modeling carbofuran leaching in four different pH conditions (pH 5.25, 6.5, 7.0, and 8.7), representing the range in the Wisconsin aquifer system. The upper and lower bound of pH values that EPA chose for this assessment were measured values from the aquifer, and the remaining two values were chosen to reflect common pH values between the measured values. Based on EPA's assessment, the maximum 1-in-10-year peak carbofuran concentrations in vulnerable ground water for a single application on corn in Wisconsin, at a rate of 1 pound per acre were estimated to range from a low of less than 1 ppb based on a pH of 7 or higher, to a high of 16 ppb, based on a pH of 6.5.
The results of EPA's revised corn modeling, based on a scenario in Wisconsin, are consistent with the results of the PGW study developed by FMC in Maryland in the early 1980s. Using higher use rates than currently permitted, the peak concentration measured in the PGW study was 65 ppb; when scaled to current use rates, the estimated peak concentration was 11 ppb. EPA's modeling is also consistent with a number of other targeted ground water studies conducted in the 1980s showing that high concentrations of carbofuran can occur in vulnerable areas; the results of these studies as well as the PGW study are summarized in References 13 and 67.
While there have been additional ground water monitoring studies that included carbofuran as an analyte since that time, there has been no additional monitoring targeted to carbofuran use in areas where aquifers are vulnerable. However, data compiled in 2002 by EPA's Office of Water show that carbofuran was detected in treated drinking water at a few locations. Based on samples collected from 12,531 ground water supplies in 16 states, carbofuran was found at one public ground water system at a concentration of greater than 7 ppb and in two ground water systems at concentrations greater than 4 ppb (measurements below this limit were not reported). An infant receiving these concentrations would receive doses equivalent to 220% of the aPAD or 130% aPAD, respectively, based on a single 8 ounce serving of water. As this monitoring was not targeted to carbofuran, the likelihood is low that these samples capture peak concentrations. Given the lack of targeted monitoring, EPA has primarily relied on modeling to develop estimates of carbofuran residues in ground water sources of drinking water.
EPA compiled a distribution of estimated carbofuran concentrations in water based on these estimates, which was used to generate probabilistic assessments of the potential exposures from drinking water derived from vulnerable ground water sources. Based on these assessments, estimated exposures ranged between 770% aPAD for adults to 9400% aPAD for infants.
EPA estimated carbofuran concentrations resulting from the use on pumpkins by adjusting the estimated drinking water concentrations (EDWC) from a previous run simulating melons in Missouri; adjustments accounted for differences in application rate and row spacing. Two EDWCs were calculated for pumpkins: One based on a 36-inch row spacing, representing pumpkins for consumption (77.6 ppb); and a second based on a 60-inch row spacing, representing decorative pumpkins (46.6 ppb).
EPA had previously evaluated the corn rootworm rescue treatment at seven representative sites, representing use in states with extensive carbofuran usage at locations more vulnerable than most in each state in areas corn is grown. Using measured rainfall values, and assuming typical rather than maximum use rates, peak concentrations for the corn rescue treatments simulated for Illinois, Iowa, Indiana, Kansas, Minnesota, Nebraska, and Texas ranged from 16.6–36.7 ppb (Ref. 47). Under the revised assessment to account for the September 2008 use restrictions, concentrations for corn, calculated including the proposed spray drift buffers in Kansas and Texas, decreased 5.1% and 4.7%, respectively, from simulations with no buffer from the previous assessment (Ref. 47). In Kansas, the 1-in-10-year peak EDWCs decreased from 33.5 to 31.8 ppb when a 300-foot buffer was added, and in Texas, from 29.9 to 28.5 ppb with the addition of a 66-foot buffer.
For the sunflower use, 12 simulations were performed for sunflowers, 9 in Kansas, and 3 in North Dakota. The North Dakota scenario was used to represent locations where sunflowers are grown that are vulnerable to pesticide movement to surface water while the Kansas scenario represents places that are not particularly vulnerable, based on the limited rainfall and generally well-drained soils (hydrologic group B soils) that are found in that area. Estimated 1-in-10-year concentrations ranged from 11.6 to 32.7
These predicted carbofuran water concentrations are similar or lower than the peak concentrations reported in the United States Geological Survey-National Ambient Water Quality Survey (USGS–NAWQA) monitoring data. In addition, these data, which represent concentrations in surface water prior to any treatment by a public drinking water system, are consistent with the results of the 2002 data on finished water compiled by EPA's Office of Water. Based on samples collected from 1,394 surface water source drinking water supplies in 16 states, carbofuran was found at no public drinking water supply systems at concentrations exceeding maximum contaminant level (MCL) of 40 ppb. However, carbofuran was found at one surface water public water system in finished (
There are few surface water field-scale studies targeted to carbofuran use that could be compared with modeling results. Most of these studies were conducted in fields that contain tile drains, which is a common practice throughout midwestern states to increase drainage in agricultural fields (Ref. 13). Drains are common in the upper Mississippi river basin (Illinois, Iowa, and the southern part of Minnesota), and the northern part of the Ohio River Basin (Indiana, Ohio, and Michigan) (Ref. 58). Although it is not possible to directly correlate the concentrations found in most of the studies with drinking water concentrations, these studies confirm that carbofuran use under such circumstances can contaminate surface water, as tile drains have been identified as a conduit to transport water and contaminants from the field to surface waters.
EPA conducted dietary exposure analyses based on the modeling scenarios for the proposed September 2008 label. Exposures from all modeled scenarios substantially exceeded EPA's level of concern (Ref. 12). For example, a Kansas sunflower scenario, assuming two foliar applications at a typical 1 lb active ingredient (a.i.) per acre use rate, applied at 14-day intervals, estimated a 1-in-10-year peak carbofuran water concentration of 11.6 ppb. Exposures at the 99.9th percentile based on this modeled distribution ranged from 160% of the aPAD for youths 13 to 19 years, to greater than 2,000% of the aPAD for infants. This scenario is intended to be representative of sites that are less vulnerable than most on which sunflowers could be grown. By contrast, exposure estimates from a comparable North Dakota sunflower scenario, intended to represent more vulnerable sites, estimated a 1-in-10-year peak concentration of 22.4 ppb. These concentrations would result in estimated exposures ranging between 450% aPAD for youths 13 to 19 years, to 5,500% aPAD for infants. Similarly, exposures based on a Washington surface water potato scenario, and using a 3 lb a.i. acre rate, ranged from 230% of the aPAD for children 6 to 12 years to 890% of the aPAD for infants, with a 1-in-10-year peak carbofuran concentration of 7.2 ppb. Although other crop scenarios resulted in higher exposures, estimates for these two crops are presented here, as they are major crops on which a large percentage of carbofuran use occurs. For example, one of EPA's refined exposure analyses is based on a Nebraska corn rootworm “rescue treatment” scenario, and assumes a single aerial application at a typical rate of 1 lb a.i. per acre. The full distribution of daily concentrations over a 30-year period was used in the probabilistic dietary risk assessment. The 1-in-10-year peak concentration of the distribution of values for the Nebraska corn rescue treatment was 22.3 ppb. Estimated dietary exposures based on these concentrations ratned from 340% of the aPAD for adults to 3900% of the aPAD for infants. More details on these assessments, as well as the assessments EPA conducted for other crop scenarios, can be found in References 12, 47, and 67.
The results of aggregate exposures from food and from drinking water derived from ground water in extremely vulnerable areas (
The results of aggregate exposure from food and water derived from one of the least conservative surface water scenarios—Kansas sunflower, with two foliar applications—ranged from 190% of the aPAD for adults to 2,100% aPAD for infants. These estimates reflect the risks only for those people in watersheds with characteristics similar to that used in the scenario, and assuming that water treatment does not remove carbofuran. The estimated water concentrations are comparable to the maximum peak concentrations reported in monitoring studies that were not designed to detect peak, daily
More details on this assessment, as well as the assessments EPA conducted for other crop scenarios, can be found in References 12, 47, and 67. For example, in the proposed rule, EPA presented the results from aggregate exposures resulting from a Nebraska surface water scenario based on a Nebraska corn rootworm “rescue treatment.” Estimated exposures from that scenario ranged from 330% of the aPAD for youths 13 to 19 years to 3,900% of the aPAD for infants.
As noted previously, EPA's food and water exposure assessments typically sum exposures over a 24-hour period, and EPA used this 24-hour total in developing its acute dietary risk assessment for carbofuran. Because of the rapid nature of carbofuran toxicity and recovery, EPA conducted an analysis using information about dietary exposure, timing of exposure within a day, and half-life of AChE inhibition from rats to estimate risk to carbofuran at durations less than 24 hours. Specifically, EPA has evaluated individual eating and drinking occasions and used the AChE half-life to recovery information (herein called half-life information) to estimate the residual effects from carbofuran from previous exposures within the day. The carbofuran analyses are described in the 2009 aggregate (dietary) memo (Ref. 55).
Using the two FMC time course studies in rat pups, EPA calculated half-lives for recovery of 186 and 426 minutes (Refs. 24 and 25). The two values provide an indication that half-lives to recovery can vary among juvenile rats. By extension, children are expected to vary in their ability to recover from AChE inhibition where longer recoveries would be associated with a potentially higher “persisting dose” (as described below).
This analysis had little impact on the exposures from food alone. However, accounting for drinking water consumption throughout the day and using the half-life to recovery information, risk is reduced by approximately 2–3X. Consequently, risk estimates for which food and drinking water are jointly considered and incorporated (
Moreover, even accounting for the estimated decreased risk from accounting for carbofuran's rapid reversibility, the Agency remains concerned about the risks from single eating or drinking events, as illustrated in the following example, based on an actual food consumption diary from the CSFII survey. A 4-month old male non-nursing infant weighing 10 kg is reported to have consumed a total of 1,070 milliters (ml) of indirect water over eight different occasions during the day. The first eating occasion occurred at 6:30 a.m., when this 4 month old consumed 8 fluid ounces of formula prepared from powder. The FCID food recipes indicate that this particular food item consists of approximately 87.7% water, and therefore, 8 ounces of formula contains approximately 214 ml (or grams) of indirect water; with the powder (various nutrients, dairy, soy, oils, etc.) accounting for the remaining 12.3%. This infant also reportedly consumed a full 8-ounce bottle of formula at 12 p.m., 4 p.m., and 8 p.m. that day. The food diary also indicates that the infant consumed about 1 tablespoon of water (14.8 ml) added to prepare rice cereal at 10 a.m., about 2 ounces of water (59.3 ml) added to pear juice at 11 a.m., another
The infant's total daily water intake (1,070 ml, or approximately 107 ml/kg/day) is not overly conservative, and represents substantially less than the 90th percentile value from CSFII on a ml water/kg bodyweight (ml/kg/bw) basis. As noted, carbofuran has been detected in finished water at concentrations of 4 ppb. For this 10 kg body weight infant, an 8-ounce bottle of formula prepared from water containing carbofuran at 4 ppb leads to drinking water exposures of 0.0856 micrograms of active ingredient/kilogram of bodyweight (µg ai/kg bw), or 114% of the aPAD. Based on the total daily water intake of 1,070 ml/day (no reversibility), total daily exposures from water at 4 ppb concentration would amount to 0.4158 µg ai/kg bw, or 555% of the aPAD; this is the amount that would be used for this person-day in the Total Daily Approach.
Peak inhibition occurs following each occasion on which the infant consumed 8 fluid ounces of formula (6 a.m., 12 p.m., 4 p.m. and 8 p.m.); however, the maximum persisting dose occurs following the 9:30 p.m. eating occasion, based on a 186-minute half-life parameter. This produces a maximum persisting dose of 0.1457 µg ai/kg bw, or about 30% of the total daily exposure of 0.4158 µg ai/kg bw derived above, or expressed as a fraction of the level of concern, the maximum persisting dose amounts to about 194% of the aPAD (or 30% of 554%). Note that with drinking water concentration at 4 ppb, an infant consuming one 8 oz bottle of formula—prepared from powder and tap water containing carbofuran at 4 ppb will obtain exposures of approximately 114% of aPAD. Since many infants consume the equivalent of this amount on a single eating occasion, accounting for reversibility over multiple occasions is not essential to ascertain that infants quite likely have obtained drinking water exposures to carbofuran exceeding the level of concern based on drinking water concentrations found in public drinking water supplies.
In this regard, it is important to note EPA's Eating Occasion Analyses underestimate exposures to the extent that they do not take into account carry-over effects from previous days, and because drinking water pesticide concentrations are randomly picked from the entire 30-year distribution. As discussed previously, DEEM-FCID [FN(TM)] is a single day dietary exposure model, and the DEEM-based Eating Occasion Analysis accounts for reversibility within each simulated person-day. All of the empirical data regarding time and amounts consumed (and corresponding exposures based on the corresponding residues) from the CSFII survey are used, along with the half-life to assess an equivalent persisting dose that produced the peak inhibition expected over the course of that day. This is a reasonable assumption for food alone; since the time between exposure events across 2 days is relatively high (compared to the half-life)—most children (>9 months) tend to sleep through the night—and the time between dinner and breakfast the following morning is long enough it is reasonable to “ignore” persisting effects from the previous day. A single day exposure model will underestimate the persisting effects from drinking water exposures (formula) among infants, and newborns in particular (<3 months), since newborns tend to wake up every 2 to 4 hours to feed. Any carry over
FMC's comments raised a range of issues. Those issues are not summarized here because FMC basically refilled many of its comments as objections without modifying them in response to EPA's decision in the final rule. In addition, FMA submitted a an alternate risk analysis purporting to show that aggregate carbofuran exposures to children would be safe. However, FMC failed to provide the data and details of that assessment to the Agency. They also failed to provide several critical components that served to support key inputs into that assessment; and for several of these, EPA was unable to replicate the claimed results based on the information contained in the comments. In the absence of such critical components, the Agency was unable to accept the validity or utility of the analyses, let alone rely on the results.
Nonetheless, based on the summary descriptions provided in the registrant's comments, EPA concluded that the risk analyses contained a critical flaw. The commenters' determination of safety rests on the presumption that under real world conditions, events will always occur exactly as hypothesized by the multiple assumptions in their assessment. For example, the comments assumed, despite all available evidence to the contrary, that children would not be appreciably more sensitive to carbofuran's effects than adults. They assumed that carbofuran's effects will be highly reversible, and that children will be uniformly sensitive, such that the effects will be adequately accounted for by the assumption of a 150-minute half-life, despite the fact that children are not uniformly sensitive. They further assumed that there would be no carry over effect from the preceding day's exposures for infants. They assumed that the cancellation of use on alfalfa would reduce carbofuran residues in milk by over 70%, even though many cows' diet consists primarily of corn. They assumed that residues would decrease between 19% and 23% as a result of the buffer requirements on the September 2008 label, even though the label does not require the use of all of the recommended “best management practices” (
Determining whether residues will be safe for U.S. children is not a theoretical paper exercise; it cannot suffice to hypothesize a unique set of circumstances that make residues “fit in the box.” There must be a reasonable certainty that under the variability that exists under real world conditions, exposures will be “safe.” EPA's assessments incorporate a certain degree of conservatism precisely to account for the fact that assumptions must be made that may not prove accurate. This consideration is highly relevant for carbofuran, because as refined as EPA's assessments are, areas of uncertainty remain with regard to carbofuran's risk potential. For example, a recent epidemiological study reported that 45% of maternal and cord blood samples in a cohort of New York City residents of Northern Manhattan and the South Bronx between 2000 and 2004, contained low, but measurable residues of carbofuran (Ref. 88). The Agency is currently unable to account for the source of such sustained exposures at this frequency.
A further consideration is that the risks of concern are acute risks to children. For acute risks, the higher values in a probabilistic risk assessment are often driven by relatively high values in a few exposures rather than relatively lower values in a greater number of exposures. This is due to the fact that an acute assessment looks at a narrow window of exposure where there are unlikely to be a great variety of consumption sources. Thus, to the extent that there is a high exposure it will be more likely due to a high residue value in a single consumption event. Additionally worrisome in this regard is that carbofuran is a highly potent (
Petitioners raised several objections that correspond to four basic categories of issues. The first category of objections and hearing requests relates to challenges to EPA's selection of the appropriate children's safety factor. In this category of issues, they raise primarily two claims: (1) That EPA's scientific basis for retaining a 4X safety factor is flawed, and (2) the statistical calculations supporting the 4X safety factor are flawed, and based on faulty assumptions. The second category of issues relate to the manner in which EPA conducted its assessment of the exposure from carbofuran through drinking water sources. In this regard, all of their objections fall within three basic categories of issues: (1) EPA should have accounted for a more realistic percent of the crop treated (PCT) in its surface water modeling; (2) EPA's ground water concentration estimates are not based on the best available data, but on obsolete data and overly conservative assumptions; and (3) FMC's new label restrictions and revised terms of registration will ensure that drinking water concentrations will not exceed 1.1 ppb. The third category of issues relates to the manner in which EPA conducted its dietary risk assessment. Under this category, the objections and hearing requests raise four primary issues: (1) Petitioners challenge the way in which EPA's risk assessments accounted for individuals to recover from the effects of carbofuran between exposures; (2) EPA should have relied on the carbofuran human study and therefore use of the default 10X interspecies factor is inconsistent with
EPA denies each of the Petitioners' objections as well as their hearing requests. In the first instance, EPA denies Petitioners' objections and their hearing requests because the objections are inextricably intertwined with proposed changes to carbofuran's FIFRA registration that were not submitted until after publication of the final tolerance revocation rule. Objections to EPA's decision based on FIFRA registration amendments proposed after EPA's decision are irrelevant, and thus immaterial, to a challenge to EPA's decision (See Unit VI.C.). Secondly, an individual analysis of Petitioners' objections and hearing requests leads to the same conclusion for the reasons summarized below.
The Petitioners' hearing requests fail to meet the statutory and regulatory requirements for holding a hearing. In most cases, EPA has denied the request on the grounds that the objection is irrelevant, and therefore immaterial, with regard to EPA's final tolerance revocation regulation. In particular, many claims are immaterial because they largely restate the claims in their combined comments on EPA's proposed rule without challenging the substance or even responding to EPA's explanations for the reasons that EPA declined to adopt the approaches or otherwise make the revisions suggested by the Petitioners in their comments. These claims are irrelevant to the determinations reached in the final rule. In several instances, EPA concluded that Petitioners evidentiary proffer was inadequate, because the data and information submitted, even if accurate, would be insufficient to justify the factual determination urged, or to resolve one or more of the issues in their favor. Further, in many cases, the evidence submitted constituted mere allegations and general denials and contentions, which EPA regulations expressly provide to be insufficient to justify a hearing. In addition, many of Petitioners' claims do not present genuine and substantial issues of fact and/or are immaterial to the relief requested.
On the merits, the majority of Petitioners' objections are denied for substantially the same reasons given in EPA's final rule and response to comments. As noted, many of Petitioners' objections are simply their recycled comments which do not address the conclusions reached by EPA in the final rule. To the extent a response is even needed to such a stale claim, it is provided in the final rule and the response to comments.
The remainder of this Unit is organized in the following manner. Unit VI.B describes in greater detail the requirements pertaining to when it is appropriate to grant a hearing request. In Unit VI.C, EPA generally denies all of Petitioners' objections and hearing requests. Unit VI.D provides EPA's response to the Petitioners legal objection that EPA lacks the legal authority to limit the issues and supporting information that can be raised in an objection and hearing to those raised in comments on the proposed rule. Units VI. G and I provide Petitioners' claims regarding EPA's risk assessment. EPA's conclusions on the hearing requests and objections are summarized in Unit VI.K.
EPA has adopted a 4-part format in Units VI.E through I. for explaining its ruling on each of the subissues EPA identified in the objections. First, the Petitioners' claim and any arguments or evidence tendered to support that claim are described. Second, background information on the claim is provided including whether and how the claim was presented in Petitioners' comments and, if it was presented, EPA's reasons for denying the claim in its final rule and response to comments. Third, EPA explains its reasons for denying a hearing on that claim. Finally, EPA explains its reasons for denying the claim on the merits.
EPA has established regulations governing objections to tolerance rulemakings and tolerance petition denials and requests for hearings on those objections. (40 CFR Part 178; 55 FR 50291 (December 5, 1990)). Those regulations prescribe both the form and content of hearing requests and the standard under which EPA is to evaluate requests for an evidentiary hearing.
As to the form and content of a hearing request, the regulations specify that a hearing request must include: (1) A statement of the factual issues on which a hearing is requested and the requestor's contentions on those issues; (2) a copy of any report, article, or other written document “upon which the objector relies to justify an evidentiary hearing;” and (3) a summary of any other evidence relied upon to justify a hearing. (40 CFR 178.27).
The standard for granting a hearing request is set forth in section 178.32. That section provides that a hearing will be granted if EPA determines that the “material submitted” shows all of the following:
(1) There is a genuine and substantial issue of fact for resolution at a hearing. An evidentiary hearing will not be granted on issues of policy or law.
(2) There is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary. An evidentiary hearing will not be granted on the basis of mere allegations, denials, or general descriptions of positions and contentions, nor if the Administrator concludes that the data and information submitted, even if accurate, would be insufficient to justify the factual determination urged.
(3) Resolution of the factual issue(s) in the manner sought by the person requesting the hearing would be adequate to justify the action requested. An evidentiary hearing will not be granted on factual issues that are not determinative with respect to the action requested. For example, a hearing will not be granted if the Administrator concludes that the action would be the same even if the factual issue were resolved in the manner sought.
(40 CFR 178.32(b)).
This provision essentially imposes four requirements upon a hearing requestor. First, the requestor must show it is raising a question of fact, not one of law or policy. Hearings are for resolving factual issues, not for debating law or policy questions. Second, the requestor must demonstrate that there is a genuine dispute as to the issue of fact. If the facts are undisputed or the record is clear that no genuine dispute exists, there is no need for a hearing. Third, the requestor must show that the disputed factual question is material—
EPA's hearing request requirements are based heavily on FDA regulations establishing similar requirements for hearing requests filed under other provisions of the FFDCA (53 FR 41126, 41129 (October 19, 1988)). FDA pioneered the use of summary judgment-type procedures to limit hearings to disputed material factual issues and thereby conserve agency resources. FDA's use of such procedures was upheld by the Supreme Court in 1972, (
Unlike EPA, FDA has had numerous occasions to apply its regulations on hearing requests. FDA's summary of the thrust of its regulations, which has been repeatedly published in the
A party seeking a hearing is required to meet a threshold burden of tendering evidence suggesting the need for a hearing.' [] An allegation that a hearing is necessary to sharpen the issues' or fully develop the facts' does not meet this test. If a hearing request fails to identify any evidence that would be the subject of a hearing, there is no point in holding one.
A hearing request must not only contain evidence, but that evidence should raise a material issue of fact concerning which a meaningful hearing might be held. [] FDA need not grant a hearing in each case where an objection submits additional information or posits a novel interpretation of existing information. [] Stated another way, a hearing is justified only if the objections are made in good faith and if they “draw in question in a material way the underpinnings of the regulation at issue.” Finally, courts have uniformly recognized that a hearing need not be held to resolve questions of law or policy
(49 FR 6672, 6673 (February 22, 1984); 72 FR 39557, 39558 (July 19, 2007) (citations omitted)).
EPA has been guided by FDA's application of its regulations in this proceeding. Congress confirmed EPA's authority to use summary judgment-type procedures with hearing requests when it amended FFDCA section 408 in 1996. Although the statute had been silent on this issue previously, the FQPA added language specifying that when a hearing is requested, EPA “shall * * * hold a public evidentiary hearing if and to the extent the Administrator determines that such a public hearing is necessary to receive factual evidence relevant to material issues of fact raised by the objections” (21 U.S.C. 346a(g)(2)(B)). This language grants EPA broad discretion to determine whether a hearing is “necessary to receive factual evidence” to objections (H.R. Rep. No. 104–669, at 49 (1996)).
Petitioners' objections and hearing requests are denied in their entirety as irrelevant, and therefore immaterial, to EPA's determination in the May 15, 2009 final rule that the carbofuran tolerances were unsafe and could not be sustained under FFDCA section 408. In that final rule, EPA assessed the risks from carbofuran based on existing uses of carbofuran, as modified by all use restrictions proposed by FMC. EPA concluded that the carbofuran tolerances substantially exceeded the FFDCA safety standard, particularly as to infants and children.
Petitioners' objections and hearing requests as to that final rule disclose on their face their irrelevance to the conclusions reached in the May 15, 2009 final rule. As Petitioners summarize their objections on the first page of their submission:
Petitioners disagree that the carbofuran tolerances are unsafe and argue that the available scientific data show that there is a reasonable certainty of no harm to human health from the continued use of carbofuran for certain specific uses and related tolerances
(Objections at 1) (footnote omitted) (emphasis added). As Petitioners' footnote to this sentence reveals, however, the proposed terms for FIFRA reregistration referenced by Petitioners include significant terms submitted to EPA on June 29, 2009, 44 days after publication of the final rule revoking carbofuran's FFDCA tolerances. In fact, the body of Petitioners' objections show that FMC's June 29, 2009 proposed FIFRA registration amendments are inextricably intertwined with the claims made in the objections. Thus, Petitioners are actually not objecting to the conclusions in EPA's final rule; rather, they are suggesting that EPA might reach a different result in a different factual scenario.
Objections, however, must be directed “with particularity [at] the provisions of the regulation or order deemed objectionable.” 21 U.S.C. 346a(g)(2). The key here is that a party must file particularized objections to—that is, identify some type of error in—a specific regulatory decision. In no sense, however, can it be claimed that EPA erred, or that there is something objectionable, in its May 15, 2009 file rule because EPA did not consider a proposed revision to the terms of the carbofuran registration that had not yet been made. EPA need not shoot at a moving target, much less a target that is not in existence. Therefore, Petitioners' objections are irrelevant, and thus immaterial, to the May 15, 2009 final rule; they are based on hypothetical terms of carbofuran use not before the Agency as it made its determination in that final rule.
Moreover, it is not as if Petitioners' proposed terms for carbofuran use are simple, straightforward use deletions that could be immediately effectuated. While such a proposal is still irrelevant as a challenge to a prior EPA determination, such a proposal might lead EPA to expeditiously modify its action. Rather, Petitioners have proposed an unprecedented scheme involving FMC playing a role as a middleman between EPA and growers to ensure that carbofuran use in no one area exceeds a certain percentage of the cropped area. FMC has properly filed proposed amendments to its FIFRA registration, which would incorporate these new restrictions on carbofuran use and EPA will review these proposals consistent with the substantive and procedural requirements of FIFRA. At such time as these new terms of registration are determined by EPA to meet the standard for registration, and not before, would it be appropriate for EPA to consider whether the tolerance revoked by the May 15, 2009 rule should be re-established.
Finally, Petitioners argue that it can raise its proposed terms of carbofuran use because EPA cannot limit them from putting forward new issues in a hearing. As explained below, EPA believes Petitioners have misconstrued the law on this point. However, even assuming for the sake of argument that Petitioners are correct that new issues can be raised at a hearing on objections, Petitioners admit that any newly raised issues must meet the standard of relevance. As explained above, however, objections based on terms or FIFRA registration proposed after EPA's final rule are irrelevant to the correctness of EPA's determination in that final rule.
EPA has nonetheless evaluated each of Petitioners' objections and hearing requests and determined that there are alternate grounds for denying them. (See Units VI.E through I). EPA has undertaken this analysis for all of the objections despite the fact that it is not at all clear that those of Petitioners'
These arguments are premised on several fundamental misconstructions of the FFDCA section 408 and the APA. None of the cases they cite address the specific question of whether and how the requirements of section 553 of the APA apply to FFDCA section 408. And for many of these cases, Petitioners misquote the cases, misinterpret the holdings, or misconstrue language taken out of context.
Petitioners' first argument, that neither section 408(g) nor EPA's regulations limit the issues that can be raised in objections or in any hearing, is incorrect and misses the point. As discussed at length in the Final Rule, the provisions of 408(g) are not to be viewed in isolation, but as part of a coherent statutory structure inextricably linked to the FFDCA's informal rulemaking procedures and section 553 of the APA. Petitioners concede that FFDCA section 408 establishes an informal rulemaking process (Obj at 62–63). As an informal rulemaking, the process is governed by section 553 of the APA and the case law interpreting these requirements, except to the extent that section 408 provides otherwise.
Moreover, EPA clearly stated in the proposed rule that the Agency considered that the usual requirements applicable to informal rulemakings would remain applicable in this informal rulemaking. The proposal explicitly noted that “[i]f you anticipate that you may wish to file objections on the final rule, you must raise those issues in your comments on this proposal. EPA will treat as waived, any issue not originally raised in comments on this proposal” (73 FR 44,865 (July 31, 2008)).
The fact that FFDCA section 408 in certain limited circumstances supplements the informal rulemaking with a hearing does not fundamentally alter the requirements applicable to informal rulemakings. Nor, as discussed below, does it convert this into a formal rulemaking, subject to the exception in section 553. The FFDCA section 408 establishes a unique statutory structure with multiple procedural stages, and delegates to EPA the discretion to determine the implementation that best achieves the statutory objectives. Accordingly, EPA interprets the notice and comment rulemaking portion of the FFDCA section 408 process as an integral part of the FFDCA process, inextricably linked to the administrative hearing. The point of the rulemaking is to resolve the issues that can be resolved, and to identify and narrow any remaining issues for adjudication. Consequently the administrative hearing does not represent an unlimited opportunity to supplement the record, particularly with information that was available during the comment period, but that commenters have chosen to withhold. For example, as discussed at greater length in Unit VI.E.2, both in their comments, and again in their objections, the Petitioners failed to provide the underlying mathematical modeling that supported their claim that the appropriate children's safety factor was 1X, rather than 4X. Instead, they presented only summary results. Similarly, although the Petitioners claimed in their comments to have conducted an alternate analysis showing that aggregate carbofuran exposures to children would be safe, they failed to provide the data and details of that assessment to the Agency. They also failed to provide several critical components that served to support key inputs into that assessment.
To read the statute otherwise would be to render the rulemaking portion of the process entirely duplicative of the hearing, and thus, ultimately meaningless.
Contrary to Petitioners' contention, EPA's interpretation is entirely consistent with the FFDCA's language and structure. The fact that the statute and regulations allow “any person” to file objections is immaterial. At issue is not “who” may raise objections, but what issues may be raised as part of the objections to justify a hearing. And on the relevant question, the statute is clear that only certain issues—those of material fact—may be raised in objections to justify a hearing (21 U.S.C. 346a(g)(2)(B)). EPA's regulations expand on this limitation, providing, among other requirements, that hearings will not be held on legal or policy issues, nor on the basis of mere allegations, nor where EPA concludes that the data and information submitted, even if accurate, would be insufficient to justify the factual determination urged (
In construing that requirement, EPA gives weight to the fact that 408(g) is only one part of a larger, multi-stage, administrative process, and that the statute does not support an interpretation that this one phase be granted greater significance than the rest of the process. Also relevant is that Congress delegated broad discretion to the Agency to determine whether a hearing is “necessary” (21 U.S.C. 346a(g)(2)(B)). Accordingly, EPA believes that whether an objection states “reasonable grounds” is to be measured against the context of the rulemaking, and the provisions applicable to hearing requests.
Fundamentally, FFDCA section 408 delegates broad discretion to EPA, both to determine how best to harmonize the statutory process and to determine what constitutes “reasonable grounds” for objections. Consequently, the relevant question is whether EPA's exercise of discretion in requiring parties to present all available factual issues and evidence during the rulemaking is reasonable. It is undeniably a reasonable exercise of discretion to ensure that the rulemaking is not an opportunity for one party to waste the time and resources of all parties—both the government and other rulemaking participants—by failing to raise all of their issues or withholding information for the purpose of surprising the government at a later point during the proceeding.
EPA has consistently interpreted section 408 in this fashion since the 1996 amendments. For example, EPA previously ruled that a petitioner could not raise new issues in filing objections to EPA's denial of its Original petition.
The two cases Petitioners cite that are specific to section 408(d) do not alter this assessment. Neither of those cases addressed the scope of the evidence that could be properly raised as part of objections to justify a hearing. Nor were the courts examining the extent of EPA's authority to impose requirements on the filing of objections under 408(g). Rather these courts were evaluating the scope of the FFDCA's exclusive review provisions, and whether the plaintiffs could bring a challenge to EPA policies and individual tolerance decisions without first exhausting the FFDCA's petition process.
Nor do the Petitioners' other cases compel a different result. The majority of the Petitioners' cases concern FFDCA section 701(e), which differs in several significant respects from FFDCA section 408. Section 701(e) imposes no requirements whatsoever on the party submitting the objection: “any person may file objections * * * specifying the provisions of the order deemed objectionable, stating the grounds therefore * * *” 21 U.S.C. 371(e)(2). This section also expressly provides that FDA must hold a hearing upon request: “As soon as practicable after such request for a public hearing, the Secretary, after due notice, shall hold such a public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections.” 21 U.S.C. 371(e)(3). In the face of this language, it is unsurprising that the courts held that FDA lacked discretion to deny a hearing. Further, under FFDCA section 701(e) the mere filing of an objection automatically stays the effectiveness of the challenged provisions. “Until final action is taken upon such objections is taken by the Secretary under paragraph (3), the filing of such objections shall operate to stay the effectiveness of those provisions of the order to which the objections are made.” 21 U.S.C. 371(e)(3). By contrast, section 408 grants the Administrator the discretion to stay the effectiveness of the regulation if objections are filed. 21 U.S.C. 346a(g)(1). Indeed, the Petitioners' own cases specifically distinguish between section 701(e) and other FFDCA provisions. See
Petitioners' second argument is equally incorrect.
The APA section 553 on its face applies to all rulemakings except “[w]hen rules are required by statute to be made on the record after opportunity for an agency hearing” (5 U.S.C. 553(c)). Under this language, APA section 553 will apply unless two requirements are met: (1) The statute requires an opportunity for a hearing as part of the rulemaking, and (2) the hearing is required to be “on the record.” FFDCA section 408 hearings are neither “required,” nor mandated to be “on the record.” The case law is clear that statutes containing both characteristics are the hallmark of formal rulemaking, and that formal rulemaking is the rare exception.
The Supreme Court made clear in
Unless the statute providing for agency action prescribes “hearings on the record,” either in those exact words or by using similar words to indicate that Congress specifically intended to impose the full trial-type requirements of sections 556 and 557, the statute does not fall within section 553's exception.
Thus the question is whether Congress indicated any intent to entirely remove the FFDCA section 408 process from the requirements of 553. The mere fact that FFDCA section 408 requires some (or even many) of the procedures applicable under section 556 and 557 does not resolve the question.
In fact, the language and legislative history of section 408 provide clear indication of Congressional intent not to subject proceedings under these sections to APA sections 556 and 557. FFDCA section 408 does not reference APA sections 556 or 557 (see,
Nor does any provision of FFDCA section 408 include the requirement that the hearing be “on the record.” By contrast, several other provisions of the FFDCA include that exact phrase.
Equally significant is that the language of section 408 explicitly grants EPA broad discretion to deny a hearing. Section 408(g)(2)(B) provides that EPA shall “hold a public evidentiary hearing,
EPA's construction is confirmed by the House Commerce Committee Report accompanying the final bill, which states:
New subparagraph (g)(2)(B) allows an objector to request a public evidentiary hearing.
H.R. Rep. No. 104–669, at 49 (1996) (emphasis added). Notably, in an earlier version of the 1996 amendments, the House bill provided for a mandatory hearing during the notice-and-comment rulemaking stage of an EPA-initiated proceeding. [H.R. 1627, 104th Cong. Section 405 (new FFDCA section 408(e)(2)) (“EPA
If this were not sufficient indication of Congressional intent, further evidence is provided by the fact that in amending section 408, Congress chose not to adopt the provisions of section 701(e) that Petitioners cite in their objections. Clearly, Congress could have
EPA agrees that, when a hearing is warranted, the FFDCA requires an evidentiary hearing that comports with the procedures contemplated by 408(g)(2)(B). But that is not the same as a requirement that section 553 be inapplicable to the proceedings, or that any hearing be held in accordance with APA sections 556 and 557.
Finally, Petitioners' citation to case law interpreting FFDCA section 701(e) does not compel a different result. Petitioners claim that the provisions of FFDCA 701(e) are “near identical” to those under section 408, and on this basis, argue that, “by analogy” these decisions compel an identical interpretation of the requirements of FFDCA section 408 (Obj at 65). Petitioners are correct that section 701(e) of the FFDCA has been held to be “one of those statutes, few in number, that does require rule-making hearings to be on the record in accordance with APA sections 556.”
As previously discussed, there are several significant differences between the statutory language of FFDCA sections 701 and 408 that render Petitioners' citation to these cases inapposite. Hearings are mandatory upon request under section 701, and the filing of objections operates to automatically stay the provisions of the rule. Section 701(e)(2) requires only that the objection “state the grounds therefore,” rather than requiring the a statement of “reasonable grounds.”
Petitioner's reliance on the “substantial evidence” standard in FFDCA section 408(i) is equally misplaced. Incorporation of that standard into judicial review provisions alone has been consistently held to be insufficient to indicate Congressional intent to impose the full requirements of APA sections 556 and 557 to a rulemaking.
The specific language of 408(i) defines the standard for the reviewing court; it does not describe the process by which the agency hearing is to be conducted. This is quite different from the language under 501(c) of the CWA, on which the DC Circuit relied in holding that hearings pursuant to APA section 554 were required.
In any event, even if section 556 did apply to hearings under section 408, Petitioners cannot avoid the case law under section 553 and EPA's interpretation of the interrelationship between any hearing granted under section 408(g)(2) and the rulemaking preceding it. Petitioners cite to the general evidentiary provision in section 556(d) that provides that only irrelevant or immaterial evidence may be excluded and argue that this generic standard necessarily defines the scope of a hearing regardless of the statutory scheme in which it is embedded. However, context matters. As the DC Circuit noted, “the informal procedures of section 553 of the APA and the more formal requirements of sections 556 and 557 are not mutually exclusive.”
Similarly unavailing is Petitioners' argument concerning section 556(e)'s
Finally, Petitioners complain that EPA “raised a host of new issues and assertions for the first time in the Final [rule],” and it would be inequitable for EPA to prevent them from raising objections on these new assessments. Petitioners identify ten categories of “new computations and contentions” that they claim raise issues that go beyond those addressed in their prior comments. With one exception, all of these “new computations and contentions” were revisions to analyses conducted in response to Petitioners' comments. Indeed, some of these were revisions undertaken in response to Petitioners' specific request; for example, the “new” BMD analyses they identify were: (1) Corrections made in response to an EPA error identified in their comments; (2) an extrapolation of BMD
Regarding the remaining analyses: The “new exposure estimates for ground and surface water,” as well as the “revised dietary risk and drinking water assessments” and “new assessment of the impact of buffers and setbacks” were conducted to accurately reflect the use under the registration, as modified by FMC's cancellation of uses and additional mitigation measures. The same is true for the “new analysis of the various carbofuran labels;” the analysis related to the labels submitted as part of the September 2008 comments. The chlopyrifos studies were raised in response to the Petitioners' citation to a subset of chlorpyrifos data. They acknowledge that the “new literature citations” were provided to address one of their contentions (Obj at 56). The sole exception relates to EPA's calculation of carbofuran-specific half-lives for use in the dietary risk assessment. As discussed in Unit VI.G.2, EPA does not reject Petitioners' challenge to EPA's calculation of the 186-minute half-life on the basis that it is untimely.
A fair indication that EPA has not raised a host of new issues in the final rule is that, with the exception of the revised half-lives, Petitioners do not challenge the substance of any of the allegedly “new” information. Indeed, as discussed in the sections below, Petitioners have in many instances failed to address any of the explanations or revised analyses EPA presented in the final rule.
Ultimately, Petitioners' complaint misses the point. EPA does not interpret the statute and regulations to preclude the submission of any new information as part of the objections phase. Such a position would in fact be inconsistent with EPA's own regulations and past practice, which require that in order to support a hearing request, a party submit more than “mere allegations or denials” (40 CFR 178.32(b)(2)). Rather, EPA's interpretation in this regard is analogous to the determination of whether a final rule is the logical outgrowth of the proposal and the comments. For example, EPA does not reject Petitioners' citation to new studies in support of the contention that RBC AChE data are generally more sensitive than PNS tissues on the grounds that they are untimely. This is because these studies are simply more evidence supplementing the issue they fairly raised in their comments, and are intended to rebut EPA's response in the final rule. Similarly, the submission of new analyses relating to the ground water pH in Exhibit 14 is not considered untimely, as the issues they raise relating to ground water pH were fairly raised in comments and discussed throughout the rulemaking. Ultimately, EPA's policy is merely that the objections phase does not present an opportunity for parties to begin the process entirely anew, by raising issues or information that could have been fairly presented as comments on the proposed rule. Nor is the statute's additional procedural step an excuse to withhold information that was clearly available at the time of the rulemaking.
In addition, FMC proposed to add geographic restrictions that would prohibit use in certain parts of the country. Specifically, they proposed to restrict the use of carbofuran on potatoes to the three states: Idaho, Oregon, and to select counties in Washington. They proposed to restrict use on Sunflowers to only Colorado, Kansas, Nebraska, and South Dakota, as well as limited portions of North Dakota and Oklahoma. Under this proposal, use on corn would be restricted to Colorado, Iowa, Illinois, Indiana, Kansas, Missouri, Nebraska, and limited counties in Wisconsin. Further, they
As made clear in Unit VI.C., FMC's newly-proposed registration amendments are irrelevant to the prior determinations made in the final tolerance revocation rule. Further, as discussed in Unit VI.D., as a consequence of the failure to raise these amendments measures as part of their comments on the proposal, EPA considers that all issues arising exclusively as a result of these proposed amendments have been waived. There is no evident reason that FMC could not have offered these amendments as part of its September 2008 proposals. All of the information on which they rely was available in September of 2008. All of the risk concerns that the amendments were intended to address were discussed at length in EPA's proposed rule. Since 2006, EPA has clearly stated its determination that carbofuran's potential to leach into ground water and to runoff into surface water caused unacceptable dietary risks. EPA's methodologies for evaluating these risks have not changed since 2006. Indeed, EPA deferred regulatory action for several months, subsequent to the Agency's determination in 2006 that carbofuran did not meet either the FIFRA or FFDCA standard, to allow the Petitioners time to generate data to address the exact same issues these proposals are intended to address. In their comments on the proposed rule, Petitioners provided some mitigation measures intended to address issues relating to the carbofuran's leaching and runoff potential: Well set-backs, buffers, geographic use restrictions, and aerial application recommendations.
As previously discussed, EPA provided clear notice in the proposed rule that issues that that were not raised during the comment period would be considered waived in subsequent stages of the administrative process (73 FR 44,865). Petitioners were well aware of this, as they commented that “EPA's requirement to raise all issues in the comments does not appear to be legally binding” (Ref. 18 at 118). Indeed they acknowledged that they “agree that identifying disputed issues in the comments is efficient and desirable, and may help to narrow the issues arising in subsequent objections and an administrative hearing. Therefore, the commenters have made a good faith attempt to raise in these comments the principal issues of which they are aware” (Id.).
At this stage of the process, the statute requires the Petitioners to object to the conclusions and provisions in EPA's final rule, not to propose some new alternate license that they claim would meet the statutory standards (21 U.S.C. 346a(g)(2)(A) (“any person may file objections * * * specifying with particularity the provisions of the regulation * * * deemed objectionable”). In fact, one might fairly read their proposal as an admission that the existing license fails to meet the statutory standards.
A further consideration is that the question of whether these amendments can be approved depends on whether the Agency eventually determines the amended registration meets the standards of FIFRA, which include considerations beyond the dietary risks evaluated under the FFDCA. Under FIFRA, the Agency's review of the amendments is also subject to a statutorily mandated schedule (established as part of the Pesticide Regulatory Improvement Act (PRIA)). These are no small matters. In terms of timing, FMC explicitly acknowledged in its letter submitting the proposed amendments that the amendments were subject to the PRIA review process, requesting that the actions be subject to the PRIA 8-month statutory deadline (which would establish a statutory deadline of February 2010 for Agency consideration of FMC's application). It is not clear whether FMC is arguing that its application be accorded a higher priority than other applications and be taken out of turn, or whether FMC is arguing that the consideration of the objections and request for hearing must be delayed until the FIFRA review process is completed. EPA rejects either position; Petitioners cannot use this tolerance proceeding to evade FIFRA's statutory review scheme, or use that scheme to delay this tolerance proceeding.
As noted, although FIFRA incorporates the FFDCA dietary risk standard, FIFRA also requires the Agency to evaluate a much wider scope of issues in determining whether to grant new license requirements. For example, EPA must evaluate the impact this proposal would have on worker and ecological risks. In addition, EPA must carefully evaluate the policy implications involved in authorizing Petitioners' scheme. In this regard, it is worth noting that FMC's scheme is a novel one that raises significant policy questions that are specific to FIFRA, such as whether the steps proposed could be adequately enforced, which could affect the confidence that everybody would, in fact, comply with all the steps, (
Indeed it is questionable whether consideration of the proposed amendments would be appropriate even under Petitioners' position that all objections made in good faith may be presented at this stage of the proceeding (Obj at 61). For example, less than six months prior to their recent submission, the Petitioners proposed voluntarily cancellation of all use on pumpkins except in the Southeastern United States, alleging that sales data demonstrated that carbofuran was needed in the Southeastern U.S. In response to this amendment, which was submitted as part of their comments on the proposed rule, EPA analyzed the dietary risks based on this proposed use pattern for the final rule. A request, mere months later, for additional use on pumpkins in states with different geographic and weather conditions and
For all of these reasons, EPA has determined that reliance on these proposed amendments as a basis for raising objections to the final rule, or for requesting a hearing is not appropriate. Nevertheless, EPA evaluated the individual objections premised on the newly requested terms and conditions of registration. And in each case, the submitted materials relating to these objections and hearing requests independently failed to meet the statutory and regulatory requirements to justify a hearing, as discussed in the Units below.
To more fully understand Petitioners' objection and hearing request with regard to EPA's choice of a 4X children's safety factor and EPA's responses, a little background is helpful. Section 408 of the FFDCA imposes a default additional safety factor for the protection of infants and children, to take into account the fact that children are frequently more sensitive to a pesticide's effects than adults. This default 10X safety factor can only be revised if the Agency has “reliable data” to demonstrate that the alternative safety factor—or no safety factor—“will be safe for infants and children” (21 U.S.C. 346a(b)(2)(C)). In determining whether a different factor is safe for children, EPA focuses on the three factors listed in section 408(b)(2)(C)—the completeness of the toxicity database, the completeness of the exposure database, and potential pre- and post-natal toxicity. In examining these factors, EPA strives to make sure that its choice of a safety factor, based on a weight-of-the-evidence evaluation, does not understate the risk to children. (Ref. 79). The Agency's approach to evaluating whether sufficient “reliable” data exist to support the reduction or removal of the statutory default 10X is described below in Figure 1.
EPA has consistently required that data comparing the AChE inhibition in young rat pups (typically PND11) and adult rats be submitted on AChE-inhibiting pesticides, such as carbofuran, to determine the extent of children's potential sensitivity. The study measures the levels of AChE inhibition in both potentially relevant target tissues: The brain and either the PNS or red blood cell (RBC), which serves as a surrogate for the PNS. EPA required these data from FMC for carbofuran, and FMC on two occasions submitted the studies. Both sets of data, however, were rejected by EPA as scientifically flawed because they inaccurately measured the levels of RBC AChE.
Despite the invalidity of the two FMC studies as to RBC AChE, EPA still has certain, limited RBC AChE data and other PNS-related data on carbofuran from other studies. These other carbofuran data indicate the following: (1) PNS-related effects (tremors) occur in pups as a result of exposure to carbofuran at low doses; (2) juveniles are more sensitive than adults to carbofuran based on brain measures; (3) juveniles are more sensitive than adults to carbofuran based on RBC AChE measures; and (4) the relative sensitivity of juveniles compared to adults as to RBC AChE is significantly greater the relative sensitivity of juveniles compared to adults as to brain AChE. It is also noteworthy that the data in adult rats showed RBC AChE was generally more sensitive to carbofuran's effects than brain AChE (RBC AChE inhibition was higher than brain at every dose except the lowest), although these data are of limited relevance, because they were conducted on adult animals rather than pups, and adult responses are frequently not predictive of children's responses. However, because the available pup RBC AChE data from EPA–ORD did not involve testing at doses that produced a sufficiently low level of inhibition, the data were not sufficient to develop a PoD for juveniles based on RBC AChE.
Accordingly, in making its children's safety factor determination for carbofuran, EPA was faced with three significant issues: (1) Sufficient data on carbofuran that are routinely-required for AChE-inhibiting pesticides to measure PNS effects was not available; (2) available data measuring the levels of AChE inhibition in brain and RBC indicated that juveniles were more sensitive than adults to carbofuran and other carbofuran data indicated that PNS-related effects could occur in pups at low dose levels; and (3) although the evidence on carbofuran as to RBC AChE inhibition in juveniles indicated that effects on juveniles' PNS might be the most sensitive endpoint, there was not sufficient data to calculate a PoD (for use in determining the safe dose or PAD) on these effects. Despite the incompleteness of the toxicity database and the evidence indicating the potential for pre- and post-natal toxicity at a very sensitive level, which indicate the need to retain a children's safety factor, EPA nonetheless determined that, because there was limited reliable data in juveniles, a full statutory default 10X was not necessary to ensure that children's exposures would be “safe.” EPA undertook a complex comparison of the brain and RBC AChE data in juveniles and determined that the likely increased level of sensitivity for RBC AChE inhibition is 4X. EPA thus concluded that using an additional children's safety factor of 4X applied to the PoD from data on brain AChE inhibition in juveniles would protect infants and children.
In essence, these two main issues overlap, particularly with respect to the evidence submitted. Petitioners rely on the same studies to support both points. However, they are presented below separately as discrete issues in the interest of clarity. Supplemental to these two main points, EPA has identified three separate allegations made by Petitioners in support of this objection, which are also analyzed individually in this section.
a.
As explained in Unit IV.A, EPA uses a weight of evidence approach to determine the toxic effect that will serve as the appropriate PoD (or regulatory endpoint) for a risk assessment for AChE inhibiting pesticides, such as carbofuran (Ref. 78). Neurotoxicity resulting from carbofuran exposures can occur in both the central (brain) and peripheral nervous systems (PNS). In its weight of the evidence analysis, EPA reviews data, such as AChE inhibition data from the brain, peripheral tissues and blood (
There are laboratory data on carbofuran for cholinesterase activity in plasma, RBC, and brain from studies in
The studies in juvenile rats show a consistent pattern that juvenile rats are more sensitive than adult rats to the effects of carbofuran. These effects include inhibition of brain AChE in addition to the incidence of clinical signs of PNS neurotoxicity, such as tremors, at lower doses in the young rats. This pattern has also been observed for other NMC pesticides, which exhibit the same mechanism of toxicity as carbofuran (Ref. 81). The 2008 SAP, in its review of the carbofuran draft NOIC, concurred with EPA that the brain AChE data clearly indicate that the juvenile rat is more sensitive than the adult rat (Ref. 36).
The Agency does not have any AChE inhibition data for carbofuran in the PNS tissue of adult or juvenile animals. There is data on RBC AChE inhibition, which is a surrogate for PNS tissue AChE inhibition, in adult animals at both high and low doses, and RBC data in pups, but only at doses causing greater than 50% AChE inhibition (a very high level of inhibition). In adults, the data show that RBC is generally more sensitive to the effects of carbofuran than the brain, but that at the lowest dose tested, brain and RBC have similar sensitivity. In pups, the available data at higher doses show that, like adults, RBC is more sensitive than brain. For example, the EPA–ORD studies showed that RBC AChE inhibition is more sensitive than brain AChE inhibition in both PND11 and PND17 pups at the lowest dose tested. However, the lowest dose (0.1 mg/kg) in both studies missed the lower portion of the RBC AChE inhibition dose-response curve for pups. At the lowest dose, PND 11 pups had approximately 40% brain and 53% RBC AChE inhibition while PND17 pups had approximately 25% brain and 50% RBC AChE inhibition. Consequently, the Agency does not have RBC AChE inhibition data in pups at the low doses (
EPA explained that additional evidence for the sensitivity of the PNS to carbofuran's effects comes from data in pregnant rats exposed to carbofuran that showed clinical signs that may be indicative of peripheral toxicity. Finally, EPA explained that data from other AChE inhibiting pesticides show that direct measures of peripheral nervous system (
Normally, EPA would regulate based on the most sensitive endpoint, which in this case would appear to be the effects on children's PNS. However, as discussed above, EPA lacked the information that would allow it to establish a PoD (or regulatory endpoint) based on the effects on children's PNS. EPA therefore established its PoD based on the AChE inhibition in pup brain. Generally, by regulating based on pup data, EPA would directly account for any additional sensitivity that children might have, because the safe levels estimated from these data would be the levels at which infants and children would be affected. In such circumstances, EPA could reduce the children's safety factor.
But because EPA lacked the data on the PNS effects in pups at low doses of carbofuran, which are most analogous to the exposures that infants and children will receive from eating food with carbofuran residues, the Agency could not be confident that assessing risk using brain AChE inhibition would be protective of potential effects in the PNS for infants and children. Accordingly, EPA determined that, even though the Agency was relying on pup data, consistent with the statutory mandate that an additional safety factor be applied to account for children's increased sensitivity in the absence of information affirmatively demonstrating that no such safety factor is necessary, the Agency could not conclude that removal of the statutory default 10X would be “safe for infants and children.” As some information was available to characterize the effects on infants and children, EPA concluded that the full default 10X was unnecessary, and that it could safely reduce the factor to 4X.
Petitioners raised many of the same assertions in their comments on EPA's proposed rule that they raise in their objections. For example, the Petitioners claimed that because EPA relied on pup brain data, no additional safety factor would be necessary to account for children's increased sensitivity, because “brain data are a better surrogate for the PNS than RBC data.” The comments also contended that RBC data are problematic in a number of regards,
In the final rule and response to comments EPA responded to all of the Petitioners' claims, and comprehensively restated its reasoning that the lack of PNS inhibition data warranted retention of some portion of the children's safety factor for carbofuran (74 FR 68694–68695 (May 15, 2009)). In essence, EPA explained that Petitioners had not presented any information that fundamentally altered the available risk information before the Agency. Specifically, EPA concluded that, given that (1) the EPA–ORD data clearly show that a surrogate measure of the peripheral nervous system (RBC AChE) in juvenile rats is more sensitive to the effects of carbofuran than brain AChE inhibition; (2) clinical signs consistent with toxicity to the peripheral nervous system were seen at very low doses of carbofuran; and (3) data from other AChE inhibiting pesticides show that direct measures of peripheral nervous system (
It is important to remember that to obtain a hearing on EPA's children's safety factor decision, Petitioners must proffer more than evidence on whether
For purposes of resolving whether the statute requires the retention of a children's safety factor, the critical issue is whether sufficient data exists to determine the effects on children's peripheral nervous systems from low doses of carbofuran. None of the evidence submitted affirmatively addresses this question. As discussed in more detail below, the only evidence proffered in support of this objection was: (1) A subset of the available carbofuran data from adult animals; and (2) data, primarily in adult animals, from other chemicals to demonstrate that generally, reliance on brain data will be protective of PNS effects, and therefore EPA can assume that the same will hold true for carbofuran. However, the Petitioners have failed to submit any data to demonstrate that the effects seen in adults will be predictive of the effects in juveniles. They have also submitted no evidence specific to carbofuran that demonstrates the effects of low doses on children's peripheral nervous systems. This is critical because the evidence they do proffer on other chemicals fails to establish that as a general matter, reliance on brain data will always be protective of the effects on the PNS. The majority of the evidence in other chemicals actually proves that reliance on brain data is frequently not protective of the effects on the PNS. And the remainder of the evidence on this point, taken in the light most favorable to the Petitioners, provides only equivocal support for Petitioners. Such evidence, by itself, is insufficient to relieve the uncertainty that remains with respect to carbofuran, based on the affirmative evidence in carbofuran-specific data, showing that reliance on brain data may not be protective. And such evidence, that entirely fail to address the points that the statute makes central to a determination of the appropriate children's safety factor, cannot justify a hearing.
When examined more closely, their overall evidentiary proffer is even less impressive. As discussed, much of the evidence was conducted in adult rats. Indeed the only evidence Petitioners submitted in support of this objection that was specific to carbofuran's effects on the PNS was data in adult rats. No evidence was submitted to demonstrate that adult data are generally predictive of responses in pups. Nor was any evidence submitted to support the assumption that pups will respond to low doses of carbofuran in the same way as adults. Thus their evidentiary proffer is effectively based on mere speculation that adult data will be predictive of pup responses, which cannot justify a hearing (40 CFR 178.32(b)(2)). As EPA previously explained in the proposed and final rules, responses in adult rats are not necessarily predictive of, or relevant to, responses in juveniles since the metabolic capacity of juveniles is less than that of adults (73 FR 44864, 74 FR 23046). As such, juvenile rats can be more sensitive to some toxic agents. Simply put, studies that only involve adult animals, therefore, do not provide information on effects on the young, which is the focus of the children's safety factor. No matter how much evidence Petitioners can amass showing that brain AChE is protective of RBC AChE in adult animals, that does not relieve the uncertainty concerning potential sensitivity of PNS tissues in juvenile animals, particularly when all of the existing carbofuran data shows that pups are more sensitive than adults to the effects of carbofuran, and that clinical signs consistent with toxicity to the PNS were seen in pups at very low doses of carbofuran. Accordingly, in the absence of carbofuran data in pup PNS tissues or a surrogate such as RBC data, the Petitioners' evidentiary proffer fails to establish a reasonable possibility that this issue could be resolved in their favor. A hearing is not appropriate in such cases (40 CFR 178.32(b)(2)).
The central tenet of this objection is that regulating based on the effects in the CNS will ensure that the PNS is protected. In this regard, Petitioners do cite to studies in juvenile animals, but all of them are conducted with chemicals other than carbofuran.
When data are not available for a specific chemical, conclusions based on other chemicals can only be scientifically supported if it has been demonstrated that the conclusion is always true. If, “in some cases,” the conclusion is not true, then in the absence of data on the specific chemical, the conclusion cannot be made for that chemical, and uncertainty exists regarding the effects of the individual chemical. Since there are no data on the effects of carbofuran in PNS tissues or RBC data at low doses in pups, even assuming that they were able to prove that for the specific chemicals identified, the CNS is sometimes more sensitive than the PNS, significant uncertainty would remain regarding carbofuran's effects on the PNS. This is because the only evidence specific to the effects of carbofuran on the PNS at low dose levels that can be used as a comparison with the brain AChE levels is the adult RBC data.
This also affects the materiality of this objection. If the adult RBC AChE data are not considered, as Petitioners suggest, no carbofuran-specific data exists to demonstrate the level of AChE inhibition in the PNS of either adults or pups at the low dose levels relevant to risk assessment. Thus, even assuming Petitioners could successfully establish every point they raise in this regard, the fact still remains that a decision maker would have no data that provides any information relating to the potential effects of carbofuran on a child's PNS. Given that FFDCA section 408(b)(2)(C) compels the application of a 10X safety factor in the absence of information to account for the presumptive sensitivity of children, the lack of any data bearing on carbofuran's PNS effects would require the Agency to apply a 10X safety factor, rather than the 4X factor applied in the final rule.
A further flaw in the Petitioners' evidence is that it is internally inconsistent. Notwithstanding their allegations (discussed in subissue b below) that RBC data are inherently unreliable and should be discounted in favor of brain data, the carbofuran adult RBC data are one of the primary pieces of evidence proffered to support the claim that reliance on the carbofuran pup brain data will protect against all
Accordingly, the sum of their evidence is no more than mere speculation that the effects of carbofuran exposure in the CNS will be protective of effects in the PNS. This falls far short of the “reliable data” on the safety of infants and children needed to justify the entire removal of the 10X children's safety factor and thus cannot justify a hearing (40 CFR 178.21(b)(2)).
A detailed examination of Petitioners' evidence follows below.
Essentially this testimony fails to prove any dispute of material fact. EPA relied on the carbofuran pup brain AChE inhibition data to establish carbofuran's PoD. The Petitioners have not argued that PNS effects are irrelevant. Indeed, their submissions make clear that effects on the PNS are appropriate considerations in a risk assessment; the only point they dispute is whether brain or RBC data best account for those effects (Exhibits 4, 6).
Alternatively, if they intend to argue that RBC data entirely lacks any scientific validity, this is contradicted in several places by their other objections and their own submissions. As discussed above, the commenters rely on the adult carbofuran RBC data to support their claim that reliance on the pup brain data is adequately protective of PNS effects. Moreover, they explicitly acknowledge that reliance on RBC data is scientifically valid in the context of the human data (Obj at 13). Consequently, the submitted materials are insufficient to justify the factual determinations urged, and therefore fail to support a determination that an evidentiary hearing is warranted (40 CFR 178.32(b)(2)).
Petitioners' first claim simply reiterates points made in their comments on the proposed rule. As explained in the final rule, EPA agrees that the data show that the brain responds rapidly to carbofuran, and that it readily passes the blood/brain barrier. However, evidence regarding the speed with which the brain reacts proves nothing with regard to the relative sensitivity of PNS tissues (Ref. 85 at 46). Petitioners have presented nothing that challenges the substance of EPA's response. Consequently, these claims do not present a live controversy as to a material issue of disputed fact; both parties agree on the facts at issue, which is that the brain responds rapidly to carbofuran. Moreover, a simple repetition of comments made on the proposal without more is insufficient to warrant a hearing.
Petitioners' second point—that brain AChE inhibition correlates closely with PNS inhibition, and demonstrates that reliance on brain data will be protective of the PNS—is a disputed material issue of fact that could warrant a hearing, except that none of the evidence submitted in support of this point presents a reasonable possibility that the Petitioners could establish the points alleged. Consequently, they have failed to demonstrate that a hearing is warranted on this objection (40 CFR 178.32(b)(2)).
None of the published studies conducted with other chemicals cited in the Report provide more than equivocal support for the points above; in fact, in several instances, the study results support EPA rather than the Petitioners.
Marable,
Chen,
The second group of studies consists of data on NMC chemicals. McDaniel
Somani
In sum, based on the evidence contained in this exhibit, EPA concludes that there is not a reasonable probability that the proffered evidence would resolve the issue in Petitioners' favor, and that consequently no hearing is warranted on this basis. First, all but one of the studies discussed in this exhibit were conducted with adult animals, rather than pups. As such, they provide evidence of little relevance to the question of whether pups' PNS are more sensitive than the CNS. In the absence of carbofuran PNS data, or pup RBC data, much of this evidence is effectively mere speculation about whether adult data will be predictive of pup responses, which cannot justify a hearing (40 CFR 178.32(b)(1)).
EPA concludes that there is not a reasonable probability that the evidence contained in this exhibit would resolve the issue in Petitioners' favor. The results of these studies fail to demonstrate the point for which Petitioners cite them—that brain AChE is always equally or more sensitive than PNS AChE, and therefore exclusive reliance on brain data can be assumed to be protective. Consequently, the fact that Petitioners can identify examples of other chemicals, whether OPs or NMCs, that sometimes affect the brain more severely than the PNS does not prove
As explained in EPA's final rule, Petitioners are relying on only a subset of the chlorpyrifos data. The data, when examined in total, do not support a conclusion that brain data will always be protective of PNS effects (74 FR 23054–23055 (May 15, 2009)). But even relying solely on the studies Petitioners reference in this exhibit, it is clear that brain is not always inhibited to the same degree as peripheral tissues, nor is it always protective of peripheral tissues. The data in Padilla
The results are similar for the disulfoton studies. Schwab
Finally, the Lifshitz study does not support the claim for which it was cited. The study presents no data on the dose levels associated with the poisoning incidents, and in fact concludes that there was “insufficient information to compare the doses ingested by [adults and children].” However, based on the symptomology reported (comas, stupor, and severe hypotoxicity) it is likely that the doses were high, not low, as the Report claims. Also, this study cannot be used to discount PNS effects in children; a large percentage of the children clearly showed PNS effects (myosis, diarrhea). In addition, because this was a retrospective study of patients admitted to a hospital intensive care unit, given the severity of some of the CNS symptoms, such as comas, it is not unlikely that even if the subjects also showed PNS symptoms, they were not reported. Finally, the study authors' conclusion was that in children, the “clinical presentation [of carbamate poisoning] differs from adult poisoning manifestations” (Ref. 50). Or in other words, that the effects in adults from exposure to carbamates such as carbofuran are not necessarily predictive of the effects in children. It is difficult to see how this study could be fairly argued to support Petitioners' allegations.
In conclusion, the totality of the evidence in Exhibits 4 and 6 fail to support Petitioners' contention. As shown in Table 1 below, the majority of the study results demonstrate that the PNS is frequently more sensitive than the CNS. The remainder, taken in the light most favorable to the Petitioners, provide merely equivocal support.
iii.
Similar to other AChE inhibiting pesticides, carbofuran can affect both the central and peripheral nervous system. Because the relative sensitivity of the central and peripheral nervous system varies among pesticides and the children's safety factor should account for the most sensitive toxicity endpoint, the Agency considers the availability of data in both the central and peripheral nervous systems important in its safety factor evaluation.
As shown in Figure 1, above, there are several datasets that evaluate the effects of carbofuran on the central nervous system (
Given that (1) data from other AChE inhibiting pesticides show that direct measures of peripheral nervous system (
Additional evidence for sensitivity of the PNS comes from carbofuran data in pregnant rats that showed clinical signs that may be indicative of peripheral toxicity. The California Department of Pesticide Regulation (CDPR) has calculated a BMD
Further support for the Agency's concern comes from other clinical reports of the effects of carbamate poisoning in children. For example, Lifshitz reported that all children presented with CNS symptoms (coma, stupor), but CNS symptoms were observed in only 54% and 23% of children as reported by Zweiner and Ginsburg (1988) and El-Naggar
In addition, Petitioners' own data show that effects can differ significantly between high and low doses. In Chen, for example, the data from Hoberman showed that at the lowest doses the levels of inhibition were higher in the PNS than in the brain, but at higher doses, the levels were higher in the brain.
Thus, for a number of reasons, the Agency has concerns that children's PNS may be more sensitive to the effects of carbofuran than the CNS. This concern is the basis for retention of a portion of the children's safety factor.
The carbofuran RBC data in adult animals does not resolve this question. There can be substantial differences in response between pups and adults, and, as noted, the data show clearly that pups are more sensitive to the effects of carbofuran. It is not unusual for juvenile rats, or indeed, for infants or young children, to be more sensitive to chemical exposures as metabolic detoxification processes in the young are still developing. Because pups are more sensitive than adult rats, data from pups provide the most relevant information for evaluating risk to infants and young children and are thus used to derive the PoD. In addition, typically (and this is the case for carbofuran) young children (ages 0–5) tend to be the most exposed age groups because they tend to eat larger amounts of food per their body weight than do teenagers or adults.
Petitioners do not argue that RBC data are entirely irrelevant, but rather that brain data are “preferred.” They raise several points in support of this contention; first, that “RBC AChE inhibition data are only preferred for risk assessment purposes in two circumstances: (1) Where the PoD is set using data from human studies where only RBC data are available or (2) where data from the relevant target tissues are unavailable.” They allege that, despite the absence of carbofuran data in the PNS tissues, brain is preferred in this case because the brain is “target tissue” from the nervous system, and because brain data are a “better predictor” of PNS effects than RBC. As further evidentiary support, they cite to evidence from OP studies that RBC AChE can “in some cases” be inhibited to a greater degree than either PNS or brain AChE, and therefore reliance on RBC AChE data can overstate potential PNS effects. They also argue that RBC AChE is more variable and less reliably measured at low response levels, such as 10% AChE inhibition. The evidence in Exhibits 4 and 6 is also proffered in support of this objection.
Petitioners raised many of the same issues raised in the objections in their comments on the proposed rule. For example, they argued that, “as a matter of science policy, brain AChE inhibition is the preferred endpoint over RBC AChE inhibition.” They also argued that no physiological function has been demonstrated for RBC, and RBC AChE inhibition is not itself an adverse effect.
In the final rule, EPA responded to each of their comments, but concluded that no information had been submitted to justify altering the Agency's general policy that reliance on RBC is appropriate as a surrogate for PNS effects in the absence of direct measurements in PNS tissues.
Nor does the proffered evidence present any other issue that would warrant a hearing. The evidence submitted in Exhibits 4 and 6 on this point only relates to the question of whether brain data can sometimes correspond more closely with PNS effects than RBC AChE data, rather than the question of whether the RBC data are scientifically invalid. Or in other words, the submitted materials relate only to the point that reliance on RBC data is unnecessarily conservative, because sometimes it overestimates the potential PNS effects, rather than to the factual question of whether RBC data bears no relation whatsoever to PNS effects. Unless Petitioners can show that RBC AChE is not related to CNS effects generally or specifically for carbofuran, or that brain AChE is protective of CNS effects generally or specifically for carbofuran, then the mere fact that RBC AChE may be a conservative, or even very conservative, indicator of PNS effects is simply immaterial to the question of whether there are “reliable data” to justify removing the presumptive 10X children's safety factor in the absence of sufficient RBC AChE data. As shown in the discussion of subissue 1, the Petitioners' evidence does not demonstrate that reliance on juvenile brain data as a surrogate for effects in the juvenile PNS will guarantee that the levels chosen on that basis will be predictive of all PNS effects from carbofuran, because the PNS effects occur only at the same or higher doses than those that produce effects on the brain AChE—
Indeed, much of the evidence in the Exhibit 4 and 6 Reports is ultimately an irrelevance, and thus fails to present a material factual dispute. Instead of focusing the stated objection—RBC AChE is inappropriate marker for CNS effects—the Reports attempt to link EPA's children's safety factor decision to findings concerning chlorpyrifos (Exhibit 4 at 4). In fact, a fair portion of the Report in Exhibit 6 is dedicated to a rebuttal of EPA's conclusion that the majority of the more recent and more relevant chlorpyrifos evidence did not support Petitioners' contention. EPA, however, has been clear throughout the rulemaking that the basis for retention of a children's safety factor has been the absence of carbofuran data to determine the levels of exposure that will be protective of children's PNS, in the context of a statutory provision that expressly requires EPA to account for missing data. EPA's point in discussing the chlorpyrifos data—which Petitioners initially raised as relevant—was simply that it showed that because peripheral tissues can be more sensitive than central nervous system tissues, the absence of data addressing carbofuran's effects on the PNS is highly relevant. Whatever the chlorpyrifos data show cannot resolve the extent of carbofuran's risks. As the Petitioners' experts themselves point out, “Even conceding that [EPA's conclusion in the final rule that peripheral tissues are often shown to be more sensitive than brain tissue following exposure to chlorpyrifos] may be true, it is still unclear how this would be relevant to carbofuran * * *” (Exhibit 6 at 3). Accordingly, this evidentiary submission fails to demonstrate that a dispute exists on a question of material fact.
Finally, their submission provides an inadequate basis on which to grant a hearing; because evidence is not proffered on critical points, the objection ultimately rests on allegation, speculation, and general denials (40 CFR 178.32(b)(2)). As discussed in preceding section, the majority of the evidence comes from adult data, which are of limited relevance. Further, and more significantly, the evidence fails to demonstrate that brain data always—or even more frequently than not—correlates more closely with PNS effects than RBC AChE data. Instead, the proffered evidence only demonstrates that whether brain or RBC data correlate better with actual PNS effects can vary depending on the chemical. This, therefore, cannot resolve the question as to whether, in the case of carbofuran, brain AChE data will necessarily correspond more closely with the PNS. Finally, as also discussed in the preceding section, Petitioners' argument is internally inconsistent, because they rely on carbofuran adult RBC AChE data to support their argument that exclusive reliance on the brain data will be protective of potential PNS effects in pups. No hearing is appropriate where the proffered evidence fails to prove the points for which it is offered, or offers merely equivocal support (See, 73 FR 42705 (July 23, 2008) (hearing denied because published articles focus on an issue not applicable to the facts of the case at hand); 68 FR 46405–46406 (August 5, 2003) (a hearing was denied because the cited studies only contained equivocal statements)).
Chen
In its denial of the hearing request on the previous issue, EPA examined the results of the studies in this exhibit at length, and demonstrated that the results of the studies failed to support a conclusion that brain data correlate more closely to PNS effects than RBC data. Indeed, in most of these studies, brain AChE inhibition poorly reflected the AChE inhibition in PNS tissues. For example, the Carr
The remainder of the report consists of criticisms of EPA's conclusions, and contentions that EPA was inconsistent, without citation to biological evidence to support these claims. For example, the Report addresses EPA's rejection of the Bretaud study in goldfish on the grounds that the “distribution of carbofuran across fish and mammalian tissues may be quite different,” by criticizing EPA for failing to provide “evidence or a citation to support this point” (Exhibit 6 at 1). But they cite to nothing demonstrating the similarity of fish and mammalian tissues or otherwise supporting their proposed extrapolation across taxa; at this stage of the administrative process the obligation is on the Petitioners to come forward with evidence to call EPA's conclusions into question.
Finally, based on the record, FMC seemingly intended in the past for RBC AChE to be used as a surrogate for peripheral AChE inhibition. In 2005, FMC submitted a time course study with plasma and RBC AChE inhibition following acute exposure to carbofuran in adult rats. The title of this study is “The toxicokinetics of peripheral cholinesterase inhibition from orally administered carbofuran in adult male and female CD rats (Ref. 5).” Although this study is entitled “peripheral cholinesterase inhibition,” there are no actual measures of peripheral toxicity (
c.
The Petitioners did not raise the allegation contained in their objections as part of the Petitioners' comments. The context in which “lip smacking” was addressed was a sentence that states, “One issue raised at the FIFRA SAP meeting was whether ‘lip smacking’ observed in the adult females in the developmental toxicity study were the result of PNS or CNS AChE inhibition” (Ref. 18 at 82). In a footnote to this allegation, the Petitioners stated “Moreover, it is impossible to tell from the study data whether this “lip smacking” was a PNS or a CNS effect.” (Ref. 18 at 82). The Petitioners' comments focused instead on the contention that the study was irrelevant because the dose levels in the study were higher than the dose levels at which EPA was regulating for AChE inhibition (Ref. 18 at 82).
EPA did not respond to the Petitioners' description of the discussion at the SAP, since it correctly characterized the discussion. However EPA responded fully to the Petitioners' comment regarding the dose levels in the final rule and response to comments.
But in any event, this issue is not material. EPA's decision to retain a 4X children's safety factor did not rest exclusively, or even significantly—on the effects observed in this developmental study. Rather, EPA retained the children's safety factor based on the lack of data in the PNS and/or a surrogate at the low end of the response curve, and the fact that the available pup RBC data at higher doses affirmatively indicate that the PNS appears to be significantly more sensitive than the CNS (73 FR 44871–44872; 74 FR 23073–23075). Indeed, it is clear from both the proposed and final rules that the results of this study merely supplemented the Agency's bases for concern (73 FR 44871–44872; 74 FR 23073–23075). The Petitioners' complaint that the effects occurred at dose levels three times higher than PoD and therefore do not quantitatively support the 4X children's safety factor is equally immaterial. The record is clear that EPA relied on comparisons between the BMD
Similarly, the claim that the “the masticatory response” is clearly a CNS effect is equally misleading and inaccurate. The report in Exhbit 5 claims that “[t]he masticatory response is considered a preliminary index of convulsive activity and convulsions have been demonstrated to be caused by changes in brain chemistry.” None of the papers the Petitioners cited describe this “masticatory response” in that way. Instead, those papers all state that this response is seen at relatively low doses of these anticholinesterases. By way of contrast, convulsions are seen at high doses. The Exhibit also implies that the “masticatory” response and convulsions are a continuum of the same phenomemon; however EPA is aware of no scientific support for this claim, and Petitioners have provided none.
Petitioners' objection on this issue is therefore denied.
The Exhibit also implies that the “masticatory” response and convulsions are a continuum of the same phenomemon; however EPA is aware of no scientific support for this claim, and Petitioners have provided none.
d.
EPA's regulations at 40 CFR part 160 establish a set of principles that provides a framework within which laboratory studies are planned, performed, monitored, recorded, reported, and archived. GLP helps assure EPA that the data submitted are a true reflection of the results obtained during the study and can therefore be relied upon when making risk/safety assessments. The regulations are applicable only to studies that support, or are intended to support applications for “research or marketing permits” for pesticides regulated under FIFRA (40 CFR 160.1(a)).
A further defect is that Petitioners have submitted no evidence on this point. In fact, this claim consists of nothing more than the bare statement that EPA's analysis does not rely on GLP-compliant studies. A hearing will not be granted on “mere allegations” or “general contentions” (40 CFR 178.32(b)(2)). To the extent the Petitioners are relying on the information submitted as part of their comments on the proposed rule, this does not cure the defect, since no substantiating information or other evidence was presented in support of their comments. Nor can simple reiteration of a comment made on the proposed rule justify a hearing. EPA responded to these comments in the final rule, and by ignoring the EPA's final rule on this subissue, Petitioners have failed to lodge a relevant objection. Both EPA and FDA precedent make clear that when the agency substantively responds to comments on the proposal, the commenter may only keep that issue alive in its objections by addressing the agency's substantive response.
Indeed, this entire objection is not material. The EPA–ORD data are the only valid pup RBC data using carbofuran; in the absence of these data, EPA would have no data that would provide relevant information on carbofuran's effects on children's PNS. Under such circumstances, EPA would be required to retain the statutory default 10X, because there would be no “reliable data” on which to base any other factor.
Nor does compliance with EPA's GLP regulations guarantee the validity of the study's results. The RBC data from FMC's carbofuran CCA studies, which were conducted in accordance with EPA's GLP regulations, were unanimously determined to be scientifically invalid by the FIFRA SAP (Ref. 36).
Any claim that the conduct of the EPA–ORD studies raised questions as to their scientific validity is equally baseless. EPA's ORD data were reviewed by the FIFRA SAP, which concluded that, “EPA–ORD has provided excellent
As EPA explained in response to the Petitioners' comments, all of the information the Petitioners claimed was missing had been previously made publically available as part of the SAP review of the carbofuran NOIC, and was provided again in response to FMC's FOIA request. A complete study protocol, as well as a report of the quality assurance (QA), technical, and data reviews of the study, were available, which demonstrated that the procedures and documentation are in accordance with the National Health and Environmental Effects Laboratory (NHEERL)/ORD Quality Assurance Management Plan. Concerning standardization of brain and RBC AChE in terms of protein concentration, the Agency notes that this analysis has not been performed or provided in all the studies on the record, including those sponsored by FMC. However, in the Moser study (Ref. 56), the AChE activity was standardized in terms of tissue weight per ml, so the amount of protein was consistent across samples, which is an acceptable and widely used practice. Further, abnormal (or “clinical”) observations were recorded when they occurred, although the animals could not be watched while they were in the motor activity chambers. Finally, the registrant is correct that the dosing solutions for the comparative ChE study were not analyzed, but ORD performed this analysis for the adult studies in McDaniel
Petitioners raised this issue in their comments on the proposed rule. In the final rule, EPA explained at length, the basis for its conclusion that the available data using carbaryl, provided by the carbaryl registrant, supported a finding that a 1X children's safety factor would be “safe” (74 FR 23058 and Ref. 85). EPA explained that the different safety factors established for carbaryl and carbofuran resulted from differences in the chemicals themselves, as reflected by the available data (Id).
In addition, the Petitioners make no claim other than to reiterate the allegation made in their comments on the proposed rule, that EPA's assessment of carbofuran is inconsistent with its assessment of carbaryl. Consequently, Petitioners' objection on this subissue is irrelevant, and therefore immaterial, with regard to EPA's final tolerance revocation regulation because Petitioners ignored EPA's extensive analysis of this issue in the final rule and refiled their comments on the proposal as if EPA's determination in the final rule did not exist. By ignoring the EPA's final rule on this subissue, Petitioners have failed to lodge a relevant objection. Nor have they proffered any evidence in support of this claim. When EPA responds to a comment in the final rule, mere reiteration of the comment in objections does not present a live controversy unless the objector proffers some evidence calling EPA's objection into question (
It is typical EPA practice to use the central estimate on the BMD as an appropriate measure for comparing chemical potency and the lower limit on the central estimate (
“Although the RBC BMDL
The approach used for carbaryl—
With regard to the carbaryl children's safety factor, the available brain and RBC dose-response data in PND11 pups include data from the lower end of the dose-response curves. ORD's comparative ChE data with carbaryl show that at the lowest dose at or near 20% inhibition in brain and RBC AChE were observed. Although not ideal, the carbaryl data provide information closer to the benchmark response of 10%, and therefore allow for a reasonable estimation of the BMD
Second, the Petitioners claim that there are several technical errors in the way EPA conducted the statistical modeling that formed the quantitative support for the 4X children's safety factor. They also object that the mathematical assumptions underlying EPA's modeling are not justified and fail to support the 4X children's safety factor. In this regard, they allege that EPA's children's safety factor was based on calculations that (i) are not based on “within animal comparisons;” (ii) have been applied incorrectly and inconsistently to the data, which exaggerated the difference; (iii) overstate the evidence for higher relative RBC sensitivity; and (iv) treated carbofuran inconsistently as compared to other NMCs. They claim that by removing the inconsistencies from EPA's data, the data yield a brain/RBC ratio of 1.3, which confirms Petitioners' approach. These five allegations are addressed separately below.
In support of these claims, the Petitioners offer allegations on the points above, referencing two memoranda from Drs. R. Sielken and C. Valdez-Flores (Exhibits 7, 8, 9) that generally describe and summarize the analyses and modeling they conducted. The full analyses underlying these memoranda were not included with the objections.
EPA also compared the BMD
In their comments on the proposed rule, Petitioners presented essentially the same arguments raised in this objection. They argued that a more plausible and straightforward approach would be to compare the RBC and brain AChE levels at the same time in the same rat when these rats are exposed to carbofuran
In the final rule, EPA provided a detailed explanation of its rationale for rejecting the Petitioners' approach (74 FR 23055; Ref. 85).
Second, Petitioners' hearing request is inadequate because they do not object to the basis EPA asserted in the final rule for rejecting this approach. Specifically, Petitioners do not challenge EPA's conclusion that their suggested approach is fundamentally flawed in several regards, nor proffer evidence in support of that challenge. Petitioners also do not challenge EPA's analyses, showing that the results of their suggested approach are in fact consistent with EPA's conclusions. As a consequence, Petitioners' objections are irrelevant, and therefore immaterial, with regard to EPA's final tolerance revocation regulation. The statute, however, requires that objections be filed on the final rule not the proposal. By ignoring the EPA's final rule on this subissue, Petitioners have failed to lodge a relevant objection. Prior FDA decisions under its regulations are instructive here. Objections and hearing requests were filed in response to a food additive regulation covering the irradiation of poultry. (62 FR 64102 (December 3, 1997)). The objector argued that the addition of an anti-oxidant (ethoxyquin) to irradiated chicken prior to the chicken's use in animal feeding studies compromised the studies because the ethoxyquin would have decreased the level of lipid peroxides in the chicken to levels found in chicken that had not been irradiated. The FDA noted, however, that it had considered the question of ethoxyquin's effect on lipid peroxide levels in the final rule and determined that while ethoxyquin can retard the normal oxidation of chicken fat to peroxides, ethoxyquin cannot reverse oxidation that has already occurred. FDA denied the hearing request reasoning that because the objector did “not dispute FDA's explanation in the final rule as to why addition of ethoxyquin did not compromise the CIVO studies, and provided no information that would have altered the agency's conclusion on this issue * * * there is no factual issue that can be resolved by available and specifically identified reliable evidence” (62 FR 64105).
EPA's analyses of the Petitioners' approach identified several significant deficiencies. First, the comparison suggested by the Petitioners would require that EPA ignore existing data. This is because only EPA's study of PND 11 animals contains both brain and RBC data, so the comparisons suggested by the commenter can only be made using that dataset. However, the dose levels in that study were so high that the lower portion of the dose-response curve was missed. At these higher doses, there is little difference between the levels of brain and RBC inhibition. This phenomenon—
Second, the Petitioners' approach is fundamentally flawed. The Petitioners' suggested alternative relies exclusively on comparisons between the degree of inhibition in the treated animals without any regard to the doses at which the effects occurred. For example, one animal may have shown, on average, 10% inhibition in the brain, when it demonstrated 20% RBC inhibition. Under this approach, what would be relevant would simply be the ratio of 1:2. But the Agency believes it is critical to focus on the ratios of potency, which is the ratio of the doses in the data that cause the same level of AChE inhibition. The Agency's approach of comparing potencies is more directly relevant for regulatory purposes than comparisons of average inhibition. This is because dose corresponds more directly to potential exposures, which is what EPA regulates (
Finally, the range of ratios of effects that the Petitioners propose as an alternative is consistent with range of potencies that EPA has calculated
In addition, a hearing on this objection is denied on the ground of materiality (40 CFR 178.32(b)(1)). In the absence of EPA's assumption, EPA would have no basis for deriving an alternate children's safety factor. Thus, EPA would have to raise the children's safety factor from 4X to the statutory
EPA acknowledges that it lacks information to confirm its assumption that the dose-response curves remain parallel at lower doses. EPA believes this is the most reasonable assumption, given the absence of information at low doses, since it neither presumes that RBC inhibition will increase or decrease at lower doses. Contrary to Petitioners' naked assertion that EPA's approach overestimates the difference, there is no inherent reason to expect that EPA's assumption would overestimate or underestimate the difference between BMD
Regarding the Petitioners' claim that data for other carbamates suggests that BMD
c.
For purposes of the PoD, the Agency used a meta-analysis that combined valid data from all available studies to calculate the BMD
EPA also combined studies in calculating the 4X children's safety factor. EPA derived the ratio of RBC and brain AChE inhibition using the data on administered dose for the PND11 animals from the EPA–ORD studies and the FMC studies combined. In other words, EPA estimated the BMD
In their comments on the proposed rule, Petitioners claimed that EPA's decision to combine data for different strains of rats, sexes, experiments, laboratories, dates, dose preparations, rat ages, and times between dosing and AChE measurement, is problematic, claiming that these differences in study design severely limit the validity of EPA's comparisons. Further, they alleged that differences in data and methods EPA used to estimate its BMD
EPA responded to these comments in full during the rulemaking (74 FR 23055–23057 (May 14, 2009); Ref. 85). Petitioners referenced these comments in their objections, but presented no further argument or evidence on any of these points. Because Petitioners originally raised this claim also with respect to the derivation of EPA's PoD, even though they only raise it in this objection here, the Agency responds to both points below.
Second, this objection is not material. In the case of carbofuran, EPA used a sophisticated analysis of multiple studies and datasets to develop the PoD for the carbofuran risk assessment. Instead of this analysis, EPA could simply have followed the general approach laid out in its BMD policy (Ref. 100), which is used in the majority of risk assessments. Under this general approach, EPA would regulate using the most sensitive effect, study, and/or dataset. If the Agency chose not to combine the data in its analyses, as the commenters' suggested, data collected at or near the peak time of effect (
By contrast, the Petitioners' suggested analysis ignores relevant, scientifically valid data. Their analysis left out the 30-minute data from MRID no. 47143705 (Ref. 2), but provided no rationale as to why it would be appropriate to selectively exclude data from the time frame in this study most relevant to the risk assessment (
Although the Petitioners complain that EPA's approach of combining data across multiple studies is scientifically inappropriate, the Petitioners themselves combined the results of analysis from four datasets in the information presented with their comments and referenced in their objections. Indeed, it is notable that most of the criticisms raised by the Petitioners also apply equally to the Petitioners' own analysis, as described in more detail in EPA's Response to Comments document (Ref. 85).
The Petitioners are also incorrect that differences in the data available for brain and RBC are so great as to invalidate comparisons of the BMD estimates. EPA used all the data available in each case, and used a hierarchical model to account for variability of the BMD among laboratories for the brain endpoint, which the SAP has explicitly reviewed and approved numerous times (Refs. 34, 35, 36).
The Petitioners are correct that data from both sexes were combined for brain but only male data were used for RBC. However, EPA first performed an evaluation of the differences between the sexes. EPA combined data from males and females only after showing that they did not respond differently.
EPA believes that its decision to combine data for purposes of its BMD
Although it is true that EPA's BMD
For all of the foregoing reasons, this objection is denied.
Petitioners have provided neither further details of their concerns than the explanation above, nor any other evidence to support this objection.
Petitioners have provided little detail in their objections on the issues they intend to raise in their testimony; in most instances, they simply allege that EPA's modeling was incorrect. But as the objections reference the Petitioners' comments on the proposed rule, EPA assumes that they intend to raise only the points previously discussed in their comments.
Second, as in their comments, Petitioners failed to submit the underlying modeling they claim to have conducted in support of their objections. Petitioners' consultants merely assert that the results are as presented in their summarized testimony. In the absence of the underlying scientific analyses, these are effectively no more than mere allegation or general contentions. Hearings will not be granted on this basis. (40 CFR 178.32(b)(2); see also 68 FR 46403, 46406–46407 (August 5, 2003) (FDA denied a hearing involving a challenge to FDA's reliance on consumption pattern data because the objector “did not present any specific information to dispute P & G's consumption pattern data; instead, [objector] simply asserted that other consumption patterns were likely.”); accord
The Petitioners' allegation on this point is incorrect. The model itself does not need to change in order to develop a BMD
However in response to the comments, EPA conducted their suggested calculation, and the ratio of brain to RBC BMD
With regard to the EPA's purported statement that the BMD
As noted in the previous objection response, EPA used the dose-time-response model to extrapolate BMD
Although it is true that EPA's BMD
EPA is unable to comment on the analyses referenced in the Petitioners' objections as they failed to provide them. However, EPA has previously explained the reasons for rejecting the suggested analysis based on brain RBC comparisons within the same animal. This is discussed at length in the final rule and response to comments, as well as Unit V
EPA responded to these comments in both the final rule and the accompanying response to comments document (74 FR 23058 (May 15, 2009)).
In their objections, Petitioners have not identified any specific facts that they believe demonstrate inconsistency. They merely allege that the “relative potency of carbofuran as compared to other N-methyl carbamates does not correspond with OPP's aPAD for carbofuran relative to those same compounds.”
In addition, Petitioners have not challenged the substance of EPA's response to their comments, but simply reiterated their comments on the proposed rule. Accordingly, a hearing is
Nor have they submitted evidence that calls the substance of EPA's conclusions into question. Petitioner's entire argument concerning this issue is a single conclusory sentence. A hearing will not be granted on “mere allegations” or “general contentions.” (40 CFR 178.32(b)(2)) (See 53 FR 53176, 53199 (December 30, 1998)) (“Rather than presenting evidence, [the objector] asserts that FDA did not adequately justify its conclusions. Such an assertion will not justify a hearing.”).
In their comments, the Petitioners provided information on the oral LD
The allegations and the supporting information contained in Petitioners' comments were inaccurate. For example, the LD
The Petitioners' assertions regarding aldicarb were based on an earlier assessment. At the time the Agency conducted the assessment to which the commenters refer, the Agency was unaware of the difference in sensitivity between PND17 and PND11 animals. Since EPA became aware of the differences, EPA has required the aldicarb registrant to conduct a CCA study in PND11 rats; the Agency anticipates the receipt of this study and the companion range-finding and time course studies in 2009. In the absence of these data, EPA will apply the statutory default children's safety factor to account for the additional sensitivity of PND11 animals, because the Agency lacks any “reliable data” that could be used to derive a reduced factor that EPA could determine will be “safe for infants and children.”
With regard to the carbaryl children's safety factor, the available brain and RBC dose-response data in PND11 pups include data from the lower end of the dose-response curves. ORD's comparative AChE data with carbaryl show that at the lowest dose 20% or near 20% inhibition in brain and RBC AChE was observed. Although not ideal, the carbaryl data provide information closer to the benchmark response of 10%, which allows for a reasonable estimation of the BMD
Petitioners' other comparisons are equally inapposite. The LD
Accordingly, this objection is denied.
F.
Petitioners raise separate objections to EPA's estimates of drinking water exposures from contaminated ground water and to the estimates from contaminated surface water. In each objection, Petitioners argue that, based on newly proposed restrictions submitted as part of their objections, the exposure estimates will be significantly lower than EPA's estimates in the final rule.
In their comments, the Petitioners complained that EPA's reliance on the PGW was inappropriate because that study no longer reflected current conditions. Petitioners also summarized the results of their “National Leaching Assessment” which used PRZM and “databases specifically created to provide access to all necessary inputs for a national scale PRZM modeling.” They claimed that after accounting for the use prohibitions on their September 2008 label, the maximum 1-in-10 year peak concentrations in all potential carbofuran use areas is 1.2–1.3 ppb, while expected concentrations in most areas covered by this assessment are below 1.0 ppb. Neither the “National Leaching Assessment” nor the “National Pesticide Assessment Tool” upon which the assessment appears to have been based, were submitted to EPA as part of the Petitioners' comments.
In the final rule, EPA revised the assessment conducted for the proposed rule in response to the FMC comments submitted during the comment period, which requested cancellation of the use on a number of crops and imposed a number of restrictions intended to address the potential for groundwater contamination. These restrictions included use prohibitions in certain states, and well setbacks. Taking these into account, ground water concentrations were estimated for all remaining crops on carbofuran labels, using two new Tier 2 scenarios. Based on a new corn scenario in Wisconsin, representative of potentially vulnerable areas in the upper Midwest where use remained, EPA estimated one-in-ten year concentrations for ground water source drinking water of 16 to 1.6 × 10
EPA concluded that the results of the revised corn modeling were consistent with the PGW. Using higher use rates than currently permitted, the peak concentration measured in the PGW study was 65 ppb; when scaled to current use rates, the estimated peak concentration was 11 ppb. The final rule explained that EPA's modeling is also consistent with a number of other targeted groundwater studies conducted in the 1980s showing that high concentrations of carbofuran can occur in vulnerable areas; the results of these studies as well as the PGW study are summarized in References 13 and 67 (74 FR 23079).
“[a] model validation study was conducted in which the results of a prospective groundwater monitoring (PGW) study conducted for cabofuran in Maryland from 1981–1983 were compared to the model simulations that most closely matched the PGW study site in terms of location, soil texture, organic carbon content, and pH. The annual peak concentrations during the simulation are on the order of 9 to 11 ppb, which are similar to the measured concentrations in the PGW study (9 to 10 ppb after adjusting for application rate). The validation provides context that the model predictions are reasonable.”
Second, this objection is premised on inaccurate factual statements that are directly contradicted by the record. For example, the objection disregards the fact that EPA scaled the PGW modeling to reflect the lower current use rates. The Petitioners present no challenge to the methods EPA used to scale the study results; indeed, it is likely that their contractor used the same or similar methodology. Equally, the objection that EPA relied on “historical monitoring data from a period when carbofuran use was an order of magnitude larger” is simply incorrect (Ref. Obj at 40). The monitoring results EPA cited in the final rule were from the 1980s, but the targeted monitoring studies were conducted with the same or lower use rates as those permitted under the current labeling (74 FR 23085, May 15, 2009). Such a submission is insufficient to justify a hearing (
Further, the Petitioners' misrepresentation of EPA's analyses also affects the materiality of the hearing request (40 CFR 178.32(b)(3)). Even if Petitioners were able to successfully refute the validity of the PGW study, it would not affect the validity of the additional monitoring data cited in the final rule (74 FR 23079 (May 15, 2009)), on which EPA also relied to validate its monitoring.
Finally, the evidentiary proffered with respect to the Petitioners' allegation that all areas with conditions similar to those found in the PGW have been removed from the label is insufficient to warrant a hearing (40 CFR 178.32(b)(2)). To the extent this allegation is based on the information presented as part of the 2008 comments, this claim was rebutted in EPA's final rule, by the modeling based on the Wisconsin corn scenario, and by the lack of any underlying analyses to support of Petitioners' comments. As explained in the final rule, the information provided is insufficient to allow EPA to confirm the Petitioners' contention that there is no overlap between use and all potentially vulnerable ground water (74 FR 23061–23062 (May 15, 2009)).
The evidence submitted along with this objection does not cure this defect. The only evidence proffered in this regard is the Petitioners' comments on
Further, the available scientific information does not support their contentions. EPA examined readily available data with respect to ground water and soil pH in order to evaluate the spatial variability of pH. Data from the USGS and other readily available sources do not necessarily encompass the entire range of ground water pH values present within a state. This is especially true for shallow ground water systems, where local conditions can greatly affect the quality and characteristics of the water. Also, pH in a water body can be higher or lower than the tabulated average values. In addition, average ground water pH values for a given area do not truly characterize the area's temporal and especially spatial heterogeneity. This can be seen by comparing differences in pH values between counties within a state, and by the fact that even within a county individual wells will consistently yield ground water with either above- or below-average pH values for that county. The ground water simulations in Reference 84, Appendix I reflect variability in pH by modeling carbofuran leaching in four different soil and subsurface pH conditions (pH 5.25, 6.5, 7.0, and 8.7), representing the range in the aquifer system in that area. This range also approximates the pH range of natural waters in general. The results of the ground water simulations for corn use showed that a relatively small (0.5) decrease in pH from 7 to 6.5 resulted in an increase in the 1-in-10-year peak concentrations of carbofuran in ground water of 4 orders of magnitude.
The results of EPA's revised corn modeling, based on a new scenario in Wisconsin, are consistent with the results of the PGW study developed by the registrant in Maryland in the early 1980s. Using higher use rates than currently permitted, the peak concentration measured in the PGW study was 65 ppb; when scaled to current use rates, the estimated peak concentration was 11 ppb. EPA's modeling is also consistent with a number of other targeted ground water studies conducted in the 1980s showing that high concentrations of carbofuran can occur in vulnerable areas; the results of these studies as well as the PGW study are summarized in References 13 and 67. For example, a study in Manitoba, Canada assessed the movement of carbofuran into tile drains and ground water from the application of liquid carbofuran to potato and corn fields. The application rates ranged between 0.44–0.58 pounds a.i./acre, and the soils at the site included fine sand, loamy fine sand, and silt loam, with pH ranging between 6.5–8.3. Concentrations of carbofuran in ground water samples ranged between 0 (non-detect) and 158 ppb, with a mean of 40 ppb (Refs. 13 and 67).
Finally, as discussed above, to the extent this objection relies on untimely information and analyses, and on the newly submitted registration amendments, the objection is denied as irrelevant and immaterial.
In support of this objection, Petitioners cite the analyses submitted as part of their comments, and the new analyses in Exhibits 12, 13, and 14. Exhibits 12 and 13 contain the revised modeling of the estimated groundwater concentrations from carbofuran use, based on the label restrictions proposed as part of the objections. Exhibit 14 consists of a statistical summary of groundwater pH statistics from the USGS NAWQA database. Means, standard deviations, and numbers of groundwater measurements in the database are summarized by state and land use within each state.
As part of their comments on the proposed rule, FMC requested that EPA amend their registration to include a number of geographic use restrictions and migitation measures intended to address the risks to groundwater. In their comments, Petitioners claimed that “[g]roundwater sources are vulnerable to carbofuran leaching only under certain conditions, namely where permeable soils (
On December 24, 2008, FMC again requested that EPA amend their registration to include additional restrictions intended to further mitigate carbofuran's risks to groundwater.
In response to the September 2008 proposed label restrictions submitted as part of the comments, EPA revised its risk assessment to take into account the new geographic restrictions, as well as the proposed risk mitigation measures. Based on its revised assessment, EPA explained in the final rule that it disagreed that the criteria on the September 2008 label defined 100% of the conditions where ground water sources would be vulnerable to carbofuran leaching. EPA noted that no comprehensive analysis had been provided that evaluated how the Petitioners had reached this conclusion. As discussed in greater detail in EPA's Response to Comments, the information provided as part of the Petitioners' comments—primarily maps depicting areas identified as vulnerable—was not sufficient to allow the Agency to evaluate their claim (Ref. 84).
EPA also disagreed that the commenters provided sufficient information to support their general claim that only high pH conditions (pH above 7) existed in all the areas in which carbofuran could be used under FMC's September 2008 revised label. EPA presented its assessment of the newly submitted label in its Response to Comments document and these issues were addressed in substantial detail there (Ref. 84).
EPA did not evaluate the mitigation measures proposed in the December 24, 2008 submission. The mitigation measures in that submission were incorporated into the measures proposed by the Petitioners as part of their objections on June 30, 2009.
Petitioners' objections provide no further clarification as to what is meant by their claim that EPA's assessment relied on “unrealistic and overly conservative assumptions.” Therefore, this objection, and the attendant hearing request, is denied based on Petitioners' failure to state with “particularity * * * the basis for the objection * * *” (40 CFR 178.25(a)(2)). As Petitioners raised similar allegations in their comments, EPA has assumed that they intended to incorporate all of the issues raised in the comments on the proposed rule.
To the extent this objection relies on the September 2008 mitigation measures, EPA denies the hearing request because the evidentiary proffer in support of this objection is insufficient to warrant a hearing. The record is clear on its face that EPA did account for the mitigation measures in its revised risk assessment supporting the final rule. A hearing can only be based on a genuine issue of disputed fact (40 CFR 178.32(b)(1)). Where a party's factual allegations are contradicted by the record, there is no genuine dispute (73 FR 42701–42702 (July 23, 2008) (Denying NRDC's hearing request where EPA had revised its residential exposure assessment to address the issue complained of); 57 FR 6667, 6668 (February 27, 1992) (“A hearing must be based on reliable evidence, not on mere allegations or on information that is inaccurate and contradicted by the record.”)).
The objection also suffers from a further defect; many of the allegations in this objection merely reiterate points Petitioners had raised in their earlier comments. For example, EPA addressed the claim that the NAWQA data from 1993–2006 rarely show detections of carbofuran, and that in “almost every instance” the observed concentrations are low. EPA also addressed the claim that only areas with permeable soils (
The evidence submitted in Exhibits 12–14 does not cure these defects. As a preliminary matter, much of this evidence is untimely. The analyses in Exhibits 12 and 13 appear to be the National Leaching Assessment described in Petitioners' comments, but modified to account for the proposed amendments submitted as part of the objections. As noted previously, neither the National Leaching Assessment nor the model on which it was based was submitted as part of the comments. Certainly, there is no justification for Petitioners' refusal to provide the analyses that were available during the comment period. Because the National Leaching Assessment was available during the comment period but was withheld, this information is considered to be untimely and the Petitioners have waived the right to rely on it. Accordingly, as discussed in Unit VI.D, because this evidence was not presented as part of the Petitioners' comments, EPA considers that the evidence submitted in support of this objection is not appropriately considered as a basis for justifying a hearing on the final rule.
But even assuming that the evidence was appropriately considered, the evidence is insufficient, even if established, to justify the factual determination urged (40 CFR 178.32(b)(3)). Nothing in Exhibits 12–13 provides any information that substantively differs from the information summarized in the comments. Second, even assuming that the analysis in Exhibit 14 is valid, on its face the submission states that the analysis only addresses 95% of the samples chosen by the study; no information was provided to explain how the samples relate to the state or other geographic area in which carbofuran would be used. This is important because NAWQA samples were not evenly distributed across most states, but tended to be concentrated in particular regions; in statistical parlance, the samples were not collected randomly. The maps in Exhibit 14 clearly demonstrate that the study samples were not randomly distributed across the state but were primarily in the southern and eastern portions of each state, even though carbofuran use is not restricted to those portions of the states. In other words, no evidence was provided that would allow the Agency to determine the percentage of the carbofuran use area represented by the 95% of the samples the Petitioners' analysis addressed. Nor was any information provided to document the significance of the remaining 5% of the samples that were not captured by their analysis; for example, although this may have only represented 5% of the samples, it is not clear whether this 5% relates to only 5% of the areas where carbofuran may be used, or whether it actually represent a far greater percentage of the use area.
The contention that the NAWQA monitoring data—or indeed any available carbofuran monitoring data—provide an adequate basis for concluding that concentrations will remain low in the areas where use is now permitted is incorrect. The NAWQA program focuses on ambient water rather than on drinking water sources, is not specifically targeted to the high use area of any specific pesticide, and is sampled at a frequency (generally weekly or bi-weekly during the use season) insufficient to provide reliable estimates of peak pesticide concentrations in surface water. For example, significant fractions of the data may not be relevant to assessing exposure from carbofuran use, as there may be no use in the basin above the monitoring site. Unless ancillary usage data are available to determine the amount and timing of the pesticide applied, it is difficult to determine whether non-detections of carbofuran were due to a low tendency to move to water or from a lack of use in the basin. As a consequence, the data do not support relying on the non-detections as a lower bound, or relying on the detections as an upper bound. The program, rather, provides a good understanding on a national level of the occurrence of pesticides in flowing water bodies that can be useful for screening assessments of potential drinking water sources, especially for those assessments concerned with chronic, rather than acute toxicants.
While there have been additional groundwater monitoring studies that included carbofuran as an analyte, there has been no additional monitoring targeted to carbofuran use in areas where aquifers are vulnerable, and the locations of sampling and the sampling frequencies generally are not sufficient to capture peak concentrations of the pesticide in a watershed or aquifer where carbofuran is used. Capturing these peak concentrations is particularly important for assessing risks from carbofuran because the toxicity end-point of concern results from single-day exposure (acute effects). Pesticide concentrations in ground water are generally the result of longer-term processes and less frequent sampling can often adequately characterize peak ground water concentrations. However, such data must be targeted at vulnerable aquifers in locations where carbofuran applications are documented in order to capture peak concentrations. As a consequence, monitoring data tends to underestimate exposure for acute endpoints.
EPA also disagrees that the Petitioners' criteria of soils composed of 90% sand and less than 1% organic matter, and wells of less than 30 feet define all of the conditions under which ground water sources are vulnerable to carbofuran leaching. No comprehensive analysis was provided evaluating how they reached this conclusion. Although the Petitioners proposed these criteria as restrictions on the carbofuran label, the spatial extent of the label restrictions was not provided. Moreover, as discussed in greater detail in EPA's Response to Comments, the information provided as part of the Petitioners' comments (primarily maps depicting areas identified as vulnerable) was not sufficient to allow the Agency to evaluate their claim (Ref. 84). For example, the percent sand, one of the criteria used in this analysis, varies significantly across a field and the whole range of soil textures may occur at a county-level. The national map provided purports to represent this parameter and several others aggregated together to identify vulnerable locations. This national-scale map does not provide the level of detail needed to verify the combination of paramters at locations identified as vulnerable.
While the assertion that soils with 90 percent sand are the most vulnerable to leaching is in part true, it is misleading. While many states have only small areas of sandy soils, several of the states in which carbofuran would continue to be used under the Petitioners' proposals have quite extensive areas. For example, according to the Petitioners' own assessment of states with high amounts of carbofuran application (Ref. 6), Texas had 4.2% of soils classified “as sand”, Michigan had 21.3% and Nebraska had
Petitioners' claims regarding pH concentrations are also incorrect. As an initial matter, their analysis fails to prove that pH values in all use areas will ensure that concentrations are below the level of concern because the analysis in Exhibit 14 is based on a flawed statistical analysis. The methodology on which the Petitioners relied—the use of the mean minus two standard deviations—to estimate the 5th percentile (
In conducting its modeling for the final rule, EPA examined readily available data with respect to ground water and soil pH to evaluate the spatial variability of pH in Wisconsin. As part of the final rule, EPA explained that ground water pH values can span a wide range; this is especially true for shallow ground water systems, where local conditions can greatly affect the quality and characteristics of the water (higher or lower pHs compared to average values). As noted even within counties in the same state, wells will consistently yield ground water with either above- or below-average pH values for that county. Thus, EPA concluded that average ground water pH values for a given area do not truly characterize the (temporal and especially spatial) heterogeneity common in most areas. The actual significance of using a single pH even if it is a 95th percentile value, which as described above was not demonstrated to be accurately calculated, is not clear. For this reason, EPA bracketed potential exposure using a range of pH values.
As further explained in the final rule, the considerable spatial variability in pH conditions for both the subsurface and surface environments is significant because the pH has a large effect on the persistence of carbofuran. This is demonstrated by the results of the ground water modeling simulations from the South-Central Wisconsin scenario, which show that what might appear as relatively small variations in soil pH can have a significant impact on estimates of carbofuran in ground water. Under more acidic conditions, the hydrolysis half-life increases from 28 days at pH 7 to years or more at pHs less than 6. Further, the results of EPA's corn ground water simulations (bounded by the high and low pH values of the aquifer system underlying the scenario location) showed that a relatively small (0.5) decrease in pH from 7 to 6.5 resulted in an increase by 4 orders of magnitude in the 1-in-10-year peak concentration of carbofuran.
The ground water simulations reflect variability in pH by modeling carbofuran leaching in four different pH conditions (pH 5.25, 6.5, 7.0, and 8.7), representing the range in the Wisconsin aquifer system. The upper and lower bound of pH values that EPA chose for this assessment were measured values from the aquifer, and the remaining two values were chosen to reflect common pH values between the measured values. Estimated 1-in-10-year peak ground water concentrations at pH 7 are 1.6×10
For all of these reasons, the objection is therefore denied.
Although the Petitioners alleged that their estimates were consistent with the NMC CRA in their comments on the proposed rule, they did not identify any specific inconsistency between EPA's groundwater estimates for the proposed rule and its estimates for the NMC CRA.
Neither does the claim that their modeling is consistent with the NMC CRA justify a hearing on this question. As EPA explained in the final rule, the values estimated in the modeling conducted for the NMC CRA are greater than the 1 ppb that FMC claims is the maximum expected 1-in-10-year peak concentration. A hearing is not warranted where the claim is clearly contradicted by the record (40 CFR 178.32(b)(2)).
In support of this objection, the Petitioners reference county level sales data that were submitted to the Agency on November 7, 2008, after the close of the comment period. They also reference the use tracking system proposed in their recent registration amendments (Exhibit 2) and the modeling contained in Exhibit 15.
In their comments on the proposed rule, the Petitioners criticized the Agency for this assumption, arguing that because carbofuran is used on such a low percentage of crops nationally that it is unrealistic to assume that such a large percentage of any individual watershed would be treated. To support their claims that the PCT would generally be below 4%, they referenced county-level “use” data, but failed to provide either the data or methodology on which they relied until after the close of the comment period.
In the final rule, EPA explained at length the reasons that the information provided during the comment was insufficient to allow the Agency to reliably estimate a lower PCT for carbofuran. EPA did not review the information submitted after the close of
An additional flaw in this objection is that the proffered evidence is untimely and insufficient. Neither the proposed registration amendments nor the evidence submitted as part of this objection, including the modeling in Exhibit 15, was provided to the Agency during the comment period. The modeling in Exhibit 15 was available, because it was summarized in Petitioners' comments; however the underlying modeling was withheld. Equally, there is no evident reason that the sales data could not have been submitted as part of the Petitioners' comments. Petitioners relied on this data to perform analyses completed in 2006–2007, for purposes of the January 2008 SAP review of the draft carbofuran NOIC, so the information was available long before their comments needed to be filed. Accordingly, as discussed in Unit VI.D, this information is not appropriately considered as a basis for justifying a hearing on its final rule. Moreover, as explained below, because no evidence was submitted in support of the newly proposed use tracking system, reliance on that proposal to support a low PCT constitutes nothing more than an allegation. This is not an adequate basis on which to grant a hearing (40 CFR 178.32(b)(2)). Finally, to the extent this objection relies on Petitioners' recently proposed risk mitigation measures, as discussed in Units VI.C and D, objections and hearing requests based on these new risk mitigation measures are not appropriately considered at this stage of the administrative process, and are denied as immaterial (40 CFR 178.32(b)(3)).
For this reason, among others, for drinking water exposure estimation, the Agency assumes that 100% of the cropped area (or 100% PCT) is treated with the pesticide. EPA also makes this assumption due to the large uncertainties in the actual PCT on a watershed-by-watershed basis. EPA included an extensive discussion of the uncertainties in PCT and how they impact drinking water exposure assessment in its proposed rule (73 FR 44834) and in a background document provided to the SAP considering the draft carbofuran NOIC (Ref. 45). Because usage is often not evenly distributed across the landscape, due to differences in factors like pest pressure, local consultant recommendations and weather, it may be much higher in some areas. Further, temporal uncertainties can result in changes in use that might be driven by weather, changes in insect resistance over time, and changes in agronomic practices. To date, methods that account for this uncertainty, given the nature of the available data, have not been developed. Consequently, EPA cannot accurately estimate a drinking-water watershed scale PCT that, when used in a quantitative risk assessment on a national or regional basis, standing alone, provides the necessary level of certainty to allow the Agency to confidently conclude that exposures will meet the FFDCA section 408 safety standard.
In most cases, EPA agrees that it is unlikely that 100% of the crop will be treated with a single pesticide in most watersheds, particularly in larger watersheds. However, for small watersheds, it is reasonable to assume that an extremely high percentage of the crops in the watershed may be treated.
Moreover, EPA has an obligation to evaluate all legally permitted use practices under the label, and to ensure that all such use meets the requisite statutory standards, not simply to base its decisions on the practices the majority might typically use. The September 2008 proposed label, submitted during the comment period, imposes no restriction on the application of carbofuran related to whether a particular percent of the watershed has been treated. Thus, even with the restrictions on FMC's September 2008 labels, it remains legally permissible for 100% of the watershed to be treated with carbofuran.
Nor is EPA aware of an enforceable mechanism to ensure that farmers applying pesticide to their individual fields will have the ability to indendently determine whether a particular percentage of the watershed has been treated. There are significant practical difficulties inherent in implementing such label directions, as
However, in the final rule, EPA conducted a sensitivity analysis to explore the impact of the PCT assumption on dietary risk using an assumed 10% PCT, a figure proposed previously by FMC (74 FR 23065–23066). The results of that analysis demonstrated that even at these low percentages, which may significantly underestimate exposures, particularly in small watersheds, carbofuran exposures from drinking water contribute significantly to children's dietary risks. EPA conducted a similar sensitivity analysis for the final rule, discussed below in Unit VI.F.3, which demonstrates that even assuming that a low percentage of a watershed is treated, exposures will still be unsafe for infants.
Since EPA's 2006 determination that carbofuran does not meet the safety standard, FMC has submitted three assessments that relied in part on what they refer to as “county-level usage data” (Refs. 29, 74, and 89). Based on the information provided with the objections, the original source of the “county-level usage data” is sales data, apparently collected at the distributor level. The Petitioners claim to have augmented these sales data in an unspecified manner, by incorporating information from the distributors, which was used to allocate carbofuran usage at the county level. In their comments on the proposed rule, the Petitioners provided maps representing county level and watershed-scale use estimates, but did not provide the actual usage estimates in any clearly understandable format.
The Petitioners did submit these sales data as part of their objections, but have provided only a limited description of how these data were collected and no description of how they were actually analyzed or validated; what was characterized as “careful and proven techniques to capture this data” were not described. The method used to attribute carbofuran sales to counties was not described. Nor have they explained what is meant by negative usage estimates.
The Agency agrees that county-level use data would be useful in generating reasonable estimates of PCT that might be appropriately used in drinking water assessments. However, no usage data have been provided. Rather, the Petitioners only provided county-level use estimates for Illinois, although they have not submitted the analyses that presumably are the basis for the estimates. County-level estimates to support other risk assessments have not been submitted by the Petitioners. Further, the Petitioners have provided limited characterization of the source data, noting that these data were derived from FMC billings and “EDI data”, but they did not provide either the billings or the EDI data, nor explain how they were collected.
There are two major problems in equating sales information with use information: (1) Mapping the point and time of sale to the point and time of use and (2) allocating the amount sold across the crops on which it can be used. The submission did not explain how either of these two problems was resolved.
The first problem is highlighted by the fact that for some county/crop/year combinations in the submitted tables, estimated usage is negative. Use of a pesticide clearly cannot be negative, but sales at a particular point and time can be negative because buyers can return unused product. The fact that some usage estimates are negative suggests that buyers are returning carbofuran product purchased in an earlier time period or from another location. But if farmers are returning carbofuran purchased in a previous time period, any assessment must also account for the possibility that they also could use stocks purchased previously. Thus, use in a given year may be greater than sales in that year. Similarly, if farmers are returning carbofuran purchased in another location, it must be recognized that they could be using carbofuran purchased in another location. Thus, use in any given county or watershed could be greater than sales in that locality. That is, regardless of whether the issue is use over space, time, or both, the results are that usage will be underestimated in some localities. Further, zeroing out the negative values will not result in appropriate estimates; the negative usage estimates merely make the problem manifest. Even total sales at a point in time may underestimate actual use.
The second problem arises with the allocation of product sales across the crops on which it can be used. The data provided as part of the objections were aggregated for all crops, including crops on which use is no longer allowed, such as cotton or alfala; the data were not collected based on the individual crops. No explanation is provided to indicate how the Petitioners divided the quantity sold between the amount used on cotton, on alfalfa, and on all other crops. Since part of the purpose of the Petitioners' assessment is presumably to show that eliminating the use on the cancelled crops, such as alfalfa, will sufficiently reduce any risks, it is critical to know how they determined the amount used on alfalfa as opposed to other crops, and it is difficult to imagine how this could be done with any accuracy. For example, one could assume that the chemical is used on equal proportion of all crops, but there is no basis for such an assumption. It might not matter if all EPA were interested in was the total amount used in an area, but this is not useful for purposes of assessing the risk on a smaller scale, such as in the present case.
The method the Petitioners used to generate use estimates from the sales data does not account for the uncertainties described above nor for the potential for use to be locally concentrated due to pest pressures. The method that is summarily described as having been used to allocate county-level usage estimates to watersheds appears to be similar to a method that has been used by others to calculate “best-estimate” county-level PCT (Ref. 73) to map nationwide pesticide usage. However, these methods are not appropriate for calculating PCTs for surface drinking water sources or watersheds that drain to community water systems, because they do not adequately account for the uncertainty in the data at the appropriate spatial scale. This methodology produces an estimate that is a measure of central tendency and, as such, roughly half the estimated values will underestimate the PCT. Furthermore, because pesticide use varies from year to year, and can in some cases be patchy, with high levels of use in small areas and little use in most areas, the underestimates of PCT can be substantial in small watersheds. As previously noted, methods for calculating PCT that account for these uncertainties have not been developed. Accordingly, EPA denies this objection.
In the final rule, EPA explained the flaws in all of the Petitioners' assessments that caused the Agency to reject the studies' conclusions. For the two assessments that had actually been submitted to the Agency, EPA was able to definitively explain the flaws. With respect to the Nationwide CWS modeling that was summarized in their comments, EPA evaluated the modeling based on the information it was able to glean from the description provided in the comment discussion.
With respect to the modeling submitted in Exhibit 15, this evidence is untimely. The modeling submitted in Exhibit 15 appears to be a fuller description of Petitioners' National CWS Assessment, which was described but not provided as part of their comments on the proposed rule. The modeling also has been revised to account for the newly proposed risk mitigation measures. However, even with the greater detail provided, the information contained in Exhibit 15 still fails to address many of the deficiencies EPA identified in the final rule. For example, although some further detail has been provided of how the Petitioners modeled the vegetated buffer strip, the complete information EPA would need to assess the modeling was not provided; the material provided is insufficient to understand how the simulations were performed or how the simulations were parameterized. Nor have the Petitioners submitted the inputs used in modeling estimated concentration from spray drift. As discussed in Unit VI.D, because the modeling in Exhibit 15 was not provided during the comment period, and to the extent that the detailed information EPA identified as lacking in the final rule has still not been provided, the evidence submitted in Exhibit 15 is not appropriately considered as a basis for justifying a hearing on its final rule. And in the absence of this evidence, this objection consists of mere allegations and general denials, which are inadequate to justify a hearing (40 CFR 178.32(b)(2)).
Further, to the extent that this objection relies on the “no application buffers,” or the proposed use tracking system newly submitted as part of their objections to support the models' assumption of a low PCT, the hearing request is denied as irrelevant, and therefore immaterial, to EPA's determination in the May 15, 2009 final rule, for the reasons discussed in Unit VI.C. Petitioners are actually not objecting to the conclusions in EPA's final rule; rather, they are suggesting that EPA might reach a different result in a different factual scenario. Objections, however, must be directed “with particularity [at] the provisions of the regulation or order deemed objectionable” (21 U.S.C. 346a(g)(2). And, as explained below, because no evidence was submitted in support of the newly proposed use tracking system, reliance on that proposal to support a low PCT constitutes nothing more than an allegation. This is not an adequate basis on which to grant a hearing (40 CFR 178.32(b)(2)).
EPA has previously reviewed the Indiana surface water assessment, and has provided comments on that submission (Ref. 45), many of which were reiterated at length in the final rule and response to comments documents (74 FR 23062–23064, Ref. 84). The Petitioners originally submitted this study to demonstrate that “EPA's standard index reservoir scenario
The study also fails to support the Petitioners' other conclusions. The study was originally intended to demonstrate two points: (1) That the vulnerability of the Indiana CWS “brackets” the Index Reservoir, and (2) that the concentrations they estimated for these locations are significantly less than EPA estimates. Regarding the vulnerability of the CWS, the assessment describes their approach for modifying the parameters of the Index Reservoir scenario to represent 15 reservoir-based watersheds in Indiana cropped in corn. The study indicates the Petitioners have included data that, based on EPA's review of these submissions, are not available at the appropriate scale to determine all site-specific parameters. The Petitioners modified some of the parameters based on available data to represent more localized conditions that are more or less vulnerable than for the Index Reservoir. From the description, the Petitioners' approach is similar to the methods that EPA uses to develop new scenarios, in that soil and weather data are varied in order to represent different locations. However, for other parameters, EPA believes the modifications are inconsistent with fundamental assumptions upon which the modeling is based. In previous submissions to the Agency, FMC has described that they have made modifications to scenarios to reflect local conditions of each CWS in Indiana by modifying the soil and weather data and altering the ratio of watershed drainage area to the reservoir capacity (Ref. 89). EPA agrees that soil and weather data can be modified to reflect conditions at local watersheds. However, EPA disagrees that altering the ratio of watershed drainage area to the reservoir capacity (
The DA/NC parameter is associated with increased concentrations in drinking water reservoirs to a certain point. The Petitioners adjusted their EDWCs for each drinking water facility by a factor representing the ratio of the DA/NC for each reservoir divided by the DA/NC for the Index Reservoir (which is 12). EPA does not believe this is appropriate for two reasons. First, the relationship between concentrations and the DA/NC is not strictly linear. Small DA/NCs imply a small watershed combined with a large reservoir. As the DA/NC increases, the relative watershed size increases, and thus the runoff volume going into the reservoir also increases. This is also means the reservoir's ability to dilute the runoff decreases; the result is that concentrations increase with an increase in the DA/NC. However, at some point, the runoff volume exceeds the reservoir capacity, and rather than increasing the pesticide concentration, the excess runoff flows out of the reservoir, carrying the pesticide with it. Thus, because pesticide concentrations are not linearly related to the DA/NC, it is not appropriate to multiply the model output by a linear DA/NC adjustment factor. Secondly, the PRZM model, which is used to simulate the watershed for the Index Reservoir, is a field-scale model. As the watershed size (and the DA/NC) increases, assumptions upon which PRZM relies (namely: uniformity of soils, equal and simultaneous movement of runoff to the reservoir, and uniform weather across the watershed) no longer hold and the model becomes less valid for simulating the runoff processes. The geometry of the Index Reservoir was chosen partly to avoid these two limitations (Ref. 43).
The study authors also calculated their own PCA values
Regarding the statement that the concentrations estimated for the study locations in Indiana are significantly less than EPA estimates, EPA has determined that the Petitioners included an adjustment factor to account for the percent of a crop that is treated with carbofuran. As previously discussed, EPA does not believe that it is appropriate to base its aggregate risk estimates on PCT within watersheds. This is because data and/or methods are not available that would allow EPA to develop PCT at the watershed scale with the necessary level of confidence to allow EPA to make a safety finding. The PCT factors that the Petitioners applied would generate significantly lower concentrations than those estimated by EPA.
EPA has reviewed the WARP assessment previously and has provided comments on the submission (Refs. 45 and 86). The WARP model has not been fully evaluated for quantitative use in exposure estimation by the Agency, although it has been preliminarily reviewed by the SAP (Ref. 32). EPA used WARP to select monitoring sites for the herbicide atrazine, based on predicted vulnerability of watersheds to atrazine runoff within the corn/sorghum growing regions. EPA presented its approach to the FIFRA SAP in December 2007. The SAP report concluded that “WARP appears to be a logical approach to identify the areas of high vulnerability to atrazine exposure,” endorsing EPA's use of this tool only for atrazine, and for the limited purpose of designing a monitoring program. The SAP noted that the most important explanatory variable with WARP was use intensity, which underscores the
WARP is a regression model developed by the USGS to estimate concentrations of the pesticide atrazine in rivers and streams. As a regression model, it is based on monitoring data from 112 USGS NAWQA monitoring locations. WARP does not directly estimate daily concentrations, but predicts the percent of the time in a randomly selected year that concentrations of the pesticide are less than a specified value, with a specified level of confidence. USGS attempted to develop an approach to estimate annual time series for other pesticides, and concluded that “further data collection and model development may be necessary to determine whether the model should be used for areas for which fewer historical data are available * * * Because of the relative simplicity of the time-series model and because of the inherent noise and unpredictability of pesticide concentrations, many limitations of the model need to be considered before the model can be used to assess long-term pesticide exposure risks” (Ref. 92).
The Petitioners had previously relied on their WARP assessment to support the conclusion that the “maximum 1-in-10-day estimated concentrations of carbofuran at the 90th percentile level in Illinois, Indiana, Iowa, and Nebraska * * * will be less than or equal to 0.3687 ppb.” This is erroneous. WARP does not provide direct estimates of return frequency,
The Agency also disagrees that the differences between the Petitioners' and EPA estimates are only due to Petitioners' use of county-level use estimates. Most importantly, the Petitioners relied on estimates of 1-in-10-day concentrations, rather than the 1-in-10-year peak concentrations estimates used routinely by EPA. 1-in-10-day concentrations are not the measurement endpoint EPA uses for human health risk assessment and are not appropriate for estimating drinking water exposure. The Agency uses 1-in-10-year peak concentrations for screening level assessments, and the full time series (typically 30 years) of daily concentration values for refined assessments. EPA's reliance on the 1-in-10-year peak concentration has been reviewed and approved by the FIFRA SAP (Ref. 30).
A concentration that occurs 1-in-10 days occurs 350 times as often as a 1-in-10-year event. Using this value instead of the one EPA used would result in significantly lower estimates of pesticide water concentration and human exposure. For example, EPA's estimate of the 1-in-10-year peak concentration from the simulation of corn in Kansas with a 300 ft buffer was 31.8 ppb. By contrast, EPA's estimate of the 1-in-10-day concentration from the same simulation was 4.5. Use of the 1-in-10 day concentration to assess dietary risk would be inconsistent with the SAP's advice and EPA's typical practice, as well as with EPA's statutory requirement to protect human health.
EPA disagrees with the Petitioners' claim that “the extreme nature of a 1-in-10-year event would result in dilution effects that cancel out any increased loading.” The Index Reservoir scenario has been validated against monitoring collected at the site it was designed to represent, Shipman City Lake in Illinois (Ref. 43). This assessment showed that the 1-in-10-year event EPA modeled was similar in magnitude to the peak value of the pesticide concentrations shown in 5 years of monitoring data collected at that site. The 1-in-10-year peak concentration calculated for that pesticide (not carbofuran), using the Index Reservoir was 33 ppb, while the peak value from 5 years of monitoring was 34 ppb.
EPA cannot determine the validity of the use intensities assumed for the Petitioners' assessment. The source of county level use data appears to have been sales data at the distributor level, similar to the data provided in the Petitioners' November 7, 2008 submission. However, as previously explained, the method chosen to estimate county level use estimates from the sales data was not provided. The county level estimates used in the assessment for 2002 to 2004 for Illinois were provided in a table. These estimates for each county were averaged over the 3 years for input to the model. A summary description of how watershed-scale use estimated from county level use data was provided, but because the sales data for the individual crops and the method that was used to generate county level estimates were not available, the validity of this assessment cannot be evaluated.
EPA has previously reviewed the Petitioners' “Nationwide CWS Assessment” and provided a response to the submission as part of the final rule and Response to comments (Ref. 45). As a preliminary matter, this assessment only included use intensity for reservoir-based systems, and excluded use intensity for all stream- or river-based systems from their assessment. Therefore, this assessment provides no evidence to demonstrate that carbofuran can be safely used in stream or river-based community water systems.
Similar to the Indiana CWS study discussed above, this study relied on county-level usage estimates to estimate use intensity. The National CWS Assessment concluded that a use intensity below 2.1 lbs a.i/mi
To evaluate the study, it is therefore important to understand how the use intensities were derived. The Petitioners' methods have been poorly described, but EPA has been able to piece together a general sense of the methods from the various reports provided to EPA. To summarize, the Petitioners relied on sales data to generate the use intensity estimates, but the method used to generate the county-level use estimates from the sales data is not described. The actual county level use estimates used in the use intensity calculations were not provided. There is a limited description indicating only that the county level use estimates were apportioned to different crops, but the method used to do this was not provided. The Petitioners appear to have used an objective method to group the county-level use estimates into 5 classes, but the method is only briefly described. Thus, because EPA cannot determine how use intensity was estimated, the Agency cannot determine if the conclusions made in the National CWS Assessment are justified by the underlying data.
In the absence of this information, EPA is unable to substantiate the study conclusion that 75% of the permissible use areas have a carbofuran use intensity below 2.1 lbs a.i/mi
As noted, the National CWS Assessment assumed that a use intensity below 2.1 lbs a.i/mi
EPA is equally unable to confirm the study's claim that the no-application buffers on the September 2008 labels will adequately mitigate the risks “in areas with historical use intensities greater than 2.1 lbs a.i./sq. mi.” On the September 2008 labels, FMC included buffers of 300 feet on water bodies in Kansas, and 66 feet around water bodies in other places, but EPA cannot evaluate how these buffers relate to areas where carbofuran use intensities exceeded a specific value, for all of the reasons stated above. EPA did, however, model the effects from the buffers proposed on the September 2008 labels and found that these buffers reduce exposure by 5.1% (33.5 to 31.8 ppb) for corn in Kansas with a 300-foot spray drift buffer and 4.7% (29.9 to 28.5 ppb) for corn in Texas with a 66-foot spray drift buffer. However, even with the buffers, EPA's analyses clearly demonstrate that estimated exposures will substantially exceed safe levels. These results are described in more detail in Unit V.E. of this order, the final rule, and Reference 84, Appendix I. For all of these reasons, the objection is denied.
In their comments on the proposed rule, the Petitioners alleged that comparisons between EPA's modeling concentrations and Zollner Creek detections were inappropriate because they were based on “older data [that] are not reflective of future carbofuran use areas and/or intensities” (Ref. 18 at 55). In support, they claimed that “carbofuran was once used at several nurseries and strawberry farms in the Zollner Creek watershed at estimated application rates of up to 15 lbs. a.i./acre (5 times higher than the maximum rate on the current label, and 15 times higher than the most common use rates)” (Id at 56).
In the final rule, EPA explained that it had not relied solely on Zollner Creek concentrations to validate its modeling. EPA again described the results of all available modeling, which included the detections at Zollner Creek, but also included results from all other NAWQA sites, SDWA post-treatment monitoring, and the results of field studies. Based on all of these data, EPA concluded that the results of the revised modeling conducted for the final rule was consistent with the available monitoring data.
In the final rule, EPA was clear that it considered the levels seen at Zollner Creek to be a rare circumstance:
While available monitoring from other portions of the country suggests that the circumstances giving rise to high concentrations of carbofuran may be rare, overall, the national monitoring data indicate that EPA cannot dismiss the possibility of detectable carbofuran concentrations in some surface waters under specific use and environmental conditions.
Petitioners' contentions regarding the NAWQA monitoring also fail to present a genuinely-disputed issue of material fact. In both the proposed and final rules, EPA acknowledged the large percentage of non-detections and low concentration levels in the majority of the NAWQA monitoring data, and repeatedly explained the reasons that these data cannot serve as lower or upper bounds (73 FR 44882–44883; 74 FR 23081). Petitioners do not dispute those conclusions, or submit evidence to rebut them. When an objector does not challenge EPA conclusions in the final rule, but merely reiterates
Unlike drinking water derived from private ground water wells, drinking water from public water supplies (surface water or ground water source) will generally be treated before it is distributed to consumers. An evaluation of laboratory and field monitoring data indicate that carbofuran may be effectively removed (60–100%) from drinking water by lime softening and activated carbon; other treatment processes are less effective in removing carbofuran (Ref. 81). The detections between 4 and 7 ppb, reported above, represent concentrations in samples collected post-treatment. As such, these levels are of particular concern to the Agency. An infant who consumes a single 8-ounce serving of water with a concentration of 4 ppb, as detected in the monitoring, would receive approximately 130% of the aPAD from water consumption alone.
To further characterize carbofuran concentrations in surface water (
The national monitoring data indicate that EPA cannot dismiss the possibility of detectable carbofuran concentrations in some surface waters under specific use and environmental conditions. Even given the limited utility of the available monitoring data, there have been relatively recent measured concentrations of carbofuran in surface water systems at levels above 4 ppb and levels of approximately 1 to 10 ppb measured in streams representative of those in watersheds that support drinking water systems (Ref. 81). Based on this analysis, and since monitoring programs have not been sampling at a frequency sufficient to detect daily-peak concentrations that are needed to assess carbofuran's acute risk, the available monitoring data, in and of themselves, are not sufficient to establish that the risks posed by carbofuran in surface drinking water are below thresholds of concern. Nor can the non-detections in the monitoring data be reasonably used to establish a lower bound of potential carbofuran risk through this route of exposure. Nevertheless, these results are consistent with the results of EPA's surface water modeling (Refs. 12, 47, 67). For all of these reasons, the Petitioners objection is denied.
However, there is a further equally material defect in this hearing request. The Petitioners have submitted no evidence to support their allegation that these proposed requirements would be effective in ensuring that carbofuran would be applied to no more than 2% of any watershed. The only submission was the description provided in the June 30 letter (Exhibit 3), and repeated above. However, this vague description leaves several critical questions unanswered. For example, the critical component of this proposal is a post-use reporting scheme, with a five-day delay between use and reporting. Even assuming that one accepts that reporting an address would allow for complete identification of the location within an individual watershed—a point on which no evidence has been submitted—no evidence, or even an explanation, has been provided to demonstrate how this after-the-fact reporting requirement will prevent application to greater percentages of the watershed. For smaller watersheds, as discussed in the final rule, application to only one or two farms may be sufficient to substantially exceed 2% of the watershed. In such cases, since applicators are only required to report within five days after application, it is likely that FMC would not be informed until after the 2% cap had been exceeded. Further, there will inevitably be some delay between FMC's attempt to repurchase the product and the reports suggesting (or confirming) that the cap either has been or will shortly be exceeded. Given the inevitable delay, it is not unlikely that further application would occur before FMC could even attempt to repurchase the product. No details whatsoever have been provided regarding the timing or mechanism by which this would occur. Further, this program operates in the absence of any enforceable use restriction, and no description of the means by which this would be enforced is provided. Although the company would “attempt to recall the product” or make it less available by “attempting” to direct sales to particular distributorships, in the absence of some mechanism to prevent sales or use, such as a permitting process, there is no real assurance that these voluntary measures would be effective (Exhibit 3). This is further complicated by the extremely low percentages contemplated by this proposal.
Additionally, this scheme rests on a variety of assumptions that no evidence has been submitted to substantiate. For example, the proposal to restrict sales to distributors in particular watersheds rests on an assumption that farmers always purchase products from a distributor within their watershed. It also assumes that growers and distributors will accept FMC's offer to repurchase unused stock of the products, rather than seeking to stockpile the product for use in the next growing season.
In the absence of any evidence to demonstrate the efficacy of these proposed restrictions, any objection based on these proposed amendments constitute no more than mere allegations or denials. Hearings will not be granted on such a basis (40 CFR 178.32(b)(2)).
In addition, Petitioners have not challenged the substance of EPA's response to their comments or submitted evidence that calls the substance of EPA's conclusions into question (40 CFR 178.32(b)(3)). Consequently, the Petitioners' objection on this issue is irrelevant, and therefore immaterial, with regard to EPA's final tolerance revocation regulation because Petitioners ignored EPA's extensive analysis of this issue in the final rule and essentially resubmitted their comments on the proposal as if EPA's determination in the final rule did not exist. The statute, however, requires that objections be filed on the final rule, not on the proposal (21 U.S.C. 346a(g)(2)). By ignoring the EPA's final rule on this subissue, Petitioners have failed to lodge a relevant objection. Both EPA and FDA precedent make clear that when the agency substantively responds to comments on the proposal, the commenter may only keep that issue alive in its objections by addressing the agency's substantive response.
To the extent this objection is simply an allegation that the results of the modeling are consistent with the surface water estimates in EPA's NMC risk assessment, the hearing request also suffers from a fatal flaw. The modeling is based on the assumption the recently proposed label restrictions are effective, and that the PCT will be 2%. Because the objection and hearing request are inextricably intertwined with the Petitioners' newly submitted proposed FIFRA registration amendments, the objection and hearing request are denied as irrelevant, as discussed in Unit VI.C. Further, as discussed, no evidence was submitted to support the assumption that the newly submitted use tracking proposal will be effective. The only evidence submitted in this regard is the results of the modeling in Exhibit 15, which as previously discussed is untimely, and therfore provides an inappropriate basis for a hearing. This evidence, therefore, on multiple grounds is insufficient to support a reasonable possibility that the issue will be resolved in the Petitioners' favor. No hearing is warranted under such circumstances (40 CFR 178.32(b)(2)).
In evaluating the acute risks associated with a single chemical's contamination of drinking water, EPA must consider all of the variations permitted under the label. Drinking water exposures are driven by uniquely local factors; not only is the source of drinking water local (
By contrast, it is not feasible to conduct the identical analysis for a cumulative assessment of related chemicals. Since the potential combinations of variations in pesticide use practices for the group of pesticides to be assessed are essentially infinite, even with computer modeling it would be impossible to model or evaluate all of the combinations allowed under the labels. EPA therefore needed to narrow its evaluation of the possible combinations to those deemed “likely” to occur. In contrast to the single chemical assessment, a cumulative assessment is intended to develop a snapshot in time of what is likely occurring at the moment. Moreover, the purpose of a cumulative assessment is to identify major sources of risk that could potentially accrue due to the concurrent use of several pesticides that act through a common mechanism of toxicity. Thus, EPA is primarily interested in the subset of circumstances in which residues from such pesticides occur concurrently (or co-occur).
In addition, one of the important attributes of a cumulative risk assessment is that its scope and complexity can potentially lead to inflated estimates of risk due to compounding conservatisms, which would reduce the interpretability and ultimately the utility of the assessments. Because many data sets need to be combined, reducing the impact and likelihood of compounding conservative assumptions and over-estimation bias becomes very important in constructing a reasonable cumulative risk assessment.
When little or no information is available to inform potential sources of exposure, such as a reasonable or maximum watershed scale PCT, it is both scientifically and legally reasonable for a single chemical assessment to incorporate conservative assumptions to reflect reasonable worst-case exposure estimates. But in a cumulative risk assessment, the incorporation of such conservative assumptions would imply multiple simultaneous reasonable worst-case exposure estimates for each individual chemical. This is so unlikely that the results would no longer represent even a reasonable worst-case estimate of the likely risks. Consequently, some of the conservative assumptions appropriately used in the single chemical risk assessments are not appropriate or reasonable for use in a cumulative risk assessment, and vice versa.
As a result, EPA chose in the NMC to work with those data that most closely reflect “representative” exposures, and developed “representative” estimates of PCT in regional watersheds. However, to be clear, the PCT values used in the NMC assessment do not represent estimates of 50% of watersheds, or even the “average” watershed; rather, they represent values that are expected to be as likely to be accurate as not, based on a random selection of watersheds. A comparable example is the statistic that the average American family has approximately 2 children; this may or may not be true for any individual family, but there is an equally good chance that it will be accurate for any randomly selected family, as that it will not be accurate. For the cumulative assessment, EPA is able accept this level of uncertainty in these estimates, precisely because it has confidence that aggregate exposures from the individual chemicals will be safe, based on the level of conservatism in the single chemical assessments. But given the statute's mandate to ensure a “reasonable certainty of no harm,” EPA could not rely on the approach used under the cumulative assessment in the absence of the more conservative single-chemical assessment that evaluates the full range of exposures permitted by the registration.
Nevertheless, as discussed in the final rule, in response to FMC's concerns EPA performed a sensitivity analysis of an exposure assessment using a PCT in the watershed to determine the extent to which some consideration of this factor could meaningfully affect the outcome of the risk assessment. The results suggest that, even at levels below 10% CT, exposures from drinking water derived from surface waters can contribute significantly to the aggregate dietary risks, particularly for infants and children. Accordingly, these assessments suggest that use of a reasonably conservative PCT estimate,
EPA is also denying the requested hearing on the grounds that the evidence, even if established, is insufficient to justify the action urged (40 CFR 178.32(b)(3)). The analyses presented in Exhibit 16, as the Petitioners explicitly acknowledge, only capture 95% of the values; five percent of exposures are not,
EPA is also denying this hearing request on the grounds the Petitioners' evidentiary proffer is insufficient to justify the factual issue urged (40 CFR 178.32(b)(2)). The analysis in Exhibit 17 is based on the percentage of the total population across all states combined, not the percentage of the local populations served by an individual surface water source—or even the percentage within each state. Even assuming that the 60% figure could legitimately be translated to a state-by-state basis, their own analysis shows that some percentage of the population in individual states will remain unprotected. In Colorado, only 24% of the population obtains their drinking water from groundwater, and in Illinois, only 33% of the population obtains their drinking water from groundwater. Sixteen percent of Colorado's population is not
A further consideration in this regard is that drinking water exposures are driven by uniquely local factors; not only is the source of drinking water local (
The evidence submitted therefore does not support their contention that 60% of the population in “affected states” obtain their drinking water from public systems that use the treatment processes effective at mitigating carbofuran residues. For example, Exhibit 17 shows that a major Chicago surface water drinking water system, which serves a population of 9,000,000, has neither lime softening processes nor filters. Petitioners have submitted no evidence that this population is protected. The fact that a small population remains unprotected is not outweighed by the fact that a larger population in another community or state is protected. Their own evidence also shows that only 26 of 141 of community water systems use lime softening/filters (Exhibit 17 at 4–9), which supports the conclusion in the final rule that approximately 20% facilities have appropriate treatment. See 57 FR 33244 (7/27/92) (Studies cited by NRDC do not provide a basis for the hearing because they “support the [FDA] conclusion in question.”); 57 FR 6667 (2/27/1992) (“A hearing must be based on reliable evidence, not on mere allegations or on information that is inaccurate and contradicted by the record.”); 49 FR 6672 (2/22/84) (no hearing if claim based on demonstrably false premise).
Petitioners raise two related objections to the way in which EPA evaluated the aggregate dietary exposures to carbofuran residues. First they raise several technical challenges to the way in which EPA calculated the two recovery half-lives that were used in the risk assessment supporting the final rule to account for the potential for individuals to recover from the effect of ingesting carbofuran residues between exposures. Second, they object to the fact that in the final rule EPA included both aggregate exposure estimates that did not account for the potential for individuals to recover from the effects between exposures as well as estimates that did account for such recovery. In support the Petitioners cite to Exhibits 9 and 10. Exhibit 9 is a memorandum prepared by Robert Sielken and Ciriaco Valdez-Flores. Exhibit 10 is a published literature study by Elsa Reiner that presents data on the rates of spontaneous reactivation of phosphorylated and carbamylated cholinesterases.
In the proposed rule, EPA conducted an Eating Occasion analysis based on two half-lives: 150 minutes and 300 minutes (73 FR 44887 (July 31, 2008)). These half-lives were not specific to carbofuran, but were calculations derived for the NMC Cumulative Risk Assessment. EPA concluded that incorporating these analyses into the risk assessment had little impact on the risk estimates from exposures from food alone, but that risk estimates from combined exposures from food and water were reduced by approximately 2–3X (Id). However, because many of EPA's risk concerns stemmed from a single exposure (
In their comments, Petitioners complained that EPA had failed to incorporate recovery into their risk assessment. They further argued that EPA should calculate the per capita 99.9th percentile based on all person minutes rather than all person-days. In addition, they submitted an aggregate dietary risk assessment they had conducted using a 150-minute half-life input. They submitted no explanation for using only the 150-minute half-life rather than also including estimates based on the 300-minute half-life that EPA has used for the proposed rule.
In the final rule EPA explained that it had conducted a revised Eating Occasion analysis to evaluate the impact of carbofuran's rapid reversibility on its risk estimates (74 FR 23086 (May 15, 2009)). EPA concluded that incorporating Eating Occasion Analysis and the 186-minute or 426-minute recovery half-lives for carbofuran did not significantly change the risk estimates for food exposures alone (74 FR 23086 (May 15, 2009)). EPA concluded that risk estimates based on combined food and drinking water exposures are reduced considerably—by a factor of two or more in some cases, but nonetheless still substantially exceed EPA's level of concern for infants and children. EPA also explained that the Agency remains concerned about the risks from single eating or drinking events. Finally, EPA noted that the Eating Occasion Analyses underestimate exposures to the extent that they do not take into account carry-over effects from previous days, and because drinking water concentrations are randomly picked from the entire 30-year distribution (Id at 23087).
Second, the fact that EPA relied on 24-hour aggregate exposures in addition to analyses that accounted for recovery is not material. As documented in the final rule, EPA would still have concluded that revocation of all tolerances were warranted on the grounds that, even accounting for recovery, aggregate exposures are not “safe.” Even though accounting for recovery resulted in a 2–3X reduction in exposure estimates, many of EPA's estimates for aggregate exposures ranged between 2700% aPAD and 9400% aPAD for infants. Accounting for recovery does not, therefore, demonstrate that aggregate exposures will be safe for infants. Of greater significance in this regard is EPA's finding that infants are at risk from a single exposure. Recovery is only relevant, by definition, where the risk is derived from multiple exposures over time.
Moreover, even accounting for the estimated decreased risk from accounting for carbofuran's rapid reversibility, for which recovery between exposures is irrelevant. The Agency remains concerned about the
The infant's total daily water intake (1,070 ml, or approximately 107 ml/kg/day) is not overly conservative, and represents substantially less than the 90th percentile value from CSFII on a ml water/kg bodyweight (ml/kg/bw) basis. As noted, carbofuran has been detected in finished water at concentrations of 4 ppb. For this 10 kg body weight infant, an 8-ounce bottle of formula prepared from water containing carbofuran at 4 ppb leads to drinking water exposures of 0.0856 micrograms of active ingredient/kilogram of bodyweight (μg ai/kg bw), or 114% of the aPAD from that bottle alone. Based on the total daily water intake of 1,070 ml/day (no reversibility), total daily exposures from water at 4 ppb concentration would amount to 0.4158 μg ai/kg bw, or 555% of the aPAD; this is the amount that would be used for this person-day in the Total Daily Approach.
Peak inhibition occurs following each occasion on which the infant consumed 8 fluid ounces of formula (6 a.m., 12 p.m., 4 p.m. and 8 p.m.); however, the maximum persisting dose occurs following the 9:30 p.m. eating occasion, based on a 186-minute half-life parameter. This produces a maximum persisting dose of 0.1457 μg ai/kg bw, or about 30% of the total daily exposure of 0.4158 μg ai/kg bw derived above, or expressed as a fraction of the level of concern, the maximum persisting dose amounts to about 194% of the aPAD (or 30% of 554%). Note that with drinking water concentration at 4 ppb, an infant consuming one 8 oz bottle of formula—prepared from powder and tap water containing carbofuran at 4 ppb will obtain exposures of approximately 114% of aPAD. Since many infants consume the equivalent of this amount on a single eating occasion, accounting for reversibility over multiple occasions is not essential to ascertain that infants quite likely have obtained drinking water exposures to carbofuran exceeding the level of concern based on drinking water concentrations found in public drinking water supplies.
The approach discussed above is used to evaluate the extent to which the Agency's 24-hour approach to dietary risk assessment overestimates risk from carbofuran exposure. The results of both approaches indicate that the risk from carbofuran is indeed not substantively overestimated using the current exposure models and the 24-hour approach.
In this regard, it is important to note EPA's Eating Occasion Analyses underestimate exposures to the extent that they do not take into account carry-over effects from previous days, and because drinking water concentrations are randomly picked from the entire 30-year distribution. As discussed previously, DEEM–FCID is a single day dietary exposure model, and the DEEM-based Eating Occasion Analysis accounts for reversibility within each simulated person-day. All of the empirical data regarding time and amounts consumed (and corresponding exposures based on the corresponding residues) from the CSFII survey are used, along with the half-life to assess an equivalent persisting dose that produced the peak inhibition expected over the course of that day. This is a reasonable assumption for food alone; since the time between exposure events across 2 days is relatively high (compared to the half-life)—most children (>9 months) tend to sleep through the night—and the time between dinner and breakfast the following morning is long enough it is reasonable to “ignore” persisting effects from the previous day. A single day exposure model will underestimate the persisting effects from drinking water exposures (formula) among infants, and newborns in particular (<3 months), since newborns tend to wake up every 2 to 4 hours to feed. Any carry over effects may be important, especially if exposures from the previous day are relatively high, since the time between the last feeding (formula) of the day and the first feeding of the subsequent day is short. A single day model also does not account for the effect of seasonal variations in drinking water concentrations, which will make this effect more pronounced during the high use season (
In summary, there are several factors that may cause EPA's exposure/risk model to either understate or overstate exposure/risk. It is unreasonable to present risks only incorporating factors that tend to reduce exposure/risk estimates (
In the final rule, EPA calculated half-lives specific to carbofuran to ensure that its analyses accurately reflected carbofuran's risk. Using the two FMC
In any event, Petitioners' objection would have ultimately no effect on the Agency's conclusion that the carbofuran tolerances are not “safe.” Given EPA's assessments showing that a single exposure can result in excessive risks to infants—a conclusion that Petitioners have not challenged—the extent of recovery between subsequent exposures is irrelevant. This conclusion alone provides an adequate basis to revoke the carbofuran tolerances. Accordingly, because the action would be the same even if the factual issue were resolved in the manner sought, this request does not meet the standard for granting a hearing (40 CFR 178.32(b)(3)).
There is yet a further consideration affecting the materiality of this objection. EPA's recalculation of half-lives in the final rule would ordinarily mean that Petitioners could appropriately challenge EPA's methodology for deriving the revised half-lives for the first time in their objections. This is because the Petitioners would have had no prior opportunity to challenge the manner in which these estimates were developed, as EPA had not previously relied on carbofuran-specific estimates. However in this case, the Petitioners never commented on the 300-minute estimate EPA used in the proposal, nor raised any issue to challenge the reliance on a longer half-life to account for the variation in children's sensitivity. For the reasons discussed in Unit VI.D, they have therefore waived any objection to use of a 300-minute half-life. Accordingly, the question of whether the Petitioners' half-life of 150-minutes or EPA's estimated half-life of 186-minutes is immaterial, since the lower amount of recovery associated with the longer 300-minute half-life would be expected to have a far greater impact than the use of a 186-minute half-life.
EPA is also denying the hearing request because the evidentiary proffer in support of this objection is inadequate. Petitioners have not provided the underlying analyses conducted in support of their calculated half-lives. The remainder of Exhibit 9 consists of contentions that EPA's analyses were mistaken. In the absence of the analyses that support their claim that the data support a half-life of 150 minutes, Petitioners' evidentiary proffer consists of no more than mere allegations and denials. Hearings will not be granted on this basis (40 CFR 178.32(b)(2)) (See 73 FR 42706 (July 23, 2008) (“NRDC does no more than state `[w]e are aware of no statistical test' which would support EPA's use of the Gledhill data. As EPA's regulations make clear, a mere `denial' of an EPA position is not sufficient to satisfy the standard for granting a hearing”) (citations omitted); 53 FR 53176, 53199 (December 30, 1998) (“Rather than presenting evidence [the objector] asserts that FDA did not adequately justify its conclusions. Such an assertion will not justify a hearing.”).
The published paper in Exhibit 10 does not cure this defect. The paper was submitted to support the claim that the Petitioners' 150-minute half-life is consistent with the “available literature on the AChE recovery” (Obj at 32). This evidence is immaterial. The Reiner paper relates to the reactivation of the AChE enzyme; however the relevant issue is not the reactivation of the cholinesterase enzyme, but the level of chemical in that target tissue, which this study does not address. Moreover, this study concludes that “[I]t follows from the data in Tables 1 and 2 that the rate of spontaneous reactivation cannot be predicted, but must be separately determined for each compound and each enzyme source (Exhibit 10 at 1). The paper did not include data specifically on carbofuran, and it is therefore difficult to see how this could be argued to support the Petitioners' half-life of 150-minutes.
More significantly, the Petitioners' approach fails to account for the variability of the estimated AChE activity at each time point. As a point of background, the level of the highest inhibition is not something that can be observed, in the way that motor activity is observed. To determine inhibition, samples are taken and measured—the samples may or may not capture the highest point of inhibition; the technician has not external indicia that will determine the moment of the “peak.” Determining peak inhibition is estimated based on the available measurements. But because measurements are generally variable—the animals differ and the sampling itself is not identical, as people cannot perfectly replicate their actions time after time—in order to accurately capture the peak levels, the variability needs to be accounted for. When, as here, the individual values are quite variable, then for a half-life as long as carbofuran's, the sampling variability will make the study means bounce up and down around a trend line representing the true recovery rate. Figure 2 illustrates the sampling variability of the measured AChE activity and its relationship to EPA's modeling estimates for PND11 pups. In brief, this plots observed versus predicted for all the data. Each little point is an individual animal, while the time-group mean is the larger version of the same plotting symbol. The vertical lines are the 95 percent confidence intervals for each mean, the vertical lines. The diagonal line in each figure is the identity line—
Petitioners object to EPA's reliance on a default 10X interspecies factor, which accounts for the uncertainties inherent in extrapolating from animal data to the anticipated effects in humans. They argue, for several reasons, that EPA should have instead used a 3X interspecies factor. All of their arguments, however, depend on EPA consideration of an oral carbofuran dosing study conducted in humans. EPA did not rely on the cited human study because it found, taking into account the advice of the HSRB, that the study was scientifically invalid. EPA's Human Research rule prohibits EPA from considering scientifically invalid human studies (40 CFR 26.1701). In their objections, Petitioners argue that the HSRB's, and presumably EPA's, evaluation of the scientific validity of the human study was flawed because (1) the human study was not considered in light of the animal data on carbofuran; (2) insufficient weight was given prior independent reports on the value of the Arnold study which reached the opposite conclusion from the HSRB; (3) the “technical” concerns raised by the HSRB are addressed by “the data within the study” and that these “technical” deficiencies do not render the Arnold study unreliable.
As previously noted, EPA did not rely upon any of the existing intentional dosing human toxicity study deriving an acceptable level of exposure for carbofuran. Instead, EPA relied on data conducted with rats, and applied the default 10 × interspecies factor to account for the potential uncertainty in extrapolating from animal data. EPA's decision not to rely on the Arnold studies was made pursuant to its Human Research rule. As explained in Unit III.B, that rule establishes different ethical standards for the review of completed human studies depending on whether they were initiated before or after the effective date of the rule on April 7, 2006. For an intentional human exposure study such as the Arnold studies, that was initiated prior to April 7, 2006, EPA is barred, subject to a very limited exception, from relying on it if there is clear and convincing evidence that the conduct of the research was fundamentally unethical or significantly deficient with respect to the ethical standards prevailing at the time the research was conducted (40 CFR 26.1704, 26.1706). Further, the rule limits the human research that can be relied upon by EPA to “scientifically valid and relevant data” (40 CFR 26.1701). Finally, because the Arnold study was conducted with the purpose of identifying or measuring a toxic effect, EPA is required by the rule to submit its determination regarding these issues to an independent expert advisory body known as the Human Studies Review Board (“HSRB”) for review. These procedures were followed with regard to the Arnold study.
The HSRB reviewed the Arnold oral and dermal carbofuran human studies at its May, 2006 meeting (Refs. 7, 8, 9). The Board found numerous technical deficiencies regarding the conduct of the oral study and that overall, the weaknesses of the studies far outweigh the strengths. These deficiencies included: (1) There was no justification or rationale for the selection of doses used in any of the three studies. (2) The sample size was very small (typically two subjects per dose or condition) with few or no controls (no more than two control subjects in any study). Such a design prevented evaluation of statistical significance for any parameter measured in the studies. (3) The values obtained for RBC and plasma cholinesterase levels were highly variable. Factors that contributed to this variability included the small sample size, the inclusion of only a single baseline sample collected immediately prior to dosing used to compare all post-dosing samples, the small number of control subjects, and an uncommon method for analytical determination of cholinesterase activities. The contribution of potential laboratory error cannot be ruled out. (4) Plasma cholinesterase levels were highly variable in all studies so as to preclude any useful interpretation. In general, plasma cholinesterase levels were not consistent with changes in RBC cholinesterase activities. (5) One subject who presented with abnormal vestibular mechanisms in the pre-dose evaluation was used in the oral study and showed serious symptoms after treatment. (6) Subjects were allowed to smoke during the study period.
In response to a specific request from the Agency, the Board provided additional analysis concerning the potential for the data in human subjects for carbofuran to be applied to: (1) The calculation of a benchmark dose (BMD
The utility of the human studies with carbofuran was limited by the very small sample size used in all of the studies. The Agency proposed to use the RBC cholinesterase data for determination of the BMDL
In a similar manner, the small sample size, compounded by the lack of consistent changes in cholinesterase activities in all studies, the inappropriate methods used for dermal application of the compound in the dermal studies and the inclusion of at least one subject who presented with abnormal vestibular function in a pre-dose assessment limited the general utility of the data. Collectively, the weaknesses in the conduct and outcomes of the carbofuran human studies cast doubt on the utility of the data for identifying a NOAEL or LOAEL or for comparing across species in consideration of the interspecies uncertainty factor for the cumulative risk assessment. Thus the majority of HSRB members agreed the human oral data should not be used to identify a NOAEL or LOAEL, and there was unanimous agreement that the human dermal data should also not be used for these evaluations.
The HSRB concluded that while these studies were informative, due to the numerous technical issues regarding the conduct of the oral study, overall, the weaknesses of the studies far outweigh the strengths. Describing the studies as “poor science,” the HSRB recommended against the use of the oral study conducted with carbofuran in human subjects for the single chemical assessment or in informing the interspecies uncertainty factor for the cumulative assessment.
In their comments opposing EPA's proposal to revoke carbofuran tolerances, Petitioners essentially raised the same arguments they present in their objections.
In responding to Petitioners' comments, EPA explained that it agreed with the HSRB's conclusions that the studies were scientifically flawed, and that, therefore, under the Human Research rule, EPA was barred from considering them (Ref. 85 at 9).
Petitioners' first argument as to why EPA erred in its determination that the Arnold study was scientifically invalid is that EPA failed to consider the animal data on carbofuran in assessing the scientific quality of the Arnold study. This claim is not material and thus not
Second, Petitioners argue that insufficient weight was given the prior independent reports on the Arnold study. However, the weight EPA should give under the Human Research rule to pre-rule independent reviews as opposed to the conclusions of the HSRB—the body established by the rule for the purpose of aiding EPA's implementation of it—is a legal/policy question and not a factual one. Hearings will not be granted on legal/policy issues (40 CFR 178.32(b)(1)).
Finally, Petitioners' claims that EPA and the HSRB identified merely “technical” deficiencies in the Arnold study and that these deficiencies are “address[ed]” by “data within the study itself” and, therefore, do not render the study “unreliable” are no more than mere allegations and thus provide an insufficient basis for the granting of a hearing (40 CFR 178.32(b)(2)). Petitioners have proffered no evidence regarding the “technical” nature of the deficiencies in the Arnold study or how the deficiencies in sample size or variability are addressed within the study. Moreover, the record is clear that the deficiencies in the study are fundamental in nature and a hearing will not be granted on bald objections that are contradicted by the record (73 FR 42696 (July 23, 2008) (hearing denied when objection was contradicted by record and no evidence proffered in support)).
The bulk of Petitioners' argument concerning EPA's determination on the scientific validity of the Arnold study is devoted to suggesting that the HSRB's review of the Arnold study was somehow “inadequate” because two members of the HSRB (Drs. Brimijoin and Chambers) were recused from the review due to their prior participation in a prior independent peer review. Petitioners also assert that the HSRB was hampered because EPA “never informed the HSRB that it could call upon these experts for questioning or information regarding their prior peer review of the human studies, nor was it informed of—or provided with—those prior reviews.”
These claims are wholly without merit. As laid out in a letter responding to FMC's complaint regarding the recusal of Drs. Brimijoin and Chambers from the HSRB review of the carbofuran human studies, the recusal was entirely appropriate, and consistent with EPA's policies and regulations. The facts outlined in that letter also demonstrate that the HSRB's review was in no way restricted or hampered by the limited recusal of the two Board members.
First, the HSRB was fully apprised of the earlier peer review reports. EPA relied on the reports because EPA's position before the HSRB was that the Arnold study should be found to meet the standard of the Human Research rule and would be useful in establishing points of departure for the carbofuran's single chemical assessment and in informing the interspecies uncertainty factor for the NMC CRA. It was clearly in EPA's interest that the HSRB be made aware of the earlier reports. In fact, the background materials provided to the Board included the peer review reports by Drs. Brimijoin, Chambers, and Pope, and the Agency's Weight-of-the-Evidence presentation to the HSRB which noted the contributions of these reviewers. Further, both the peer review reports and EPA's Weight-of-Evidence presentations were included in the public docket for the HSRB review. To the extent that the HSRB was still somehow unaware of the prior reports, FMC clearly referenced them in both its written and oral comments to the Board.
Second, EPA's determination on the recusal of Drs. Brimijoin and Chambers was clearly consistent with Agency policy and well with EPA's discretion. The EPA's Peer Review Handbook (3rd Edition) (Ref. 80) provides guidance about peer review processes of the Agency. Of particular relevance is the Handbook's guidance regarding independent peer reviewers. While the Handbook notes that there is no prohibition against using the same peer reviewer more than once on the same product, it nevertheless advises that “it is preferable to use different people each time to provide a broader perspective (Ref. 80 at 13). Further the Handbook advises that the review of experts who “have participated substantially in the development of a product * * * may not qualify as unbiased, independent peer review * * *” (Id.). Therefore, EPA concluded that, under the circumstances, a question could be raised regarding the impartiality of Drs. Brimijoin and Chambers from the particular matter under review by the HSRB. Further support on this point can be found in the regulations at 5 CFR 2635.502(a)(2), and in the preamble to the original regulation (56 FR 33778 (July 23, 1991)).
In light of these considerations, EPA addressed the appearance issue regarding Drs. Brimijoin and Chambers by determining whether authorization by the Agency designee should be invoked (see, 5 CFR 2635.502(d)). Three factors were particularly relevant to the determination of Drs. Brimijoin and Chambers (see, 5 CFR 2635.502(d)(4), (5), and (6)): the sensitivity of the
As documented in Dr. William Farland's May 1, 2006 memorandum entitled, “Ethics Determination for Participation at the May 2–3, 2006 EPA Human Studies Review Board Meeting” (Ref. 39), EPA authorized the HSRB to ask Drs. Brimijoin and Chambers clarifying questions regarding their 1997 review, in the event that the HSRB deemed it necessary as part of their deliberations. At no point during the meeting did any of the HSRB's members indicate in any way that they wanted to consult with their recused colleagues. Nor did any of the members state that they wanted clarification on any point associated with the study.
For all of the above reasons, Petitioners' objection on this point is denied.
Petitioners object to EPA's revocation of the tolerances for imported foods along with the tolerances associated with domestic uses. Petitioners allege that the revocation of the import tolerances is not supported by the available data because EPA's own risk assessments conclude that, when considered separately from the domestic uses, the residues from imported foods covered by these tolerances are “safe.” Petitioners further argue that EPA “has not asserted any claim or rationale in the Final Order justifying its conclusions that the import tolerances are unsafe” and therefore the revocation is unjustified.
No one submitted any comments alleging the need to retain individual tolerances for purposes of imports, or indicated an intention to seek to maintain those tolerances. The only subset of tolerances that commenters suggested was safe was the subset identified by the Petitioners, which included the import tolerances along with four domestic food uses.
In the final rule, EPA analyzed the aggregate exposures from the subset of tolerances the Petitioners sought to retain, and concluded that the aggregate residues from food covered by those tolerances and from residues in drinking water are unsafe (74 FR 23084–23088).
In addition, Petitioners failed to raise this issue as part of their comments on the proposed rule, and never requested retention of only the import tolerances. Accordingly, as discussed in Unit VI.D, EPA considers this issue to have been untimely raised, and therefore waived. (See, 73 FR 42,696 (July 23, 2008) (denying NRDC's hearing request on claims not presented in their original petition); 72 FR 39318, 39324 (July 18, 2007) (ruling that parties may not raise new issues in filing objections to EPA's denial of original petition)).
EPA can only maintain tolerances that it can determine will be “safe” within the meaning of section 408(b)(2)(A)(ii). In making this determination, EPA must consider aggregate exposures from “dietary exposure under the tolerance and all other tolerances in effect for the pesticide chemical residue, and exposure from other non-occupational sources” (21 U.S.C. 346a(b)(2)(D)(vi)). At the time of the final rule, EPA evaluated the safety to the public from all dietary exposures to residues of carbofuran, which included not only the import tolerances, but also from residues on foods associated with domestic registrations and from residues in drinking water contaminated by the domestic uses. Indeed, until domestic use ceases—or at least until EPA has a reasonable basis to believe that it will cease—the Agency has no discretion to ignore the exposures from those uses. And revocation of the tolerances themselves does not necessarily resolve the issue, given the circumstances here. Until the registrations are cancelled, residues from contaminated drinking water, which is the primary contributor to the risks, must be included in EPA's risk assessment (Id).
The consequence of this requirement is that, when one tolerance is unsafe, all tolerances are equally unsafe until aggregate exposures have been reduced to acceptable levels. Accordingly, in circumstances where aggregate exposures exceed the risk cup, there are potentially multiple variations of the potential subset of tolerances that might meet the safety standard. FFDCA section 408 does not compel EPA to determine the appropriate subset that would meet the safety standard. EPA is compelled “to revoke or modify a tolerance if [EPA] determines it is not safe,” but the statute grants EPA the discretion to determine how to proceed where more than one tolerance is unsafe. EPA's general policy in such situations is not to independently select the subset that meets the standard, but to rely on the pesticide registrant and the public to determine which of the various subsets of tolerances are of sufficient importance to warrant retention. There are a number of reasons EPA adopted this policy; it would be an unreasonable burden for the Agency to evaluate every possible combination of tolerances that might fit within the risk cup. In addition, if there were multiple different combinations that might within the risk cup, it is not clear that any party would
FMC has had ample opportunity prior to issuance of the final tolerance revocation regulation to amend its FIFRA registration, whether during the comment period on the proposed rule, the extended reregistration process, or the public process initiated as part of the NOIC for carbofuran. And FMC has requested a number of modifications to its registrations during that time period. Yet, FMC has waited until EPA issued a final revocation regulation finding that carbofuran tolerances are unsafe, particularly as to infants and children, before filing its latest series of proposed FIFRA registration amendments. For this FFDCA proceeding, that is too late. The FFDCA commands that EPA “shall modify or revoke a tolerance if the Administrator determines it is not safe” (21 U.S.C. 346a(b)(2)(A)(i)). The statute also places EPA under a special injunction to protect infants and children from the risks of pesticides (21 U.S.C. 346a(b)(2)(C)). EPA has made a final determination that carbofuran tolerances are unsafe and further determined that that lack of safety falls hardest on infants and children. Petitioners had the statutory right under FFDCA to challenge the accuracy of EPA's safety finding on carbofuran tolerances. FMC also has the statutory right under FIFRA to request amendment of its registration. What Petitioners may not do is prolong the FFDCA tolerance revocation process by challenging EPA's safety determination based on proposed FIFRA registration changes that were not before EPA at the time of its final revocation decision.
There are multiple problems with Petitioners' hearing requests. Many of these problems stem from the Petitioners' decision to withhold analyses and information from the notice-and-comment rulemaking portion of this proceeding. Thus, despite EPA's clear warning that issues not raised in comments on the proposed rule, and information not submitted in that same timeframe, would be considered waived, Petitioners included several new issues, and numerous documents and analyses for the first time with their objections although they were clearly available earlier. Petitioners also have, for the most part, ignored how EPA responded to the comments they did submit in the notice-and-comment rulemaking, and instead have often merely recycled their earlier comments as objections without addressing the reasons why EPA found them lacking in the first instance. This strategy, unfortunately for Petitioners, is fatal to many of their hearing requests and objections. EPA will not grant hearings on issues that have been waived, on issues where supporting documents were untimely submitted, or on claims that have become stale in that EPA addressed them in the final rule and Petitioners have not responded by clarifying where disputed issues still remain.
It is not as if Petitioners lacked warning that EPA would take such an approach. Not only did EPA clearly state in the proposed rule that comments and information must be submitted in the comment period to be preserved but in 2007 EPA denied a hearing to a party who treated the notice-and-comment rulemaking process in a similarly cavalier fashion. In that instance, the party in question, like Petitioners, filed objections that largely mirrored its earlier submissions to the Agency without taking into account how EPA's final action had altered the nature of issues in dispute (See,
Petitioners' hearing requests and objections on this issue are denied for identical reasons: the available evidence
To reiterate, if EPA chooses to select a children's safety factor different than 10X, it bears the statutory burden of showing that reliable data support its determination that the selected factor is safe for infants and children. Thus, Petitioners, in seeking to establish that EPA erred by not selecting an even lower children's safety factor for carbofuran (in fact, no such factor at all), similarly bear the burden of showing that there are reliable data for the proposition that juvenile brain AChE data for carbofuran are protective of PNS effects in children. Petitioners' equivocal and largely irrelevant proffer cannot meet that standard, particularly where EPA is lacking data it has traditionally-required on cholinesterase-inhibiting pesticides to protect against PNS effects, and the data EPA does have on measures of PNS effects indicate that effects on the juvenile PNS occur at lower doses than effects on brain AChE.
As to Petitioners' objection to EPA's science policy decision to use RBC cholinesterase as a surrogate for PNS effects, EPA explains in detail in Unit VI.E, the biological basis for its policy decision, the multitude of data supporting its approach, and the frequent consultations with the SAP concerning the wisdom of using such an approach. The equivocal data submitted by Petitioners does not raise a serious question regarding EPA's policy. In any event, as noted with regard to the hearing request, this subissue lacks materiality in that success on this subissue by Petitioners would retard rather than advance their challenge to EPA's action.
Petitioners' objection on this subissue is denied because both parties agree that muscle fasiculations, which are the movements EPA described at the SAP meeting and in the proposed and final rules, are PNS-mediated effects. Further, it is unclear that the effects described in the studies Petitioners submitted are actually the same effects seen in the carbofuran study; other factors in the studies suggest that the movements being studied are not purely cholinergic, which calls into question whether the effects are the same. For the same reason, this calls into question the contention that the effects are exclusively CNS-related. Finally, the cited studies fail to support Petitioners' remaining contentions. Since it is unclear that the studies actually describe the same effects, and Petitioners have failed to demonstrate that the effects are exclusively CNS-related, the evidence does not, therefore, rebut EPA's conclusions regarding the movements described in the carbofuran study.
A hearing on this subissue is not appropriate for two reasons. First, Petitioners' repeated failure to submit the analysis supporting their claim reduces this objection to a mere allegation. Under EPA's regulations, hearings will not be granted on the basis of mere allegations. More importantly, Petitioners' objection on this subissue is irrelevant, and therefore immaterial, with regard to EPA's final tolerance revocation regulation because Petitioners ignored EPA's extensive analysis of this subissue in the final rule and refiled their comments on the proposal as if EPA's determination in the final rule did not exist. The statute, however, requires that objections be filed on the final rule, not on the proposal. By ignoring the EPA's final rule on this subissue, Petitioners have failed to lodge a relevant objection. Both EPA and FDA precedent make clear that when the agency substantively responds to comments on the proposal, the commenter may only keep that issue alive in its objections by addressing the agency's substantive response. In other words, the final rule is the focal point for determining whether issues remain that must be resolved by the objection and hearing process. Any other approach relegates the notice-and-comment rulemaking stage of the revocation process to a meaningless exercise.
Petitioners' objections on this subissue are denied as irrelevant to the conclusions reached in the final rule. The final rule explains why Petitioners' arguments are without a basis, and Petitioners have failed to address that explanation. For essentially the same reasons, EPA denies the objection.
For essentially the same reasons, EPA denies the hearing request and objection designated above as
Petitioners' hearing request on this subissue is denied for two reasons. First, Petitioners proffered no evidence on any carbamate, much less carbofuran, in support of their claim that BMD
The objection that EPA's modeling is scientifically invalid is denied. EPA's modeling has been repeatedly reviewed and approved by the SAP, including most recently with respect to the modeling of carbofuran's dose-response curves. There is no indication in the modeling that EPA's assumption of parallel dose-response curves overstates the difference, and given the absence of data supplied by Petitioners in support of this objection, the objection is denied.
A hearing is not appropriate on this subissue because Petitioners have not challenged the basis EPA asserted in the final rule for rejecting their concerns nor have they proffered any evidence that calls the substance of EPA's conclusions into question. A hearing is not warranted on the basis of mere denials or contentions, nor when the commenter simply reiterates comments raised in response to the proposed rule (40 CFR 178.32(b)(1) and (2)). Additionally, this hearing request is rejected for lack of materiality. If EPA abandoned its sophisticated analysis of multiple studies and datasets and simply followed the general approach laid out in its BMD policy, EPA would have chosen a significantly lower BMD dramatically raising EPA's risk estimates.
Petitioners' objection on this subissue is denied because Petitioners have not responded to the explanation EPA provided in the final rule supporting its meta-analysis of multiple studies. Consistent with Agency guidance, EPA believes that consideration of all available data is the scientifically more defensible approach, rather than the selective exclusion of reliable data. Petitioners' objection on this point is particularly weak given that their analysis also combines various data sets and only arrives at a higher estimate of the BMD by selectively excluding, without explanation, the data most pertinent to assessing carbofuran's acute affects.
The first four subissues below pertain to EPA's assessment of the carbofuran groundwater exposure assessment and the last eight address the surface water assessment. In this regard, it is important to note that, in order to determine that a tolerance for a particular use will be safe, EPA must be able to determine that anticipated concentrations in both surface water and ground water resulting from that use will be safe.
A hearing is not appropriate on this subissue because the Petitioners have failed to proffer evidence, which would, if established, resolve a material issue in their favor. First, Petitioners fail to take into account the clear record evidence that EPA scaled the PGW modeling to reflect the lower current use rates. Second, Petitioners are simply incorrect to claim that EPA “validated” its quantitative groundwater assessment based on historic monitoring data that are not reflective of current application rates. The targeted monitoring data used for validation were based on application rates that are identical or lower than the current use rates. Third, the majority of Petitioners' evidence is untimely, and to the extent Petitioners' are claiming that the PGW and other targeted monitoring data are not reflective of FMC's June 29, 2009 proposed registration amendments, that claim is irrelevant to the current proceeding. Finally, Petitioners' evidentiary proffer on the PGW is internally contradictory given that Petitioners' own experts relied on the PGW to validate the modeling submitted in support of this objection.
The objection on this subissue is denied because timely evidence and reasoning submitted by Petitioners is contradictory, non-probative, or flatly contradicted by the record.
Nonetheless, to the extent possible EPA has attempted to evaluate this objection based on the label mitigation measures submitted and adopted prior to issuance of the final tolerance revocation rule and ruled on it on that basis. EPA denies the objection and its associated hearing request because Petitioners have again failed to object to EPA's final rule. It is clear from the record that EPA's final rule and risk assessment did account for all of the risk mitigation measures submitted as part of the September 2008 comments. Petitioners have not raised any substantive challenge to the manner in which EPA's modeling addressed those measures. In addition, Petitioners' objections provide no further clarification as to what is meant by their claim that EPA's assessment relied on “unrealistic and overly conservative assumptions.” Therefore, this objection, and the attendant hearing request, is denied based on Petitioners' failure to state with “particularity * * * the basis for the objection * * *.”(40 CFR 178.25(a)(2)). As Petitioners raised similar allegations in their comments, EPA has assumed that they intended to incorporate all of the issues raised in the comments on the proposed rule. However, EPA addressed these assertions in the final rule. Because Petitioners have once again ignored the explanations provided in the final rule, this objection and hearing request are denied as immaterial.
EPA denies the request for a hearing on this sub-issue because there is no disputed factual matter for resolution (
On the merits, Petitioners' objection is denied because the results of Petitioners' groundwater assessment are not consistent with the estimates developed for the NMC CRA. The NMC CRA examined carbofuran at two sites, northeast Florida and the Delmarva Peninsula. In Florida, concentrations were found to be below levels of concern because of high pH, but in Delmarva, both in corn and in melon scenarios EPA estimated that 90% of daily concentrations could be as high as 20.5 and 25.6 ppb, respectively. These values are far greater than the 1.1 ppb that Petitioners claim is the maximum expected 1-in-10-year peak concentration.
To the extent Petitioners' objection on this subissue is limited to EPA's refusal to use a 4% PCT in estimating drinking water concentrations in individual watersheds based on the information provided as part of their comments on the proposed rule, this objection and hearing request are also denied as immaterial. The Petitioners have failed to respond to EPA's explanation in the final rule that the information and methodology on which they relied to estimate a 4% PCT was fundamentally flawed, and to submit any evidence calling the basis of EPA's response into question (40 CFR 178.32(b)(3)). Additionally, the proffered evidence here is untimely. The sales data and methodology used to generate use estimates, as well as the modeling in Exhibit 15, were not submitted during the comment period on the proposed rule even though the information was clearly available to Petitioners (40 CFR 178.32(b)(2)).
Petitioners' objection on this subissue is denied because the proffered evidence is untimely and, even if considered, insufficient. Although EPA does use reliable data on pesticide usage in estimating exposure levels in food, this approach has limited applicability in drinking water assessments due to the differences in the sources of food and water for consumers. The food market in the United States is national in scope but the sources of drinking water are primarily local. Thus, while differences in the usage of pesticides across the country will average out in estimating pesticide exposure from food, such averaging is not applicable to estimating pesticide exposure in drinking water—
A hearing is also denied on this sub-issue because Petitioners' objection on this subissue is irrelevant, and therefore immaterial, with regard to EPA's final tolerance revocation regulation. Petitioners have not responded to EPA's extensive analysis of these studies, which included an explanation for the Agency's conclusion that they were significantly flawed, presented in the final rule. The statute, however, requires that objections be filed on the final rule not the proposal. By ignoring EPA's final rule on this subissue, Petitioners have failed to lodge a relevant objection. Both EPA and FDA precedent make clear that when the agency substantively responds to comments on the proposal, the commenter may only keep that issue alive in its objections by addressing the agency's substantive response (40 CFR 178.32(b)(3)). Similarly, the Petitioners' new assessment directly relies on FMC's newly-proposed FIFRA registration amendments and is thus irrelevant to this proceeding. Their new assessment is also untimely in that it primarily appears to be a fuller description of Petitioners' National CWS Assessment, which was described, but not provided as part of their comments on the proposed rule (40 CFR 178.32(b)(2)).
EPA has outlined the substantial flaws in the previously-submitted assessments in the final tolerance revocation rule and in Unit VI.F, above. For the all the reasons cited therein, this objection is denied.
Even assuming Petitioners' allegation concerning soil pH can be separated from the proposed registration amendments, Petitioners' claims are insufficient to justify the action urged (40 CFR 178.32(b)(3)). Petitioners admit that their pH analyses explicitly only capture 95% of surface waters. Because EPA cannot ignore the other 5% of surface water, this information, even if established, would provide an insufficient basis on which EPA could reasonably conclude that the drinking water exposures would be “safe.” Additionally, the proffered evidence for this objection is untimely because although the effects of pH were clearly discussed in the proposed rule, Petitioners' claim and the analyses supporting it were not submitted during the comment period.
For the same reasons, the Petitioners' objection is denied.
Separating out the allegations that are independent from the new registration amendments, EPA denies this hearing request on the grounds that Petitioners' claims are insufficient to justify the action urged (40 CFR 178.32(b)(3)) in that they would fail to justify a conclusion that the carbofuran tolerances are safe. The fact that the majority of people are protected is irrelevant if major identifiable subpopulations are not. Further, both the objection and the proffered evidence are untimely because Petitioners' claims and analyses supporting them were not submitted during the comment period. For the same reasons, this objection is denied.
EPA is denying this hearing request on two grounds. First, the objection fails
Second, the fact that EPA relied on 24-hour aggregate exposures in addition to analyses that accounted for recovery is not material, because even though accounting for recovery resulted in a 2–3X reduction in exposure estimates, many of EPA's estimates for aggregate exposures ranged between 2700% aPAD and 9400% aPAD for infants. Accounting for recovery does not, therefore, demonstrate that aggregate exposures will be safe for infants. Of greater significance in this regard is EPA's finding that infants are at risk from a single exposure. Recovery is only relevant, by definition, where the risk is derived from multiple exposures over time.
Petitioners' objection to EPA's policy decision to present acute risks in terms of 24 hours of exposure is denied because EPA's policy approach here is reasonable. For the reasons explained in Unit VI.G, there are several factors that may cause EPA's exposure/risk model to either understate or overstate exposure/risk. It is unreasonable to present risks only incorporating factors that tend to reduce exposure/risk estimates (
Petitioners' hearing requests on this subissue are denied for two reasons. First, Petitioners have not provided the underlying analyses conducted in support of their claims that the appropriate half-life for carbofuran is 150 minutes, rather than the 186 or 426 minutes that EPA calculated. Petitioners' evidentiary proffer thus consists of no more than mere allegations and denials. Hearings will not be granted on this basis (40 CFR 178.32(b)(2)).
Further, the issue of the appropriate half-lives for carbofuran is not material. Petitioners have proffered no evidence to show that reliance on a 150-minute half-life rather than a 186-minute half-life would make a significant difference to their estimates. By contrast, in the risk assessment supporting the final rule, EPA's estimates show that the use of a 150-minute or 186-minute half-life makes little or no difference. In addition, EPA's final risk assessment found that infants are at risk from a single exposure. Recovery is only relevant, by definition, where the risk is derived from multiple exposures over time.
EPA denies Petitioners' objection on this subissue because the evidence submitted fails to establish their allegations, or to rebut the data and analyses discussed in the final rule.
Although Petitioners have made a number of arguments in support of adopting a 3X interspecies factor, all of the arguments rely on consideration of the Arnold study. Thus, as a preliminary matter, Petitioners must show that a hearing is appropriate based exclusively on whether EPA erred in determining that the Arnold study cannot be considered under the Human Research rule or, that even if a hearing is not warranted, that EPA's decision under the Human Research rule was incorrect.
Petitioners have proffered no evidence that merits a hearing on EPA's application of the Human Research rule to the Arnold study. As an evidentiary proffer, Petitioners claim (1) that review of the Arnold study under the Human Research rule was too narrow in that it did not consider the Arnold study in light of the animal data; (2) that insufficient weight was given prior independent reports on the value of the Arnold study; (3) that the “technical” concerns raised by the HSRB are addressed by “the data within the study” and that these “technical” deficiencies do not render the Arnold study unreliable. The first proffer is not material because the availability of animal data does not address the validity of the Arnold human study. At bottom, this issue involves a challenge to the policy underlying the Human Research rule that allows only limited consideration of human toxicity studies. A hearing is not appropriate on such a policy issue, nor on the Human Research rule itself. Petitioners' second proffer is a legal/policy question regarding the weight to be accorded to existing peer review reports. No hearing is required on such issues. To the extent the third proffer even constitutes a proffer of “evidence,” it fails because it is nothing more than a mere allegation. Petitioners have supplied no information as to how the HSRB's “technical” concerns are resolved by the study itself.
Viewed on their merits, these claims do not convince EPA that it erred in determining that the Arnold study did not meet the Human Research rule because it lacked scientific validity. EPA concluded, based on the advice of the HSRB, that, because the Arnold study had an extremely small sample size (2 persons per dose) and highly variable measurement of RBC and plasma AChE, it had no scientific value. The claim by Petitioners that somehow the Arnold study could be rehabilitated by considering it in the context of carbofuran animal data misunderstands the issue. The question under the Human Research rule is whether the human study at issue is scientifically valid. Here, EPA found the Arnold study to be flawed at its core. Animal data on carbofuran are simply irrelevant to the problems with sample size and AChE measurement in the Arnold study. As to the earlier reports on the Arnold study, Petitioners have provided no reason as to why these should outweigh the HSRB's conclusion concerning whether the Arnold study met the Human Research rule standard. The earlier reports were completed well before the Human Research rule was promulgated and thus could not have addressed the rule's requirements. Further, the earlier reports identified the same defects, but concluded that the Arnold's study's flaws could be addressed by the use of additional safety
For all of the reasons set forth above, EPA denies the Petitioners' objections and their requests for a hearing on those objections.
As indicated previously, this action announces the Agency's final order regarding objections filed under section 408 of FFDCA. As such, this action is an adjudication and not a rule. The regulatory assessment requirements imposed on rulemaking do not, therefore, apply to this action.
The Congressional Review Act, (5 U.S.C. 801
EPA has established an official record for this rulemaking. The official record includes all information considered by EPA in developing this proposed rule including documents specifically referenced in this action and listed below, any public comments received during an applicable comment period, and any other information related to this action, including any information claimed as CBI. This official record includes all information physically located in docket ID number EPA–HQ–OPP–2005–0162, as well as any documents that are referenced in the documents listed below or in the docket. The public version of the official record does not include any information claimed as CBI.
• FMC's letter of 9–29–08 and accompanying label amendments.
• FMC's letter of 12–24–08 and accompanying label amendments.
• FMC's letter of 6–30–09 and accompanying label amendments.
• Expert Report: Carbofuran's FQPA Safety Factor and Interspecies Uncertainty Factor by K. Wallace (6 p.)
• 13 published articles on pesticide effect on cholinesterase activity.
• Central Nervous System as the Primary Target for Carbofuran's Effects on Lip Smacking by Neal, Williams, & Lamb (3 p.)
• 10 published articles on effects of cholinergic stimulation.
• Expert Report: Carbofuran FQPA Safety Factor by K. Wallace (8 p.)
• 9 published articles on HBC versus brain cholinesterase inhibition.
• Dose Response Modeling Issue in Carbofuran by Sielken: AChE and BMD Ratios
• Dose Response Modeling Issue in Carbofuran by Sielken: Statistical Comparison of AChE Inhibition in RBC and Brain in Rats Exposed to Carbofuran.
• Dose Response Modeling Issue in Carbofuran by Sielken: OPP's Estimates of the Half-Life of AChE Recovery.
• Reiner, 1971. Spontaneous Reactivation of Phosphorylated and Carbamylated Cholinesterases Bulletin WHO 44, 109–112.
• Carbofuran Dietary Risk Assessment. 2009. (Exponent Inc., for FMC)
• Williams, Cheplick, Engle, Fawcett and Hoogeweg. 2009. National Carbofuran Leaching Assessment. Vol 1. Waterborne Environmental Inc., Engel Consulting, and Fawcett Consulting for FMC.
• Williams, Cheplick, Engle, Fawcett and Hoogeweg. 2009. National Carbofuran Leaching Assessment. Vol 2. Setback Analysis. Waterborne Environmental Inc., Engel Consulting, and Fawcett Consulting for FMC.
• Memorandum. From: Hoogeweg and Williams, Waterborne, Inc., To: Fuge, Latham and Watkins, LLP. June 30, 2009. Subject: Groundwater pH in selected states.
• Williams, Fawcett and Engle. 2009. The Development and Evaluation of a Carbofuran Management Plan to Protect Drinking Water Derived from Surface Water Sources. Waterborne Environmental Inc., for FMC.
• Memorandum. From: Hoogeweg and Williams, Waterborne, Inc., To: Fuge, Latham and Watkins, LLP. June 30, 2009. Subject: Surface water pH in selected states.
• Memorandum. From: Williams, Waterborne, Inc., To: Fuge, Latham and Watkins, LLP. June 30, 2009. Subject: Water Treatment Assessment in Carbofuran Use States.
• Petition of the National Corn Grower's Association, the National Sunflower Association, the National Potato Council, and FMC Corporation to Defer the Effective Date of Certain Tolerance Revocations for Carbofuran.
1. Acute oral (gavage) dose range-finding study of cholinesterase depression from carbofuran technical in juvenile (day 11) rats. Hoberman, 2007. MRID 47143703 (unpublished FMC study) EPA–HQ–OPP–2007–1088–0062.
2. Acute oral (gavage) time course study and final report of cholinesterase depression from carbofuran technical in adult and juvenile (day 11 postpartum) rats. Hoberman, 2007. MRID 47143704, 05 (unpublished FMC studies) EPA–HQ–OPP–2007–1088–0063 and –0066.
3. Acute time-course study of carbofuran technical administered by gavage to adult and postnatal day 11 male and female CD (Sprague-Dawley) rats: Tyl, Marr, and Myers. 2005. (Unpublished study received Nov. 14, 2005; prepared by RTI International, RTP, NC; submitted by FMC Corp., Philadelphia, Pa.; FMC Study No: A2005–5982. MRID 46688913. EPA–HQ–OPP–2005–0162–0058.
4. Acute dose-response study of carbofuran technical administered by gavage to adult and postnatal day 11 male and female CD (Sprague-Dawley) rats: Tyl and Myers. 2005. MRID 46688914. EPA–HQ–OPP–2005–0162–0078.
5. Anderson, S. A. (2002). The Toxicokinetics of Peripheral Cholinesterase Inhibition from Orally Administered Carbofuran in Adult Male and Female CD Rats. (Unpublished study received May 15, 2002; prepared by Toxicokinetics Laboratory, RTP, NC; submitted by FMC Corp., Philadelphia, Pa.; FMC Study No: A2001–5379. MRID 456757–01.
6. An Investigation into the Potential for Carbofuran Leaching to Ground Water Based on Historical and Current Use Practices. Submitted by FMC Corporation, Philadelphia, PA.: Report No. PC–0363. MRID 47221602. EPA–HQ–OPP–2007–1088–0022.
7. Arnold, J.D. (1976
8. Arnold, J.D. (1977)
9. Arnold, J.D. (1978)
10. Benjamins, J.A. and McKhann, G.M. (1981) Development, regeneration, and aging of the brain. In: Basic Neurochemistry, 3rd edition. Edited by Siegel, G.J., Albers, R.W., Agranoff, B.W., and Katzman, R. Little, Brown and Co., Boston. pp 445–469.
11. Bretaud S, Toutant JP, Saglio P. 2000. Effects of carbofuran, diuron, and nicosulfuron on acetylcholinesterase activity in goldfish (Carassius auratus). Ecotoxicol Environ Saf. 2000 Oct.; 47(2):117–24.
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Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.
Department of Education.
Final priorities, requirements, definitions, and selection criteria.
The Secretary of Education (Secretary) announces priorities, requirements, definitions, and selection criteria for the Race to the Top Fund. The Secretary may use these priorities, requirements, definitions, and selection criteria in any year in which this program is in effect.
James Butler, U.S. Department of Education, 400 Maryland Ave., SW., room 3E108, Washington, DC 20202–6400. Telephone: 202–205–3775 or by e-mail:
(a) Adopting internationally benchmarked standards and assessments that prepare students for success in college and the workplace;
(b) Building data systems that measure student success and inform teachers and principals about how they can improve their practices;
(c) Increasing teacher and principal effectiveness and achieving equity in their distribution; and
(d) Turning around our lowest-achieving schools. Additional information on the Race to the Top program can be found at:
We published a notice of proposed priorities, requirements, definitions, and selection criteria (NPP) for this program in the
There are a number of differences between the NPP and this notice of final priorities, requirements, definitions, and selection criteria as discussed in the
In response to our invitation in the NPP, 1,161 parties submitted comments on the proposed priorities, requirements, definitions, and selection criteria.
Generally, we do not address technical and other minor changes, nor do we address suggested changes that the law does not authorize us to make under the applicable statutory authority. In addition, we do not address general comments that raised concerns not directly related to the NPP.
The Race to the Top program, a $4.35 billion fund created under the American Recovery and Reinvestment Act of 2009 (ARRA), is the largest competitive education grant program in U.S. history. The Race to the Top Fund (referred to in the ARRA as the State Incentive Grant Fund) is designed to provide incentives to States to implement large-scale, system-changing reforms that result in improved student achievement, narrowed achievement gaps, and increased graduation and college enrollment rates.
The ARRA specifies that applications for Race to the Top funds must address the four assurance areas referenced in section 14006(a)(2): Enhancing standards and assessments, improving the collection and use of data, increasing teacher effectiveness and achieving equity in teacher distribution, and turning around struggling schools. The Department published the NPP to solicit public comment on the priorities, requirements, and selection criteria that State applications will address in accordance with this statutory requirement.
The NPP prompted an outpouring of public comments. Some 1,161 commenters submitted thousands of unique comments, ranging from one paragraph to 67 pages. Parents submitted comments, as did professional associations. From the statehouse to the schoolhouse, scores of public officials and educators, governors, chief State school officers, teachers, and principals weighed in with suggestions and critiques. All told, individuals from all 50 States and the District of Columbia, including over 550 individuals and 200 organizations, commented on the NPP.
The extensive and thoughtful public commentary on the NPP has been invaluable in helping the Department revise, improve, and clarify the priorities, requirements, definitions, and selection criteria for the Race to the Top program. A discussion of the most significant changes follows.
Many of the commenters expressed concern that the NPP's encouragement of comprehensive and coherent statewide reform was undercut by the need for State applicants to organize their plans around each of the four reform assurances, one at a time. In response to this concern, the Department has reorganized a number of the criteria, moving key criteria from the Overall section to a new section at the beginning of the selection criteria called State Success Factors. This new section provides States with the opportunity to start their proposals with clear statements of their coherent, coordinated, statewide reform agendas.
As several commenters noted, States face at least three overarching issues critical to their success in implementing their Race to the Top plans—the need for a coherent reform agenda, the capacity to lead LEAs, and the ability to improve outcomes. In this notice, these three issues are reflected in the State Success Factors as follows: Criterion (A)(1) pertains to a State's ability to articulate a comprehensive and coherent education reform agenda, and to engage its local educational agencies (LEAs) in strongly committing to and participating in that agenda; criterion (A)(2) relates to a State's capacity to implement its proposed plans through strong leadership, successfully supporting its LEAs in improving student outcomes, administering a grant of this magnitude efficiently, and organizing its financial resources to optimize impact; and finally, criterion (A)(3) asks States to demonstrate their ability to significantly improve education outcomes for students across the State.
More specifically, criterion (A)(1)(i) is a new criterion that asks States to set forth a comprehensive and coherent reform agenda that clearly articulates their goals for implementing reform in
Under criterion (A)(1)(ii) (proposed criterion (E)(3)(iv)), States will demonstrate the participation and commitment of their LEAs. First, as described in criterion (A)(1)(ii)(a), the strength of LEAs' commitments to their State's plans will be evaluated based on the terms and conditions in a State's binding agreements with its LEAs. (To support States' efforts, the Department has drafted a model Memorandum of Understanding (MOU) and included it in Appendix D of this notice.) Criterion (A)(1)(ii)(b) has been added to make it clear that the commitment of participating LEAs will also be judged, in part, based on LEAs' agreements to implement all or significant portions of the work outlined in the State's plan. Criterion (A)(1)(ii)(c) clarifies that the extent of an LEA's leadership support for participating in the State's Race to the Top plans will be assessed by how many signatures are on the binding agreement between the State and the LEA, from among (if applicable) the superintendent, the president of the local school board, and the local teachers' union leader, or their equivalents (provided that there is at least one authorized LEA signatory on the agreement). For all of these criteria, States will be asked to provide as evidence examples of their participating LEA agreements as well as tables that summarize which portions of the State plans LEAs are committing to implement and how extensive the LEAs' leadership support is.
Criterion (A)(1)(iii) (adapted from proposed criteria (E)(3)(iv) and (E)(4)) asks States to describe how the engagement of those LEAs that are participating in the State's Race to the Top plans will translate into broad statewide impact on student outcomes, including increasing achievement and decreasing achievement gaps for (at a minimum) reading/language arts and mathematics on the National Assessment of Educational Progress (NAEP) and on the assessments required under the Elementary and Secondary Education Act of 1965, as amended (ESEA); and increasing high school graduation rates, college enrollment rates, and college credit accumulation.
Criterion (A)(2) asks States to describe their capacity to implement, scale up, and sustain their proposed plans. Criterion (A)(2)(i) (adapted from proposed criterion (E)(5)) concerns States' capacity to implement their plans. Criterion (A)(2)(i)(a) asks States to demonstrate that they have strong leadership and dedicated teams to implement their statewide education reform plans; and criterion (A)(2)(i)(b) (proposed (E)(5)(ii)) encourages States to describe the activities they will undertake in supporting participating LEAs in successfully implementing their plans. Criterion (A)(2)(i)(c) (proposed criterion (E)(5)(i)) asks States about the effectiveness and efficiency of their operations and processes for implementing a Race to the Top grant. Criterion (A)(2)(i)(d) (proposed (E)(5)(v)) further clarifies that States will be evaluated based on how they plan to use the funds for this grant, as described in their budgets and accompanying budget narratives, to accomplish their plans and meet their performance targets. Proposed criterion (E)(5)(iv), regarding collaboration between States, is not included in this final notice.
In criterion (A)(2)(ii) (proposed (E)(3)(i) and (E)(3)(ii)), States demonstrate that they have a plan to use the support from a broad group of stakeholders to better implement their reform plans. Criterion (A)(2)(ii)(a) concerns enlisting the support of teachers and principals as key stakeholders. Criterion (A)(2)(ii)(b) asks States to describe the strength of statements and actions of support from other critical stakeholders, and examples of these are listed. Proposed criterion (E)(3)(iii), regarding the support of grant-making foundations and other funding sources, is not included in this final notice.
Criterion (A)(3) addresses the extent to which the State has demonstrated significant progress in raising achievement and closing gaps. Criterion (A)(3)(i) (proposed criteria (E)(1)(i) and (E)(1)(ii)) provides for the evaluation of States based on whether they have made progress in each of the four education reform areas over the past several years and used ARRA and other Federal and State funding to pursue such reforms.
Criterion (A)(3)(ii) (proposed criterion (E)(1)(iv)) addresses States' track records of increasing student achievement, decreasing achievement gaps, and increasing graduation rates. When evaluating these student academic outcomes, reviewers will examine student assessment results in reading/language arts and mathematics, both on the NAEP and on the assessments required under the ESEA; progress will be considered for each subgroup as well as for the “all students” group.
In response to comments indicating that some States would have difficulty meeting a June 2010 deadline for adopting a new set of common, kindergarten-to-grade-12 (K–12) standards, this notice extends the deadline for adopting standards as far as possible, while still allowing the Department to comply with the statutory requirement to obligate all Race to the Top funds by September 30, 2010. As set forth in criterion (B)(1)(ii), the new deadline for adopting a set of common K–12 standards is August 2, 2010. States that cannot adopt a common set of K–12 standards by this date will be evaluated based on the extent to which they demonstrate commitment and progress toward adoption of such standards by a later date in 2010 (
For criteria (B)(1) and (B)(2) (proposed criteria (A)(1) and (A)(2), respectively), regarding the development and adoption of common, high-quality standards and assessments, the term “significant number of States” has been further explained in the scoring rubric that will be used by reviewers to judge the Race to the Top applications (
Further, for criterion (B)(2), concerning the development and implementation of common, high-quality assessments, States will be asked to present, as evidence, copies of their Memoranda of Agreement showing that the State is part of a consortium that intends to develop high-quality assessments aligned with the consortium's common set of standards. This is similar to the evidence required for criterion (B)(1) concerning the development and adoption of common standards.
Finally, this notice clarifies the language in criterion (B)(3) (proposed criterion (A)(3)) regarding the transition to enhanced standards and high-quality assessments; the criterion now lists a number of activities in which States or LEAs might engage as they work to translate the standards and assessments into classroom practice.
The data systems selection criteria in the Race to the Top competition involve two types of data systems—statewide longitudinal data systems and instructional improvement systems. While numerous comments addressed the Department's emphasis on statewide longitudinal data systems in the NPP, the Department intends to give equal priority in this program to using instructional data as a critical tool for teachers, principals, and administrators to identify student needs, fill curriculum gaps, and target professional development. The final selection criteria, therefore, place significant emphasis on using data to inform professional development and fostering a culture of continuous improvement in schools and LEAs.
More specifically, the final notice contains new language in criterion (C)(3)(i) (proposed (B)(3)(i)) that clarifies that this criterion concerns local instructional improvement systems, not statewide longitudinal data systems, and further clarifies the LEA's role in the acquisition, adoption, and use of local instructional improvement systems.
New criterion (C)(3)(ii) was added to encourage LEAs and States to provide effective professional development on using data from these systems to support continuous instructional improvement.
The teachers and leaders criteria are built on two core principles that remain consistent with the NPP—that teacher and principal quality matters, and that effective teachers and principals are those whose students grow academically. Thus, this notice continues to include criteria directed at improving teacher and principal effectiveness and at ensuring that highly effective teachers and principals are serving in the high-poverty, high-minority schools where their talents are needed the most. In addition, this notice continues to define effective teachers and principals as those whose students make significant academic growth. While the final notice reaffirms these core principles, it also includes a number of changes to the criteria and related definitions based on public input.
The Department received over 400 comments in this reform area, many of which provided helpful suggestions that informed our revisions. One commenter suggested that the greatest contribution that the Race to the Top program could make would be to encourage the development of outstanding models for teacher and principal evaluation systems, now widely described as flawed and superficial. Based on this and similar comments, the Department has revised criterion (D)(2), now titled Improving Teacher and Principal Effectiveness Based on Performance, to encourage the design of high-quality evaluation systems, and to promote their use for feedback, professional improvement, and decision-making.
The Department concurs with the many commenters who cautioned that teacher and principal “effectiveness” should not be based solely on student test scores. In this notice, “effectiveness” is defined as based on input from multiple measures, provided that student growth is a significant factor. In addition, this notice re-emphasizes that it is student growth—not raw student achievement data or proficiency levels—that is the “significant factor” to be considered in evaluating effectiveness.
Finally, this notice expands and improves the four selection criteria that deal with teacher and principal professional development (criteria (B)(3), (C)(3)(ii), (D)(2)(iv)(a), and (D)(5)). It clarifies that professional collaboration and planning time, individualized professional development plans, training and support in the analysis and use of data, classroom observations with immediate feedback, and other activities are critical to supporting the development of teachers and principals.
Specifically, criterion (D)(1) (proposed (C)(1)), concerning high-quality pathways for aspiring teachers and leaders, has been expanded. It now includes a new criterion (D)(1)(iii), under which States will be evaluated based on the extent to which they have in place a process for monitoring, evaluating, and identifying areas of teacher and principal shortage and for preparing teachers and principals to fill these areas of shortage.
Criterion (D)(2) (proposed (C)(2)) has been revised to focus on the design and use of rigorous, transparent, and fair evaluation systems that provide regular feedback on performance to teachers and principals. This criterion also has been changed to clarify that the LEAs, not the States, should implement the teacher and principal effectiveness reforms under this criterion, and that the role of the States is to support their participating LEAs in implementing these reforms.
Criterion (D)(2)(ii) (proposed (C)(2)(b)) now emphasizes that these evaluation systems should differentiate effectiveness using multiple rating categories, and should be designed and developed with teacher and principal involvement. Criterion (D)(2)(iii) (proposed criteria (C)(2)(c) and (C)(2)(d)(i)) encourages such evaluations to be conducted annually and to include timely and constructive feedback, while criterion (D)(2)(iv) (proposed criterion (C)(2)(d)) addresses uses of evaluations to inform decision-making.
Criteria (D)(2)(iv)(c) and (D)(2)(iv)(d) (proposed criterion (C)(2)(d)(iii)) separately address the use of these evaluation systems to inform decisions regarding whether to grant tenure and/or full certification to effective teachers and principals (in criterion (D)(2)(iv)(c)), and removing ineffective teachers and principals (in criterion (D)(2)(iv)(d)). In addition, the Department has clarified that these decisions should be made using rigorous standards and streamlined, transparent, and fair procedures.
Criterion (D)(3) (proposed (C)(3)) has been revised to clarify that the State's plan for the equitable distribution of effective teachers and principals should be informed by the State's prior actions and data, and should ensure that students in high-poverty as well as high-minority schools have equitable access to highly effective teachers and principals—and are not served by ineffective ones at higher rates than are other students. The performance measures for this criterion now include, for comparison purposes, data on the presence of highly effective and ineffective teachers and principals in low-poverty and low-minority schools.
Criterion (D)(4) concerns improving the effectiveness of teacher and principal preparation programs. Criterion (D)(4)(i) (proposed (C)(4)) was revised to specify that, when reporting the effectiveness of teacher and principal credentialing programs, States should report student growth as well as student achievement data; they should report the data for all in-State credentialing programs, regardless of the number of graduates; and they should publicly report data, not “findings.”
Criterion (D)(4)(ii) has been added to encourage States to expand those preparation and credentialing options and programs that are successful at producing effective teachers and principals (both as defined in this notice).
Criterion (D)(5) (proposed criterion (C)(5)) focuses on providing effective support to teachers and principals. Here, the Department has inserted a new paragraph, (D)(5)(i), to provide additional guidance on, and examples of, effective support. The Department has also removed the reference to using
The Department made three noteworthy changes to the selection criteria on turning around the persistently lowest-achieving schools. First, this notice removes the restriction, proposed in the NPP, that permitted the “transformation” model to be used solely as a last resort. Instead, we simply specify that an LEA with more than nine persistently lowest-achieving schools may not use the transformation model for more than 50 percent of its schools.
Second, the Department has fully aligned the school intervention requirements and definitions across Race to the Top, the State Fiscal Stabilization Fund, and the forthcoming Title I School Improvement Grants final notice. The Department's intention, in so doing, is to make it easier for States to develop consistent and coherent plans across these three programs.
Third, the public comments suggested that there was confusion about the role of charter schools in the Department's reform agenda. Some commenters concluded that by placing the charter school criterion in the school turnaround section, the Department was advancing charter schools as the chief remedy for addressing the needs of the persistently lowest-achieving schools. While the Department believes that charter schools can be strong partners in school turnaround work, it does not believe that charter schools are the only or preferred solution to turning around struggling schools. In fact, it is the Department's belief that turning around the persistently lowest-achieving schools is a core competency that every district needs to develop, and that closing bad schools and opening good ones is the job of school district leaders. Notwithstanding research showing that charter schools on average perform similarly to traditional public schools, a growing body of evidence suggests that high-quality charter schools can be powerful forces for increasing student achievement, closing achievement gaps, and spurring educational innovation. As a consequence, the selection criterion pertaining to charter schools (criterion (F)(2), proposed (D)(2)) has been shifted from the Turning Around the Lowest-Achieving Schools section to the General section, where it more appropriately reflects charter schools' broader role as a tool for school innovation and reform.
Specifically, the following changes have been made to criterion (E)(2) (proposed criterion (D)(3)), regarding turning around the lowest-achieving schools. Criterion (E)(2)(i) (proposed (D)(3)(i)) has been changed to allow States, at their discretion, to use Race to the Top funds to turn around non-Title I eligible secondary schools that would be considered “persistently lowest-achieving schools” if they were eligible to receive Title I funds.
Criterion (E)(2)(ii) (proposed criterion (D)(3)(ii)) has been changed by removing the clause that restricted the use of the “transformation” model to situations where the other intervention models were not possible and by specifying that an LEA with more than nine persistently lowest-achieving schools may not use the transformation model for more than 50 percent of its schools. In addition, the four intervention models LEAs may use under this criterion are now described in detail in Appendix C, and these models have been made identical across the Race to the Top, State Fiscal Stabilization Fund, and Title I School Improvement Grants notices.
Finally, the evidence collected for criterion (E)(2) will include the State's historic performance on school turnaround efforts, as evidenced by the total number of persistently lowest-achieving schools that States or LEAs attempted to turn around in the last five years, the approach used, and the results and lessons learned to date.
The General section includes a number of other key reform conditions or plans.
First, criterion (F)(1) concerns education funding across the State. Criterion (F)(1)(i) (proposed (E)(2)) addresses the State's efforts to maintain education funding between FY 2008 and FY 2009. New criterion (F)(1)(ii) has been added to reward States whose policies lead to equitable funding between high-need LEAs and other LEAs, and within LEAs, between high-poverty schools and other schools.
As noted above, criterion (F)(2) regarding charter schools has been moved to the General section from the Turning Around the Lowest-Achieving Schools section, where it was proposed criterion (D)(2). In this notice, the Department maintains its focus on high-quality charter schools as important tools for school reform.
As was the case with the NPP, the final charter school criteria presented under (F)(2) encourage both unrestrictive charter school growth laws and strong charter school accountability. In support of charter school growth, the criteria also provide for the evaluation of States based on the extent to which they provide equitable funding for charter schools and offer them access to facilities. Criterion (F)(2)(ii) has also been revised to urge authorizers to encourage charter schools that serve student populations that are similar to local district student populations, especially relative to high-need students.
In their comments, a number of States argued that they had laws—other than charter school laws—that spurred school innovation. In response to these comments, the Department has added a new criterion, (F)(2)(v), that invites States to describe the extent to which they enable LEAs to operate innovative, autonomous public schools other than charter schools.
It is the Department's hope that the Race to the Top competition gives States ample opportunity to explain and implement proven and promising ideas for bolstering student learning and educational attainment, and to do this in ways that work best in their local contexts. To ensure that the application reflects a broad range of effective State and local solutions, criterion (F)(3) (proposed criterion (E)(1)(iii)) asks States to describe laws, regulations, or policies (other than those asked about in other selection criteria) that have created conditions in the State that are conducive to education reform and improved student outcomes.
Many commenters offered suggestions about the proposed priorities, in particular the invitational and competitive preference priorities. A number of commenters urged the Department to increase the importance of each invitational priority by making it a competitive or absolute priority, while others wanted to add new priorities. Because of the Department's desire to give States latitude and flexibility in developing focused plans to best meet their students' needs, we are not changing any of the priorities from invitational to competitive or absolute. We did, however, add a new invitational priority and make some changes to the proposed priorities.
Regarding the proposed absolute priority, which stated that States' applications must comprehensively and coherently address all of the four education reform areas specified in the ARRA, the Department has added the requirement that States must comprehensively and coherently address the new State Success Factors criteria as well.
The final notice adds a new invitational priority 3, Innovations for Improving Early Learning Outcomes, expressing the Secretary's interest in applications that will improve early learning outcomes for high-need students who are young children.
In invitational priority 4 (proposed priority 3), Expansion and Adaptation of Statewide Longitudinal Data Systems, programs such as at-risk and dropout prevention programs, school climate and culture programs, and early learning programs have been added to the list of programs that a State may choose to integrate with its statewide longitudinal data system.
In invitational priority 5 (proposed priority 4), P–20 Coordination, Vertical and Horizontal Alignment, horizontal coordination of services was added as a critical component for supporting high-need students.
In invitational priority 6 (proposed priority 5), School-level Conditions for Reform, Innovation, and Learning, new paragraph (vi) adds school climate and culture, and new paragraph (vii) adds family and community engagement to the list of school conditions conducive to reform and innovation.
The first eligibility requirement, requirement (a), has been changed to provide that a State must have both phases of its State Fiscal Stabilization Fund application approved by the Department prior to being awarded a Race to the Top grant. In the NPP, we proposed that a State would have to receive approval of its Stabilization Fund applications prior to December 31, 2009 (for Race to the Top Phase 1 applicants) or prior to submitting a Race to the Top application (for Race to the Top Phase 2 applicants).
The second eligibility requirement, requirement (b), was revised to clarify that the State must not have any legal, statutory, or regulatory barriers at the State level to linking data on student achievement (as defined in this notice) or student growth (as defined in this notice) to teachers and principals for the purpose of teacher and principal evaluation.
In addition, several changes were made to the application requirements. The Department removed two proposed application requirements, application requirements (c) and (d), which would have required States to provide information about making education funding a priority and about stakeholder support. Note that the final notice retains the selection criteria that request this same information.
Application requirement (c)(2) provides additional clarity about how to calculate the relative shares of the Race to the Top grant that participating LEAs will be eligible to receive.
The Department has added a new application requirement, requirement (g), to clarify specific issues related to the term “subgroup,” to NAEP, and to the assessments required under the ESEA. In addition to requiring States to include, at a minimum, the listed student subgroups when reporting past outcomes and setting future targets, this application requirement includes statutory references. This addition eliminates the need for statutory references that define subgroups elsewhere in the notice, and they therefore have been removed.
The program requirements have also changed. First, the Department has indicated its final approach to evaluation. The Institute of Education Sciences will conduct a series of national evaluations of Race to the Top State grantees as part of its evaluation of programs funded under the ARRA. States that are awarded Race to the Top grants will be required to participate in these evaluations and are welcome, but not required, to conduct their own independent, statewide evaluations as well.
Finally, the program requirements have clarified that funds awarded under this competition may not be used to pay for costs related to statewide summative assessments.
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In the following section, the Department has summarized and provided its responses to the comments received.
There is a similar re-designation of the priorities. Specifically, we added a new invitational priority on innovations for improving early learning outcomes and designated it as priority 3. Subsequent priorities were re-numbered, and thus, proposed priorities 3, 4, and 5 are now priorities 4, 5, and 6, respectively. As with the selection criteria, generally, we will refer only to the final designation for these priorities and will use headers, as appropriate, to remind the reader of the changes. Thus, for example, we will refer to the priority
Other commenters expressed their overall opposition to the Race to the Top program because of what they described as its “one-size-fits-all” approach to education reform involving “a top-down, narrow definition of innovation that has little research to support it.” Another commenter stated that the Department is prescribing a national formula for education reform, which threatens to undermine the program. In particular, several
To create “room” for States to meet this goal, this final notice, consistent with the NPP, includes only one absolute priority and two eligibility requirements—none of which interferes with a State's flexibility to put forward its best ideas and practices for reform. The absolute priority focuses on comprehensiveness and coherence across the reform areas, and the eligibility requirements include (1) approved applications for funding under Phase 1 and Phase 2 of the Stabilization program, and (2) no legal, statutory, or regulatory barriers at the State level to linking data on student achievement or student growth to teachers and principals for the purpose of teacher and principal evaluation. As we noted in the NPP, section 14005(d) of the ARRA requires a State that receives funds under the Stabilization program to provide assurances in the same four education reform areas that are advanced by the Race to the Top program. We, therefore, believe it would be inconsistent to award a Race to the Top grant, which requires a determination that a State has made significant progress in the four education reform areas, to a State that has not met requirements for receiving funds under the Stabilization program. With regard to the second eligibility requirement, we believe that the capability to link student achievement to teachers and principals for the purposes of evaluation is fundamental to the Race to the Top reforms and to the requirement in section 14005(d)(2) of the ARRA that States take actions to improve teacher effectiveness. Furthermore, without the legal authority to use student achievement or student growth data for teacher and principal evaluations, States would not be able to execute reform plans related to several selection criteria in this notice.
In addition, the proposed selection criteria were not designated as eligibility requirements; instead, they were proposed as recommended elements of a comprehensive State plan that would provide an individual State with the flexibility to emphasize its own priorities and craft a winning application. This flexible approach has been retained in this final notice. For instance, States need not address every selection criterion, so long as they comprehensively and coherently address all of the four education reform areas as well as the State Success Factors Criteria.
Through this program, the Department will reward success in at least two ways: First, by giving States credit for having already put into place key conditions for reform, improving student achievement, and closing achievement gaps; and second, by encouraging States to build on their assets and successes. We believe that State plans that build on a foundation of successful existing practices will be more likely to succeed in improving student outcomes.
It is important to note that the Race to the Top program is a voluntary competitive grant program. Consistent with section 14006(b) of the ARRA, we may use “such other criteria as the Secretary determines appropriate” in making Race to the Top awards; our intention is not to fund every State but to identify and reward the subset of States that demonstrate the greatest promise of making meaningful gains in developing standards and assessments, using data to drive improved student outcomes, improving teacher and principal effectiveness and achieving equity in the distribution of effective teachers and principals, and turning around struggling schools. Moreover, because the effects of the Race to the Top program might not be captured by existing State accountability systems, such as those created under the ESEA, this final notice retains the separate performance measures included in the NPP.
In response to commenters' concerns pertaining to “unproven” interventions in the Race to the Top program, there is ample evidence, for example, that high-performing charter schools can significantly improve the achievement of high-need students. Likewise, the research supports that effective teachers and principals are essential to improving student achievement; accordingly, the Department believes that identifying, recruiting, developing, and retaining effective teachers and school leaders is critical to creating high-performing schools and a world-class education system. Finally, we are providing States with flexibility to incorporate these reforms into their plans through their own innovative and thoughtful approaches that are designed to address their specific needs. In addition, we are including in this final notice two additional criteria intended to make this flexibility for innovation more explicit.
Other commenters recommended that the notice encourage States to include faith-based schools in their applications. These commenters pointed to positive effects on at-risk youth attributed to Catholic and other faith-based schools. A few commenters specifically requested that faith-based schools be eligible to apply for Race to the Top funds directly. One commenter noted that because private school students participate in Title I, Part A programs under the ESEA, they should be allowed
Another commenter asserted that Congress should conduct a broad review of the NPP and of our determination that the NPP would “not unduly interfere with State, local, and Tribal governments in the exercise of governmental functions.” Two commenters also stated that it appeared that we were using Race to the Top, in the context of the fiscal emergency currently faced by many States, to impose education reform policies that would not otherwise be accepted by States and LEAs.
Moreover, the ARRA specifically provides that Race to the Top funds must be awarded not later than September 30, 2010. In order to provide States the maximum amount of time possible to plan, organize, and draft their applications for the Phase 1 and Phase 2 competitions, while still allowing and responding fully to public comment, the Department sought comment on the NPP for a 30-day time period. Notably, section 437(d)(1) of the General Education Provisions Act, 20 U.S.C. 1232(d)(1), allows the Department to waive rulemaking for the first grant competition under a new or substantially revised program authority. The Race to the Top program is a new program, so the Department was not required to conduct notice-and-comment rulemaking. The Department, however, instead of taking advantage of that option, specifically sought public comment in order to inform the development of the program. Moreover, the comments received from over 1,100 commenters during the NPP's 30-day comment period suggest that this period of time was sufficient for broad public review and comment.
In response to claims that the Race to the Top requirements would interfere with State, local, or Tribal governments or impose policies on these governments, we note that the Race to the Top program is a voluntary competitive grant program that, like other such programs, includes requirements and criteria that must be met in order for States to participate and receive funding. States and LEAs that do not wish to comply with these conditions and criteria are not required to apply for a grant. While the fiscal crises currently faced by many States may encourage States to apply for Race to the Top funds, ameliorating State and local deficits is not the primary purpose of this program. Instead, the Race to the Top program, which will award only about 4 percent of all education funds provided by the ARRA, was specifically intended to encourage and reward those States that are making “significant progress” toward the four assurances. This final notice, like the NPP, represents our effort to establish reasonable and appropriate criteria for defining the “significant progress” as required by the statute.
Another commenter urged us to make Race to the Top awards as soon as possible, but not later than early 2010, so that States and school districts can begin implementing reforms in the 2010–2011 school year. Two commenters suggested that we will not be able to create the momentum to accomplish national education reform unless a sufficient number of States receive Race to the Top funds. One commenter suggested that the Race to the Top program would have a broader national impact if 26–30 States participated in the program, and recommended structuring the award phases so that the first round provides large “lead” grant awards followed by a second round of smaller “but still substantial” awards.
We are aware of the need for successful applicants to begin implementing their Race to the Top plans as soon as possible. Toward this
States already issue annual reports on AYP status for schools and LEAs, including proficiency rates for all schools; there is no need to duplicate this reporting by requiring its inclusion in a State's annual Race to the Top report. However, States that desire to include AYP data in their annual Race to the Top reports are free to do so. The Department declines to add a requirement for peer review of these annual reports.
Finally, we are retaining the “ambitious yet achievable” language throughout the Race to the Top State Reform Plan Criteria. As noted elsewhere in this notice, the Department believes that this language strikes the right balance between encouraging States to set a high bar for Race to the Top goals while recognizing that real change in education is difficult and takes time. The goal is to encourage realistic thinking and planning that connects specific activities to specific, achievable results, while acknowledging that improvements in the Nation's education system are urgently needed and the country's children cannot wait.
Finally, the Department has taken extraordinary measures to ensure accountability in the use of all ARRA funds, including the Race to the Top fund, so that all dollars are used wisely and accounted for in a transparent manner. Indeed, as explained in the Reporting section of this final notice and in the notice inviting applications, successful applicants must comply with the ARRA annual reporting requirements in section 14008 of the ARRA and with quarterly reporting requirements in section 1512(c) of the ARRA, which are designed to ensure thorough and public oversight of the expenditure of ARRA funds. In addition, the Department has established a Recovery Act Web site and hotline for members of the public to report suspected misuse of funds.
In addition, States have considerable flexibility in awarding or allocating the remaining 50 percent of their Race to the Top awards, which are available for State-level activities, disbursements to LEAs, and other purposes as the State may propose in its plan. Many of the activities recommended by commenters would be allowable uses of the State's share of Race to the Top funds, including: Serving high-need students in non-Title I schools, State-level activities in support of Race to the Top plans, competitive or formula-based subgrants to LEAs, contracts with non-profit organizations, or supporting the participation of private school students and teachers in Race to the Top.
However, we agree that in this final notice, the Department should place greater emphasis on equitable funding of high-need LEAs and students. For this reason, we are adding criterion (F)(1)(ii), which examines the extent to which a State's policies lead to equitable funding (a) between high-need LEAs (as defined in this notice) and other LEAs, and (b) within LEAs, between high-poverty schools (as defined in this notice) and other schools.
One commenter requested that the final notice include an explanation of the differences and significance of the competitive preference priority for STEM and the invitational priorities for data systems, P–20 coordination, and school-level conditions for reform and innovation. Another commenter asked whether different weights will be assigned to the absolute priority versus the competitive preference and invitational priorities.
Two commenters expressed concern with the statement in the NPP that the Secretary reserves the right to propose additional priorities, requirements, definitions, or selection criteria. These commenters requested that any additional priorities, requirements, definitions, or selection criteria be published in the
The designation of priorities as invitational in the NPP and in this final notice demonstrates the Department's interest in particular topics or issues and applicants' interest in and capacity to address those areas. Applicants are not required to address these invitational priorities in their applications. Because the Department is interested in State focus and capacity in the areas identified as invitational priorities, we decline to remove them in this final notice.
In this final notice, we are designating priority 1, Comprehensive Approach to Education Reform, as an absolute priority that all applicants must meet. Priority 2, Emphasis on Science, Technology, Engineering, and Mathematics (STEM), has been designated as a competitive preference priority for which a State can receive additional points (
Another commenter recommended that States be required to address the following issues to strengthen the quality of early care and education programs: (1) Appropriate compensation to attract and retain talented administrators and teachers in early care and education programs; (2) the need for a technological infrastructure to establish a data-driven decision-making system, as well as to document the benefits of early care and education services; (3) creation of a State-level advisory body to develop a State early learning plan, monitor the implementation of the plan and recommend adjustments to strengthen strategies as the plan is implemented; and (4) creation of a panel, that includes providers, to determine the true cost of supporting a quality early care and education system.
A few commenters recommended adding an invitational priority to the final notice focusing on the coordination of preschool services (including Head Start services and services provided under the Individuals with Disabilities Education Act (IDEA)) in order to ensure that more young children begin school ready to learn.
We do not believe that States should be required to include an early learning focus in their applications or that States should be given competitive preference points for doing so. Nor do we believe that quality early learning strategies should be required to be part of a State's plan for turning around struggling schools, given that efforts to turn around struggling schools focus primarily on improving educational outcomes for students currently enrolled in the Nation's persistently lowest-achieving schools. We believe that an invitational priority will encourage applicants to consider how their reform efforts can be strengthened by focusing on activities that promote school readiness and ensure that all children have access to high-quality early learning programs.
With regard to the request that States be required to address the issues that one commenter stated were necessary for strengthening the quality of early care and education programs, a State that chooses to include a focus on early learning in its application could include activities addressing the educational needs of young children in its State reform plan. We note, however, that funds could not be used to address issues related to early child care needs, absent an educational component, because the purpose of Race to the Top is for States and LEAs to address educational reforms. Given the variation in State needs and priorities, we do not believe that it would be appropriate to require all applicants to follow the commenter's recommendations.
In response to the recommendation to add an invitational priority focusing on the coordination of preschool services, this focus is already included in priority 5, P–20 Coordination, Vertical and Horizontal Alignment, which encourages State reform plans to address how early childhood programs, K–12 schools, postsecondary institutions, and other State agencies and community partners will coordinate to create a more seamless P–20 route for students.
Other commenters strongly recommended that the final notice include language that would require schools to address the needs of the whole child, including by providing character education; instruction in social, emotional, and physical wellness; civic education and engagement; arts education; community-based learning; and opportunities for parent involvement. One commenter stated that it is essential for schools to work in collaboration with health, social, civic, faith-based, business and community organizations in order to successfully educate the whole child. One commenter expressed concern that the proposed priorities emphasize math, reading, and science at the expense of the other core academic subjects and argued that there should be an equal emphasis on the social, emotional, and creative development of students. Another commenter stated that efforts to shift education to address the needs of the whole child should be part of, and fully integrated into, a well-rounded core curriculum of academic instruction. Finally, one commenter stated that the proposed priorities incorrectly omit any reference to reducing the use of punitive measures in schools, and recommended that the final notice emphasize the Secretary's policy on reducing the use of restraints, seclusion, and corporal punishment.
In addition, we note that the final notice addresses issues of school climate and culture in several ways. First, invitational priority 4, Expansion and Adaptation of Statewide Longitudinal Data Systems, invites States to include school climate and culture measures in extending and adapting their statewide longitudinal data systems. Consistent with commenters' examples of school policies and programs to improve school climate, we also have included references to “service learning” and “experiential and work-based learning opportunities” in the definition of
We acknowledge that positive behavioral interventions and supports, as well as other systemic programs and policies that address bullying, student harassment, and disciplinary problems, are important to consider in ensuring that students have a safe and supportive environment in which to learn. However, we do not believe it is necessary to include this level of detail in this final notice and, therefore, decline to make the changes requested by the commenters.
Finally, in response to the comment that the notice does not reference reducing the use of punitive measures, on July 31, 2009, the Secretary encouraged each State to review its current policies and guidelines regarding the use of restraints and seclusion in schools to ensure that every student is safe and protected and, if appropriate, develop or revise its policies and guidelines. We believe that this is the proper approach to addressing this issue, rather than in a notice for a competitive grant program for which all States will not necessarily apply or receive funding. It would be appropriate for States that choose to address priority 6 to include, in their reform plans, a focus on ensuring that policies and guidelines address the use of restraints and seclusions in schools to ensure that every student is safe and protected.
Another commenter recommended that the final notice include a competitive preference priority for serving students who are still in school, but are off-track to graduate and those who have disengaged from school and dropped out. The commenter noted that educational continuity and stability are also needed for children in foster care. One commenter recommended establishing a competitive preference priority for applicants that include data-driven strategies to re-engage high-school students who fail to graduate on time and recommended that the final notice encourage States to coordinate Race to the Top funding with funding they receive through other sources such as programs under the Workforce Investment Act.
With regard to the comment that the final notice encourage coordinating ARRA funding with other funding streams, we believe this issue is addressed in criterion (A)(2)(i)(d), which will evaluate the extent to which a State has the capacity to use Race to the Top funds, as described in the State's budget and budget narrative, to accomplish the State's plan and meet its targets, including, where feasible, by coordinating, reallocating, or “repurposing” education funds from other Federal, State, and local sources to
In addition, this final notice recognizes and specifically references the unique needs of students with disabilities and English language learners in the following areas: (a) Priority 4 encourages State plans to expand statewide longitudinal data systems to include or integrate data from special education and English language learner programs; (b) criterion (C)(3)(iii) will be used to assess the extent to which States make their data systems available and accessible to researchers so that they have information to evaluate the effectiveness of instructional materials, strategies, and approaches for educating different types of students, such as students with disabilities and English language learners; and (c) criterion (D)(3) will be used to examine States' plans to increase the number and percentage of highly effective teachers teaching in hard-to-staff subjects and specialty areas, such as special education and language instruction educational programs (as defined under Title III of the ESEA). In addition, the measures used to document increases in achievement, closing achievement gaps, and increasing graduation rates, all require data to be disaggregated by subgroups, including the students with disabilities and limited English proficient students subgroups (
Therefore, we believe that this final notice ensures that students with disabilities and English language learners are not overlooked in State reform plans and that it is unnecessary to add an invitational priority focused on students with disabilities and English language learners.
Furthermore, criteria (B)(3), (C)(3)(ii), (D)(2)(iv)(a), and (D)(5) explicitly focus on professional development. Criterion (B)(3) focuses on, among other activities, professional development to support the transition to new standards and assessments; as noted elsewhere, criterion (C)(3)(ii) has been added to focus on professional development for teachers, principals and administrators on using instructional improvement systems to support continuous instructional improvement; criterion (D)(2)(iv)(a) refers to using teacher and principal evaluations to inform relevant professional development; and criterion (D)(5) focuses on the need for States and LEAs to provide effective data-informed professional development, coaching, induction, and common planning and collaboration time to teachers and principals that are, where appropriate, ongoing and job-embedded.
Another commenter recommended adding the development of longitudinal data systems as a competitive preference priority in order to accelerate development and implementation of next-generation, user-oriented data systems that provide timely, useful data for teachers and principals to use in managing performance and improving student achievement; prioritize academic data with an emphasis on leading predictive indicators; include routine data inquiry processes and training to support educators in the effective interpretation and use of data that result in improved student achievement; and enhance State and local capacity to use data and improve the systematic integration and use of data over time.
As noted elsewhere, we are adding to this final notice a new section (A), State Success Factors. We are revising a number of the selection criteria from proposed section (E) (Overall Selection Criteria) and including them as State Success Factors Criteria (A). The purpose of this change is to provide States with the opportunity to begin their proposals with clear statements of their integrated, coordinated, statewide reform agendas. In order to be consistent with this change, we are changing the language in priority 1 to provide that, in addition to addressing the four education reform areas, State applications also must address the State Success Factors Criteria. Consistent with this focus on the State Success Factors Criteria, we are adding clarifying language and removing the reference to the four reform areas in the title of absolute priority 1.
With regard to the use of NAEP scores to measure increasing student achievement, we are removing this reference in priority 1 because, as noted elsewhere, the new section on State Success Factors describes how increases in student achievement and closing achievement gaps across subgroups will be measured. State Success Factors Criteria (A)(1)(iii) and (A)(3)(ii) specify that when evaluating increases in student achievement and gap-closing, reviewers will examine results in reading/language arts and mathematics based on the NAEP and on the assessments required under the ESEA.
However, many commenters stated that designating STEM as a competitive preference priority implies that STEM subjects are more important than other subjects and recommended omitting or changing the STEM priority to an invitational priority. One commenter asked why the Department chose to emphasize STEM subjects over other subjects.
Numerous commenters expressed concern that including a competitive preference priority on STEM education would lead to a narrowing of the curriculum. One commenter expressed concern that a competitive preference priority emphasizing STEM education might encourage STEM-only programs, as opposed to STEM-focused programs in which the content is integrated into various curricular areas. The commenter expressed concern that the priority would prohibit States from applying data-driven reform and school achievement interventions that do not focus on STEM. Another commenter recommended changing the priority to give States the option of using data to develop plans that meet the needs of their low-performing schools.
Another commenter noted that programs supported by universities use technology and multimedia to improve teaching and learning of STEM subjects and recommended that universities and the business sector work in partnership with schools to prepare students for postsecondary education and workplace success.
Numerous commenters stated that community-based organizations play a key role in assisting youth at the secondary level, particularly in helping them transition to postsecondary education, and therefore, should be included as partners in creating a seamless P–20 route for students. A few commenters stated that the educational system should work with child welfare, juvenile justice, and criminal justice agencies to help re-engage high school dropouts.
With regard to the comment that State reform plans address how the improvement process will be managed effectively, we note that criterion (A)(2) focuses on the extent to which States have built strong statewide capacity to
With regard to the comment asking whether States could focus on the transition between early childhood and elementary school exclusively without penalty for excluding middle and high school transitions, and the comment regarding how alignment will be evaluated in the peer review process, we note that States will be judged on the extent to which their plans set forth comprehensive and coherent reform agendas for improving student outcomes statewide (
The ways in which early childhood and higher education programs participate in States' reform strategies
We agree that one way to improve transitions from early childhood programs to K–12 programs is for SEAs to work with State early childhood advisory councils. We are not including specific examples of processes the State may use to improve transitions across the P–20 system; we believe such decisions are best left to local decision-makers.
Under criterion (C)(1), States will be judged on the extent to which they have a statewide longitudinal data system that includes the America COMPETES Act elements. Beyond these 12 elements, the Department has not specified any additional elements that States must include in their statewide longitudinal data systems.
Several commenters urged the Department to make priority 6 a competitive preference priority in order to ensure that districts create the preconditions for dramatically improving student achievement. Other commenters stated that the flexibilities and autonomies listed in the priority are essential to school success and that it is highly unlikely that any State will turn around low-performing schools without these ingredients. Another commenter stated that LEA actions are fundamental to enabling schools to turn around and that if this priority was a competitive preference priority, it would motivate LEAs to undertake challenging reforms. Lastly, one commenter recommended that the priority be changed to an absolute priority.
A few commenters recommended that the Department provide additional regulatory waivers and flexibilities to improve the coordination of funds and create the conditions for systemic reforms and instructional innovations. One commenter stated that Federal funding and regulatory flexibility could have a significant effect on State and LEA reform efforts and suggested that funds be competitively awarded in return for a State meeting a number of key requirements.
In response to commenters who recommended that the Department provide additional regulatory waivers and flexibilities, we note that such waivers and flexibilities are often limited by statute. However, the Department fully supports efforts to coordinate the use of funds in order to make the most efficient and effective use of limited resources and will continue to consider States' requests for waivers that are permissible under current Federal statutes and regulations.
Another commenter suggested using the term “comprehensive supports” rather than “comprehensive services,” stating that “comprehensive supports” includes services and has more salience with educators. Another commenter recommended clarifying that comprehensive services for high-need students address the health, safety, social, emotional, behavioral, physical, and educational needs of a child.
With regard to comments concerning the need for comprehensive services and creating a safety net of wrap-around services with involvement of both communities and districts, we note that priority 5 focuses on the need to coordinate services across schools, State agencies, and community partners in order to ensure that high-need students have access to the broad array of opportunities and services they need (
We decline to change the term “comprehensive services” to “comprehensive supports,” as requested by one commenter; we do not agree that the two terms are substantively different or that one term has more salience for educators than the other. We also decline to specify the array of services included in “comprehensive services” because, by doing so, we could inadvertently restrict the range of services that a State may determine are necessary to serve high-need students.
Several commenters, however, claimed that there is a lack of research or evidence demonstrating that the use of such data for teacher and principal evaluations has any positive impact on teacher, principal, or student performance. A few commenters disagreed with the Department's reference to research indicating that teacher qualifications, including certification status and years of experience, are not accurately predictive of teacher quality. Other commenters identified research explaining the difficulty in disaggregating student achievement data to determine a teacher's effect from other variables. One commenter suggested that States should pass laws requiring a peer reviewed validation of any value-added methodology before including student achievement data as part of any evaluation or compensation mechanism and further argued that such laws should not constitute a State barrier under the eligibility requirements.
Another commenter argued that an existing statute regulating the use of student achievement data in tenure determinations in another State should not make the State ineligible to apply for the Race to the Top competition. The commenter argued that the statute does not prohibit use of student test data in annual teacher performance reviews or for tenure consideration.
The Department notes that this notice requires the State's Attorney General to certify that the State has no legal, statutory, or regulatory barriers at the State level to linking student achievement or student growth data to teachers and principals for the purpose of evaluations.
In addition, we note that we are changing application requirement (f) to be consistent with the changes to eligibility requirement (b), as discussed earlier, and separating application requirement (f) into two subparagraphs.
Consistent with section 14006(c) of the ARRA, States must subgrant 50 percent of their grant awards to participating LEAs, based on the LEAs' relative share of Title I, Part A allocations in the most recent year. We have clarified in application requirement (c)(2) that, because all Race to the Top grants will be made in 2010, relative shares will be based on total funding received in FY 2009, including both the regular Title I, Part A appropriation and the amount made available by the ARRA.
Consistent with section 14005(c)(4) of the ARRA, application requirement (c)(2) requires a State to include in its application a budget detailing how the State will use Race to the Top funds to “give priority to high-need LEAs” beyond the base amount provided to all participating LEAs. States have flexibility to determine the meaning of “give priority to,” which could include, for example, additional funding, more comprehensive technical assistance, coordination of State or local social services for students in such LEAs, expanded professional development, and larger incentives for teachers and principals who agree to work in these LEAs.
Other commenters requested information on funding for Race to the Top evaluations, and two commenters recommended that up to 10 percent of Race to the Top awards be available to support those evaluations. One commenter expressed concern that the reporting requirements were focused on outcomes only, and did not include a description of the processes used to achieve those outcomes. Finally, four commenters suggested that a national evaluation should focus on identifying promising or best practices, while two commenters recommended the inclusion of “process metrics” to ensure that best practices can be fully documented to facilitate dissemination and adoption by others.
Comments regarding the preceding definitions are addressed, as appropriate, below.
Selection Criteria (A)(1)(ii) and (iii): Participating LEAs (proposed criteria (E)(3)(iv) and (E)(4)):
A number of comments common to criteria (A)(1)(iii) and (A)(3)(ii) are addressed in the discussion of (A)(3)(ii) later in this notice.
States do not have the discretion to select participating LEAs; instead, each LEA will make the decision to sign on to the State's plan as a participating
Participating LEAs must in turn use their funding in a manner that is consistent with the State's plan and its MOU or other binding agreement with the State. States may establish more detailed rules on uses of funds provided they are consistent with the ARRA, the terms of the grant award, and the Department's applicable administrative regulations. Although participating LEAs will receive subgrants from the State as described earlier, Race to the Top funds are not governed by the Title I restrictions on the uses of funds.
As described earlier, participating LEAs agree to implement all or a significant portion of State's Race to the Top plans. However, other LEAs may choose to work with the State to implement those specific portions of the State's plan that require statewide or nearly statewide implementation, such as transitioning to a common set of K–12 standards. We have defined these LEAs in this notice as
In general, involved LEAs are not included in, and are not subject to, the requirements of a State's Race to the Top plan.
It is important to note that this notice does not require LEAs to participate in a State's plan (whether as participating or as involved LEAs) or give States the authority to impose such a requirement. Rather, through the definitions of
The definition of
Because the extent of LEA participation should be measured partly by the expected effects on student outcomes statewide, we have incorporated into criterion (A)(1)(iii) the language from proposed criterion (E)(4) regarding a State's goals for increasing student achievement, decreasing achievement gaps, and increasing graduation rates. As discussed later, we also include new criterion (A)(1)(iii)(d) regarding increasing college enrollment and credit accumulation.
In addition, as evidence to support the State's response to criteria (A)(1)(ii) and (A)(1)(iii), Appendix A to this notice asks States for the following information: (1) An example of the State's standard participating LEA MOU and description of variations used, if any; (2) the completed summary table indicating which specific portions of the State's plan each LEA is committed to implementing and relevant summary statistics; (3) the completed summary table, indicating which LEA leadership signatures have been obtained; (4) the completed summary table, indicating
As discussed in greater detail elsewhere in this notice, the Department is providing a sample MOU (see Appendix D) to assist States and LEAs during this process.
(a) Terms and conditions that reflect strong commitment by the participating LEAs (as defined in this notice) to the State's plans;
(b) Scope-of-work descriptions that require participating LEAs (as defined in this notice) to implement all or significant portions of the State's Race to the Top plans; and
(c) Signatures from as many as possible of the LEA superintendent (or equivalent), the president of the local school board (or equivalent, if applicable), and the local teachers' union leader (if applicable) (one signature of which must be from an authorized LEA representative) demonstrating the extent of leadership support within participating LEAs (as defined in this notice).
In addition, criterion (A)(1)(iii) specifies that LEA participation will be evaluated based on the extent to which the LEAs that are participating in the State's Race to the Top plans (including considerations of the numbers and percentages of participating LEAs, schools, K–12 students, and students in poverty) will translate into broad statewide impact, allowing the State to reach its ambitious yet achievable goals, overall and by student subgroup, for—
(a) Increasing student achievement in (at a minimum) reading/language arts and mathematics, as reported by the NAEP and the assessments required under the ESEA;
(b) Decreasing achievement gaps between subgroups in reading/language arts and mathematics, as reported by the NAEP and the assessments required under the ESEA;
(c) Increasing high school graduation rates (as defined in this notice); and
(d) Increasing college enrollment (as defined in this notice) and increasing the number of students who complete at least a year's worth of college credit that is applicable to a degree within two years of enrollment in an institution of higher education.
Finally, Appendix A, Evidence and Performance Measures, has been revised to specify the evidence that States must submit when responding to criteria (A)(1)(ii) and (A)(1)(iii).
With regard to the question of whether a State's Race to the Top application must include an MOU with each LEA or whether an outline of what would be covered in an MOU with an LEA would suffice, criterion (A)(1)(ii) makes clear that the MOUs included in a State's application will be used as evidence of LEAs' commitment to the State's plan. Therefore, in order to receive maximum points on criterion (A)(1)(ii), a State should have an MOU for each participating LEA. However, in acknowledgement of the short timeline, we are clarifying in the new
Note that for clarity, we have moved “charter school authorizers” from this list to the list in criterion (A)(2)(ii)(b), regarding other critical stakeholders.
This section includes issues common to criteria (A)(1)(iii) and (A)(3)(ii).
(i) Make progress over the past several years in each of the four education reform areas, and used its ARRA and other Federal and State funding to pursue such reforms;
(ii) Improve student outcomes overall and by student subgroup since at least 2003, and explain the connections between the data and the actions that have contributed to—
(a) Increasing student achievement in reading/language arts and mathematics, both on the NAEP and on the assessments required under the ESEA;
(b) Decreasing achievement gaps between subgroups in reading/language arts and mathematics, both on the NAEP and on the assessments required under the ESEA; and
(c) Increasing high school graduation rates.
Regarding the comment that we should allow States to demonstrate achievement gains on assessments or achievement measures under the ESEA, such as the annual proficiency scores and targets used to determine AYP, we note that States already issue annual reports on AYP status for schools and LEAs, including proficiency rates for all schools; there is no need to duplicate this reporting by requiring its inclusion in a State's annual Race to the Top report. However, States that desire to include AYP data (or other measures) in their annual Race to the Top reports would be free to do so.
After careful consideration of the comments, the Department believes that this new criterion, in combination with the proposed measures—which focus on reading, mathematics, and increasing graduation rates—reflect the right emphasis on key areas that States can report on with some validity and comparability. Further increasing the number of measures would increase data collection and reporting burdens on States and LEAs, many of which have not been collecting data in the areas suggested by commenters. States that want to include their own supplemental measures and targets are free to do so, and the ongoing expansion of State data systems, which is supported by the Race to the Top program and encouraged under invitational priority 4, will likely facilitate future indicators and targets in such areas as early childhood, drop-out prevention, and student mobility.
(a) Increasing student achievement in reading/language arts and mathematics, both on the NAEP and on the assessments required under the ESEA;
(b) Decreasing achievement gaps between subgroups in reading/language arts and mathematics, both on the NAEP and on the assessments required under the ESEA; and
(c) Increasing high school graduation rates.
(1) For student subgroups with respect to the NAEP, the State must provide data for the NAEP subgroups described in section 303(b)(2)(G) of the National Assessment of Educational Progress Authorization Act (
(2) For student subgroups with respect to graduation rates, college enrollment and credit accumulation rates, and the assessments required under the ESEA, the State must provide data for the subgroups described in section 1111(b)(2)(C)(v)(II) of the ESEA (
(3) When asked to provide information regarding the assessments required under the ESEA, States should refer to section 1111(b)(3) of the ESEA; in addition, when describing this assessment data in the State's application, the State should note any factors (
A few commenters, however, were opposed to the adoption of common standards for various reasons, such as a lack of evidence that common standards will benefit students and the potential cost of adopting new content standards. One commenter urged removing participation in a consortium as a necessary condition of funding because of concerns that the size and the complexity of the relationships in a consortium may have the potential for conflicts of interest. Some commenters regarded the proposed criterion as punitive. A few commenters suggested making participation in common standards an invitational priority in the interest of making adoption truly voluntary. Another commenter expressed concern that a criterion under which States would be rewarded for their commitment for adopting a common set of K–12 standards will preempt what, up to now, has been a State-led process and would call into question the voluntary nature of State adoption of standards.
Many commenters argued that States should be excused from the requirement to adopt common core standards if their current standards are as rigorous as common standards. One commenter suggested that the Department include in the final notice an additional criterion to provide recognition for those States with rigorous standards and improved student achievement. Another recommended an external review focused on rigor, college and career readiness and international benchmarking to determine whether adoption of a common set of K–12 standards is necessary.
Some readers appear to have been confused about the role of the criteria. One mistakenly believed that joining a consortium was a condition of funding under Race to the Top. This is not the case. Criteria are used to evaluate grant applications and applicants. States receive points for the strength and content of their responses to the criteria. In this program, we proposed that States' applications would be evaluated and receive points for demonstrating their commitment to improve standards by participating in a consortium of States working toward jointly adopting common K–12 standards. Thus, States with stronger proposals would receive more points; however, a State could receive a grant even without getting any points for this criterion. An individual State that chooses not to participate in a consortium for the development and adoption of common standards is eligible to apply for funds, but the application will not receive points under this criterion. A State that chooses not to join a consortium could describe its accomplishments in response to new criteria (F)(3) under which it could earn points for other significant reform conditions that have contributed to increased student achievement, narrowed achievement gaps, or other important outcomes. We decline to make participation in common standards an invitational priority for which a State would receive no points in the competition, rather than a selection criterion. We believe that common internationally benchmarked standards that prepare students for college and careers are a critical foundation for students' education and, therefore, are a component of a State's application deserving of evaluation and points in the competition.
We agree that there is potential for conflicts of interest to arise within consortia, but believe there are ways for consortia to mitigate such conflicts and that removal of the criterion on these grounds is not warranted.
We also have revised and reorganized criterion (B)(1) non-substantively for purposes of clarity. When describing how a State can demonstrate its commitment to developing standards we have changed the phrase, “improving the quality of its standards” to “adopting a common set of high-quality standards, as evidenced by * * *”. In criterion (B)(1)(ii)(a), we also have removed the qualifier to a common set of K–12 standards (“that are internationally benchmarked and that build toward college and career readiness by the time of high school graduation * * *”) because it is redundant with similar language in criterion (B)(1)(i)(a).
Selection Criterion (B)(2): Developing and Implementing Common, High-quality Assessments (Proposed Selection Criterion (A)(2)):
We understand commenters' concerns about the overemphasis of standardized testing, but believe that educators need good information about what students know and can do so that they can guide their students' learning, and adjust and differentiate their instruction appropriately. This information needs to come, in part, from academic assessments.
With respect to support for local assessments, criteria (B)(3) and (C)(3) provide opportunities for focus on local assessments and instructional improvement systems. Criterion (B)(3) evaluates a State on the extent to which it has a high-quality plan for supporting statewide transition to and implementation of enhanced standards and high-quality assessments and provides examples of State or LEA support activities, including implementation of high-quality instructional materials and assessments. In responding to this criterion, States could propose to support development of local assessments, including formative and interim assessments, that would assist in the transition to new statewide standards and assessments. Criterion (C)(3) evaluates a State on the extent to which it has a high-quality plan to increase the acquisition, adoption, and use of local instructional improvement systems (as defined in this notice); supports LEAs and schools that are using instructional improvement systems; and makes data from these systems available and accessible to researchers. Instructional improvement systems may include local assessment data.
In addition, we have made some non-substantive changes to this section for clarity. We have replaced “whether” with “to the extent to which” in criterion (B)(2); we have added “as evidenced by (i) the State's participation * * *”; and we have removed the phrase “that are internationally benchmarked” when we refer to a common set of K–12 standards because the phrase is unnecessary and redundant with language in criterion (B)(1)(i)(a).
We do not believe it is necessary to clarify that open-ended items, performance-based tasks, and technology should be appropriate for the grade and subject to be assessed and consistent with the skills to be measured, as recommended by commenters. We believe this is implicit in the design of any assessment and have included open-ended responses, performance-based tasks, and technology as examples, not as requirements of a high-quality assessment.
Finally, based on the Department's internal review, we are making several changes to the definition. First, in the NPP, we stated that a high-quality assessment uses a “variety of item types, formats, and administration conditions (
However, not all commenters supported additional supports and resources during a State's transition to enhanced standards and high-quality assessments. One commenter questioned whether limited Race to the Top funds should be used by States and LEAs to develop instructional materials. Another commenter was critical of requiring a plan for transition; instead this commenter suggested that a State should be judged on its transition after implementation of common standards and assessments, not before the State has developed best practices.
We disagree with commenters who questioned whether limited Race to the Top funds should be used by States and LEAs to develop instructional materials. We believe that the transition to enhanced assessments and a common set of K–12 standards will not be successful without support from the States doing this work in collaboration with their participating LEAs.
We have made several edits for clarity in the illustrative list of State and LEA support activities for transition to enhanced standards and high-quality assessments. We deleted the reference to developing curricular frameworks, for example, but added a reference to “high-quality instructional materials and assessments (including, for example, formative and interim assessments).” Additionally, we accepted commenters' suggestion to add “development of a rollout plan for the standards with all supporting components,” which could include, among other things, development of curricular frameworks and materials.
We decline to take the commenter's suggestion that a State focus its professional development on middle and high school teachers because we believe all teachers implementing enhanced standards and high-quality assessments would benefit from high-quality professional development.
Comments regarding the preceding definition are addressed, as appropriate, below.
Commenters indicated that these data systems should include multiple achievement measures and multiple data sources, such as annual achievement data for all core academic subjects, as defined in the ESEA, valid and reliable local and State assessment results, formative assessment results, performance assessment results, and English language proficiency results. One commenter recommended that the data systems include data that demonstrate a student's ability to apply, analyze, synthesize and evaluate content knowledge. A few commenters recommended collecting data on the rates of students reading at grade-level by grade 3.
Some commenters recommended various ways data should be disaggregated. They suggested that statewide longitudinal data systems be designed to allow for analysis of student achievement by race, ethnicity, socioeconomic status, gender, disability, and English language learner status. One commenter recommended that the Department encourage States to disaggregate data of vulnerable populations such as pregnant and parenting students. One commenter noted that it is critical that the statewide longitudinal data system measure all proficiency levels (
Other commenters recommended non-assessment related data elements to be included in statewide longitudinal data systems, such as college readiness indicators, graduation rates, attendance rates, student enrollment data, course enrollment, student mobility rates, budget information, completion rates, curriculum changes, and instructional time. A few commenters suggested that in order to evaluate the progress of individual students through the K–12 system and into postsecondary education, systems should include information such as the percentage of students from each high school enrolling in institutions of higher education, students taking remedial or developmental coursework in college, or the points at which students exit, transfer in, transfer out, drop out, or complete P–16 education programs. One commenter suggested that the data systems include model lesson plans for teachers.
Some commenters recommended including data related to indicators of school safety, culture and climate. Others suggested including information about student, family and community engagement. A few commenters requested that the data systems include student social service-related data elements and health indicators, such as immunization rates, asthma rates, vision and hearing screening, and obesity rates. Several commenters recommended including measures of students' social and emotional health and character development. Others believed that data systems should provide data regarding the numbers of transfers, dropout rates, chronic absenteeism, suspension rates, truancy, and dropout re-enrollment in order to trigger supports and interventions for students and families.
Commenters also suggested that statewide longitudinal data systems should include data about teaching and learning conditions, such as teacher recruitment and retention, educator turnover, pupil and teacher ratios,
One commenter recommended that statewide longitudinal data systems include information about English language learners, such as the type of English language learner instructional program in which a student participates, time in that program, level of English proficiency, and date of reclassification. Some commenters suggested requiring data about student participation in other programs, such as data on students served in gifted and talented education programs, innovative programs, expanded learning programs, or students receiving advanced coursework. One commenter recommended that data on technology use be explicitly included in statewide longitudinal data systems.
Some commenters recommended that statewide longitudinal data systems include linkages with students in adult basic education, workforce and skills training programs and corrections systems, and student information from State employment wage records.
One commenter stated that we did not provide sufficient justification for why all these data elements are essential. Another commenter suggested that the Department give States latitude to define the elements included in their data systems.
As stated in invitational priority 4, the Secretary is particularly interested in applications in which the State plans to expand statewide longitudinal data systems to include or integrate data from special education programs, English language learner programs, early childhood programs, at-risk and drop-out prevention programs, and school climate and culture programs, as well as information on student mobility, human resources (
A few commenters recommended that States and LEAs provide parents and the public with clear and concise annual reports that are useful and relevant to all constituencies. Commenters suggested topics that should be included in these reports, such as an overall assessment of education, reports on school quality, descriptions of progress in the core academic subjects, and indicators of the health and safety of children. One commenter suggested that States include in reports an opportunity-to-learn index to track data about the quality of State and local education systems. Another commenter suggested that reports provide teachers with data on the growth of their students on interim or summative assessments. A few commenters noted the importance of consultation with stakeholders after the data are reported, recommending that States and LEAs address in their application how they plan to disseminate and explain the data to stakeholders and how they will use community input to develop a plan of action to improve schools.
The Department agrees that teacher and principal privacy also must be protected. However, teacher and principal privacy is governed by State law. States, LEAs, and schools should consider their individual State privacy statutes when addressing these privacy issues in the establishment of a statewide longitudinal data system.
We first address the question of the disclosure and redisclosure of personally identifiable information in the pre-kindergarten context. The disclosure of personally identifiable information from pre-kindergarten to LEAs is not affected by FERPA with respect to pre-kindergarten programs that do not receive funding from the Department, as FERPA does not apply to those programs. With respect to pre-kindergarten programs that receive funding from the Department, the non-consensual disclosure of personally identifiable information from the students' pre-kindergarten education records to LEAs is permitted under the enrollment exception in the FERPA regulations, provided that certain notification and access requirements are met. (20 U.S.C. 1232g(b)(1)(B); 34 CFR 99.31(a)(2) and 99.34).
The second issue raised by commenters involved the sharing of information between postsecondary institutions and SEAs. Similar to the pre-kindergarten context, the non-consensual disclosure of personally identifiable information from K–12 education records to a postsecondary institution is permitted under the enrollment exception, provided the notification and access conditions are met. Postsecondary institutions may disclose personally identifiable information to an SEA under the evaluation exception if the SEA has the authority to conduct an audit or evaluation of the postsecondary institution's education programs. (20 U.S.C. 1232g(b)(1)(C), (b)(3), and (b)(5); 34 CFR 99.31(a)(3) and 99.35). States that have not established the requisite authority may do so in a number of ways, such as: (1) Creating an entity in the State to house the statewide longitudinal data system and endowing that entity with the authority to conduct evaluations of elementary, secondary, and postsecondary education programs; or (2) granting authority at the SEA or IHE level to conduct evaluations of elementary, secondary and postsecondary education programs. States may grant authority through various vehicles, including for example, Executive Orders, regulations and legislation. In some States the formation documents for SEAs, IHEs or other educational entities may already grant the necessary authority; however, explicit statutory authority is not required by FERPA.
The Department recognizes that there is considerable variation among States' governance structures and laws, and that using this exception to obtain personally identifiable information from postsecondary institutions may be difficult. The Department is currently reviewing its regulations and policies in this area and will be in close communications with States over the next several months regarding these issues. Of course, the Department also is available, upon request, to provide States with technical assistance on how to implement a statewide longitudinal data system that meets the requirements of FERPA.
Further, as noted in the preceding paragraph and in the preamble to the FERPA NPRM, use of minimum cell sizes or data suppression is only one of several ways in which information from education records may be de-identified before release. Statistical Policy Working Paper 22 describes other disclosure limitation methods, such as “top coding” and “data swapping,” which may be more suitable than simple data suppression for releasing the maximum amount of information to the public without breaching confidentiality requirements. Decisions regarding whether to use data suppression or some other method or combination of methods to avoid disclosing personally identifiable information in statistical information must be made on a case-by-case basis.
With regard to issues with ESEA reporting in particular, determining the minimum cell size to ensure statistical reliability of information is a completely different analysis than that used to determine the appropriate minimum cell size to ensure confidentiality.
One commenter suggested that a State should articulate the means by which it will require educators seeking certification or re-certification to receive training and show competence in the analysis, interpretation, and use of data. Several commenters suggested that time during the school day should be dedicated to data analysis and action planning for teachers. Another commenter suggested that a State be required to explain how it will promote an environment (
We do not believe we should require a State to articulate the means by which it will require educators seeking certification or re-certification to receive training and show competence in the analysis, interpretation, and use of data. A State may address this issue in its plan if it chooses.
In response to the commenters who indicated that instructional improvement systems should be research-based, we believe that much research has been done on the effectiveness of using data to inform instructional decisions. Instructional improvement systems provide teachers and instructional leaders with the evidence they need to make informed instructional decisions. Therefore, such systems are a critical element of any classroom-based, evidence-driven approach to instruction.
Commenters also had different views on the level and type of coursework that should be part of alternative routes to certification. One commenter supported alternative routes to certification involving limited amounts of coursework, one commenter disagreed, and a third commenter specifically recommended requiring substantive coursework in reading and math content and teaching methods.
Several commenters recommended that the definition include a requirement that all alternative routes to certification ensure that graduates of such programs have the skills to address the needs of all students. One commenter expressed concern that alternative routes to certification, given their shortened timeframe, are not designed to ensure that teachers develop the skills needed to effectively instruct students with disabilities. The commenter recommended strengthening both traditional and alternative route preparation programs so that all teachers are more skilled in teaching students with disabilities.
Two commenters sought changes aimed at ensuring that graduates of alternative routes to certification receive the same level of certification as teachers and leaders who complete traditional preparation programs. Similarly, a few commenters recommended that the Department require States to verify that teachers certified through alternative routes to certification are treated equally and fairly in hiring under all State regulations and statutes, while another commenter suggested sanctioning States that treat alternative routes to certification as a “route of last resort.” On the other hand, one commenter stated that teachers certified through alternative routes generally should not be assigned to high-need schools because of their limited experience.
The Department believes it is important to provide prospective teachers and principals with direct school and classroom experiences as part of their preparation. Because alternative routes to certification are accelerated and vary in delivery models, there are a variety of ways, in addition to clinical or student teaching experiences, to provide this experience, such as through practicum and job embedded experiences, coupled with intensive mentoring or support during the first months of teaching, as suggested by the commenters. We agree with the commenters and are revising the definition to refer to school-based experiences and ongoing support such as effective mentoring and coaching.
As to the extent of the coursework required by programs providing alternative routes to certification, the Department believes that States are in the best position to determine the courses and coursework that could be reduced or limited as a part of any alternative route to certification program, consistent with the needs of local schools, the accelerated nature of alternative routes to certification, and the wide range of previous education and experience that candidates bring to these programs. The Department, therefore, declines to change the definition to specify the amount or type of coursework that must be included in programs providing alternative routes to certification. We are specifying in the final definition, however, that alternative routes to certification should include standard features such as demonstration of subject-matter mastery and high-quality instruction in pedagogy.
We also believe that programs providing alternative route to certification should not award levels of certification that are different from the certifications available from traditional preparation programs, which could limit the opportunities for teachers to teach and leaders to lead; rather, alternative routes to certification programs, whether for teachers or principals, should be considered different pathways to certification with the same rigor as other State-approved routes. The Department's view is that States, LEAs, and schools should treat individuals prepared through State-approved alternative routes to certification in the same manner as those prepared and certified through traditional teacher and principal preparation programs, and we are changing the definition to reflect this view.
The Department agrees that there is a need to strengthen preparation programs to prepare teachers and principals to meet the needs of all students. We are revising the definition of
At the same time, we believe it is important to retain the original substance of proposed criterion (C)(1), regarding alternative routes to certification, for two reasons. First, to increase the supply of high-quality talent entering the field of education we must reduce the barriers to entry into the education profession, especially for high-achieving individuals, such as individuals who have changed careers and recent college graduates who have the potential to be good educators. Alternative routes to certification are typically optimized for such new entrants into the profession. Second, the Secretary believes that competition between traditional and alternative certification providers will help increase the quality of all programs. To provide clarity, and to emphasize the importance of alternative routes actually being in use, we are separating proposed criterion (C)(1) into two criteria, (D)(1)(i) and (D)(1)(ii).
To further support the notion that all teacher and administrator preparation programs must train candidates to become high-performing professionals, we proposed in the NPP and establish in this final notice, criterion (D)(4). This
Together, we believe that criteria (D)(1) and (D)(4) provide a combination of rewards, incentives, and transparency that could result in significant quality improvements in educator preparation and recruitment.
Finally, we do not believe we should remove principals from this criterion. Well-prepared principals are critical to providing the instructional leadership necessary to support teaching and learning in our schools. We know that chronically underperforming schools too often have poor leadership, and that poor leadership drives away good teachers. The focus on principal preparation is therefore critical.
(i) Legal, statutory, or regulatory provisions that allow alternative routes to certification (as defined in this notice) for teachers and principals, particularly routes that allow for providers in addition to institutions of higher education;
(ii) Alternative routes to certification (as defined in this notice) that are in use; and
(iii) A process for monitoring, evaluating, and identifying areas of teacher and principal shortage and for preparing teachers and principals to fill these areas of shortage.”
In addition, we have added criterion (D)(4)(ii), which encourages States to “expand preparation and credentialing options and programs that are successful at producing effective teachers and principals (both as defined in this notice).”
While differentiating performance is an important component of evaluation systems, we agree that criterion (D)(2) is focused on improving teacher and principal effectiveness, and we are changing the title to make this clear. We
One commenter did not believe the definition should include a teacher's commitment and ability to use feedback and performance data to improve instructional practices. The commenter reasoned that a teacher who improves student achievement is using (1) practices that are both effective for student learning and healthy for social and emotional development of students and (2) feedback to improve practice. One commenter urged the Department
We do not agree that using student growth data as a part of a rigorous, transparent, and fair evaluation system that is designed and developed with teacher and principal involvement will lead to corruption or detract from other priorities. We contend that implementing fair and transparent evaluation systems developed with the involvement of both teachers and principals, and that include student growth as a significant factor in evaluations, will lead to greater trust between teachers and principals, enable meaningful decision-making and support, and push educators to remain focused on the ultimate priority — improving student achievement.
We also recognize that pay-for-performance systems in education are controversial and spark much debate. Some States, LEAs, and schools have experimented with such models and shown relative success and promise, while others have experienced less encouraging results. The ARRA also includes funds for the Teacher Incentive Fund, which will award grants to LEAs to develop performance-based compensation models. While research on pay-for-performance plans is limited, there is evidence to suggest that a well-designed performance-based pay system can lead to improved student achievement.
We also note that the criterion refers to decisions regarding promotion and retention as well as compensation because we believe that great teaching and school leadership should be recognized and rewarded as much as possible, and that talented educators should have opportunities for increased responsibilities and other retention incentives, where appropriate, as well as for additional compensation.
We believe that LEAs and schools, in collaboration with their teachers and principals, are best situated to determine the timing and types of additional responsibilities that should be given to their staff and that it would be inappropriate for the Department to set requirements around this issue.
Race to the Top includes a number of criteria, in addition to criterion (D)(2), that are dedicated to teacher and principal professional development and supports; parts of criteria (B)(3) and (C)(3) and all of criterion (D)(5) concern this issue, including discussions of professional collaboration and planning time, individualized development plans, training and support in the analysis and use of data, classroom observations with immediate feedback, and other activities critical to supporting and improving teacher and principal capacity. These supports are paired, in the Race to the Top criteria, with criteria that focus on rigorous, fair and transparent teacher and principal evaluation systems that should include providing feedback on areas where professional improvements are needed.
We decline to specify the amount of time teachers should be given to make improvements in their performance, beyond specifying that they should have “ample opportunities to improve.” It is the responsibility of the LEA and school to provide their students with effective teachers and principals, to provide their teachers and principals with effective support, and to take action when appropriate. We have deleted the phrase “but have not done so” to reflect this.
We appreciate the suggestion from commenters that this criterion should reflect States' past actions, and we are revising this criterion to specify that the plans States submit should be informed by past actions and data. We understand the skepticism expressed by commenters who note that States have had Teacher Equity Plans in place since 2002 and have not made sufficient progress, but we emphasize that Race to the Top will use States' performance targets to create a level of accountability that did not exist for these prior plans.
Furthermore, we believe that judging State progress to date would be difficult given the lack of measures of teacher and principal effectiveness and the imperfections with the existing input-based measures, and we believe that asking States to report on their progress using one type of measure and to craft plans using another type would be confusing. Therefore, we choose not to give more weight to progress to date. At the same time, we encourage States to build on their successes and learn from their experiences in recent years.
We are also clarifying that the State's plan for ensuring equitable distribution of effective teachers and principals should be developed in collaboration with the State's participating LEAs. This revision is necessary to ensure consistency with criteria (D)(2) and (D)(5) and to respond to commenters' general concerns about the roles of States and LEAs.
We appreciate the suggestions we received for examples of the types of professional development activities that are most effective, and we have chosen to include several of these in this notice (
Comments regarding the preceding definitions are addressed, as appropriate, below.
A central purpose of ARRA funds is to increase the academic achievement of students in struggling schools. As a result, the Notices of Proposed Requirements (NPRs) regarding the State Fiscal Stabilization Fund Phase II and the School Improvement Grants programs, as well as the Race to the Top NPP, each included requirements related to struggling schools. The most explicit requirements were included in the School Improvement Grants NPR that was published in the
Because both the Stabilization Fund and Race to the Top notices of final requirements are being published prior to the final School Improvement Grants notice, we have published the requirements for the four models in the final notice for the Stabilization Fund, are including them in Appendix C to this final notice, and will incorporate them into the final School Improvement Grants notice when it is issued. In order to clarify and fully explain the definition of persistently lowest-achieving schools and the changes that we made to the four models, we also are including in this notice the comments and responses related to the definition and those models from the School Improvement Grants NPR. In the following sections, we first discuss the comments we received on struggling schools in reply to the Race to the Top NPP and our responses. We then discuss the comments we received related to the definition and the four intervention models as proposed in the School Improvement Grants NPR and our responses to those comments.
This final notice, like the NPP, does include criteria that allow States to earn points for their own existing or planned efforts to support effective school interventions. Criterion (F)(3) (proposed criterion (E)(1)(iii)) provides that a State will receive points if the State, through law, regulation, or policy, has created other conditions supporting education reform and innovation that are not addressed under other State Reform Conditions Criteria and that have increased student achievement or graduation rates, narrowed achievement gaps or resulted in other important outcomes.
To identify the lowest-achieving schools, a State must take into account both (i) The academic achievement of the “all students” group in a school in terms of proficiency on the assessments under section 1111(b)(3) of the ESEA in reading/language arts and mathematics combined; and (ii) The school's lack of progress on those assessments over a number of years in the “all students” group.
And while the Department does not agree that the elements of the transformation model should be required under the turnaround and restart models, largely because doing so would undermine the flexibility to innovate that is a key benefit of changing governance and leadership or a charter school conversion, the turnaround model described in Appendix C specifically permits the implementation of “any of the required and permissible activities under the transformation model.” However, the Department declines the suggestion by one commenter to deemphasize the other options, primarily because we believe that changing governance, leadership, and staff often are essential for turning around the lowest-achieving schools; we also note that such actions (
As noted earlier, the following discussion summarizes the comments we received, and our responses, on the “Tier I” and “Tier II” schools proposed in the SIG NPR that are now included in the definition of
Several commenters said this proposed process was too prescriptive and recommended that States have more flexibility in determining the lowest-achieving five percent. The commenters specifically suggested permitting States to restrict Tier I schools to schools in restructuring if this group constitutes more than five percent of a State's identified schools; to apply a State's growth model; or to consider such other factors as measures of individual student growth, writing samples, grades, and portfolios. One commenter suggested that the Department determine the lowest-achieving five percent of schools in the Nation rather than have each State determine its own lowest-achieving five percent. Other commenters recommended changes that include taking into account the length of time a school has been designated for restructuring, measuring gains related to English language proficiency, and including newly designated Title I schools (especially secondary schools) that do not yet have an improvement status.
Several commenters also suggested changing the method for determining “lack of progress,” including using subgroups rather than the “all students” group, measuring progress in meeting adequate yearly progress targets, and narrowing achievement gaps. Another commenter recommended clarifying that, even if a school shows gains greater than the State average, it should not be considered to be making progress if those gains are not greater than zero.
Finally, several commenters suggested that graduation rates be taken into account in determining the lowest-achieving Title I high schools. One of these commenters suggested including in Tier I all Title I high schools in improvement, corrective action, or restructuring with a graduation rate below 60 percent as well as their feeder middle and junior high schools.
In general, we believe that the changes and alternatives suggested by commenters would add complexity to the method for determining the lowest-achieving five percent of schools without meaningfully improving the outcome. With the changes noted subsequently, we believe the definition proposed in the SIG NPR is straightforward, can be easily applied using data available in all States, and can produce easily understood results in the form of a list of State's lowest-achieving schools that have not improved in a number of years.
Regarding the determination of whether a school is making progress in improving its scores on State assessments, the commenters highlighted the complexity and potential unreliability of measuring year-to-year gains on such assessments. In response, we are simplifying this aspect of the definition to give SEAs greater flexibility in determining a school's lack of progress on State assessments over a number of years.
We also agree that it is important to include Title I high schools in improvement, corrective action, or restructuring that have low graduation rates in the definition. The Secretary has made addressing our Nation's unacceptably high drop-out rates—an estimated 1 million students leave school annually, many never to return—a national priority. In recognition of this priority, and in response to recommendations from commenters, we are including in the definition any Title I high school in improvement, corrective action, or restructuring that has had a graduation rate that is less than 60 percent over a number of years.
Accordingly, we have made these changes and incorporated the process for determining the lowest-achieving five percent of Title I schools in improvement, corrective action, or restructuring—also known as Tier I schools for purposes of SIG funds—into a new definition of
As proposed in the SIG NPR, such secondary schools would have been eligible if they were equally as low-achieving as a Tier I school. We realized that this standard was too vague, particularly in light of the rigorous interventions that would be required if an SEA identified, and an LEA decided to serve, such a school. As a result, we have changed the definition to include secondary schools that are eligible for, but do not receive, Title I funds and that are among the lowest-achieving five percent of such schools in a State (or the lowest five such schools, whichever number of schools is greater). An SEA must identify these schools using the same criteria as it uses to identify the lowest-achieving Title I schools in improvement, corrective action, and restructuring.
For the reasons noted earlier in this notice, we have also included in the definition any high school that is eligible for, but does not receive, Title I funds and that has had a graduation rate that is less than 60 percent over a number of years.
Conversely, several commenters suggested that the four interventions are too prescriptive and do not leave room for State innovation and discretion to fashion similarly rigorous interventions that may be more workable in a particular State. The commenters noted that for some school districts, particularly the most rural districts, none of the interventions may be feasible solutions. In addition, several commenters rejected the idea that there should be any Federal requirements governing struggling schools. The commenters suggested that schools in need of improvement be permitted to engage in self-improvement strategies
The four school intervention models described in the SIG NPR also are internally flexible, permitting LEAs to develop their own approaches in the broad context created by the models' requirements. For example, the turnaround and restart models focus on governance and leadership changes, leaving substantial flexibility and autonomy for new leadership teams to develop and implement their own comprehensive improvement plans. Even the transformation model includes a wide variety of permissible activities from which LEAs may choose to supplement required elements, which are primarily focused on creating the conditions to support effective school turnarounds rather than the specific methods and activities targeting the academic needs of the students in the school.
We also note that over the course of the past eight years, States and LEAs have had considerable time, and have been able to tap new resources, to identify and implement effective school turnaround strategies. Yet they have demonstrated little success in doing so, particularly in the Nation's persistently lowest-achieving schools, including an estimated 2,000 “dropout factories.” Under the ESEA, States have been required to set up statewide systems of support for LEA and school improvement; to identify low-achieving schools for a range of improvement, corrective action, and restructuring activities; and to use the school improvement reservation under section 1003(a) of the ESEA to fund such improvement activities. However, the overall number of schools identified for improvement, corrective action, and restructuring continues to grow; in particular, the number of chronically low-achieving Title I schools identified for restructuring has roughly tripled over the past three years to more than 5,000 schools. SEAs have thus far helped no more than a handful of these schools to successfully restructure and exit improvement status, in large part, we believe, because of an unwillingness to undertake the kind of radical, fundamental reforms necessary to improve the persistently lowest-achieving schools.
Finally, although we believe this recent history of failed school improvement efforts justifies using ARRA SIG funds to leverage the adoption of the more far-reaching reforms required by the four school intervention models, we note that Part A of Title I of the ESEA continues to make available nearly $15 billion annually, as well as an additional $10 billion in fiscal year 2009 through the ARRA, that SEAs and LEAs may use to develop and implement virtually any reform strategy that they believe will significantly improve student achievement and other important educational outcomes in Title I schools. In particular, we would applaud State and local efforts to use existing Title I funds to scale up successful interventions or to build State and local capacity to develop and implement other promising school intervention models. For all of these reasons, we decline to add a fifth school intervention model to this notice.
In addition, many commenters opposed sanctioning principals and staff, partly because, as one commenter claimed, the turnaround model assumes that most problems in a school are attributable to these individuals. One
Accordingly, the Department believes that dramatic and wholesale changes in leadership, staffing, and governance—such as those required by the turnaround model—are an appropriate intervention option for creating an entirely new school culture that breaks a system of institutionalized failure. Although we acknowledge the possibility that the turnaround model could discourage some principals and teachers from working in the lowest-achieving schools, others will likely be attracted by the opportunity to participate in a school turnaround with other committed staff. In addition, other Federal programs, such as the Teacher Incentive Fund and Race to the Top programs, are helping to create incentives and provide resources that can be used to attract and reward effective teachers and principals and improve strategies for recruitment, retention, and professional development.
We also recognize that the staff selected for a turnaround school must have the skill and expertise to be effective in this context. We are adding language clarifying that all personnel must be screened and selected based on locally adopted competencies to measure their effectiveness in a turnaround environment.
In addition, while the SIG NPR would have required an LEA to replace at least 50 percent of the staff of a turnaround school, new paragraph (a)(1)(ii)(A) of the turnaround model requires an LEA, after screening all staff using locally adopted competencies, to rehire no more than 50 percent of the school's staff. Further, some commenters appear to have overlooked proposed section I.B.1 in the SIG NPR, which would give LEAs flexibility to continue implementing interventions begun within the last two years that meet, in whole or in part, the requirements of the turnaround, restart, or transformation models and, thus, would in many cases allow an LEA to retain a recently hired principal in a turnaround school. We are retaining this flexibility provision in this notice.
Finally, the turnaround model includes significant provisions aimed at supporting teachers. For example, the SIG NPR called for “ongoing, high-quality, job-embedded professional development to staff,” as well as increased time for collaboration and professional development for staff. These supports for teachers and other staff are retained in this final notice.
These concerns led several commenters to recommend flexibility regarding the staff replacement requirement of the turnaround model, including the opportunity to request a waiver if an LEA could demonstrate an inability to fill vacancies, and a required evaluation before principals and staff can be replaced. Other commenters opposed the replacement of principals without consideration of such factors as years of experience and district-level support, recommended a three-year window in which to make replacement decisions based upon multiple measures, and suggested the provision of high-quality professional development before replacing any staff.
Finally, we wish to clarify that the requirements for the turnaround model do not require “blanket firings” of staff. The Department agrees that staff should be carefully evaluated before any replacement decisions are made and has added new language requiring LEAs to use “locally adopted competencies to measure the effectiveness of staff who can work within the turnaround environment to meet the needs of students.” If required by State laws or union contracts, principals and staff may have to be reassigned to other schools as necessary.
Several commenters called for the Department to foster collaboration with teacher unions as well as the larger community. One of these commenters claimed that collaboration “increases leadership and builds professionalism” and recommended that evidence of collaboration be documented. Another asserted the involvement of school-based personnel in decision-making is key to the successful implementation of school interventions. Another recommended that an LEA seek “feedback” from all stakeholders, including students, parents, and unions, as to whether an intervention is “feasible or warranted.”
The Department also recognizes the concerns expressed by commenters about the potential disruption to students, parents, and communities that may be connected with a restart plan that involves closing and then reopening a school. To help address this concern, we are adding language to this notice allowing a school conversion—and not just closing and reopening a school—to qualify as an acceptable restart model.
At the same time, the Department emphasizes that just as the restart model is one of four school intervention models supported by this notice, charter schools are just one option under the restart model. Contracting with an EMO is another restart option that may provide sufficient flexibility in States without charter school laws or in rural areas where few charter schools operate. An EMO also may be able to develop and implement a plan that permits students to stay in their school while undergoing a restart. For example, some EMOs hired to turn around a low-achieving school may begin planning for the turnaround in late winter or early spring, hire and train staff in late spring and early summer, reconfigure and re-equip the school—including the acquisition of curricular materials and technology—during the summer, and then reopen promptly in the fall, resulting in minimal, if any, disruption to students and parents.
The Department does not believe it is necessary to add new or additional reporting requirements for EMOs and CMOs, as their performance will be captured by the reporting metrics established in the final SIG notice. More specifically, SEAs and LEAs already must report on the intervention model used for each persistently lowest-achieving school, as well as outcome data for those schools, including
To address the disruptiveness school closure may cause to a community, we have modified the definition of
A few commenters responded that the transformation model would still not enable some communities, particularly those with difficult demographics, to make adequate yearly progress. Other commenters worried that, if not monitored carefully, the transformation model would become like the “other” restructuring option under section 1116(b)(8)(B)(v) of the ESEA, perceived as the easiest (but least meaningful) way to intervene in a struggling school. One of these commenters recommended adding strong language to make clear that the transformation model is not an incremental approach and that, except in the area of changing staff, the model is as rigorous as the turnaround model.
In anticipation of receiving unprecedented amounts of SIG funds, SEAs and LEAs should begin now to plan for how they can use those funds most effectively by putting in place the systems and conditions necessary to support reform in their persistently lowest-achieving schools. Despite the best preparation, however, we know that not every LEA with persistently lowest-achieving schools has the capacity to implement one of the four interventions in this notice in each such school. As indicated in the SIG NPR, therefore, an LEA that lacks the capacity to implement an intervention in each persistently lowest-achieving school may apply to the SEA to implement an intervention in just some of those schools.
Nonetheless, it is important to note that the Secretary believes that student achievement data must be included as a significant factor in evaluations of teacher and principal effectiveness. We are confident that the legitimate concerns of the commenters regarding use of student data can be addressed.
Other commenters suggested adding references to high school study-abroad programs as an example of a student enrichment activity and activities designed to reduce out-of-school suspensions and expulsions as a strategy for addressing school climate.
Section 14005(d)(1)(A) of the ARRA sets forth a condition for receiving a formula award from the State Fiscal Stabilization Fund; this requirement does not apply to section 14006 of the ARRA, which authorizes the Race to the Top program. Instead, criterion (F)(1)(i) is consistent with the waiver for the State Fiscal Stabilization Fund MOE requirement, which the Secretary has already granted to a number of States. The two-year comparison used in criterion (F)(1)(i) reflects the Department's understanding of the difficult choices that many States have been forced to make in the recent economic recession, while at the same time recognizing that States that have made education funding a priority in such difficult budgetary times are better positioned to successfully implement their Race to the Top plans.
Similarly, one commenter also asserted that many regular public schools demonstrate the creativity, innovation, and continuous improvement claimed by the proponents of charter schools.
Finally, we acknowledge that charter school operators do not have a monopoly on educational innovation (
We also are revising the minimum evidence States should submit in response to this criterion. Appendix A provides that such evidence should include, among other items, for each of the past five years: The number of charter school applications made in the State; the number of charter school applications approved; the number of charter school applications denied, and the reasons for the denials. This additional data will support an assessment of the rigor of a State's approval process. We are not, however, requiring in this final notice that this data be disaggregated by charter school authorizer, primarily because the very large number of LEA charter school authorizers in many States would make such disaggregation overly burdensome.
(a) For tested grades and subjects: (1) a student's score on the State's assessments under the ESEA; and, as appropriate, (2) other measures of student learning, such as those described in paragraph (b) of this definition, provided they are rigorous and comparable across classrooms.
(b) For non-tested grades and subjects: alternative measures of student learning and performance such as student scores on pre-tests and end-of-course tests; student performance on English language proficiency assessments; and other measures of student achievement that are rigorous and comparable across classrooms.
When inviting applications for a competition using one or more priorities, we designate the type of each priority as absolute, competitive preference, or invitational through a notice in the
To meet this priority, the State's application must comprehensively and coherently address all of the four education reform areas specified in the ARRA as well as the State Success Factors Criteria in order to demonstrate that the State and its participating LEAs are taking a systemic approach to education reform. The State must demonstrate in its application sufficient LEA participation and commitment to successfully implement and achieve the goals in its plans; and it must describe how the State, in collaboration with its participating LEAs, will use Race to the Top and other funds to increase student achievement, decrease the achievement gaps across student subgroups, and increase the rates at which students graduate from high school prepared for college and careers.
To meet this priority, the State's application must have a high-quality plan to address the need to (i) offer a rigorous course of study in mathematics, the sciences, technology, and engineering; (ii) cooperate with industry experts, museums, universities, research centers, or other STEM-capable community partners to prepare and assist teachers in integrating STEM content across grades and disciplines, in promoting effective and relevant instruction, and in offering applied learning opportunities for students; and (iii) prepare more students for advanced study and careers in the sciences, technology, engineering, and mathematics, including by addressing the needs of underrepresented groups and of women and girls in the areas of science, technology, engineering, and mathematics.
The Secretary is particularly interested in applications that include practices, strategies, or programs to improve educational outcomes for high-need students who are young children (pre-kindergarten through third grade) by enhancing the quality of preschool programs. Of particular interest are proposals that support practices that (i) improve school readiness (including social, emotional, and cognitive); and (ii) improve the transition between preschool and kindergarten.
The Secretary is particularly interested in applications in which the State plans to expand statewide longitudinal data systems to include or integrate data from special education programs, English language learner
The Secretary is also particularly interested in applications in which States propose working together to adapt one State's statewide longitudinal data system so that it may be used, in whole or in part, by one or more other States, rather than having each State build or continue building such systems independently.
The Secretary is particularly interested in applications in which the State plans to address how early childhood programs, K–12 schools, postsecondary institutions, workforce development organizations, and other State agencies and community partners (
The Secretary is particularly interested in applications in which the State's participating LEAs (as defined in this notice) seek to create the conditions for reform and innovation as well as the conditions for learning by providing schools with flexibility and autonomy in such areas as—
(i) Selecting staff;
(ii) Implementing new structures and formats for the school day or year that result in increased learning time (as defined in this notice);
(iii) Controlling the school's budget;
(iv) Awarding credit to students based on student performance instead of instructional time;
(v) Providing comprehensive services to high-need students (as defined in this notice) (
(vi) Creating school climates and cultures that remove obstacles to, and actively support, student engagement and achievement; and
(vii) Implementing strategies to effectively engage families and communities in supporting the academic success of their students.
The Secretary establishes the following requirements for this program.
A State must meet the following requirements in order to be eligible to receive funds under this program.
(a) The State's applications for funding under Phase 1 and Phase 2 of the State Fiscal Stabilization Fund program must be approved by the Department prior to the State being awarded a Race to the Top grant.
(b) At the time the State submits its application, there must not be any legal, statutory, or regulatory barriers at the State level to linking data on student achievement (as defined in this notice) or student growth (as defined in this notice) to teachers and principals for the purpose of teacher and principal evaluation.
(a) The State's application must be signed by the Governor, the State's chief school officer, and the president of the State board of education (if applicable). States will respond to this requirement in the application, Section III, Race to the Top Application Assurances. In addition, the assurances in Section IV must be signed by the Governor.
(b) The State must describe the progress it has made over the past several years in each of the four education reform areas (as described in criterion (A)(3)(i)).
(c) The State must include a budget that details how it will use grant funds and other resources to meet targets and perform related functions (as described in criterion (A)(2)(i)(d)), including how it will use funds awarded under this program to—
(1) Achieve its targets for improving student achievement and graduation rates and for closing achievement gaps (as described in criterion (A)(1)(iii)); the State must also describe its track record of improving student progress overall and by student subgroup (as described in criterion (A)(3)(ii)); and
(2) Give priority to high-need LEAs (as defined in this notice), in addition to providing 50 percent of the grant to participating LEAs (as defined in this notice) based on their relative shares of funding under Part A of Title I of the ESEA for the most recent year as required under section 14006(c) of the ARRA. (
(d) The State must provide, for each State Reform Conditions Criterion (listed in this notice) that it chooses to address, a description of the State's current status in meeting that criterion and, at a minimum, the information requested as supporting evidence for the criterion and the performance measures, if any (see Appendix A).
(e) The State must provide, for each Reform Plan Criterion (listed in this notice) that it chooses to address, a detailed plan for use of grant funds that includes, but need not be limited to—
(1) The key goals;
(2) The key activities to be undertaken and rationale for the activities, which should include why the specific activities are thought to bring about the change envisioned and how these activities are linked to the key goals;
(3) The timeline for implementing the activities;
(4) The party or parties responsible for implementing the activities;
(5) The information requested in the performance measures, where applicable (see Appendix A), and where the State proposes plans for reform efforts not covered by a specified performance measure, the State is encouraged to propose performance measures and annual targets for those efforts; and
(6) The information requested as supporting evidence, if any, for the criterion, together with any additional information the State believes will be
(f) The State must submit a certification from the State Attorney General that—
(1) The State's description of, and statements and conclusions concerning State law, statute, and regulation in its application are complete, accurate, and constitute a reasonable interpretation of State law, statute, and regulation; and
(2) At the time the State submits its application, the State does not have any legal, statutory, or regulatory barriers at the State level to linking data on student achievement or student growth to teachers and principals for the purpose of teacher and principal evaluation.
(g) When addressing issues relating to assessments required under the ESEA or subgroups in the selection criteria, the State must meet the following requirements:
(1) For student subgroups with respect to the NAEP, the State must provide data for the NAEP subgroups described in section 303(b)(2)(G) of the National Assessment of Educational Progress Authorization Act (20 U.S.C. 9622) (
(2) For student subgroups with respect to high school graduation rates, college enrollment and credit accumulation rates, and the assessments required under the ESEA, the State must provide data for the subgroups described in section 1111(b)(2)(C)(v)(II) of the ESEA (
(3) When asked to provide information regarding the assessments required under the ESEA, States should refer to section 1111(b)(3) of the ESEA; in addition, when describing this assessment data in the State's application, the State should note any factors (
A State receiving Race to the Top funds must submit to the Department an annual report which must include, in addition to the standard elements, a description of the State's and its LEAs' progress to date on their goals, timelines, and budgets, as well as actual performance compared to the annual targets the State established in its application with respect to each performance measure. Further, a State receiving funds under this program and its participating LEAs are accountable for meeting the goals, timelines, budget, and annual targets established in the application; adhering to an annual fund drawdown schedule that is tied to meeting these goals, timelines, budget, and annual targets; and fulfilling and maintaining all other conditions for the conduct of the project. The Department will monitor a State's and its participating LEAs' progress in meeting the State's goals, timelines, budget, and annual targets and in fulfilling other applicable requirements. In addition, the Department may collect additional data as part of a State's annual reporting requirements.
To support a collaborative process between the State and the Department, the Department may require that applicants who are selected to receive an award enter into a written performance or cooperative agreement with the Department. If the Department determines that a State is not meeting its goals, timelines, budget, or annual targets or is not fulfilling other applicable requirements, the Department will take appropriate action, which could include a collaborative process between the Department and the State, or enforcement measures with respect to this grant, such as placing the State in high-risk status, putting the State on reimbursement payment status, or delaying or withholding funds.
A State that receives Race to the Top funds must also meet the reporting requirements that apply to all ARRA-funded programs. Specifically, the State must submit reports, within 10 days after the end of each calendar quarter, that contain the information required under section 1512(c) of the ARRA in accordance with any guidance issued by the Office of Management and Budget or the Department (ARRA Division A, Section 1512(c)).
In addition, for each year of the program, the State will submit a report to the Secretary, at such time and in such manner as the Secretary may require, that describes:
○ The uses of funds within the State;
○ how the State distributed the funds it received;
○ the number of jobs that the Governor estimates were saved or created with the funds;
○ the State's progress in reducing inequities in the distribution of highly qualified teachers, implementing a State longitudinal data system, and developing and implementing valid and reliable assessments for English language learners and students with disabilities; and
○ if applicable, a description of each modernization, renovation, or repair project approved in the State application and funded, including the amounts awarded and project costs (ARRA Division A, Section 14008).
The Department anticipates that the national evaluations will involve such components as—
• Surveys of States, LEAs, and/or schools, which will help identify how program funding is spent and the specific efforts and activities that are underway within each of the four education reform areas and across selected ARRA-funded programs;
• Case studies of promising practices in States, LEAs, and/or schools through surveys and other mechanisms; and
• Evaluations of outcomes, focusing on student achievement and other performance measures, to determine the impact of the reforms implemented under Race to the Top.
Race to the Top grantee States are not required to conduct independent evaluations, but may propose, within their applications, to use funds from Race to the Top to support such evaluations. Grantees must make available, through formal (
The Secretary establishes the following criteria for reviewing applications submitted under this program. In the Scoring Rubric, in Appendix B, the Secretary establishes the maximum number of points assigned to each criterion.
(A)(1)
(i) The State has set forth a comprehensive and coherent reform agenda that clearly articulates its goals for implementing reforms in the four education areas described in the ARRA and improving student outcomes statewide, establishes a clear and credible path to achieving these goals, and is consistent with the specific reform plans that the State has proposed throughout its application;
(ii) The participating LEAs (as defined in this notice) are strongly committed to the State's plans and to effective implementation of reform in the four education areas, as evidenced by Memoranda of Understanding (MOUs) (as set forth in Appendix D)
(a) Terms and conditions that reflect strong commitment by the participating LEAs (as defined in this notice) to the State's plans;
(b) Scope-of-work descriptions that require participating LEAs (as defined in this notice) to implement all or significant portions of the State's Race to the Top plans; and
(c) Signatures from as many as possible of the LEA superintendent (or equivalent), the president of the local school board (or equivalent, if applicable), and the local teachers' union leader (if applicable) (one signature of which must be from an authorized LEA representative) demonstrating the extent of leadership support within participating LEAs (as defined in this notice); and
(iii) The LEAs that are participating in the State's Race to the Top plans (including considerations of the numbers and percentages of participating LEAs, schools, K–12 students, and students in poverty) will translate into broad statewide impact, allowing the State to reach its ambitious yet achievable goals, overall and by student subgroup, for—
(a) Increasing student achievement in (at a minimum) reading/language arts and mathematics, as reported by the NAEP and the assessments required under the ESEA;
(b) Decreasing achievement gaps between subgroups in reading/language arts and mathematics, as reported by the NAEP and the assessments required under the ESEA;
(c) Increasing high school graduation rates (as defined in this notice); and
(d) Increasing college enrollment (as defined in this notice) and increasing the number of students who complete at least a year's worth of college credit that is applicable to a degree within two years of enrollment in an institution of higher education.
(A)(2)
(i) Ensure that it has the capacity required to implement its proposed plans by—
(a) Providing strong leadership and dedicated teams to implement the statewide education reform plans the State has proposed;
(b) Supporting participating LEAs (as defined in this notice) in successfully implementing the education reform plans the State has proposed, through such activities as identifying promising practices, evaluating these practices' effectiveness, ceasing ineffective practices, widely disseminating and replicating the effective practices statewide, holding participating LEAs (as defined in this notice) accountable for progress and performance, and intervening where necessary;
(c) Providing effective and efficient operations and processes for implementing its Race to the Top grant in such areas as grant administration and oversight, budget reporting and monitoring, performance measure tracking and reporting, and fund disbursement;
(d) Using the funds for this grant, as described in the State's budget and accompanying budget narrative, to accomplish the State's plans and meet its targets, including, where feasible, by coordinating, reallocating, or repurposing education funds from other Federal, State, and local sources so that they align with the State's Race to the Top goals; and
(e) Using the fiscal, political, and human capital resources of the State to continue, after the period of funding has ended, those reforms funded under the grant for which there is evidence of success; and
(ii) Use support from a broad group of stakeholders to better implement its plans, as evidenced by the strength of statements or actions of support from—
(a) The State's teachers and principals, which include the State's teachers' unions or statewide teacher associations; and
(b) Other critical stakeholders, such as the State's legislative leadership; charter school authorizers and State charter school membership associations (if applicable); other State and local leaders (
(A)(3)
(i) Make progress over the past several years in each of the four education reform areas, and used its ARRA and
(ii) Improve student outcomes overall and by student subgroup since at least 2003, and explain the connections between the data and the actions that have contributed to—
(a) Increasing student achievement in reading/language arts and mathematics, both on the NAEP and on the assessments required under the ESEA;
(b) Decreasing achievement gaps between subgroups in reading/language arts and mathematics, both on the NAEP and on the assessments required under the ESEA; and
(c) Increasing high school graduation rates.
(B)(1)
(i) The State's participation in a consortium of States that—
(a) Is working toward jointly developing and adopting a common set of K–12 standards (as defined in this notice) that are supported by evidence that they are internationally benchmarked and build toward college and career readiness by the time of high school graduation; and
(b) Includes a significant number of States; and
(ii)(a) For Phase 1 applications, the State's high-quality plan demonstrating its commitment to and progress toward adopting a common set of K–12 standards (as defined in this notice) by August 2, 2010, or, at a minimum, by a later date in 2010 specified by the State, and to implementing the standards thereafter in a well-planned way; or
(b) For Phase 2 applications, the State's adoption of a common set of K–12 standards (as defined in this notice) by August 2, 2010, or, at a minimum, by a later date in 2010 specified by the State in a high-quality plan toward which the State has made significant progress, and its commitment to implementing the standards thereafter in a well-planned way.
(B)(2)
(i) Is working toward jointly developing and implementing common, high-quality assessments (as defined in this notice) aligned with the consortium's common set of K–12 standards (as defined in this notice); and
(ii) Includes a significant number of States.
(B)(3)
(C)(1)
(C)(2)
(C)(3)
(i) Increase the acquisition, adoption, and use of local instructional improvement systems (as defined in this notice) that provide teachers, principals, and administrators with the information and resources they need to inform and improve their instructional practices, decision-making, and overall effectiveness;
(ii) Support participating LEAs (as defined in this notice) and schools that are using instructional improvement systems (as defined in this notice) in providing effective professional development to teachers, principals, and administrators on how to use these systems and the resulting data to support continuous instructional improvement; and
(iii) Make the data from instructional improvement systems (as defined in this notice), together with statewide longitudinal data system data, available and accessible to researchers so that they have detailed information with which to evaluate the effectiveness of instructional materials, strategies, and approaches for educating different types of students (
(D)(1)
(i) Legal, statutory, or regulatory provisions that allow alternative routes to certification (as defined in this notice) for teachers and principals, particularly routes that allow for providers in addition to institutions of higher education;
(ii) Alternative routes to certification (as defined in this notice) that are in use; and
(iii) A process for monitoring, evaluating, and identifying areas of
(D)(2)
(i) Establish clear approaches to measuring student growth (as defined in this notice) and measure it for each individual student;
(ii) Design and implement rigorous, transparent, and fair evaluation systems for teachers and principals that (a) differentiate effectiveness using multiple rating categories that take into account data on student growth (as defined in this notice) as a significant factor, and (b) are designed and developed with teacher and principal involvement;
(iii) Conduct annual evaluations of teachers and principals that include timely and constructive feedback; as part of such evaluations, provide teachers and principals with data on student growth for their students, classes, and schools; and
(iv) Use these evaluations, at a minimum, to inform decisions regarding—
(a) Developing teachers and principals, including by providing relevant coaching, induction support, and/or professional development;
(b) Compensating, promoting, and retaining teachers and principals, including by providing opportunities for highly effective teachers and principals (both as defined in this notice) to obtain additional compensation and be given additional responsibilities;
(c) Whether to grant tenure and/or full certification (where applicable) to teachers and principals using rigorous standards and streamlined, transparent, and fair procedures; and
(d) Removing ineffective tenured and untenured teachers and principals after they have had ample opportunities to improve, and ensuring that such decisions are made using rigorous standards and streamlined, transparent, and fair procedures.
(D)(3)
(i) Ensure the equitable distribution of teachers and principals by developing a plan, informed by reviews of prior actions and data, to ensure that students in high-poverty and/or high-minority schools (both as defined in this notice) have equitable access to highly effective teachers and principals (both as defined in this notice) and are not served by ineffective teachers and principals at higher rates than other students; and
(ii) Increase the number and percentage of effective teachers (as defined in this notice) teaching hard-to-staff subjects and specialty areas including mathematics, science, and special education; teaching in language instruction educational programs (as defined under Title III of the ESEA); and teaching in other areas as identified by the State or LEA.
Plans for (i) and (ii) may include, but are not limited to, the implementation of incentives and strategies in such areas as recruitment, compensation, teaching and learning environments, professional development, and human resources practices and processes.
(D)(4)
(i) Link student achievement and student growth (both as defined in this notice) data to the students' teachers and principals, to link this information to the in-State programs where those teachers and principals were prepared for credentialing, and to publicly report the data for each credentialing program in the State; and
(ii) Expand preparation and credentialing options and programs that are successful at producing effective teachers and principals (both as defined in this notice).
(D)(5)
(i) Provide effective, data-informed professional development, coaching, induction, and common planning and collaboration time to teachers and principals that are, where appropriate, ongoing and job-embedded. Such support might focus on, for example, gathering, analyzing, and using data; designing instructional strategies for improvement; differentiating instruction; creating school environments supportive of data-informed decisions; designing instruction to meet the specific needs of high-need students (as defined in this notice); and aligning systems and removing barriers to effective implementation of practices designed to improve student learning outcomes; and
(ii) Measure, evaluate, and continuously improve the effectiveness of those supports in order to improve student achievement (as defined in this notice).
(E)(1)
(E)(2)
(i) Identify the persistently lowest-achieving schools (as defined in this notice) and, at its discretion, any non-Title I eligible secondary schools that would be considered persistently lowest-achieving schools (as defined in this notice) if they were eligible to receive Title I funds; and
(ii) Support its LEAs in turning around these schools by implementing one of the four school intervention models (as described in Appendix C): Turnaround model, restart model, school closure, or transformation model (provided that an LEA with more than nine persistently lowest-achieving schools may not use the transformation model for more than 50 percent of its schools).
(F)(1)
(i) The percentage of the total revenues available to the State (as defined in this notice) that were used to support elementary, secondary, and public higher education for FY 2009 was greater than or equal to the percentage of the total revenues available to the State (as defined in this notice) that were used to support elementary, secondary, and public higher education for FY 2008; and
(ii) The State's policies lead to equitable funding (a) between high-need LEAs (as defined in this notice) and other LEAs, and (b) within LEAs,
(F)(2)
(i) The State has a charter school law that does not prohibit or effectively inhibit increasing the number of high-performing charter schools (as defined in this notice) in the State, measured (as set forth in Appendix B) by the percentage of total schools in the State that are allowed to be charter schools or otherwise restrict student enrollment in charter schools;
(ii) The State has laws, statutes, regulations, or guidelines regarding how charter school authorizers approve, monitor, hold accountable, reauthorize, and close charter schools; in particular, whether authorizers require that student achievement (as defined in this notice) be one significant factor, among others, in authorization or renewal; encourage charter schools that serve student populations that are similar to local district student populations, especially relative to high-need students (as defined in this notice); and have closed or not renewed ineffective charter schools;
(iii) The State's charter schools receive (as set forth in Appendix B) equitable funding compared to traditional public schools, and a commensurate share of local, State, and Federal revenues;
(iv) The State provides charter schools with funding for facilities (for leasing facilities, purchasing facilities, or making tenant improvements), assistance with facilities acquisition, access to public facilities, the ability to share in bonds and mill levies, or other supports; and the extent to which the State does not impose any facility-related requirements on charter schools that are stricter than those applied to traditional public schools; and
(v) The State enables LEAs to operate innovative, autonomous public schools (as defined in this notice) other than charter schools.
(F)(3)
To identify the lowest-achieving schools, a State must take into account both (i) The academic achievement of the “all students” group in a school in terms of proficiency on the State's assessments under section 1111(b)(3) of the ESEA in reading/language arts and mathematics combined; and (ii) The school's lack of progress on those assessments over a number of years in the “all students” group.
(a) For tested grades and subjects: (1) A student's score on the State's assessments under the ESEA; and, as appropriate, (2) other measures of student learning, such as those described in paragraph (b) of this definition, provided they are rigorous and comparable across classrooms.
(b) For non-tested grades and subjects: Alternative measures of student learning and performance such as student scores on pre-tests and end-of-course tests; student performance on English language proficiency assessments; and other measures of student achievement that are rigorous and comparable across classrooms.
This notice does not preclude us from proposing additional priorities, requirements, definitions, or selection criteria, subject to meeting applicable rulemaking requirements.
This notice does not solicit applications. In any year in which we choose to use these priorities, requirements, definitions, and selection criteria, we invite applications through a notice in the
Under Executive Order 12866, the Secretary must determine whether this regulatory action is “significant” and therefore subject to the requirements of the Executive Order and subject to review by OMB. Section 3(f) of Executive Order 12866 defines a “significant regulatory action” as an action likely to result in a rule that may (1) have an annual effect on the economy of $100 million or more, or adversely affect a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local or tribal governments, or communities in a material way (also referred to as an “economically significant” rule); (2) create serious inconsistency or otherwise interfere with an action taken or planned by another agency; (3) materially alter the budgetary impacts of entitlement grants, user fees, or loan programs or the rights and obligations of recipients thereof; or (4) raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in the Executive Order. Pursuant to the Executive Order, it has been determined that this regulatory action will have an annual effect on the economy of more than $100 million because the amount of government transfers provided through the Race to the Top Fund will exceed that amount. Therefore, this action is “economically significant” and subject to OMB review under section 3(f)(1) of the Executive Order.
The potential costs associated with this regulatory action are those resulting from statutory requirements and those we have determined as necessary for administering this program effectively and efficiently.
In assessing the potential costs and benefits—both quantitative and qualitative—of this regulatory action, we have determined that the benefits of the final priorities, requirements, definitions, and criteria justify the costs.
We have determined, also, that this regulatory action does not unduly interfere with State, local, and tribal governments in the exercise of their governmental functions.
These final priorities, requirements, definitions, and criteria are needed to implement the Race to the Top program. The Secretary does not believe that the statute, by itself, provides a sufficient level of detail to ensure that Race to the Top truly serves as a mechanism for driving significant education reform in the States. The authorizing language is very brief, and we believe the Congress likely expected the Secretary to augment this language, through rulemaking, in order to give greater meaning to the statutory provisions. Additionally, the statute expressly provides the Secretary the authority to require States to include in their application such information as the Secretary may reasonably require and to determine which States receive grants on the basis of other criteria as the Secretary determines appropriate.
In the absence of specific criteria for Race to the Top grants, the Department would use the general criteria in 34 CFR 75.210 of the Education Department General Administrative Regulations in selecting States to receive grants. The Secretary does not believe the use of those general criteria would be appropriate for the Race to the Top competition, because they do not focus on the educational reforms that States must be implementing in order to receive a Race to the Top grant, on the specific uses of funds under Race to the Top, or on the plans that the Secretary believes States should develop for their Race to the Top grants.
The Department believes that the final priorities, requirements, definitions, and selection criteria will not impose significant costs on States, or on the LEAs and other entities that will receive assistance through the Race to the Top Fund. As discussed elsewhere, this final regulatory action is intended to create a framework for the award of approximately $4 billion in support of State and local efforts to implement critical educational reforms and to making substantial gains in student achievement, closing achievement gaps, improving high school graduation rates, and ensuring student preparation for success in college and careers. Without promulgation of priorities, requirements, definitions, and criteria for the Race to the Top competition, the Department would not have clear and defensible criteria for making very large grants to States.
The Department believes that the costs imposed on States by the final priorities, requirements, definitions, and selection criteria will be limited to the paperwork burden discussed elsewhere in this notice. The benefits conveyed on a State through its receipt of a grant will greatly exceed those costs. In addition, even States that apply but are unsuccessful in the competition may derive benefits, as the process of working with LEAs and other stakeholders on the State application may help accelerate the pace of education reforms in the State.
As required by OMB Circular A–4 (available at
As previously explained, ARRA provides approximately $4.3 billion for the Race to the Top Fund (referred to in
The application requirements and criteria finalized in this notice will require the collection of information that is subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501–3520). The Department has received emergency approval for the information collections described below under Information Collection Reference Number 200910–1810–004.
There are seven application requirements that States must meet when submitting their applications:
(a) Required signatures.
(b) Progress in the four education reform areas (as described in criterion (A)(3)(i)).
(c) The State's proposed budget (as described in criterion (A)(2)(i)(d)), including how it will (1) Achieve its targets (as described in criterion (A)(1)(iii)) and (2) give priority to high-need LEAs.
(d) Required information for State Reform Conditions Criteria.
(e) Required information for Reform Plan Criteria.
(f) Attorney General certification.
(g) Required information for addressing issues relating to assessments required under the ESEA or subgroups.
(Please see the Application Requirements section for detailed descriptions.)
There are 19 criteria that States may address when submitting their applications. These are—
(A)(1)
(A)(2)
(A)(3)
(B)(1)
(B)(2)
(B)(3)
(C)(1)
(C)(2)
(C)(3)
(D)(1)
(D)(2)
(D)(3)
(D)(4)
(D)(5)
(E)(1)
(E)(2)
(F)(1)
(F)(2)
(F)(3)
(Please see the “Selection Criteria” section for detailed descriptions.)
We estimate that each SEA would spend approximately 681 hours of staff time to address the application requirements and criteria, prepare the application, and obtain necessary clearances. This estimate has increased slightly from the estimate of 642 hours in the NPP due to changes in the criteria. The total number of hours for all 52 SEAs is an estimated 35,412 hours (52 SEAs (the 50 States plus the District of Columbia and Puerto Rico) times 681 hours equals 35,412 hours). We estimate the average total cost per hour of the State-level staff who carry out this work to be $30.00 an hour. The total estimated cost for all States would be $1,062,360 ($30.00 × 35,412 hours = $1,062,360).
This document provides early notification of our specific plans and actions for this program.
• An example of the State's standard Participating LEA MOU, and description of variations used, if any.
• The completed summary table indicating which specific portions of the State's plan each LEA is committed to implementing, and relevant summary statistics (see Summary Table for (A)(1)(ii)(b)).
• The completed summary table indicating which LEA leadership signatures have been obtained (see Summary Table for (A)(1)(ii)(c)).
• The completed summary table indicating the numbers and percentages of participating LEAs, schools, K–12 students, and students in poverty (see Summary Table for (A)(1)(iii)).
• Tables and graphs that show the State's goals, overall and by subgroup, requested in the criterion, together with the supporting narrative. In addition, describe what the goals would look like were the State not to receive an award under this program.
• The completed detailed table, by LEA, that includes the information requested in the criterion (see Detailed Table for (A)(1)).
• None required.
• The State's budget, as completed in Section XI of the application. The narrative that accompanies and explains the budget and how it connects to the State's plan, as completed in Section XI of the application.
• A summary in the narrative of the statements or actions and inclusion of key statements or actions in the Appendix.
• None required.
NAEP and ESEA results since at least 2003. Include in the Appendix all the data requested in the criterion as a resource for peer reviewers for each year in which a test was given or data was collected. Note that this data will be used for reference only and can be in raw format. In the narrative, provide the analysis of this data and any tables or graphs that best support the narrative.
• None required.
• A copy of the Memorandum of Agreement, executed by the State, showing that it is part of a standards consortium.
• A copy of the final standards or, if the standards are not yet final, a copy of the draft standards and anticipated date for completing the standards.
• Documentation that the standards are or will be internationally benchmarked and that, when well-implemented, will help to ensure that students are prepared for college and careers.
• The number of States participating in the standards consortium and the list of these States.
For Phase 1 applicants:
• A description of the legal process in the State for adopting standards, and the State's plan, current progress, and timeframe for adoption.
For Phase 2 applicants:
• Evidence that the State has adopted the standards. Or, if the State has not yet adopted the standards, a description of the legal process in the State for adopting standards and the State's plan, current progress, and timeframe for adoption.
• None required.
• A copy of the Memorandum of Agreement, executed by the State, showing that it is part of a consortium that intends to develop high-quality assessments (as defined in this notice) aligned with the consortium's common set of K–12 standards; or documentation that the State's consortium has applied, or intends to apply, for a grant through the separate Race to the Top Assessment Program (to be described in a subsequent notice); or other evidence of the State's plan to develop and adopt common, high-quality assessments (as defined in this notice).
• The number of States participating in the assessment consortium and the list of these States.
• None required.
• Any supporting evidence the State believes will be helpful to peer reviewers.
• Optional.
• Documentation for each of the America COMPETES Act elements (as defined in this notice) that is included in the State's statewide longitudinal data system.
• None required.
• Any supporting evidence the State believes will be helpful to peer reviewers.
• Optional.
• Any supporting evidence the State believes will be helpful to peer reviewers.
• Optional.
• A description of the State's applicable laws, statutes, regulations, or other relevant legal documents, including information on the elements of the State's alternative routes (as described in the alternative routes to certification definition in this notice).
• A list of the alternative certification programs operating in the State under the State's alternative routes to certification (as defined in this notice), and for each:
○ The elements of the program (as described in the alternative routes to certification definition in this notice).
○ The number of teachers and principals that successfully completed each program in the previous academic year.
○ The total number of teachers and principals certified statewide in the previous academic year.
• None required.
• Any supporting evidence the State believes will be helpful to peer reviewers.
General goals to be provided at time of application, including baseline data and annual targets:
• (D)(2)(i) Percentage of participating LEAs that measure student growth (as defined in this notice).
• (D)(2)(ii) Percentage of participating LEAs with qualifying evaluation systems for teachers.
• (D)(2)(ii) Percentage of participating LEAs with qualifying evaluation systems for principals.
• (D)(2)(iv) Percentage of participating LEAs with qualifying evaluation systems that are used to inform:
○ (D)(2)(iv)(a) Developing teachers and principals.
○ (D)(2)(iv)(b) Compensating teachers and principals.
○ (D)(2)(iv)(b) Promoting teachers and principals.
○ (D)(2)(iv)(b) Retaining effective teachers and principals.
○ (D)(2)(iv)(c) Granting tenure and/or full certification (where applicable) to teachers and principals.
○ (D)(2)(iv)(d) Removing ineffective tenured and untenured teachers and principals.
General data to be provided at time of application, including baseline data:
• Total number of participating LEAs.
• Total number of principals in participating LEAs.
• Total number of teachers in participating LEAs.
Data to be requested of grantees in the future:
• (D)(2)(ii) Number of teachers and principals in participating LEAs with qualifying evaluation systems.
• (D)(2)(iii) Number of teachers and principals in participating LEAs with qualifying evaluation systems who were evaluated as effective or better in the prior academic year.
• (D)(2)(iii) Number of teachers and principals in participating LEAs with qualifying evaluation systems who were evaluated as ineffective in the prior academic year.
• (D)(2)(iv)(b) Number of teachers and principals in participating LEAs with qualifying evaluation systems whose evaluations were used to inform compensation decisions in the prior academic year.
• (D)(2)(iv)(b) Number of teachers and principals in participating LEAs with qualifying evaluation systems who were evaluated as effective or better and were retained in the prior academic year.
• (D)(2)(iv)(c) Number of teachers in participating LEAs with qualifying evaluation systems who were eligible for tenure in the prior academic year.
• (D)(2)(iv)(c) Number of teachers in participating LEAs with qualifying evaluation systems whose evaluations were used to inform tenure decisions in the prior academic year.
• (D)(2)(iv)(d) Number of teachers and principals in participating LEAs who were removed for being ineffective in the prior academic year.
• Definitions of high-minority and low-minority schools as defined by the State for the purposes of the State's Teacher Equity Plan.
All information below is requested for Participating LEAs.
Performance Measures for (D)(3)(i):
General goals to be provided at time of application, including baseline data and annual targets:
• Percentage of teachers in schools that are high-poverty, high-minority, or both (as defined in this notice) who are highly effective (as defined in this notice).
• Percentage of teachers in schools that are low-poverty, low-minority, or both (as defined in this notice) who are highly effective (as defined in this notice).
• Percentage of teachers in schools that are high-poverty, high-minority, or both (as defined in this notice) who are ineffective.
• Percentage of teachers in schools that are low-poverty, low-minority, or both (as defined in this notice) who are ineffective.
• Percentage of principals leading schools that are high-poverty, high-minority, or both (as defined in this notice) who are highly effective (as defined in this notice).
• Percentage of principals leading schools that are low-poverty, low-minority, or both (as defined in this notice) who are highly effective (as defined in this notice).
• Percentage of principals leading schools that are high-poverty, high-minority, or both (as defined in this notice) who are ineffective.
• Percentage of principals leading schools that are low-poverty, low-minority, or both (as defined in this notice) who are ineffective.
General data to be provided at time of application, including baseline data:
• Total number of schools that are high-poverty, high-minority, or both (as defined in this notice).
• Total number of schools that are low-poverty, low-minority, or both (as defined in this notice).
• Total number of teachers in schools that are high-poverty, high-minority, or both (as defined in this notice).
• Total number of teachers in schools that are low-poverty, low-minority, or both (as defined in this notice).
• Total number of principals leading schools that are high-poverty, high-minority, or both (as defined in this notice).
• Total number of principals leading schools that are low-poverty, low-minority, or both (as defined in this notice).
Data to be requested of grantees in the future:
• Number of teachers and principals in schools that are high-poverty, high-minority, or both (as defined in this notice) who were evaluated as highly effective (as defined in this notice) in the prior academic year.
• Number of teachers and principals in schools that are high-poverty, high-minority, or both (as defined in this notice) who were evaluated as ineffective in the prior academic year.
• Number of teachers and principals in schools that are low-poverty, low-minority, or both (as defined in this notice) who were evaluated as highly effective (as defined in this notice) in the prior academic year.
• Number of teachers and principals in schools that are low-poverty, low-minority, or both (as defined in this notice) who were evaluated as ineffective in the prior academic year.
General goals to be provided at time of application, including baseline data and annual targets:
• Percentage of mathematics teachers who were evaluated as effective or better.
• Percentage of science teachers who were evaluated as effective or better.
• Percentage of special education teachers who were evaluated as effective or better.
• Percentage of teachers in language instruction educational programs who were evaluated as effective or better.
General data to be provided at time of application, including baseline data:
• Total number of mathematics teachers.
• Total number of science teachers.
• Total number of special education teachers.
• Total number of teachers in language instruction educational programs.
Data to be requested of grantees in the future:
• Number of mathematics teachers in participating LEAs who were evaluated as effective or better in the prior academic year.
• Number of science teachers in participating LEAs who were evaluated as effective or better in the prior academic year.
• Number of special education teachers in participating LEAs who were evaluated as effective or better in the prior academic year.
• Number of teachers in language instruction educational programs in participating LEAs who were evaluated as effective or better in the prior academic year.
• Any supporting evidence the State believes will be helpful to peer reviewers.
General goals to be provided at time of application, including baseline data and annual targets:
• Percentage of teacher preparation programs in the State for which the public can access data on the achievement and growth (as defined in this notice) of the graduates' students.
• Percentage of principal preparation programs in the State for which the public can access data on the achievement and growth (as defined in this notice) of the graduates' students.
General data to be provided at time of application, including baseline data:
• Total number of teacher credentialing programs in the State.
• Total number of principal credentialing programs in the State.
• Total number of teachers in the State.
• Total number of principals in the State.
Data to be requested of grantees in the future:
• Number of teacher credentialing programs in the State for which the information (as described in the criterion) is publicly reported.
• Number of teachers prepared by each credentialing program in the State for which the information (as described in the criterion) is publicly reported.
• Number of principal credentialing programs in the State for which the information (as described in the criterion) is publicly reported.
• Number of principals prepared by each credentialing program in the State for which the information (as described in the criterion) is publicly reported.
• Number of teachers in the State whose data are aggregated to produce publicly available reports on the State's credentialing programs.
• Number of principals in the State whose data are aggregated to produce publicly available reports on the State's credentialing programs.
• Any supporting evidence the State believes will be helpful to peer reviewers.
• Optional.
• A description of the State's applicable laws, statutes, regulations, or other relevant legal documents.
• None required.
• The State's historic performance on school turnaround, as evidenced by the total number of persistently lowest-achieving schools (as defined in this notice) that States or LEAs attempted to turn around in the last five years, the approach used, and the results and lessons learned to date.
• The number of schools for which one of the four school intervention models (described in Appendix C) will be initiated each year.
• Financial data to show whether and to what extent expenditures, as a percentage of the total revenues available to the State (as defined in this notice), increased, decreased, or remained the same.
• Any supporting evidence the State believes will be helpful to peer reviewers.
• None required.
• A description of the State's applicable laws, statutes, regulations, or other relevant legal documents.
• The number of charter schools allowed under State law and the percentage this represents of the total number of schools in the State.
• The number and types of charter schools currently operating in the State.
• A description of the State's approach to charter school accountability and authorization, and a description of the State's applicable laws, statutes, regulations, or other relevant legal documents.
• For each of the last five years:
○ The number of charter school applications made in the State.
○ The number of charter school applications approved.
○ The number of charter school applications denied and reasons for the denials (academic, financial, low enrollment, other).
○ The number of charter schools closed (including charter schools that were not reauthorized to operate).
○ The reasons for the closures or non-renewals (academic, financial, low enrollment, other).
• A description of the State's applicable statutes, regulations, or other relevant legal documents.
• A description of the State's approach to charter school funding, the amount of funding passed through to charter schools per student, and how those amounts compare with traditional public school per-student funding allocations.
• A description of the State's applicable statutes, regulations, or other relevant legal documents.
• A description of the statewide facilities supports provided to charter schools, if any.
• A description of how the State enables LEAs to operate innovative, autonomous public schools (as defined in this notice) other than charter schools.
• None required.
• A description of the State's other applicable key education laws, statutes, regulations, or relevant legal documents.
• None required.
There are four school intervention models referred to in Selection Criterion (E)(2): Turnaround model, restart model, school closure, or transformation model. Each is described below.
(a)
(i) Replace the principal and grant the principal sufficient operational flexibility (including in staffing, calendars/time, and budgeting) to implement fully a comprehensive approach in order to substantially improve student achievement outcomes and increase high school graduation rates;
(ii) Using locally adopted competencies to measure the effectiveness of staff who can work within the turnaround environment to meet the needs of students,
(A) Screen all existing staff and rehire no more than 50 percent; and
(B) Select new staff;
(iii) Implement such strategies as financial incentives, increased opportunities for promotion and career growth, and more flexible work conditions that are designed to recruit, place, and retain staff with the skills necessary to meet the needs of the students in the turnaround school;
(iv) Provide staff with ongoing, high-quality, job-embedded professional development that is aligned with the school's comprehensive instructional program and designed with school staff to ensure that they are equipped to facilitate effective teaching and learning and have the capacity to successfully implement school reform strategies;
(v) Adopt a new governance structure, which may include, but is not limited to, requiring the school to report to a new “turnaround office” in the LEA or SEA, hire a “turnaround leader” who reports directly to the Superintendent or Chief Academic Officer, or enter into a multi-year contract with the LEA or SEA to obtain added flexibility in exchange for greater accountability;
(vi) Use data to identify and implement an instructional program that is research-based and “vertically aligned” from one grade to the next as
(vii) Promote the continuous use of student data (such as from formative, interim, and summative assessments) to inform and differentiate instruction in order to meet the academic needs of individual students;
(viii) Establish schedules and implement strategies that provide increased learning time (as defined in this notice); and
(ix) Provide appropriate social-emotional and community-oriented services and supports for students.
(2) A turnaround model may also implement other strategies such as—
(i) Any of the required and permissible activities under the transformation model; or
(ii) A new school model (
(b)
(c)
(d)
(1)
(i)
(A) Replace the principal who led the school prior to commencement of the transformation model;
(B) Use rigorous, transparent, and equitable evaluation systems for teachers and principals that—
(
(
(C) Identify and reward school leaders, teachers, and other staff who, in implementing this model, have increased student achievement and high-school graduation rates and identify and remove those who, after ample opportunities have been provided for them to improve their professional practice, have not done so;
(D) Provide staff with ongoing, high-quality, job-embedded professional development (
(E) Implement such strategies as financial incentives, increased opportunities for promotion and career growth, and more flexible work conditions that are designed to recruit, place, and retain staff with the skills necessary to meet the needs of the students in a transformation school.
(ii)
(A) Providing additional compensation to attract and retain staff with the skills necessary to meet the needs of the students in a transformation school;
(B) Instituting a system for measuring changes in instructional practices resulting from professional development; or
(C) Ensuring that the school is not required to accept a teacher without the mutual consent of the teacher and principal, regardless of the teacher's seniority.
(2)
(i)
(A) Use data to identify and implement an instructional program that is research-based and “vertically aligned” from one grade to the next as well as aligned with State academic standards; and
(B) Promote the continuous use of student data (such as from formative, interim, and summative assessments) to inform and differentiate instruction in order to meet the academic needs of individual students.
(ii)
(A) Conducting periodic reviews to ensure that the curriculum is being implemented with fidelity, is having the intended impact on student achievement, and is modified if ineffective;
(B) Implementing a schoolwide “response-to-intervention” model;
(C) Providing additional supports and professional development to teachers and principals in order to implement effective strategies to support students with disabilities in the least restrictive environment and to ensure that limited English proficient students acquire language skills to master academic content;
(D) Using and integrating technology-based supports and interventions as part of the instructional program; and
(E) In secondary schools—
(
(
(
(
(3)
(i)
(A) Establish schedules and implement strategies that provide increased learning time (as defined in this notice); and
(B) Provide ongoing mechanisms for family and community engagement.
(ii)
(A) Partnering with parents and parent organizations, faith- and community-based organizations, health clinics, other State or local agencies, and others to create safe school environments that meet students' social, emotional, and health needs;
(B) Extending or restructuring the school day so as to add time for such strategies as advisory periods that build relationships between students, faculty, and other school staff;
(C) Implementing approaches to improve school climate and discipline, such as implementing a system of positive behavioral supports or taking steps to eliminate bullying and student harassment; or
(D) Expanding the school program to offer full-day kindergarten or pre-kindergarten.
(4)
(i)
(A) Give the school sufficient operational flexibility (such as staffing, calendars/time, and budgeting) to implement fully a comprehensive approach to substantially improve student achievement outcomes and increase high school graduation rates; and
(B) Ensure that the school receives ongoing, intensive technical assistance and related support from the LEA, the SEA, or a designated external lead partner organization (such as a school turnaround organization or an EMO).
(ii)
(A) Allowing the school to be run under a new governance arrangement, such as a turnaround division within the LEA or SEA; or
(B) Implementing a per-pupil school-based budget formula that is weighted based on student needs.
If a school identified as a persistently lowest-achieving school has implemented, in whole or in part within the last two years, an intervention that meets the requirements of the turnaround, restart, or transformation models, the school may continue or complete the intervention being implemented.
Participating LEAs (as defined in this notice) in a State's Race to the Top plans are required to enter into a Memorandum of Understanding (MOU) or other binding agreement with the State that specifies the scope of the work being implemented by the participating LEA (as defined in this notice).
To support States in working efficiently with LEAs to determine which LEAs will participate in the State's Race to the Top application, the U.S. Department of Education has produced a model MOU, which is attached. This model MOU may serve as a template for States; however, States are not required to use it. They may use a different document that includes the key features noted below and in the model, and they should consult with their State and local attorneys on what is most appropriate for their State that includes, at a minimum, these key elements.
The purpose of the model MOU is to help to specify a relationship that is specific to Race to the Top and is not meant to detail all typical aspects of State/LEA grant management or administration. At a minimum, a strong MOU should include the following, each of which is described in detail below: (i) Terms and conditions; (ii) a scope of work; and, (iii) signatures.
(i) Terms and conditions: Each participating LEA (as defined in this notice) should sign a standard set of terms and conditions that includes, at a minimum, key roles and responsibilities of the State and the LEA; State recourse for LEA non-performance; and assurances that make clear what the participating LEA (as defined in this notice) is agreeing to do.
(ii) Scope of work: MOUs should include a scope of work (included in the model MOU as Exhibit I) that is completed by each participating LEA (as defined in this notice). The scope of work must be signed and dated by an authorized LEA and State official. In the interest of time and with respect for the effort it will take for LEAs to develop detailed work plans, the scope of work submitted by LEAs and States as part of their Race to the Top applications may be preliminary. Preliminary scopes of work should include the portions of the State's proposed reform plans that the LEA is agreeing to implement. (Note that in order to participate in a State's Race to the Top application an LEA must agree to implement all or significant portions of the State's reform plans.)
If a State is awarded a Race to the Top grant, the participating LEAs (as defined in this notice) will have up to 90 days to complete final scopes of work (which could be attached to the model MOU as Exhibit II), which must contain detailed work plans that are consistent with the preliminary scope of work and with the State's grant application, and should include the participating LEA's (as defined in this notice) specific goals, activities, timelines, budgets, key personnel, and annual targets for key performance measures.
(iii) Signatures: The signatures demonstrate (a) an acknowledgement of the relationship between the LEA and the State, and (b) the strength of the participating LEA's (as defined in this notice) commitment.
• With respect to the relationship between the LEA and the State, the State's counter-signature on the MOU indicates that the LEA's commitment is consistent with the requirement that a participating LEA (as defined in this notice) implement all or significant portions of the State's plans.
• The strength of the participating LEA's (as defined in this notice) commitment will be demonstrated by the signatures of the LEA superintendent (or an equivalent authorized signatory), the president of the local school board (or equivalent, if applicable) and the local teacher's union leader (if applicable).
Please note the following with regard to the State's Race to the Top application:
• In its application, the State need only provide an example of the State's standard Participating LEA MOU; it does not have to provide copies of every MOU signed by its participating LEAs (as defined in this notice). If, however, States and LEAs have made any changes to the State's standard MOU, the State must provide description of the changes that were made. Please note that the Department may, at any time, request copies of all MOUs between the State and its participating LEAs.
• Please see criterion (A)(1)(ii) and (A)(1)(iii), and the evidence requested in the application, for more information and ways in which States will be asked to summarize information about the LEA MOUs.
(a) Adopting internationally-benchmarked standards and assessments that prepare students for success in college and the workplace;
(b) Building data systems that measure student success and inform teachers and principals in how they can improve their practices;
(c) Increasing teacher effectiveness and achieving equity in teacher distribution; and
(d) Turning around our lowest-achieving schools.
To meet this priority, the State's application must comprehensively and coherently address all of the four education reform areas specified in the ARRA as well as the State Success Factors Criteria in order to demonstrate that the State and its participating LEAs are taking a systemic approach to education reform. The State must demonstrate in its application sufficient LEA participation and commitment to successfully implement and achieve the goals in its plans; and it must describe how the State, in collaboration with its participating LEAs, will use Race to the Top and other funds to increase student achievement, decrease the achievement gaps across student subgroups, and increase the rates at which students graduate from high school prepared for college and careers.
To meet this priority, the State's application must have a high-quality plan to address the need to (i) offer a rigorous course of study in mathematics, the sciences, technology, and engineering; (ii) cooperate with industry experts, museums, universities, research centers, or other STEM-capable community partners to prepare and assist teachers in integrating STEM content across grades and disciplines, in promoting effective and relevant instruction, and in offering applied learning opportunities for students; and (iii) prepare more students for advanced study and careers in the sciences, technology, engineering, and mathematics, including by addressing the needs of underrepresented groups and of women and girls in the areas of science, technology, engineering, and mathematics.
The Secretary is particularly interested in applications that include practices, strategies, or programs to improve educational outcomes for high-need students who are young children (pre-kindergarten through third grade) by enhancing the quality of preschool programs. Of particular interest are proposals that support practices that (i) improve school readiness (including social, emotional, and cognitive); and (ii) improve the transition between preschool and kindergarten.
The Secretary is particularly interested in applications in which the State plans to expand statewide longitudinal data systems to include or integrate data from special education programs, English language learner programs,
The Secretary is also particularly interested in applications in which States propose working together to adapt one State's statewide longitudinal data system so that it may be used, in whole or in part, by one or more other States, rather than having each State build or continue building such systems independently.
The Secretary is particularly interested in applications in which the State plans to address how early childhood programs, K–12 schools, postsecondary institutions, workforce development organizations, and other State agencies and community partners (
The Secretary is particularly interested in applications in which the State's participating LEAs (as defined in this notice) seek to create the conditions for reform and innovation as well as the conditions for learning by providing schools with flexibility and autonomy in such areas as—
(i) Selecting staff;
(ii) Implementing new structures and formats for the school day or year that result in increased learning time (as defined in this notice);
(iii) Controlling the school's budget;
(iv) Awarding credit to students based on student performance instead of instructional time;
(v) Providing comprehensive services to high-need students (as defined in this notice) (
(vi) Creating school climates and cultures that remove obstacles to, and actively support, student engagement and achievement; and
(vii) Implementing strategies to effectively engage families and communities in supporting the academic success of their students.
(a) The State's application must be signed by the Governor, the State's chief school officer, and the president of the State board of education (if applicable). States will respond to this requirement in the application, Section III, Race to the Top Application Assurances. In addition, the assurances in Section IV must be signed by the Governor.
(b) The State must describe the progress it has made over the past several years in each of the four education reform areas (as described in criterion (A)(3)(i)).
(c) The State must include a budget that details how it will use grant funds and other resources to meet targets and perform related functions (as described in criterion (A)(2)(i)(d)), including how it will use funds awarded under this program to—
(1) Achieve its targets for improving student achievement and graduation rates and for closing achievement gaps (as described in criterion (A)(1)(iii)); the State must also describe its track record of improving student progress overall and by student subgroup (as described in criterion (A)(3)(ii)); and
(2) Give priority to high-need LEAs (as defined in this notice), in addition to providing 50 percent of the grant to participating LEAs (as defined in this notice) based on their relative shares of funding under Part A of Title I of the Elementary and Secondary Education Act of 1965 (ESEA) for the most recent year as required under section 14006(c) of the ARRA. (
(d) The State must provide, for each State Reform Conditions Criterion (listed in this notice) that it chooses to address, a description of the State's current status in meeting that criterion and, at a minimum, the information requested as supporting evidence for the criterion and the performance measures, if any (
(e) The State must provide, for each Reform Plan Criterion (listed in this notice) that it chooses to address, a detailed plan for use of grant funds that includes, but need not be limited to—
(1) The key goals;
(2) The key activities to be undertaken and rationale for the activities, which should include why the specific activities are thought to bring about the change envisioned and how these activities are linked to the key goals;
(3) The timeline for implementing the activities;
(4) The party or parties responsible for implementing the activities;
(5) The information requested in the performance measures, where applicable (
(6) The information requested as supporting evidence, if any, for the criterion, together with any additional information the State believes will be helpful to peer reviewers in judging the credibility of the State's plan.
(f) The State must submit a certification from the State Attorney General that—
(1) The State's description of, and statements and conclusions concerning State law, statute, and regulation in its application are complete, accurate, and constitute a reasonable interpretation of State law, statute, and regulation; and
(2) At the time the State submits its application, the State does not have any legal, statutory, or regulatory barriers at the State level to linking data on student achievement or student growth to teachers and principals for the purpose of teacher and principal evaluation.
(g) When addressing issues relating to assessments required under the ESEA or subgroups in the selection criteria, the State must meet the following requirements:
(1) For student subgroups with respect to the National Assessment of Educational Progress (NAEP), the State must provide data for the NAEP subgroups described in section 303(b)(2)(G) of the National Assessment of Educational Progress Authorization Act (20 U.S.C. 9622) (
(2) For student subgroups with respect to high school graduation rates, college enrollment and credit accumulation rates, and the assessments required under the ESEA, the State must provide data for the subgroups described in section 1111(b)(2)(C)(v)(II) of the ESEA (
(3) When asked to provide information regarding the assessments required under the ESEA, States should refer to section 1111(b)(3) of the ESEA; in addition, when describing this assessment data in the State's application, the State should note any factors (
The Department anticipates that the national evaluations will involve such components as—
• Surveys of States, LEAs, and/or schools, which will help identify how program funding is spent and the specific efforts and activities that are underway within each of the four education reform areas and across selected ARRA-funded programs;
• Case studies of promising practices in States, LEAs, and/or schools through surveys and other mechanisms; and
• Evaluations of outcomes, focusing on student achievement and other performance measures, to determine the impact of the reforms implemented under Race to the Top.
Race to the Top grantee States are not required to conduct independent evaluations, but may propose, within their applications, to use funds from Race to the Top to support such evaluations. Grantees must make available, through formal (
To identify the lowest-achieving schools, a State must take into account both (i) The academic achievement of the “all students” group in a school in terms of proficiency on the State's assessments under section 1111(b)(3) of the ESEA in reading/language arts and mathematics combined; and (ii) The school's lack of progress on those assessments over a number of years in the “all students” group.
(a) For tested grades and subjects: (1) A student's score on the State's assessments under the ESEA; and, as appropriate, (2) other measures of student learning, such as those described in paragraph (b) of this definition, provided they are rigorous and comparable across classrooms.
(b) For non-tested grades and subjects: Alternative measures of student learning and performance such as student scores on pre-tests and end-of-course tests; student performance on English language proficiency assessments; and other measures of student achievement that are rigorous and comparable across classrooms.
The Department is not bound by any estimates in this notice. The Department will decide on the size of each State's award based on a detailed review of the budget the State requests, considering such factors as the size of the State, level of LEA participation, and the proposed activities.
To support States in planning their budgets, the Department has developed nonbinding budget ranges for each State; these are listed below. These ranges may be used as rough blueprints to guide States as they think through their budgets, but States may prepare budgets that are above or below the ranges specified. The categories were developed by ranking every State according to its share of the national population of children ages 5 through 17, and identifying the natural breaks. Then, based on population, overlapping budget ranges were developed for each category.
1.
A State must meet the following requirements in order to be eligible to receive funds under this program.
(a) The State's applications for funding under Phase 1 and Phase 2 of the State Fiscal Stabilization Fund program must be approved by the Department prior to the State being awarded a Race to the Top grant.
(b) At the time the State submits its application, there must not be any legal, statutory, or regulatory barriers at the State level to linking data on student achievement (as defined in this notice) or student growth (as defined in this notice) to teachers and principals for the purpose of teacher and principal evaluation.
2.
1.
You can obtain an application package via the Internet or from the Education Publications Center (ED Pubs). To obtain a copy via the Internet, use the following address:
You can also contact ED Pubs at its Web site:
If you request an application from ED Pubs, be sure to identify this program or competition as follows: CFDA 84.395A.
Individuals with disabilities can obtain a copy of the application package in an accessible format (
2.
• A “page” is 8.5″ x 11″, on one side only, with 1″ margins at the top, bottom, and both sides.
• Each page is numbered.
• Line spacing is set to 1.5 spacing, and the font used is 12 point Times New Roman.
3.
Applications Available: November 18, 2009.
Deadline for Notice of Intent to Apply: The Department will be able to develop a more efficient process for reviewing grant applications if we have a better understanding of the number of applications we will receive. Therefore, we strongly encourage each potential applicant to send an e-mail notice of its intent to apply for funding for Phase 1 to the e-mail address
To assist States in preparing the application and to respond to questions, the Department intends to host two Technical Assistance Planning Workshops for potential applicants prior to the Phase 1 application submission deadline. The first will be in Denver, Colorado on December 3, 2009. The second will be in the Washington, DC area on December 10, 2009. We recommend that applicants attend one of these two workshops.
The purpose of the workshops would be for Department staff to review the selection criteria, requirements, and priorities with teams of participants responsible for drafting State applications, as well as for Department staff to answer technical questions about the Race to the Top program. The Department plans to release more details regarding the workshops in late November. Updates will be available at the Race to the Top Web site
Applications for grants under this competition, as well as any amendments regarding adoption of common standards that Phase 2 applicants may file after June 1 and through August 2, 2010, must be submitted in electronic format on a CD or DVD, with CD–ROM or DVD–ROM preferred. In addition, States must submit an original and one hard copy of Sections III and IV of the application, which include the Race to the Top Application Assurances and the Accountability, Transparency, Reporting and Other Assurances. E-mailed submissions will not be read. For information (including dates and times) about how to submit your electronic application, please refer to section IV.6,
The Department will not consider an application that does not comply with the deadline requirements.
Individuals with disabilities who need an accommodation or auxiliary aid in connection with the application process should contact the person listed under
4.
5.
6.
a.
All electronic application files must be in a .DOC (document), .DOCX (document), .RTF (rich text), or .PDF (Portable Document) format. Each file name should clearly identify the part of the application to which the content is responding. If a State submits a file type other than the four file types specified in this paragraph, the Department will not review that material. States should not password-protect these files.
The CD or DVD should be clearly labeled with the State's name and any other relevant information.
The Department must receive all grant applications by 4:30:00 p.m., Washington, DC time, on the application deadline date. We will not accept an application for this competition after 4:30:00 p.m., Washington, DC time, on the application deadline date. Therefore, we strongly recommend that applicants arrange for mailing or hand delivery of their applications in advance of the application deadline date.
b.
If we receive an application after the application deadline, we will not consider that application.
c.
The Application Control Center accepts hand deliveries daily between 8:00 a.m. and 4:30:00 p.m., Washington, DC time, except Saturdays, Sundays, and Federal holidays. If we receive an application after the application deadline, we will not consider that application.
d.
(1) It must indicate on the envelope that the CFDA number of the competition under which it is submitting its application is 84.395A; and
(2) The Application Control Center will mail to the applicant a notification of receipt of the grant application. If the applicant does not receive this notification, it should call the U.S. Department of Education Application Control Center at (202) 245–6288.
In accordance with EDGAR § 75.216(b) and (c), an application will not be evaluated for funding if the applicant does not comply with all of the procedural rules that govern the submission of the application or the application does not contain the information required under the program.
(A)(1)
(i) The State has set forth a comprehensive and coherent reform agenda that clearly articulates its goals for implementing reforms in the four education areas described in the ARRA and improving student outcomes statewide, establishes a clear and credible path to achieving these goals, and is consistent with the specific reform plans that the State has proposed throughout its application;
(ii) The participating LEAs (as defined in this notice) are strongly committed to the State's plans and to effective implementation of reform in the four education areas, as evidenced by Memoranda of Understanding (MOUs) (as set forth in Appendix D)
(a) Terms and conditions that reflect strong commitment by the participating LEAs (as defined in this notice) to the State's plans;
(b) Scope-of-work descriptions that require participating LEAs (as defined in this notice) to implement all or significant portions of the State's Race to the Top plans; and
(c) Signatures from as many as possible of the LEA superintendent (or equivalent), the president of the local school board (or equivalent, if applicable), and the local teachers' union leader (if applicable) (one signature of which must be from an authorized LEA representative) demonstrating the extent of leadership support within participating LEAs (as defined in this notice); and
(iii) The LEAs that are participating in the State's Race to the Top plans (including considerations of the numbers and percentages of participating LEAs, schools, K–12 students, and students in poverty) will translate into broad statewide impact, allowing the State to reach its ambitious
(a) Increasing student achievement in (at a minimum) reading/language arts and mathematics, as reported by the NAEP and the assessments required under the ESEA;
(b) Decreasing achievement gaps between subgroups in reading/language arts and mathematics, as reported by the NAEP and the assessments required under the ESEA;
(c) Increasing high school graduation rates (as defined in this notice); and
(d) Increasing college enrollment (as defined in this notice) and increasing the number of students who complete at least a year's worth of college credit that is applicable to a degree within two years of enrollment in an institution of higher education.
(A)(2)
(i) Ensure that it has the capacity required to implement its proposed plans by—
(a) Providing strong leadership and dedicated teams to implement the statewide education reform plans the State has proposed;
(b) Supporting participating LEAs (as defined in this notice) in successfully implementing the education reform plans the State has proposed, through such activities as identifying promising practices, evaluating these practices' effectiveness, ceasing ineffective practices, widely disseminating and replicating the effective practices statewide, holding participating LEAs (as defined in this notice) accountable for progress and performance, and intervening where necessary;
(c) Providing effective and efficient operations and processes for implementing its Race to the Top grant in such areas as grant administration and oversight, budget reporting and monitoring, performance measure tracking and reporting, and fund disbursement;
(d) Using the funds for this grant, as described in the State's budget and accompanying budget narrative, to accomplish the State's plans and meet its targets, including, where feasible, by coordinating, reallocating, or repurposing education funds from other Federal, State, and local sources so that they align with the State's Race to the Top goals; and
(e) Using the fiscal, political, and human capital resources of the State to continue, after the period of funding has ended, those reforms funded under the grant for which there is evidence of success; and
(ii) Use support from a broad group of stakeholders to better implement its plans, as evidenced by the strength of statements or actions of support from—
(a) The State's teachers and principals, which include the State's teachers' unions or statewide teacher associations; and
(b) Other critical stakeholders, such as the State's legislative leadership; charter school authorizers and State charter school membership associations (if applicable); other State and local leaders (
(A)(3)
(i) Make progress over the past several years in each of the four education reform areas, and used its ARRA and other Federal and State funding to pursue such reforms;
(ii) Improve student outcomes overall and by student subgroup since at least 2003, and explain the connections between the data and the actions that have contributed to—
(a) Increasing student achievement in reading/language arts and mathematics, both on the NAEP and on the assessments required under the ESEA;
(b) Decreasing achievement gaps between subgroups in reading/language arts and mathematics, both on the NAEP and on the assessments required under the ESEA; and
(c) Increasing high school graduation rates.
(B)(1)
(i) The State's participation in a consortium of States that—
(a) Is working toward jointly developing and adopting a common set of K–12 standards (as defined in this notice) that are supported by evidence that they are internationally benchmarked and build toward college and career readiness by the time of high school graduation; and
(b) Includes a significant number of States; and
(ii)(a) For Phase 1 applications, the State's high-quality plan demonstrating its commitment to and progress toward adopting a common set of K–12 standards (as defined in this notice) by August 2, 2010, or, at a minimum, by a later date in 2010 specified by the State, and to implementing the standards thereafter in a well-planned way; or
(b) For Phase 2 applications, the State's adoption of a common set of K–12 standards (as defined in this notice) by August 2, 2010, or, at a minimum, by a later date in 2010 specified by the State in a high-quality plan toward which the State has made significant progress, and its commitment to implementing the standards thereafter in a well-planned way.
(B)(2)
(i) Is working toward jointly developing and implementing common, high-quality assessments (as defined in this notice) aligned with the consortium's common set of K–12 standards (as defined in this notice); and
(ii) Includes a significant number of States.
(B)(3)
(C)(1)
(C)(2)
(C)(3)
(i) Increase the acquisition, adoption, and use of local instructional improvement systems (as defined in this notice) that provide teachers, principals, and administrators with the information and resources they need to inform and improve their instructional practices, decision-making, and overall effectiveness;
(ii) Support participating LEAs (as defined in this notice) and schools that are using instructional improvement systems (as defined in this notice) in providing effective professional development to teachers, principals, and administrators on how to use these systems and the resulting data to support continuous instructional improvement; and
(iii) Make the data from instructional improvement systems (as defined in this notice), together with statewide longitudinal data system data, available and accessible to researchers so that they have detailed information with which to evaluate the effectiveness of instructional materials, strategies, and approaches for educating different types of students (
(D)(1)
(i) Legal, statutory, or regulatory provisions that allow alternative routes to certification (as defined in this notice) for teachers and principals, particularly routes that allow for providers in addition to institutions of higher education;
(ii) Alternative routes to certification (as defined in this notice) that are in use; and
(iii) A process for monitoring, evaluating, and identifying areas of teacher and principal shortage and for preparing teachers and principals to fill these areas of shortage.
(D)(2)
(i) Establish clear approaches to measuring student growth (as defined in this notice) and measure it for each individual student;
(ii) Design and implement rigorous, transparent, and fair evaluation systems for teachers and principals that (a) differentiate effectiveness using multiple rating categories that take into account data on student growth (as defined in this notice) as a significant factor, and (b) are designed and developed with teacher and principal involvement;
(iii) Conduct annual evaluations of teachers and principals that include timely and constructive feedback; as part of such evaluations, provide teachers and principals with data on student growth for their students, classes, and schools; and
(iv) Use these evaluations, at a minimum, to inform decisions regarding—
(a) Developing teachers and principals, including by providing relevant coaching, induction support, and/or professional development;
(b) Compensating, promoting, and retaining teachers and principals, including by providing opportunities for highly effective teachers and principals (both as defined in this notice) to obtain additional compensation and be given additional responsibilities;
(c) Whether to grant tenure and/or full certification (where applicable) to teachers and principals using rigorous standards and streamlined, transparent, and fair procedures; and
(d) Removing ineffective tenured and untenured teachers and principals after they have had ample opportunities to improve, and ensuring that such decisions are made using rigorous standards and streamlined, transparent, and fair procedures.
(D)(3)
(i) Ensure the equitable distribution of teachers and principals by developing a plan, informed by reviews of prior actions and data, to ensure that students in high-poverty and/or high-minority schools (both as defined in this notice) have equitable access to highly effective teachers and principals (both as defined in this notice) and are not served by ineffective teachers and principals at higher rates than other students; and
(ii) Increase the number and percentage of effective teachers (as defined in this notice) teaching hard-to-staff subjects and specialty areas including mathematics, science, and special education; teaching in language instruction educational programs (as defined under Title III of the ESEA); and teaching in other areas as identified by the State or LEA.
Plans for (i) and (ii) may include, but are not limited to, the implementation of incentives and strategies in such areas as recruitment, compensation, teaching and learning environments, professional development, and human resources practices and processes.
(D)(4)
(i) Link student achievement and student growth (both as defined in this notice) data to the students' teachers
(ii) Expand preparation and credentialing options and programs that are successful at producing effective teachers and principals (both as defined in this notice).
(D)(5)
(i) Provide effective, data-informed professional development, coaching, induction, and common planning and collaboration time to teachers and principals that are, where appropriate, ongoing and job-embedded. Such support might focus on, for example, gathering, analyzing, and using data; designing instructional strategies for improvement; differentiating instruction; creating school environments supportive of data-informed decisions; designing instruction to meet the specific needs of high-need students (as defined in this notice); and aligning systems and removing barriers to effective implementation of practices designed to improve student learning outcomes; and
(ii) Measure, evaluate, and continuously improve the effectiveness of those supports in order to improve student achievement (as defined in this notice).
(E)(1)
(E)(2)
(i) Identify the persistently lowest-achieving schools (as defined in this notice) and, at its discretion, any non-Title I eligible secondary schools that would be considered persistently lowest-achieving schools (as defined in this notice) if they were eligible to receive Title I funds; and
(ii) Support its LEAs in turning around these schools by implementing one of the four school intervention models (as described in Appendix C): Turnaround model, restart model, school closure, or transformation model (provided that an LEA with more than nine persistently lowest-achieving schools may not use the transformation model for more than 50 percent of its schools).
(F)(1)
(i) The percentage of the total revenues available to the State (as defined in this notice) that were used to support elementary, secondary, and public higher education for FY 2009 was greater than or equal to the percentage of the total revenues available to the State (as defined in this notice) that were used to support elementary, secondary, and public higher education for FY 2008; and
(ii) The State's policies lead to equitable funding (a) between high-need LEAs (as defined in this notice) and other LEAs, and (b) within LEAs, between high-poverty schools (as defined in this notice) and other schools.
(F)(2)
(i) The State has a charter school law that does not prohibit or effectively inhibit increasing the number of high-performing charter schools (as defined in this notice) in the State, measured (as set forth in Appendix B) by the percentage of total schools in the State that are allowed to be charter schools or otherwise restrict student enrollment in charter schools;
(ii) The State has laws, statutes, regulations, or guidelines regarding how charter school authorizers approve, monitor, hold accountable, reauthorize, and close charter schools; in particular, whether authorizers require that student achievement (as defined in this notice) be one significant factor, among others, in authorization or renewal; encourage charter schools that serve student populations that are similar to local district student populations, especially relative to high-need students (as defined in this notice); and have closed or not renewed ineffective charter schools;
(iii) The State's charter schools receive (as set forth in Appendix B) equitable funding, compared to traditional public schools, and a commensurate share of local, State, and Federal revenues;
(iv) The State provides charter schools with funding for facilities (for leasing facilities, purchasing facilities, or making tenant improvements), assistance with facilities acquisition, access to public facilities, the ability to share in bonds and mill levies, or other supports; and the extent to which the State does not impose any facility-related requirements on charter schools that are stricter than those applied to traditional public schools; and
(v) The State enables LEAs to operate innovative, autonomous public schools (as defined in this notice) other than charter schools.
(F)(3)
2.
The Department intends to use a two-tiered review process to judge the eligible applications. In the initial tier, the reviewers would consider only the written applications; in the finalist tier, reviewers would consider both the written applications and in-person presentations. In both tiers, the Department would use independent reviewers who have been chosen from a pool of qualified educators, scholars, and other individuals knowledgeable in education reform. The Department will thoroughly screen all reviewers for conflicts of interest to ensure a fair and competitive review process.
In the initial tier, reviewers will read, comment on, and score their assigned applications, using the selection criteria and scoring rubric included in this notice (see Appendix B). The Department will select the finalists after
The Department intends to ask each finalist to send a team to Washington, DC to present the State's proposal to a panel of reviewers. The panel will take this opportunity to ask the State's team further questions in order to gain a more comprehensive picture of the State's application proposal, including its plans and its capabilities to implement them. (Exact timing will be announced when the finalists are selected.) A State's presentation team may include up to five individuals; because the panel of reviewers is interested primarily in hearing from, and asking questions of, State leaders who would be responsible for implementing the State's Race to the Top plan, only those individuals who would have significant ongoing roles in and responsibilities in executing the State's plan should present, and in no case could presentation teams include consultants. At the conclusion of the presentation process, reviewers will finalize their scoring of the applications based on the selection criteria and scoring rubric in this notice.
After the review process is complete, the Secretary will select, consistent with 34 CFR 75.217, the grantees after considering the rank order of applications, each applicant's status with respect to the Absolute Priority and eligibility requirement (a), and any other relevant information. All applicants will receive their reviewers' comments and scores.
After awards are made for each phase of the competition, all of the submitted applications (both successful and unsuccessful) will be posted on the Department's Web site, together with the final scores each received. The Department also intends to post on its Web site a transcript and/or video of each finalist's presentation of its proposal.
States that apply in Phase 1 but are not awarded grants may reapply for funding in Phase 2 (together with those States that are applying for the first time in Phase 2). Phase 1 winners receive full-sized awards, and so do not apply for additional funding in Phase 2.
1.
If an application is not evaluated or not selected for funding, the Department will notify the State.
2.
We reference the regulations outlining the terms and conditions of an award in the
3.
A State receiving Race to the Top funds must submit to the Department an annual report which must include, in addition to the standard elements, a description of the State's and its LEAs' progress to date on their goals, timelines, and budgets, as well as actual performance compared to the annual targets the State established in its application with respect to each performance measure. Further, a State receiving funds under this program and its participating LEAs are accountable for meeting the goals, timelines, budget, and annual targets established in the application; adhering to an annual fund drawdown schedule that is tied to meeting these goals, timelines, budget, and annual targets; and fulfilling and maintaining all other conditions for the conduct of the project. The Department will monitor a State's and its participating LEAs' progress in meeting the State's goals, timelines, budget, and annual targets and in fulfilling other applicable requirements. In addition, the Department may collect additional data as part of a State's annual reporting requirements.
To support a collaborative process between the State and the Department, the Department may require that applicants who are selected to receive an award enter into a written performance or cooperative agreement with the Department. If the Department determines that a State is not meeting its goals, timelines, budget, or annual targets or is not fulfilling other applicable requirements, the Department will take appropriate action, which could include a collaborative process between the Department and the State, or enforcement measures with respect to this grant, such as placing the State in high-risk status, putting the State on reimbursement payment status, or delaying or withholding funds.
A State that receives Race to the Top funds must also meet the reporting requirements that apply to all ARRA-funded programs. Specifically, the State must submit reports, within 10 days after the end of each calendar quarter, that contain the information required under section 1512(c) of the ARRA in accordance with any guidance issued by the Office of Management and Budget or the Department (ARRA Division A, Section 1512(c)).
In addition, for each year of the program, the State will submit a report to the Secretary, at such time and in such manner as the Secretary may require, that describes:
○ The uses of funds within the State;
○ How the State distributed the funds it received;
○ The number of jobs that the Governor estimates were saved or created with the funds;
○ The State's progress in reducing inequities in the distribution of highly qualified teachers, implementing a State longitudinal data system, and developing and implementing valid and reliable assessments for English language learners and students with disabilities; and
○ If applicable, a description of each modernization, renovation, or repair project approved in the State application and funded, including the amounts awarded and project costs (ARRA Division A, Section 14008).
4.
If a TDD is needed, call the Federal Relay Service, toll free, at 1–800–877–8339.
(A)(1)
• An example of the State's standard Participating LEA MOU, and description of variations used, if any.
• The completed summary table indicating which specific portions of the State's plan each LEA is committed to implementing, and relevant summary statistics (see Summary Table for (A)(1)(ii)(b)).
• The completed summary table indicating which LEA leadership signatures have been obtained (see Summary Table for (A)(1)(ii)(c)).
• The completed summary table indicating the numbers and percentages of participating LEAs, schools, K–12 students, and students in poverty (see Summary Table for (A)(1)(iii)).
• Tables and graphs that show the State's goals, overall and by subgroup, requested in the criterion, together with the supporting narrative. In addition, describe what the goals would look like were the State not to receive an award under this program.
• The completed detailed table, by LEA, that includes the information requested in the criterion (see Detailed Table for (A)(1)).
• None required.
(A)(2)
• The State's budget, as completed in Section XI of the application. The narrative that accompanies and explains the budget and how it connects to the State's plan, as completed in Section XI of the application.
• A summary in the narrative of the statements or actions and inclusion of key statements or actions in the Appendix.
• None required.
(A)(3)
• None required.
(B)(1)
• A copy of the Memorandum of Agreement, executed by the State, showing that it is part of a standards consortium.
• A copy of the final standards or, if the standards are not yet final, a copy of the draft standards and anticipated date for completing the standards.
• Documentation that the standards are or will be internationally benchmarked and that, when well-implemented, will help to ensure that students are prepared for college and careers.
• The number of States participating in the standards consortium and the list of these States.
For Phase 1 applicants:
• A description of the legal process in the State for adopting standards, and the State's plan, current progress, and timeframe for adoption.
For Phase 2 applicants:
• Evidence that the State has adopted the standards. Or, if the State has not yet adopted the standards, a description of the legal process in the State for adopting standards and the State's plan, current progress, and timeframe for adoption.
• None required.
(B)(2)
Evidence for (B)(2):
• A copy of the Memorandum of Agreement, executed by the State, showing that it is part of a consortium that intends to develop high-quality assessments (as defined in this notice) aligned with the consortium's common set of K–12 standards; or documentation that the State's consortium has applied, or intends to apply, for a grant through the separate Race to the Top Assessment Program (to be described in a subsequent notice); or other evidence of the State's plan to develop and adopt common, high-quality assessments (as defined in this notice).
• The number of States participating in the assessment consortium and the list of these States.
• None required.
(B)(3)
• Any supporting evidence the State believes will be helpful to peer reviewers.
• Optional.
(C) Data Systems to Support Instruction
(C)(1)
• Documentation for each of the America COMPETES Act elements (as defined in this notice) that is included in the State's statewide longitudinal data system.
• None required.
(C)(2)
• Any supporting evidence the State believes will be helpful to peer reviewers.
• Optional.
(C)(3)
• Any supporting evidence the State believes will be helpful to peer reviewers.
• Optional.
(D)(1)
• A description of the State's applicable laws, statutes, regulations, or other relevant legal documents, including information on the elements of the State's alternative routes (as described in the alternative routes to certification definition in this notice).
• A list of the alternative certification programs operating in the State under the State's alternative routes to certification (as defined in this notice), and for each:
○ The elements of the program (as described in the alternative routes to certification definition in this notice).
○ The number of teachers and principals that successfully completed each program in the previous academic year.
○ The total number of teachers and principals certified statewide in the previous academic year.
• None required.
(D)(2)
• Any supporting evidence the State believes will be helpful to peer reviewers.
General goals to be provided at time of application, including baseline data and annual targets:
• (D)(2)(i) Percentage of participating LEAs that measure student growth (as defined in this notice).
• (D)(2)(ii) Percentage of participating LEAs with qualifying evaluation systems for teachers.
• (D)(2)(ii) Percentage of participating LEAs with qualifying evaluation systems for principals.
• (D)(2)(iv) Percentage of participating LEAs with qualifying evaluation systems that are used to inform:
○ (D)(2)(iv)(a) Developing teachers and principals.
○ (D)(2)(iv)(b) Compensating teachers and principals.
○ (D)(2)(iv)(b) Promoting teachers and principals.
○ (D)(2)(iv)(b) Retaining effective teachers and principals.
○ (D)(2)(iv)(c) Granting tenure and/or full certification (where applicable) to teachers and principals.
○ (D)(2)(iv)(d) Removing ineffective tenured and untenured teachers and principals.
General data to be provided at time of application, including baseline data:
• Total number of participating LEAs.
• Total number of principals in participating LEAs.
• Total number of teachers in participating LEAs.
Data to be requested of grantees in the future:
• (D)(2)(ii) Number of teachers and principals in participating LEAs with qualifying evaluation systems.
• (D)(2)(iii) Number of teachers and principals in participating LEAs with qualifying evaluation systems who were evaluated as effective or better in the prior academic year.
• (D)(2)(iii) Number of teachers and principals in participating LEAs with qualifying evaluation systems who were evaluated as ineffective in the prior academic year.
• (D)(2)(iv)(b) Number of teachers and principals in participating LEAs with qualifying evaluation systems whose evaluations were used to inform compensation decisions in the prior academic year.
• (D)(2)(iv)(b) Number of teachers and principals in participating LEAs with qualifying evaluation systems who were evaluated as effective or better and were retained in the prior academic year.
• (D)(2)(iv)(c) Number of teachers in participating LEAs with qualifying evaluation systems who were eligible for tenure in the prior academic year.
• (D)(2)(iv)(c) Number of teachers in participating LEAs with qualifying evaluation systems whose evaluations were used to inform tenure decisions in the prior academic year.
• (D)(2)(iv)(d) Number of teachers and principals in participating LEAs who were removed for being ineffective in the prior academic year.
(D)(3)
• Definitions of high-minority and low-minority schools as defined by the State for the purposes of the State's Teacher Equity Plan.
All information below is requested for Participating LEAs.
General goals to be provided at time of application, including baseline data and annual targets:
• Percentage of teachers in schools that are high-poverty, high-minority, or both (as defined in this notice) who are highly effective (as defined in this notice).
• Percentage of teachers in schools that are low-poverty, low-minority, or both (as defined in this notice) who are highly effective (as defined in this notice).
• Percentage of teachers in schools that are high-poverty, high-minority, or both (as defined in this notice) who are ineffective.
• Percentage of teachers in schools that are low-poverty, low-minority, or both (as defined in this notice) who are ineffective.
• Percentage of principals leading schools that are high-poverty, high-minority, or both (as defined in this notice) who are highly effective (as defined in this notice).
• Percentage of principals leading schools that are low-poverty, low-minority, or both (as defined in this notice) who are highly effective (as defined in this notice).
• Percentage of principals leading schools that are high-poverty, high-minority, or both (as defined in this notice) who are ineffective.
• Percentage of principals leading schools that are low-poverty, low-minority, or both (as defined in this notice) who are ineffective.
General data to be provided at time of application, including baseline data:
• Total number of schools that are high-poverty, high-minority, or both (as defined in this notice).
• Total number of schools that are low-poverty, low-minority, or both (as defined in this notice).
• Total number of teachers in schools that are high-poverty, high-minority, or both (as defined in this notice).
• Total number of teachers in schools that are low-poverty, low-minority, or both (as defined in this notice).
• Total number of principals leading schools that are high-poverty, high-minority, or both (as defined in this notice).
• Total number of principals leading schools that are low-poverty, low-minority, or both (as defined in this notice).
Data to be requested of grantees in the future:
• Number of teachers and principals in schools that are high-poverty, high-minority, or both (as defined in this notice) who were evaluated as highly effective (as defined in this notice) in the prior academic year.
• Number of teachers and principals in schools that are high-poverty, high-minority, or both (as defined in this notice) who were evaluated as ineffective in the prior academic year.
• Number of teachers and principals in schools that are low-poverty, low-minority, or both (as defined in this notice) who were evaluated as highly effective (as defined in this notice) in the prior academic year.
• Number of teachers and principals in schools that are low-poverty, low-minority, or both (as defined in this notice) who were evaluated as ineffective in the prior academic year.
General goals to be provided at time of application, including baseline data and annual targets:
• Percentage of mathematics teachers who were evaluated as effective or better.
• Percentage of science teachers who were evaluated as effective or better.
• Percentage of special education teachers who were evaluated as effective or better.
• Percentage of teachers in language instruction educational programs who were evaluated as effective or better.
General data to be provided at time of application, including baseline data:
• Total number of mathematics teachers.
• Total number of science teachers.
• Total number of special education teachers.
• Total number of teachers in language instruction educational programs.
Data to be requested of grantees in the future:
• Number of mathematics teachers in participating LEAs who were evaluated as effective or better in the prior academic year.
• Number of science teachers in participating LEAs who were evaluated as effective or better in the prior academic year.
• Number of special education teachers in participating LEAs who were evaluated as effective or better in the prior academic year.
• Number of teachers in language instruction educational programs in participating LEAs who were evaluated as effective or better in the prior academic year.
(D)(4)
• Any supporting evidence the State believes will be helpful to peer reviewers.
General goals to be provided at time of application, including baseline data and annual targets:
• Percentage of teacher preparation programs in the State for which the public can access data on the achievement and growth (as defined in this notice) of the graduates' students.
• Percentage of principal preparation programs in the State for which the public can access data on the achievement and growth (as defined in this notice) of the graduates' students.
General data to be provided at time of application, including baseline data:
• Total number of teacher credentialing programs in the State.
• Total number of principal credentialing programs in the State.
• Total number of teachers in the State.
• Total number of principals in the State.
Data to be requested of grantees in the future:
• Number of teacher credentialing programs in the State for which the information (as described in the criterion) is publicly reported.
• Number of teachers prepared by each credentialing program in the State for which the information (as described in the criterion) is publicly reported.
• Number of principal credentialing programs in the State for which the information (as described in the criterion) is publicly reported.
• Number of principals prepared by each credentialing program in the State for which the information (as described in the criterion) is publicly reported.
• Number of teachers in the State whose data are aggregated to produce publicly available reports on the State's credentialing programs.
• Number of principals in the State whose data are aggregated to produce publicly available reports on the State's credentialing programs.
(D)(5)
• Any supporting evidence the State believes will be helpful to peer reviewers.
• Optional.
(E)(1)
• A description of the State's applicable laws, statutes, regulations, or other relevant legal documents.
• None required.
(E)(2)
• The State's historic performance on school turnaround, as evidenced by the total number of persistently lowest-achieving schools (as defined in this notice) that States or LEAs attempted to turn around in the last five years, the approach used, and the results and lessons learned to date.
• The number of schools for which one of the four school intervention models (described in Appendix C) will be initiated each year.
(F)(1)
• Financial data to show whether and to what extent expenditures, as a percentage of the total revenues available to the State (as defined in this notice), increased, decreased, or remained the same.
• Any supporting evidence the State believes will be helpful to peer reviewers.
• None required.
(F)(2)
• A description of the State's applicable laws, statutes, regulations, or other relevant legal documents.
• The number of charter schools allowed under State law and the percentage this represents of the total number of schools in the State.
• The number and types of charter schools currently operating in the State.
• A description of the State's approach to charter school accountability and authorization, and a description of the State's applicable laws, statutes, regulations, or other relevant legal documents.
• For each of the last five years:
○ The number of charter school applications made in the State.
○ The number of charter school applications approved.
○ The number of charter school applications denied and reasons for the denials (academic, financial, low enrollment, other).
○ The number of charter schools closed (including charter schools that were not reauthorized to operate).
○ The reasons for the closures or non-renewals (academic, financial, low enrollment, other).
• A description of the State's applicable statutes, regulations, or other relevant legal documents.
• A description of the State's approach to charter school funding, the amount of funding passed through to charter schools per student, and how those amounts compare with traditional public school per-student funding allocations.
• A description of the State's applicable statutes, regulations, or other relevant legal documents.
• A description of the statewide facilities supports provided to charter schools, if any.
• A description of how the State enables LEAs to operate innovative, autonomous public schools (as defined in this notice) other than charter schools.
• None required.
(F)(3)
Evidence for (F)(3):
• A description of the State's other applicable key education laws, statutes, regulations, or relevant legal documents.
• None required.
There are four school intervention models referred to in Selection Criterion (E)(2): Turnaround model, restart model, school closure, or transformation model. Each is described below.
(a)
(i) Replace the principal and grant the principal sufficient operational flexibility (including in staffing, calendars/time, and budgeting) to implement fully a comprehensive approach in order to substantially improve student achievement outcomes and increase high school graduation rates;
(ii) Using locally adopted competencies to measure the effectiveness of staff who can work within the turnaround environment to meet the needs of students,
(A) Screen all existing staff and rehire no more than 50 percent; and
(B) Select new staff;
(iii) Implement such strategies as financial incentives, increased opportunities for promotion and career growth, and more flexible work conditions that are designed to recruit, place, and retain staff with the skills necessary to meet the needs of the students in the turnaround school;
(iv) Provide staff with ongoing, high-quality, job-embedded professional development that is aligned with the school's comprehensive instructional program and designed with school staff to ensure that they are equipped to facilitate effective teaching and learning and have the capacity to successfully implement school reform strategies;
(v) Adopt a new governance structure, which may include, but is not limited to, requiring the school to report to a new “turnaround office” in the LEA or SEA, hire a “turnaround leader” who reports directly to the Superintendent or Chief Academic Officer, or enter into a multi-year contract with the LEA or SEA to obtain added flexibility in exchange for greater accountability;
(vi) Use data to identify and implement an instructional program that is research-based and “vertically aligned” from one grade to the next as well as aligned with State academic standards;
(vii) Promote the continuous use of student data (such as from formative, interim, and summative assessments) to inform and differentiate instruction in order to meet the academic needs of individual students;
(viii) Establish schedules and implement strategies that provide increased learning time (as defined in this notice); and
(ix) Provide appropriate social-emotional and community-oriented services and supports for students.
(2) A turnaround model may also implement other strategies such as—
(i) Any of the required and permissible activities under the transformation model; or
(ii) A new school model (
(b)
(c)
(d)
(1)
(i)
(A) Replace the principal who led the school prior to commencement of the transformation model;
(B) Use rigorous, transparent, and equitable evaluation systems for teachers and principals that—
(
(
(C) Identify and reward school leaders, teachers, and other staff who, in implementing this model, have increased student achievement and high-school graduation rates and identify and remove those who, after ample opportunities have been provided for them to improve their professional practice, have not done so;
(D) Provide staff with ongoing, high-quality, job-embedded professional development (
(E) Implement such strategies as financial incentives, increased opportunities for promotion and career growth, and more flexible work conditions that are designed to recruit, place, and retain staff with the skills necessary to meet the needs of the students in a transformation school.
(ii)
(A) Providing additional compensation to attract and retain staff with the skills necessary to meet the needs of the students in a transformation school;
(B) Instituting a system for measuring changes in instructional practices resulting from professional development; or
(C) Ensuring that the school is not required to accept a teacher without the mutual consent of the teacher and principal, regardless of the teacher's seniority.
(2)
(i)
(A) Use data to identify and implement an instructional program that is research-based and “vertically aligned” from one grade to the next as well as aligned with State academic standards; and
(B) Promote the continuous use of student data (such as from formative, interim, and summative assessments) to inform and differentiate instruction in order to meet the academic needs of individual students.
(ii)
(A) Conducting periodic reviews to ensure that the curriculum is being implemented with fidelity, is having the intended impact on student achievement, and is modified if ineffective;
(B) Implementing a schoolwide “response-to-intervention” model;
(C) Providing additional supports and professional development to teachers and principals in order to implement effective strategies to support students with disabilities in the least restrictive environment and to ensure that limited English proficient students acquire language skills to master academic content;
(D) Using and integrating technology-based supports and interventions as part of the instructional program; and
(E) In secondary schools—
(
(
(
(
(3)
(i)
(A) Establish schedules and implement strategies that provide increased learning time (as defined in this notice); and
(B) Provide ongoing mechanisms for family and community engagement.
(ii)
(A) Partnering with parents and parent organizations, faith- and community-based organizations, health clinics, other State or local agencies, and others to create safe school environments that meet students' social, emotional, and health needs;
(B) Extending or restructuring the school day so as to add time for such strategies as advisory periods that build relationships between students, faculty, and other school staff;
(C) Implementing approaches to improve school climate and discipline, such as implementing a system of positive behavioral supports or taking steps to eliminate bullying and student harassment; or
(D) Expanding the school program to offer full-day kindergarten or pre-kindergarten.
(4)
(i)
(A) Give the school sufficient operational flexibility (such as staffing, calendars/time, and budgeting) to implement fully a comprehensive approach to substantially improve student achievement outcomes and increase high school graduation rates; and
(B) Ensure that the school receives ongoing, intensive technical assistance and related support from the LEA, the SEA, or a designated external lead partner organization (such as a school turnaround organization or an EMO).
(ii)
(A) Allowing the school to be run under a new governance arrangement, such as a turnaround division within the LEA or SEA; or
(B) Implementing a per-pupil school-based budget formula that is weighted based on student needs.
If a school identified as a persistently lowest-achieving school has implemented, in whole or in part within the last two years, an intervention that meets the requirements of the turnaround, restart, or transformation models, the school may continue or complete the intervention being implemented.
Participating LEAs (as defined in this notice) in a State's Race to the Top plan are required to enter into a Memorandum of Understanding (MOU) or other binding agreement with the State that specifies the scope of the work being implemented by the participating LEA (as defined in this notice).
To support States in working efficiently with LEAs to determine which LEAs will participate in the State's Race to the Top application, the U.S. Department of Education has produced a model MOU, which is attached. This model MOU may serve as a template for States; however, States are not required to use it. They may use a different document that includes the key features noted below and in the model, and they should consult with their State and local attorneys on what is most appropriate for their State that includes, at a minimum, these key elements.
The purpose of the model MOU is to help to specify a relationship that is specific to Race to the Top and is not meant to detail all typical aspects of State/LEA grant management or administration. At a minimum, a strong MOU should include the following, each of which is described in detail below: (i) Terms and conditions; (ii) a scope of work; and, (iii) signatures.
(i) Terms and conditions: Each participating LEA (as defined in this notice) should sign a standard set of terms and conditions that includes, at a minimum, key roles and responsibilities
(ii) Scope of work: MOUs should include a scope of work (included in the model MOU as Exhibit I) that is completed by each participating LEA (as defined in this notice). The scope of work must be signed and dated by an authorized LEA and State official. In the interest of time and with respect for the effort it will take for LEAs to develop detailed work plans, the scope of work submitted by LEAs and States as part of their Race to the Top applications may be preliminary. Preliminary scopes of work should include the portions of the State's proposed reform plans that the LEA is agreeing to implement. (Note that in order to participate in a State's Race to the Top application an LEA must agree to implement all or significant portions of the State's reform plans.)
If a State is awarded a Race to the Top grant, the participating LEAs (as defined in this notice) will have up to 90 days to complete final scopes of work (which could be attached to the model MOU as Exhibit II), which must contain detailed work plans that are consistent with the preliminary scope of work and with the State's grant application, and should include the participating LEA's (as defined in this notice) specific goals, activities, timelines, budgets, key personnel, and annual targets for key performance measures.
(iii) Signatures: The signatures demonstrate (a) an acknowledgement of the relationship between the LEA and the State, and (b) the strength of the participating LEA's (as defined in this notice) commitment.
• With respect to the relationship between the LEA and the State, the State's counter-signature on the MOU indicates that the LEA's commitment is consistent with the requirement that a participating LEA (as defined in this notice) implement all or significant portions of the State's plans.
• The strength of the participating LEA's (as defined in this notice) commitment will be demonstrated by the signatures of the LEA superintendent (or an equivalent authorized signatory), the president of the local school board (or equivalent, if applicable) and the local teacher's union leader (if applicable).
Please note the following with regard to the State's Race to the Top application:
• In its application, the State need only provide an example of the State's standard Participating LEA MOU; it does not have to provide copies of every MOU signed by its participating LEAs (as defined in this notice). If, however, States and LEAs have made any changes to the State's standard MOU, the State must provide a description of the changes that were made. Please note that the Department may, at any time, request copies of all MOUs between the State and its participating LEAs.
• Please see criteria (A)(1)(ii) and (A)(1)(iii), and the evidence requested in the application, for more information and ways in which States will be asked to summarize information about the LEA MOUs.
Transportation Security Administration (TSA), DHS.
Notice of proposed rulemaking (NPRM).
TSA is proposing to issue regulations to improve the security of domestic and foreign aircraft repair stations as required by the Vision 100–Century of Aviation Reauthorization Act. The proposed regulations establish requirements for repair stations that are certificated by the Federal Aviation Administration (FAA) under 14 CFR part 145 to adopt and implement a standard security program and to comply with security directives issued by TSA. This rule proposes to codify the scope of TSA's existing inspection program and to require regulated parties to allow TSA and Department of Homeland Security (DHS) officials to enter, inspect, and test property, facilities, and records relevant to repair stations. The proposed regulations also provide procedures for TSA to notify repair stations of any deficiencies in their security programs, and to determine whether a particular repair station presents an immediate risk to security. The proposal includes a process whereby a repair station may seek review of a determination by TSA that the station has not adequately addressed security deficiencies or that the repair station poses an immediate risk to security.
Submit comments by January 19, 2010.
You may submit comments, identified by Docket No. TSA–2004–17131, to the Federal Docket Management System (FDMS), a government-wide, electronic docket management system, using any one of the following methods:
See
Celio Young, Office of Security Operations, TSA–29, Transportation Security Administration, 601 South 12th Street, Arlington, VA 20598–6029; telephone (571) 227–3580; facsimile (571) 227–1905; e-mail
TSA invites interested persons to participate in this rulemaking by submitting written comments, data, or views. We also invite comments relating to the economic, environmental, energy, recordkeeping, or federalism impacts that might result from adopting the proposals in this document. See
With each comment, please identify the docket number at the beginning of your comments. TSA encourages commenters to provide their names and addresses. The most helpful comments reference a specific portion of the rulemaking, explain the reason for any recommended change, and include supporting data. You may submit comments and material electronically, in person, or by mail as provided under
If you want TSA to acknowledge receipt of your comments submitted by mail, include with your comments a self-addressed, stamped postcard on which the docket number appears. We will stamp the date on the postcard and mail it to you.
TSA will file in the public docket address, as well as items sent to the address or email under
Do not submit comments that include trade secrets, confidential commercial or financial information, or SSI to the public regulatory docket. Please submit such comments separately from other comments on the rulemaking. Comments containing this type of information should be appropriately marked as containing such information and submitted by mail to the address listed in
TSA will not place comments containing SSI in the public docket and will handle them in accordance with applicable safeguards and restrictions on access. TSA will hold documents containing SSI, confidential business information, or trade secrets in a separate file to which the public does not have access, and place a note in the public docket explaining that commenters have submitted such documents. TSA may include a redacted version of the comment in the public docket. If an individual requests to examine or copy information that is not in the public docket, TSA will treat it as any other request under the Freedom of Information Act (FOIA) (5 U.S.C. 552) and the Department of Homeland Security's (DHS') FOIA regulation found in 6 CFR part 5.
Please be aware that anyone is able to search the electronic form of all comments received into any of our dockets by the name of the individual submitting the comment (or signing the comments, if submitted on behalf of an association, business, labor union,
You may review TSA's electronic public docket on the Internet at
You may obtain an electronic copy using the Internet by
(1) Searching the Federal Docket Management System (FDMS) Web page at
(2) Accessing the Government Printing Office's Web page at
(3) Visiting TSA's Security Regulations Web page at
In addition, copies of the rulemaking document are available by writing or calling the individual in the
Civil aviation remains a target of terrorist activity worldwide. Terrorists continue to seek opportunities to destroy public confidence in the safety and security of travel, deny the ability of the public to move and travel freely, and damage international economic security.
TSA is proposing to issue regulations to provide for the security of maintenance and repair work conducted on aircraft and aircraft components at domestic and foreign repair stations, of the aircraft and aircraft components located at these repair stations, and of the repair station facilities as required by Vision 100—Century of Aviation Reauthorization Act, codified at 49 U.S.C. 44924 (Vision 100).
For purposes of this rulemaking, “repair stations” are those facilities certificated by the FAA to perform maintenance, repair, overhaul, or alterations on U.S. aircraft or aircraft components, including engines, hydraulics, avionics, safety equipment, airframes, and interiors. According to the FAA, there are 4,227 domestic repair stations located in the United States and 694 foreign repair stations located outside the United States that have an FAA certificate under part 145 of the FAA's rules.
In addition, for purposes of this rulemaking, the term “component” includes any article, airframe, aircraft engine, propeller, appliance, or part that is under repair. The term is used broadly to encompass both articles and appliances as defined by the FAA.
Aircraft repair stations vary widely in size, type of repair work performed, number of employees, and proximity to an airport. The FAA issues ratings to certificated repair stations for the work that can be performed at the repair station.
Repair stations are closely regulated and monitored by the FAA and both the FAA and the air carriers inspect work done at repair stations. FAA performance standards for foreign and domestic repair stations are the same. While the FAA has implemented extensive safety requirements for both foreign and domestic repair stations, supplementing those requirements with specific security measures for both foreign and domestic repair stations would further reduce the likelihood that terrorists would be able to gain access to aircraft under repair at a repair station. As terrorist organizations continue to seek new and creative means of using aircraft to undermine the security and safety of the traveling public, the importance of requiring all aircraft repair stations to have measures in place to prevent persons from commandeering, tampering, or sabotaging aircraft has increased as well. Enhancement of repair station security will mitigate the potential threat that an aircraft could be used as a weapon or that an aircraft could be destroyed.
This rulemaking sets forth proposed regulations to require all FAA certificated repair stations to adopt and carry out a standard security program. The proposed regulations list performance standards for security measures that would be included in the standard security program. The proposed regulations also would require repair stations to carry out Security Directives issued by TSA in the event of a specific threat.
In addition, the proposed regulations codify the scope of TSA's authority to conduct inspections of both domestic and foreign repair stations. The proposed regulations also provide procedures for TSA to notify repair stations of deficiencies in their security program and to determine whether a particular repair station represents an immediate risk to security. Finally, the proposal contains a process whereby a repair station may seek review of a determination by TSA that security deficiencies have not been addressed or that the repair station poses an immediate risk to security.
Vision 100 requires DHS to promulgate security regulations for domestic and foreign aircraft repair
• TSA must complete a security review and audit of foreign repair stations certificated by the FAA no later than six months after regulations are issued.
• TSA must notify the FAA of any security issues or vulnerabilities identified during the audit and require foreign repair stations to address any such issues or vulnerabilities within 90 days. If, after 90 days, TSA determines that the foreign repair station does not maintain and carry out effective security measures, TSA must notify the FAA and the FAA must suspend the repair station's certificate until such time as TSA determines that the repair station does maintain and carry out effective security measures.
• TSA must notify the FAA if TSA determines that a foreign repair station poses an immediate risk to security and the FAA must revoke the repair station's certificate. TSA must establish an appeal procedure to be used when a certificate is revoked.
TSA is proposing regulations to:
• Codify TSA's inspection authority.
• Require foreign and domestic repair stations certificated by the FAA under part 145 of the FAA's rules to allow TSA and DHS officials to enter, inspect, audit, and test property, facilities, and records relevant to repair stations.
• Require foreign and domestic repair stations certificated by the FAA to adopt and carry out a standard security program issued by TSA to safeguard the security of the repair station, the repair work conducted at the repair station, and all aircraft and aircraft components at the repair station.
• Require each security program to describe the specific measures the repair station has implemented to identify individuals authorized access to the repair station, aircraft, and aircraft components; control access to the repair station, aircraft, and aircraft components; challenge individuals who are not authorized access and use escort measures for authorized visitors; provide security awareness training to all employees; verify employee background information; designate a security coordinator; and establish a contingency plan.
• Require each repair station to comply with Security Directives issued by TSA.
• Establish a process to notify the FAA to suspend a certificate upon written notification by TSA that a repair station has not corrected security deficiencies identified during a security audit within 90 days and to permit appeal of a certificate suspension.
• Establish a process to notify the FAA to revoke a certificate upon written notification by TSA that a repair station is an immediate risk to security and to permit appeal of a certificate revocation.
In developing these proposals, TSA has consulted with FAA officials responsible for repair station safety matters.
The security regulations proposed in this NPRM are designed to build upon the extensive certification and safety requirements for repair stations instituted by the FAA. The FAA certificates repair stations, as well as repairmen who work in repair stations.
While these quality control measures provide a significant layer of protection and oversight of the components and aircraft under repair, the proposed regulations would supplement those measures by requiring that FAA certificated repair stations also adopt and carry out a security program that would include procedures to control access to the repair station itself, the components and aircraft under repair, and the work being performed; verify the identity of repair station employees; and establish a security coordinator to serve as the point of contact for security-related matters.
On February 27, 2004, TSA held a public listening session to receive input from stakeholders and other interested parties on repair station security issues. TSA also invited written comments to be submitted by March 29, 2004.
• Security measures that are currently deployed.
• Existing security vulnerabilities.
• Standards that should be in place to prevent unauthorized access, tampering, and any other security breaches.
• Current security system costs.
• Whether security requirements should be tailored to the type of authorization the repair station holds, number of employees, proximity to an airport, number of repairs completed, or other characteristics.
• Whether aircraft operators should play a role in ensuring that repair stations maintain a secure workplace.
• Whether any repair station operator has experienced a breach in security.
Twelve parties, representing air carriers, repair station operators and employees, manufacturers, and unions, spoke during the public meeting.
TSA also received 21 written comments, representing the views of repair station operators and employees, unions, air carriers, aircraft owners, and manufacturers regarding potential security regulations. The majority of those submitting written comments also supported the need for security regulations, and agreed that the regulations should be tailored to reflect the particular characteristics of a repair station. Some commenters suggested that TSA include general security criteria for domestic and foreign repair stations and others offered recommendations regarding specific provisions that should be included in the regulations, such as access controls, personnel identification, employee background checks, and security awareness training. The comments provide valuable input as to how repair station security issues should be addressed and the proposal reflects many of the issues, as well as the recommendations, contained in these initial comments. TSA looks forward to receiving further comments on the proposed regulations.
In addition to the information gathered during the public listening session and through written comments, TSA visited repair stations to conduct research on the physical characteristics of repair stations, the type of repair work performed, and the extent of security measures that had been implemented. The following site visits were conducted:
• June 2005—1 repair station in Hamburg, Germany, and 1 repair station in Amsterdam, the Netherlands.
• August 2005—5 repair stations in Singapore.
• November 2006—9 repair stations in the state of Arizona.
• December 2006—3 repair stations in Naples, Italy.
• January 2007—3 repair stations in the state of Georgia.
• May 2007—1 repair station in Singapore and 1 repair station in Guangzhou, China.
• July 2007—1 repair station in Teterboro, New Jersey.
• May 2008—3 repair stations in Bogota, Colombia.
These repair station site visits provided valuable insight into the different types of facilities certificated by the FAA, the different types of repair work conducted at the facilities, and the different types of security measures deployed by the various facilities. All of the stations visited had some security measures in place. For example, one foreign repair station had over 10,000 employees with many buildings and its own airport. This facility had perimeter fencing, security guards, and surveillance cameras to control access to the facility. Its employees were required to display identification media. Another foreign repair station had only seven employees and was located at an industrial park. That facility was planning to install surveillance cameras to be monitored by a private security company. In two countries the government had mandated security requirements for certain repair stations.
In the United States, one domestic repair station facility with 40 employees relied on personal recognition to identify individuals authorized entry into the facility, while another domestic repair station with fifteen employees used identification media and surveillance cameras. By conducting these site visits, TSA was able to study security measures already deployed and develop a proposal that reflects repair station diversity.
TSA proposes to add a new part 1554 to its regulations, entitled “Aircraft Repair Station Security.” The new part would require aircraft repair stations that are certificated by the FAA under 14 CFR part 145, both domestic and foreign, to adopt and carry out a standard security program. The regulations would require repair stations to safeguard the security of the aircraft and components located at the station, the maintenance and repair work performed there, as well as the repair station's facilities as required by 49 U.S.C. 44924. For a more detailed discussion of the proposed regulations, see the Section-by-Section Analysis portion of this preamble.
TSA is also proposing changes to its regulations regarding the protection of sensitive security information (SSI) to specify that a repair station security program is categorized as SSI and that the repair station operator or owner is subject to the SSI requirements described in 49 CFR part 1520.
FAA certificated repair stations, whether located at airports that have a TSA security program,
The proposed regulations list the general security requirements that each repair station would be required to carry out in the standard security program. The standard security program would require each repair station to include (1) a description of access controls for the facility as well as for the aircraft and/or aircraft components; (2) a description of the measures used to identify employees and others who are authorized to access aircraft and/or aircraft components; (3) a description of the procedures to challenge unauthorized individuals; (4) a description of security awareness training for employees; (5) the name of the designated security coordinator; (6) a contingency plan; and (7) a description of the means used to verify employee background information. The complete security program contents are discussed in the Section by Section analysis.
These requirements are consistent with the recommendations included in the written comments received by TSA,
Recognizing that a “one size fits all” approach would not appropriately address the diversity in repair station characteristics, TSA believes that repair stations should have some flexibility regarding the particular equipment, facilities, and measures that would be listed in the standard security program and used to comply with the proposed regulations. While TSA would provide a standard security program which would contain the majority of security measures that a repair station must adopt to comply with the proposed regulations, certain measures in the standard security program that the repair station must adopt may differ depending upon risk factors considered by TSA.
TSA would not require repair stations that are not located on or adjacent to an airport to implement the same physical security measures in the standard security program as those repair stations that are located on or adjacent to an airport. In adopting this approach, TSA considered the security risks of repair station operations to determine whether there were any factors that could increase the security risks of a repair station. The factors TSA considered were (1) size and type of aircraft to which employees had access; (2) the type of repair work permitted by the FAA certificate; (3) whether the repair station was located on an airport and the type of airport; and (4) the number of employees at the repair station.
Based on the information acquired during the repair stations site visits, an examination of FAA safety requirements, and discussions with FAA safety inspectors, TSA determined that while all of the characteristics examined had some effect on security risks, repair stations that are located on or adjacent to an airport could pose a higher security risk. TSA found that at airport locations, there was greater accessibility to aircraft and proximity to a runway, thereby increasing the possibility that an aircraft could be commandeered and used as a weapon or sabotaged. At off-airport locations, TSA found that repair station employees had little, if any, access to operational aircraft or runways. Repair station employees at off airport locations typically are not the last individuals with access to aircraft prior to the reintroduction of the aircraft into service. TSA believes that it would be difficult for an individual to damage an aircraft at a repair station location that is only rated to repair aircraft components if the individual does not have access to aircraft. FAA safety regulations require inspection of the repair work and the component before it is installed in an aircraft and before the aircraft is deemed to be airworthy. Thus, TSA believes it is less likely that a terrorist would attempt to target an aircraft by sabotaging a component at an off airport location.
This assessment of the greater risk posed by repair stations located on or adjacent to an airport was also supported by several commenters. One commenter noted that repair stations located within an airport posed the greatest risk to security because of the larger number of entry points in such a location. Another explained that repair facilities located off airport generally only work on aircraft components and that the multiple layers of testing and oversight already conducted by the FAA serves as an important security function as well. Another commenter agreed, stating that repair stations that do not have access to aircraft do not pose a security risk because the airworthiness of the components are tested before they are released into service.
Based on this risk assessment, TSA would specify particular security measures in the standard security program that would apply to repair stations on or adjacent to an airport, but that would not be required for other repair stations. TSA believes that this approach would be consistent with its efforts to strengthen security measures at the non public areas of the airport.
In addition, TSA would not require repair stations on or adjacent to airports that only serve aircraft with a maximum certificated take-off weight (MTOW) of 12,500 pounds or less to include the same security measures in the standard security program as repair stations located on or adjacent to airports that serve larger aircraft. TSA has long recognized that aircraft with a MTOW over 12,500 pounds pose a greater risk to security because such aircraft are of sufficient size and weight to inflict significant damage and loss of lives.
TSA is aware that the FAA may certificate repair stations operating on a Federal government facility, such as a U.S. military base. TSA believes that the security at such a facility would likely meet and exceed the security requirements proposed herein. Therefore, TSA would not apply its requirements to any FAA certificated repair station at which the Federal government has assumed responsibility for security measures.
The issue of requiring drug and alcohol testing of repair station employees was raised during the public listening session. TSA is not proposing to include drug and alcohol testing as part of its security program requirements. TSA notes that the FAA has instituted alcohol and drug testing as part of its safety regulations.
TSA believes that the standard security program would be useful to repair stations that have not developed or implemented a security program, particularly small repair stations that may lack the resources to create their own security program. Further, the standard security program would provide consistency in format and content for the thousands of security programs that would be implemented under this proposal. TSA anticipates requesting comment from repair stations on the standard security program before a final rule is adopted and will make a draft of the standard security program available for review and comment by the repair stations subject to the regulations either electronically, through meetings, or both.
To assess the security risks of a repair station and to establish the priority by which repair stations must be inspected, TSA would require each repair station to provide a brief profile, to include general information as to location, such as whether the repair station is located
Further, the profile will assist TSA in determining which measures included in the standard security program must be implemented to address the higher risk posture of repair stations that are located on or adjacent to an airport.
The proposed regulations would codify TSA's inspection authority and would require repair stations to permit TSA and DHS officials to enter, inspect, and test property, facilities, and records relevant to repair stations. The purpose of the inspection would be to assess threats to aviation security, enforce TSA security regulations, directives, and requirements, evaluate all aspects of the repair station security program, verify whether the security program is being implemented and whether it is effective, as well as to identify and correct security deficiencies. Such oversight is also necessary to monitor continuing compliance with the security requirements. Since the inspection program is critical to the enforcement of the security program requirement, TSA's inspection authority would extend to all repair stations. TSA would initiate foreign repair station inspections by giving priority to those foreign repair stations that pose the greatest risk to aviation security as required by Vision 100, and that have identified themselves through the profile as being located on or adjacent to an airport and as performing repair work on large aircraft.
Pursuant to the inspection process and consistent with Vision 100, TSA is proposing to notify the repair station and the FAA of any deficiencies in a security program and to permit the repair station 90 days to correct such deficiencies. If the deficiencies are not corrected within 90 days, TSA would notify the FAA that it must suspend the repair station's certificate until such time as TSA determines that the deficiencies are resolved. The proposed regulations also contain a process whereby a repair station may request further review of TSA's determination regarding security deficiencies.
The proposed regulation contains a specific process whereby a repair station that poses an immediate risk to security is identified and the FAA is notified of such a determination. The FAA must revoke the certificate of a station that TSA determines poses an immediate risk to security. Whether the threat is immediate would be evaluated on a case by case basis considering existing and potential circumstances as information is received and analyzed. The proposal provides a repair station with the opportunity to obtain the releasable materials upon which the determination was made and to seek review of such a determination.
Protection of Sensitive Security Information (SSI), as codified at 49 CFR part 1520, would apply to each repair station required to adopt and carry out a security program. Airport and aircraft operator security programs and plans, amendments, security directives and information circulars, technical specifications of security screening and detection systems and devices, among other types of information, all constitute SSI under current § 1520.5 and are prohibited from public disclosure. TSA is proposing to amend its part 1520 rules to include a repair station security program as SSI. This change would prevent the public disclosure of the security measures implemented and utilized by a repair station covered under the new rules because such disclosure would pose a threat to transportation security. It would also ensure that the repair station standard security program is protected just as other TSA required security programs are protected.
TSA proposes to amend § 1520.7 to include repair station operators as covered persons subject to its SSI requirements. This change would require that repair station operators adhere to the SSI rules and protect SSI from public dissemination. Access to SSI is strictly limited to those persons with a need to know, as defined in 49 CFR 1520.11. In general, a person has a need to know specific SSI when he or she requires access to the information in order to carry out transportation security activities that are government-approved, -accepted, -funded, -recommended, or -directed, including for purposes of training on, and supervision of, such activities or to provide legal or technical advice regarding security-related requirements. Accordingly, the protection of SSI would apply to each repair station standard security program pursuant to part 1554.
Section 1554.1 of the proposed regulation sets forth the scope and purpose of new part 1554. The proposed regulations would apply to all repair stations, both domestic and foreign, that are certificated by the FAA pursuant to 14 CFR part 145. The purpose of the proposed regulations would be to safeguard the security of domestic and foreign aircraft repair stations as required by 49 U.S.C. 44924. The requirements would not apply to any FAA certificated repair station at which the U.S. government has assumed responsibility for security measures.
Section 1554.3 of the proposed rule sets forth the definitions of certain terms used in this part. The term “repair station” is defined as any maintenance facility that is certificated by FAA pursuant to 14 CFR part 145 to perform maintenance, preventive maintenance, repair, overhaul, or alterations of an aircraft, airframe, aircraft engine, propeller, appliance, or component part.
Section 1554.5 would codify TSA's authority to inspect repair stations and would require repair stations to permit TSA and DHS officials to enter, inspect, and test property, facilities, and records relevant to repair stations. This section would allow TSA to assess threats, enforce regulations, security directives, and requirements, inspect all facilities and equipment, test the adequacy of security measures, verify the implementation of security measures, review security programs and other records, and perform such other duties as appropriate. This section also would allow TSA to request evidence of compliance, including copies of records in English.
The proposed regulatory language is consistent with the inspection authority currently codified at 49 CFR 1542.5 and 1546.3, which apply to certain U.S. airports and foreign air carriers. TSA has established protocols and procedures on conducting inspections outside the United States through its Foreign Airport and Foreign Air Carrier Assessment Programs. These established procedures require advance notice to the facility to be inspected and coordination with the U.S. Department of State and the appropriate foreign government authorities. TSA inspectors are required to have TSA identification media and credentials with them when inspecting facilities and must display them when requested to do so. TSA will use these established procedures when conducting inspections of foreign repair stations.
TSA is also amenable to working with the U.S. Department of State and foreign government authorities to facilitate inspections of U.S. repair stations that are certificated by a foreign government authority. TSA currently permits such inspections of U.S. airports and air carriers by foreign government authorities consistent with ICAO Annex 17, Section 2.1.
TSA has kept ICAO apprised of the rulemaking and will continue its efforts to harmonize its regulations with those of other countries through its participation in ICAO.
Section 1554.101 would require each repair station to adopt and carry out a security program designed to safeguard aircraft and aircraft components located within the repair station, the maintenance and repair work performed there, and the facility itself. Repair stations would be required to use the TSA standard security program unless otherwise authorized by TSA.
This section would also require a repair station to submit a profile. The purpose of the profile would be to provide basic information regarding repair station operations to assist TSA in determining what measures the repair station must include in its security program to meet the security requirements. The profile would also assist TSA in prioritizing repair stations for purposes of conducting inspections. TSA would make the profile template available to all repair stations either through the TSA web site, by mail, or both. The profile would request the following types of information:
• Identification of the repair stations, such as FAA certificate number, repair station name as it appears on the FAA certificate, and repair station address.
• Description of location (on or adjacent to an airport, off airport in a business location, off airport private residence).
• Security coordinator who will serve as the TSA point of contact.
• If on an airport, the name and three letter designator of the airport.
• Total number of employees.
• Number of employees authorized unescorted access to aircraft over 12,500 MTOW.
The name and location of each repair station would assist TSA in identifying the repair station and determining its proximity to an airport since, as explained above, TSA would consider such repair stations to be a higher risk than those that are not located on or adjacent to an airport. The profile information would also help TSA to prioritize its inspections. Repair stations would also be required to update their profile information within 30 calendar days if a change in the information submitted occurs. This requirement would enable TSA to maintain current information on each regulated repair station and make certain that it is appraised of changes that could impact the security posture of a repair station. Repair stations would not be required to alert TSA to changes in total number of employees or number of employees who work on large aircraft to prevent the submission of a new profile every time an employee is hired or terminated.
Section 1554.103 would describe the general requirements describing the measures that each repair station must adopt in the standard security program. The standard security program must include:
(1) A description of the measures used to identify individuals who are authorized to enter the repair station to prevent unauthorized individuals from entering the repair station;
(2) a description of the measures used to control access to the repair station and to detect and prevent the entry, presence, and movement of unauthorized individuals and vehicles into or within the repair station;
(3) a description of the measures used to control access to the aircraft and/or aircraft components to allow only authorized individuals to have such access;
(4) a description of the measures used to challenge any individual entering the repair station to ascertain the authority of the individual to enter or be present in the repair station and measures to escort an individual who does not have unescorted authority while within the repair station;
(5) a description of the measures to train all individuals with authorized access to aircraft and components on the provisions of this part and the security program;
(6) a description of the measures used to verify employee background information through confirmation of prior employment and any other means as appropriate to validate employee information;
(7) the name, 24-hour contact information, duties, and training requirements of the designated security coordinator who will serve as the primary and immediate contact for security-related activities and communications with TSA;
(8) a contingency plan;
(9) a diagram with dimensions detailing boundaries and pertinent physical features of the repair station;
(10) a list and description of all entry points; and
(11) an emergency response contact list.
The regulations also would require that the security program be in writing, and signed by the repair station operator, owner, or other authorized person. Each repair station would not have to submit the security program to TSA, but would have to make it available to TSA upon request or during an inspection.
The individual standard security program requirements are discussed below.
The proposed regulations would require the repair station to adopt and
• Number of employees and number of shifts.
• Physical size of the repair station.
• Number of visitors.
• Proximity of other businesses or operations.
• Type of work, size of aircraft, and length of runway.
• Number of entry points into the repair station.
• Airport security features.
• Other factors that increase ability of unauthorized individuals or vehicles to access the repair station.
For example, a repair station with 50 employees who work multiple shifts at a repair station, located adjacent to an airport with many access points, might be required to adopt and carry out the personnel identification media system. Such a repair station would be considered to be a higher risk because of its proximity to an airport. Further, the large number of employees working multiple shifts would make it difficult for employees to rely solely on personal recognition as workers from different shifts may not be able to recognize each other. A repair station located in a residence with a single employee would not be required to adopt the personnel identification media system in the security program. TSA would not anticipate requiring a repair station located at an airport to adopt a personnel identification media system if employees were required to obtain and display airport identification media.
The standard security program would specify the access control security requirements for all repair stations. Such requirements would include measures to control access to the facility and to the aircraft and components within the repair station, to challenge any individuals to determine if they are authorized to enter or be present in the facility, and to respond if unauthorized individuals or vehicles are discovered.
Acceptable access control measures would be specified in the security program. Such measures would cover a broad spectrum, including standard locks with key control, card swipe access locks, cipher locks, locks with coded keys, biometric access cards, fencing, security guards, surveillance cameras, and motion detectors.
As part of the standard security program, the repair station would be required to describe all of the entry points to the facility and the specific access control measures used for each. During the inspection process, TSA would determine whether the access control measures deployed at the entry point are appropriate. A repair station located on or adjacent to an airport that performs substantial maintenance on large aircraft would be required to have more stringent access controls. Such controls could include such measures as card swipe access locks, security guards, electronically monitored access or motion detectors, fencing or a combination of such controls. A repair station located in a private residence or in a small component shop in an industrial park would be required to have less sophisticated controls, such as standard locks with key control and an inventory system to track the number of keys. A repair station would be able to select the above or other measures that would provide a appropriate level of security.
Access controls would also be required to restrict unauthorized access to components located within the facility, such as locked storage containers and inventory control of keys.
In addition, the security program would include measures to control access to aircraft, such as requiring repair stations located on or adjacent to an airport to secure large aircraft by locking or disabling the aircraft, keeping the aircraft in a secure hangar during non-operational hours, fencing, surveillance cameras, lighting, and security guards.
The security program would describe the procedures to be followed when challenging individuals who cannot be readily identified. Only those individuals who are designated and trained in escort procedures would be permitted to escort visitors to the repair station. The responsibilities of the escort would be specified in the security program. At a small facility with few employees, the ability to observe individuals present within the facility may be sufficient to ensure that access to repair work and/or components is controlled. At large repair station facilities, such as those that use a personnel identification media system, employees may have to escort individuals as part of their responsibilities.
The security program would include measures to conduct initial and recurrent security training programs, such as providing guidance to repair station personnel on how to implement and maintain the security measures included in the security program. The security program would also specify that the training curriculum be updated to reflect current security requirements. The repair station would be required to maintain records of initial and recurrent security training for each employee. The standard security program would include a model curriculum that the repair station could modify based on the specific security requirements applicable to that repair station.
The security program would include the measures by which the repair station verifies the employment history of its employees and conducts background checks, to the extent permitted by the laws of the country in which the repair station is located. The employment history, length of employment, and measures used to verify the individual's employment would be listed in the security program.
Each repair station would be required to designate a security coordinator who would serve as the immediate and primary point of contact for security-related activities and communications with TSA. Each repair station would include the name, responsibilities, and contact information of the security coordinator in the security program and would also specify the training curriculum required for the security coordinator. The security coordinator would not necessarily need to be on-site at the repair station, but they must be able to coordinate incident management at any time.
The security program would include a contingency plan to include the specific measures that would be taken to address security-related incidents. The security program would include such items as the names of the repair station employees designated to perform specific tasks, the name and contact information for any contingency response organizations that would assist the repair station, a description of the
The proposed regulations would also require that each security program include a diagram of the repair station detailing the boundaries and describing the physical features of the repair station. The security program would also include a list and description of all entry points into the repair station that would be supplied by the repair station operator. These requirements would assist TSA in assessing the security vulnerability of the repair station and determining whether security measures are appropriate. The security program would also include emergency response contact information.
Section 1554.103(b) would require that the security program be in writing, and hand-signed by the repair station operator, owner, or other authorized person. The security program would be required to be accessible to employees at the repair station facility and be written in English and in the official language of the repair station's country. The security program could be accessible electronically so long as it meets all of the requirements. This section would also include a requirement that repair stations must restrict the distribution, disclosure, and availability of sensitive security information as described in 49 CFR part 1520.
Section 1554.103(c) would require a repair station to notify TSA of any amendment to the standard security program and would require that the repair station acknowledge receipt and adopt an emergency amendment issued by TSA within the time prescribed in the emergency amendment. If the repair station cannot implement the emergency amendment, the repair station must immediately notify TSA to obtain approval of alternative measures. They may contact their TSA inspector or the TSA Repair Stations Office at TSA headquarters.
This section would require a repair station to comply with any Security Directive issued by TSA mandating security measures. Security Directives may be issued when TSA determines that additional or specific security measures are necessary to respond to a threat assessment or a specific threat against aviation. Upon receipt of a Security Directive, the repair station would be required to comply with the measures in the time prescribed or immediately notify TSA if it is unable to implement the specified security measures so that the repair station can obtain approval of alternative measures. The repair station would also be required to restrict the availability of a Security Directive to only those individuals with an operational need to know.
Proposed § 1554.201 implements the requirements of 49 U.S.C. 44924(c)(1) regarding the suspension of a repair station certificate. Vision 100 requires audits to be conducted of foreign repair stations within a specified timeframe.
The proposed regulation would provide that TSA would notify the repair station and the FAA in writing of any security deficiencies identified by TSA during an audit. Repair stations would be required to respond within 90 days of receipt of the written notification that the deficiency has been corrected and include a written explanation of the efforts, methods, and procedures used to correct the deficiency. TSA may re-audit the repair station to verify that the deficiencies have been corrected. The proposal specifies that TSA would provide written notification to the FAA if the repair station failed to respond and/or to correct the deficiencies within the 90-day period and that, consistent with the statute, FAA would suspend the repair station certificate. The suspension would remain in effect until TSA makes a determination that the deficiencies had been corrected; TSA would then notify the FAA requesting that the suspension be lifted.
Proposed § 1554.203 implements 49 U.S.C. 44924(c)(2) and requires that if TSA makes an initial determination that a repair station poses an immediate risk to security, TSA would notify the repair station and the FAA that the station's certificate must be revoked. The repair station may seek review of TSA's determination that the station poses an immediate risk to security; however, the revocation would remain in effect unless and until the review is complete and a determination is made that the repair station does not pose an immediate risk to security.
Proposed § 1554.203(b) would allow the repair station to request the releasable materials upon which the determination is based. Proposed § 1554.203(c) would permit the repair station to request a review and to provide a response to TSA. The response may include any information that the repair station deems relevant to a final decision. TSA would conduct an initial review of the basis for the determination and the response and, if the determination is upheld, a final review by the TSA Assistant Secretary. TSA would notify the FAA of its final determination.
This section preserves TSA's authority not to disclose classified information or other information protected by law or regulation.
The Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501
TSA is soliciting comments to—
(1) Evaluate whether the proposed information requirement is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of the burden;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including using appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Individuals and organizations may submit comments on the information collection requirements by January 19, 2010. Direct the comments to the address listed in the
As protection provided by the Paperwork Reduction Act, as amended, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
In keeping with U.S. obligations under the Convention on International Civil Aviation, it is TSA policy to comply with ICAO Standards and Recommended Practices where possible. TSA has determined that these proposed regulations are consistent with ICAO Standards and Recommended Practices for security of airports and facilities contained in Annex 17 of the Convention, the ICAO Security Manual and the ICAO Security Audit Reference Manual.
Changes to Federal regulations must undergo several economic analyses. First, Executive Order 12866, Regulatory Planning and Review (58 FR 51735, October 4, 1993), directs each Federal agency to propose or adopt a regulation only upon a reasoned determination that the benefits of the intended regulation justify its costs. Second, the Regulatory Flexibility Act of 1980 (5 U.S.C. 601
TSA has prepared a separate detailed analysis document, which is available to the public in the docket.
a. This proposed rule is not an economically “significant regulatory action” as defined in the Executive Order. However, this rulemaking may be considered significant because of Congressional and stakeholder interest in security since the events of September 11, 2001.
b. The Initial Regulatory Flexibility Analysis (IRFA) shows that there may be a significant impact on a substantial number of small entities.
c. This proposed rule imposes no significant barriers to international trade.
d. This proposed rule does not impose an unfunded mandate on State, local, or tribal governments, or on the private sector in excess of $100 million (adjusted for inflation) in any one year.
This summary highlights the costs and benefits of the proposed rule to amend the transportation security regulations to further enhance and improve the security of repair stations. TSA has determined that this is not a major rule within the definition of Executive Order (EO) 12866, as annual costs to all parties do not pass the $100 million threshold in any year. The Initial Regulatory Flexibility Analysis (IRFA) shows that there may be a significant impact on a substantial number of small entities. There are no significant economic impacts for the required analyses of international trade
Comparison of the total undiscounted domestic costs of the proposed rule with potential benefits from the proposed aircraft repair station security program relies on a breakeven comparison based on the extent to which the program must reduce the underlying baseline risk of specific attack impact scenarios in order for the program benefits to be greater than the expected costs. Such a comparison is presented in Table 2 following the “Benefits” section below. This comparison is discussed briefly above and in greater depth in the body of the analysis.
A major line of defense against an aviation-related terrorist act is the prevention of explosives, weapons, and/or incendiary devices from getting on board a plane. To date, efforts have been primarily related to inspection of baggage, passengers, and cargo, and security measures at airports that serve air carriers. With this rule, attention is given to aircraft that are located at repair stations, and to aircraft parts that are at repair stations, themselves to reduce the likelihood of an attack against aviation and the country. Since repair station personnel have direct access to all parts of an aircraft, the potential exists for a terrorist to seek to commandeer or compromise an aircraft when the aircraft is at one of these facilities. Moreover, as TSA tightens security in other areas of aviation, repair stations increasingly may become attractive targets for terrorist organizations attempting to evade aviation security protections currently in place.
To better inform the comparison of the costs of the repair station security program in the proposed rule with the benefits to homeland security it might afford due to reduced risk of successful terror attack involving an aircraft, a breakeven analysis was performed. In this analysis, the annualized costs of the program, discounted at seven percent, are compared to the expected benefits of avoiding or preventing three attack scenarios of varying consequence. For each scenario, the required extent of annual risk reduction due to the proposed program, expressed as the frequency with which attacks must be averted, is reported in the final column of the break-even analysis (Table 2) below.
As required, alternatives to the primary rule requirements were analyzed. Table 31 that follows provides the 10-year cost of the preferred alternative and two other alternatives, undiscounted and at three and seven percent discount rates.
Using a seven percent discount rate, TSA estimated the 10-year cost impacts for the primary scenario of this proposed rule would total $241.0 million. This total is distributed among domestic repair stations, which would incur total costs of $118.6 million; foreign repair stations, which would incur costs of $68.7 million; and TSA-projected Federal Government costs, which would be $53.7 million.
The Regulatory Flexibility Act of 1980 (RFA) establishes “as a principle of regulatory issuance that agencies shall endeavor, consistent with the objective of the rule and of applicable statutes, to fit regulatory and informational requirements to the scale of the business, organizations, and governmental jurisdictions subject to regulation.” To achieve that principle, the RFA requires agencies to solicit and consider flexible regulatory proposals and to explain the rationale for their actions. The RFA covers a wide range of small entities, including small businesses, not-for-profit organizations, and small governmental jurisdictions.
Agencies must perform a review to determine whether a proposed or final rule will have a significant economic
As part of implementing this NPRM, TSA expects security to be integrated into actions the same way safety has and to become an integral component of doing business rather than adding layers or extra program costs. The primary cost to repair stations resulting from this NPRM would be additional hours for personnel to perform the duties of the repair station security coordinator. For many stations this may constitute an insignificant impact, while for others the costs to comply with the proposed rule may prove significant. TSA has conducted an initial regulatory flexibility analysis and believes the proposed requirements may result in a significant economic impact on a substantial number of small entities. TSA requests comments, particularly those supported by data, on this preliminary conclusion.
In 2003, Congress enacted Vision 100—Century of Aviation Reauthorization Act (Vision 100), Public Law 108–176, (117 Stat. 2490, December 12, 2003). Vision 100, which was signed into law by President George W. Bush on December 12, 2003, expands TSA's authority to address the security of the civil aviation system by requiring TSA to issue final regulations to ensure the security of both domestic and foreign aircraft repair stations.
The requirements proposed in this NPRM are designed to increase overall civil aviation security by bolstering the level of security at domestic and foreign aircraft repair stations.
Aircraft repair stations are classified by the U.S. Census Bureau as falling primarily within the North American Industry Classification System (NAICS), code 488190 Other Support Activities for Air Transportation. In its account of the industry, the U.S. Census Bureau describes firms in this market as “providing specialized services for air transportation (except air traffic control and other airport operations).”
To estimate the number of small businesses in the aircraft repair station industry affected by this NPRM, TSA accessed information maintained by Dun & Bradstreet, a provider of international and U.S. business data. The data obtained for this effort did not identify the type of maintenance the repair stations are certificated to perform or their location. This made it difficult for TSA to determine compliance costs for the identified small businesses (this is discussed more below).
Through its research, TSA obtained Dun & Bradstreet revenue and employment records for 2,276 domestic aircraft repair stations. Of this total, 2,123 reflected small businesses, as defined by SBA, and 153 did not. TSA was unable to find data on the remaining domestic repair stations. For the purposes of this analysis, and to remain conservative in its estimates, TSA assumed that the remaining domestic repair stations are also small. TSA thus estimated that 4,115 of 4,268 domestic aircraft repair stations are small businesses, as defined by SBA.
In order to address the need for security measures at aircraft repair stations and to fulfill the obligations set forth by Congress, TSA is proposing to add a new part 1554 to its regulations, entitled “Aircraft Repair Station Security.” The new part would require all aircraft repair stations that are certificated by the FAA under 14 CFR part 145, both domestic and foreign, to adopt and carry out a security program that includes specific security requirements. The regulations would require repair stations to safeguard aircraft and components located at the station, the maintenance and repair work conducted there, as well as the repair station's facilities, as required by 49 U.S.C. 44924.
TSA is also proposing changes to its regulations regarding the protection of sensitive security information (SSI) to specify that a repair station security program is categorized as SSI and that the repair station operator or owner is subject to the SSI requirements.
The proposed rule would require repair stations to establish security programs. TSA would provide a standard security program that would include the following: Access controls, a personnel identification system, security awareness training, the designation of a security coordinator, employee background verification, and a contingency plan. While repair stations would have some flexibility regarding the particular equipment, facilities, and measures used to comply with the general security requirements, their security methods would need to address each of these requirements in a manner commensurate with the station's security risk. For example, small repair stations may meet the requirement for a personal identification system through employee recognition and challenge procedures, while TSA would require stations located on or adjacent to an airport and having 50 or more employees to implement a formal badging system.
The proposed rule would require each repair station to complete and return to TSA a brief profile form. The profile would identify information, such as whether the repair station is located at an airport,
The proposed regulations also would establish TSA's authority to conduct security audits, assessments, and inspections in order to ascertain the adequacy of the measures employed by the repair stations to implement and maintain the security requirements. The proposed inspections and appeals processes are described in detail in the NPRM.
In its effort to fulfill the requirements of the RFA, TSA attempted to estimate all costs of complying with the above described requirements for each firm for which it had Dun & Bradstreet data and to calculate those costs as a percent of the repair station's reported revenues. TSA determined that this methodology would best conclude whether the proposed rule would represent a considerable economic burden to a large number of small businesses. After completing this preliminary analysis (described below), TSA has tentatively concluded that the proposed rule may impose a significant economic impact on a substantial number of small entities. The agency seeks comment on this preliminary conclusion.
Compliance costs for the proposed rule would vary across firms. A small business with one employee who only services one component of a particular aircraft may incur very low compliance costs. Such a business is likely to be operated from a small shop or even a private residence. Conversely, a larger repair station that works on more complex systems or even entire aircraft may incur higher costs as a result of this NPRM. These types of facilities may be located at an airport, in an industrial park, or may be part of an aircraft manufacturing facility. For example, in the “Cost of Compliance” section above, TSA estimated repair stations located on or adjacent to an airport would require 8 hours on average to complete their security programs whereas repair stations located off-airport would require only 4. Unfortunately, TSA was unable to pair the data from Dun & Bradstreet with repair station data provided by the FAA. As a result, TSA could not estimate compliance costs particular to repair station characteristics such as whether it is located on an airport or performs substantial maintenance on commercial aircraft.
Therefore, in order to characterize compliance costs as a percentage of repair station revenues, TSA estimated unit compliance costs based on weighted averages so as not to underestimate the costs of the rule. As a result, these estimates likely overstate the costs to some small businesses while understating them for others. TSA welcomes comments that will assist it in more accurately estimating compliance costs for small businesses.
Using the assumptions and methods described above, TSA estimated the average compliance costs to be about $3,013 for a business with one employee to $4,216 for a business with 45 employees. Of this total, $2,733 represents costs for security coordinators, and $253 represents costs for development and implementation of security programs. The remainder is comprised of employee training costs.
These totals exclude costs for repair stations located on or adjacent to an airport and having 50 or more employees to implement a badging system. TSA assumed that firms with 100 or more employees likely already have a badging system. Based on the Dun and Bradstreet data, TSA estimated the average compliance cost for firms reported as having between 50 and 99 employees would be approximately $4,728 before adding costs to implement a badging system. These firms employ an average of 64 individuals. Using the estimate of $25 per badge cited in the Regulatory Evaluation, badges would add an average of nearly $1,600 to these repair stations' compliance costs, resulting in a total cost of $6,328. Firms having between 50 and 99 employees in the Dun and Bradstreet sample reported average revenue of nearly $6 million. The estimated compliance costs would therefore constitute less than one percent of their annual revenues. Since the proposed ID requirement would affect a subset of these repair stations—only those which are located on or adjacent to an airport—TSA does not believe the proposed ID requirement would result in a significant impact on affected repair stations.
Table 32 below shows the distribution of compliance costs, excluding ID costs, as a percent of repair station revenues.
The table uses rounded percentages to show that TSA's initial assessment is that the NPRM may have a significant impact on a substantial number of small businesses. TSA believes that for 47.8 percent of the small businesses, the compliance costs will result in an economic impact of two percent of annual revenue or less, and for 71.9 percent of the small businesses, the compliance costs will be less than three percent of annual revenue. TSA requests comment on these estimates.
During the course of drafting this NPRM, TSA considered regulatory alternatives. These alternatives included requiring security threat assessments for certain repair station employees and requiring each repair station to complete a vulnerability self-assessment. Both of these alternatives would have increased the burden on repair stations and thus on small entities. A description of these alternatives and the reasons they were not adopted can be found in the section of the Regulatory Evaluation titled, “Alternatives Considered.”
Additionally, as noted above, TSA requests comment on whether it should exempt certain repair stations after it conducts security reviews and audits. For instance, TSA may consider whether to exempt repair stations that only perform maintenance on small aircraft (aircraft having a maximum certificated takeoff weight of 12,500 pounds or less). To help the agency evaluate the impact of this alternative, TSA requests comments, supported by data, on the number of repair stations that work exclusively on such aircraft and their compliance costs under the proposed rule.
TSA has no knowledge of any duplicative, overlapping, or conflicting Federal rules.
Based on this preliminary analysis, TSA believes the proposed requirements may result in a significant economic impact on a substantial number of small entities. However, TSA holds a final assessment in abeyance until such time as information becomes available to facilitate the development of a Final Regulatory Flexibility Analysis (FRFA). TSA requests comments, particularly those supported by data, to inform this process.
The Trade Agreement Act of 1979 prohibits Federal agencies from engaging in any standards or related activities that create unnecessary obstacles to the foreign commerce of the United States. Legitimate domestic objectives, such as security, are not considered unnecessary obstacles. The statute also requires consideration of international standards and, where appropriate, that they be the basis for U.S. standards. In addition, it is the policy of TSA to remove or diminish, to the extent feasible, barriers to international trade, including both barriers affecting the export of American goods and services to foreign countries and barriers affecting the import of foreign goods and services into the U.S.
In keeping with U.S. obligations under the Convention on International Civil Aviation, it is TSA's policy to comply with International Civil Aviation Organization (ICAO) Standards and Recommended Practices where possible. TSA has determined that there are no ICAO Standards and Recommended Practices that correspond to the regulatory standards established by this notice of proposed rulemaking (NPRM). TSA has assessed the potential effect of this NPRM and has determined that it is unlikely it would create barriers to international trade. The full evaluation provides an analysis of a number of issues directly related to international trade that were considered with this proposed rule.
The Unfunded Mandates Reform Act of 1995 is intended, among other things, to curb the practice of imposing unfunded Federal mandates on State, local, and tribal governments. Title II of the Act requires each Federal agency to prepare a written statement assessing the effects of any Federal mandate in a proposed or final agency rule that may result in a $100 million or more expenditure (adjusted annually for inflation) in any one year by State, local, and tribal governments, in the aggregate, or by the private sector; such a mandate is deemed to be a “significant regulatory action.” This rulemaking does not contain such a mandate. The requirements of Title II of the Act, therefore, do not apply.
TSA has analyzed this proposed rule under the principles and criteria of Executive Order 13132, Federalism. We have determined that this action will not have a substantial direct effect on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government, and therefore will not have federalism implications.
TSA has reviewed this action under DHS Management Directive 5100.1, Environmental Planning Program (effective April 19, 2006) which guides TSA compliance with the National Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321–4347). TSA has determined that this proposal is covered by the following categorical exclusions (CATEX) listed in the DHS directive: Number A3(a) (administrative and regulatory activities involving the promulgation of rules and the development of policies); paragraph A4 (information gathering and data analysis); paragraph A7(d) (conducting audits, surveys, and data collection of a minimally intrusive nature, to include vulnerability, risk, and structural integrity assessments of infrastructures); paragraph B3 (proposed activities and operations to be conducted in existing structures that are compatible with ongoing functions); paragraph B11 (routine monitoring and surveillance activities that support homeland security, such as patrols, investigations, and intelligence gathering), and H1 (approval or disapproval of security plans required under legislative mandates where such plans do not have a significant effect on the environment). In addition, TSA has determined that this proposal meets the three conditions required for a CATEX to apply, as described in paragraph 3.2, (Conditions and Extraordinary Circumstances).
The energy impact of this NPRM has been assessed in accordance with the Energy Policy and Conservation Act (EPCA) Public Law 94–163, as amended (42 U.S.C. 6362). TSA has determined that this rulemaking is not a major regulatory action under the provisions of the EPCA. TSA has also analyzed this proposed rule under E.O. 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use,” 66 FR 28355 (May 18, 2001). TSA has determined that this is not a “significant energy action” under that order.
Air carriers, Aircraft, Aircraft repair stations, Airports, Maritime carriers, Rail hazardous materials receivers, Rail hazardous materials shippers, Rail transit systems, Railroad carriers, Railroad safety, Railroads, Reporting and recordkeeping requirements, Security measures, Vessels.
Aircraft, Aircraft repair stations, Aviation safety, Reporting and recordkeeping requirements, Security measures.
In consideration of the foregoing, the Transportation Security Administration proposes to amend Chapter XII of Title 49, Code of Federal Regulations, to read as follows:
1. The authority citation for part 1520 continues to read as follows:
46 U.S.C. 70102–70106, 70117; 49 U.S.C. 114, 40113, 44901–44907, 44913–44914, 44916–44918, 44935–44936, 44942, 46105.
2. In § 1520.5, revise paragraph (b)(1)(i) to read as follows:
(b) * * *;
(1) * * *;
(i) Any aircraft operator, airport operator, fixed base operator, repair station, or air cargo security program, or security contingency plan under this chapter;
3. In § 1520.7, add paragraph (o) to read as follows:
(o) Each operator or owner of an aircraft repair station required to have a security program under part 1554 of this chapter.
49 U.S.C. 114, 40113, 44903, 44924.
This part applies to domestic and foreign repair stations that are certificated by the Federal Aviation Administration pursuant to 14 CFR part 145 except for a repair station certificated by the Federal Aviation Administration at which the U.S. Government has assumed responsibility for security. The purpose of this part is to provide for the security of maintenance and repair work conducted on aircraft and aircraft components at domestic and foreign repair stations, of the aircraft and aircraft components located at the repair stations, and of the repair station facilities, as required in 49 U.S.C. 44924.
In addition to the terms in §§ 1500.3 and 1540.5 of this chapter, the following terms apply in this part:
(1)
(2)
(a)
(1) Assess threats to transportation security;
(2) Enforce security-related regulations, directives, and requirements;
(3) Inspect, maintain, and test security facilities, equipment, and systems;
(4) Ensure the adequacy of security measures;
(5) Verify the implementation of security measures;
(6) Review security programs; and,
(7) Carry out such other duties, and exercise such other powers, relating to transportation security as the Assistant Secretary of Homeland Security for the TSA considers appropriate, to the extent authorized by law.
(b)
(1) All records required under this part must be available in English.
(2) All responses and submissions provided to TSA or its designee, pursuant to this part, must be in English, unless otherwise requested by TSA.
(c)
(2) Repair stations may request TSA inspectors and DHS officials working with TSA to present their credentials for examination, but the credentials may not be photocopied or otherwise reproduced.
(a)
(b)
(c)
(a)
(1) Include measures to identify all individuals who are authorized to enter the repair station to prevent unauthorized individuals from entering the repair station.
(2) Include measures to control access to the repair station. Such measures must be designed to prevent, detect and resolve any unauthorized entry, presence, and movement of individuals and vehicles into or within the repair station.
(3) Include measures to control access to the aircraft and aircraft components to allow only authorized individuals to have access to the aircraft and aircraft components within the repair station.
(4) Include measures to challenge any individual entering the repair station or who is present in the repair station to ascertain the authority of that individual to enter or be present in the area and measures to escort an unauthorized individual while within the repair station.
(5) Include measures to conduct initial and recurrent security training of all individuals with authorized access to aircraft and components on the provisions of this part and the security program and to maintain a record of training completed by each employee.
(6) Include measures to verify employee background information through confirmation of prior employment and any other means as appropriate to validate employee information.
(7) Include the name, means of contact on a 24 hour basis, duties, and training requirements of the security coordinator(s) who will serve as the primary and immediate contact for security-related activities and communications with TSA.
(8) Include a contingency plan.
(9) Include a diagram with dimensions detailing boundaries and physical features of the repair station.
(10) Include a list and description of all repair station entry points.
(11) Include an emergency response contact list.
(12) Be in writing and signed by the operator, owner, or any person delegated authority in this matter.
(b)
(i) Be written both in English and in the official language of the repair station's country.
(ii) Be accessible at each facility.
(2) Each repair station must restrict the distribution, disclosure, and availability of sensitive security information (SSI) as defined in part 1520 of this chapter to persons with a need to know and refer all requests for SSI by other persons to TSA.
(c)
(2) If TSA finds that there is a situation requiring immediate action to respond to a security threat, TSA may issue an emergency amendment to the standard security program. TSA will provide an explanation of the reason for the amendment. Each repair station must acknowledge receipt and adopt the emergency amendment within the time prescribed. If a repair station is unable to implement the emergency amendment, the repair station immediately must notify TSA to obtain approval of alternative measures.
(a)
(b)
(1) Verbally acknowledge receipt of the Security Directive.
(2) Specify the method by which security measures have been or will be implemented to meet the effective date.
(3) Notify TSA to obtain approval of alternative measures, if the repair station is unable to implement the measures in the Security Directive.
(c)
(1) Restrict the availability of the Security Directive and the information contained in the document to persons who have an operational need to know.
(2) Refuse to release the Security Directive or the information contained in the document to persons other than those who have an operational need to know without the prior written consent of TSA.
(a)
(b)
(c)
(d)
(e)
(f)
(1) TSA considers the initial notification, the repair station's reply, and any other relevant materials before issuing the Final Determination.
(2) If TSA determines that security deficiencies exist and have not been addressed, TSA serves upon the repair station and the FAA a Final Determination. The Final Determination shall include a statement that TSA has reviewed all of the relevant information available and has determined that the repair station is not in compliance with this section.
(3) If TSA determines that security deficiencies do not exist or have been corrected in a manner consistent with the requirements of this part, TSA notifies the repair station and the FAA that the repair station's certification may be reinstated.
(a)
(b)
(1) A statement that a review is requested; and
(2) A response to the determination of immediate risk to security, including any information TSA should consider in reviewing the basis for the determination.
(c)
(d)
In connection with the procedures under this subpart, TSA does not disclose classified information, as defined in Executive Order 12968 section 1.1(d), and TSA reserves the right not to disclose any other information or material not warranting disclosure or protected from disclosure under law or regulation.