The Federal Civil Penalties Inflation Adjustment Act of 1990 (28 U.S.C. 2461 note, Pub. L. 101-410) (Act) requires Federal agencies to periodically adjust certain civil monetary penalties (CMPs) for inflation. Under the Act, a CMP is defined as any penalty, fine, or other sanction for which a Federal statute specifies a monetary amount, including a range of minimum and maximum amounts. Each Executive Agency is responsible for adjusting, pursuant to the Act, all CMPs within the agency's jurisdiction. The Act does not apply to any CMP under the Internal Revenue Code of 1986, the Tariff Act of 1930, the Occupational Safety and Health Act of 1970, or the Social Security Act.

The Act requires each Executive Agency to make an initial inflation adjustment for all applicable CMPs not later than 180 days after the enactment of the Debt Collection Improvement Act of 1996 (31 U.S.C. 3701 note, section 31001 of Pub. L. 104-134, 110 Stat. 1321) and subsequent inflation adjustments at least once every 4 years thereafter. USDA published its initial round of inflation adjustments in theFederal Registeron July 31, 1997, and those adjustments became effective on September 2, 1997 (62 FR 40924). USDA published its second round of inflation adjustments in theFederal Registeron May 24, 2005, and those adjustments became effective on June 23, 2005 (70 FR 29573). All USDA CMP adjustments are codified in subpart I of part 3 of title 7 of the Code of the Federal Regulations (7 CFR 3.91).

This final rule amends 7 CFR 3.91(b) to reflect the third round of USDA inflation adjustments and 7 CFR 3.91(a)(2) to reflect the new effective date of this rule. This final rule also makes conforming amendments to other agency regulations that currently specify dollar amounts for CMPs that are being adjusted by this final rule.

Under the Act, the required inflation adjustment is determined by adjusting each applicable CMP by the “cost of living adjustment” (COLA). The COLA is defined in the Act as the percentage (if any) by which the Consumer Price Index (CPI) for the month of June of the calendar year preceding the adjustment, exceeds the CPI for the month of June of the calendar year in which the amount of such CMP was last set or adjusted pursuant to law. As required by the Act, USDA used the CPI for all urban consumers published by the U.S. Department of Labor. In calculating the COLA, USDA rounded to the nearest tenth.

When USDA first adjusted its CMPs pursuant to the Act in 1997, USDA explained that “[t]he rule contained in this notice reflects the initial adjustment to the listed civil monetary penalties required by the Act” (62 FR 40924; July 31, 1997). USDA continues to interpret the Act such that all listed CMPs undergo the required adjustment whenever USDA adjusts those CMPs by regulation pursuant to the Act and publishes the regulation in theFederal Register.In other words, the CMP is considered to have been adjusted even though the dollar amount of the penalty does not increase (a situation that arises due to application of the rounding formulas in section 5(a) of the Act). Thus, all CMPs contained in the final rule are being adjusted pursuant to the Act. USDA believes that this interpretation most accurately reflects the plain language of the statutory text.

For all CMP adjustments in this final rule, USDA used the CPI for the month of June 2008 (218.8) as the numerator CPI. However, USDA used different denominator CPI values depending on the penalty being adjusted:

History

On November 9, 1993, the FAA published a final rule in theFederal Register(58 FR 27527), Airspace Docket No. 92-AWP-15 entitled “Alteration and Subdivision of Restricted Area R-2510A; El Centro, CA”. That action inadvertently omitted the nautical miles reference in the description. The impact of this action was not apparent until recently, when the U.S. Navy requested clarification of the airspace description. Without reference to nautical miles, the description reads in statute miles. However, the FAA's National Aeronautical Navigation Services office currently charts the airspace in nautical miles. Since this is an administrative change and does not affect the boundaries, altitudes, or operating requirements of the airspace, notice and public comment under 5 U.S.C. 553(b) are unnecessary.

The U.S. Army Rock Island Arsenal requested a temporary deviation for the Rock Island Railroad and Highway Drawbridge, across the Upper Mississippi, mile 482.9, at Rock Island, Illinois to remain closed-to-navigation position for a two-hour period while a heart walk is held in the city of Davenport, IA. The Rock Island Railroad and Highway Drawbridge currently operates in accordance with 33 CFR 117.5, which states the general requirement that drawbridges shall open promptly and fully for the passage of vessels when a request to open is given in accordance with the subpart.

There are no alternate routes for vessels transiting this section of the Upper Mississippi River.

The Rock Island Railroad and Highway Drawbridge, in the closed-to-navigation position, provides a vertical clearance of 23.8 feet above normal pool. Navigation on the waterway consists primarily of commercial tows and recreational watercraft. This temporary deviation has been coordinated with waterway users. No objections were received.

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.

We encourage you to participate in this study by submitting comments and related materials. All comments received will be posted, without change, tohttp://www.regulations.govand will include any personal information you have provided.

A. Submitting comments:If you submit comments, please include the docket number for this notice (USCG-2009-0765), indicate the specific section of this document to which each comment applies, and provide a reason for each suggestion or recommendation. You may submit your comments and material online, or by fax, mail or hand delivery, but please use only one of these means. We recommend that you include your name and a mailing address, an e-mail address, or a telephone number in the body of your document so that we can contact you if we have questions regarding your submission.

To submit your comment online, go tohttp://www.regulations.gov,click on the “submit a comment” box, which will then become highlighted in blue. In the “Document Type” drop down menu select “Notices” and insert “USCG-2009-0576” in the “Keyword” box. Click “Search” then click on the balloon shape in the “Actions” column. If you submit your comments by mail or hand delivery, submit them in an unbound format, no larger than 81/2by 11 inches, suitable for copying and electronic filing. If you submit them by mail and would like to know that they reached the Facility, please enclose a stamped, self-addressed postcard or envelope. We will consider all comments and material received during the comment period.

B. Viewing the comments and documents:To view comments and documents mentioned in this preamble as being available in the docket, go tohttp://www.regulations.gov,click on the “read comments” box, which will then become highlighted in blue. In the “Keyword” box insert “USCG-2009-0765” and click “Search.” Click the “Open Docket Folder” in the “Actions” column. If you do not have access to the Internet, you may view the docket online by visiting the Docket Management Facility in Room W12-140on the ground floor of the Department of Transportation West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. We have an agreement with the Department of Transportation to use the Docket Management Facility.

C. Privacy Act: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, system of records notice regarding our public dockets in the January 17, 2008, issue of theFederal Register(73 FR 3316).

The following definitions (except “Regulated Navigation Area”) are from the International Maritime Organization's (IMO's) publication “Ships' Routeing” and should help you review this notice:

Area to be avoided(ATBA) means a routing measure comprising an area within defined limits in which either navigation is particularly hazardous or it is exceptionally important to avoid casualties and which should be avoided by all vessels, or certain classes of vessels.

Deep-water routemeans a route within defined limits, which has been accurately surveyed for clearance of sea bottom and submerged obstacles as indicated on nautical charts.

Inshore traffic zonemeans a routing measure comprising a designated area between the landward boundary of a traffic separation scheme and the adjacent coast, to be used in accordance with the provisions of Rule 10(d), as amended, of the International Regulations for Preventing Collisions at Sea, 1972 (COLREGS).

Precautionary areameans a routing measure comprising an area within defined limits where vessels must navigate with particular caution and within which the direction of traffic flow may be recommended.

Recommended routemeans a route of undefined width, for the convenience of vessels in transit, which is often marked by centerline buoys.

Recommended trackis a route which has been specially examined to ensure so far as possible that it is free of dangers and along which vessels are advised to navigate.

Regulated Navigation Area (RNA)means a water area within a defined boundary for which regulations for vessels navigating within the area have been established under 33 CFR part 165.

Roundaboutmeans a routing measure comprising a separation point or circular separation zone and a circular traffic lane within defined limits. Traffic within the roundabout is separated by moving in a counterclockwise direction around the separation point or zone.

Separation Zoneorseparation linemeans a zone or line separating the traffic lanes which vessels are proceeding in opposite or nearly opposite directions; or from the adjacent sea area; or separating traffic lanes designated for particular classes of vessels proceeding in the same direction.

Traffic lanemeans an area within defined limits in which one-way traffic is established. Natural obstacles, including those forming separation zones, may constitute a boundary.

Traffic Separation Scheme (TSS)means a routing measure aimed at the separation of opposing streams of traffic by appropriate means and by the establishment of traffic lanes.

Two-way routemeans a route within defined limits inside which two-way traffic is established, aimed at providing safe passage of ships through waters where navigation is difficult or dangerous.

Vessel routing systemmeans any system of one or more routes or routing measure aimed at reducing the risk of casualties; it includes traffic separation schemes, two-way routes, recommended tracks, areas to be avoided, no anchoring areas, inshore traffic zones, roundabouts, precautionary areas, and deep-water routes.

A. Requirement for port access route studies:Under the Ports and Waterways Safety Act (PWSA) (33 U.S.C. 1223(C)), the Commandant of the Coast Guard may designate necessary fairways and traffic separation schemes (TSSs) to provide safe access routes for vessels proceeding to and from United States ports. The designation of fairways and TSSs recognizes the paramount right of navigation over all other uses in the designated areas.

The PWSA requires the Coast Guard to conduct a study of potential traffic density and the need for safe access routes for vessels before establishing or adjusting fairways or TSSs. Through the study process, we must coordinate with Federal, State, and foreign State agencies (as appropriate) and consider the views of maritime community representatives, environmental groups, and other interested stakeholders. A primary purpose of this coordination is, to the extent practicable, to reconcile the need for safe access routes with other reasonable waterway uses.

B. Previous port access route studies:From 1993 through 1996, the Coast Guard conducted a port access route study to analyze vessel routing measures in the approaches to California ports. We published the study results in theFederal Registeron October 25, 1996 (61 FR 55248). The study recommended shifting the southern approach lanes of the existing TSS off San Francisco westward (seaward) and extending the existing TSS in the Santa Barbara Channel from Point Conception to Point Arguello. The study concluded that no changes to the TSS in the approaches to Los Angeles-Long Beach were necessary at that time.

In 1995, the Ports of Los Angeles and Long Beach initiated major port improvement projects. These projects are completed and included the following:

Lengthening of the Los Angeles Approach Channel to extend approximately 3.5 nautical miles beyond the Los Angeles breakwater.

Deepening of the Los Angeles Approach Channel to a project depth of 81 feet.

A slight shift of the Long Beach Approach to a 355 deg. True inbound course.

Deepening of the Long Beach Approach Channel to a project depth of 69 feet.

The Coast Guard published a notice of study in theFederal Register(64 FR 12139, March 11, 1999) which announced that we would conduct a PARS for the approaches to Los Angeles-Long Beach. The Coast Guard published a notice of study results in theFederal Registeron May 19, 2000 (65 FR 31856). The PARS evaluated the potential effects of the port improvement projects on navigational safety and vessel traffic management efficiency. It concluded that modifications to the TSS in the approaches to Los Angeles-Long Beach and the Precautionary Area were necessary for the safety of the maritime community utilizing the Ports of Los Angeles and Long Beach.

C. Necessity for a new port access route study:The Coast Guard is always seeking ways to enhance the safety of life at sea. Increased vessel traffic has been observed bypassing the Santa Barbara Channel TSS and opting for routes south of San Miguel, Santa Rosa and Santa Cruz Islands approaching the San Pedro Channel. Vessels, which have traditionally utilized the established TSS in the Santa Barbara Channel to access ports in Los Angeles-Long Beach, have recently shifted to transit in thearea south of San Miguel, Santa Rosa and Santa Cruz Islands.

The Coast Guard has identified a potential safety enhancement by increasing predictability of vessel traffic patterns in this area with an established vessel routing system. When vessels follow predictable and charted routing measures such as a TSS, congestion may be reduced, and mariners may be better able to predict where vessel interactions may occur and act accordingly.

This study will assess whether the creation of a vessel routing system is necessary to increase the predictability of vessel movements, which may decrease the potential for collisions, oil spills, and other events that could threaten the marine environment.

The Eleventh Coast Guard District will conduct this PARS. The study will begin upon publication of this notice and should take 6 to 12 months to complete.

The study area will be the area with a northern boundary at 34°30′ N; a western boundary 121°00′ W; a southern boundary at 33°15′ N; and an eastern boundary along the shoreline. This area encompasses the TSSs in the Santa Barbara Channel and in the approaches to Los Angeles-Long Beach and the approach to the San Pedro Channel from the Pacific Ocean, particularly the area south of San Miguel, Santa Rosa and Santa Cruz Islands and north of San Nicholas, Santa Barbara, and Santa Catalina Islands where an increase in vessel traffic has been identified.

As part of this study, we will analyze vessel traffic density, agency and stakeholder experience in vessel traffic management, navigation, ship handling, and effects of weather. We encourage you to participate in the study process by submitting comments in response to this notice.

We will publish the results of the PARS in theFederal Register. It is possible that the study may validate existing vessel routing measures and conclude that no changes are necessary. It is also possible that the study may recommend one or more changes to enhance navigational safety and the efficiency of vessel traffic management. The recommendations may lead to future rulemakings or appropriate international agreements.

We are attempting to determine the scope of any safety problems associated with vessel transits in the study area. We expect that information gathered during the study will help us identify any problems and appropriate solutions. The study may recommend that we—

• Maintain the current vessel routing measures,

• Modify the existing traffic separations schemes;

• Create one or more precautionary areas;

• Create one or more inshore traffic zones;

• Establish area(s) to be avoided;

• Create deep-draft routes;

• Establish a regulated navigation Area (RNA) with specific vessel operating requirements to ensure safe navigation near shallow water; and

• Identify any other appropriate ships' routing measures.

To help us conduct the port access route study, we request information that will help answer the following questions, although comments on other issues addressed in this notice are also welcome. In responding to a question, please explain your reasons for each answer and follow the instructions under “Public Participation and Request for Comments” above.

1. What navigational hazards do vessels operating in the study area face? Please describe.

2. Are there strains on the current vessel routing system, such as increasing traffic density? Please describe.

3. Are modifications to existing vessel routing measures needed to improve traffic management efficiency in the study area? If so, please describe.

4. What costs and benefits are associated with the potential study recommendations listed above? What measures do you think are most cost-effective?

5. What impacts, both positive and negative, would changes to existing vessel routing measures or establishing new routing measures have on the study area?

This notice is issued under authority of 33 U.S.C. 1223(c) and 5 U.S.C. 552.

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 underFOR FURTHER INFORMATION CONTACT.

You may access a frequently updated electronic version of 40 CFR part 180 through the Government Printing Office's e-CFR site athttp://www.gpoaccess.gov/ecfr.

Under section 408(g) of Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2008-0770 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before June 7, 2010.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described inADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit your copies, identified by docket ID number EPA-HQ-OPP-2008-0770, by one of the following methods:

•Federal eRulemaking Portal:http://www.regulations.gov. Follow the on-line instructions for submitting comments.

•Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

•Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In a final rule published in theFederal Registerof June 26, 2009 (74 FR 30470) (FRL-8413-6), EPA amended 40 CFR 180.628 by establishing time-limited tolerances for indirect or inadvertent residues of chlorantraniliprole in or on cowpea, forage and hay at 0.20 ppm; field pea, vines and hay at 0.20 ppm; cereal grain, forage, fodder and straw, crop group 16 at 0.20 ppm; grass, forage, fodder and hay, crop group 17 at 0.20 ppm; vegetable, leaves of root and tuber, crop group 2 at 0.20 ppm; leek at 0.20 ppm; nongrass animal feed, forage, fodder, straw and hay, crop group 18 at 0.20 ppm; okra at 0.70 ppm; onion, green at 0.20 ppm; onion, welsh at 0.20 ppm; peanut, hay at 0.20 ppm; shallot at 0.20 ppm; soybean, forage and hay at 0.20 ppm; strawberry at 1.2 ppm; and sugarcane, sugar at 0.20 ppm, with an expiration date of April 10, 2010.

In theFederal Registerof February 3, 2010 (75 FR 5526) (FRL-8809-3), permanent tolerances were established for various commodities and crop groups, including vegetables, foliage of legume, except soybean, crop group 7A, forage and hay (includes cowpea, forage and hay; field pea, vines and hay); grass, forage, fodder and hay, crop group 17; okra; strawberry; and sugarcane, cane and molasses. Therefore, the previously established time-limited tolerances for cowpea, forage and hay; field pea, vines and hay; grass, forage, fodder and hay, crop group 17; okra; strawberry; and sugarcane were deleted.

The Agency, acting on its own initiative, is extending the current remaining time-limited tolerances for indirect or inadvertent residues of chlorantraniliprole in or on cereal grain, forage, fodder, and straw, crop group 16 at 0.20 ppm; leek at 0.20 ppm; onion, green at 0.20 ppm; onion, welsh at 0.20 ppm; peanut, hay at 0.20 ppm; shallot at 0.20 ppm; soybean, forage and soybean, hay at 0.20 ppm; and vegetable, leaves of root and tuber, crop group 2 at 0.20 ppm. The current tolerances are set to expire on April 10, 2010. This rule extends the expiration/revocation date of these time-limited tolerances for an additional 4-year period, to April 10, 2014. This extension will provide additional time for the registrant to submit data to support permanent tolerances on these commodities.

This final rule establishes a tolerance under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory Planning and Review(58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection of Children from Environmental Health Risks and Safety Risks(62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et seq., nor does it require any special considerations under Executive Order 12898, entitledFederal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations(59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerances in this final rule, do not require the issuance of a proposed rule,the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation and Coordination with Indian Tribal Governments(65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

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 those engaged in the following activities:

• 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 to provide 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 underFOR FURTHER INFORMATION CONTACT.

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR cite athttp://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines referenced in this document electronically, please gohttp://www.epa.gov/opptsand select “Test Methods and Guidelines.”

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on thoseobjections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0553 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before June 7, 2010. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described inADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2009-0553, by one of the following methods:

•Federal eRulemaking Portal:http://www.regulations.gov. Follow the on-line instructions for submitting comments.

•Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

•Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In theFederal Registerof September 4, 2009 (74 FR 45848) (FRL-8434-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 9F7542) by Nichino America, Inc., 4550 New Linden Hill Rd., Suite 501, Wilmington, DE 19808. The petition requested that 40 CFR 180.484 be amended by establishing tolerances for residues of the fungicide flutolanil, (N-(3-(1-methylethoxy) phenyl) -2-(trifluoromethyl) benzamide) and its metabolite, M-4, desisopropylflutolanil (N-(3-hydroxyphenyl)-2-(trifluromethyl) benzamide), expressed as 2-trifluoromethyl benzoic acid and calculated as flutolanil, in or on cotton at 0.05 parts per million (ppm) and in or on soybean at 0.05 ppm. That notice referenced a summary of the petition prepared by Nichino America, Inc., the registrant, which is available to the public in the docket,http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

EPA has modified the proposed tolerance expression to: “residues of flutolanil, (N-(3-(1-methylethoxy) phenyl)-2-(trifluoromethyl) benzamide), including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only flutolanil and its metabolites converted to 2-(trifluoromethyl) benzamide and calculated as flutolanil.” Based on review of the data supporting the petition, EPA has also modified the proposed tolerances to be established under paragraph (a),General, for flutolanil at 40 CFR 180.484 as follows: Soybean, seed, 0.20 ppm; soybean, forage, 8.0 ppm; soybean, hay, 2.5 ppm; cotton, undelinted seed, 0.20 ppm and cotton, gin byproducts, 0.20 ppm. Additionally, the following tolerances will be removed from paragraph (d),Indirect or inadvertent residues, for flutolanil as redundant: Soybean, seed 0.20 ppm; soybean, forage, 8.0 ppm and soybean hay, 2.5 ppm. The reasons for these changes are explained in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue. . . . ”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for flutolanil including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with flutolanil follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

Specific information on the studies received and the nature of the adverse effects caused by flutolanil as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies are discussed in the final rule published in theFederal Registerof June 11, 2008, (73 FR 33013) (FRL-8365-6). The complete toxicological profile for flutolanil can be found athttp://www.regulations.govon pages 7 through 12 in the document “Flutolanil, Human Health Risk Assessment: Requests for Inadvertent or Indirect Tolerances for Use on Soybean, Wheat, Corn and Cotton” in docket ID number EPA-HQ-OPP-2007-1021.

Once a pesticide's toxicological profile is determined, EPA identifies toxicological points of departure (POD) and levels of concern to use in evaluating the risk posed by human exposure to the pesticide. For hazards that have a threshold below which there is no appreciable risk, the toxicological POD is used as the basis for derivation of reference values for risk assessment. PODs are developed based on a careful analysis of the doses in each toxicological study to determine the dose at which no adverse effects are observed (the NOAEL) and the lowest dose at which adverse effects of concern are identified (the LOAEL). Uncertainty/safety factors are used in conjunction with the POD to calculate a safe exposure level-generally referred to as a population-adjusted dose (PAD) or a reference dose (RfD) and a safe margin of exposure (MOE). For non-thresholdrisks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for flutolanil used for human risk assessment is discussed in Unit III,Aggregate Risk Assessment and Determination of Safety, of the final rule published in theFederal Registerof June 11, 2008 (73 FR 33013) (FRL-8365-6).

1.Dietary exposure from food and feed uses. In evaluating dietary exposure to flutolanil, EPA considered exposure under the petitioned-for tolerances as well as all existing flutolanil tolerances in 40 CFR 180.484. EPA assessed dietary exposures from flutolanil in food as follows:

i.Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

No such effects were identified in the toxicological studies for flutolanil; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii.Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey of Food Intake by Individuals (CSFII). As to residue levels in food, the chronic dietary analysis included tolerance level residues, 100 percent crop treated estimates and processing factors (default).

iii.Cancer. EPA determines whether quantitative cancer exposure and risk assessments are appropriate for a food-use pesticide based on the weight-of-the-evidence from cancer studies and other relevant data. Cancer risk is quantified using a linear or nonlinear approach. If sufficient information on the carcinogenic mode of action is available, a threshold or non-linear approach is used and a cancer RfD is calculated based on an earlier noncancer key event. If carcinogenic mode of action data are not available, or if the mode of action data determines a mutagenic mode of action, a default linear cancer slope factor approach is utilized. Based on the lack of evidence of carcinogenicity in two rodent studies and the lack of evidence of mutagenicity, flutolanil is not expected to pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv.Anticipated residue and percent crop treaded (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for flutolanil. Tolerance level residues and/or 100% CT were assumed for all food commodities.

2.Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for flutolanil in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of flutolanil. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttp://www.epa.gov/oppefed1/models/water/index.htm.

The Agency used the First Approximation Rice Model (FARM) to estimate pesticide concentrations in surface water after applying flutolanil on rice and Screening Concentrations in Ground Water (SCI-GROW), which predicts pesticide concentrations in ground water. In general, EPA will use Generic Expected Environmental Concentrations (GENEEC) (a Tier 1 model) before using Pesticide Root Zone/Exposure Analysis Modeling System (PRZM/EXAMS) (a Tier 2 model) for a screening-level assessment for surface water, but given the unique hydrological issues arising from pesticide application to rice paddies, EPA used the FARM rather than GENEEC or PRZM/EXAMS for surface water estimates.

Based on the SCI-GROW model, and the FARM (to estimate pesticide concentrations in surface water after applying flutolanil on rice) the estimated environmental concentrations (EECs) of flutolanil for acute exposures are estimated to be 3.8 parts per billion (ppb) for surface water and 0.34 ppb for ground water. The EEC for peak acute exposure is estimated to be 11.6 ppb for surface water. The EECs for chronic exposures are estimated to be 3.8 ppb for surface water and 0.34 ppb for ground water.

For chronic dietary risk assessment, the water concentration of value 3.8 ppb was used to assess the contribution to drinking water.

3.From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Flutolanil is currently registered for the following uses that could result in residential exposures: Turf grass and ornamental plants. EPA assessed residential exposure using the following assumptions: Although residential (non-occupational) exposure exists, a quantitative exposure assessment was not conducted since no toxicological endpoint attributable to acute, short-term or intermediate-term exposure have been identified and the current use pattern does not indicate chronic or long-term exposure (6 or more months of continuous exposure) potential. Further information regarding EPA standard assumptions and generic inputs for residential exposures may be found athttp://www.epa.gov/pesticides/trac/science/trac6a05.pdf.

4.Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found flutolanil to share a common mechanism of toxicity with any other substances, and flutolanil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that flutolanil does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website athttp://www.epa.gov/pesticides/cumulative.

1.In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA Safety Factor (SF). In applying this provision, EPA either retains the default value of 10X, or uses a differentadditional safety factor when reliable data available to EPA support the choice of a different factor.

2.Prenatal and postnatal sensitivity. There was no evidence of increased susceptibility of rat or rabbit fetuses toin uteroexposure or rat pups to post-natal exposure to flutolanil. Flutolanil is not a developmental or reproductive toxicant. No maternal, reproductive, or developmental toxicity was observed at the limit dose.

3.Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for flutolanil is complete except for acute and subchronic neurotoxicity and immunotoxicity studies. Recent changes to 40 CFR part 158 make acute and subchronic neurotoxicity testing (OPPTS Test Guideline 870.6200), and immunotoxicity testing (OPPTS Test Guideline 870.7800) required for pesticide registration. However, the available data for flutolanil do not suggest that the compound produces hematological or thymus/spleen organ effects indicative of immunotoxicity. Further, there is no evidence of neurotoxicity in any study in the toxicity database for flutolanil. Therefore, EPA does not believe that conducting neurotoxicity and immunotoxicity studies will result in a NOAEL lower than the NOAEL of 50 milligrams/kilogram/day (mg/kg/day) already established for flutolanil. Consequently, an additional database uncertainty factor does not need to be applied.

ii. There is no indication that flutolanil is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that flutolanil results in increased susceptibility inin uterorats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100% CT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground water and surface water modeling used to assess exposure to flutolanil in drinking water. Residential exposure does not pose a concern for flutolanil because (1) chronic residential exposure is not expected; and (2) although short-term or intermediate-term residential exposure may occur, no relevant adverse effects were identified for dermal or incidental oral or inhalation exposure related to residential use. These assessments will not underestimate the exposure and risks posed by flutolanil.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer given the estimated aggregate exposure. Short-term, intermediate-term, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the appropriate PODs to ensure that an adequate MOE exists.

1.Acute Risk.An acute aggregate risk assessment takes into account acute exposure estimates from dietary consumption of food and drinking water. No adverse effect resulting from a single oral exposure was identified and no acute dietary endpoint was selected. Therefore, flutolanil is not expected to pose an acute risk.

2.Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to flutolanil from food and water will utilize 2% of the cPAD for children between 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of flutolanil is not expected.

3.Short-term and intermediate-term risk. Short-term and intermediate-term aggregate exposure take into account short-term and intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Because no short- or intermediate-term adverse effect was identified, flutolanil is not expected to pose a short-term or intermediate-term risk.

4.Aggregate cancer risk for U.S. population. EPA has classified flutolanil as “not likely” to be a human carcinogen.

5.Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to flutolanil residues.

An adequate enforcement methodology, (Method AU/95R/04), a common moiety Gas Chromatography/Mass Spectrometry (GC/MS) method which determines residues of flutolanil and metabolites as 2-trifluoromethyl benzoic acid (2-TFBA) is available to enforce the tolerance expression.

The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:residuemethods@epa.gov.

Codex maximum residue limits (MRLs) are established for residues of flutolanil in rice commodities at 1-10 ppm, and in livestock commodities at 0.05-0.2 ppm. No Canadian or Mexican MRLs have been established. No Codex MRLs are established for soybean, cotton seed, or sugar beet commodities.

One comment was received from a private citizen objecting to the establishment of tolerances for flutolanil. The commenter criticized EPA's reliance on toxicology testing on animals. The Agency has received, and responded to, similar comments from this commenter on numerous previous occasions. Refer to theFederal Registerissues of June 30, 2005 (70 FR 37686), January 7, 2005 (70 FR 1354), October 28, 2004 (FR 69 63096) for the Agency's response to these objections.

The Agency is establishing tolerances that are greater than the proposed tolerance for soybean seed and cotton seed because the enforcement analytical method has not been validated at a level below 0.20 ppm, and the greater tolerance value is needed to accommodate indirect residues from soybean rotational crops. Additional tolerances are established for cotton gin byproducts, as the radiolabeled seed treatment study revealed residues on cotton gin trash, and soybean hay to accommodate the seed treatment use and the inadvertent residue from soybean as a rotational crop.

EPA is revising the tolerance expression in §180.484 to clarify that, as provided in FFDCA section 408(a)(3), the tolerance covers metabolites and degradates of flutolanil not specifically mentioned; and that compliance with the specified tolerance levels is to be determined by measuring only thespecific compounds mentioned in the tolerance expression. The tolerance definition previously read “residues of the fungicide flutolanil,N-(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, and its metabolites converted to 2-(trifluoromethyl) benzoic acid and calculated as flutolanil.” It is being changed to “residues of flutolanil,N-(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, including its metabolites and degradates, in or on the commodities. Compliance with the tolerance levels is to be determined by measuring only flutolanil and its metabolites converted to 2-(trifluoromethyl) benzoic acid and calculated as flutolanil.”

Finally, the inadvertent residue, rotational crop tolerances previously established for soybean forage and soybean hay encompass the use on soybean as a seed treatment. Therefore the tolerances established under paragraph (d),Indirect or inadvertent residues, for soybean, seed at 0.20 ppm; soybean, forage at 8.0 ppm, and soybean hay at 2.5 ppm are being revoked since the same tolerance values are being established under paragraph (a),General.

Therefore, tolerances are established for residues of flutolanil,N-(3-(1-methylethoxy)phenyl)-2-(trifluoromethyl)benzamide, including its metabolites and degradates, in or on cotton, undelinted seed at 0.20 ppm; soybean, seed at 0.20 ppm; soybean, forage at 8.0 ppm; soybean, hay at 2.5 ppm; cotton, gin byproducts at 0.20 ppm. Compliance with the tolerance levels is to be determined by measuring only flutolanil and its metabolites converted to 2-(trifluoromethyl) benzoic acid and calculated as flutolanil.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory Planning and Review(58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection of Children from Environmental Health Risks and Safety Risks(62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et seq., nor does it require any special considerations under Executive Order 12898, entitledFederal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations(59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation and Coordination with Indian Tribal Governments(65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

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 those engaged in the following activities:

• 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 to provide 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 underFOR FURTHER INFORMATION CONTACT.

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR cite athttp://www.gpoaccess.gov/ecfr.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0673 in the subject line on the first page of your submission. All objections and requests for a hearing must be in writing, and must be received by the Hearing Clerk on or before June 7, 2010. Addresses for mail and hand delivery of objections and hearing requests are provided in 40 CFR 178.25(b).

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described inADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2009-0673, by one of the following methods:

•Federal eRulemaking Portal:http://www.regulations.gov. Follow the on-line instructions for submitting comments.

•Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

•Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In theFederal Registerof January 6, 2010 (75 FR 864) (FRL-8801-5), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 9F7576) by BASF Corporation, 26 Davis Drive, Research Triangle Park, NC 27709. The petition requested that 40 CFR 180.361 be amended by increasing the tolerance for the combined residues of the herbicide pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, in or on alfalfa, forage from 3.0 parts per million (ppm) to 3.5 (ppm). That notice referenced a summary of the petitionprepared by BASF Corporation, the registrant, which is available in the docket,http://www.regulations.gov. Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for combined residues of pendimethalin and its metabolite including exposure resulting from the tolerance established by this action. EPA's assessment of exposures and risks associated with pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine] and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol follows.

On January 27, 2010, the Agency published a final rule (75 FR 4279, FRL-8804-2) establishing tolerances for combined residues of pendimethalin and its metabolite in or on various grass commodities in crop group 17. When the Agency conducted the risk assessment in support of the January, 2010 tolerance action, it considered the use of pendimethalin on alfalfa, including potential residues of pendimethalin and its metabolite in or on alfalfa hay and forage. EPA also considered the potential for secondary residues of pendimethalin in livestock commodities from consumption of treated alfalfa hay and forage and determined that there was no reasonable expectation of finite residues to occur. Since alfalfa hay and alfalfa forage are both categorized as roughage, EPA assessed the pendimethalin dietary burden of livestock using the higher (more conservative) of the two tolerances (alfalfa hay at 4.0 ppm). Increasing the tolerance for alfalfa forage to 3.5 ppm will not affect the estimated livestock dietary burden or the estimated aggregate risks resulting from use of pendimethalin, as discussed in the January 27, 2010 (75 FR 4279-4284, FRL-8804-2)Federal Register. Refer to thisFederal Registerdocument, available athttp://www.regulations.gov, for a detailed discussion of the aggregate risk assessments and determination of safety. EPA relies upon those risk assessments and the findings made in theFederal Registerdocument in support of this action.

Therefore, based on the risk assessments discussed in the final rule published in theFederal Registerof January 27, 2010 (75 FR 4279, FRL-8804-2), EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to pendimethalin residues.

Adequate enforcement methodology, using liquid chromatography/mass spectrometry analysis (LC/MS/MS), is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:residuemethods@epa.gov

There are no established or proposed Codex maximum residue limits (MRLs) for pendimethalin.

EPA has revised the pendimethalin tolerance expression for the new and existing tolerances to clarify the chemical moieties that are covered by the tolerances and specify how compliance with the tolerances is to be measured. The revised tolerance expression makes clear that the tolerances cover residues of pendimethalin and its metabolites and degradates, but that compliance with the tolerance levels will be determined by measuring only pendimethalin, [N- (1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite 4-[(1-ethylpropyl)amino]-2-methyl-3,5-dinitrobenzyl alcohol, calculated as the stoichiometric equivalent of pendimethalin.

EPA has determined that it is reasonable to make this change final without prior proposal and opportunity for comment, because public comment is not necessary, in that the change has no substantive effect on the tolerance, but rather is merely intended to clarify the existing tolerance expression.

EPA received comments from an anonymous submitter objecting to pesticides and other “toxic” chemicals generally and recommending against any tolerances greater than zero for this product. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned completely. However, the existing legal framework provided by section 408 of the Federal Food, Drug and Cosmetic Act (FFDCA) contemplates that tolerances greater than zero may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This submitter's comments appear to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.

Therefore, a tolerance is established for residues of pendimethalin, including its metabolites and degradates, in or on the alfalfa, forage at 3.5 ppm. Compliance with the tolerance level is to be determined by measuring only pendimethalin, [N-(1-ethylpropyl)-3,4-dimethyl-2,6-dinitrobenzenamine], and its metabolite, 4-[(ethylpropyl) amino]-2-methyl-3,5-dinitrobenzyl alcohol, calculated as the stoichiometric equivalent of pendimethalin, in or on alfalfa, forage.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory Planning and Review(58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211,entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection of Children from Environmental Health Risks and Safety Risks(62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et seq., nor does it require any special considerations under Executive Order 12898, entitledFederal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations(59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation and Coordination with Indian Tribal Governments(65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

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 those engaged in the following activities:

• 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 to provide 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 underFOR FURTHER INFORMATION CONTACT.

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR site athttp://www.gpoaccess.gov/ecfr. You may also access the OPPTS harmonized test guidelines referenced in this document electronically athttp://www.epa.gov/opptsand select “Test Methods and Guideline.”

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0057 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before June 7, 2010.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described inADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2009-0057, by one of the following methods:

•Federal eRulemaking Portal:http://www.regulations.gov. Follow the on-line instructions for submitting comments.

•Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

•Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In theFederal Registerof April 8, 2009 (74 FR 15971) (FRL-8407-4), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 8F7501) by E. I. du Pont de Nemours and Company, P.O. Box 80038, Wilmington, DE 19880-0038. The petition requested that 40 CFR 180.454 be amended by establishing tolerances for residues of the herbicide nicosulfuron, 3-Pyridinecarboxamide, 2-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]amino]sulfonyl]-N,N-dimethyl-, in or on grass, forage at 9.0 parts per million (ppm); grass, hay at 25.0 ppm; fat (of cattle, goat, hog, horse, and sheep) at 0.05 ppm; meat (of cattle, goat, hog, horse, and sheep) at 0.05 ppm; meat byproducts (of cattle, goat, hog, horse, and sheep) at 0.05 ppm; milk at 0.05 ppm; and milk, fat at 0.02 ppm. That notice referenced a summary of the petition prepared by E. I. du Pont de Nemours and Company, the registrant, which is available to the public in the docket,http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon review of the data supporting the petition, EPA is not establishing the proposed tolerances for hog, fat; hog, meat; hog, meat byproducts; and milk, fat. The proposed tolerance levels for cattle, fat; cattle, meat; goat, fat; goat, meat; horse, fat; horse, meat; milk; sheep, fat; and sheep, meat are being established at 0.01 ppm, not 0.05 ppm. The reasons for these changes are explained in Unit IV.C.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of nicosulfuron and its metabolites and degradates in or on cattle, fat at 0.01 ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts at 0.05 ppm; goat, fat at 0.01 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.05 ppm; grass, forage at 9.0 ppm; grass, hay at 25.0 ppm; horse, fat at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat byproducts at 0.05 ppm; milk at 0.01 ppm; sheep, fat at 0.01 ppm; sheep, meat at 0.01 ppm; and sheep, meatbyproducts at 0.05 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. Specific information on the studies received and the nature of the adverse effects caused by nicosulfuron as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found athttp://www.regulations.govin document “Nicosulfuron Human Health Risk Assessment for the Proposed Use on Grasses,” p. 30 in docket ID number EPA-HQ-OPP-2009-0057.

Nicosulfuron has low acute toxicity by oral, dermal, and inhalation routes of exposure. It is a moderate eye irritant and is not a dermal sensitizer. No adverse effects were observed following subchronic or chronic dietary administrations of doses exceeding the limit dose in rats and mice. Chronic dietary administration to dogs produced mild effects (decreased body weight gains in males, increased relative liver and kidney weights) at the limit dose. No findings were reported in dogs following subchronic dosing at comparable dietary levels.

There was no evidence of potential immunotoxicity or neurotoxicity in the submitted studies.

Nicosulfuron was classified by EPA as a “not likely” human carcinogen based on the lack of evidence of carcinogenicity in studies conducted in rats and mice and in thein vitroandin vivogenotoxicity studies.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) or a benchmark dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). The aPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the level of concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for nicosulfuron used for human risk assessment can be found athttp://www.regulations.govin document “Nicosulfuron Human Health Risk Assessment for the Proposed Use on Grasses,” p. 15 in docket ID number EPA-HQ-OPP-2009-0057.

1.Dietary exposure from food and feed uses. In evaluating dietary exposure to nicosulfuron, EPA considered exposure under the petitioned-for tolerances as well as all existing nicosulfuron tolerances in 40 CFR 180.454. EPA assessed dietary exposures from nicosulfuron in food as follows:

i.Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure.

No such effects were identified in the toxicological studies for nicosulfuron; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii.Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed tolerance-level residues and 100 percent crop treated (PCT) for all existing (corn) and new uses (meat and milk commodities) of nicosulfuron.

iii.Cancer. Based on the lack of evidence of carcinogenicity observed in the 2-year rat and 18-month mouse carcinogenicity studies and a lack of evidence of mutagenicity in thein vitroandin vivogenotoxicity studies, EPA does not expect nicosulfuron to pose a cancer risk to humans. Therefore, an exposure assessment for evaluating cancer risk is not needed for this chemical.

iv.Anticipated residue and PCT information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for nicosulfuron. Tolerance level residues and/or 100 PCT were assumed for all food commodities.

2.Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for nicosulfuron in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of nicosulfuron. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttp://www.epa.gov/oppefed1/models/water/index.htm.

Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of nicosulfuron for chronic exposures for non-cancer assessments are estimated to be 0.685 ppb for surface water and 0.056 ppb for ground water. EDWCs of nicosulfuron for acute exposures and chronic exposures for cancer assessments are not relevant to this dietary exposure assessment as explained in unit III.C.1.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 0.685 ppb was used to assess the contribution to drinking water. The surface water value was used in the chronic, non-cancer dietary risk assessment since it was higher than the ground water value and, therefore, more protective.

3.From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Nicosulfuron is not registered for any specific use patterns that would result in residential exposure.

4.Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found nicosulfuron to share a common mechanism of toxicity with any other substances, and nicosulfuron does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that nicosulfuron does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website athttp://www.epa.gov/pesticides/cumulative.

1.In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the FQPA SF. In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2.Prenatal and postnatal sensitivity. In the developmental toxicity in rats, no developmental toxicity was seen at the highest dose tested (6,000 mg/kg/day). In the developmental study in rabbits, developmental toxicity (decreased fetal body weight, post-implantation loss) occurred at the same dose (500 mg/kg/day) as the dose (500 mg/kg/day) resulting in maternal toxicity (abortions, clinical signs, decreased body weight gain, post-implantation loss). In the 2-generation reproductive toxicity study in rats, F2a offspring effects (decreased litter size at birth, decreased pup weights at postpartum day 14 through 21) also occurred at the same dose (1265 mg/kg/day) as the dose (1265 mg/kg/day) resulting in parental toxicity (decreased body weight gain in F1 females during the last week of gestation). Consequently, there is no quantitative or qualitative evidence of increased susceptibility following pre- and/or postnatal exposure to nicosulfuron.

3.Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for nicosulfuron is adequate to assess potential pre- and/or postnatal toxicity. In accordance with 40 CFR part 158 Toxicology Data Requirements, an immunotoxicity study (870.7800), and acute and subchronic neurotoxicity studies (870.6200) are required for nicosulfuron. Despite the absence of specific immunotoxicity and neurotoxicity studies, EPA has evaluated the available toxicity data and has determined that there is no evidence that nicosulfuron either causes neurotoxic effects or targets the immune system, and, therefore, EPA does not expect that these studies will result in a lower NOAEL than the NOAEL currently used in assessing nicosulfuron risk.

ii. There is no indication that nicosulfuron is a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that nicosulfuron results in increased susceptibility inin uterorats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study.

iv. There are no significant residual uncertainties identified in the exposure databases for nicosulfuron. Additional storage stability studies are required for residues of nicosulfuron in grass forage and hay, and in livestock tissues. However, as explained in this Unit, EPA does not expect these studies to have a measurable impact on exposure estimates for nicosulfuron.

a. Data must be submitted on the stability of nicosulfuron and its metabolite in grass forage and hay stored frozen for intervals of up to 9.6 and 12.4 months, respectively. Interim data are available showing that residues of nicosulfuron in grass hay and forage are stable when stored frozen up to 3 months. Additionally, storage stability data are available for corn, a related crop, which indicate that nicosulfuron residues are stable when stored frozen up to 12 months. Based on these data, EPA expects nicosulfuron to be stable in grass forage and hay stored frozen for the required 9.6 and 12.4 month intervals but is requiring submission of the final study reports as confirmation.

b. Data must also be submitted on the stability of nicosulfuron and its metabolite in livestock tissues stored frozen up to 9.4 months. Despite the absence of data, EPA has assumed that nicosulfuron is stable in frozen livestock tissues, based on data for similar sulfonylurea (SU) pesticides, such as prosulfuron, where studies have shown residues to be stable for up to 25 months. In addition, EPA notes that dietary exposure to nicosulfuron is low (< 1% of the cPAD for all population subgroups), and that the contribution of residues in livestock to overall dietary exposure to nicosulfuron is minor, accounting for only 2.5% of total exposure for children 1-2 years old, the population subgroup with the highest estimated dietary exposure to nicosulfuron. Therefore, any adjustments in livestock residue estimates that might be necessary following submission of the required storage stability data would have little impact on overall dietary exposure estimates.

The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to nicosulfuron in drinking water. There are no residential uses for nicosulfuron; therefore, residential exposure is not expected. These assessments will not underestimate the exposure and risks posed by nicosulfuron.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1.Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietaryconsumption of food and drinking water. No adverse effect resulting from a single-oral exposure was identified and no acute dietary endpoint was selected. Therefore, nicosulfuron is not expected to pose an acute risk.

2.Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to nicosulfuron from food and water will utilize <1% of the cPAD for the general population and all population subgroups, including children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for nicosulfuron.

3.Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Nicosulfuron is not registered for any use patterns that would result in residential exposure. Therefore, the short-term aggregate risk is the sum of the risk from exposure to nicosulfuron through food and water and will not be greater than the chronic aggregate risk.

4.Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level).

Nicosulfuron is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to nicosulfuron through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk.

5.Aggregate cancer risk for U.S. population. Based on a lack of evidence for carcinogenicity in mice and rats following long-term dietary administration and lack of evidence for mutagenicity in a battery of genotoxicity studies, nicosulfuron is not expected to pose a cancer risk.

6.Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population or to infants and children from aggregate exposure to nicosulfuron residues.

Adequate enforcement methodology (high performance liquid chromatography with tandem mass spectrometric (HPLC/MS/MS) detection method) is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:residuemethods@epa.gov.

There are currently no established Codex or Mexican maximum residue limits (MRLs) for residues of nicosulfuron. Canadian MRLs are established on blueberries and corn, and are expressed in terms of nicosulfuron. There are no Canadian MRLs established on the grass and livestock commodities associated with this petition.

EPA is not establishing the proposed tolerances for hog, fat; hog, meat; and hog, meat byproducts because there are no swine feed items associated with the proposed use on grasses, and the dietary burden to swine resulting from registered use on corn is low enough that there is no reasonable expectation of finite residues in hog commodities. The proposed tolerance for milk fat is not being established because residues did not concentrate in cream and thus the tolerance for milk will be sufficient to cover residues in milk fat from legal uses of nicosulfuron. The proposed tolerances for cattle, fat; cattle, meat; goat, fat; goat, meat; horse, fat; horse, meat; milk; sheep, fat; and sheep, meat were lowered from 0.05 ppm to the level of quantitation (LOQ) at 0.01 ppm, since the maximum adjusted residue for meat and fat was at 0.008 ppm.

EPA has also revised the tolerance expression for all existing and new nicosulfuron tolerances. The revised tolerance expression makes clear that the tolerances cover “residues of nicosulfuron, including its metabolites and degradates” and that compliance with the tolerance levels will be determined by measuring only nicosulfuron, 3-Pyridinecarboxamide, 2-[[[[(4,6-dimethoxy-2-pyrimidinyl)amino] carbonyl]amino]sulfonyl]-N,N-dimethyl-. EPA has determined that it is reasonable to make this change in the tolerance expression final without prior proposal and opportunity for comment, because public comment is not necessary, in that the change has no substantive effect on the tolerance, but rather is merely intended to clarify the existing tolerance expression.

Finally, EPA is removing the redundant and obsolete tolerance for residues of nicosulfuron on “corn, forage” at 0.1 ppm. “Corn, forage” is an obsolete commodity term that has been replaced by the terms “corn, field, forage” and “corn, sweet, forage.” Since there are existing tolerances for residues of nicosulfuron on “corn, field, forage” and “corn, sweet, forage” at 0.1 ppm, the tolerance on “corn, forage” at the same level is unnecessary. EPA is making this change final without prior proposal and opportunity for comment because it merely corrects a redundancy in the nicosulfuron tolerances and has no substantive effect on them.

Therefore, tolerances are established for residues of nicosulfuron, including its metabolites and degradates, in or on cattle, fat at 0.01 ppm; cattle, meat at 0.01 ppm; cattle, meat byproducts at 0.05 ppm; goat, fat at 0.01 ppm; goat, meat at 0.01 ppm; goat, meat byproducts at 0.05 ppm; grass, forage at 9.0 ppm; grass, hay at 25.0 ppm; horse, fat at 0.01 ppm; horse, meat at 0.01 ppm; horse, meat byproducts at 0.05 ppm; milk at 0.01 ppm; sheep, fat at 0.01 ppm; sheep, meat at 0.01 ppm; and sheep, meat byproducts at 0.05 ppm.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory Planning and Review(58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection of Children from Environmental Health Risks and Safety Risks(62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et seq., nor does it require any special considerations under Executive Order 12898, entitledFederal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations(59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the RegulatoryFlexibility Act (RFA) (5 U.S.C. 601et seq.) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation and Coordination with Indian Tribal Governments(65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

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 those engaged in the following activities:

• 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 to provide 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 underFOR FURTHER INFORMATION CONTACT.

You may access a frequently updated electronic version of EPA's tolerance regulations at 40 CFR part 180 through the Government Printing Office's e-CFR cite athttp://www.gpoaccess.gov/ecfr. To access the OPPTS harmonized test guidelines referenced in this document electronically, please go tohttp://www.epa.gov/opptsand select “Test Methods & Guidelines” on the left-side navigation menu.

Under section 408(g) of FFDCA, 21 U.S.C. 346a, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. You must file your objection or request a hearing on this regulation in accordance with the instructions provided in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number EPA-HQ-OPP-2009-0141 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk as required by 40 CFR part 178 on or before June 7, 2010.

In addition to filing an objection or hearing request with the Hearing Clerk as described in 40 CFR part 178, please submit a copy of the filing that does not contain any CBI for inclusion in the public docket that is described inADDRESSES. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit this copy, identified by docket ID number EPA-HQ-OPP-2009-0141, by one of the following methods:

•Federal eRulemaking Portal:http://www.regulations.gov. Follow the on-line instructions for submitting comments.

•Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

•Delivery: OPP Regulatory Public Docket (7502P), Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Deliveries are only accepted during the Docket Facility's normal hours of operation (8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays). Special arrangements should be made for deliveries of boxed information. The Docket Facility telephone number is (703) 305-5805.

In theFederal Registerof May 6, 2009 (74 FR 20947) (FRL-8412-7), EPA issued a notice pursuant to section 408(d)(3) of FFDCA, 21 U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP 8F7455) by Dow AgroSciences, 9330 Zionsville Rd., Indianapolis, IN 46268. The petition requested that 40 CFR 180.610 be amended by establishing tolerances for combined residues of the herbicide aminopyralid, 4-amino-3,6-dichloro-2-pyridinecarboxylic acid, and its glucose conjugate, expressed as total parent, in or on corn, forage at 0.30 parts per million (ppm); corn, grain at 0.20 ppm; and corn, stover at 0.20 ppm. That notice referenced a summary of the petition prepared by Dow AgroSciences, the registrant, which is available to the public in the docket,http://www.regulations.gov. Comments werereceived on the notice of filing. EPA's response to these comments is discussed in Unit IV.C.

Based upon review of the data supporting the petition, EPA has revised the corn commodity terminology and tolerance expression for aminopyralid. The reasons for these changes are explained in Unit IV.D.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is “safe.” Section 408(b)(2)(A)(ii) of FFDCA defines “safe” to mean that “there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.” This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to “ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue.”

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for the petitioned-for tolerances for residues of aminopyralid, including its metabolites and degradates, on corn, field, forage at 0.30 ppm; corn, field, grain at 0.20 ppm; and corn, field, stover at 0.20 ppm. EPA's assessment of exposures and risks associated with establishing tolerances follows.

EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children.

The toxicology database for aminopyralid includes toxicity studies conducted with the acid (XDE-750) and the triisopropanolammonium (TIPA) salt (GF-871). The acute toxicity data indicate that both the acid and salt have low toxicity via oral, dermal, and inhalation routes of exposure; and that neither is a skin irritant or skin sensitizer. The TIPA salt is not irritating to the eye; however, aminopyralid acid is severely irritating to the eye.

Longer term studies indicate that the stomach, ileum, and cecum are targets for aminopyralid. In a subchronic feeding study in rats (XDE-750), hyperplasia of the mucosal epithelium of the ileum and cecum was observed at the highest dose tested (HDT) of 1,000 milligrams/kilograms/day (mg/kg/day). Chronic exposure in rats (XDE-750) also resulted in hyperplasia of the mucosal epithelium, along with cecal enlargement and decreased body weights at a lower dose of 500 mg/kg/day. Hypertrophy and hyperplasia of the mucosal epithelium were seen after subchronic exposure in dogs (XDE-750) at the HDT of 929 mg/kg/day. Thickening of the stomach mucosa (females), hyperplasia and hypertrophy of the mucosal epithelium, slight lymphoid hyperplasia of the gastric mucosa, and very slight/slight chronic mucosal inflammation were observed in dogs after chronic exposure at the HDT of 967 mg/kg/day. No adverse effects were observed in subchronic or chronic feeding studies in mice.

Stomach effects were also observed in a developmental toxicity study in rabbits conducted with the acid (XDE-750). Ulcers and erosions were seen in the glandular mucosa of the stomach at 500 mg/kg/day in maternal animals. Other effects noted were decreased body weights and incoordinated gait. No developmental effects were seen in fetuses at 500 mg/kg/day. The high dose group was removed from the study because of the severity of the clinical signs that were observed (incoordinated gait, significant body weight losses, and decreased food intake). In another developmental rabbit study conducted with the TIPA salt (GF-871), severe inanition (exhaustion from lack of food), body weight loss, decreased fecal output, and incoordinated gait were observed at 260 mg/kg/day. At 520 mg/kg/day, decreased fetal body weights were observed. No effects were noted in developmental toxicity studies in rats with XDE-750 or GF-871 or a reproduction study in rats with XDE-750. There was no qualitative or quantitative evidence of increased susceptibility of fetuses or offspring in any of the developmental and reproduction toxicity studies conducted with aminopyralid.

No systemic toxic effects were observed in a 28-day dermal toxicity study in rats with XDE-750; however, dermal toxicity was indicated by slight epidermal hyperplasia in males at 1,000 mg/kg/day.

In an acute neurotoxicity study in rats (XDE-750), fecal soiling in males and urine soiling in females were observed at 2,000 mg/kg/day. No adverse effects were observed in a chronic neurotoxicity study in rats up to 1,000 mg/kg/day.

Aminopyralid is classified as “not likely to be carcinogenic to humans.” No increase in any tumors was found in carcinogenicity studies in rats and mice. Aminopyralid was negative in all mutagenicity studies, except for anin vitrochromosome aberration assay in Sprague Dawley rats. In this assay, XDE-750 induced chromosome aberrations, but only at cytotoxic concentrations. The clastogenic response was induced secondarily to toxicity.

Specific information on the studies received and the nature of the adverse effects caused by aminopyralid as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found athttp://www.regulations.govin the document“Aminopyralid. Human Health Risk Assessment for the Proposed Use on Field Corn (PP#8F7455)”at page 40 in docket ID number EPA-HQ-OPP-2009-0141.

For hazards that have a threshold below which there is no appreciable risk, a toxicological point of departure (POD) is identified as the basis for derivation of reference values for risk assessment. The POD may be defined as the highest dose at which no adverse effects are observed (the NOAEL) in the toxicology study identified as appropriate for use in risk assessment. However, if a NOAEL cannot be determined, the lowest dose at which adverse effects of concern are identified (the LOAEL) or a benchmark dose (BMD) approach is sometimes used for risk assessment. Uncertainty/safety factors (UFs) are used in conjunction with the POD to take into account uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. Safety is assessed for acute and chronic dietary risks by comparing aggregate food and water exposure to the pesticide to the acute population adjusted dose (aPAD) and chronic population adjusted dose (cPAD). TheaPAD and cPAD are calculated by dividing the POD by all applicable UFs. Aggregate short-, intermediate-, and chronic-term risks are evaluated by comparing food, water, and residential exposure to the POD to ensure that the margin of exposure (MOE) called for by the product of all applicable UFs is not exceeded. This latter value is referred to as the level of concern (LOC).

For non-threshold risks, the Agency assumes that any amount of exposure will lead to some degree of risk. Thus, the Agency estimates risk in terms of the probability of an occurrence of the adverse effect greater than that expected in a lifetime. For more information on the general principles EPA uses in risk characterization and a complete description of the risk assessment process, seehttp://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for aminopyralid used for human risk assessment can be found athttp://www.regulations.govin the document“Aminopyralid: Human Health Risk Assessment for the Proposed Use on Field Corn (PP#8F7455)”at page 20 in docket ID number EPA-HQ-OPP-2009-0141.

1.Dietary exposure from food and feed uses. In evaluating dietary exposure to aminopyralid, EPA considered exposure under the petitioned-for tolerances as well as all existing aminopyralid tolerances in 40 CFR 180.610. EPA assessed dietary exposures from aminopyralid in food as follows:

i.Acute exposure. Quantitative acute dietary exposure and risk assessments are performed for a food-use pesticide, if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a 1-day or single exposure. No such effects were identified in the toxicological studies for aminopyralid; therefore, a quantitative acute dietary exposure assessment is unnecessary.

ii.Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the U.S. Department of Agriculture (USDA) 1994-1996 and 1998 Continuing Survey of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed that residues are present in all commodities at the tolerance level and that 100% of commodities are treated with aminopyralid. The Dietary Exposure Evaluation Model (DEEM)(tm) 7.81 default concentration factors were used to estimate residues of aminopyralid in processed commodities.

iii.Cancer. Based on the results of carcinogenicity studies in rats and mice, EPA classified aminopyralid as “not likely to be carcinogenic to humans.” Therefore, an exposure assessment to evaluate cancer risk is unnecessary for this chemical.

iv.Anticipated residue and percent crop treated (PCT) information. EPA did not use anticipated residue or PCT information in the dietary assessment for aminopyralid. Tolerance level residues and 100 PCT were assumed for all food commodities.

2.Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for aminopyralid in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of aminopyralid. Further information regarding EPA drinking water models used in pesticide exposure assessment can be found athttp://www.epa.gov/oppefed1/models/water/index.htm.

Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of aminopyralid for chronic exposures for non-cancer assessments (the only dietary exposure scenario of concern for aminopyralid) are estimated to be 1.937 parts per billion (ppb) for surface water and 0.63 ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model. For chronic dietary risk assessment, the water concentration of value 1.937 ppb was used to assess the contribution to drinking water.

3.From non-dietary exposure. The term “residential exposure” is used in this document to refer to non-occupational, non-dietary exposure (e.g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets).

Aminopyralid is currently registered for the following uses that could result in residential exposures: Natural recreation areas, such as wildlife management areas, campgrounds, trailheads and trails. EPA assessed residential exposure using the following assumptions:

Aminopyralid is not applied by homeowners to residential or recreational settings; therefore, only post-application residential exposures were considered. A dermal endpoint of concern has not been identified for aminopyralid and postapplication inhalation exposure following treatment of recreation areas is expected to be negligible for adults and children. There is, however, the potential for short-term postapplication oral exposure of children playing in areas treated with aminopyralid. EPA assessed the following incidental oral exposure scenarios: Hand-to-mouth transfer of residues; object-to-mouth transfer of residues; and ingestion of soil containing aminopyralid residues.

4.Cumulative effects from substances with a common mechanism of toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider “available information” concerning the cumulative effects of a particular pesticide's residues and “other substances that have a common mechanism of toxicity.”

EPA has not found aminopyralid to share a common mechanism of toxicity with any other substances, and aminopyralid does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that aminopyralid does not have a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see EPA's website athttp://www.epa.gov/pesticides/cumulative.

1.In general. Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an additional tenfold (10X) margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the database on toxicity and exposure unless EPA determines based on reliable data that a different margin of safety will be safe for infants and children. This additional margin of safety is commonly referred to as the Food Quality Protection Act Safety Factors (FQPA SF). In applying this provision, EPA either retains the default value of 10X, or uses a different additional safety factor when reliable data available to EPA support the choice of a different factor.

2.Prenatal and postnatal sensitivity. The prenatal and postnatal toxicity database for aminopyralid includes harmonized guideline rat and rabbit developmental toxicity studies for both the acid and TIPA salt of aminopyralid and a two-generation reproduction toxicity study in rats conducted using aminopyralid acid. As discussed in Unit III.A (Toxicological Profile), there is noquantitative or qualitative evidence of increased susceptibility of fetuses or offspring in any of these studies.

3.Conclusion. EPA has determined that reliable data show the safety of infants and children would be adequately protected if the FQPA SF were reduced to 1X. That decision is based on the following findings:

i. The toxicity database for aminopyralid is adequate to assess pre- and postnatal toxicity. In accordance with 40 CFR part 158 Toxicology Data requirements, an immunotoxicity study (guideline 870.7800) is required for aminopyralid. In the absence of specific immunotoxicity studies, EPA has evaluated the available aminopyralid data to determine whether an additional uncertainty factor is needed to account for potential immunotoxicity. The toxicology database for aminopyralid does not show any evidence of treatment-related effects on the immune system. The overall weight-of-evidence suggests that this chemical does not directly target the immune system, and the Agency does not believe that conducting a functional immunotoxicity study will result in a lower POD than that currently used for overall risk assessment. Therefore, a database uncertainty factor (UFDB) is not needed to account for the lack of this study.

ii. No evidence of neurotoxicity was observed in acute or chronic neurotoxicity studies. Incoordinated gait, along with a lack of ambulatory movement, was observed in developmental toxicity studies (XDE-750 and GF-871) in rabbits at 500 mg/kg/day. However, the incoordination was transient (complete resolution within 2 hours postdosing) and considered to be a result of frank toxicity, rather than a neurotoxic event. Additionally, no signs of neurotoxicity were observed in other toxicity studies, and no evidence of quantitative or qualitative susceptibility was observed in developmental toxicity studies in rats or rabbits or a reproduction study in rats. Based on these findings, EPA has concluded that there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity.

iii. There is no evidence that aminopyralid results in increased susceptibility inin uterorats or rabbits in the prenatal developmental studies or offspring in the 2-generation reproduction study.

iv. There are no residual uncertainties identified in the exposure databases. The dietary food exposure assessments were performed based on 100 PCT and tolerance-level residues. EPA made conservative (protective) assumptions in the ground and surface water modeling used to assess exposure to aminopyralid in drinking water. EPA used similarly conservative assumptions to assess postapplication exposure of children as well as incidental oral exposure of toddlers. These assessments will not underestimate the exposure and risks posed by aminopyralid.

EPA determines whether acute and chronic pesticide exposures are safe by comparing aggregate exposure estimates to the aPAD and cPAD. The aPAD and cPAD represent the highest safe exposures, taking into account all appropriate SFs. EPA calculates the aPAD and cPAD by dividing the POD by all applicable UFs. For linear cancer risks, EPA calculates the probability of additional cancer cases given the estimated aggregate exposure. Short-, intermediate-, and chronic-term risks are evaluated by comparing the estimated aggregate food, water, and residential exposure to the POD to ensure that the MOE called for by the product of all applicable UFs is not exceeded.

1.Acute risk. An acute aggregate risk assessment takes into account exposure estimates from acute dietary consumption of food and drinking water. No adverse effect resulting from a single-oral exposure was identified and no acute dietary endpoint was selected. Therefore, aminopyralid is not expected to pose an acute risk.

2.Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to aminopyralid from food and water will utilize <1% of the cPAD for the general U.S. population and all population subgroups, including children 1 to 2 years old, the population group receiving the greatest exposure. Based on the explanation in Unit III.C.3., regarding residential use patterns, chronic residential exposure to residues of aminopyralid is not expected.

3.Short-term risk. Short-term aggregate exposure takes into account short-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Aminopyralid is currently registered for uses that could result in short-term residential exposure and the Agency has determined that it is appropriate to aggregate chronic exposure through food and water with short-term residential exposures to aminopyralid.

Using the exposure assumptions described in this unit for short-term exposures, EPA has concluded the combined short-term food, water, and residential exposures aggregated result in aggregate MOEs of between 25,000 and 33,000 for children's population subgroups. The aggregate MOEs include dietary exposures from food and drinking water as well as postapplication incidental oral exposure of children and toddlers playing in recreational areas treated with aminopyralid. Although short-term residential postapplication exposure of adults could result from the use of aminopyralid, inhalation exposures are expected to be negligible and a dermal endpoint of concern has not been identified for aminopyralid. Therefore, the short-term aggregate risk for adults is the sum of the risk from exposure to aminopyralid through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk.

4.Intermediate-term risk. Intermediate-term aggregate exposure takes into account intermediate-term residential exposure plus chronic exposure to food and water (considered to be a background exposure level). Aminopyralid is not registered for any use patterns that would result in intermediate-term residential exposure. Therefore, the intermediate-term aggregate risk is the sum of the risk from exposure to aminopyralid through food and water, which has already been addressed, and will not be greater than the chronic aggregate risk.

5.Aggregate cancer risk for U.S. population. Based on a lack of evidence for carcinogenicity in mice and rats following long-term dietary administration, aminopyralid is not expected to pose a cancer risk.

6.Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, or to infants and children from aggregate exposure to aminopyralid residues.

Adequate enforcement methodology, Liquid Chromatography/Mass Spectrometry/Mass Spectrometry (LC/MS/MS), Method GRM 07.07, is available to enforce the tolerance expression. The method may be requested from: Chief, Analytical Chemistry Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD 20755-5350; telephone number: (410) 305-2905; e-mail address:residuemethods@epa.gov.

No Codex, Canadian or Mexican MRLs have been established for corn commodities.

EPA received comments from an anonymous submitter objecting to pesticides and other “toxic” chemicals generally and recommending against any tolerances greater than zero for this product. The Agency understands the commenter's concerns and recognizes that some individuals believe that pesticides should be banned completely. However, the existing legal framework provided by section 408 of the FFDCA contemplates that tolerances greater than zero may be set when persons seeking such tolerances or exemptions have demonstrated that the pesticide meets the safety standard imposed by that statute. This submitter's comments appear to be directed at the underlying statute and not EPA's implementation of it; the citizen has made no contention that EPA has acted in violation of the statutory framework.

EPA has revised the commodity terms “corn, forage,” “corn, grain,” and “corn, stover,” to read “corn, field, forage,” “corn, field, grain,” and “corn, field, stover” to agree with the Agency's Food and Feed Commodity Vocabulary.

EPA is also revising the tolerance expression for existing tolerances and the new tolerances on corn commodities to clarify the chemical moieties that are covered by the tolerances and specify how compliance with the tolerances is to be measured. Plant tolerances are currently expressed in terms of “free and conjugated residues of the herbicide aminopyralid, 2-pyridine carboxylic acid, 4-amino-3,6-dichloro-, calculated as aminopyralid.” Livestock tolerances are currently expressed in terms of “residues of the herbicide aminopyralid.” The tolerance expression for plants is being revised to make clear that the tolerances cover residues of aminopyralid, 4-amino-3,6-dichloro-2-pyridinecarboxylic acid, including its metabolites and degradates. Compliance with the tolerances is to be determined by measuring only free and conjugated aminopyralid. Similarly, the tolerance expression for livestock commodities is being revised to clarify that the tolerances cover residues of aminopyralid, including its metabolites and degradates, but that compliance with the tolerance levels will be determined by measuring only aminopyralid.

EPA has determined that it is reasonable to make these changes final without prior proposal and opportunity for comment, because public comment is not necessary, in that the changes have no substantive effect on the tolerances, but rather are merely intended to clarify the existing tolerance expressions.

Therefore, tolerances are established for residues of aminopyralid, 4-amino-3,6-dichloro-2-pyridinecarboxylic acid, including its metabolites and degradates, in or on corn, field, forage at 0.30 ppm; corn, field, grain at 0.20 ppm; and corn, field, stover at 0.20 ppm. Compliance with these tolerance levels is to be determined by measuring only free and conjugated aminopyralid.

This final rule establishes tolerances under section 408(d) of FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget (OMB) has exempted these types of actions from review under Executive Order 12866, entitledRegulatory Planning and Review(58 FR 51735, October 4, 1993). Because this final rule has been exempted from review under Executive Order 12866, this final rule is not subject to Executive Order 13211, entitledActions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use(66 FR 28355, May 22, 2001) or Executive Order 13045, entitledProtection of Children from Environmental Health Risks and Safety Risks(62 FR 19885, April 23, 1997). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501et seq., nor does it require any special considerations under Executive Order 12898, entitledFederal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations(59 FR 7629, February 16, 1994).

Since tolerances and exemptions that are established on the basis of a petition under section 408(d) of FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.) do not apply.

This final rule directly regulates growers, food processors, food handlers, and food retailers, not States or tribes, nor does this action alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132, entitledFederalism(64 FR 43255, August 10, 1999) and Executive Order 13175, entitledConsultation and Coordination with Indian Tribal Governments(65 FR 67249, November 9, 2000) do not apply to this final rule. In addition, this final rule does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 (UMRA) (Public Law 104-4).

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note).

The Congressional Review Act, 5 U.S.C. 801et seq., generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in theFederal Register. This final rule is not a “major rule” as defined by 5 U.S.C. 804(2).

This is a synopsis of the Commission's Report and Order in CC Docket No. 02-6, FCC 09-105, adopted December 1, 2009, and released December 2, 2009. The complete text of this document is available for inspection and copying during normal business hours in the FCC Reference Information Center, Portals II, 445 12th Street, SW., Room CY-A257, Washington, DC 20554. The document may also be purchased from the Commission's duplicating contractor, Best Copy and Printing, Inc., 445 12th Street, SW., Room CY-B402, Washington, DC 20554, telephone (800) 378-3160 or (202) 863-2893, facsimile (202) 863-2898, or via the Internet athttp://www.bcpiweb.com. It is also available on the Commission's Web site athttp://www.fcc.gov.

People with Disabilities:To request materials in accessible formats for people with disabilities (braille, large print, electronic files, audio format), send an e-mail tofcc504@fcc.govor call the Consumer & Governmental Affairs Bureau at 202-418-0530 (voice), 202-418-0432 (tty).

1. In the Report and Order, we conclude that interconnected VoIP service is eligible for E-rate support and should continue to be an eligible service under the E-rate program. We also conclude that text messaging is eligible for E-rate support. In response to the 2010 ESL Public Notice, we clarify the E-rate program eligibility of video on-demand servers, ethernet, web hosting, wireless local area network (LAN) controllers, and virtualization software. We find that telephone broadcast messaging, unbundled warranties, power distribution units, softphones, interactive white boards, and e-mail archiving are ineligible for E-rate program funding. Finally, we release the Eligible Services List (ESL) for E-rate funding year 2010.

2. Under the E-rate program, eligible schools, libraries, and consortia that include eligible schools and libraries may receive discounts for eligible telecommunications services, Internet access, and internal connections. Section 254 of the Communications Act of 1934, as amended (the Act), gives the Commission the authority to designate “telecommunications services” and certain additional services eligible for support under the E-rate program. The Commission may also designate services eligible for E-rate support as part of its authority to enhance, to the extent technically feasible and economically reasonable, access to advanced telecommunications and information services for all public and non-profit elementary and secondary school classrooms and libraries.

3. Since the initial implementation of the E-rate program in 1998, and consistent with the Commission's rules and requirements, USAC has developed procedures and guidelines to ensure that E-rate funding is provided only for eligible services. Initially, the Commission directed USAC, in consultation with the Commission, to determine whether particular services fell within the eligibility criteria established under the Act and the Commission's rules and policies. USAC began to update and post to its Web site on an annual basis a list of services and products eligible to receive discounts under the E-rate program, now known as the ESL. In consultation with the Wireline Competition Bureau (Bureau), USAC updated the list to reflect anychanges in rules that had occurred during the previous year and to address issues that arose in the application review process.

4. On December 23, 2003, the Commission adopted section 54.522 of its rules, formalizing the process for updating the ESL for the E-rate program. Specifically, under section 54.522 of the Commission's rules, the Commission must seek comment on USAC's proposed ESL and issue a public notice attaching the final ESL for the upcoming funding year at least 60 days prior to the opening of the application funding window for the E-rate program. In its current form, the ESL is divided into five main categories—telecommunications service, Internet access, internal connections, basic maintenance of internal connections, and miscellaneous.

5. In the 2010 ESL Public Notice, the Bureau sought comment on changes to the ESL proposed by USAC for funding year 2010. Comments on the 2010 ESL Public Notice were due on June 23, 2009, and reply comments were due on June 30, 2009. In the ESL NPRM, released in July 2008, the Commission sought comment on issues related to eligible services that had been raised by commenters but had not yet been resolved through the ESL public notice and revision process. For example, the Commission sought comment on the inclusion of interconnected VoIP service in the ESL, and whether text messaging, telephone broadcast messaging, and other individual services should be eligible for E-rate support under section 254(c)(3) of the Act. The Commission also sought comment on which rules, if any, would need to be amended to implement any changes made as a result of the ESL NPRM. Comments on the ESL NPRM were due on September 18, 2008, and reply comments were due on October 3, 2008.

6. In this Report and Order, we modify our rules to expressly include interconnected VoIP and text messaging as eligible services under the E-rate program.

7.Interconnected VoIPWe conclude that we should modify our rules to expressly include interconnected VoIP as a service eligible for E-rate support, and we will continue to fund interconnected VoIP service under the E-rate support mechanism. We also determine that interconnected VoIP service should be a Priority 1 service because regardless of its ultimate regulatory classification, it is defined as “enabl[ing] real-time, two-way voice communications,” 47 CFR 9.3, and thus provides basic connectivity akin to other Priority 1 services. We note, however, that not all of the components of an interconnected VoIP service are eligible for Priority 1 funding. Any components of an interconnected VoIP system that would be considered internal connections would be eligible for Priority 2 funding only, and any components of an interconnected VoIP system that are end-user equipment are ineligible for funding. We also adopt USAC's proposal that interconnected VoIP be listed in both the telecommunications and Internet access categories of the ESL, despite the fact that the Commission has not yet determined the regulatory classification of interconnected VoIP.

8. We find that, pursuant to section 254 of the Act, the Commission has the authority to include interconnected VoIP service as an additional service eligible for E-rate support. We therefore amend section 54.503 of our rules to designate interconnected VoIP as a supported special service. We note that the Commission has not yet classified interconnected VoIP service as either a telecommunications service or an information service. If interconnected VoIP service is found to be a telecommunications service, sections 254(c)(1), (c)(3), and (h)(1)(B) of the Act provide the Commission with the authority to provide E-rate support for all commercially available telecommunications services. 47 U.S.C. 254(c)(1), (c)(3). If, however, interconnected VoIP is determined to be an information service, sections 254(c)(3), (h)(1)(B), and (h)(2) of the Act, as explained in the Universal Service First Report and Order, provide the Commission with the authority to provide E-rate support for interconnected VoIP when provided by both telecommunications carriers and non-telecommunications carriers because such support will “enhance * * * access to advanced telecommunications and information services” for schools and libraries. 47 U.S.C. 254(c)(3), (h)(1)(B), (h)(2)(A). No matter how interconnected VoIP is ultimately classified, we find that the Commission has statutory authority to include it as an eligible supported service. Therefore, we amend section 54.517 of our rules to permit interconnected VoIP to be provided by non-telecommunications carriers.

9. Furthermore, we agree with commenters that the permanent inclusion of interconnected VoIP service increases the options available to schools and libraries to encourage meaningful communications among parents, teachers, and school and library administrators. Indeed, because interconnected VoIP is increasingly used to replace analog voice service, funding interconnected VoIP service is consistent with the concept of competitive neutrality, which is the principle of treating similarly situated services in the same manner for E-rate funding purposes, as mandated by the Commission. We also agree with commenters that the inclusion of interconnected VoIP service as an eligible service allows schools and libraries to benefit from the same cost efficiencies and service features that have led many consumers and businesses to choose this technology.

10. We also sought comment on whether interconnected VoIP service should remain classified in the miscellaneous service category, as it has been in previous ESLs. As proposed by USAC in its annual ESL submission, we conclude that interconnected VoIP service should be listed in both the telecommunications and Internet access categories to help minimize applicant confusion noted by commenters. We clarify that we are not, by this action, ultimately determining that interconnected VoIP is either a telecommunications service or an Internet access service. Rather, we put interconnected VoIP in both of those ESL categories because interconnected VoIP can be provided by both telecommunications service providers or non-telecommunications service providers. Because of this change, it will no longer be necessary to list interconnected VoIP in the miscellaneous category of the ESL. We believe this change will also clarify that applicants can apply for and receive E-rate funding for interconnected VoIP service provided by either a telecommunications service provider or an Internet access service provider. We encourage applicants soliciting bids for interconnected VoIP services to post for the services in both categories to expand the number of service providers that can bid on the services sought. Consistent with USAC's recommendation, we clarify that applicants are not required to prepare a technology plan if they are seeking discounts only for interconnected VoIP. Thus, we amend section 54.504(b) of our rules to make clear that no technology plan is needed if applicants are applying only for interconnected VoIP.

11. We also agree with Funds for Learning that any interconnected VoIP hardware that does not meet the test for Priority 1 services in the TennesseeOrder should be considered Priority 2 internal connections and should be ineligible for Priority 1 funding. In the Tennessee Order, the Commission stated that a service is considered a component of internal connections if it is necessary to “transport information within one or more instructional buildings of a single school campus.” The Commission also stated that it was reasonable to presume that if facilities are located on an applicant's premises, then such facilities are necessary to transport information within one or more buildings of the school campus, and are thus a Priority 2 internal connections service and not part of an end-to-end Internet access service, i.e., a Priority 1 service. This presumption can be rebutted with evidence that the applicant does not own or have exclusive use of the facilities. Thus, leased VoIP telephone systems will need to be evaluated in accordance with the conditions in the Tennessee Order, to determine whether they should be eligible as Priority 2 internal connections only or if some portion of the system would be eligible as Priority 1. For example, only the lease of a single basic terminating component is eligible as a Priority 1 service under E-rate and this may include a VoIP gateway device located on the applicant's premises, but hubs, routers and switches are not considered basic terminating components and would be subject to the on-premise Priority 1 equipment conditions set forth in the Tennessee Order.

12. In the ESL NPRM, we also sought comment on whether applicants requesting funding for interconnected VoIP service as an Internet access service must comply with and certify to requirements identified in the Children's Internet Protection Act (CIPA). 47 U.S.C. 254(h)(5), (l). Enacted in 2001, CIPA imposed requirements on schools and libraries “having computers with Internet access” and prohibits schools and libraries from receiving discounted services if those requirements are not met. 47 U.S.C. 254(h)(5), (h)(6). This prohibition is not applicable to a school or library that receives discounted services “only for purposes other than the provision of Internet access, Internet service, or internal connections.” 47 U.S.C. 254(h)(5)(A)(ii), (h)(6)(A)(ii). Thus, the Commission determined that schools or libraries receiving only discounted telecommunications services were not required to comply with CIPA. Consistent with the majority of commenters' arguments, we conclude that applicants requesting funds for interconnected VoIP service alone are not required to comply with and certify to CIPA requirements. While interconnected VoIP service may traverse the Internet, interconnected VoIP service, by definition, is not used to provide an Internet access service, Internet service, or internal connections. 47 CFR 9.3. Therefore, we find that CIPA compliance is not required for applicants that receive funding for interconnected VoIP service. Applicants seeking support for interconnected VoIP service that also seek support for Internet access, Internet service, or internal connections would certify their CIPA compliance separately for the Internet access.

13.Text Messaging.We find that we should modify our rules to include text messaging, known as short message service (SMS), as a service eligible for E-rate support. We agree with commenters who noted that text messaging is similar to other E-rate-eligible services used by applicants to communicate, such as e-mail and paging services. Moreover, we believe our decision to add text messaging is analogous to our decision in the Schools and Libraries Second Report and Order to add voice mail service to the list of E-rate-eligible services. Thus, for similar reasons, we designate text messaging as a service eligible for E-rate support. We note that we include text messaging as an eligible service irrespective of whether text message is ultimately categorized as a telecommunications service or an information service. This service will be categorized in the ESL in the telecommunications service category as a component of telephone service because text messaging has generally been available in conjunction with wireless telephone service, and the charges for text messaging are typically bundled with wireless telephone service or the separate charges for the text messaging service appear on the same bill as the telephone service. We therefore amend section 54.503 of our rules to designate text messaging as a supported special service.

14. We remind applicants that text messaging is eligible for E-rate support when used for educational purposes only. The Commission had established a presumption that activities that occur in a library or classroom or on library or school property are integral, immediate, and proximate to the education of students or the provision of library services to library patrons. We caution applicants that for purposes of the E-rate program, eligible text messaging would not include applications, software or other special features that, for example, are used to facilitate the mass distribution of text messages, or the creation or management of distribution groups for text messaging.

15. We also release the ESL for E-rate funding year 2010 and make findings about the particular changes to the ESL recommended by USAC. Specifically, we clarify the eligibility of video on-demand servers, ethernet, Web hosting, wireless LAN controllers, VoIP-related services, and virtualization software. We also find that telephone broadcast messaging, unbundled warranties, power distribution units, softphones, interactive white boards, and e-mail archiving are ineligible for E-rate program funding.

16.Video On-Demand Servers.Although USAC had proposed to make “video on-demand servers” ineligible in their entirety, we clarify that applicants can continue to receive E-rate discounts as internal connections for the portion of a video on-demand server that enables the transport of video to the classroom or parts of a library. The portion of a video on-demand server that enables the storage of video or other content, however, would remain ineligible. To clarify the eligibility status of a video on-demand server, we add the term “video content storage” to the list of ineligible storage components on the ESL. This should more clearly delineate the portion of a video on-demand server that is ineligible for discounts. Currently, applicants are using servers that house video for various purposes, including transporting information over a wide area network (WAN) or LAN to classrooms from a central server. We note that there may be video on-demand servers that are primarily dedicated to the storage of video and other content and the cost-allocation used by the manufacturer should accurately reflect the true use of the server. We also caution applicants that duplicative products or services are ineligible. If applicants are using other products or services to transport video or information throughout their school or library buildings, the portion of a video on-demand server that also provides this capability will be considered duplicative and ineligible.

17.Ethernet.We clarify that ethernet is an eligible digital transmission technology in the telecommunications funding category of the ESL. Ethernet technology provides a network that connects computers. Although traditionally associated with local areanetworks, technology has evolved such that ethernet networks can span large distances and can provide connections from within an eligible school or library to other locations beyond the school or library. Therefore, we find that for purposes of the E-rate program, ethernet service is eligible in the telecommunications funding category. We agree with commenters who state that adding ethernet to the ESL “reflects the evolution of telecommunications technologies that are commercially available and is a clarification of previous eligibility.” We also note that although it was not specifically listed in the ESL for funding year 2009, ethernet is a type of digital transmission service that has been eligible for E-rate discounts when purchased as a Priority 1 telecommunications service.

18.Web hosting.We clarify that web pages protected by a username and password are eligible for funding as part of web hosting services. The fact that a school or library restricts access to all or part of its Web site to certain users—e.g.,school administrators, teachers, librarians and students—does not render the service ineligible for E-rate funds. Web hosting has been on the ESL since funding year 2004, as Internet access. We emphasize that an eligible Web hosting service is limited to hosting a school or library's Web site—software applications, end-user file storage, and content editing features are still ineligible components of a web hosting service. Such ineligible web hosting features would include, but would not be limited to, the posting of content created by third party vendors, any type of interactive application feature that would allow for blogging, and any features involving data input or retrieval including searching of databases for grades, student attendance files, or other reports. We caution applicants that they must cost-allocate these types of ineligible features. The clarification to allow funding for web pages protected by a username and password was intended to allow school administrators, parents, students, and library employees to view web pages that, may, for various reasons, need to be restricted from viewing by the rest of the public. This clarification was not intended to allow applicants to obtain funding for additional web hosting-related applications and features beyond the service that enables a school or library to have hosted web pages, including any application software or features that may be required to maintain password protected Web pages.

19.Wireless LAN Controllers.We agree with USAC that wireless LAN controllers should be specifically listed in the ESL as eligible internal connections under the data distribution category. A wireless LAN controller is a device that is a central component of a wireless network solution and that helps to manage the large-scale deployment of a wireless network. In its proposed changes to the ESL for E-rate funding year 2010, USAC proposes to include a definition of a wireless LAN controller as a component that is used in conjunction with access points to create a wireless local area network. USAC defines an “access point” as a base station in a wireless LAN and states that access points are typically stand-alone devices that may plug into an ethernet hub or server or may provide a repeater function for wireless networks. When a school or library is relying on a wireless network solution, wireless LAN controllers, in conjunction with access points, are necessary for the delivery of information all the way to the classrooms of the school or rooms of the library. Under the E-rate program, internal connections components are those that are necessary to “transport information within one or more instructional buildings of a single school campus or within one or more non-administrative buildings that comprise a single library branch.” Wireless LAN controllers, therefore, are eligible for support under the E-rate program as internal connections. Applicants have been receiving support for wireless LAN controllers as eligible internal connections and this change to the ESL is merely a clarification of the service's existing funding status.

20.Interconnected VoIP-Related Software.We agree with USAC that we should clarify that funding for user licenses for VoIP systems are eligible server based software and can be requested in the internal connections funding category. Interconnected VoIP user licenses are necessary for the utilization of the VoIP system. They are similar to client access licenses for eligible software products, except that they are specific to VoIP systems. Client access licenses are currently eligible for E-rate funding. Commenters agree with the proposed clarification, noting that applicants have received funding for these services in prior funding years.

21.Virtualization Software.We agree with USAC that virtualization software is eligible for E-rate support as internal connections. As stated above, under the E-rate program, internal connections components are those that are necessary to “transport information within one or more instructional buildings of a single school campus or within one or more non-administrative buildings that comprise a single library branch.” USAC's draft ESL for funding year 2010 states that virtualization software allows for the creation of multiple virtual servers on a single server, essentially allowing the work of multiple servers to be performed on one server. We agree with Funds for Learning that virtualization software should be eligible for E-rate funding when it is used for eligible server functions. Moreover, one of the internal connections for which the E-rate program provides discounts is operating system software, which enables the basic operations of a computer system or other electronic device. We find that virtualization software is a type of operating system software. Applicants can use virtualization software to transport information within its school or library, and, in so doing, would be using a single server to perform the tasks of what would usually take multiple servers. Thus, virtualization software may be a cost-effective technology for applicants and is eligible for E-rate funding. If applicants also use virtualization software for functions that are ineligible for E-rate support, such as archiving, functions that support ineligible applications, or network management, the applicants must perform a cost allocation to remove the ineligible functions from their E-rate funding requests.

22.Telephone Broadcast Messaging.We agree with USAC that telephone broadcast messaging should not be added to the ESL because we find that it does not fit within any of the current categories of supported services. A broadcast messaging service is one that can call hundreds or thousands of recipients and play a pre-recorded message from school administrators about information including, but not limited to, weather delays or closings, school absences, or child safety issues. Broadcast messaging has been described by commenters as an add-on to voice mail service and an application riding on top of a service provider's telecommunications infrastructure. Only a few categories of software are eligible for E-rate funding, however, including operating system software, e-mail software, and software for a server-based, shared voice mail system. While voice mail has been designated as an eligible service, and the E-rate program pays for the software for a server-based shared voice mail system, the record in the ESL NPRM proceeding established that telephone broadcast messaging is an “add-on to voice mail” service and not software for voice mail itself. Therefore, we find that broadcastmessaging consists of applications or features that do not fit into any of the current categories of supported services and thus, should not be added to the list of software applications that are currently eligible for support as internal connections. Moreover, we find that it would not be in the public interest to add telephone broadcast messaging to the ESL when requests for E-rate funding consistently exceed the funding cap. While we believe that many school districts find telephone broadcast messaging a useful service, we do not believe it is essential to the educational purposes of schools and libraries, and funding this service may have an adverse effect on funds available for other already eligible services.

23.Unbundled Warranties.We find that unbundled warranties are not services eligible for E-rate discounts as basic maintenance of internal connections. In its proposed changes to the ESL, USAC proposes to add unbundled warranty to the basic maintenance category of the ESL and defines “unbundled warranty” as a separately priced warranty allowing for broken equipment to be fixed or, in the event that the problem is beyond repair, replaced. The Commission has found that basic maintenance services are eligible for universal service support as Priority 2 internal connections service if, but for the maintenance at issue, the internal connection would not function and serve its intended purpose with the degree of reliability ordinarily provided in the marketplace to entities receiving such services. We do not add unbundled warranties to the ESL at this time because we find that a warranty may be duplicative of an applicant's maintenance agreement or contract, which is eligible for E-rate discounts. To avoid the potential waste of E-rate resources, we decline to allow applicants to receive E-rate discounts for duplicative unbundled warranties. Moreover, the current ESL states that basic maintenance is eligible for discount only if it is a component of a maintenance agreement or contract for eligible components. An unbundled warranty would not be a component of a maintenance agreement or contract for eligible components. Therefore, we find that an unbundled warranty is not eligible for E-rate funds as basic maintenance.

24.Power Distribution Units.We agree with USAC that the ESL should be updated to clearly state that power distribution units are not eligible for E-rate support as internal connections. USAC proposes to define a “power distribution unit” as a power strip designed for data centers or racks with greater capacity and features than a power strip, and a “power strip” as a group of sockets that allow for multiple power cords to plug into a single device. Power strips have not previously been eligible for E-rate funding and, because a power distribution unit is merely a type of power strip with additional capacities and features, we find that it is also ineligible for E-rate program funds.

25.Softphones.We agree with USAC's proposal to clarify in the ESL that softphones are software that is ineligible for E-rate funding. The Commission has approved operating system software, e-mail software, and software for a server-based, shared voice mail system as eligible software under the internal connections funding category for E-rate. USAC proposes to define a softphone as end-user application software that allows users the use of a personal computer's microphone and speakers to make telephone calls in place of a physical end-user telephone. This type of application software is unlike the types of software the Commission has previously approved for E-rate funding and, as commenters note, softphones perform the same functions as physical desktop telephones, which are end-user equipment and are not eligible for E-rate funding.

26.Interactive White Boards.We agree with USAC and commenters that the ESL should clarify that interactive white boards are end-user equipment that is ineligible for E-rate funding. End-user equipment, such as desktop telephones, personal computers, fax machines, and modems, for example, is not eligible for E-rate discounts. In its draft ESL for funding year 2010, USAC defines an “interactive white board” as a device that allows end-users to display information with a vast array of interactive features. We find, therefore, that interactive white boards are end-user equipment that is not eligible for E-rate funding.

27.E-mail Archiving.We agree with USAC's proposal to clarify in the ESL that e-mail archiving is an ineligible component of an e-mail service. In addition, we agree with USAC's clarification to the draft ESL for funding year 2010 that, for purposes of E-rate support, storage products may be used for eligible e-mail files but not for e-mail archiving. USAC's draft ESL for funding year 2010 defines e-mail archiving as a form of electronic recordkeeping, often compressing e-mail files to make available greater in-box space. For example, when e-mail is archived to reduce in-box size, reduce hard drive space, and retain records for future retrieval, it constitutes the storage of end-user files and is ineligible for E-rate discounts. Although E-rate eligible e-mail services can include a short-term storage component that enables the user to view current e-mails, any long-term storage service is ineligible for E-rate discounts and we agree with USAC that this distinction should be made clear to applicants in the 2010 ESL.

28. The Regulatory Flexibility Act (RFA),see5 U.S.C. 603, requires that an agency prepare a regulatory flexibility analysis for notice-and-comment rulemaking proceedings, unless the agency certifies that “the rule will not, if promulgated, have a significant economic impact on a substantial number of small entities.”See5 U.S.C. 605(b). The RFA generally defines “small entity” as having the same meaning as the terms “small business,” “small organization,” and “small governmental jurisdiction.” 5 U.S.C. 601(6). In addition, the term “small business” has the same meaning as the term “small business concern” under the Small Business Act. 5 U.S.C. 601(3). A “small business concern” is one which: (1) Is independently owned and operated; (2) is not dominant in its field of operation; and (3) satisfies any additional criteria established by the Small Business Administration (SBA). 15 U.S.C. 632.

29. In the report and order, we modify our rules to expressly include interconnected voice over Internet protocol (VoIP) and text messaging as eligible services in our rules governing the E-rate program. We also release the list of services that will be eligible for discounts for E-rate funding year 2010. This Eligible Services List (ESL) is released on an annual basis to enable school and library applicants and other affected entities to determine the services and products that are eligible for E-rate discounts. In the report and order we add services to the ESL but do not remove any services from the list. Thus, the only changes made in our report and order result in the ability of schools and libraries to seek E-rate discounts for more services than were available to them in the prior funding year. This means that the rule revisions will result in a positive net impact on small entities. Therefore, we certify that the requirements of the report and order will have no significant economic impact.

30. The Commission will send a copy of the report and order, including a copyof this Final Regulatory Flexibility Certification, in a report to Congress pursuant to the Congressional Review Act.See5 U.S.C. 801(a)(1)(A). In addition, the report and order (or summary thereof) and this final certification will be published in theFederal Register,and will be sent to the Chief Counsel for Advocacy of the U.S. Small Business Administration.See5 U.S.C. 605(b).

31. This report and order does not contain proposed information collection(s) subject to the Paperwork Reduction Act of 1995 (PRA), Public Law 104-13. In addition, therefore, it does not contain any new or modified “information collection burden for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198, see 44 U.S.C. 3506(c)(4).

32. The Commission will send a copy of this Report and Order [CC Docket No. 02-6; FCC 09-105] in a report to Congress and the Government Accountability Office pursuant to the Congressional Review Act,seeU.S.C. 801(a)(1)(A).

33. These matters shall be treated as a “permit-but-disclose” proceeding in accordance with the Commission's ex parte rules. 47 CFR 1.1200 through 1.1216. Persons making oral ex parte presentations are reminded that memoranda summarizing the 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 is generally required. 47 CFR 1.1206(b)(2). Other requirements pertaining to oral and written presentations are set forth in section 1.1206(b) of the Commission's rules. 47 CFR 1.1206(b).

34.It is ordered,that pursuant to the authority contained in sections 1 through 4, 201-205, 254, 303(r), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151-154, 201 through 205, 254, 303(r), and 403, this report and orderis adopted.

35.It is further ordered,that pursuant to the authority contained in sections 1 through 4, 201-205, 254, 303(r), and 403 of the Communications Act of 1934, as amended, 47 U.S.C. 151-154, 201 through 205, 254, 303(r), and 403, sections 54.503, 54.507, and 54.517 of the Commission's rules, 47 CFR 54.503, 54.507 and 54.517,is amended,effective May 7, 2010.

36.It is further orderedthat the Commission's Consumer and Governmental Affairs Bureau, Reference Information Center, shall send a copy of this report and order, including the Final Regulatory Flexibility Certification, to the Chief Counsel for Advocacy of the Small Business Administration.

Table of Contents I. Background A. Final Rule Upgrading FMVSS No. 216 B. Challenge by NTEA C. Consent Motion To Stay Briefing Schedule II. Today's Document and Related Actions III. Multi-Stage Vehicles and the Multi-Stage Certification Scheme A. Multi-Stage Vehicles B. Safety Standards and Certification C. 2005 and 2006 Final Rules on Certification of Vehicles Built in Two or More Stages IV. Multi-Stage Issues in the Rulemaking To Upgrade FMVSS No. 216 A. FMVSS No. 216 Prior to the Upgrade B. The Proposed Rule C. Public Comments D. May 2009 Final Rule V. Further Response to Comments Regarding Multi-Stage Vehicles A. Introduction B. The Current Certification Scheme Is Not an Unlawful Delegation of Agency Authority C. Current IVDs Concerning FMVSS No. 216 are Workable D. Final-Stage Manufacturers Can Certify Their Vehicles Built on Chassis-Cabs as Being Compliant With FMVSS No. 216a E. In General, IVDs Are Workable F. NHTSA Provided a Testing Alternative, FMVSS No. 220 G. There Is Little Cost for Multi-Stage Manufacturers To Comply With FMVSS No. 216a H. Conclusion I. Background A. Final Rule Upgrading FMVSS No. 216

On May 12, 2009, as part of a comprehensive plan for reducing the serious risk of rollover crashes and the risk of death and serious injury in those crashes, NHTSA published in theFederal Register(74 FR 22348) a final rule substantially upgrading Federal Motor Vehicle Safety Standard (FMVSS) No. 216,Roof Crush Resistance.The upgraded standard is designated FMVSS No. 216a.

First, for the vehicles previously subject to the standard, i.e., passenger cars and multipurpose passenger vehicles, trucks and buses with a Gross Vehicle Weight Rating (GVWR) of 2,722 kilograms (6,000 pounds) or less, the rule doubled the amount of force the vehicle's roof structure must withstand in the specified test, from 1.5 times the vehicle's unloaded weight to 3.0 times the vehicle's unloaded weight. We note that this value is sometimes referred to as the strength-to-weight ratio (SWR), e.g., a SWR of 1.5, 2.0, 2.5, and so forth.

Second, the rule extended the applicability of the standard so that it will also apply to vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds), but not greater than 4,536 kilograms (10,000 pounds). The rule established a force requirement of 1.5 times the vehicle's unloaded weight for these newly included vehicles.

Third, the rule required all of the above vehicles to meet the specified force requirements in a two-sided test, instead of a single-sided test. For the two-sided test, the same vehicle must meet the force requirements when tested first on one side and then on the other side of the vehicle.

Fourth, the rule established a new requirement for maintenance of headroom, i.e., survival space, during testing in addition to the existing limit on the amount of roof crush. The rule also included a number of special provisions, including ones related to leadtime, to address the needs of multi-stage manufacturers, alterers, and small volume manufacturers.

NTEA filed a petition for review of the May 2009 final rule in the United States Court of Appeals for the Sixth Circuit. That organization had submitted comments during the rulemaking opposing the agency's proposed revisions with respect to multi-stage vehicles.

NHTSA filed with the Court a motion for a stay of the briefing schedule. The agency stated that it believed the Court's consideration of the challenge by NTEA would be facilitated by a fuller response to the comments that organization had submitted during the rulemaking, which would permit both NTEA and the Court to more fully address the agency's rationale. NHTSA also noted that petitions for reconsideration of the rule were pending before the agency. NTEA consented to the motion and the Court granted a six-month stay of the briefing schedule on October 2, 2009.

In this document, we provide a fuller response to comments submitted by NTEA on our proposal to upgrade FMVSS No. 216.

We are also publishing two separate documents related to the May 2009 final rule. One is a response to petitions for reconsideration of that rule. The other is a correcting rule. The correcting rule incorporates a provision that was discussed in the preamble but inadvertently omitted from the regulatory text. As explained in the preamble, the agency decided toexclude a narrow category of multi-stage vehicles from FMVSS No. 216 altogether, multi-stage trucks with a GVWR greater than 2,722 kilograms (6,000 pounds) not built on either a chassis-cab or an incomplete vehicle with a full exterior van body. The regulatory text inadvertently omitted the reference to incomplete vehicles with a full exterior van body.

Multi-stage vehicles are motor vehicles that are produced in two or more stages. These vehicles are not produced by a single manufacturer on an assembly line as is the typical passenger car or sport utility vehicle. Instead, one manufacturer produces an “incomplete vehicle” which requires further manufacturing operations to become a completed vehicle. As defined in 49 CFR 567.3, an incomplete vehicle is an assemblage consisting, at a minimum, of chassis (including the frame) structure, power train, steering system, suspension system, and braking system, in the state that those systems are to be part of the completed vehicle, but requires further manufacturing operations to become a completed vehicle.1

Most incomplete vehicles are manufactured by large manufacturers, such as General Motors, Ford and Chrysler. Most final-stage manufacturers are small businesses.2 Multi-stage vehicles are aimed at a variety of niche markets, most of which are too small to be serviced economically by single stage manufacturers.

In terms of degree of completeness, the spectrum of incomplete vehicles ranges from a stripped chassis, i.e., an incomplete vehicle without an occupant compartment, to a chassis-cab. As defined in 49 CFR 567.3, a chassis-cab is an incomplete vehicle, with a completed occupant compartment, that requires only the addition of cargo-carrying, work-performing, or load-bearing components to perform its intended functions. A type of incomplete vehicle that falls between stripped chassis and chassis-cabs on this spectrum is a chassis cutaway, which is an incomplete vehicle delivered with a partial occupant compartment that does not have a rear wall.

In a typical situation, the incomplete vehicle is delivered to the final-stage manufacturer which adds work-performing or cargo-carrying components to complete the vehicle. For example, the incomplete vehicle may be a chassis-cab, i.e., have a cab, but nothing built on the frame behind the cab. As completed, it may be a dry freight van (box truck), dump truck, tow truck, or plumber's truck. In some cases, there may also be intermediate stage manufacturers involved in the production of a multi-stage motor vehicle.

NHTSA issues Federal motor vehicle safety standards applicable to the manufacture and sale of new motor vehicles and certain items of motor vehicle equipment under the authority of the National Traffic and Motor Vehicle Safety Act, as amended, codified as Chapter 301 of Title 49 of the United States Code, “Motor Vehicle Safety” (Vehicle Safety Act).3 The agency does not provide approvals of motor vehicles or equipment. Instead, the Vehicle Safety Act establishes a “self-certification” process under which each manufacturer is responsible for certifying that its products meet all applicable safety standards.4

Each of NHTSA's safety standards specifies the test conditions and procedures that the agency will use to evaluate the performance of the vehicle or equipment being tested for compliance with the particular safety standard. NHTSA follows these specified test procedures and conditions when conducting its compliance testing. However, manufacturers are not required to test their products in the manner specified in the relevant safety standard, or even to test the product at all, as their basis for certifying that the product complies with all relevant standards.

A manufacturer may evaluate its products in various ways to determine whether the vehicle or equipment will comply with the safety standards when tested by the agency according to the procedures specified in the standard and to provide a basis for its certification of compliance. Depending on the circumstances, the manufacturer may be able to base its certification on actual testing (according to the procedure specified in the standard or some other procedure), computer simulation, engineering analysis, engineering judgment or other means.5

All motor vehicles, whether single stage or multi-stage, must be certified to meet applicable FMVSSs.6 NHTSA has developed specific certification regulations for multi-stage vehicles. The certification process is governed by 49 CFR part 567Certification.49 CFR 567.5 sets forth the certification requirements for manufacturers of vehicles manufactured in two or more stages. Certification responsibilities for the applicable FMVSSs are communicated between manufacturers with the use of an incomplete vehicle document (IVD). With limited exceptions,7 each manufacturer of an incomplete vehicle and each intermediate manufacturer8 assumes legal responsibility for all certification-related duties under the Vehicle Safety Act with respect to:

Final-stage manufacturers have complementary duties. Pursuant to 49 CFR 567.5(d), final-stage manufacturers assume

Final-stage manufacturers also have the duty to affix a certification label to each vehicle in a manner that does not obscure labels affixed by previous stage manufacturers and that, among other things, contains certification statements.11 The final-stage manufacturer may make one of the following alternative certification statements: (1) The vehicle conforms to all applicable FMVSS; (2) the vehicle was completed in accordance with the prior manufacturers' IVD where applicable and conforms to all applicable FMVSS; or (3) the vehiclewas completed in accordance with the prior manufacturers' IVD where applicable except for certain listed exceptions by FMVSS and the vehicle conforms to all applicable FMVSS.12

As reflected above, the incomplete vehicle manufacturer furnishes an IVD for incomplete vehicles pursuant to 49 CFR 568.4. For each applicable FMVSS, the incomplete vehicle manufacturer makes one of three affirmative statements in the IVD: (1) a Type 1 statement that the vehicle when completed will conform to the standard if no alterations are made in identified components (this representation is most often made with respect to chassis-cabs since, as indicated earlier, they have a completed occupant compartment); (2) a Type 2 statement that sets forth the specific conditions of final manufacture under which the incomplete vehicle manufacturer specifies that the completed vehicle will conform to the standard (e.g., the vehicle, when completed, will meet the brake standard if it does not exceed gross axle weight ratings, the center of gravity at a specific vehicle weight rating is not above a certain height and no alterations are made to any brake system component on the incomplete vehicle); or (3) a Type 3 statement that conformity to the standard cannot be determined based on the incomplete vehicle as supplied, and the incomplete vehicle manufacturer makes no representation as to conformity with the standard (e.g., when components and systems must be added by the final-stage manufacturer and compliance cannot be decided at the time the incomplete vehicle leaves the incomplete vehicle manufacturer).

When the IVD makes a Type 1 or Type 2 statement, there is “pass-through” certification unless obviated by a subsequent manufacturer. The final-stage manufacturer can rely on the IVD to certify the vehicle to a particular standard.

Multi-stage vehicle manufacturers sometimes “alter” a vehicle to the end-users' specifications. An altered vehicle is one that is completed and certified in accordance with the agency's regulations and then altered before the first retail sale of the vehicle, in such a manner as may affect the vehicle's compliance with one or more FMVSS or the validity of the vehicle's stated weight ratings or vehicle type classification. This definition does not include the addition, substitution, or removal of readily attachable components, such as mirrors or tire and rim assemblies, or by minor finishing operations such as painting. The person which performs such operations on a completed vehicle is referred to as a vehicle “alterer.” An alterer must certify that the vehicle remains in compliance with all applicable FMVSS affected by the alteration.

On February 14, 2005, NHTSA published in theFederal Register(70 FR 7414) a final rule amending four different parts of Title 49 to address various certification issues related to vehicles built in two or more stages and, to a lesser degree, to altered vehicles. Among other things, the rule allowed the use of pass-through certification so that it can be used not only for multi-stage vehicles based on chassis-cabs, but also for those based on other types of incomplete vehicles.

In the preamble to the February 2005 final rule, and in other documents in that rulemaking, NHTSA discussed the history of issues related to the certification of vehicles built in two or more stages, which have long been sources of contention within the affected industry and before the agency and the courts.

Since 1977, NHTSA's regulations for certification of multi-stage vehicles have contained provisions for certification statements by chassis-cab manufacturers.13 In 1990, the United States Court of Appeals for the Sixth Circuit ruled inNational Truck and Equipment Ass'nv.NHTSA,919 F.2d 1148 (6th Cir. 1990), that the requirements of a particular FMVSS were impracticable for final-stage manufacturers using vehicles other than chassis-cabs for which the incomplete vehicle manufacturer was not required to provide “pass-through” certification. That decision led to rulemaking that ultimately resulted in the February 2005 multi-stage certification final rule.

NTEA petitioned for reconsideration of the February 2005 multi-stage certification final rule. NHTSA responded to that organization's petition in a final rule; response to petition for reconsideration published in theFederal Register(71 FR 28168) on May 15, 2006. While the agency made some changes in the February 2005 final rule in response to the petition, it denied the remainder of the petition for reconsideration that addressed issues regarding certification of multi-stage vehicles and responsibility for recalls of multi-stage vehicles.

In its petition for reconsideration of the February 2005 certification final rule, NTEA challenged the regulatory scheme of certifying multi-stage vehicles.14 It claimed, among other things, that the provided IVDs are unworkable, insufficient, and that it is not possible for a final-stage manufacturer to comply with the agency's multi-stage certification regulations. Furthermore, NTEA argued that even if compliance were possible, it would be economically ruinous to NTEA's members.

In denying most aspects of NTEA's petition for reconsideration, NHTSA provided specific and detailed responses to these and other relevant arguments. We explained that certification is important for safety and that the certification scheme is “workable.”

We stated that in recognition of the fact that incomplete vehicle manufacturers do not control work performed by final-stage manufacturers and can fairly anticipate only some things, but not everything done by final-stage manufacturers, the regulatory system of “pass-through” certification is reasonable. The IVD provides the basis for the final-stage manufacturer's certification with enumerated FMVSS, on various conditions, including, for example, that the final-stage manufacturer does not exceed the GVWR of the chassis or introduce modifications to the incomplete vehicle that interfere with compliance. As we explained, the IVD is a general document that accompanies the incomplete vehicle. IVDs are typically not limited to one application (one body or type of equipment), but contain limits and conditions in light of the nature and capacity of the chassis and potential problems resulting from completion of an incomplete vehicle. Final-stage manufacturers are informed, by the IVD, of components and systems that should not be altered, and, by following those instructions and other information from the incomplete vehicle manufacturer, they are able to certify.

Overall, NTEA sought to remove the certification responsibility from final-stage manufacturers and impose much of that responsibility on incomplete vehicle manufacturers. NTEA's petition ignored the fact that incomplete vehiclemanufacturers do not control what final-stage manufacturers do with the incomplete vehicles.

As we noted, a system of pass-through certification has existed for more than 25 years, and in that time many multi-stage vehicles have been built and certified by final-stage manufacturers. This fact alone indicates that the system is workable and operates as intended. Moreover, as we pointed out, the availability of multi-stage vehicles belies NTEA's position,15 and, contrary to that petitioner's position, market forces create business reasons for incomplete vehicle manufacturers to provide workable IVDs. We noted that NTEA's argument ignores the fact that the system is not broken—many types of multi-stage vehicles are being manufactured and offered for sale, including those manufactured by NTEA members. These include ambulances, service trucks, small school buses, mid-size buses, tow trucks and vans.16 The fact that vehicles such as these are being made indicates that the IVDs are workable. We also noted that NTEA ignored the cooperative relationships between incomplete and final-stage manufacturers.17

In our May 2006 response to petitions, we explained that certification serves an important safety function in the multi-stage vehicle business. Many multi-stage vehicles carry people and important cargo—from schoolchildren on school buses to liquid fuel on propane and gasoline trucks. The safety need for certification of compliance with FMVSS in these types of vehicles is uncontroverted.18

As part of responding to NTEA's claim in its petition to the 2005 Rule that the existing IVD's are not workable, we carefully examined the certification statements included in an IVD that NTEA appended to its petition.19 The IVD was for the General Motors (GM) CK chassis-cab. We analyzed certification statements for FMVSS Nos. 105, Hydraulic and Electric Brake Systems; 135,Light Vehicle Brake Systems;204,Steering Control Rearward Displacement;201,Occupant Protection in Interior Impact;212,Windshield Mounting;219,Windshield Zone Intrusion;214,Side Impact Protection;208,Occupant Crash Protection;216,Roof Crush Resistance;and 301,Fuel System Integrity.In each instance, we showed why the IVD was workable and why various limitations were reasonable.

We also explained that many resources are available to final-stage manufacturers.20 As a group, final-stage manufacturers do not operate in an informational vacuum. In addition to the IVDs, these resources include upfitter21 guides from incomplete vehicle manufacturers, incomplete vehicle manufacturer help lines, the final-stage manufacturers' own experience and judgment, and commercially available software.

We also explained that issues regarding impracticability should be decided in the context of rulemaking for each FMVSS.22

FMVSS No. 216 seeks to reduce deaths and serious injuries resulting from the roof of a vehicle being crushed and pushed into the occupant compartment when the roof strikes the ground during rollover crashes. Prior to the upgrade, the standard required that when a large steel test plate (sometimes referred to as a platen) is placed in contact with either side of the forward edge of the roof of a vehicle and then pressed downward, simulating contact of the roof with the ground during a rollover crash, with steadily increasing force until a force equivalent to 1.5 times the unloaded weight of the vehicle is reached, the distance that the test plate has moved from the point of contact must not exceed 127 mm (5 inches). The criterion of the test plate not being permitted to move more than a specified amount is sometimes referred to as the “platen travel” criterion. The application of force was limited to 22,240 Newtons (5,000 pounds) for passenger cars, even if the unloaded weight of the car times 1.5 is greater than that amount.

Since 1991, this standard applied to passenger cars, multipurpose passenger vehicles (MPVs), trucks, and buses with a GVWR of 2,722 kilograms (6,000 pounds) or less.23 Compliance with the final rule was required on September 1, 1994. Therefore, FMVSS No. 216 has applied to some multi-stage vehicles, e.g., certain small trucks and small recreation vehicles, since 1994.24

On August 23, 2005, NHTSA published in theFederal Register(70 FR 49223) a NPRM to upgrade FMVSS No. 216,Roof Crush Resistance. 25 The NPRM reflected comments received in response to a Request for Comments (“RFC”) published in theFederal Register(66 FR 53376) on October 22, 2001, and research and testing conducted prior to the publication of the RFC.

To better address fatalities and injuries occurring in roof-involved rollover crashes, we proposed to extend the application of the standard to vehicles with a GVWR of up to 4,536 kilograms (10,000 pounds), and to strengthen the requirements of FMVSS No. 216 by mandating that the vehicle roof structures withstand a force equivalent to 2.5 times the unloaded vehicle weight (“SWR”), and to eliminate the 22,240 Newton (5,000 pound) force limit for passenger cars. We note that shortly before the NPRM was published, Congress enacted the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU), which included a specific requirement for us to upgrade FMVSS No. 216 relating to roof strength for driver and passenger sides for motor vehicles with a GVWR of not more than 4,536 kilograms (10,000 pounds).

Further, in recognition of the fact that the pre-test distance between the interior surface of the roof and a given occupant's head varies from vehicle model to vehicle model, we proposed to regulate roof strength by requiring that the crush not exceed the available headroom. Under the proposal, this requirement would replace the current limit on platen travel.

We also proposed to:

• Allow vehicles manufactured in two or more stages, other than chassis-cabs, to be certified to the roof crush requirements of FMVSS No. 220,School Bus Rollover Protection,instead of FMVSS No. 216.

• Clarify the definition and scope of exclusion for convertibles.

• Revise the vehicle tie-down procedure to minimize variability in testing.

On January 30, 2008, NHTSA published in theFederal Register(73 FR 5484) a supplemental notice of proposed rulemaking (SNPRM) for our ongoing roof crush resistance rulemaking.26 In that document, we asked for public comment on a number of issues that might affect the content of the final rule, including possible variations in the proposed requirements. We also announced the release of the results of various vehicle tests conducted since the proposal.

In our August 2005 NPRM to upgrade FMVSS No. 216, we included a section titled “Vehicles Manufactured in Two or More Stages.”27 For vehicles manufactured in two or more stages, other than vehicles incorporating chassis-cabs, we proposed to give manufacturers the option of certifying to either the existing roof crush requirements of FMVSS No. 220,School Bus Rollover Protection,or the new roof crush requirements of FMVSS No. 216. FMVSS No. 220 uses a horizontal plate, instead of the angled plate of Standard No. 216.

In developing our proposal, we considered whether the proposed standard would be appropriate for the type of motor vehicle for which it would be prescribed. We stated that we believed it was appropriate to consider incomplete vehicles, other than those incorporating chassis-cabs, as a vehicle type subject to different regulatory requirements. We anticipated that final-stage manufacturers using chassis-cabs to produce multi-stage vehicles would be in position to take advantage of “pass-through certification” of chassis-cabs, and therefore did not believe the option of alternative compliance with FMVSS No. 220 was appropriate.

We noted that while we believed that the requirements in FMVSS No. 220 have been effective for school buses, we were concerned that they may not be as effective for other vehicle types. The FMVSS No. 216 test procedure results in roof deformations that are consistent with the observed crush patterns in the real world for light vehicles. Because of this, we explained that our preference would be to use the FMVSS No. 216 test procedure for light vehicles. We believed, however, that this approach would fail to consider the practicability problems and special issues for multi-stage manufacturers.

We stated that in these circumstances, we believed that the requirements of FMVSS No. 220 appeared to offer a reasonable avenue to balance the desire to respond to the needs of multi-stage manufacturers and the need to increase safety in rollover crashes. We noted that several states already require “para-transit” vans and other buses, which are typically manufactured in multiple stages, to comply with the roof crush requirements of FMVSS No. 220.28 We tentatively concluded that these state requirements show the burden on multi-stage manufacturers for evaluating roof strength in accordance with FMVSS No. 220 is not unreasonable, and applying FMVSS No. 220 to these vehicles would ensure that there are some requirements for roof crush protection where none currently exist.

We received comments concerning requirements for multi-stage and altered vehicles from Advocates for Highway Safety (“Advocates”), NTEA, National Mobility Equipment Dealers Association (NMEDA) and Recreational Vehicle Industry Association (RVIA).

Advocates stated that it opposed permitting FMVSS No. 220 as an alternative for multi-stage vehicles. It claimed that FMVSS No. 220 is a “weak” standard whose effects on roof strength in actual rollover crashes are mostly unknown.

NTEA recommended that all multi-stage vehicles be excluded from roof crush resistance requirements. It stated that manufacturers of non-chassis-cab vehicles will not be able to conduct the tests or perform engineering analysis to ensure conformance to FMVSS No. 220. NTEA also disagreed with the assumption that the presence of State requirements for FMVSS No. 220 compliance demonstrates that final-stage manufacturers can actually comply.

NTEA also stated it is impractical for the agency to assume manufacturers of multi-stage vehicles built on chassis-cabs will be able to rely on IVDs to provide pass-through certification for compliance as it relates to roof strength. It argued that the final-stage manufacturer would therefore be responsible for conducting costly analyses and testing to verify compliance with FMVSS No. 216.

NMEDA expressed concern that the FMVSS No. 220 option would only be available for multi-stage vehicles. It asked that the FMVSS No. 220 option be extended to raised or altered roof vehicles. To encompass the modifiers in the proposed upgrade to FMVSS No. 216, NMEDA asked that a vehicle roof that is altered after first retail sale be considered in compliance if it meets the requirements of FMVSS No. 216 or FMVSS No. 220. NMEDA also stated that raising a roof increases the available headroom and that the roof therefore can crush more before there is any contact with an occupant's head. NMEDA requested the agency account for the additional headroom beyond the original vehicle's headroom in establishing any requirement.

RVIA supported our proposal to permit FMVSS No. 220 as an option for small motor homes as this would allow manufacturers to address the unique issues concerning such specialized vehicles built in two or more stages.

NTEA stated that NHTSA incorrectly assumes that final-stage manufacturers of vehicles built on chassis-cabs will be able to use pass-through certification as a means to comply with the rule. According to NTEA, NHTSA acknowledged certification problems faced by final-stage manufacturers with respect to safety standards that are based on the performance of a vehicle in a dynamic test. NTEA stated that in the preamble to the proposed rule to upgrade FMVSS No. 216, NHTSA made several references to the compliance difficulties and compliance issues faced by final-stage manufacturers, but without any explanation of the root cause of those problems. NTEA said the proposed standard is a dynamic test standard. NTEA stated that in the rulemaking revising certification regulations for multi-stage vehicles, NHTSA concluded that the cost of dynamic vehicle testing is a legitimate concern when relatively small numbers of similarly configured vehicles are produced by a small manufacturer. NTEA stated that the agency also noted that alternative means of compliance such as computer modeling are not appreciably more affordable for small volume manufacturing.

According to NTEA, under these circumstances, no company could incur the costs of performing the tests described in the proposed rule (or in any other dynamic test standard). NTEA stated that the multi-stage manufacturers, for the most part, do not produce any standard models. Theoverwhelming majority of multi-stage vehicles are produced to end-user specifications on a custom-order basis reflecting specifications provided by the customer.

NTEA argument that an FMVSS is not practicable if the only means of compliance offered in the Standard is the use of pass-through certification.

NTEA argued that an FMVSS is not practicable if the only means of compliance offered in the Standard is the use of pass-through certification. It noted that the Vehicle Safety Act at 49 U.S.C. 30111(a) states that each FMVSS must “be practicable, meet the need for motor vehicle safety, and be stated in objective terms.” NTEA cited the 1990NTEAcase, and stated that the Sixth Circuit ruled that “for a standard to be practicable, it must offer in the body of the standard, a means for all subject to the standard to prove compliance.”29

NTEA stated that NHTSA anticipates that final-stage manufacturers will be able to pass-through, and thereby rely on, the conformity statements provided by the chassis-cab manufacturers in IVDs. NTEA stated there is no requirement in NHTSA's regulations that compels an incomplete vehicle manufacturer to provide the type of conformity statement as to any safety standard that would facilitate pass-through opportunities for the final-stage manufacturer. That organization said that the chassis-cab manufacturer has absolute discretion whether to provide a Type 1, Type 2, or Type 3 statement.

NTEA said that NHTSA apparently believes market forces will cause chassis-cab manufacturers to provide reasonable compliance envelopes when making conformity statements. NTEA cited the agency's multi-stage vehicle certification rulemaking, and the petition for reconsideration it submitted on the May 2005 final rule which, at that time, had not yet been responded to by NHTSA. NTEA claimed that it demonstrated through the submission of IVDs with its petition that NHTSA's market forces theory is not supported by the IVDs that are provided by major incomplete vehicle manufacturers. NTEA stated that those IVDs show that incomplete vehicle manufacturers routinely provide Type 1 and Type 2 conformity statements that are so restrictive that they provide no opportunity whatsoever for pass-through certification.

NTEA stated that if a chassis-cab manufacturer provides a Type 3 conformity statement, there is nothing to pass-through to the final-stage manufacturer. It stated that if the chassis-cab manufacturer provides a Type 1 conformity statement—i.e., one that states the vehicle will conform to the standard if no alterations are made to identified components in the vehicle—or if the manufacturer provides a Type 2 conformity statement—i.e., one that sets out specific conditions of final manufacture under which the vehicle would conform to the test—then the final-stage manufacturer's ability to rely on (or “pass-through”) the conformity statement depends entirely on whether the vehicle can be completed by the final-stage manufacturer within the parameters and limitations contained in the conformity statement. NTEA stated that if the parameters and limitations are reasonable, then there is some chance of pass-through, but if the parameters and limitations are unreasonable (or if the stated conditions of conformity are simply conservative as an engineering matter), pass-through will not be possible.

NTEA also argued that incomplete vehicle manufacturers have strong incentive to provide very narrow compliance envelopes, given responsibilities set forth in the agency's certification regulation. NTEA cited 49 CFR 567.5 and stated that the certification regulations allocate to the incomplete vehicle manufacturer legal responsibility for all components incorporated by a final-stage manufacturer (other than defective components and systems) to the extent the vehicle is completed in accordance with the instructions contained in the IVD, while the regulations allocate to the final-stage manufacturer legal responsibility for any work done by the final-stage manufacturer to complete the vehicle that was not performed in accordance with instruction contained in the IVD.

NTEA argued that in the context of pass-through certification, a conformity statement in an IVD is a zero-sum game. It said that if the final-stage manufacturer can complete the vehicle within the parameters and conditions of the incomplete vehicle manufacturer's Type 1 or Type 2 conformity statement, the incomplete vehicle manufacturer bears legal responsibility for compliance with the FMVSS in question; if the final-stage manufacturer cannot complete the vehicle within the parameters of the incomplete vehicle manufacturer's Type 1 or Type 2 conformity statement, or if the incomplete vehicle manufacturer provides a Type 3 conformity statement, the final-stage manufacturer bears legal responsibility for compliance with the subject FMVSS. NTEA stated that the incomplete vehicle manufacturer's control over the type and text of its conformity statements essentially gives it unfettered discretion to allocate to itself or to the final-stage manufacturer the legal responsibilities and liability for compliance with the safety standard, and its decision is not subject to review or challenge because the regulations do not require the incomplete vehicle manufacturer to be reasonable or to act in good faith in crafting its conformity statements. NTEA argued that this aspect of the certification scheme—the ability of an interested private party to determine the legal liability of another party with respect to a safety standard—amounts to an impermissible delegation of NHTSA's statutory authority to a private party. It cited several cases.30

NTEA argued that a safety standard cannot meet the statutory requirement that it be practicable if the sole, plausible means of compliance available to affected manufacturers is the use of pass-through certification. It said that this is the case because that means of compliance depends entirely on the actions of private parties (i.e., incomplete vehicle manufacturers) that are free to provide Type 3 statements as to any standard, and that are free to establish any parameters and conditions they wish, reasonable or unreasonable, in any Type 1 or Type 2 conformity statement. NTEA argued that the proposed rule thus fails to meet the requirement of the 1990NTEAcase that a standard offer in the body of the standard a means for all subject to the standard to prove compliance. NTEA cited its petition for reconsideration of the multi-stage vehicle certification rule, and claimed that it had demonstrated that incomplete vehicle manufacturers routinely provide Type 1 and Type 2 conformity statements with respect to dynamic test standards that are so restrictive as to effectively provide no pass-through opportunity whatsoever. NTEA argued that in the real world, i.e., the reality defined by the IVDs that chassis manufacturers provide with their products, pass-through certification is not a viable option for final-stage manufacturers.

NTEA argument that the conformity statements in existing IVDs make clear that final-stage manufacturers are not likely to have pass-through opportunities for the proposed rule.

NTEA claimed that the inadequacy of pass-through certification as the sole, plausible means of demonstrating compliance to the proposed rule is plainly reflected in the IVDs that exist for chassis-cabs rated up to 2,722kilograms (6,000 pounds) GVWR and for those rated 2,723 and 4,536 kilograms (6,001—10,000 pounds) GVWR. That organization provided IVDs with conformity statements as examples of the restrictiveness of IVDs.

NTEA stated that there is currently only one chassis-cab sold today that is rated 2,722 kilograms (6,000 pounds) or less and is therefore subject to the existing FMVSS No. 216: the General Motors GMT-355 chassis-cab. According to NTEA, all other currently available chassis-cabs are rated above 2,722 kilograms (6,000 pounds) GVWR and thus fall outside the purview of the existing standard.

NTEA cited language from the IVD for the 2006 model year GMT-355, and attached a copy of the IVD to its comments. That organization claimed that the Type I conformity statement to FMVSS No. 216 included in that IVD would provide no pass-through opportunity whatsoever to a final-stage manufacturer. NTEA argued that it would be invalidated by any alteration that affected the function, physical, chemical, or mechanical properties of any component, assembly or system in the chassis-cab. NTEA stated that final-stage manufacturers at a minimum will install a truck body onto the GMT-355 chassis-cab. NTEA claimed that the simplest installation of a truck body likely weighing several hundred pounds, plus the means used by the final-stage manufacturer to mount that body (e.g., by drilling holes in to the frame of the chassis-cab and bolting the body to the frame) will affect the physical properties, for example, of the chassis frame and numerous other structural components of the chassis-cab.

NTEA stated that GM includes an identical conformity statement for FMVSS No. 216 in its C/K fullsize pickup truck IVD. That organization stated that this also shows that GM is inclined to give a highly restrictive Type I statement. NTEA also stated that the IVDs provided by Ford for incomplete vehicles in the 2,723 and 4,536 kilograms (6,001 to 10,000 pound) GVWR range provide highly restrictive conformity statements, and cited conformity statements for FMVSS Nos. 212, 219 and 301.

NTEA argument that it is impracticable for multi-stage vehicles built on non-chassis-cabs to be certified to the proposed rule or to FMVSS No. 220.

NTEA argued that manufacturers of multi-stage vehicles built on non-chassis-cabs will be unable to confirm compliance of those vehicles either to the proposed rule or to FMVSS No. 220. It stated that those manufacturers will be unable to conduct the tests described in the proposed rule or to perform some alternative engineering analysis . NTEA argued that NHTSA's attempt to provide manufacturers with a reasonable certification option is well-intended, but misses the mark for several reasons.

NTEA stated that, as NHTSA seems to recognize, pass-through certification is unlikely to be available to manufacturers of multi-stage vehicles built on non-chassis-cabs, either for FMVSS No. 216 or for FMVSS No. 220, because those vehicles do not have completed cab compartments (which likely will cause the incomplete vehicle manufacturers to provide Type 3 conformity statements or highly restrictive Type 1 or 2 conformity statements). NTEA stated that NHTSA proposed to permit manufacturers of multi-stage vehicles built on non-chassis-cabs the option of certifying to FMVSS No. 220 instead of FMSS No. 216.

First, according to NTEA, the only vehicles rated 10,000 pounds or less that are subject to FMVSS No. 220 are Type A school buses. NTEA stated that these vehicles are built primarily on the Ford E series cutaway chassis and the GM G-Van cutaway chassis. That organization stated that Ford and GM provide Type 3 conformity statements for these vehicle and that, accordingly, manufacturers of multi-stage vehicles completed on these non-chassis-cabs will have no opportunity to pass-through the certification of the incomplete vehicle manufacturer. NTEA attached copies of the IVDs for these vehicles to its comment.

NTEA stated that as to all of the other models of non-chassis-cabs rated 10,000 pounds or less, there simply is no conformity statement provided with respect to FMVSS No. 220. That organization stated that this reflects the fact that none of these incomplete vehicles are used in the manufacturing of school buses.

NTEA stated that NHTSA indicated in the preamble of the proposed rule that certain States require para-transit vans and other buses to comply with FMVSS No. 220 and that these State requirements show that the burden on multi-stage manufacturers for evaluating roof strength in accordance with FMVSS No. 220 is not unreasonable. NTEA stated that the existence of State requirements concerning compliance with a dynamic test standard is not good evidence that final-stage manufacturers in fact are able to confirm compliance of vehicles with that standard.

NTEA also stated that to the extent school bus manufacturers or para-transit bus manufacturers are able to comply with FMVSS No. 220, that would merely reflect the particular circumstances regarding the manufacture of those vehicles, i.e., the production of relatively standardized models in relatively large production runs. NTEA stated that the fact that manufacturers in certain niche markets may be able to comply with FMVSS No. 220 does not change the fact that the typical final-stage manufacturer, which produces scores of vehicle configurations in small production runs, cannot demonstrate compliance with that dynamic testing standard through testing or engineering analysis.

NTEA compliance cost estimates.

NTEA stated that, in connection with its proposal, NHTSA presented extensive cost data which explain how much it would cost to structurally upgrade a vehicle in order to meet the new testing requirements, and then factored in increased vehicle weight and the effect on fuel costs. That organization stated that these costs are applied to populations of vehicle models each in the hundreds of thousands of vehicles.

NTEA stated that NHTSA's cost estimates do not factor in the costs of compliance testing for multi-stage produced vehicles. That organization stated that its members are faced with at least 1,085 identifiable vehicle configurations in the affected weight category that would require separate compliance testing. It stated that these vehicle configurations could be built by almost any of the 1,000 or more final-stage manufacturers in the U.S. NTEA stated that as each of these companies are competitors, there is no reason to believe that if one company actually tested one configuration that they would or could share that testing with another company. It also stated that no trade association or consortium could ever conduct over 1,000 compliance tests for the affected vehicle designs and then continue to test each year any of these configurations that are redesigned.

NTEA cited cost estimates for conducting the FMVSS No. 216 test and a test based on FMVSS 220. It also stated that the test is a destructive test, and that while the vehicle could be repaired and sold as used, this would be unwise for liability reasons and the vehicle should be destroyed after the test. NTEA stated that there are few, if any, final-stage manufacturers that have the equipment or personnel to conduct such tests, and that they would need to outsource the testing. NTEA stated that to its knowledge there are only three companies in the country that regularly perform such tests for third parties, andfinal-stage manufacturers would have to incur substantial costs to transport their vehicles long distances to have them tested. It also said that following the testing, the vehicles could not be sold as new and would need to be repaired even to be sold as used, resulting in additional costs to be absorbed by the final-stage manufacturer. NTEA stated that, given these costs, it would be impracticable for manufacturers to demonstrate compliance by performing tests.

NTEA stated that NHTSA appeared to recognize that the cost of testing would be prohibitive for both vehicles built on chassis-cabs and those built on non-chassis-cabs, and that it would also be impracticable to demonstrate compliance by computer simulation or other engineering analysis. And, despite that recognition, NTEA stated that NHTSA proposed to apply the standard.

Based on discussions with one of the companies that conduct FMVSS compliance tests, NTEA understands that the average cost of conducting the existing test in FMVSS No. 216 is approximately $3,600 per vehicle configuration. It stated that NHTSA estimates that tests to comply with the proposed regulation will cost approximately $5,000. NTEA stated that a total test cost of $5,000 plus a vehicle value loss of $15,000 for 1,085 vehicle configurations results in testing costs of $21,700,000. It stated that this figure does not include design or structural costs for compliance or certain other costs.

NTEA concluded this portion of its comment by stating that the cost benefit analysis prepared by NHTSA ignores more than 20 million dollars in compliance tests primarily placed on small businesses.

NTEA conclusion.

NTEA stated that, as demonstrated, final-stage manufacturers will face compliance burdens that are not reasonable under NHTSA's proposed rule, and that compliance with the proposed requirements in FMVSS No. 216 will not be possible for final-stage manufacturers.

That organization stated that while it applauded NHTSA's decision to propose an alternative to compliance with FMVSS No. 216, the option to comply with FMVSS No. 220 would not provide any relief to manufacturers of multi-stage vehicles built on non-chassis-cabs. It stated that, due to costs, those manufacturers will not be able to perform the dynamic tests set forth in the proposed rule or in FMSVS No. 220, nor conduct engineering analyses to simulate the performance of vehicles in those tests. It also stated that because manufacturers of non-chassis-cabs do not have a completed occupant compartment, there will be no pass-through certification opportunities for multi-stage vehicles built on those chassis. NTEA argued that the option of certifying to FMVSS No. 220 is no option at all.

NTEA stated that as the demonstration of compliance with neither FMVSS No. 220 nor the proposed FMVSS No. 216 requirements will be possible for most final-stage manufacturers building on chassis-cabs or non-chassis-cabs, it urged that all vehicles manufactured in two or more stages be excluded from the rule.

As discussed earlier, on May 12, 2009, as part of a comprehensive plan for reducing the serious risk of rollover crashes and the risk of death and serious injury in those crashes, NHTSA published in theFederal Register(74 FR 22348) a final rule substantially upgrading FMVSS No. 216. The upgraded standard is designated FMVSS No. 216a.

First, for the vehicles currently subject to the standard, i.e., passenger cars and MPVs, trucks and buses with a GVWR of 2,722 kilograms (6,000 pounds) or less, the rule doubled the amount of force the vehicle's roof structure must withstand in the specified test, from 1.5 times the vehicle's unloaded weight to 3.0 times the vehicle's unloaded weight.

Second, the rule extended the applicability of the standard so that it will also apply to vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds), but not greater than 4,536 kilograms (10,000 pounds). The rule established a force requirement of 1.5 times the vehicle's unloaded weight for these newly included vehicles.

Third, the rule required all of the above vehicles to meet the specified force requirements in a two-sided test, instead of a single-sided test, i.e., the same vehicle must meet the force requirements when tested first on one side and then on the other side of the vehicle.

Fourth, the rule established a new requirement for maintenance of headroom, i.e., survival space, during testing in addition to the existing limit on the amount of roof crush.

The rule also included a number of special provisions, including ones related to leadtime, to address the needs of multi-stage manufacturers, alterers, and small volume manufacturers.

In the May 2009 final rule upgrading FMVSS No. 216, we included a section in the preamble titled “Requirements for Multi-Stage and Altered Vehicles.”31 We included a summary of the comments concerning requirements for multi-stage and altered vehicles from NTEA, NMEDA, Advocates, and RVIA, and a response to those comments.

In addressing the issues raised by NTEA, we stated that, as a general matter, we believe that it is neither necessary nor would it be appropriate to exclude all multi-stage vehicles from roof crush resistance requirements. We explained that the purpose of FMVSS No. 216 is to improve occupant safety in the event of a rollover. If a multi-stage vehicle is involved in a rollover, the vehicle's roof strength will be an important factor in providing occupant protection. We stated that, therefore, while we seek to address the special needs and circumstances of multi-stage manufacturers, we declined to provide any blanket exclusion for all multi-stage vehicles. However, based on NTEA's comments, we did not extend FMVSS No. 216 to any trucks built on van cutaways or other types of incomplete vehicles without a completed roof structure, a difference from the NPRM.

The upgraded FMVSS No. 216 rule does not apply to any vehicles with a GVWR greater than 4,536 kilograms (10,000 pounds), including multi-stage vehicles. A good number of multi-stage vehicles, such as tow-trucks, some airport shuttles, and customized farm trucks, have a GVWR greater than 4,536 kilograms (10,000 pounds). Also, as with the previous version of FMVSS No. 216, the standard does not apply to school buses, which have been covered by FMVSS No. 220.

In the final rule, we then addressed the issues raised by NTEA and other commenters separately for the different types of multi-stage vehicles. The requirements that apply to multi-stage vehicles with a GVWR of 4,536 kilograms (10,000 pounds) or less are dependent on the GVWR and type of vehicle, including whether the vehicle was built using a chassis-cab.

Multi-stage vehicles built on chassis-cab incomplete vehicles.

If a vehicle is built on a chassis-cab, and it has a GVWR of 4,536 kilograms (10,000 pounds) or less, it is required to meet the same FMVSS No. 216 requirements as single stage vehicles. Therefore, these vehicles must meet the requirements of FMVSS No. 216a andhave a SWR of at least 3.0 if they have a GVWR of 2,722 kilograms (6,000 pounds) or less and a SWR of 1.5 if they have a GVWR above that level but not greater than 4,536 kilograms (10,000 pounds).

As background, we explained that a chassis-cab is an incomplete vehicle, with a completed occupant compartment, that requires only the addition of cargo-carrying, work-performing, or load-bearing components to perform its intended functions. As such, chassis-cabs have intact roof designs. Chassis-cabs are based on vehicles that are sold as complete vehicles by larger manufacturers, e.g., medium and full size pickup trucks, so their roof structure will be designed to meet the upgraded requirements of FMVSS No. 216. A good example of a chassis-cab vehicle is a moving truck. The driver of a chassis-cab vehicle would need to exit the vehicle to access the contents in the rear of the vehicle.

We stated that after considering the comments of NTEA, we believed that final-stage manufacturers can rely on the incomplete vehicle documents (IVD) for pass-through certification of compliance with FMVSS No. 216 for vehicles built using chassis-cabs. To do this, final-stage manufacturers will need to remain within specifications contained in the IVD. We stated that since the stringency of FMVSS No. 216 (SWR requirement) is dependent on a vehicle's unloaded vehicle weight, the final-stage manufacturer would need to remain within the specification for unloaded vehicle weight. If they did not, the roof would not likely have the strength to comply with FMVSS No. 216. We also explained that final-stage manufacturers will need to avoid changes to the vehicle that would affect roof strength adversely.32

Multi-stage trucks with a GVWR greater than 2,722 kilograms (6,000 pounds) not built using a chassis-cab and not built using an incomplete vehicle with a full exterior van body.

We explained that, based on the comments received, we had decided to exclude from FMVSS No. 216 multi-stage trucks with a GVWR greater than 2,722 kilograms (6,000 pounds) not built using a chassis cab and not built using an incomplete vehicle with a full exterior van body. This was a change from the NPRM. First, to be excluded, these multi-stage vehicles must be a truck. A truck is defined in 49 CFR 571.3 as being a “motor vehicle with motive power * * * designed primarily for the transportation of property or special purpose equipment.” Second, to be excluded, these multi-stage trucks cannot be built using a chassis-cab or using an incomplete vehicle with a full exterior van body. Both chassis-cabs and incomplete vehicles built on a full exterior van body contain a completed roof structure, but would need additions before a final-stage manufacturer could certify its compliance as a completed vehicle. Incomplete vehicles with full exterior van bodies could include a van that did not have any seats. An incomplete vehicle such as this could, for example, be completed as a truck (cargo van) by adding front seats and interior shelves and partitions. Such a vehicle would not be excluded from the standard.

If a multi-stage truck within this weight range is not built on a chassis-cab or on a full exterior van body, then the vehicle is excluded from FMVSS No. 216 and the final-stage manufacturer would not need to certify compliance with the standard. Typically, these vehicles would be built on cutaways or on a stripped chassis. A cutaway chassis is a van cab design whose occupant compartment is not complete and ends immediately behind the driver and front passenger seat, i.e. there is no wall behind the front seats. A good example of this type of a multi-stage truck is a parcel delivery vehicle. These specialized vehicles are typically built on van cutaways because the driver or passenger may need access to the contents in the rear of the vehicle. A stripped chassis is an incomplete vehicle that is less complete than a cutaway, and could be nothing more than a rolling chassis consisting of only the engine, transmission, and ladder-type frame.

The agency excluded these vehicles in the final rule because there may be practicability problems. These incomplete vehicles will not have an intact roof. Because the strength of the roof may be dependent on the structure to be added by the final-stage manufacturer, the incomplete vehicle manufacturer may not provide IVD or similar information that would permit pass-through certification. Moreover, the design of the completed truck may be such that it is not possible to test the vehicle to FMVSS No. 216 (due to interference with the FMVSS test device) or inappropriate for testing with FMVSS No. 220.

For other multi-stage vehicles not built on chassis-cabs, we stated that we continued to believe, for the reasons discussed in the NPRM, that permitting FMVSS No. 220 as an option is a reasonable way to balance the desire to respond to the needs of multi-stage manufacturers and the need to increase safety in rollover crashes. These vehicles would be classified as a bus or MPV. Under 49 CFR 571.3, a bus is a motor vehicle “* * * designed for carrying more than ten persons,” and a MPV is defined as a motor vehicle “* * * designed to carry ten passengers or less which is constructed on a truck chassis or with special features for occasional off-road operation.” These buses and MPVs are built commonly using a van cutaway and would include, e.g., transit shuttle vehicles, ambulances, mobility vehicles and recreation vehicles. The FMVSS No. 220 test uses a single, horizontal platen and requires a SWR of 1.5.

In responding to Advocates' comment arguing against permitting FMVSS No. 220 as an alternative for multi-stage vehicles because it believes that FMVSS No. 220 is not sufficiently stringent, we noted that the organization did not provide analysis or data addressing the special circumstances faced by multi-stage manufacturers, or explain why it believed these manufacturers could certify compliance of their vehicles to FMVSS No. 216. We stated, therefore, that the commenter had not provided a basis for us to take a different position than we had taken in the NPRM. We stated that, as we had discussed in the NPRM, we believed the requirements in FMVSS No. 220 have been effective for school buses, but we are concerned that they may not be as effective for other vehicle types. We explained that our preference would be to use the FMVSS No. 216 test procedure for light vehicles, but that this approach would fail to consider the practicability problems and special issues for multi-stage manufacturers.

We noted that RVIA supported our proposal permitting testing to the FMVSS No. 220 standard, and that some of the vehicles in this category are already required to meet the requirements of FMVSS No. 220 as a result of State regulations.

In the May 2009 final rule preamble, we stated that, in response to the comments of NMEDA, we agreed that the FMVSS No. 220 option should be available to multi-stage and complete vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds) which have been changed by raising their original roof.

We stated that we believed that practicability issues arise for vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds) whose roofs are raised. We also stated that we believe that the FMVSS No. 220 option is appropriate for the “para-transit” vans and buses. We stated that the FMVSS No. 220 option will help ensure that these occupants are afforded a level of protection that is currently not required. We stated that we were not providing this option to vehicles with raised roofs and a GVWR of less than or equal to 2,722 kilograms (6,000 pounds).

We stated that we believed that the practicability issues for vehicle alterers which raise roofs on the vehicles at issue are comparable to those of final-stage manufacturers. An alterer may raise a roof on a vehicle that was originally certified to FMVSS No. 216. We also stated that we believe that permitting alterers which raise roofs on these vehicles the option of certifying to FMVSS No. 220 balances potential practicability issues with the need to increase safety in rollovers.

If a multi-stage vehicle has a GVWR of 2,722 kilograms (6,000 pounds) or less, it previously was subject to FMVSS No. 216. If these vehicles are built using a chassis-cab, they must comply with the upgraded roof crush resistance standard, including the 3.0 SWR requirement. For these vehicles that are not built on a chassis-cab, the final-stage manufacturer has the option of meeting either the upgraded roof crush resistance standard in FMVSS No. 216a, or can meet the standard in FMVSS No. 220 (1.5 SWR). As previously discussed, that test uses a single, horizontal platen.

As a general matter, NTEA's comments on the agency's proposal to upgrade FMVSS No. 216 centered on two premises: (1) NHTSA's assumption that pass-through certification is available is invalid as evidenced by present IVDs; and (2) because NHTSA's pass-through certification scheme is invalid, NHTSA's analysis of the rule's impact and costs are flawed. The end result, according to NTEA, is that NHTSA's regulation on roof crush is impracticable for multi-stage vehicles, and, therefore, NHTSA's roof crush regulations should not include any requirements for multi-stage vehicles.

To get to NTEA's conclusion—FMVSS No. 216 should not apply to multi-stage vehicles—one has to believe that the certification scheme for multi-stage vehicles, which has been in place for several decades, is unworkable and invalid, at least as applied to FMVSS No. 216. NTEA has been making this argument in various contexts for over 25 years.33

Generally, NTEA makes the argument that pass-through certification is an impermissible delegation of NHTSA's statutory authority to a private party. Specific to FMVSS No. 216, NTEA believes NHTSA incorrectly assumes that pass-through certification will be available. NTEA argues that current IVDs prepared by incomplete vehicle manufacturers for FMVSS No. 216 and other standards are so restrictive that a final-stage manufacturer would violate the IVD by making a simple installation.

If that is so, NTEA argues, the final-stage manufacturers would be left to conduct their own testing to certify compliance with FMVSS No. 216. According to that organization, neither the two-sided platen test in FMVSS No. 216 nor the horizontal platen school bus test in FMVSS No. 220 is workable. Testing to either standard is, in NTEA's estimation, too burdensome and costly. According to NTEA, because NHTSA incorrectly assumes that pass-through certifications will be available, the agency's analysis of the costs of the rule is incorrect, and the rule is overly burdensome as to final-stage manufacturers.

For the reasons discussed below, NHTSA rejects NTEA's arguments and their conclusions.

While NTEA has repeatedly claimed that the present certification scheme for multi-stage vehicles is invalid and unworkable, the availability of multi-stage vehicles belies that claim. There are many multi-stage vehicles on the road that have been certified to a number of standards, and the final-stage manufacturers are still in business. There are large numbers of multi-stage vehicles, such as school buses, box trucks, tanker trucks, work trucks, flatbed and stake trucks, tow trucks, dump trucks, and gasoline tank trucks on the road.

Moreover, final-stage manufacturers have certified multi-stage vehicles with a GVWR of 2,722 kilograms (6,000 pounds) or less to the current version of FMVSS No. 216. As noted earlier, FMVSS No. 216 was extended to trucks, buses, and MPVs with a GVWR of 2,722 kilograms (6,000 pounds) or less in a final rule published in 1991. This is a relatively low gross vehicle weight rating for commercial vehicles, which results in limited offerings. But, significantly, General Motors (GM) has sold an incomplete vehicle chassis-cab, the GMT-355, that has a GVWR of 2,722 kilograms (6,000 pounds) or less and is therefore subject to FMVSS No. 216. GM would not have offered the vehicle for years if there was not a market for them, as completed by final-stage manufacturers.

We note that under the May 2009 final rule, FMVSS No. 216 will not be applicable to vehicles with a GVWR greater than 4,536 kilograms (10,000 pounds). Incomplete vehicle manufacturers will not need to provide an IVD regarding FMVSS No. 216 for these heavier vehicles. In our estimation, the largest number of multi-stage vehicles are in this category.

In addition, final-stage manufacturers are currently certifying the compliance of their vehicles with a number of complex safety standards that include crash testing as part of the agency's compliance tests. These include, for example, FMVSS No. 214,Side Impact Protection,FMVSS No. 208,Occupant Crash Protection(frontal air bag technology), and FMVSS No. 301,Fuel System Integrity.These manufacturers ordinarily rely on the IVD in making these certifications.

NTEA's comments further contemplate no assistance from the incomplete vehicle manufacturer. However, NHTSA has seen the converse to be true—there are IVDs, upfitter guides, best practices manuals and help lines provided by incomplete vehicle manufacturers. Final-stage manufacturers also have their own technical expertise and engineering judgment, and commercially available computer aided engineering software.

Final-stage manufacturers can use their judgment, including engineering or technical judgment, to certify vehicles. Testing, as provided in the FMVSS, is not required as a matter of law to certifya vehicle.34 Instead, sound judgment may be used. Many final-stage manufacturers bring considerable judgment to bear. They have been building and certifying vehicles for years. Final-stage manufacturers can and do use their base of experience in certifying vehicles as complying with the FMVSS.

In addition, NHTSA provided substantial leadtime. The rule becomes effective for multi-stage vehicles with a GVWR of 2,722 kilograms (6,000 pounds) or less, i.e., the vehicles already covered by FMVSS No. 216, on September 1, 2016, and for the other multi-stage vehicles with a GVWR of 4,536 kilograms (10,000 pounds) or less on September 1, 2017. These dates are one year after the requirements are fully effective for single stage vehicles.

NTEA argued that under the current certification scheme the ability of an interested private party to determine the legal responsibility of another party with respect to a safety standard, which it contends is the result of the incomplete vehicle manufacturer creating the IVD, amounts to an impermissible delegation of NHTSA's statutory authority to a private party.

NTEA made the same argument in its petition for reconsideration of the certification rule, and the agency addressed it in its May 2006 response to that petition.35 As we explained in that response, NTEA relied on a case involving an unlawful delegation of an agency's authority to a private entity.36 However, NTEA ignored the holding in that case, that the relevant inquiry on a private delegation issue is to assess Congressional intent, based on the pertinent statute(s) and its legislative history.

In the Vehicle Safety Act, Congress imposed the responsibility to certify compliance on manufacturers and distributors.37 The Safety Act created a self-certification scheme. Under this statutory framework, the agency promulgates the FMVSSs, and it is then the manufacturer's or distributor's responsibility to comply with these standards and to furnish a certification to the distributor or dealer that the vehicle or equipment conforms to all applicable FMVSSs. The statute, as originally enacted, did not provide for agency review and approval of the manufacturer's certification or for agency allocation of responsibility of certification in the multi-stage vehicle context.

NHTSA's regulations do not provide for the agency to allocate certification responsibility between incomplete vehicle manufacturers and final-stage manufacturers.

In 2000, Congress enacted the Transportation Recall Enhancement, Accountability, and Documentation (TREAD) Act.38 Section 9 of the Act amended 49 U.S.C. 30115 to address certification labels.39 In general, the amendments required an intermediate or final-stage manufacturer to certify with respect to each FMVSS either that it has followed the compliance documents provided by the incomplete vehicle manufacturer or that it has chosen to assume responsibility for compliance with that standard.40 The amendments further provided that if an intermediate or final-stage manufacturer assumes responsibility for compliance with a standard covered by the documentation, it must notify the incomplete vehicle manufacturer within a reasonable time.41 Significantly, the TREAD Act amendments did not alter the regulatory approach in 49 CFR 567.5 and 49 CFR part 568. They did not require NHTSA to allocate certification responsibilities between the various manufacturers in the chain of production of multi-stage vehicles.

In contrast to this regulatory approach, Congress has enacted other regulatory schemes that require agency review and approval of manufacturers' certifications. For example, the Clean Air Act requires the Administrator of the Environmental Protection Agency (EPA) to test or require testing of motor vehicles or engines to determine whether they comply with the emissions requirements and, if they conform, to issue a certificate of conformity.42 In that context, EPA has a significant administrative role. In contrast, in the Vehicle Safety Act, Congress did not provide for agency review or approval of a manufacturer's certification before first sale. Moreover, the TREAD Act amendments specifically addressed certification in the multi-stage vehicle context and did not assign the agency an arbiter role in the certification process.

In view of the foregoing, NHTSA does not accept NTEA's argument that the certification scheme in NHTSA's regulations delegates too much power to a private entity.

NTEA submitted with its comment relevant portions of the IVDs with Type 1 conformity statements for the General Motors 2006 GMT-355 incomplete truck and also the IVD for the GM 2006 C/K full size incomplete truck.43 NTEA attached these documents to demonstrate that the simplest installation of a truck body likely weighing several hundred pounds, plus the means used by the final-stage manufacturer to mount that body (e.g., by drilling holes into the frame of the chassis-cab and bolting the body to the frame) will affect the physical properties, e.g., of the chassis frame and numerous other structural components of the chassis-cab.

GM's IVD allows for additions to the chassis-cab. The GMT-355's IVD states that the incomplete vehicle will comply with FMVSS No. 216 “providing no alterations are made which affect the function, physical, chemical, or mechanical properties, environment, location, or vital spatial clearances of the components, assemblies or systems including but not limited to those listed below: antennae; body roof structure or components/reinforcements; body sheet metal/reinforcements; body structural components/reinforcements; front rear and side glazing materials and mounting; structural components and door assemblies; windshield wipers; and windshield wiper motor.”

NTEA read the IVD and claimed that adding a box to a chassis-cab frame would affect the physical, chemical, or mechanical properties of the body's structural components/reinforcements. Based on this statement, NTEA concluded that pass-through certification is not available. NHTSA disagrees.

Before turning to the specifics, we note that NTEA characterized the FMVSS No. 216 test as a dynamic test. As a technical matter, the test is considered a quasi-static test rather than a dynamic test. In a quasi-static test, the conditions vary slowly enough so thatthe dynamic effects are negligible.44 In developing our proposal to upgrade FMVSS No. 216, we considered potential dynamic tests, e.g., the Jordan Rollover System test and the Controlled Rollover Impact System test, but decided to focus on the quasi-static test procedure. This was an issue that was addressed in detail in the rulemaking. The quasi-static test in this standard does, however, have some dynamic characteristics.45 In any event, potential compliance difficulties relate to the specific details of a test and relevant requirements based on that test rather than whether the test is called quasi-static or dynamic.

We now turn to the GMT-355 incomplete vehicle. This incomplete vehicle is classified as a body-on-frame, as distinguished from unibody construction used in making passenger cars, which generally do not have frames. The cab is attached to the frame. Roof strength is dependent on structural members of the vehicle's largely vertical pillars, including the A pillar (between the windshield and the front of the front door) and the B pillar (behind the front door), and the roof itself.

In completing an incomplete GMT-355, the final-stage manufacturer adds a unit behind the cab. That unit or truck body is attached to the frame. Commonly, the attached unit is a box of some form that goods or materials can be carried in. The attached unit does not attach to the cab. Pass-through certification is readily available for this vehicle. The conformity statement in the IVD is written to allow modifications to the incomplete vehicle, but not to the components that affect the vehicle's roof strength.

While pass-through certification is not provided if vehicle components related to roof strength are modified, NTEA has not provided an example where the addition of a truck body would modify the structural members of the A- and B- pillars, and NHTSA is unaware of one. NTEA did not provide other examples where roof modifications would be necessary. In the example of mounting a box to the frame, there would be no modifications to the roof.

FMVSS No. 216 has applied to multi-stage vehicles with a GVWR of 2,722 kilograms (6,000 pounds) or less since the early 1990s. Despite NTEA's articulated problems with the GMT-355 IVD, final-stage manufacturers undoubtedly have made additions to this incomplete vehicle and certified it compliant. Otherwise, GM would not have offered it for sale for years.

There are a number of resources available for final-stage manufacturers. Many of these were mentioned in the 2006 response to NTEA's petition.46 These resources are still available. For example, General Motors has relationships with final-stage manufacturers, which it refers to as “Special Vehicle Manufacturers,” or SVMs. According to GM Upfitters' Best Practices Manual, “[t]he success of the Upfitter Integration group depends on an atmosphere of communication, cooperation and trust between SVMs and GM. SVMs would therefore be expected to use the Upfitter Integration resources available to them (i.e., telephone hotline, quality surveys, guideline manuals and Upfitter Integration engineering expertise). SVMs are expected to have documented processes which are understood and accepted by all.” (p. 4).47

According to the GM Upfitters' Best Practices Manual, NTEA reviews and recommends Body-Mounting Practices in the GM Upfitters' Best Practices Manual that identifies industry recognized processes and procedures. NTEA has a “Body Practices Subcommittee” that reviewed the mounting methods of several chassis manufacturers. NTEA approved four general mounting types. All mount to the frame and are permissible under the IVD for the GMT-355. None of the mounting methods involve attachments to the A- and B-pillars.

A final-stage manufacturer is not limited to the IVD. If a final-stage manufacturer wanted to make modifications beyond the IVD, it could still use the IVD as a starting point and then utilize technical judgment. This is different from a vehicle built on a stripped chassis where the final-stage manufacturer would be designing the complete occupant compartment structure. The final-stage manufacturer is beginning with a vehicle with a completed occupant compartment structure, including the roof, that it knows already meets FMVSS No. 216, and can use judgment to ensure that the modifications it makes will not weaken the roof. As such, a final-stage manufacturer could complete the vehicle and certify it.

In the case of chassis-cabs, for example, data are available on the strength of the roofs. Chassis-cabs have intact roof designs and for the most part are the same as vehicles that are sold as complete vehicles, such as large pickup trucks. The roof structures of those trucks will be designed to meet the upgraded requirements of FMVSS No. 216. NHTSA tests vehicles, including pickup trucks, to FMVSS No. 216 and makes the data available.48 Final-stage manufacturers can readily refer to these data for certification.

NTEA also argued that Ford provided guidance for 10 safety standards in its 2006 Pickup Box Removal/Alterations Design Recommendations for the pick-up box removal for the Ford Ranger, but not for FMVSS No. 216 (p. 8 of NTEA's comments, footnote 4). It said that, therefore, in the alterer context, the alterer is on its own as to the roof crush resistance standard. We note that Ford's 2006 Pickup Box Removal/Alterations Design Recommendations do not involve incomplete vehicles. The Ranger is not sold as an incomplete vehicle. Ford's recommendations are foralterers49 that remove a pick-up box from a completed vehicle. Ford has already certified that vehicle. The document cited in NTEA's comment is guidance and is not required under 49 CFR 567.7 for certification.

Moreover, we have reviewed the Ford document in question and believe that NTEA has not shown a real problem for alterers. For pickup trucks such as the Ranger, the passenger compartment is completely separate from the cargo box. Each is separately secured to a common frame. For this reason, simply replacing the pickup box with an aftermarket body would not affect the strength of the roof.50

In the FMVSS No. 216a test procedure adopted in the 2009 final rule, the body of the vehicle is securely mounted. In the case of a body-on-frame pickup truck, the occupant compartment cab would be rigidly mounted such that only the roof strength of the occupant compartment of the vehicle is tested. In support of the final rule, the agency tested a number of pickup trucks in one- and two-sided test configurations.51 In addition, the agency also tested an incomplete 2008 Ford F-250 (NHTSA Test No. 571)52 chassis-cab pickup. The F-250 was delivered and tested without a cargo bed. From our testing, the presence of the cargo box did not have any impact on the strength of the roof.53

NTEA also stated that for the 2004 model year, Ford produced the Freestar/Monterey van as an incomplete vehicle to be used in the manufacturer of mobility vehicles. It stated that these vehicles had a GVWR of 2,722 kilograms (6,000 pounds) or less, and were thus subject to FMVSS No. 216. NTEA stated that for reasons that are unclear, Ford did not provide a conformity statement for FMVSS No. 216 in the IVD for this vehicle. NTEA stated that this is a situation where the final-stage manufacturer would have no pass-through certification opportunity. NHTSA notes that the Freestar/Monterey vans have not been produced for years and NTEA did not demonstrate that the issue is likely to recur with newer models. We note, however that Ford has a mobility vehicle program, for transporting handicapped people, and NTEA has not demonstrated that there are any problems with respect to availability or certification of mobility vehicles. We also note that NMEDA did not cite any such difficulties. In addition, Ford has programs to assist mobility manufacturers.54

FMVSS No. 216 is not, of course, currently applicable to vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds). For that reason, the IVDs for chassis-cabs currently used for these heavier vehicles do not and cannot be expected to address FMVSS No. 216. However, as the upgraded standard will apply to these vehicles, manufacturers will address it in the future.55

NTEA claimed that IVDs containing conformity statements for standards other than FMVSS No. 216 are overly restrictive. It cited the conformity statements provided by GM for the C/K fullsize pickup truck IVD. It also cited the IVD provided by Ford for the E-series incomplete vehicle with respect to FMVSS Nos. 212, 219 and 301. NTEA stated that the conformity statements are based on the performance of the vehicle in the dynamic tests in those standards.

As noted earlier, in our May 2006 response to NTEA's petition for reconsideration of the certification rule, we addressed in detail NTEA's arguments in connection with the certification statements in the GM IVD that NTEA identified as inadequate. In each case, the agency's findings supported the conclusion that the existing IVDs are workable. Moreover, we demonstrated that the current multi-stage certification is workable and pointed out the errors in NTEA's arguments. Among other things, we noted that NTEA's petition did not identify any final-stage manufacturer that has been unable to certify a vehicle under the existing framework. Since this rulemaking is about FMVSS No. 216, and given the above discussion, there is no need to address other standards.

The final rule becomes effective for multi-stage vehicles with a GVWR of 2,722 kilograms (6,000 pounds) or less, i.e., the vehicles already covered by FMVSS No. 216, on September 1, 2016, and to the other multi-stage vehicles with a GVWR of 4,536 kilograms (10,000 pounds) or less on September 1, 2017. These dates are one year after the requirements are fully effective for single stage vehicles. This is a seven-year leadtime for vehicles currently subject to the standard, and an eight-year leadtime for the vehicles newly subject to the standard. NHTSA anticipates that this leadtime will be ample for incomplete vehicle manufacturers and final-stage manufacturers to work out any issues.

NTEA commented that final-stage manufacturers of vehicles built on incomplete vehicles other than chassis-cabs (cutaways, chassis cowls,56 or stripped chassis) cannot rely on pass-through certification or perform the tests in FMVSS Nos. 216 or 220. It did not agree with statements in the NPRM that the existence of State operational requirements for para-transit vans and other buses to comply with FMVSS No. 220 is good evidence that final-stage manufacturers in fact are able to comply with that standard. It also said that the fact that final-stage manufacturers are able to comply with FMVSS No. 220 for some vehicles merely reflects the particular manufacturing of that vehicle, and the fact that certain niche markets can comply with FMVSS No. 220 does not translate to final-stage manufacturers that produce scores of vehicles in small production runs. NTEA thus advocated a lowest common denominator approach.

NHTSA sees no reason to exclude all multi-stage vehicles from the requirements of FMVSS No. 216. We do recognize, unlike vehicles derived from chassis-cabs, there will not be an opportunity for a pass-through certification of FMVSS No. 216 for vehicles without intact roofs such as cutaways and stripped chassis. In light of this, in the 2009 final rule, for multi-stage trucks, NHTSA decided not to extend the coverage of the upgraded FMVSS No. 216 as proposed in the NPRM. Multi-stage trucks not built on a chassis-cab or a full exterior van body with a GVWR greater than 2,722 kilograms (6,000 pounds) are not covered. This is discussed below.

Multi-stage trucks with a GVWR of 2,722 kilograms (6,000 pounds) or less have already been subject to FMVSS No. 216, and no practicability issues have been identified. While there are differences between the existing requirements and those of the upgraded standard, the basic nature of the FMVSS No. 216 test is the same, i.e., a quasi-static test that applies a force to the roof. Moreover, the FMVSS No. 220 option will also be available (other than for trucks built using chassis-cabs). Given these considerations, we believe that these vehicles do not raise practicability concerns. We note that we are not aware of any incomplete cutaway vehicles with a GVWR of 2,722 kilograms (6,000 pounds) or less.

We decided not to extend the standard to multi-stage trucks with a GVWR above 2,722 kilograms (6,000 pounds) not built on a chassis-cab or a full exterior van body. The incomplete vehicles for these excluded multi-stage trucks will not have an intact roof, and because the strength of the roof may be dependent on the structure to be added by the final-stage manufacturer in completing the truck, the incomplete vehicle manufacturer may not provide for pass-through certification. Moreover, the FMVSS No. 220 test was designed for school buses and uses a horizontal plate over the driver and passenger compartment instead of the angled plate of Standard No. 216. This test may not be appropriate for trucks with certain roof configurations.

For the remaining multi-stage vehicles other than trucks, we believe that the FMVSS No. 220 option is a reasonable way to balance the need to increase safety in rollover crashes of multi-stage vehicles and the capabilities of multi-stage manufacturers. Examples of vehicles in this category include Type II ambulances,57 small recreation vehicles, and shuttle vans with a GVWR greater than 2,722 kilograms (6,000 pounds) but not greater than 4,536 kilograms (10,000 pounds). Some of these vehicles involve vans with raised roofs.

First, NTEA's argument, which appears to be largely in the context of work trucks, on relatively unique configurations and very limited production numbers, does not truly apply. There are companies that make ambulances, other companies that make small RVs, and others that make shuttle vans. These vehicles are generally made in larger production runs and/or with relatively standardized exterior structures. Therefore, there are significantly fewer issues related to special structural issues potentially affecting roof configuration and roof strength for multipurpose vehicles and buses than for trucks which may have more specialized and customized uses.58

Second, these vehicles transport passengers, not property. While we are concerned about the safety of occupants in all kinds of vehicles, there is a greater safety concern about unnecessarily excluding passenger vehicles, such as 15-passenger vans and small shuttle buses from roof strength requirements, given the number of occupants.

NTEA is correct that current IVDs do not provide a Type I or Type II statement regarding FMVSS No. 220,School Bus Rollover Protection.The Type 3 statements for Ford and GM cutaway chassis used for school buses are reasonable given the fact that these incomplete vehicles do include occupant compartment structures. School bus manufacturers using these chassis provide their own occupant compartment structures, and have long certified their vehicles to FMVSS No. 220.

As we noted in the NPRM, several states already require “para-transit” vans and other buses, which are typically manufactured in multiple stages, to comply with the roof crush requirements of FMVSS No. 220. Moreover, the RVIA endorsed the agency's proposal. Recreational vehicles, including motorhomes, are used to transport passengers, not property, and are commonly built on stripped chassis. The RVIA stated that several thousand of the smallest motor homes produced each year would be subject to the proposed rule and that virtually all of the affected vehicles are manufactured in two or more stages. RVIA stated that NHTSA rightly acknowledged that the requirements of FMVSS No. 220 appear to offer a reasonable avenue to balance the desire to respond to the needs of multi-stage manufacturers and the need to increase safety in rollover crashes.

While NTEA claimed that the cited State laws are not good evidence that final-stage manufacturers in fact are able to confirm compliance of vehicles with FMVSS No. 220, it did not provide reasons for us to doubt manufacturer claims that their vehicles meet these requirements. We also note that the Ambulance Manufacturers Association of NTEA adopted a standard, AMD Standard No. 001, with a test based on FMVSS No. 220. AMD Standard No. 001,Ambulance Body Structure Static Load Test,is issued by the Ambulance Manufacturers Association of NTEA. The purpose of that standard is to demonstrate the static strength of the patient compartment of an ambulance when subjected to a uniform load. NTEA stated that an ambulance manufacturer recently had three units tested at a cost of $40,000, i.e., an amount slightly over $13,000 each. NTEA stated that ambulances are unlike most multi-stage vehicles in that most manufacturers produce a small number of models that require only limited alterations to meet specific customer needs and that, as a result, these testing costs, while still significant, can be allocated over multiple vehicle sales.

A limited internet search reveals that many manufacturers, including alterers, advertise that various mobility, para-transit and other vehicles meet the requirements of FMVSS No. 220.59

For example:

• National Van sells wheelchair vans/ambulettes with modified roofs that are said to be FMVSS No. 220 School Bus Rollover certified.60 These can be built on the Ford E-150 chassis.

• New England Wheels sells a Municipal Transporter that has a 30″ raised transporter roof with a FMVSS No. 220 certified roll cage. New England Wheels also sells a Ford E-250 Van with an 18″ Executive Raised Roof w/FMVSS 220 Certified Roll Cage.61

• Accubilt sells a shuttle van with an 8,600 lbs GVWR that has an “exclusive tubular steel roll cage (FMVSS certified).”62

• MobilityWorks of Akron, Ohio advertises that “[a]ll MobilityWorks vehicles meet or exceed the requirements set forth for vehicles of gross weight less than 10,000 lbs.” for the FMVSS No. 220 load test.63

Table of Contents I. Background II. Petitions for Reconsideration III. Today's Document and Related Actions IV. Response to Petitions A. Request That All Vehicles With a GVWR Not Greater Than 4,536 Kilograms (10,000 Pounds) Be Required To Meet a 3.0 SWR 1. May 2009 Final Rule Discussion 2. Overall Rationale for Request and Petitioners' Argument Concerning Costs 3. Petitioners' Argument Concerning Equity 4. Consequences of Lower Roof Crush Protection for Heavier Light Vehicles and Documentation From NTSB 5. Agency's Cost-Benefit Analysis B. Request That Agency Adopt a Dynamic Testing Provision 1. May 2009 Final Rule Discussion 2. Overall Rationale for Request 3. Introduction to Response 4. Petitioner's Claim That Quasi-Static Test and Criteria Do Not Reasonably Differentiate Between the Injury Risk of Compliant and Non-Compliant Vehicles 5. Petitioner's Claim That JRS Test Device Has Been Available for Two Years and Extensive Test Data Submissions Show It To Be Reliable, Repeatable, Validated to Real World Injury Risk and Accurate in Assessing Comparative Injury Potential Performance C. Other Issues I. Background

On May 12, 2009, as part of a comprehensive plan for reducing the serious risk of rollover crashes and the risk of death and serious injury in those crashes, NHTSA published in theFederal Register(74 FR 22348) a final rule1 substantially upgrading Federal Motor Vehicle Safety Standard (FMVSS) No. 216,Roof Crush Resistance.

First, for the vehicles currently subject to the standard,i.e.,passenger cars and multipurpose passenger vehicles, trucks and buses with a Gross Vehicle Weight Rating (GVWR) of 2,722 kilograms (6,000 pounds) or less, the rule doubled the amount of force the vehicle's roof structure must withstand in the specified test, from 1.5 times the vehicle's unloaded weight to 3.0 times the vehicle's unloaded weight. We note that this value is sometimes referred to as the strength-to-weight ratio (SWR), e.g., a SWR of 1.5, 2.0, 2.5, and so forth.

Second, the rule extended the applicability of the standard so that it will also apply to vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds), but not greater than 4,536 kilograms (10,000 pounds). The rule established a force requirement of 1.5 times the vehicle's unloaded weight for these newly included vehicles.

Third, the rule required all of the above vehicles to meet the specified force requirements in a two-sided test, instead of a single-sided test,i.e.,the same vehicle must meet the force requirements when tested first on one side and then on the other side of the vehicle. Fourth, the rule established a new requirement for maintenance of headroom,i.e.,survival space, during testing in addition to the existing limit on the amount of roof crush. The rule also included a number of special provisions, including ones related to leadtime, to address the needs of multi-stage manufacturers, alterers, and small volume manufacturers.

The rulemaking action to improve roof strength was part of our comprehensive plan for addressing the serious problem of rollover crashes. There are more than 10,000 fatalities in rollover crashes each year. To address that problem, our comprehensive plan includes actions to: (1) Reduce the occurrence of rollovers, (2) mitigate ejection, and (3) enhance occupant protection when rollovers occur (improved roof crush resistance is included in this third category). A more complete discussion of our plan was included in the preamble to the May 2009 roof crush resistance final rule (74 FR 22348).

The roof crush final rule, by itself, addressed a relatively small subset of that problem. Our analysis shows that of the more than 10,000 fatalities, roof strength is relevant to only about seven percent (about 667) of those fatalities. We estimated that the May 2009 rule will prevent 135 of those 667 fatalities.

The portions of our comprehensive plan that will have the highest life-saving benefits are the ones to reduce the occurrence of rollovers (prevention) and to mitigate ejection (occupant containment). We estimate that by preventing rollovers, electronic stability control (ESC) will reduce the more than 10,000 fatalities that occur in rollover crashes each year by 4,200 to 5,500 fatalities (and also provide significant additional life-saving benefits by preventing other types of crashes). In the area of mitigating ejection, significant life-benefits are and/or will occur by our continuing efforts to increase seat belt use and our rulemaking on ejection mitigation. We note that on December 2, 2009, we published in theFederal Register(74 FR 63180) a notice of proposed rulemaking (NPRM) to establish a new safety standard to reduce the partial and complete ejection of vehicle occupants through side windows in crashes, particularly rollover crashes.

We received two petitions for reconsideration. One was jointly submitted by Advocates for Highway and Auto Safety, Center for Auto Safety, Consumer Federation of America and Ms. Joan Claybrook. We will refer to these petitioners jointly as “Advocateset al.” in the rest of this document. The other petition was submitted by the Center for Injury Research (CfIR).2

Advocateset al.requested reconsideration of the agency's decision to apply a lower SWR requirement to vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds) than to lighter vehicles (1.5 SWR vs. 3.0 SWR).

These petitioners argued that NHTSA's overall rationale for the 1.5 SWR requirement is inadequate, and that the agency has a duty to provide uniform, equal levels of safety protection to vehicle occupants in all light vehicles without regard to distinctions based on what they consider to be arbitrary factors such as vehicle weight. They specifically argued that the agency did not establish any specific standard for judging the reasonableness of the costs involved in increasing the stringency of the SWR for vehicles greater than 2,722 kilograms (6,000 pounds).

Advocateset al.made a variety of additional arguments in support of their request, including ones related to how the agency has addressed reasonableness of costs in a prior rulemaking, a claim that the consequences of inadequate roof protection for larger vehicles is more severe than for light passenger vehicles, concerns about 15-passenger vans, National Transportation Safety Board (NTSB) investigations and recommendations, and a claim that the agency's cost-benefit analysis underestimates the number of lives that could be saved by much stronger roofs.

CfIR asked us to reconsider the final rule with respect to the lower SWR requirement for heavier light vehicles, and also with respect to our decision not to adopt a dynamic test. That petitioner cited three basic reasons for NHTSA to reconsider the final rule. First, it argued that the quasi-static test and criteria does not reasonably differentiate between the injury risk of compliant and non-compliant vehicles. Second, CfIR argued that contrary to NHTSA assertions, the Jordan Rollover System (JRS) dynamic test has been available for two years and extensive data submissions show it to be reliable, repeatable, validated to real world rollover injury risk and accurate in assessing comparative injury potential performance. Third, CfIR argued that drivers and passengers of heavier light vehicles up to 4,536 kilograms (10,000 pounds) GVWR deserve the same rollover protection as occupants of vehicles with a GVWR of 2,722 kilograms (6,000 pounds) or less. This petitioner argued that these heavier vehicles are often less stable, occupants are more vulnerable and the vehicles are used more frequently in off-road transportation.

In its petition, CfIR cited numerous submissions it had made to the docket. This petitioner requested that the agency review the data previouslysubmitted and summarized in its petition and consider the following actions: adjust the rule to allow for an alternate dynamic compliance test, propose and allow for an alternative dynamic test for the agency's New Car Assessment Program (NCAP) ratings, allow for non-compliance or compliance exceptions based on submitted dynamic test evidence, correct statements made by the agency regarding the JRS' repeatability and reliability in testing a vehicle's dynamic performance that the petitioner considers to be misleading and inaccurate, and apply the same SWR for lighter vehicles to heavier vehicles with passenger seating positions of three or more. CfIR also claimed that the agency made errors with respect to the target population used to identify benefits and in addressing the effect of roof racks on the strength of the roof.

In September 2009, CfIR submitted a document it called a “supplement” to its petition for reconsideration. It attached a document discussing JRS test results which it said indicate that an SWR of 4.1 is required to minimize roof crush injury potential. CfIR stated that it requested reconsideration of JRS dynamic testing for the final rule for two reasons: (1) Insurance Institute for Highway Safety's3 (IIHS) SWR of 4 or greater has gained industry acceptance and timely voluntary compliance, and (2) the JRS test fixture accurately measures post crash negative headroom and can assess the injury potential of occupant protection systems. It stated that its supplement requests further (1) raising the static test criteria to the dynamically derived SWR criteria of 4, and (2) initiating a dynamic rollover crashworthiness NCAP program using the JRS fixture.

CfIR also provided the agency a copy of a document titled “Scientific Review & Evaluation of the Jordan Rollover System (JRS) Impact Crash Test Device.”4

In this document, we provide our response to the petitions for reconsideration of the May 2009 final rule upgrading FMVSS No. 216.

We are also publishing two separate documents related to the May 2009 final rule. One is a fuller response to comments submitted by NTEA on our proposal to upgrade FMVSS No. 216. The other is a correcting rule. The correcting rule incorporates a provision that was discussed in the preamble but inadvertently omitted from the regulatory text. As explained in the preamble, the agency decided to exclude a narrow category of multi-stage vehicles from FMVSS No. 216 altogether, multi-stage trucks with a GVWR greater than 2,722 kilograms (6,000 pounds) not built on either a chassis cab or an incomplete vehicle with a full exterior van body. The regulatory text inadvertently omitted the reference to incomplete vehicles with a full exterior van body.

After carefully considering the two petitions, we have decided to deny them. The reasons for our denial are set forth below. Our discussion is divided into two main sections, one addressing issues related to the lower SWR requirement for heavier light vehicles and the other addressing issues related to our decision to adopt a quasi-static test requirement.

In our May 2009 final rule, we adopted an SWR requirement of 3.0 for vehicles with a GVWR of 2,722 kilograms (6,000 pounds) or less, and 1.5 for vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds) and less than or equal to 4,536 kilograms (10,000 pounds).

In the preamble to that document, we explained that while the rulemaking involved a number of key decisions, the selection of an SWR requirement was the most important one for both costs and benefits. We note that our analysis, presented in detail in the Final Regulatory Impact Analysis (FRIA), showed that for the alternatives we evaluated, benefits in terms of reduced fatalities continued to rise with higher SWR levels due to reduced intrusion. For vehicles designed to have higher SWR levels, the benefits continued to rise because the vehicle roofs experience less intrusion in higher severity crashes. We explained further, however, that costs also increase substantially with higher SWR levels, so NHTSA needed to select the appropriate balance of safety benefits to added costs.

We explained that under the Safety Act, NHTSA must issue safety standards that are both practicable and meet the need for motor vehicle safety. 49 U.S.C. § 30111(a). The agency considers economic factors, including costs, as part of ensuring that standards are reasonable, practicable, and appropriate.

In Motor Vehicle Manufacturers Association v. State Farm, 463 U.S. 29, 54-55 (1983), the Supreme Court indicated that the agency was correct, in making its decisions about safety standards, to consider reasonableness of monetary and other costs associated with the standards. With respect to the agency's future revisiting of its earlier conclusion that the cost of detachable automatic seat belts was unreasonable in relation to the expected benefits from such belts, the Court stated, however, that “(i)n reaching its judgment, NHTSA should bear in mind that Congress intended safety to be the preeminent factor under the Motor Vehicle Safety Act:”

We explained that, in making our decision concerning SWR, we were guided by the statutory language, legislative history, and the Supreme Court's construction of the Safety Act, as well as by the specific requirement in the Safe, Accountable, Flexible, Efficient Transportation Equity Act: A Legacy for Users (SAFETEA-LU) for us to upgrade FMVSS No. 216 relating to roof strength for driver and passenger sides for motor vehicles with a GVWR of not more than 4,536 kilograms (10,000 pounds). We explained that we considered both costs and benefits, bearing in mind that Congress intended safety to be the preeminent factor under the Safety Act.

As indicated above, our analysis showed that while benefits continued to rise with higher SWR levels, costs also increase substantially. We explained that the challenge was to push to a level where the safety benefits are still reasonable in relation to the associated costs. We explained further that, as partof this, we considered issues related to cost effectiveness. We noted that the agency's analysis of cost effectiveness was presented in the FRIA and summarized in the preamble.

We also explained that another important factor in the selection of the SWR requirements was that there are much higher costs relative to benefits associated with any level SWR requirement for vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds) as compared to the lighter vehicles that were already subject to the standard.

We noted that there are a number of reasons for this differential between heavier and lighter vehicles. The absolute strength needed to meet a specific SWR is a function of the vehicle's unloaded weight. By way of example, to meet a 2.0 SWR, an unloaded vehicle that weighs 1,360 kilograms (3,000 pounds) must have a roof structure capable of withstanding 26,690 N (6,000 pounds) of force, while an unloaded vehicle that weighs 2,268 kilograms (5,000 pounds) must have a roof structure capable of withstanding 44,482 N (10,000 pounds) of force. This means more structure or reinforcement are needed for the heavier vehicle, which means more cost and weight. Moreover, vehicles in the heavier category have not previously been subject to FMVSS No. 216, so they have not been required to meet the existing 1.5 SWR single-sided requirement.

We also noted that, at the same time, these heavier vehicles account for only a very small part of the target population of occupants who might benefit from improved roof strength. Only 5 percent of the fatalities in the overall target population (33 in terms of a specific number) occur in vehicles over 2,722 kilograms (6,000 pounds) GVWR. Ninety-five percent of the fatalities (635 in terms of a specific number) occur in vehicles under 2,722 kilograms (6,000 pounds) GVWR. These differences reflect the fact that there are far fewer vehicles in this category in the on-road fleet, and may reflect their frequency of use as working vehicles.

We stated that we recognized the argument that all light vehicles should meet the same SWR requirements, to ensure the same minimum level of protection in a rollover crash. We explained, however, that in selecting particular requirements for a final rule, we believed that our focus needed to be on saving lives while also considering costs and relative risk. We stated (74 FR 22360):

We included specific explanations as to why we adopted a 3.0 SWR requirement for vehicles with a GVWR of 2,722 kilograms (6,000 pounds) or less and a 1.5 SWR requirement for vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds).

While we will not repeat all of the details of the reasons we provided for our decision concerning the 3.0 SWR required for vehicles with a GVWR of 2,722 kilograms (6,000 pounds) or less, we noted that an SWR requirement of 3.0 prevented about 66 percent more fatalities than one at 2.5, 133 instead of 80. However, costs increased by a considerably higher percentage, resulting in a less favorable cost per equivalent life saved, $5.7 million to $8.5 million for 3.0 SWR as compared to $3.8 million to $7.2 million for 2.5 SWR. We explained that in these particular circumstances, we believed that a 3.0 SWR requirement was appropriate and the costs reasonable given the increased benefits. We explained that while the cost per equivalent life saved was relatively high compared to other NHTSA rulemakings, we concluded that the higher safety benefits, the legislative mandate for an upgrade, the technical feasibility of making roofs this strong, and the fact that these costs were generally within the range of accepted values justified moving NHTSA's roof crush standards to a 3.0 SWR for vehicles that have been subject to the 1.5 SWR requirements.

As to vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds), we noted that these vehicles are not currently subject to FMVSS No. 216 and, because of their greater unloaded vehicle weight, these vehicles posed greater design challenges. These heavier vehicles also tend to have greater variations in packaging options (4-wheel drive, extended/crew cabs, engine size, etc.) which span a larger range of unloaded vehicle weights for a given body design. In response to the NPRM, vehicle manufacturers noted that to minimize their manufacturing tooling costs, they would need to design their roof strength performance to the worst-case weight for a given model line. We also noted that given the relatively small target population for these vehicles, the benefits will necessarily be small regardless of the SWR selected.

We explained that after considering our original proposal of a SWR of 2.5 and the available information, we concluded that a SWR of 1.5 was appropriate for these heavier vehicles. We noted that the requirement we were adopting is more stringent than the longstanding requirement that has applied to lighter vehicles until this rulemaking because it is a two-sided requirement. The FRIA estimated that two fatalities and 46 nonfatal injuries will be prevented annually by this requirement. We stated that because of the high cost relative to the benefits for all of the alternatives for these heavier vehicles, from the 1.5 SWR alternative and above, any alternative we select would adversely affect the overall cost effectiveness of this rulemaking (covering all light vehicles).

We stated that we believed that a SWR of 1.5 is appropriate for these heavier vehicles. We stated that given the requirements of SAFETEA-LU, we needed to ensure that the standard results in improved real world roof crush resistance for these vehicles. We declined, however, to adopt a SWR higher than 1.5 for vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds), given the small additional benefits (4 additional lives saved and 137 nonfatal injuries prevented) and substantially higher costs. We explained that adopting a SWR of 2.0 for these vehicles would more than double the costs of the rule for these vehicles.

In their petition for reconsideration, Advocateset al.argued that the agency's rationale for a SWR of 1.5 for heavier light vehicles is inadequate. While they conceded that cost burdens are a consideration to be taken into account, these petitioners claimed that the agency had unwarrantedly elevated cost considerations above the need to secure substantial increases in benefits for people involved in rollover crashes in light vehicles above 2,722 kilograms (6,000 pounds) GVWR.

While the petitioners acknowledged the agency's discussion of the Supreme Court's decision inMotor VehicleManufacturers Associationv.State Farm,they argued that NHTSA did not establish any specific standard for judging the reasonableness of costs involved in increasing the stringency of the SWR for vehicles greater than 2,722 kilograms (6,000 pounds). They stated that the point at issue, whether the costs are reasonable with respect to higher SWR levels for these vehicles, was not independently established by an appeal to any specific, recognized test that the agency sets forth for objective assessment of “what costs are tolerable for gaining additional safety benefits.”

While we believe that the basis for our decision concerning SWR was adequately presented and explained in the final rule, we will provide a more detailed discussion in responding to the petitions for reconsideration.

We begin by elaborating on our earlier discussion of the Supreme Court's statement inState Farmthat safety is the pre-eminent factor in vehicle safety rulemaking. We note that neither the Court nor the passages of legislative history it quoted suggested that the pre-eminence of safety considerations leaves no significant role for other considerations to influence rulemaking decisions. The Court's opinion, as well as each of the two passages of legislative history, all emphasize that it is necessary and appropriate to consider costs as well as other non-safety factors, in making those decisions. We take the pre-eminence of safety to mean that strict considerations of economic efficiency do not govern vehicle safety rulemaking. We do not, however, understand it to mean that we must establish requirements whose benefits are mathematically significantly disproportionate to their costs, especially when the costs are large in absolute terms.

As to the suggestion that we establish a specific numerical test for determining whether costs are reasonable in relation to likely benefits and apply it across the board to particular rulemakings, regardless of their individual circumstances, we decline to do so. Adoption of a formulaic calculus of decisionmaking would preclude a careful, fact-based assessing and weighing of competing considerations. We must consider all relevant factors in the context of the facts in any particular rulemaking, and therefore cannot consider safety in isolation or without due regard to those other factors.

We can, however, identify the types of facts that lead us to give careful scrutiny to reasonableness of costs in a rulemaking, and which lead us to place increased weight on this factor as we consider all other relevant factors in reaching a particular decision. Specifically, we give scrutiny to the issue of reasonableness of costs in rulemakings where our analyses indicate that either the overall rulemaking, or a significant portion of the rulemaking, is borderline with respect to whether it is cost beneficial,i.e.,whether the benefits of the rulemaking exceed the costs. Moreover, in situations where either the overall rulemaking or a significant portion of the rulemaking appears likely to result in net disbenefits,i.e.,net losses, our scrutiny increases as the size of the potential net disbenefits increases, and the weight we accordingly place on this factor increases.

The agency did weigh the competing considerations and relevant factors for this rule. Although Advocateset al.argue that the agency merely cited the fact that there are increased costs, the agency presented detailed cost-effectiveness and benefit-cost analyses in its FRIA for the roof crush resistance final rule and summarized those analyses in the preamble. Among other items, these analyses looked at the number of fatalities that the rule would prevent. In fact, in the FRIA, NHTSA published a table summarizing costs and benefits for various SWR alternatives (1.5, 2.0, 2.5, 3.0, 3.5). The agency also considered one-sided and two-sided tests.SeeFRIA, pp. 125-134. Based on the analysis of the alternatives in the FRIA and after considering the comments received, the agency changed the SWR requirement from that included in the proposal. In the NPRM, the agency included a 2.5 SWR, one-sided requirement for all vehicles with a GVWR of 4,536 kilograms (10,000 pounds) or less. While the agency lowered the SWR requirement, as compared to the NPRM, to 1.5 for the heavier light vehicles in the final rule, the agency actually raised the SWR to 3.0 for vehicles with a GVWR of 2,722 kilograms (6,000 pounds) or less. This was done, in part, because doing so would prevent significantly more fatalities.

In an effort to respond to the petition of Advocateset al.,the agency is including a recitation of how the agency came to its conclusions relating to the change in SWR. As with any rule, the estimates of cost effectiveness rely on a number of important inputs and calculations.5 For example, the cost effectiveness of the rule was estimated for each alternative using both 3% and 7% discount rates. The net benefits for each alternative represent the difference between total costs and the total monetary value of benefits.

In order to calculate net benefits, it is necessary to use a value per statistical life saved (VSL). Guidance from the Office of the Secretary of Transportation (OST) specifies a value of $5.8 million, with recommendations that values of $3.2 million and $8.4 million also be considered to account for uncertainty. We note that this guidance is available on the OST Web site.6 We also note that the value of $5.8 million was adopted in February 2008 and represented an increase from an earlier value of $3.0 million that had been adopted in January 2002.

The monetary value of benefits used by NHTSA also included $300,000 in economic costs prevented. Thus, for our primary estimates, the monetary value of benefits was estimated by assigning a value of $6.1 million to each equivalent fatality prevented.

The FRIA includes cost-effectiveness and benefit-cost analyses for various alternatives considered by the agency. As noted in the preamble, nearly all alternatives covering vehicles from 2,723 and 4,536 kilograms (6,001 and 10,000 pounds) GVWR yield net losses rather than net savings to society. The agency's specific estimates of net benefits for two-sided test requirements with alternative SWRs are presented in the following table.7

This table shows that for light vehicles with a GVWR greater than2,722 kilograms (6,000 pounds), all of these alternative SWRs, including the one we adopted, result in net losses to society, and also that net losses increase by a substantial amount at each higher alternative. For example, it is clear that going successively to each alternative above 1.5 can result in additional hundreds of millions of dollars of net losses. The net losses from the 3.0 SWR alternative, the one advocated by the petitioners, would be well in excess of a billion dollars.

We also note that consideration of uncertainties related to VSL does not significantly affect these numbers. The net losses are slightly higher using a VSL of $3.2 million and slightly lower using a VSL of $8.4 million.SeeTables VII-5 and VII-6 of the FRIA. However, even using a VSL of $8.4 million, the net losses are $50 million to $174 million for an SWR of 1.5 and $101 million to $524 million for an SWR of 2.0, and continue to rise substantially for higher SWRs.

The FRIA presents cost-effectiveness and benefit-cost analyses in a number of different ways, including calculations of cost per equivalent life saved for different alternatives. The cost per equivalent life saved for all of the alternatives identified in the table above is well above the range of plausible VSL,i.e.,the range where they would be considered cost-beneficial.SeeTable VII-3 of the FRIA. We note that, while well above this range, the cost per equivalent life saved is slightly less disfavorable for a 2.0 SWR than a 1.5 SWR ($18.8 million to $72.0 million vs. $27.9 million to $90.3 million). However, given the small number of additional benefits and the substantially higher costs associated with the 2.0 SWR alternative, the net losses for this alternative are substantially higher than for the 1.5 SWR alternative ($123 million to $547 million vs. $55 million to $180 million). The cost per equivalent life saved for an SWR of 3.0 would be $88.4 million to $140.0 million.

NHTSA and other agencies evaluate cost-effectiveness and benefit-cost analyses as part of ensuring that they and the public are fully aware of the consequences of their rulemaking decisions. Societies have limited resources and many alternative ways of using those resources, including many alternative ways of reducing risks. To the extent that various regulatory alternatives result in increasingly high costs to achieve limited safety benefits and net losses to society rather than net benefits, they raise the issue of whether those societal resources could better be used elsewhere, especially when the net losses are substantial. While NHTSA has always placed primary importance on safety benefits, it has never considered safety without regard to cost implications.

In our May 2009 final rule, we adopted a SWR of 1.5 for the heavier light vehicles despite the fact that, at this level, our analyses showed that there would be net losses to society. The reasons for this are cited above. We declined, however, to adopt a SWR higher than 1.5 for vehicles with a GVWR greater than 2,722 kilograms (6,000 pounds). As we stated in the FRIA, “the cost/equivalent fatality for vehicles over 6,000 lbs. GVWR is roughly 12-16 times that for the lighter vehicles at any given SWR.”8

The costs of the rule for these vehicles are substantial at 1.5 SWR,i.e.,$70.9 million to $195.0 million, and would increase to $182.3 million to $605.9 million for an SWR of 2.0.SeeTable VII-2 of the FRIA. Moreover, as noted above, given the small number of additional benefits and the substantially higher costs associated with the 2.0 SWR alternative, the net losses to society for this portion of the rulemaking would increase from the range of $55 million to $180 million for the 1.5 SWR alternative to the range of $123 million to $547 million for the 2.0 SWR alternative. Also, the increased net losses for still higher SWRs would be very substantial,e.g.,well in excess of a billion dollars for SWR of 3.0. Given the small number of additional benefits, the magnitude of the net losses to society, and given how far outside the range of cost per equivalent life that would ordinarily be considered to be cost-beneficial, we believe our decision not to adopt an SWR higher than 1.5 for these vehicles is reasonable, and we do not accept these petitioners' argument that the agency unwarrantedly elevated cost considerations above safety.

Advocateset al.also claimed that NHTSA had previously reached a significantly different result in similar circumstances, citing the agency's 1995 rule amending FMVSS No. 201,Occupant Protection in Interior Impact,to require light vehicles to provide protection when an occupant's head strikes upper interior components. They specifically cited the agency's decision to include components in the rear seating area of light trucks and vans (LTVs), despite a great disparity in the costs per equivalent life saved between preventing fatalities in front seat areas and preventing fatalities in rear seat areas, and despite a very high cost per equivalent life saved for the latter areas.

As indicated earlier, we decline to define or otherwise adopt any specific numerical test related to costs and benefits as determinative as to whether costs are reasonable or not. We instead consider all relevant factors in any particular rulemaking, and do not consider this factor in isolation. Moreover, NHTSA rulemakings where either the overall rulemaking or a signification portion of the rulemaking is borderline with respect to whether the benefits exceed the costs or where there may appear to be net disbenefits are rare. For these reasons, and in light of the unique nature of the issues involved in such rulemakings, we do not consider the specific decisions we reach in one of these rulemakings to be directly comparable to other rulemakings. We note that while the overall FMVSS No. 201 rulemaking was highly cost-beneficial, the overall FMVSS No. 216 rulemaking is not.9 We also note that the agency decided in the former rulemaking that coverage of the rear seat areas was particularly necessary because children are disproportionately likely to be seated in the rear, instead of the front, seating area and would be subject to head injuries unless the rear seating areas were included.

Advocateset al.made arguments related to equity. They claimed that it is inequitable to those who travel in large vans and large sport utility vehicles (SUVs) for those vehicles to be subject to a lower standard for roof crush resistance safety. They noted that the agency proposed an SWR of 2.5 for all light vehicles, and the petitioners claimed that the agency “reneged on the need to provide equal safety for all light motor vehicle occupants in the final rule.” CfIR argued that drivers and passengers of light trucks, SUVs and vans to 4,536 kilograms (10,000 pounds) GVWR deserve the same rollover protection as occupants of 2,722 kilograms (6,000 pounds) GVWR vehicles. It stated that trucks, SUVs and vans which accommodate four to 15 passengers are primarily used by commercial operators, schools, social groups, and non-profit entities.

In responding to these arguments, we note that we explained in the final rule preamble that while we recognized the argument that all light vehicles should meet the same SWR requirements, to ensure the same minimum level ofprotection in a rollover crash, we believed in selecting particular requirements for a final rule that our focus needed to be on saving lives while also considering costs and relative risk. We stated that what is necessary to meet the need for safety and is practicable for one type or size of vehicle may not be necessary or reasonable, practicable and appropriate for another type or size of vehicle.

We explained further that, to the extent the goal of establishing the same SWR requirements for all light vehicles would have the effect of either unnecessarily reducing the number of lives saved in lighter vehicles or imposing substantially higher, unreasonable costs on heavier vehicles despite their lesser relative risk, we believed it was appropriate to adopt different requirements for different vehicles.

NHTSA considers all relevant factors, including, where appropriate, special concerns. As noted above, in a FMVSS No. 201 rulemaking, the agency decided that it was particularly necessary to protect children, who are often seated in the rear and who would be susceptible to head injuries unless the rear seating areas were included.

The agency has never, however, adopted a position that identical safety requirements should apply to all light vehicles or at all seating positions regardless of considerations such as relative risks and costs. The Vehicle Safety Act requires us to issue standards that meet the need for motor vehicle safety. For any given aspect of vehicle safety performance, the need for motor vehicle safety, which is defined in the Act in terms of unreasonable risk, varies by type and size/weight of vehicle, as well as by other factors. Given those differences in risk, the type and level of regulation that is reasonable, practicable and appropriate for one vehicle type may differ from that for another vehicle type. Moreover, we believe that adopting an inflexible position of identical requirements regardless of the particular circumstances would be contrary to public safety. Such a position, in combination with the fact that often some light vehicles have greater compliance difficulties than other light vehicles and thus might not be able to achieve as high a level of performance as those other vehicles, could force the adoption of lower, less protective requirements for all light vehicles.

Given these considerations, we do not accept the petitioners' arguments concerning equity.

Advocateset al.argued that the consequences of what they term inadequate roof crush protection for large light truck and van occupants are more severe than for light passenger vehicles. They also argued that NTSB comments, investigations, and recommendations document the serious occupant risks of death and injury in large van rollover crashes.

The petitioners stated that the greater weight of the heavier vehicle places higher loads on the roof and roof supports during a rollover. They also stated that certain heavier passenger vehicles will be even more inadequately protected from intrusive roof crush in rollover crashes than lighter passenger vehicles because they have long roofs and multi-row seating, especially 8-occupant large SUVs, and 12- and 15-passenger vans. They stated that the specified test requirements do not test the crush resistance of C-, D- and E- pillars of heavier, longer passenger vehicles.

Advocateset al.also noted that NHTSA has published repeated advisories and research analyses warning of the very high rollover propensity of 15-passenger vans. They stated in its latest research note, titledFatalities to Occupants of 15-Passenger Vans, 2003-2007, 10 NHTSA stressed that “15-passenger vans with 10 or more occupants had a rollover rate in single vehicle crashes that is nearly three times the rate of those that had fewer than five occupants.” They also noted that the research report indicated that, in 2007, fatalities of occupants of 15-passenger vans increased nearly 20 percent from the previous year, as well as other data from that report.

The petitioners stated that NTSB also emphasized the need for much stronger roofs in heavy passenger vans both in its accident reports and in its comments filed with NHTSA rulemaking dockets on passenger vehicle roof crush resistance. Advocateset al.stated that in commenting on NHTSA's NPRM to amend FMVSS No. 216, NTSB pointed out that heavier vehicles such as 12- and 15-passenger vans, not subjected to the roof strength standard, were experiencing patterns of roof intrusion greater than vehicles already subject to the requirements and cited two investigations it conducted concerning the safety need for vehicles between 2,722 and 4,536 kilograms (6,000 and 10,000 pounds) GVWR to meet roof crush resistance requirements. These petitioners included a discussion of these investigations, and asserted that NHTSA's roof crush final rule does not fulfill NTSB recommendations for vans and heavier vehicles.

In reaching its decision on the roof crush final rule, NHTSA carefully considered the consequences of alternative SWR requirements for the heavier light vehicles. As discussed above, as part of this, the agency conducted a detailed analysis of the benefits and costs at alternative SWR levels, which is presented in detail in the agency's FRIA. Among other things, the agency conducted a detailed analysis of the target population of occupants who would be likely to benefit from a stronger roof due to an upgrade of FMVSS No. 216, and how they would benefit from stronger roofs meeting alternative SWR level requirements.

While we adopted, for reasons discussed in the final rule preamble (and also discussed above), a lower SWR level for the heavier light vehicles than for ones with a GVWR of 2,722 kilograms (6,000 pounds) or less, the 1.5 SWR requirement we adopted is more stringent than the longstanding requirement that has applied to lighter vehicles until this rulemaking. The standard now requires a two-sided test. We also note that since the amount of force that a vehicle's roof must withstand in the specified test is a multiple of the vehicle's unloaded weight,e.g.,1.5 times the unloaded weight of the vehicle, the amount of force that is applied to a vehicle's roof is higher for heavier vehicles than lighter vehicles at any constant SWR.

Advocateset al.raised specific issues concerning the safety of larger passenger vans. We note that, as discussed in the May 2009 research note11 they cited, and in documents referenced by that note, NHTSA developed a specific action plan for 15-passenger van safety. In September 2003, the agency published theNHTSA Action Plan for 15-Passenger Van Safety.It described a number of research programs, consumer information activities and potential regulatory actions with which NHTSA intended to address the safety of 15-passenger van users. The plan was updated in November 2004 and the most recent update to the plan wasprepared in April 2008.12 The action plan is discussed at pp. 4 to 5 of the referenced May 2009 research note.13

Occupant protection for 12- and 15-passenger van continues to be an agency priority and, as a result of the agency's rulemaking to upgrade FMVSS No. 216, these vehicles will for the first time be required to comply with FMVSS No. 216. The May 2009 research note indicated that fatalities, both total and in vans that rolled over, have been on a declining trend since 2001. As noted by the petitioner, there was an increase in 2007; however, we expect that the safety benefits that will occur as a result of new regulatory requirements adopted in connection with the agency's action plan for 15-passenger van safety and its comprehensive plan to address the serious problem of rollover crashes will increase over time as the new requirements are phased in and as an increasing percentage of the on-road fleet meet these requirements.

As part of our rulemaking to upgrade FMVSS No. 216, we considered the comments and recommendation of the NTSB. In the final rule, we indicated that the rule would address the NTSB's recommendation H-03-16, to include 12- and 15-passenger vans in FMVSS No. 216, to minimize the extent to which survivable space is compromised in the event of a rollover accident. We plan to consult further with NTSB about its recommendation. We note that the petitioners have not provided any information that would lead us to change our view that the rule addresses that NTSB recommendation.

In its petition, CFiR also requested the agency to adopt a higher SWR for the heavier light vehicles with passenger seating positions of three or more. CfIR stated that these vehicles are often less stable, occupants are more vulnerable, and the vehicles are used more frequently in off-road transportation. As part of analyzing the target population of occupants who would be likely to benefit from a stronger roof due to an upgrade of FMVSS No. 216, the agency has already accounted for issues related to the stability of these vehicles and vulnerability of their occupants. Historically, vehicles with a GVWR between 2,723 and 4,536 kilograms (6,001 and 10,000 pounds) comprise approximately 20 percent of the fleet with over 90 percent of these heavy vehicles allowing for three or more seating positions.14 As to the issue of more frequent off-road use, we note that the relevant agency sources would not collect data for crashes that happen during off-road transportation such as at work sites. However, CfIR has not provided any supporting information relating to its claim that the vehicles are used more frequently in off-road transportation, or that there are any significant number of rollover crashes that would meaningfully affect the target population used by the agency for its analysis of benefits and costs. We therefore do not accept this argument.

Advocateset al.argued that NHTSA's cost-benefit analysis underestimates the number of lives that could be saved by much stronger roofs. They cited benefits estimates submitted by the Insurance Institute for Highway Safety (IIHS) in a March 2008 comment and in a subsequent publication. These petitioners stated that in that publication IIHS claimed that NHTSA underestimated roof strength improvement benefits due to the agency's mistaken belief that there will be no benefits for unbelted occupants or those occupants who risk ejection. They also said that IIHS provided much higher estimates of benefits than NHTSA.

Advocateset al.claimed that the agency failed to discuss or respond to the initial IIHS benefits estimate in the final rule. They claimed that while the agency engaged in “a highly detailed, extensive evaluation in the FRIA of the strengths and weaknesses of the study attached by IIHS to its docket comments,” the agency failed in this supporting document to evaluate the benefits claims proffered by IIHS. The petitioners stated that the central point of the IIHS submission to the supplemental notice of proposed rulemaking (SNPRM) docket was to emphasize that the agency had dramatically underestimated the benefits of adopting a stronger fleet-wide FMVSS No. 216. Advocateset al.claimed that NHTSA ignored the merits of the IIHS benefits analysis “notwithstanding the internal debate set forth in the FRIA over some aspects of the methodology and data selected by IIHS in conducting its study.”

NHTSA does not accept the claim of these petitioners that the agency ignored the merits of the IIHS benefits analysis. We begin by emphasizing that NHTSA's decision is based in significant part on the agency's Final Regulatory Impact Analysis. In section VII of the preamble to the final rule, titled Costs and Benefits, we explained that “(t)he agency addresses the comments concerning its analysis of costs and benefits in detail in the FRIA.” 74 FR 22377. We also noted that, in the final rule preamble, we summarized the agency's estimates of costs and benefits and discussed the comments concerning target population and roof crush as a cause of injury.

In the FRIA, the agency provided a detailed 5-page discussion of the various IIHS studies, including both their methodology and conclusions (seepages 47-51). This discussion addressed the IIHS submissions from March 2008, May 2008, and February 2009, representing the most recent IIHS research submitted prior to publication of the final rule in May 2009. This same discussion also addressed comments by JP Research, which submitted its own evaluation of the IIHS study, and argued that there were significant flaws in its methodology.

NHTSA's discussion in the FRIA showed the limitations of the IIHS methodology and showed that its conclusions regarding ejections and belt use are not supported by the data. This discussion was not, as Advocateset al.suggest, an “internal debate” but an evaluation of the merits of the IIHS study and its findings. The FRIA also described the agency's own study, which applied previously peer-reviewed methods specifically to ejections and unbelted occupants, and which contradicted the IIHS studies. Given these considerations, the agency did not accept the benefit estimates provided by IIHS. The relevant issues concerning estimated benefits are addressed in much greater detail in Chapter IV of the FRIA.

Advocateset al.did not address any of the detailed criticisms of the IIHS analyses discussed by NHTSA in the FRIA, but simply claimed in its petition that the agency had ignored the merits of the IIHS study. Given the above discussion, we do not accept that claim.

Advocates also criticized the agency's adjustment of future target populations to reflect the required installation of electronic stability control (ESC) in all passenger vehicles. Advocates stated that the agency has only projected safety benefits as the fleet gradually isequipped with ESC, including large vans, but no actual crash data specifically verifying that rollovers have been reduced in large vans as a direct result of ESC.

The analysis presented by NHTSA in the FRIA reflects a projection of annual impacts that will occur when the entire vehicle fleet has been designed to include both ESC and stronger roofs, not the impacts to today's on-road fleet. In numerous studies as well as in vehicle tests, ESC has been shown to significantly reduce rollover crashes in passenger vehicles. During the course of the ESC rulemaking, when projecting the costs and benefits of ESC, NHTSA used effectiveness estimates based on sound, peer reviewed statistical studies to project the benefits of ESC in all passenger vehicles, including large vans. We note that in comments concerning the PRIA for ESC, Advocates acknowledged that the installation of ESC would impact the FMVSS No. 216 rulemaking by reducing the number of rollovers.

ESC will be standard equipment on all passenger vehicles before the new roof crush requirements become effective. This means that future vehicle fleets containing the stronger roofs required by FMVSS No. 216 will experience fewer rollover crashes than are experienced by the current on-road fleet. It would be inappropriate to compare the costs of improving roof strength to benefits derived from current fatality and injury levels without first adjusting for the significant impact that ESC will have on the crash experience of future vehicle fleets with enhanced roof strength.

Advocateset al.also claimed that ESC may not be effective in large vans. At the time NHTSA did its statistical analysis of this issue, there were too few vans on the road with ESC to analyze them separately from other vehicles. However, NHTSA has tested ESC on large vans and found that it is effective in improving stability in potential rollover scenarios. This study15 found that “* * * installation of ESC on 15-passenger vans may have important safety benefits in some, but not necessarily all, on-road driving situations.” This is reasonably consistent with ESC applicability in other vehicles where it is highly effective in many circumstances, but cannot prevent rollover in all situations.

Moreover, large vans make up a very small portion of the target population. NHTSA examined the sample cases included in its target population and did not find any cases involving large vans that met the criteria for inclusion. This does not imply that there would never be such cases, but it does indicate that they are a relatively rare occurrence.

One possible reason, aside from the relative rarity of these vehicles in the fleet, is that roof crush typically is only an issue in vehicles that roll more than one quarter turn. The general shape of large vans, with more extensive areas of sheet metal on each side, makes it less likely that they would roll more than one quarter turn. In NHTSA's Crashworthiness Data System (CDS) from 2004-2008, the portion of crash-involved passenger cars that rolled over was roughly equal to the portion of crash-involved vans that rolled over, but, passenger cars were twice as likely as vans to roll more than one quarter turn and thus expose their occupants to potential roof intrusion.

Given the above considerations, we decline to reconsider the target population related to ESC considerations.

As discussed in the preamble to our May 2009 final rule, we developed our proposal to upgrade roof crush resistance requirements after considerable analysis and research, including conducting a research program to examine potential test procedures that might be adopted to improve the roof crush resistance requirements. The agency testing program included full vehicle dynamic rollover testing, inverted vehicle drop testing, and comparing inverted drop testing to a modified FMVSS No. 216 test. After considering the results of the testing and other available information, the agency concluded that the quasi-static procedure generates results that suitably represent the real-world dynamic loading damage patterns, and is the most appropriate one on which to focus our upgrade efforts.

We did not propose a dynamic test procedure in either the NPRM or the SNPRM. We did discuss in the NPRM a number of types of dynamic tests and why we were not including them in the proposal. With respect to the JRS test, we noted that although the agency was open to further investigating that test, we had no data regarding the repeatability of dummy injury and roof intrusion measurements, and would also need further information on its performance measures, practicability, and relevance to real-world injuries. We stated that, in summary, we were not proposing a dynamic test procedure and that we believed the current quasi-static test procedure is repeatable and capable of simulating real-world deformation patterns. We also stated that we were unaware of any dynamic test procedures that provide a sufficiently repeatable test environment.

Consumer advocacy organizations and a number of other commenters argued that it is not enough to upgrade the current quasi-static requirement, and that a dynamic test requirement is needed. While specific recommendations varied, one was for the agency to adopt an upgraded quasi-static requirement now, and to proceed with further rulemaking at this time for a dynamic test.

After reviewing the comments, we declined to pursue a dynamic test as part of that rulemaking, or to initiate a separate rulemaking for a dynamic test. We included an analysis of the comments recommending a dynamic test in an appendix.

We stated in the preamble that we were still not aware of any dynamic test procedure that provides a sufficiently repeatable test environment. We stated further that while some commenters argued that certain procedures are repeatable, the agency was not persuaded by the arguments and data they presented. We also noted that, for reasons discussed in the appendix, there are significant issues associated with each of the cited dynamic test procedures related to possible use in a Federal motor vehicle safety standard.

We explained further that, also of importance for this rulemaking, even if NHTSA were to identify a particular dynamic test procedure, among the many known to be available, as likely to be suitable for assessing roof crush resistance (something we have not been able to do thus far), we would need additional years of research to evaluate and refine, as necessary, the procedure in order to develop a proposal, including evaluating it in the context of the current vehicle fleet. We stated that it has not yet been determined whether any dynamic test requirement that might be identified by NHTSA's research would produce significant additional benefits beyond those that will be produced by the substantial upgrade of the quasi-static procedure that we adopted in that rule.

NHTSA stated that it agreed, however, with pursuing a dynamic test as our ultimate goal. We stated that we would like to have one for rollover crashes just as we do for front and side crashes. Westated that we could not adopt or even propose one now because of issues related to test repeatability, a dummy, and lack of injury criteria. We explained that we are pursuing further research for a dynamic test. In the meantime, we did not want to delay a significant upgrade of FMVSS No. 216 that will save 135 lives each year.

As discussed above, CfIR asked us to reconsider our decision not to adopt a dynamic test. It cited two basic reasons for the agency to reconsider this issue.

First, CfIR argued that the quasi-static test and criteria do not reasonably differentiate between the injury risk of compliant and non-compliant vehicles. Second, the petitioner argued that, contrary to NHTSA's assertions, the Jordan Rollover System (JRS) dynamic test has been available for two years and extensive data submissions show it to be reliable, repeatable, validated to real world rollover injury risk and accurate in assessing comparative injury potential performance.

In its petition, CfIR cited numerous submissions it had made to the docket. This petitioner requested that the agency review the data previously submitted and summarized in its petition and consider the following actions related to a dynamic test: Adjust the rule to allow for an alternate dynamic compliance test, propose and allow for an alternative dynamic test for NCAP ratings, allow for non-compliance or compliance exceptions based on submitted dynamic test evidence, and correct statements made by the agency regarding the JRS' repeatability and reliability in testing a vehicle's dynamic performance that the petitioner considers to be misleading and inaccurate.

In responding to CfIR, we begin by noting that we do not consider a request to add a dynamic test requirement, including as an alternative test, to be a petition for reconsideration of the final rule. As we did not propose regulatory text to add a dynamic test procedure in either the NPRM or the SNPRM and did not invite comment on the possibility of including such a procedure in the final rule, adding a dynamic test procedure was not within the scope of this rulemaking. Our discussion in the preamble of the NPRM explaining why we were not including a dynamic test in the proposal did not put such a test within the scope of notice. We will nonetheless discuss the issues raised by CfIR as part of explaining our position in these areas.

We also note that CfIR requested that we propose and allow for an alternative dynamic test for NCAP ratings. In the preamble to the final rule, we addressed comments concerning NCAP by explaining that the purpose of this rulemaking is to upgrade our roof strength standard. We said that the issue of whether roof strength might be addressed in some way in our NCAP program would be considered separately in the context of that program. Moreover, the possibility of addressing roof strength in our NCAP program is not a rulemaking issue. Therefore, we are not addressing issues concerning NCAP in this document.

In addition, we note that CfIR has asked the agency to make a variety of conclusions relating to the use of the JRS in research and concerning how it compares to certain respects to various dynamic tests included in the agency's standards.Seep. 4 of CfIR's supplement to its petition for reconsideration.

We are not providing such conclusions. NHTSA provided an analysis of comments concerning dynamic testing, including a discussion of several specific tests, for the limited purpose of explaining its decision whether to pursue a dynamic test as part of the current rulemaking (which would have meant issuing either a new NPRM or an SNPRM) or to initiate at this time a separate rulemaking for a dynamic test. We were not providing a comprehensive analysis of any of these various tests, and we do not take any position concerning the use of these tests in research.

CfIR claimed that the quasi-static test and criteria do not reasonably differentiate between the injury risk of compliant and non-compliant vehicles. It argued that some compliant vehicles have substantially greater injury risk than some non-compliant vehicles and vice-versa, as shown by IIHS real world rollover statistics and JRS dynamic test data.

The petitioner stated further that the agency's final rule, as compared to the earlier version of FMVSS No. 216, has as its basis a slightly modified test and significantly increased criteria for compliance with only a statistically inferred cumulative damage effect on injury potential. CfIR stated that its concern is that impact injuries are dynamic non-cumulative events and are a composite function of a vehicle's roll and pitch orientation, structural strength, geometry, elasticity and stiffness as well as occupant kinematics, interaction and effectiveness of protection features. It stated that only dynamic testing can accurately consider these variables and rate vehicles accordingly.

We do not accept CfIR's argument that the quasi-static test does not reasonably differentiate between the injury risk of compliant and non-compliant vehicles. NHTSA addressed the relationship between the FMVSS No. 216 quasi-static test procedure, alternative SWR levels, and injury risk throughout the rulemaking to upgrade the standard. We note that two studies16 the agency conducted in support of the final rule have shown significant correlations between vertical roof intrusion and occupant injury from head contact. These studies significantly relate static test performance of a vehicle's roof to real world occupant safety.

In our SNPRM, when the second peer-reviewed study was released, the agency explained (73 FR 5490):

The agency included in the FRIA a detailed discussion of how it analyzed benefits.

While CfIR has submitted numerous JRS test results and some analysis concerning those results and FMVSS No. 216 performance, it has not presented a comprehensive evaluation of real world occupant safety and JRS performance measures. We have concluded that further research would be needed to establish a correlation between performance on the JRS and real world occupant safety.

The agency recognizes that a dynamic test, if coupled with suitable injury criteria and dummy, has the potential toassess some aspects of injury risk to occupants in rollover crashes that are not addressed by the current quasi-static test. Some of these risks are addressed by other parts of our comprehensive plan for reducing the serious risk of rollover crashes and the risk of death and serious injury in those crashes, including our rulemaking for ejection mitigation. Moreover, as discussed in the final rule preamble, we are pursuing further research for a dynamic test. However, the potential benefits that might result from a future rulemaking for a dynamic test requirement do not provide an appropriate reason to delay the significant upgrade of FMVSS No. 216 set forth in the May 2009 final rule that is estimated to save 135 lives each year.

As discussed above, CfIR requested that we adjust the rule to allow for an alternate dynamic compliance test or allow for non-compliance or compliance exceptions based on submitted dynamic test evidence.

We decline to permit such an alternative. Although we are pursuing further research on dynamic tests, we have not identified the JRS test as being suitable for inclusion in FMVSS No. 216.

In its petition, CfIR claimed that, contrary to NHTSA assertions, the JRS dynamic test device has been available for two years and extensive test data submissions show it to be reliable, repeatable, validated to real world rollover injury risk and accurate in assessing comparative injury potential performance.

NHTSA considered all comments submitted in response to a Request for Comments (RFC) notice published in 2001, the NPRM, and the SNPRM prior to developing the final rule. However, we continue to believe that there are significant issues that require further research, including ones related to correlation of JRS performance measures with real world occupant safety and repeatability, as to whether the JRS device would be suitable to use for purposes of a test requirement in a Federal motor vehicle safety standard.

In discussing the issue of a dynamic rollover test, we believe it is important to distinguish between the various types of dynamic tests that might be developed and their purposes. As we discussed in the final rule preamble, rollover crashes are complex and chaotic events. Rollovers can range from a single quarter turn to eight or more quarter turns, with the duration of the rollover crash lasting from one to several seconds. The wide range of rollover conditions occurs because these crashes largely occur off road where the vehicle motion is highly influenced by roadside conditions.

The variety and complexity of real-world rollover crashes create significant challenges in developing dynamic tests suitable for a Federal motor vehicle safety standard. Rollover crash tests presented to and/or conducted by the agency have indicated a great degree of variability in vehicle and occupant kinematics.

In assessing whether a potential dynamic test would be appropriate for a Federal motor vehicle safety standard, the agency must consider such issues as (1) Whether the test is representative of real-world crashes with respect to what happens to the vehicle and any specified test dummies; (2) for the specific aspect of performance at issue, whether the test is sufficiently representative of enough relevant real-world crashes to drive appropriate countermeasures and, if not, the number and nature of necessary tests to achieve that purpose; (3) whether the test is repeatable and reproducible so that the standard will be objective and practicable; and (4) whether the test dummies to be specified are biofidelic for the purposes used.

In considering the possibility of a dynamic rollover test in the context of this particular FMVSS No. 216 rulemaking, we primarily focused on whether a particular test would appropriately assess roof crush resistance. As we explained in the NPRM and in subsequent documents, the record showed that the quasi-static procedure provides a suitable representation of the real-world dynamic loading damage patterns, and an appropriate procedure to use in upgrading the standard.

It is possible that an alternative dynamic test could be used to assess roof crush resistance in a manner similar to that of the current quasi-static test. For example, measurements of headroom might be taken before and after a dynamic crash test, and it also might be possible to measure available headroom during a crash test. CfIR cited what it referred to as post crash negative headroom.17

The potential benefits of a dynamic rollover test could be much larger if the test provided direct measurements of injury risks in a crash test that is representative of real-world crashes and there were a dummy suitable for that purpose. The agency's dynamic front and side impact test requirements were developed based upon crash types and injury outcomes in the field using anthropomorphic test dummies that were developed for specific crash tests.

In addressing the issue of repeatability in its petition, CfIR cites data which it argues show that the procedure tests vehicles in a repeatable and reliable way, with acceptable variances, to the inputs supplied by the person conducting the test. It cites variances for road speed, contact pitch angle and contact roll angle. The data it presented suggest that it is able to control these test parameters with minimal variation.

However, while it is necessary for these kinds of control parameters to be repeatable, that is only one aspect of evaluating repeatability and reproducibility. Repeatability must be evaluated using outcome or performance measures. This would include whatever performance criteria were to be included in a standard.

Moreover, if the agency were to identify the JRS test (among the many potential alternative dynamic tests) as likely to be suitable to include in FMVSS No. 216, we would need additional research to evaluate and refine, as necessary, the procedure to develop a proposal, including evaluating it in the context of the current vehicle fleet. The agency would need, for example, to evaluate the appropriate levels for the various inputs, appropriate performance criteria, repeatability, and so forth.

As noted earlier, rollover crash tests can have an undesirable amount of variability in vehicle and occupant kinematics. Moreover, there are many types of rollover crashes, and within each crash type the vehicle speed and other parameters can vary widely. A curb trip can be a very fast event with a relatively high lateral acceleration. Soil and gravel trips have lower lateral accelerations than a curb trip and lower initial roll rates. Fall-over rollovers are the longest duration events. Viano and Parenteau18 correlated eight different tests to six rollover definitions from NASS-CDS. Their analysis indicated that the types of rollovers occurring in the real-world varied significantly.Occupant kinematics will also vary with these crash types.

Numerous issues would need to be addressed to assess the suitability of using the JRS (or any other dynamic test), in a Federal motor vehicle safety standard as a more comprehensive test providing direct measurements of various injury risks. As previously discussed, these would include, but not be limited to, the following: (1) For which of the various kinds of real-world rollover crashes the test would be representative and in what ways with respect to what happens to the vehicle and any specified test dummies during the test, (2) for each specific aspect of performance at issue, whether the test is sufficiently representative of enough relevant real-world crashes, and also whether there are appropriate performance criteria, to drive appropriate countermeasures, (3) whether the test is repeatable and reproducible with respect to both input and output measures (included any performance criteria) so that the standard will be objective and practicable, (4) whether the test dummies to be specified are biofidelic for the purposes used, (5) the extent to which the test addresses real-world injuries not already addressed by other Federal motor vehicle safety standards so that the test requirement would likely result in significant safety benefits, and (6) how the test compares to other possible dynamic tests, as well as possible non-dynamic tests, for the purpose of achieving these safety benefits.

Our analysis of potential dynamic tests is complicated by the following factors:

• The currently available anthropomorphic test devices (i.e.,dummies) were not designed for use in rollover testing and have not been shown to be valid for such use.19 Frontal impact test dummies and side impact test dummies are not interchangeable and neither is suitable for use in a rollover test. The Hybrid III dummies, for example, were designed for high acceleration impacts and their motion does not resemble human response under multi axis low acceleration loading found in rollover crashes. While CfIR claims to have developed a more appropriate neck, this device has not been documented, had its biomechanical response demonstrated and correlated to human response corridors, or independently evaluated.

• There are no generally accepted performance measures to evaluate dynamic vehicle performance in rollover crashes. CfIR claimed that “NHTSA, IIHS, and consensus biomechanical performance criteria have been established and generally accepted,” but have not substantiated that claim or otherwise demonstrated the validity of the performance measures they recommend for measuring injury risk in this context. CfIR has attempted to compare measurements between vehicles and evaluate their performance measures based on their consistency with anecdotal observations regarding rollover safety.20 However, CfIR has not shown that this is a generally accepted approach for measuring real-world injury risk or otherwise demonstrated its validity.

Given these issues, as well as others discussed in the final rule preamble and appendix, we believe that there are significant issues as to whether the JRS would be suitable to use for purposes of a test requirement to include in a Federal motor vehicle safety standard.

As discussed in the final rule preamble, we would like to have a dynamic performance test for rollover crashes just as we do for front and side crashes. To that end, we are pursuing further research into the feasibility of a comprehensive dynamic test.

We are sponsoring research that will include the following: (1) Assess vehicle, crash, occupant and injury patterns in rollover crashes through epidemiologic investigations; (2) develop priorities and parameter ranges for dynamic rollover research that are derived from analytical, epidemiological, and computational investigations; (3) develop a dynamic test fixture and associated test procedure capable of simulating the dynamic rollover loading environment; (4) perform a baseline evaluation of the sensitivity of the vehicle and occupant response to static and dynamic vehicle parameters; (5) evaluate the biofidelity of currently available anthropometric test devices in terms of their ability to predict injury risk in rollover environments; and (6) evaluate the predictive capabilities of current injury criteria for the most common rollover injuries.

Also, for several years, NHTSA has evaluated the performance of occupant restraint systems in a simulated rollover environment. This test series has evaluated the performance of a variety of restraint systems in limiting occupant motion during a simulated roof to ground impact. NHTSA has recently initiated a research program to conduct full scale rollover tests to evaluate whether the relative performance of advanced restraints shown in laboratory testing can be replicated in a full scale rollover test. NHTSA is conducting a series of full vehicle rollover tests with similarly restrained front and rear seat occupants on the same side of a large SUV. The agency desires to establish a comparable inertial environment between two occupants on the same side of the vehicle to compare restraint performance.

While we hope in the future to be able to consider rulemaking to establish a dynamic rollover test, we believe that significant additional research is needed before that would be possible. We will be conducting and sponsoring our own research and will monitor the research of others, including the petitioner's. However, for the reasons discussed in this document and in the other documents we issued in the context of the rulemaking to upgrade FMVSS No. 216, we are not prepared to initiate rulemaking for a dynamic rollover test at this time.

We note that our views concerning a dynamic test appear to be similar to those of IIHS. In its March 24, 2009 Status Report,21 IIHS stated, under the heading “A Dynamic Test Would Be Ideal, But Which One?”:

In this section, we address several additional issues raised by CfIR.

In its petition, CfIR presented benefits estimates based on JRS test results and also based on IIHS estimates of benefits. The petitioner claimed, with respect to affected population and benefits, that “(c)ontrary to submitted JRS evidence of the benefits of reduced roof crush in preserving side windows and avoiding ejection portals, the agency predicts only 667 lives saved.” We note that the 667 figure is the target population of occupants who might benefit from improved roof strength rather than the number of lives saved. CfIR claimed that the agency justified its prediction “by characterizing the effect of their own statistical injury potential data and ignoring the comparable IIHS ejection, and a general 50% reduction of incapacitating injury benefit to restrained, unrestrained and ejected occupants.”

The issue raised by CfIR about the IIHS estimates of benefits is essentially the same as the one raised by Advocateset al.As discussed earlier in this document, our decision not to accept the IIHS estimates of benefits was based on a detailed analysis of the IIHS studies and methodology presented in the FRIA. CfIRet al.did not address any of the detailed criticisms of the IIHS analyses discussed by NHTSA in the FRIA, but simply claimed in its petition that the agency had ignored the IIHS estimates. Given the above discussion, including that presented in the context of the claim made by Advocateset al.we do not accept CfIR's claim. We also do not accept estimates of benefits presented by CfIR that rely on the IIHS estimates of benefits that we did not accept.

As noted earlier, in September 2009, CfIR submitted a document it called a “supplement” to its petition for reconsideration. It attached a document discussing JRS test results which it said indicate that an SWR of 4.1 is required to minimize roof crush injury potential. CfIR stated it requested reconsideration of JRS dynamic testing for the final rule for two reasons: (1) IIHS's SWR of 4 or greater has gained industry acceptance and timely voluntary compliance, and (2) the JRS test fixture accurately measures post crash negative headroom and can assess the injury potential of occupant protection systems. It stated that its supplement requests further (1) raising the static test criteria to the dynamically derived SWR criteria of 4, and (2) initiating a dynamic rollover crashworthiness NCAP program using the JRS fixture.

We note that we may, in responding to a petition for reconsideration, consider supplementary information provided in support of a request included in that petition. We observe that raising the static SWR criterion to 4 is a new request that is not within the scope of CfIR's petition.

Moreover, the fact that IIHS has selected a SWR of 4, in a one-sided test, in order for a vehicle to be rated as “good” does not provide a reason for us to conduct rulemaking for a higher SWR. We explained the basis for our decisions concerning SWR in the May 2009 final rule preamble, and CfIR has not provided any reasons for us to conduct further rulemaking on that issue.

CfIR submitted a paper titled “Scientific Review and Evaluation of the Jordan Rollover System (JRS) Impact Crash Test Device.”22 While we reviewed that paper, we believe that it does not provide sufficient new information to lead us to change our position that there are significant issues as to whether the JRS would be suitable to use for purposes of a test requirement to include in a Federal motor vehicle safety standard.

In an appendix to its petition for reconsideration, CfIR identified what it characterized as “notable errors” regarding the JRS in the body of the May 2009 final rule preamble and in Appendix A of that document. We have discussed earlier in this document a number of the issues raised by CfIR in this appendix, and are providing additional discussion about several issues raised by CfIR in that appendix below. Beyond the issues discussed earlier in this document and the additional discussion below, we believe that much of the information CfIR provides in its appendix simply represent comment about our statements. We believe there is no need to discuss each of these detailed comments, as they do not provide information that would lead us to change our position that there are significant issues as to whether the JRS would be suitable to use for purposes of a test requirement to include in a Federal motor vehicle safety standard.

Discussion on roof racks.CfIR claimed that NHTSA observed that the roof racks the agency looked at had no appreciable effect on SWR, but ignored its submissions on the substantial Nissan Xterra (and Land Rover Discovery) tubular racks and the panel-mounted Jeep Grand Cherokee racks which it asserted focused loading and created deep intruding buckles. As discussed in the final rule preamble, the existing FMVSS No. 216 test procedure specified removal of roof racks prior to platen positioning or load application. We did not propose to change that specification and, after considering a comment submitted by Xprts, did not change it in the final rule.See49 FR 22371.

We reviewed the JRS test submissions, and it continues to be our view that there has not been any demonstration that roof racks contribute substantially to roof crush so as to warrant changing the current specification. We note that we reviewed the materials provided by CfIR and, based on what was presented, could not draw a conclusion whether the roof rack degraded the performance of the roof in the test. Moreover, given the issues discussed earlier in this document, it is not clear what significance JRS test results such as these would have in showing how significant a potential problem might be in the real world.

As we discussed in the final preamble, the agency reviewed NASS-CDS and could not find any relationship that roof racks cause catastrophic deformation of the roof in a rollover. The agency stated:

Discussion about repeatability of test dummy and initial restraint positioning.We included a discussion in Appendix A of the final rule stating that because the JRS is spinning prior to initiating the vehicle test, there are concerns about how to establish the initial belt position on the test dummy in a manner that is consistent with real world conditions. We stated that the lateral acceleration prior to rollover initiation can cause a belted occupant to introduce slack in the belt. We stated that there is also the additional complication of the timing for firing the rollover curtains and/or pretensioners in the JRS pre-spin cycle.

CfIR stated that this is a reference to the CRIS test and is not appropriate to the JRS. However, we believe the language cited by CfIR as incorrect is ambiguous as the vehicle spins in the JRS just prior to impact with the roadway surface, where the CRIS has the vehicle spinning at full velocity prior to impact with the ground. Therefore, both the JRS and CRIS have the vehicle in a pre-spin prior to impact with the road surface.

For the reasons discussed above, we deny the petitions for reconsideration submitted by Advocateset al.and CfIR.

NMFS published an emergency rule to close Federal waters of the EEZ from 3 to 200 nautical miles offshore, north of Cape Hatteras, NC, to black sea bass recreational fishing in theFederal Registereffective October 5, 2009 (74 FR 51092), for a period of 180 days. This closure was necessary as the information available indicated that the 2009 Recreational Harvest Limit (RHL), the annual catch level established for the recreational fishery, had been exceeded by a considerable amount. Subsequent to the closure implementation, information from the NMFS Marine Recreational Fisheries Statistics Survey (MRFSS) through August 2009 indicated black sea bass landings were 1,944,303 lb (882 mt). This exceeded the 2009 RHL of 1,137,810 lb (516 mt) by 71 percent.

An error occurred in promulgating the October 5, 2009, emergency closure rule. The rule was published in theFederal Registerwithout specification of when the 180-day effective period would end. The rule became effective on October 5, 2009, and will remain in effect until modified by subsequent rulemaking. While NMFS clearly intended that the closure remain in effect for 180 days, consistent with the authority provided in section 305(c) of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the lack of a published end date has been confusing to stakeholders, implements a regulation that would exceed the underlying authority used to implement the closure, and requires correction. Thus, this action is correcting the October 5, 2009 (74 FR 51092), rule so that the 180-day period end date of April 12, 2010, is provided, as originally intended by NMFS and consistent with the emergency authority in the Magnuson-Stevens Act.

At the time of the initial emergency closure, NMFS, the Council, and Commission were in the process of finalizing 2010 black sea bass specifications (i.e., RHL and commercial fishery quota) and would be undertaking the initial phases of 2010 black sea bass recreational management measures shortly thereafter. It was not known exactly what the 2010 specifications would be when the closure was implemented, but the preliminary information available suggested that recreational landings in 2010 would have to be reduced from 2009 levels to ensure the 2010 RHL would not be exceeded. Thus, NMFS implemented a 180-day closure rather than implementing a closure effective only until the end of the 2009 fishing year. The expectation at the time of the closure was that the Council and Commission's joint management process for recommending recreational measures would occur through November and December 2009, with a final recommendation for managing the 2010 recreational black sea bass provided to NMFS early in 2010 for review, analysis, and rulemaking. Several unforeseen events have transpired in the interim since the initial closure was implemented on October 5, 2009. These events have made the 2010 black sea bass recreational management measuresdevelopment process more lengthy and more complex than anticipated, outlined as follows.

In December 2009, the Council and Commission developed recommended management measures for the 2010 recreational fishery. The measures were designed to achieve a 66-percent reduction in landings from projected 2009 levels, which was consistent with the black sea bass RHL of 1,137,810 lb (516 mt) previously adopted by the Council and Commission. The 66-percent reduction was calculated using 2009 landings data from Waves 1-4 (January-August), and projected landings for Waves 5 and 6 (September-December), as data for Waves 5 and 6 were not available at the time the Council and Commission met.

On December 22, 2009, NMFS published a final rule implementing the specifications for the 2010 black sea bass fishing year. These specifications, effective January 1, 2010, included total allowable landings (TAL) for black sea bass of 2.3 million lb (1,043 mt), of which 1,137,810 lb (516 mt) was allocated to the recreational fishery as the RHL. This TAL and RHL was consistent with the recommendations of the Council and Commission.

In early January 2010, the Council's Scientific and Statistical Committee (SSC) convened to reconsider their previous recommendations regarding the Acceptable Biological Catch (ABC) for black sea bass for the 2010 fishing year. The SSC concluded that the ABC for black sea bass could be increased from 2.71 million lb (1,229 mt) to 4.5 million lb (2,041 mt), which was consistent with catch levels established for 2008.

In response, on January 15, 2010, the Council submitted a letter to NMFS requesting that the agency take emergency action to increase the black sea bass TAL for 2010 consistent with the revised ABC. The letter requested that NMFS increase both the 2010 commercial quota and RHL for black sea bass.

On February 10, 2010, in response to the Council's request, NMFS published an emergency rule to increase the 2010 black sea bass TAL from 2.3 million lb (1,043 mt) to 3.7 million lb (1,678 mt), and to increase the RHL to 1,830,390 lb (830 mt) (the commercial quota was also increased to 1,758,610 lb (798 mt)).

In mid-February 2010, the Commission and Council met separately to reconsider the recreational fishery management measures developed in December 2009. The measures adopted in December 2009 were designed to achieve a 66-percent reduction in black sea bass landings relative to 2009, but with the increased RHL implemented in the emergency rule, only a 44-percent reduction appeared necessary. Both the Council and Commission retained the status quo minimum fish size of 12.5 inches (31.75 cm) and 25-fish bag limit, but the two groups adopted different seasons. The Commission adopted a single season from May 22-September 12, and the Council recommended a split season from May 22-August 8 and September 4-October 4. Both sets of measures are projected to achieve the target 44-percent reduction in landings.

NMFS is currently reviewing the recommendations made by the Council for the 2010 black sea bass recreational fishery. The Council initially submitted for review materials analyzing the recommendations and alternatives reviewed in December 2009; however, on March 3, 2010, the Council submitted an addendum to include the new recommendation developed at its February 2010 meeting. NMFS is currently developing a proposed rule for summer flounder, scup, and black sea bass recreational fishing measures for the 2010 fishing year, and this proposed rule is expected to publish soon. With this rule, NMFS will solicit comments from the public on the Council's recommendations for the black sea bass recreational fishery, as well as other alternatives that may be available, and, once the public comment period is closed, will publish a final rule to implement the final management measures for 2010.

Absent this action, the emergency closure of the black sea bass recreational fishery would expire on April 12, 2010. However, both the Council and Commission have proposed fishing seasons that open on May 22, 2010. In order to preserve the fishing seasons proposed by both groups, and to ensure that the Federal management measures are consistent, to the maximum extent practicable, with state management measures, this action is necessary to extend the closure of the black sea bass recreational fishery through May 21, 2010.

The 44-percent reduction in landings utilized by both the Council and Commission to develop their February recommendations makes use of landings projections for both MRFSS 2009 Wave 5 and 6 (September-October and November-December, respectively). The calculations for this projection were performed by the Council's Black Sea Bass Monitoring Committee (Monitoring Committee). When the Monitoring Committee met in November 2009 to discuss black sea bass recreational management measures, it acknowledged that the closure likely had some impact on landings, but that it could not quantify the impact at that time. The Monitoring Committee utilized a precautionary approach and assumed the EEZ black sea bass closure had no effect on landings because it was known that some level of fishing continued in state waters. It was expected that 2009 MRFSS Wave 5 data would be available in mid-December 2009, which would have allowed for a more informed analysis of the closure impacts on landings.

Issues related to sampling size and the telephone survey frame of the 2009 MRFSS Wave 5 have required extensive additional analyses. Thus, the data are not yet available to inform decisionmaking on 2010 black sea bass recreational fishery management measures. It is expected that the Wave 5 data will be available in April 2010, when the final 2009 MRFSS data are available. There is significant interest in how the Wave 5 data may differ from the projection used to derive the 44-percent reduction in landings utilized by the Council and Commission to 2010 black sea bass recreational management measures.

Preliminary 2009 MRFSS Wave 6 data are now available, and NMFS has incorporated these data into the analysis of 2009 recreational landings. The black sea bass fishery was closed in the EEZ for the entire Wave 6 timeframe in 2009. The preliminary Wave 6 data indicate that 2009 landings were approximately 75-percent lower than the 2008 Wave 6 level. NMFS has conducted additional projections that make use of the preliminary 2009 Wave 6 data in conjunction with different assumptions about the impact the EEZ closure had on landings between the October 6-31, 2009, period during Wave 5 2009. Based on these revised projections, it appears likely that the percent reduction in landings from 2009 levels necessary for 2010 may be less than 44 percent. NMFS anticipates being able to fully evaluate the 2009 Wave 5 data, when available, before a final rule for the 2010 black sea bass recreational management measures is implemented, and will adjust, as appropriate, the percent reduction in 2010 landings accordingly.

In the interim, it is necessary to extend the emergency closure of the recreational black sea bass fishery in the EEZ until 11:59 p.m., May 21, 2010, for several reasons. Even under the most liberalized projections for 2009 Wave 5, a reduction in landings remains necessary, and the magnitude required is sufficient to preclude fishing until May 22, 2010, the current preferred opening date for both the Council and Commission's 2010 recreational fishingseasons. NMFS requires additional time to analyze the 2009 Wave 5 data and to confer with the Council, Commission, and the public regarding the final measures to be implemented for 2010. By ensuring that the EEZ remains closed between April 12, 2010, and the start of the current Council and Commission-preferred season start date of May 22, 2010, NMFS can ensure that these additional considerations occur in an open and transparent manner. The correction and extension implemented by this action will also help avoid confusion on when fishing may resume in the EEZ, and should provide a date certain for the season to begin for business and angler planning purposes. The actions of this rule build a necessary bridge to the planned notice-and-comment rulemaking that will be conducted to establish the final 2010 black sea bass recreational management measures. A proposed rule is anticipated in April 2010, with final rulemaking anticipated for June.

A 30-day public comment period was provided on the initial 180-day closure rule. NMFS did not receive any specific comments relating to a potential extension of the initial 180-day closure. The initial closure was highly controversial and a great deal of negative reaction was received through telephone calls, e-mail, correspondence, and in the press through various media. Many of the individuals providing feedback stated surprise that the closure was being implemented, took exception to the use of MRFSS data as the basis for the overage calculations, and discussed negative socio-economic impacts related to the closure. Others stated that the closure had no biological basis, as the stock was not subject to overfishing. Litigation has been filed (UNITED BOATMEN ET AL. v.LOCKE ET AL., Case 3:09-cv-05628-JAP-LHG) that seeks, among other things, a prohibition on utilizing MRFSS data to inform inseason recreational management actions. The full scope of complaints registered by the public regarding the initial 180-day closure appear in the plaintiff's motion for relief and, as such, NMFS will respond to them through the litigation process in briefs to the court. Some may find the extension of the emergency action controversial; however, extending the closure is necessary as previously outlined.

The Administrator, Northeast Region, NMFS, determined that this emergency rule extension is necessary for the conservation and management of the black sea bass fishery and that it is consistent with the Magnuson-Stevens Fishery Conservation and Management Act and other applicable laws.

The Assistant Administrator for Fisheries, NOAA, finds good cause pursuant to 5 U.S.C. 553(d)(3) to make this rule effective immediately, thereby waiving the 30-day delayed effective date required by 5 U.S.C. 553(d). The Assistant Administrator also finds it is unnecessary and contrary to the public interest to provide any additional notice and opportunity for public comment under 5 U.S.C. 553(b)(B) prior to publishing the emergency rule extension.

The need to correct the initial emergency rule language to specify an end date and to extend this emergency closure action for an additional 39 days was not evident until February 24, 2010, when the Council notified NMFS of its intent to prepare an addendum to its initial recommendation for 2010 black sea bass recreational management measures. Prior to this date, it was unknown what course of action was likely for the 2010 fishing season and if the Council-preferred action would require extension of the 180-day closure. In examining options for extending the closure to better synchronize with the Council and Commission-preferred season opening dates, NMFS became aware of the error in the initial emergency closure rule that lacked an end date, despite the lapse in authority provided by the Magnuson-Stevens Act, effective April 12, 2010.

Typically, the process for recreational management measures begins with a joint-Council and Commission meeting in early December; a formal recommendation is conveyed to NMFS, including appropriate analyses, in late January or early February, and rulemaking is conducted with a June 1 target implementation date. However, the 2010 process has been more complex and lengthy than usual. The Council's SSC provided an increased ABC recommendation in early January 2010, NMFS conducted emergency rulemaking to increase the 2010 black sea bass TAL (including increased RHL) and both the Council and Commission, who co-manage black sea bass in state and Federal waters, respectively, had separate meetings in early February 2010 wherein new recreational management measure recommendations were adopted. As a result, both groups have conducted analysis that indicate that 2010 black sea bass recreational harvest should be decreased by 44 percent from 2009 levels. To achieve this reduction, both the Council and Commission have recommended seasons that will begin no earlier than May 22, 2010. These recommendations were not formalized until recently. Extension of the emergency closure was developed as expediently as possible; however, it was not foreseeable that the extension would be necessary until the last week of February 2010, nor was it evident that the initial 180-closure rule needed to be corrected until NMFS undertook a more detailed examination of how the Code of Federal Regulations was modified by the initial closure.

It is now evident that the initial emergency closure contained an error by not specifying April 12, 2010, as the end of the 180-day period, and, that it must be corrected. The 2010 recreational management measures process has unfolded sufficiently to make it evident that the existing recreational closure of the EEZ must remain effective until at least May 22, 2010, to ensure that the fishing mortality objectives for the 2010 recreational black sea bass fishery are not changed from the levels contained in the Council and Commission's analyses. If the initial emergency rule was not corrected, the EEZ closure would remain in effect indefinitely, despite the regulatory authority for the closure expiring on April 12, 2010. This would create a confusing and difficult situation for fishery participants. If the black sea bass recreational fishery were reopened in the EEZ effective April 12, 2010, the current expiration date of the initial 180-day closure, it is expected that recreational fishing would resume in the EEZ. The Council and Commission's preferred 2010 recreational management measures presume that no fishing will occur until at least May 22; thus, if the emergency closure is not extended by 39 days, the projections for 2010 fishing mortality will be violated. The additional mortality that would occur if fishing resumed prior to May 22 would require additional action by NMFS to further modify 2010 measures to ensure the required reduction in 2010 landings occurs. Moreover, implementation of recreational management measures would likely be further delayed while NMFS conducted additional analyses to understand the stock impacts of reopening the EEZ before the recommended May 22 date. Additional delays in the already complicated and delayed 2010 process would not benefit the angling public for planning purposes and would likely result in different measures in state and Federal waters, a situation that the Council and Commission have sought to avoid byrecommending similar measures for 2010.

Waiver of the 30-day delay in effectiveness period will ensure that the existing recreational black sea bass EEZ closure date will be clarified by the corrective action of this rule and that the closure will remain effective for an additional 39 days until 11:59 p.m., May 21, 2010. This will ensure that development of 2010 black sea bass recreational management measures will be based on the most up-to-date data, and that the mortality objectives are not compromised by reopening the fishery before the Council and Commission preferred start date of May 22. Furthermore, the correction and extension of the closure provides a date certain for the start of the 2010 fishing season so that the interested public and fishery-dependent businesses can plan accordingly. It was not practicable to promulgate the correction and extension more expediently, given the unforeseen circumstances outlined in the preamble to this rule. Public comment was solicited on the initial 180-day emergency rule, as outlined in the preamble. For the reasons outlined herein, it is contrary to the public interest to provide any additional notice and opportunity for public comment under 5 U.S.C. 553(b)(B) prior to publication of this emergency rule extension.

This final rule has been determined to be not significant for purposes of Executive Order 12866.

This rule is exempt from the procedures of the Regulatory Flexibility Act because the rule is not subject to the requirement to provide prior notice and opportunity for public comment pursuant to 5 U.S.C. 553 or any other law.