This final rule is a statutory requirement pursuant to the Agricultural Marketing Act of 1946 [7 U.S.C. 1621-1627, 1635-1638], as amended November 22, 2000, by Public Law 106-532, 114 Stat. 2541; May 13, 2002, by Public Law 107-171, 116 Stat. 207; and September 27, 2010, by Public Law 111-239, 124 Stat. 2502.

The proposed rule was published in theFederal Registeron June 10, 2011 (76 FR 112), with comments to be submitted on or before August 9, 2011. The U.S. Department of Agriculture (USDA) has reviewed and considered all of the comments submitted in a timely manner for this final rule.

Background:The Dairy Product Mandatory Reporting Program, 7 CFR part 1170, was established on August 2, 2007, on an interim final basis (72 FR 36341). A final rule associated with implementation of the program (73 FR 34175) became effective June 22, 2008. The National Agricultural Statistics Service (NASS) has collected information for the program, and the Agricultural Marketing Service (AMS) has provided verification and enforcement functions for the program. NASS has published sales information for cheddar cheese, butter, dry whey, and nonfat dry milk (NFDM) on a weekly basis. NASS began publishing cheddar cheese sales information in 1997 and butter, nonfat dry milk (NFDM), and dry whey sales information in 1998. Information was collected on a voluntary basis before the Dairy Product Mandatory Reporting Program became effective. Any manufacturer that processes and markets less than 1 million pounds of the applicable dairy products per calendar year has been exempt from these reporting requirements.

AMS is responsible for verifying the sales information submitted by reporting entities to NASS. To verify information submitted, AMS visits larger entities that account for 80 percent of the yearly reported product volume, based on the previous year, of each specified dairy product at least once annually. AMS visits one-half of entities that account for the remaining 20 percent each year, visiting each such entity at least once every other year. During each visit, AMS reviews applicable sales transactions records for at least the 4 most recent weeks. In some cases, AMS may review sales records for up to 2 years. AMS verifies that sales transactions match the information reported to NASS and that there have been no applicable sales transactions that have not been reported to NASS. Noncompliance, appeals, and enforcement procedures are administered by AMS.

The Mandatory Price Reporting Act of 2010 (Pub. L. 111-239, Sept. 27, 2010) amended section 273(d) of the Act (7 U.S.C. 1637b) to require that the Secretary establish an electronic reporting system for manufacturers of dairy products to report certain market information for the mandatory dairy product reporting program. The amendment further states that the Secretary shall publish the information obtained under this section for the preceding week not later than 3 p.m. Eastern Time on Wednesday of each week. This final rule, in accordance with the Act, includes regulatory changes for implementing these provisions. This rule also transfers applicable data collection responsibilities from NASS to AMS and includes conforming changes.

AMS requested comments on the proposed rule. AMS has reviewed all comments received within the 60-day comment period and has considered these comments in developing this final rule.

This final rule has been determined not to be significant for purposes of Executive Order 12866 and therefore has not been reviewed by the Office of Management and Budget with respect to this Executive Order.

This final rule has been reviewed under Executive Order 12988, Civil Justice Reform. The amendments contained in this final rule are not intended to have a retroactive effect.

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), AMS has considered the economic impact of this final rule on small entities and has determined that this rule would not have a significant economic impact on a substantial number of small entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions in order that small businesses will not be unduly or disproportionately burdened.

Small businesses in the dairy product manufacturing1 industry have been defined by the Small Business Administration (SBA) as those processors employing not more than 500 employees. For purposes of determining a processor's size, if the plant is part of a larger company operating multiple plants that collectively exceed the 500-employee limit, the plant will be considered a large business even if the local plant has fewer than 500 employees. According to U.S. Census Bureau Statistics of U.S. Businesses, there were 1,583 dairy manufacturing establishments in the United States in 2008. Of these businesses, 1,039 establishments had fewer than 500 employees, and 544 establishments had greater than 500 employees (U.S. Census Bureau, 2008 County Business Patterns,http://www.census.gov/econ/susb/).

The dairy manufacturing establishments included in U.S. Census Bureau statistics include manufacturers of all types of dairy products. The number of plants that produce butter, cheese, NFDM, and dry whey with the precise specifications included in the mandatory reporting requirements is much lower than this. Furthermore, those manufacturers that process and market less than 1 million pounds of the applicable dairy products annually are exempt from reporting sales data. NASS has conducted an annual validation survey that serves to determine which plants are required to report. In 2011, this survey included 181 plants. The annual cost for plants to complete this survey is estimated at approximately $9 per plant. AMS will continue to conduct the validation survey annually. For 2011 there were 94 dairy product plants subject to mandatory reporting of sales data. There are 51 reporting entities that report data for one or more plants. (Plant numbers and numbers of reporting entities have been updated from the 2010 numbers that were reported in the proposed rule.) Based upon company profile information available on the Internet, AMS estimates that almost half of the reporting entities are considered small businesses under the criteria established by the SBA.

AMS estimates that the annual cost per plant for reporting sales information for products included in the surveys will be approximately $586. (The change from $511 shown in the proposed rule is due to recognition of greater costs associated with plants that must report sales information for both 40-pound blocks and 500-pound barrel cheddar cheese.) The majority of reporting entities have already been submitting data to NASS through a secure Web-based application. Less than three plants have been regularly faxing their information, and it is believed that these plants do have Internet access. Therefore, there would be no significant start-up costs anticipated for the reporting entities as a result of implementing this final rule.

Under the current Dairy Product Mandatory Reporting Program, dairy manufacturers are required to maintain records for verification purposes for a 2-year period. This final rule makes no changes to this requirement. These records are maintained as part of the normal course of business. Thus, there is no additional burden or cost associated with the maintenance of these records. Therefore, in total, this final rule will not have a significant economic impact on a substantial number of small entities.

In accordance with the Paperwork Reduction Act (44 U.S.C. Chapter 35), reporting and recordkeeping requirements that are utilized to collect the information required by the Act have been reviewed by the Office of Management and Budget (OMB). OMB has assigned a reference number of 0581-0274.

Abstract:The information collection requirements in the request are essential to carry out the intent of the Agricultural Marketing Act of 1946 as amended (the Act).

The Act requires each manufacturer to report to the Secretary information concerning the price, quantity, and moisture content (where applicable) of dairy products sold by the manufacturer. Dairy products reported include cheddar cheese, butter, dry whey, and NFDM. Dairy manufacturers report information for these products if the products meet certain product specifications.

The collection and reporting of sales information, as required by the Act, have been the responsibility of NASS. NASS has collected the information as part of the information collection package OMB 0535-0020. NASS has allowed manufacturers to submit information through a secure Web-based application, by email, or by fax. Manufacturers have been required to submit information to NASS by 12 noon on Wednesday on all applicable sales of products during the 7 days ending 12 midnight of the previous Saturday, local time of the plant or storage facility where the sales are made. NASS has compiled and aggregated the information reported by the reporting entities and has published the information each Friday morning. When a Federal holiday has fallen on a Tuesday or Wednesday, NASS has contacted manufacturers via email or phone concerning the applicable report deadline.

Manufacturers that process and market less than 1 million pounds of applicable dairy products annually are exempt from reporting requirements. Each year, dairy manufacturers have completed an Annual Validation Worksheet for NASS to determine which dairy manufacturers are exempt and to ascertain if valid information has been supplied.

The Mandatory Price Reporting Act of 2010 amended subsection 273(d), of the Act, requiring the Secretary to establish an electronic reporting system to collect certain information. Using this reporting system, AMS will publish, not later than 3 p.m. Eastern Time on Wednesday of each week, a report containing the preceding week's information. The information collection and reporting requirements have been the responsibility of NASS. Under this final rule, AMS will assume this responsibility. NASS will no longer collect price, quantity, or moisture content (where applicable) information for cheddar cheese, butter, NFDM, or dry whey, and NASS will no longer collect the associated annual validation information. The forms associated with this data collection will be removed from NASS collection package, OMB 0535-0020, and will be replaced by forms in AMS collection package, OMB 0581-0274.

Every effort has been made to minimize any unnecessary recordkeeping costs or requirements. The electronic submission forms will require the minimum information necessary to carry out the requirements of the program effectively, and their use is necessary to fulfill the intent of the Act. It is expected that no outside technical expertise will be needed. The forms are simple, easy to understand, and place as small a burden as possible on respondents.

To assist the industry in achieving compliance, educational and outreach sessions will be held prior to implementation. AMS will assist reporting entities in understanding requirements for submitting data through electronic means. In addition, AMS will beta test the electronic-submission technology before implementation, and all entities required to report will be encouraged to participate in the beta-testing program. Any feedback received during thisoutreach and testing period will be used to correct technical problems.

Collecting the information will coincide with normal industry business practices. The timing and frequency of collecting information are intended to meet the needs of the program while minimizing the amount of work necessary to submit the required reports. The information to be collected by AMS is almost identical to the information that has been collected by NASS. While NASS has required either the total sales dollars or the dollars per pound in addition to the total pounds of products sold to be reported, AMS will require both the total sales dollars and the dollars per pound to be reported along with the total pounds of products sold in order to provide an additional validation check. NASS has permitted manufacturers to submit information through a secure web-based application, by email, or by fax. This final rule, however, requires manufacturers to submit information only by electronic means specified by AMS. AMS has specified that each manufacturer submit the information using a secure Internet connection that includes a user name and password. The requirement that reporting entities submit information electronically is in accordance with the Act.

The frequency of data collection will not change. Reporting entities have been required to report information to NASS on a weekly basis by 12 noon local time on Wednesday. This final rule requires reporting entities to report information to AMS on a weekly basis by 12 noon, local time of the reporting entities, on Tuesday. This change is necessary to allow AMS personnel time to review and compile data and to publish the information by 3 p.m. Eastern Time on Wednesday as required by the Act. If a Federal holiday falls on Monday through Wednesday of a particular week, the due date for report submission may be adjusted. Prior to the beginning of each calendar year, AMS shall inform reporting entities of the times and dates that reports are due.

The first date reporting entities shall provide information to AMS will be Tuesday, April 3, 2012, of sales data for the week ending Saturday, March 31, 2012. The first publication by AMS will be on Wednesday, April 4, 2012, by 3 p.m. Eastern Time. The last publication by NASS will be on March 30, 2012, of sales data through the week ending March 24, 2012.

Information collection requirements included in this final rule are listed below. There have been minor changes to the number of respondents compared to the proposed rule due to updated information and the separation of cheddar cheese surveys into two types: blocks and barrels.

Estimate of Burden:Public reporting burden for this collection of information is estimated to average 20 minutes per week for each report submitted.

Respondents:Cheddar cheese manufacturers of 40-pound blocks. Each reporting entity may report for a single cheddar cheese plant or it may report for more than one cheddar cheese plant, depending upon how the business is structured.

Estimated Number of Respondents:18.

Estimated Total Annual Burden on Respondents:312 hours.

Estimate of Burden:Public reporting burden for this collection of information is estimated to average 20 minutes per week for each report submitted.

Respondents:Cheddar cheese manufacturers of 500-pound barrels. Each reporting entity may report for a single cheddar cheese plant or it may report for more than one cheddar cheese plant, depending upon how the business is structured.

Estimated Number of Respondents:14.

Estimated Total Annual Burden on Respondents:243 hours.

Estimate of Burden:Public reporting burden for this collection of information is estimated to average 20 minutes per week for each report submitted.

Respondents:Butter manufacturers. Each reporting entity may report for a single butter plant or it may report for more than one butter plant, depending upon how the business is structured.

Estimated Number of Respondents:19.

Estimated Total Annual Burden on Respondents:329 hours.

Estimate of Burden:Public reporting burden for this collection of information is estimated to average 20 minutes per week for each report submitted.

Respondents:NFDM manufacturers. Each reporting entity may report for a single NFDM plant or it may report for more than one NFDM plant, depending upon how the business is structured.

Estimated Number of Respondents:28.

Estimated Total Annual Burden on Respondents:485 hours.

Estimate of Burden:Public reporting burden for this collection of information is estimated to average 20 minutes per week for each report submitted.

Respondents:Dry whey manufacturers. Each reporting entity may report for a single dry whey plant or it may report for more than one dry whey plant, depending upon how the business is structured.

Estimated Number of Respondents:20.

Estimated Total Annual Burden on Respondents:347 hours.

Estimate of Burden:Public reporting burden for this collection of information is estimated to average 20 minutes per year for each report submitted.

Respondents:Dairy manufacturers. Each reporting entity may report for a single plant or it may report for more than one plant, depending upon how the business is structured.

Estimated Number of Respondents:181.

Estimated Total Annual Burden on Respondents:60 hours.

Estimate of Burden:Public reporting burden for this collection of information is estimated to average 5 minutes for each contact from AMS.

Respondents:Dairy manufacturers. Each reporting entity may report for a single plant or it may report for more than one plant, depending upon how the business is structured.

Estimated Number of Respondents:7 per week.

Estimated Total Annual Burden on Respondents:30 hours.

Copies of this information collection and related instructions can be obtained without charge from Clifford M. Carman, Assistant to the Deputy Administrator, Dairy Programs, AMS, USDA,clifford.carman@ams.usda.gov,phone: (202) 690-2998.

Except as otherwise directed by the Secretary of Agriculture or the U.S. Attorney General for enforcement purposes, no officer, employee, or agent of the United States shall provide the public any information, statistics, or documents obtained from or submitted by any person under the Act that does not ensure preservation of confidentiality regarding the identity of persons, including parties to contracts and proprietary business information. All report forms include a statement that individual reports are kept confidential.

With respect to the application of the Privacy Act of 1974 (5 U.S.C. 552a) tothe maintenance of records required by the Act, the Dairy Products Sales survey population consists of dairy product manufacturers. Data collected by this survey relates to manufacturers' operations and transactions and not to those of individuals. Records maintained at business sites for verification of information that would be reported to AMS include contracts, agreements, receipts, and other materials related to sales of specific dairy products. No records about individuals would be maintained by AMS for this survey, and AMS believes that none would be part of these maintained business papers.

The proposed rule solicited comments to be submitted to USDA on or before August 9, 2011. During this 60-day comment period, seven comment submissions were received: Three from dairy cooperative associations, two from cooperative federations, one from a dairy producer association, and one from a dairy manufacturer/processor trade association. Six of the commenters expressed overall support for the mandatory electronic reporting system and one commenter specifically expressed support for AMS to beta test the electronic submission technology.

Two commenters asked that AMS initiate a second rule and comment period so that the industry can address issues on product specifications, data collection, and publication. AMS will consider soliciting public comments through theFederal Registeron related issues for mandatory reporting, such as product specifications.

One commenter stated that, although the Mandatory Price Reporting Act of 2010 sets timing for mandatory electronic reporting, they believe congressional authority exists for daily reporting, citing that the 2008 Farm Bill authorizes “more frequent reporting.” AMS considered this comment, however, the Act does not permit a requirement for reporting entities to report at any frequency other than weekly. Paragraph (b)(2)(C) of section 273 of the Act provides a condition that “the frequency of the required reporting * * * does not exceed the frequency used to establish minimum prices for Class III or Class IV milk under a Federal milk marketing order.” The Federal milk marketing orders establish minimum prices for Class III and Class IV milk based upon weekly dairy products prices reported (7 CFR 1000.50). Although the 2008 Farm Bill amended subsection (d) of section 273 of the Act to require more frequent reporting, subject to the availability of funds, the Mandatory Price Reporting Act of 2010 further amended the Act, deleting the requirement for more frequent reporting. One reporting entity specifically opposed any reporting period that is more frequent than weekly, citing time needed to receive warehouse bills of lading and preparation time for reporting information.

Three commenters expressed concern about the proposed change to move the weekly manufacturers' submission of reports from Wednesday 12 noon local time to Tuesday 12 noon local time, stating that this change would result in increased regulatory costs and increased revisions. AMS acknowledges that the change in reporting date by one day may cause manufacturers to change their methods of data collection and reporting, adding some additional reporting burden. However, AMS must publish sales reports by 3 p.m. Eastern Time on Wednesday whereas NASS has published sales reports on Friday morning. USDA, therefore, must change the weekly reporting day in order to complete validation checks and data analysis before weekly publication.

Three commenters had concerns about increased burdens and revisions for weeks that include an intervening holiday. AMS plans to allow reporting later in the week than Tuesday at noon when holidays intervene with reporting dates. USDA will provide the public an annual reporting schedule prior to the beginning of each calendar year.

One commenter requested that reporting flexibility be extended to accommodate situations that arise outside the control of the reporting facility. Barring any unforeseen circumstances which would make timely reporting impossible (such as an extreme natural disaster), AMS plans to hold the Tuesday noon submission deadline steadfast each week (other than a week with an intervening holiday). This will facilitate AMS in fulfilling its obligation to report by Wednesday at 3 p.m. Eastern Time each week (other than a week with an intervening holiday).

One commenter asked for guidance on how revisions would be submitted with the new electronic reporting system. Although revision procedures are not specifically spelled out in this rule, AMS will provide instructions for reporting requirements, including reporting of revisions, to all parties that must report. These instructions will be available to respondents during the reporting process. In addition, the procedures will be covered in educational and outreach sessions that will be provided to respondents prior to implementation of the amendments.

One commenter encouraged AMS to provide weekly notices to dairy manufacturers reminding them of the reporting deadlines for the following week. AMS does not plan to send weekly reminders concerning the due dates of reports. This final rule states that a schedule shall be provided to reporting entities prior to the beginning of each calendar year; AMS plans to post the scheduled reporting due dates on the Internet. This does not preclude AMS from providing other reminders to reporting entities throughout the year, such as for weeks with upcoming holidays.

Two commenters requested that reporting requirements be expanded beyond the current four commodities: Cheddar cheese, butter, nonfat dry milk, and dry whey. One commenter asked for reporting requirements to include yogurt, sour cream, cottage cheese, and other types of cheeses with a large sales volume. Another commenter asked that other products be added to the reporting list, including mozzarella (low or high moisture), Monterey Jack, Grade A Swiss, skim milk powder, buttermilk powder, whole milk powder, whey protein concentrate, and soft products or spot cream. The Act does not permit expanding the list of mandatory reported commodities beyond the four products historically reported. Paragraph (b)(2) of section 273 of the Act provides a condition that “the information * * * is required only to the extent that the information is actually used to establish minimum prices for Class III or Class IV milk under a Federal milk marketing order.” The Federal milk marketing orders establish minimum prices for Class III and Class IV milk based upon prices reported for butter, cheddar cheese, nonfat dry milk, and dry whey (7 CFR 1000.50).

One of the commenters requested that AMS expand the required reporting plants by reducing the 1 million pounds per year threshold to 500,000 pounds per year production or sales. Paragraph (b)(2)(D) of section 273 of the Act states, “the Secretary may exempt from all reporting requirements any manufacturer that processes and markets less than 1,000,000 pounds of dairy products per year.” The Act does not permit AMS to establish a reporting exemption threshold for manufacturers at any level other than 1 million pounds of dairy products processed and marketed per year.

One commenter asked that cheese committed for sale, but not yet sold (delivered), be designated as such formandatory storage reporting. Mandatory dairy product storage reporting is the responsibility of NASS, and this final rule makes no changes with respect to mandatory storage reporting.

AMS has made one change in this final rule from the proposed rule. The reporting requirements in § 1170.7(a) have been modified to indicate that reporting entities must report both the total sales dollars and dollars per pound for the applicable products. NASS has required either the total sales dollars or dollars per pound for the applicable products to be reported, and the proposed rule would have continued this requirement without change. However, the requirement to report both the total sales dollars and dollars per pound will provide AMS with a validation check to insure that, in each instance, the total sales dollars reported equals the dollars per pound times the reported quantity. Since this is a de minimus change in reporting burden, it has no effect on the estimated reporting burden for each survey.

Accordingly, 7 CFR part 1170 is amended as follows:

The Home Mortgage Disclosure Act of 1975, as amended (HMDA; 12 U.S.C. 2801et seq.) requires most mortgage lenders located in metropolitan areas to collect data about their housing-related lending activity. Annually, lenders must report those data to the appropriate federal agencies and make the data available to the public. The Bureau's Regulation C, 12 CFR part 1003, implements HMDA.

Prior to 1997, HMDA exempted depository institutions with assetstotaling $10 million or less, as of the preceding year-end. Provisions of the Economic Growth and Regulatory Paperwork Reduction Act of 1996, 12 U.S.C. 2808(b), amended HMDA to expand the asset-size exemption for depository institutions. The statutory amendment increased the dollar amount of the asset-size exemption threshold by requiring a one-time adjustment of the $10 million figure based on the percentage by which the CPI-W for 1996 exceeded the CPI-W for 1975, and it provided for annual adjustments thereafter based on the annual percentage increase in the CPI-W, rounded to the nearest multiple of one million dollars.

The definition of “financial institution” in Regulation C provides that the Bureau will adjust the asset threshold based on the year-to-year change in the average of the CPI-W, not seasonally adjusted, for each twelve month period ending in November, rounded to the nearest million. 12 CFR 1003.2. For 2011, the threshold was $40 million. During the twelve-month period ending in November 2011, the CPI-W increased by 3.43 percent. As a result, the exemption threshold is increased to $41 million. Thus, depository institutions with assets of $41 million or less as of December 31, 2011 are exempt from collecting data in 2012. An institution's exemption from collecting data in 2012 does not affect its responsibility to report data it was required to collect in 2011.

Under the Administrative Procedure Act, notice and opportunity for public comment are not required if the Bureau finds that notice and public comment are impracticable, unnecessary, or contrary to the public interest. 5 U.S.C. 553(b)(B). Comment 2(Financial institution)-2 is amended to update the exemption threshold. The amendment in this notice is technical and non-discretionary, and it merely applies the formula established by Regulation C for determining any adjustments to the exemption threshold. For these reasons, the Bureau has determined that publishing a notice of proposed rulemaking and providing opportunity for public comment are unnecessary. Therefore, the amendment is adopted in final form.

For the reasons set forth in the preamble, the Bureau of Consumer Financial Protection amends 12 CFR part 1003 as follows:

On April 28, 2011, we issued a Notice of Proposed Rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the Eurocopter Deutschland (ECD) Model EC135 helicopters. That NPRM was published in theFederal Registeron May 13, 2011, at 76 FR 27956. That NPRM proposed to reintroduce a synchronization procedure for pilots to prevent a parameter discrepancy from arising and sustain the automatic engine control.

We gave the public the opportunity to participate in developing this AD, but we did not receive any comments on the NPRM.

We have reviewed the relevant information and determined that an unsafe condition exists and is likely to exist or develop on other products of the same type design, and that air safety and the public interest require adopting the AD requirements as proposed with the changes described previously and other minor editorial changes. These changes are consistent with the intent of the proposals in the NPRM and will not increase the economic burden on any operator nor increase the scope of the AD.

We use a 50-hour time-in-service (TIS) compliance time rather than before further flight as used in the MCAI AD. Also, the MCAI AD states to follow the ASB and insert pages into the Rotorcraft Flight Manual (RFM). We did not follow the ASB, which requires the RFM information to be filed in the Section 4, Normal Procedures, of the RFM. To make compliance with the information mandatory, we are requiring that it be inserted into the Section 2, Limitations Section of the RFM.

ECD has issued Alert Service Bulletin No. EC135-71A-024, dated August 6, 2002 (ASB). The ASB contains copies of special information to be inserted into the RFM for synchronizing fuel control components for sustaining automatic engine control. The ASB specifies making copies of the RFM pages contained in the ASB, cutting them out, and filing them in the RFM. The actions described in the MCAI AD are intended to correct the same unsafe condition as that identified in this service information.

We estimate that this AD will affect about 20 helicopters of U.S. registry. We also estimate that it will take about a half work-hour to copy and insert the synchronization procedure into the RFM. The average labor rate is $85 per hour. We estimate the cost of the AD on U.S. operators to be $850.

Title 49 of the United States Code specifies the FAA's authority to issue rules on aviation safety. Subtitle I, section 106, describes the authority of the FAA Administrator. “Subtitle VII: Aviation Programs,” describes in more detail the scope of the Agency's authority.

We are issuing this rulemaking under the authority described in “Subtitle VII, Part A, Subpart III, Section 44701: General requirements.” Under that section, Congress charges the FAA with promoting safe flight of civil aircraft in air commerce by prescribing regulations for practices, methods, and procedures the Administrator finds necessary for safety in air commerce. This regulation is within the scope of that authority because it addresses an unsafe condition that is likely to exist or develop on products identified in this rulemaking action.

We determined that this AD will not have federalism implications under Executive Order 13132. This AD will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government.

For the reasons discussed above, I certify that this AD:

1. Is not a “significant regulatory action” under Executive Order 12866;

2. Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979);

3. Will not affect intrastate aviation in Alaska to the extent that a regulatory distinction is required; and

4. Will not have a significant economic impact, positive or negative, on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.

We prepared an economic evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

Accordingly, under the authority delegated to me by the Administrator, the FAA will amend 14 CFR part 39 as follows:

Publication of Project Cost Limits Under Blanket Certificates Docket No. RM81-19-000 Order of the Director, OEP

February 9, 2012.

Section 157.208(d) of the Commission's Regulations provides for project cost limits applicable to construction, acquisition, operation and miscellaneous rearrangement of facilities (Table I) authorized under the blanket certificate procedure (Order No. 234, 19 FERC ¶ 61,216). Section 157.215(a) specifies the calendar year dollar limit which may be expended on underground storage testing and development (Table II) authorized under the blanket certificate. Section 157.208(d) requires that the “limits specified in Tables I and II shall be adjusted each calendar year to reflect the `GDP implicit price deflator' published by the Department of Commerce for the previous calendar year.”

Pursuant to § 375.308(x)(1) of the Commission's Regulations, the authority for the publication of such cost limits, as adjusted for inflation, is delegated to the Director of the Office of Energy Projects. The cost limits for calendar year 2012, as published in Table I of § 157.208(d) and Table II of § 157.215(a), are hereby issued.

This final rule is effective February 15. The provisions of 5 U.S.C. 804 regarding Congressional review of Final Rules does not apply to the Final Rule because the rule concerns agency procedure and practice and will not substantially affect the rights or obligations of non-agency parties. The Final Rule merely updates amounts published in the Code of Federal Regulations to reflect the Department of Commerce's latest annual determination of the Gross Domestic Product (GDP) implicit price deflator, a mathematical updating required by the Commission's existing regulations.

Accordingly, 18 CFR part 157 is amended as follows:

The Patient Protection and Affordable Care Act, Public Law 111-148, was enacted on March 23, 2010; the Health Care and Education Reconciliation Act of 2010, Public Law 111-152, was enacted on March 30, 2010 (collectively, the Affordable Care Act). The Affordable Care Act reorganizes, amends, and adds to the provisions of part A of title XXVII of the Public Health Service Act (PHS Act) relating to group health plans and health insurance issuers in the group and individual markets. The Affordable Care Act adds section 715(a)(1) to the Employee Retirement Income Security Act (ERISA) and section 9815(a)(1) to the Internal Revenue Code (Code) to incorporate the provisions of part A of title XXVII of the PHS Act into ERISA and the Code, and make them applicable to group health plans.

Section 2713 of the PHS Act, as added by the Affordable Care Act and incorporated into ERISA and the Code, requires that non-grandfathered group health plans and health insurance issuers offering group or individual health insurance coverage provide benefits for certain preventive health services without the imposition of cost sharing. These preventive health services include, with respect to women, preventive care and screening provided for in the comprehensive guidelines supported by the Health Resources and Services Administration (HRSA) that were issued on August 1, 2011 (HRSA Guidelines).1 As relevant here, the HRSA Guidelines require coverage, without cost sharing, for “[a]ll Food and Drug Administration [(FDA)] approved contraceptive methods, sterilization procedures, and patient education and counseling for all women with reproductive capacity,” as prescribed by a provider. Except as discussed below, non-grandfathered group health plans and health insurance issuers are required to provide coverage consistent with the HRSA Guidelines, without cost sharing, in plan years (or,in the individual market, policy years) beginning on or after August 1, 2012.2 These guidelines were based on recommendations of the independent Institute of Medicine, which undertook a review of the evidence on women's preventive services.

The Departments of Health and Human Services, Labor, and the Treasury (the Departments) published interim final regulations implementing PHS Act section 2713 on July 19, 2010 (75 FR 41726). In the preamble to the interim final regulations, the Departments explained that HRSA was developing guidelines related to preventive care and screening for women that would be covered without cost sharing pursuant to PHS Act section 2713(a)(4), and that these guidelines were expected to be issued no later than August 1, 2011. Although comments on the anticipated guidelines were not requested in the interim final regulations, the Departments received considerable feedback regarding which preventive services for women should be covered without cost sharing. Some commenters, including some religiously-affiliated employers, recommended that these guidelines include contraceptive services among the recommended women's preventive services and that the attendant coverage requirement apply to all group health plans and health insurance issuers. Other commenters, however, recommended that group health plans sponsored by religiously-affiliated employers be allowed to exclude contraceptive services from coverage under their plans if the employers deem such services contrary to their religious tenets, noting that some group health plans sponsored by organizations with a religious objection to contraceptives currently contain such exclusions for that reason.

In response to these comments, the Departments amended the interim final regulations to provide HRSA with discretion to establish an exemption for group health plans established or maintained by certain religious employers (and any group health insurance coverage provided in connection with such plans) with respect to any requirement to cover contraceptive services that they would otherwise be required to cover without cost sharing consistent with the HRSA Guidelines. The amended interim final regulations were issued and effective on August 1, 2011.3 The amended interim final regulations specified that, for purposes of this exemption, a religious employer is one that: (1) Has the inculcation of religious values as its purpose; (2) primarily employs persons who share its religious tenets; (3) primarily serves persons who share its religious tenets; and (4) is a non-profit organization described in section 6033(a)(1) and section 6033(a)(3)(A)(i) or (iii) of the Code. Section 6033(a)(3)(A)(i) and (iii) of the Code refers to churches, their integrated auxiliaries, and conventions or associations of churches, as well as to the exclusively religious activities of any religious order. In the HRSA Guidelines, HRSA exercised its discretion under the amended interim final regulations such that group health plans established and maintained by these religious employers (and any group health insurance coverage provided in connection with such plans) are not required to cover contraceptive services.

In the preamble to the amended interim final regulations, the Departments explained that it was appropriate that HRSA take into account the religious beliefs of certain religious employers where coverage of contraceptive services is concerned. The Departments noted that a religious exemption is consistent with the policies in some States that currently both require contraceptive services coverage under State law and provide for some type of religious exemption from their contraceptive services coverage requirement. Comments were requested on the amended interim final regulations, specifically with respect to the definition of religious employer, as well as alternative definitions.

The Departments received over 200,000 responses to the request for comments on the amended interim final regulations. Commenters included concerned citizens, civil rights organizations, consumer groups, health care providers, health insurance issuers, sponsors of group health plans, religiously-affiliated charities, religiously-affiliated educational institutions, religiously-affiliated health care organizations, other religiously-affiliated organizations, secular organizations, sponsors of group health plans, women's religious orders, and women's rights organizations.

Some commenters recommended that the exemption for the group health plans of a limited group of religious organizations as formulated in the amended interim final regulations be maintained. Other commenters urged that the definition of religious employer be broadened so that more sponsors of group health plans would qualify for the exemption. Others urged that the exemption be rescinded in its entirety. The Departments summarize below the major issues raised in the comments that were received.

Some commenters supported the inclusion of contraceptive services in the HRSA Guidelines and urged that the religious employer exemption be rescinded in its entirety due to the importance of extending these benefits to as many women as possible. For example, one provider association commented that all group health plans and group health insurance issuers should offer the same benefits to plan participants, without a religious exemption for some plans, and that religious beliefs are more appropriately taken into account by individuals when making personal health care decisions. Others urged that the exemption be eliminated because making contraceptive services available to all women would satisfy a basic health care need and would significantly reduce long-term health care costs associated with unplanned pregnancies.

Some of the commenters supporting the elimination of the exemption argued that section 2713 of the PHS Act does not provide any explicit basis for exempting a subset of group health plans. One commenter asserted that Congress's incorporation of section 2713 of the PHS Act into ERISA and the Code indicates its intent to require coverage of recommended preventive services under section 2713 of the PHS Act in the broadest spectrum of group health plans possible.

Many commenters that opposed the exemption asked that, at a minimum, the Departments not expand the definition of religious employer. Alternatively, they asked that, if the Departments decided to base the relevant portion of the definition of religious employer on a Code section other than section 6033, the other portions of the definition of religious employer be retained to limit the exemption largely to houses of worship.

Some commenters urged the Departments not to modify the definition of religious employer. For example, some commenters asserted that the exemption is appropriatelytargeted at houses of worship, rather than a larger set of religiously-affiliated organizations. Others argued that, while the exemption addresses legitimate religious concerns, its scope is already broader than necessary and should not be expanded.

Commenters opposing any exemption stated that, if the exemption were to be retained, clear notice should be provided to the affected plan participants that their group health plans do not include benefits for contraceptive services. In addition, they urged the Departments to monitor plans to ensure that the exemption is not claimed more broadly than permitted.

On the other hand, a number of comments asserted that the religious employer exemption is too narrow. These commenters included some religiously-affiliated educational institutions, health care organizations, and charities. Some of these commenters expressed concern that the exemption for religious employers will not allow them to continue their current exclusion of contraceptive services from coverage under their group health plans. Others expressed concerns about paying for such services and stated that doing so would be contrary to their religious beliefs.

Commenters also claimed that Federal laws, including the Affordable Care Act, have provided for conscience clauses and religious exemptions broader than that provided for in the amended interim final regulations. Some commenters asserted that the narrower scope of the exemption raises concerns under the First Amendment and the Religious Freedom Restoration Act.

Other commenters, however, disputed claims that the contraceptive coverage requirement infringes on rights protected by the First Amendment or the Religious Freedom Restoration Act. These commenters noted that the requirement is neutral and generally applicable. They also explained that the requirement does not substantially burden religious exercise and, in any event, serves compelling governmental interests and is the least restrictive means to achieve those interests.

Some religiously-affiliated employers warned that, if the definition of religious employer is not broadened, they could cease to offer health coverage to their employees in order to avoid having to offer coverage to which they object on religious grounds.

Commenters supporting a broadening of the definition of religious employer proposed a number of options, generally intended to expand the scope of the exemption to include religiously-affiliated educational institutions, health care organizations, and charities. In some instances, in place of the definition that was adopted in the amended interim final regulations, commenters suggested other State insurance law definitions of religious employer. In other instances, commenters referenced alternative standards, such as tying the exemption to the definition of “church plan” under section 414(e) of the Code or to status as a nonprofit organization under section 501(c)(3) of the Code.

In response to these comments, the Departments carefully considered whether to eliminate the religious employer exemption or to adopt an alternative definition of religious employer, including whether the exemption should be extended to a broader set of religiously-affiliated sponsors of group health plans and group health insurance coverage. For the reasons discussed below, the Departments are adopting the definition in the amended interim final regulations for purposes of these final regulations while also creating a temporary enforcement safe harbor, discussed below. During the temporary enforcement safe harbor, the Departments plan to develop and propose changes to these final regulations that would meet two goals—providing contraceptive coverage without cost-sharing to individuals who want it and accommodating non-exempted, non-profit organizations' religious objections to covering contraceptive services as also discussed below.

PHS Act section 2713 reflects a determination by Congress that coverage of recommended preventive services by non-grandfathered group health plans and health insurance issuers without cost sharing is necessary to achieve basic health care coverage for more Americans. Individuals are more likely to use preventive services if they do not have to satisfy cost sharing requirements (such as a copayment, coinsurance, or a deductible). Use of preventive services results in a healthier population and reduces health care costs by helping individuals avoid preventable conditions and receive treatment earlier.4 Further, Congress, by amending the Affordable Care Act during the Senate debate to ensure that recommended preventive services for women are covered adequately by non-grandfathered group health plans and group health insurance coverage, recognized that women have unique health care needs and burdens. Such needs include contraceptive services.5

As documented in a report of the Institute of Medicine, “Clinical Preventive Services for Women, Closing the Gaps,” women experiencing an unintended pregnancy may not immediately be aware that they are pregnant, and thus delay prenatal care. They also may not be as motivated to discontinue behaviors that pose pregnancy-related risks (e.g., smoking, consumption of alcohol). Studies show a greater risk of preterm birth and low birth weight among unintended pregnancies compared with pregnancies that were planned.6 Contraceptives also have medical benefits for women who are contraindicated for pregnancy, and there are demonstrated preventive health benefits from contraceptives relating to conditions other than pregnancy (e.g., treatment of menstrual disorders, acne, and pelvic pain).7

In addition, there are significant cost savings to employers from the coverage of contraceptives. A 2000 study estimated that it would cost employers 15 to17 percent more not to provide contraceptive coverage in employee health plans than to provide such coverage, after accounting for both the direct medical costs of pregnancy and the indirect costs such as employee absence and reduced productivity.8 In fact, when contraceptive coverage was added to the Federal Employees Health Benefits Program, premiums did not increase because there was no resultinghealth care cost increase.9 Further, the cost savings of covering contraceptive services have already been recognized by States and also within the health insurance industry. Twenty-eight States now have laws requiring health insurance issuers to cover contraceptives. A 2002 study found that more than 89 percent of insured plans cover contraceptives.10 A 2010 survey of employers revealed that 85 percent of large employers and 62 percent of small employers offered coverage of FDA-approved contraceptives.11

Furthermore, in directing non-grandfathered group health plans and health insurance issuers to cover preventive services and screenings for women described in HRSA-supported guidelines without cost sharing, Congress determined that both existing health coverage and existing preventive services recommendations often did not adequately serve the unique health needs of women. This disparity places women in the workforce at a disadvantage compared to their male co-workers. Researchers have shown that access to contraception improves the social and economic status of women.12 Contraceptive coverage, by reducing the number of unintended and potentially unhealthy pregnancies, furthers the goal of eliminating this disparity by allowing women to achieve equal status as healthy and productive members of the job force. Research also shows that cost sharing can be a significant barrier to effective contraception.13 As the Institute of Medicine noted, owing to reproductive and sex-specific conditions, women use preventive services more than men, generating significant out-of-pocket expenses for women.14 The Departments aim to reduce these disparities by providing women broad access to preventive services, including contraceptive services.

The religious employer exemption in the final regulations does not undermine the overall benefits described above. A group health plan (and health insurance coverage provided in connection with such a plan) qualifies for the exemption if, among other qualifications, the plan is established and maintained by an employer that primarily employs persons who share the religious tenets of the organization. As such, the employees of employers availing themselves of the exemption would be less likely to use contraceptives even if contraceptives were covered under their health plans.

A broader exemption, as urged by some commenters, would lead to more employees having to pay out of pocket for contraceptive services, thus making it less likely that they would use contraceptives, which would undermine the benefits described above. Employers that do not primarily employ employees who share the religious tenets of the organization are more likely to employ individuals who have no religious objection to the use of contraceptive services and therefore are more likely to use contraceptives. Including these employers within the scope of the exemption would subject their employees to the religious views of the employer, limiting access to contraceptives, and thereby inhibiting the use of contraceptive services and the benefits of preventive care.

The Departments note that this religious exemption is intended solely for purposes of the contraceptive services coverage requirement pursuant to PHS Act section 2713 and the companion provisions of ERISA and the Code.

The Departments also note that some group health plans sponsored by employers that do not satisfy the definition of religious employer in these final regulations may be grandfathered health plans15 and thus are not subject to any of the preventive services coverage requirements of section 2713 of the PHS Act, including the contraceptive coverage requirement.

With respect to certain non-exempted, non-profit organizations with religious objections to covering contraceptive services whose group health plans are not grandfathered health plans, guidance is being issued contemporaneous with these final regulations that provides a one-year safe harbor from enforcement by the Departments.

Before the end of the temporary enforcement safe harbor, the Departments will work with stakeholders to develop alternative ways of providing contraceptive coverage without cost sharing with respect to non-exempted, non-profit religious organizations with religious objections to such coverage. Specifically, the Departments plan to initiate a rulemaking to require issuers to offer insurance without contraception coverage to such an employer (or plan sponsor) and simultaneously to offer contraceptive coverage directly to the employer's plan participants (and their beneficiaries) who desire it, with no cost-sharing. Under this approach, the Departments will also require that, in this circumstance, there be no charge for the contraceptive coverage. Actuaries and experts have found that coverage of contraceptives is at least cost neutral when taking into account all costs and benefits in the health plan.16 The Departments intend to develop policies to achieve the same goals for self-insured group health plans sponsored by non-exempted, non-profit religious organizations with religious objections to contraceptive coverage.

A future rulemaking would be informed by the existing practices of some issuers and religious organizations in the 28 States where contraception coverage requirements already exist, including Hawaii. There, State health insurance law requires issuers to offer plan participants in group health plans sponsored by religious employers that are exempt from the State contraception coverage requirement the option to purchase this coverage in a way that religious employers are not obligated to fund it. It is our understanding that, in practice, rather than charging employees a separate fee, some issuers in Hawaii offer this coverage to plan participants at no charge. The Departments will work with stakeholders to propose andfinalize this policy before the end of the temporary enforcement safe harbor.

Nothing in these final regulations precludes employers or others from expressing their opposition, if any, to the use of contraceptives, requires anyone to use contraceptives, or requires health care providers to prescribe contraceptives if doing so is against their religious beliefs. These final regulations do not undermine the important protections that exist under conscience clauses and other religious exemptions in other areas of Federal law. Conscience protections will continue to be respected and strongly enforced.

This approach is consistent with the First Amendment and Religious Freedom Restoration Act. The Supreme Court has held that the First Amendment right to free exercise of religion is not violated by a law that is not specifically targeted at religiously motivated conduct and that applies equally to conduct without regard to whether it is religiously motivated—a so-called neutral law of general applicability. The contraceptive coverage requirement is generally applicable and designed to serve the compelling public health and gender equity goals described above, and is in no way specially targeted at religion or religious practices. Likewise, this approach complies with the Religious Freedom Restoration Act, which generally requires a federal law to not substantially burden religious exercise, or, if it does substantially burden religious exercise, to be the least restrictive means to further a compelling government interest.

Executive Orders 13563 and 12866, among other things, direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). Executive Order 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. Executive Order 13563 also states that where “appropriate and permitted by law, each agency may consider (and discuss qualitatively) values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts.” These final regulations have been designated a “significant regulatory action,” although not economically significant, under section 3(f) of Executive Order 12866. Accordingly, these final regulations have been reviewed by the Office of Management and Budget.

As stated earlier in this preamble, the Departments previously issued amended interim final regulations authorizing an exemption for group health plans and health insurance coverage sponsored by certain religious employers from certain coverage requirements under PHS Act section 2713 (76 FR 46621, August 3, 2011). The Departments have determined that it is appropriate to finalize, without change, these amended interim final regulations authorizing the exemption of group health plans and health insurance coverage sponsored by certain religious employers from having to cover certain preventive health services under the Patient Protection and Affordable Care Act.

The Departments expect that these final regulations will not result in any additional significant burden or costs to the affected entities.

For purposes of the Department of the Treasury, it has been determined that this Treasury decision is not a significant regulatory action for purposes of Executive Order 12866. Therefore, a regulatory assessment is not required. It has also been determined that section 553(b) of the APA (5 U.S.C. chapter 5) does not apply to these final regulations, and, because these regulations do not impose a collection of information on small entities, a Regulatory Flexibility Analysis under the Regulatory Flexibility Act (5 U.S.C. chapter 6) is not required.

These final regulations are not subject to the requirements of the Paperwork Reduction Act (44 U.S.C. 3501et seq.) because they do not contain a “collection of information” as defined in 44 U.S.C. 3502(11).

The Department of the Treasury final regulations are adopted pursuant to the authority contained in sections 7805 and 9833 of the Code.

The Department of Labor final regulations are adopted pursuant to the authority contained in 29 U.S.C. 1027, 1059, 1135, 1161-1168, 1169, 1181-1183, 1181 note, 1185, 1185a, 1185b, 1185c, 1185d, 1191, 1191a, 1191b, and 1191c; sec. 101(g), Public Law104-191, 110 Stat. 1936; sec. 401(b), Public Law 105-200, 112 Stat. 645 (42 U.S.C. 651 note); sec. 512(d), Public Law 110-343, 122 Stat. 3881; sec. 1001, 1201, and 1562(e), Public Law 111-148, 124 Stat. 119, as amended by Public Law 111-152, 124 Stat. 1029; Secretary of Labor's Order 3-2010, 75 FR 55354 (September 10, 2010).

The Department of Health and Human Services final regulations are adopted pursuant to the authority contained in sections 2701 through 2763, 2791, and 2792 of the PHS Act (42 USC 300gg through 300gg-63, 300gg-91, and 300gg-92), as amended.

29 CFR part 2590 is amended as follows:

PBGC's regulation on Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribes actuarial assumptions—including interest assumptions—for paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulation are also published on PBGC's Web site (http://www.pbgc.gov).

PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.

The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for March 2012.1

The March 2012 interest assumptions under the benefit payments regulation will be 1.25 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for February 2012, these interest assumptions are unchanged.

PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on theneed to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.

Because of the need to provide immediate guidance for the payment of benefits under plans with valuation dates during March 2012, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.

PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.

Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).

In consideration of the foregoing, 29 CFR part 4022 is amended as follows:

I. General Information A. Does this action apply to me?

You may be potentially affected by this action if you are an agriculturalproducer, 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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.To access the harmonized test guidelines referenced in this document electronically, please go tohttp://www.epa.gov/ocsppand select “Test Methods and Guidelines.”

Under FFDCA section 408(g), 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-2010-0099 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 April 16, 2012. 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. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0099, 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 March 10, 2010 (75 FR 11171) (FRL-8810-8), 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 tolerance petition (PP 9F7623) by Bio-ferm GmbH, Konrad Lorenz Str. 20, Tulln, 3430, Austria. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues ofAureobasidium pullulansstrains DSM 14940 and DSM 14941. This notice referenced a summary of the petition prepared by the petitioner Bio-ferm GmbH, which is available in the docket,http://www.regulations.gov.There were no comments received in response to the notice of filing.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(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. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require 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. * * *” Additionally, section 408(b)(2)(D) of FFDCA requires that 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 performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information 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.

Aureobasidium pullulansis a “yeast-like” saprophytic fungus found in the phyllosphere of many plants, and it has been isolated from soil and aquatic environments (Refs. 1, 2, and 3). It is commonly isolated from healthy grape (Refs. 4 and 5) and apple (Ref. 6) plants, as well as other plants (Refs. 7, 8, 9, 10, and 11). Although associated with disease in some plants, the fungus generally is recognized as a saprobe, since it derives its nourishment from nonliving or decaying organic matter, and is only considered a weak pathogen or parasite of certain plants (Refs. 2 and 12). It is a known antagonist of several plant disease-causing organisms, and is an important producer of enzymes for biotechnological and industrial applications (Ref. 1).

Aureobasidium pullulansstrains DSM 14940 and DSM 14941 were isolated from apple leaves and classified by the German Strain Collection for Microorganisms (DSMZ). Neither is amutant nor genetically modified strain and they are not closely related to toxigenic human pathogens. As discussed in Pesticide Petition (PP) 9F7623, product analysis data demonstrate thatAureobasidium pullulansstrain DSM 14941 is closely related to strain DSM 14940. The two strains share many similar genetic and morphological characteristics. Bioferm GmbH has proposed to register two manufacturing-use pesticide products (MPs): “Aureobasidium pullulansstrain DSM 14941 Technical,” and “Aureobasidium pullulansstrain DSM 14940 Technical.” The active ingredient is 80% w/w (minimum of × 109colony forming units/grams (unit of measure for bacteria (cfu/g)) in each of the proposed technical products.

Bio-ferm GmbH has proposed to register two end-use products (EPs) containing equal parts ofAureobasidium pullulansstrains DSM 14940 and DSM 14941: “Blossom Protect” will be applied to pome fruit only during the blossoming period to protect plants against bacterial fire blight, and “Botector” will be applied preharvest to grapes, pome fruit, stone fruit, and strawberries to protect these crops against fruit rot diseases caused byBotrytissp.,Moniliasp.,Penicilliumsp.,Nectriasp., andPeziculasp.

The Agency has determined that, for preharvest uses, all mammalian toxicology data requirements submitted to support the petition to exempt residues ofAureobasidium pullulansstrains DSM 14940 and DSM 14941 from the requirement of a tolerance have been fulfilled (Ref. 13).

The product analysis data demonstrated thatAureobasidium pullulansstrain DSM 14941 is closely related to strain DSM 14940. Because the strains are closely related, the Agency has determined that the findings of the submitted acute toxicity/pathogenicity studies conducted only with strain DSM 14941 supported both strains, and those studies show no evidence of toxicity, or pathogenicity at the doses tested. In addition, both strains were tested in an acute subcutaneous injection toxicity/pathogenicity study in rats. The results of this study indicated that both strains were not toxic, infective, and/or pathogenic to the test animals. These findings were supported by the results of a study of the influence of temperature on the growth of the twoAureobasidium pullulansstrains, which showed that growth of both strains does not occur at or above 35 °C. Since human body temperature is 37 °C, and based on the results from these studies as discussed in this unit the Agency concluded that neither strain would be toxic, infective and/or pathogenic in humans.

1.Acute Oral Toxicity/Pathogenicity (Office of Chemical Safety and Pollution Prevention (OCSPP) Guideline 885.3050; Master Record Identification Number (MRID) No. 47899302.Twenty-four rats were administered a single dose ofAureobasidium pullulansstrain DSM 14941. Three animals of each sex were sacrificed on days 3, 7, and 14; the remaining animals were sacrificed at test end on day 21. Body tissues were examined forAureobasidium pullulans.All samples of feces, blood, brain, lung, liver, kidney, spleen, stomach, and intestine were negative. The lymph nodes of one animal sacrificed on day 7 tested positive for the presence ofAureobasidium pullulansDSM 14941. These findings show a pattern of clearance with noAureobasidium pullulansDSM 14941 detected by day 14. The results of this acceptable study demonstrated thatAureobasidium pullulansDSM 14941 was not toxic, infective, and/or pathogenic in rats, when dosed at 4 × 108cfu/animal.

2. Acute Pulmonary Toxicity/Pathogenicity (OCSPP Guideline 885.3150; MRID No. 47899303).Male and female animals were exposed intratracheally withAureobasidium pullulansstrain DSM 14941 Technical (4 × 108cfu/g). Interim sacrifices were made 3 hours post-dose and on study days 3, 7, and 14; the remaining animals were sacrificed at study end on day 21. There was no mortality, and, except on the day of dosing when the entire test material group showed reduced motor activity and dyspnea, all animals appeared normal throughout the study. Tissue samples were evaluated forAureobasidium pullulansafter sacrifice. The following tissues were negative forAureobasidium pullulansat all time points: Feces, brain, kidney, and intestine. Blood samples were negative except for one male on day 0; lung samples were negative except for two males and two females on day 0; liver samples were negative except for three males on day 0; spleen samples were negative except for two males on day 0; lymph node samples were negative except for one animal on day 7, and stomach samples were negative except for two males on day 0. These findings show a pattern of clearance with noAureobasidium pullulansDSM 14941 detected by day 14. The results of this acceptable study demonstrated thatAureobasidium pullulansDSM 14941 was not toxic, infective, and/or pathogenic in rat, when dosed at 0.8 × 108cfu/animal.

3. Acute Injection Toxicity/Pathogenicity (OCSPP Guideline 885.3200; MRID No. 47871807 and 47871808).In an acute subcutaneous toxicity/pathogenicity study (MRID 47871807), male and female rats were injected withAureobasidium pullulansstrain DSM 14940 (2.36 × 1010cfu/g) and DSM 14941 (1.5 × 1010cfu/g). Interim sacrifices were made on days 3, 7, and 14; the remaining animals were sacrificed at test end on day 21. There were no deaths, and all animals appeared normal throughout the study except for edema or slight erythema at the injection site. Samples of the following tissues were negative forAureobasidium pullulansat all time points: Feces, blood, brain, lung, liver, kidney, spleen, stomach, and intestine. Lymph node samples were negative except for one animal sacrificed on day 7. The study author suggested this was likely a post-mortem transmission. A pattern of clearance was observed in this study, with noAureobasidium pullulansDSM 14941 or 14940 detected by day 14. The results of this acceptable study demonstrated that Aureobasidium pullulans strains DSMZ 14940 and DSMZ 14941 were not toxic, infective, and/or pathogenic in rats, when dosed at 1.95 × 107or 1.12 × 107cfu/animal, respectively.

In a second acute subcutaneous toxicity/pathogenicity study (MRID 47871808), male and female rats were injected withAureobasidium pullulansstrain DSM 14941 (1.1 × 109cfu/g). Interim sacrifices were made on days 1 and 7; the remaining animals were sacrificed at test end on day 21. There were no deaths, and all animals appeared normal throughout the study except for severe edema or slight erythema at the injection site. Samples of the following tissues were negative forAureobasidium pullulansat all time points: Brain, lung, spleen, kidney, lymph nodes, blood and urine. The skin was positive forAureobasidium pullulansin three males and three females from the test material group on day 1 and in two females of the same group on day 7. The liver of one male from the test material group was positive on day 1. The cecum contents were positive in one male and one female from the test material group on day 1 and in two females from the same group on day 7. These findings show a pattern of clearance with noAureobasidium pullulansDSM 14941 detected by day 21. The results of this acceptable study demonstrated thatAureobasidium pullulansDSM 14941 was not toxic, infective, and/orpathogenic in rats, when dosed at 1.6 × 107cfu/animal.

4.Acute Dermal Toxicity (OCSPP Guideline 870.1200; MRID 47869615).In an acute dermal toxicity study, the shaved skin of 10 rats was dosed with 2,000 milligram/kilogram (mg/kg) Blossom Protect (7 × 109cfu/g each of strains DSM 14940 and DSM 14941) for 24 hours. One male exhibited chromodacryorrhea from day 7 to day 14 and one female exhibited chromodacryorrhea from day 1 to day 2 of the study, but this was not considered to be toxicologically significant because this is a normal but rare response and it did not result in mortality. All animals appeared healthy at necropsy. The lethal dose (LD50 )was >2,000 mg/kg. This study was rated acceptable, and the end use product (EP) is classified as toxicity category IV.

5.Primary Dermal Irritation (OCSPP Guideline 870.2500; MRID 47869619).In a dermal irritation study, the shaved skin of 3 rabbits was dosed with 0.5 g Blossom Protect (7 × 109cfu/gAureobasidium pullulansstrain DSM 14940 and 7 × 109cfu/gAureobasidium pullulansstrain DSM 14941) moistened with 1.0 milliliter (mL) deionized water for 4 hours. All animals appeared normal throughout the study; thus, Blossom Protect was considered to be non-irritating. This study was rated acceptable, and the EP is classified as toxicity category IV.

6.Acute Oral Toxicity (OCSPP Guideline 870.1100; MRID No. 47869614.In an acute oral toxicity study, six animals received a single 2,000 mg/kg body weight (bw) dose of Blossom Protect 22% (2 × 1010cfu/g)Aureobasidium pullulansstrain DSM 14940, 22% (2 × 1010cfu/g)Aureobasidium pullulansstrain DSM 14941, 25% sucrose, 6% water. There was no mortality, and all animals appeared normal throughout the study. The LD50was >2,000 mg/kg. This study was rated acceptable, and the EP is classified as toxicity category III.

7. Acute Inhalation Toxicity (OCSPP Guideline 870.1300; MRID 47869617).In an acute inhalation toxicity study, 10 animals were exposed nose-only to a 10% suspension of Blossom Protect (7 × 109cfu/gA. pullulansstrain DSM 14940 and 7 × 109cfu/gA. pullulansstrain DSM 14941) at 5.17 milligrams per liter (mg/L). The Mass Medium Aerodynamic Diameter (MMAD) was 4.2 µm. There were no deaths and all animals appeared healthy throughout the study. Necropsy was unremarkable. The lethal concentration (LC50 ) was >5.17 mg/L. This study was rated acceptable, and the EP is classified as toxicity category IV.

8.Acute Eye Irritation (OCSPP Guideline 870.2400; MRID 47869618).In an eye irritation study, three rabbits were dosed with 0.1 mL (60-62 grams (g) of Blossom Protect (7 × 109cfu/gA. pullulansstrain DSM 14940 and 7 × 109cfu/gA. pullulansstrain DSM 14941). One animal had a score of 1 for conjunctival redness 1 hour after application. There were no other clinical signs, and all animals appeared normal at 24 hours. Blossom protect was considered to be virtually non-irritating. This study was rated acceptable, and the EP is classified as toxicity category IV.

9.In vivo Micronucleus Assay (MRID 47899304).Twenty mice (two groups of five male and two groups of five female mice) received single 2,000 mg/kgAureobasidium pullulansstrain DSM 14941 dissolved in water by oral gavage. There were no clinical signs observed in any of the test animals, which were sacrificed 24 or 48 hours after receiving the test material. The femoral bone marrow was immediately harvested, and the ratio of polychromatic erythrocytes to total erythrocytes (mature and immature) was determined, and 2,000 immature erythrocytes/animal were scored for the presence of micronucleated immature erythrocytes, a sign of potential toxicity or damage to genetic material in the cells.Aureobasidium pullulansstrain DSM 14941 did not produce a statistically significant increase in micronucleated immature erythrocytes compared to the untreated control animals. The response of the positive control animals (treated with a known toxic substance, cyclophosphamide, by intraperitoneal injection, at 10 mg/kg) was appropriate for comparison and did produce a statistically significant increase in micronucleated immature erythrocytes compared to the untreated control animals. This study was rated acceptable.

10.Influence of Temperature on Reproduction (MRID 47871833). Aureobasidium pullulansstrain CBS 626.85 was isolated from the peritoneal dialysis fluid of a human in Australia. The effects of temperature on the reproduction or growth ofAureobasidium pullulansstrains DSM 14940 and, DSM 14941, in liquid culture or on agar plates were examined and compared against this positive control,Aureobasidium pullulansstrain CBS 626.85, to observe the ability of these strains to reproduce at human body temperature of 37 °C. All three strains grew well at 30 °C. At 33 °C, the number of replications (per 48 hours) of theAureobasidium pullulansstrains DSM 14940 and, DSM 14941 was less than one, while the number of duplications for strain CBS 626.85 was approximately five. Neither strain DSM 14940 or strain DSM 14941 was able to grow at 35 °C or 37 °C, while strain CBS 625.85 replicated (approximately) twice at 35 °C and once at 37 °C. Based on the lack of growth of the DSM strains at 35 °C and above, and given human body temperature is 37 °C,Aureobasidium pullulanstrains DSM 14940 and DSM 14941 are expected to be non-pathogenic in humans. This study was rated acceptable.

11.Hypersensitivity Incidents (OCSPP Guideline 885.3400; MRID No. 47945023).No hypersensitivity incidents, including immediate-type or delayed-type reactions of humans and domestic animals during research, development, or testing ofAureobasidium pullulansstrains DSM 14940 and DSM 14941 were reported by the applicant. Any future hypersensitivity incidents must be reported per OCSPP Guideline 885.3400.

In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

Should this microbial pesticide be present on food, the acute toxicity, infectivity, and pathogenicity data, as well as the data demonstrating the lack of growth at human body temperature submitted forAureobasidium pullulansstrains DSM 14940 and DSM 14941 demonstrated that no toxicity, infectivity, and/or pathogenicity is likely to occur with any exposure level resulting from application of these two proposed pesticide active ingredients in accordance with good agricultural practices (see Unit III.B.).

1. Food.Naturally occurringAureobasidium pullulansis likely to be present on fresh produce. According to Webb and Mundt (1978) (Ref. 11)Aureobasidium pullulansis “a major resident on most green plants.” In a study with several species of crop plants, they determinedAureobasidium pullulansto be among the most abundant (71%-85%) of all fungi present on the plant surfaces.Aureobasidium pullulansmade up an average of 77.1% of the mold species isolated on green beans, and occurred athigh levels (up to 2.7 × 104cfu/centimeter2(cm2) on certain fruits (cucumbers and squash). Dietary exposure toAureobasidium pullulansstrains DSM 14940 and DSM 14941, therefore, is possible from strawberries, grapes, pome and stone fruits harvested naturally and from plants treated with these fungicidal active ingredients. The submitted acute oral toxicity/pathogenicity studies indicated that ifAureobasidium pullulansstrains DSM 14940 and DSM 14941 are ingested, no toxic or pathogenic effects will result. In addition,Aureobasidium pullulansstrains DSM 14940 and DSM 14941 do not reproduce at the normal human body temperature of 37 °C. Therefore, in the event oral exposure should occur by ingesting treated fruits, the Agency concludes that there is a reasonable certainty that no harm will result from exposure to such residues.

2. Drinking water exposure.Naturally occurringAureobasidium pullulansis ubiquitous and has been isolated from all types of water (Ref. 14). Exposure of humans to residues of pesticides containingAureobasidium pullulansstrains DSM 14940 and DSM 14941 in consumed drinking water is possible but potential exposure through drinking water is reduced, given the proposed use patterns, use sites, and application methods forAureobasidium pullulansstrains DSM 14940 and DSM 14941, which do not include direct application to aquatic environments. In the event thatAureobasidium pullulansstrains DSM 14940 and DSM 14941 are transferred to surface water or ground water intended for human consumption, the fungi would not survive the high temperatures, chlorination, pH adjustments, and/or filtration water is subjected to in a drinking water treatment facility. Even if oral exposure should occur through consumed drinking water, there is a reasonable certainty that no harm will result from exposure to such residues, based upon the lack of toxicity, infectivity, and/or pathogenicity, as well as the inability of these fungal strains to grow at human body temperature, demonstrated in the previously described toxicological studies (see Unit III.B.).

The use sites for these products include residential garden sites and agricultural sites.Aureobasidium pullulansis naturally present in many habitats, and based on the data and other information submitted to satisfy data requirements for registration of the MPs and EPs containing the active ingredientsAureobasidium pullulansstrains DSM 14940 and DSM 14941, no toxicity, infectivity, pathogenicity or other adverse effects from non-occupational exposure are expected (see Unit III.B.).

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.”

The likelihood of adverse cumulative effects occurring via a common mechanism of toxicity is minimal, based on the lack of toxicity/pathogenicity/infectivity potential of the active ingredients whenAureobasidium pullulansstrains DSM 14940 and DSM 14941 are used in or on food commodities and/or labeled for residential uses (see Unit III.B.). In addition,Aureobasidium pullulansstrains DSM 14940 and DSM 14941 do not appear to produce a toxic metabolite produced by 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 Web site athttp://www.epa.gov/pesticides/cumulative.

FFDCA section 408(b)(2)(C) provides that EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) 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 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. 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.

Based on the acute toxicity and pathogenicity data summarized in Unit III.B., EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues ofAureobasidium pullulansstrains DSM 14940 and DSM 14941. This includes all anticipated dietary exposures and all other exposures for which there is reliable information. EPA has arrived at this conclusion because the data and information available onAureobasidium pullulansstrains DSM 14940 and DSM 14941 do not demonstrate toxic, pathogenic, and/or infective potential to mammals. Thus, there are no threshold effects of concern and, as a result, the Agency has concluded that an additional margin of safety for infants and children is unnecessary in this instance. Further, the need to consider consumption patterns, special susceptibility, and cumulative effects does not arise when dealing with pesticides with no demonstrated significant adverse effects.

An analytical method is not required for enforcement purposes since the Agency is establishing an exemption from the requirement of a tolerance without any numerical limitation.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL forAureobasidium pullulansstrains DSM 14940 or DSM 14941.

EPA concludes that there is a reasonable certainty that no harm will result to the United States population, including infants and children, from aggregate exposure to residues of Aureobasidium pullulansstrains DSM 14940 and DSM 14941. Therefore, an exemption from the requirement of a tolerance is established for residues ofAureobasidium pullulansstrains DSM 14940 and DSM 14941 in or on all food commodities when applied as a preharvest fungicide and used in accordance with good agricultural practices.

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 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.

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).

Therefore, 40 CFR chapter I is amended as follows:

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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.To access the harmonized test guidelines referenced in this document electronically, please go tohttp://www.epa.gov/ocsppand select “Test Methods and Guidelines.”

Under FFDCA section 408(g), 21 U.S.C. 346a(g), 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-2010-0807 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 April 16, 2012. 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. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2010-0807, by one of the following methods:

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

•Mail: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 February 4, 2011 (76 FR 6465) (FRL-8858-7), 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 tolerance petition (PP 0F7749) by Pasteuria Bioscience, Inc., 12085 Research Dr., Suite 185, Alachua, FL 32615. The petition requested that 40 CFR part 180 be amended by establishing an exemption from the requirement of a tolerance for residues ofPasteuria nishizawae—Pn1. This notice referenced a summary of the petition prepared by the petitioner, Pasteuria Bioscience, Inc., which is available in the docket viahttp://www.regulations.gov.Comments were received on the notice of filing. EPA's response to these comments is discussed in Unit VII.C.

Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an exemption from the requirement for a tolerance (the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the exemption is “safe.” Section 408(c)(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. Pursuant to section 408(c)(2)(B) of FFDCA, in establishing or maintaining in effect an exemption from the requirement of a tolerance, EPA must take into account the factors set forth in section 408(b)(2)(C) of FFDCA, which require EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance exemption 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. * * *” Additionally, section 408(b)(2)(D) of FFDCA requires that EPA consider “available information concerning the cumulative effects of [a particular pesticide's] * * * residues and other substances that have a common mechanism of toxicity.”

EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through otherexposures that occur as a result of pesticide use in residential settings.

Consistent with section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action and considered its validity, completeness, and reliability and the relationship of this information 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.

Pasteuria,a genus of bacteria, includes several species that have shown potential in controlling plant-parasitic nematodes that attack and cause significant damage to many agricultural crops (see, e.g., theFederal Registerof December 28, 1994 (59 FR 66740) (FRL-4923-4) and June 30, 2010 (75 FR 37734) (FRL-8831-9) for final rules that established tolerance exemptions for residues of the nematicides,Pasteuria penetrans(40 CFR 180.1135) andPasteuria usgae(40 CFR 180.1290), respectively). These gram-positive, mycelial, endospore-forming bacteria are mostly obligate parasites (i.e., organisms that depend on particular hosts to complete their own life cycle) of plant-parasitic nematodes, although onePasteuriaspecies—Pasteuria ramosa—is known to parasitizeDaphniaspecies, which are tiny crustaceans often called “water fleas” due to their flea-like size and appearance (Refs. 1 and 2).Pasteuriaspecies are ubiquitous in most environments and are found in nematodes in at least 80 countries on 5 continents, as well as on islands in the Atlantic, Pacific, and Indian Oceans (Ref. 2). Higher population densities often occur in areas where there is an ample supply of nematode hosts (e.g., where crops susceptible to nematodes are cultivated) (Refs. 3, 4, and 5).Pasteuria nishizawae—Pn1 was specifically isolated from an Illinois soybean field in the mid-2000s (Ref. 1).

Although endospores ofPasteuria nishizawaehave been observed to attach to the cuticle of 3 nematodes of the genusHeteroderaand 1 nematode of the genusGlobodera,it is known only to infect and complete its life cycle within the female soybean cyst nematode (Heterodera glycines) (Ref. 2). In the following manner,Pasteuria nishizawae—Pn1 exerts a pesticidal effect on the soybean cyst nematode through parasitism that ultimately results in the death of infected females:

1. Endospores attach to the cuticle of a juvenile soybean cyst nematode female.

2. Once a soybean cyst nematode female invades soybean roots,Pasteuria nishizawae—Pn1 produces a germ tube that penetrates the body of the nematode.

3. Primary and secondary microcolonies ofPasteuria nishizawae—Pn1 develop and proliferate within the body of the nematode, causing its death (Ref. 2).

In light of the demonstrated nematicidal capabilities and host specificity ofPasteuria nishizawae—Pn1, Pasteuria Bioscience, Inc. has proposed to register pesticide products that could be applied to soybean or its seed to control the soybean cyst nematode.

All applicable mammalian toxicology data requirements supporting the request for an exemption from the requirement of a tolerance for residues ofPasteuria nishizawae—Pn1 in or on all food commodities have been fulfilled with data submitted by the petitioner. The results of the acute dermal toxicity and primary dermal irritation tests revealed no toxicity or irritation attributed toPasteuria nishizawae—Pn1, and these studies received a Toxicity Category IV classification (see 40 CFR 156.62). Moreover, acute oral, pulmonary, and injection toxicity/pathogenicity tests indicated thatPasteuria nishizawae—Pn1 was not toxic and/or pathogenic via the tested routes of exposure. Although infectivity and clearance were not evaluated in any of the acute toxicity/pathogenicity tests, EPA believes that these endpoints are not a concern given the host specificity ofPasteuria nishizawaefor the soybean cyst nematode (Refs. 1 and 2). Finally, the petitioner has reported that no hypersensitivity incidents occurred during development and testing of this bacterium. The overall conclusions from all toxicological information submitted by the petitioner are briefly described in this unit, while more in-depth synopses of some study results can be found in the associated Biopesticides Registration Action Document provided as a reference in Unit IX. (Ref. 6).

1. Acute oral toxicity/pathogenicity—rat (Harmonized Guideline 885.3050; Master Record Identification Number (MRID No.) 481517-09).A supplemental acute oral toxicity/pathogenicity study demonstrated thatPasteuria nishizawae—Pn1 was not toxic and/or pathogenic to laboratory rats when administered by oral gavage in a single dose of 1.6 × 109spores per animal. Although clearance and infectivity were not measured, EPA believes these endpoints are not a concern givenPasteuria nishizawae—Pn1's well-established host specificity for the soybean cyst nematode (Refs. 1 and 2).

2. Acute pulmonary toxicity/pathogenicity—rat (Harmonized Guideline 885.3150; MRID No. 481517-10).A supplemental acute pulmonary toxicity/pathogenicity study demonstrated thatPasteuria nishizawae—Pn1 was not toxic and/or pathogenic to laboratory rats when administered by intratracheal instillation in a single dose of 1.6 × 108spores per animal. Although clearance and infectivity were not measured, EPA believes these endpoints are not a concern givenPasteuria nishizawae—Pn1's well-established host specificity for the soybean cyst nematode (Refs. 1 and 2).

3. Acute injection toxicity/pathogenicity (intravenous)—rat (Harmonized Guideline 885.3200; MRID No. 481517-11).A supplemental acute injection toxicity/pathogenicity study demonstrated thatPasteuria nishizawae—Pn1 was not toxic and/or pathogenic to laboratory rats when administered intravenously in a single dose of 1.0 × 109spores per animal. Although clearance and infectivity were not measured, EPA believes these endpoints are not a concern givenPasteuria nishizawae—Pn1's well-established host specificity for the soybean cyst nematode (Refs. 1 and 2).

4. Hypersensitivity incidents (Harmonized Guideline 885.3400; MRID No. 481517-12).The petitioner reported that no hypersensitivity incidents, including immediate-type or delayed-type reactions of humans and domestic animals, occurred during research, development, or testing ofPasteuria nishizawae—Pn1.

5. Acute dermal toxicity—rabbit (Harmonized Guideline 870.1200; MRID No. 481517-14).An acceptable acute dermal toxicity study demonstrated that a test substance containingPasteuria nishizawae—Pn1 was not toxic to rabbits when dosed at 2,000 milligrams per kilogram (mg/kg) for 24 hours. The dermal median lethal dose, which is a statistically derived single dose that can be expected to cause death in 50% of test animals, was greater than 2,000 mg/kg for male and female rats combined (Toxicity Category IV).

6. Primary dermal irritation—rabbit (Harmonized Guideline 870.2500; MRID No. 481517-16).An acceptable primary dermal irritation study demonstratedthat a test substance containingPasteuria nishizawae—Pn1 was essentially non-irritating to the skin of rabbits (Toxicity Category IV).

In examining aggregate exposure, section 408 of FFDCA directs EPA to consider available information concerning exposures from the pesticide residue in food and all other non-occupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings (residential and other indoor uses).

1. Food exposure.Dietary exposure toPasteuria nishizawae—Pn1, a naturally occurring soil bacterium (Refs. 7, 8, and 9), is anticipated to be negligible. For optimal control of the target pest (soybean cyst nematode),Pasteuria nishizawae—Pn1 is applied in a manner that facilitates spore movement into or spore placement near the root zone of potentially affected plants. This requires that end users take certain actions, depending on the treatment type, that would inevitably minimize the amount ofPasteuria nishizawae—Pn1 residues on above-ground commodities. That is, althoughPasteuria nishizawae—Pn1 can be applied to soil, plants, or seeds, some seeds are incorporated into the soil immediately after treatment (at-planting, hopper box, planter box, or slurry box seed treatments), and pesticide applications made to plants or the soil are always followed by irrigation to incorporatePasteuria nishizawae—Pn1 into the soil. In instances where food commodities develop underground or where treated seed is diverted for food or feed purposes or to process into oil, exposure toPasteuria nishizawae—Pn1 is a more likely scenario. Regardless of the situation, shouldPasteuria nishizawae—Pn1 be present on food, its specificity for the soybean cyst nematode and available data indicate no toxicity, pathogenicity, and/or infectivity is likely to occur with any dietary exposure that results from pesticide applications made in accordance with good agricultural practices (see additional discussion in Unit III.).

2. Drinking water exposure.Exposure to residues ofPasteuria nishizawae—Pn1 in consumed drinking water is possible but not likely. The proposed use patterns forPasteuria nishizawae—Pn1 are soil directed, soil incorporated, and/or seed directed, thereby limiting contact with surface water by drift and runoff. Furthermore, ground water is not expected to have significant exposure toPasteuria nishizawae—Pn1 since, like other microorganisms, this microbial pesticide would likely be filtered out by the particulate nature of many soil types (Refs. 10, 11, and 12). IfPasteuria nishizawae—Pn1 were to be transferred to surface or ground waters (e.g., through spray drift or runoff) that are intended for eventual human consumption and directed to wastewater treatment systems or drinking water facilities, it may not survive some of the conditions water is subjected to in such systems or facilities, including chlorination, pH adjustments, and filtration (Refs. 13 and 14). In the remote likelihood thatPasteuria nishizawae—Pn1 is present in drinking water (e.g., water not subject to certain conditions in treatment systems and facilities), its specificity for the soybean cyst nematode and available data indicate no toxicity, pathogenicity, and/or infectivity is likely to occur with any drinking water exposure that results from pesticide applications made in accordance with good agricultural practices (see additional discussion in Unit III.).

GivenPasteuria nishizawae's natural presence in soil (Refs. 7, 8, and 9), non-occupational exposure to the bacterium is likely already occurring. Additional exposure toPasteuria nishizawae—Pn1 due to pesticidal applications is not expected because all proposed pesticide end-use products are labeled for use in distinct agricultural settings. Even if non-occupational exposures were to occur (e.g., eventual expansion of use sites), such exposures would not exceed EPA's level of concern in light ofPasteuria nishizawae—Pn1's specificity for the soybean cyst nematode and test results that indicatedPasteuria nishizawae—Pn1 is not toxic (acute dermal toxicity and acute pulmonary toxicity/pathogenicity), is essentially non-irritating (primary dermal irritation), and is not pathogenic (acute pulmonary toxicity/pathogenicity) (see additional discussion in Unit III.).

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

No mechanism of toxicity in mammals has been identified forPasteuria nishizawae—Pn1, andPasteuria nishizawae—Pn1 does not appear to produce a toxic metabolite against the target pest. For the purposes of this tolerance action, EPA has assumed thatPasteuria nishizawae—Pn1 does not have a common mechanism of toxicity with other substances. Therefore, section 408(b)(2)(D)(v) of FFDCA does not apply. 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 Web site athttp://www.epa.gov/pesticides/cumulative.

FFDCA section 408(b)(2)(C) provides that, in considering the establishment of a tolerance or tolerance exemption for a pesticide chemical residue, EPA shall assess the available information about consumption patterns among infants and children, special susceptibility of infants and children to pesticide chemical residues, and the cumulative effects on infants and children of the residues and other substances with a common mechanism of toxicity. In addition, FFDCA section 408(b)(2)(C) 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 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 Factor. 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.

Based on the acute toxicity and pathogenicity data discussed in Unit III.B., as well asPasteuria nishizawae—Pn1's host specificity for the soybean cyst nematode, EPA concludes that there are no threshold effects of concern to infants, children, or adults whenPasteuria nishizawae—Pn1 is used as labeled in accordance with good agricultural practices. As a result, EPA concludes that no additional margin of exposure (safety) is necessary to protect infants and children and that not adding any additional margin of exposure (safety) will be safe for infants and children.

Moreover, based on the same data and EPA analysis as presented in this unit, the Agency is able to conclude that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to the residues ofPasteuria nishizawae—Pn1 when it is used as labeled and in accordance with good agricultural practices as a nematicide. Such exposure includes all anticipated dietary exposures and all other exposures for which there is reliable information. EPA has arrived at this conclusion because, considered collectively, the data and information available onPasteuria nishizawae—Pn1 do not demonstrate toxic, pathogenic, and/or infective potential to mammals, including infants and children.

An analytical method is not required for enforcement purposes for the reasons stated in this document and because EPA is establishing an exemption from the requirement of a tolerance without any numerical limitation.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. In this context, EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has not established a MRL forPasteuria nishizawae—Pn1.

Two comments were submitted. An anonymous commenter (EPA-HQ-OPP-2010-0012-0019) generally expressed opposition to EPA granting tolerance exemptions to several petitioners, including Pasteuria Bioscience, Inc. Specifically, this commenter mentioned concern with the prevalence of many toxic chemicals in the environment and lack of information regarding how such chemicals combine. Another commenter (EPA-HQ-OPP-2010-0905-0003) also expressed opposition to granting tolerances and tolerance exemptions for several chemicals, includingPasteuria nishizawae—Pn1, that were described in theFederal Registerof February 4, 2011. This commenter stated that the food supply must be rigorously tested, that studies submitted by the chemical industry must be subjected to independent peer review, and that only long-term studies can provide data on the health impact of exposure to the chemicals in the February 4, 2011 notice of filing.

Data provided by the petitioner demonstrated thatPasteuria nishizawae—Pn1 is not toxic and/or pathogenic at the doses administered orally, intratracheally, intravenously, and dermally to rats or rabbits (see Unit III.B.). Although infectivity and clearance were not evaluated in any of these studies, EPA believes that these endpoints are not a concern givenPasteuria nishizawae—Pn1's well-established host specificity for the soybean cyst nematode (Refs. 1 and 2). Moreover, since no mechanism of toxicity in mammals has been identified forPasteuria nishizawae—Pn1, andPasteuria nishizawae—Pn1 does not appear to produce a toxic metabolite against the target pest, EPA has assumed thatPasteuria nishizawae—Pn1 does not have a common mechanism of toxicity with other substances. After conducting a comprehensive assessment of the data and information submitted by the petitioner, EPA has concluded there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues ofPasteuria nishizawae—Pn1. Thus, under the standard in FFDCA section 408(c)(2), a tolerance exemption is appropriate.

Two modifications have been made to the requested tolerance exemption. First, since Pasteuria Bioscience, Inc. already created a unique isolate identifier (i.e., Pn1) forPasteuria nishizawae,inclusion of the American Type Culture Collection accession number (i.e., SD-5833) within this microbial pesticide's taxonomic name was unnecessary. Use of justPasteuria nishizawae—Pn1 throughout this document, particularly in the tolerance exemption expression, is now consistent with the representation of this active ingredient in other associated regulatory documents and should assist in preventing confusion regarding its nomenclature in the future. Second, EPA is changing “in or on all raw agricultural crops” to “in or on all food commodities” to align with the terminology the Agency currently uses when establishing tolerance exemptions for residues of other like active ingredients.

EPA concludes that there is a reasonable certainty that no harm will result to the U.S. population, including infants and children, from aggregate exposure to residues ofPasteuria nishizawae—Pn1. Therefore, an exemption from the requirement of a tolerance is established for residues ofPasteuria nishizawae—Pn1.

This final rule establishes a tolerance exemption under section 408(d) of FFDCA in response to a petition submitted to EPA. 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 exemption 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. As a result, this action does not 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, EPA 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, EPA 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) (Pub. L. 104-4).

This action does not involve any technical standards that would require EPA 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).

Therefore, 40 CFR chapter I is amended as follows:

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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under section 408(g) of the FFDCA, 21 U.S.C. 346a(g), 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-2011-0783 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 April 16, 2012. 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. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0783, 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.

EPA, on its own initiative, in accordance with sections 408(e) and 408(l)(6) of FFDCA, 21 U.S.C. 346a(e) and 346a(1)(6), is establishing time-limited tolerances for combined residues of spirotetramat, including its metabolites and degradates, in or on onion, dry bulb at 0.3 parts per million (ppm). This time-limited tolerance expires on December 31, 2014.

Section 408(l)(6) of FFDCA requires EPA to establish a time-limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on FIFRA section 18 related time-limited tolerances to set binding precedents for the application of section 408 of FFDCA and the safety standard to other tolerances and exemptions. Section 408(e) of FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i.e., without having received any petition from an outside party.

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. * * *”

Section 18 of FIFRA authorizes EPA to exempt any Federal or State agency from any provision of FIFRA, if EPA determines that “emergency conditions exist which require such exemption.” EPA has established regulations governing such emergency exemptions in 40 CFR part 166.

Thrips rasp the onion tissue and drain the exuding sap, causing stunted and deformed plants. High thrip populations during bulbing can reduce yield. In addition, high thrip populations and the associated damage can shift the onion bulb size distribution downward and reduce onion quality. Of even more concern, thrips can infect plants with iris yellow spot virus. The virus in conjunction with thrips feeding activity can result in an average 25-35%decrease in yield with yield losses observed as high as 53% in some fields. Onion thrips thrive under hot, dry conditions, and can increase and spread very quickly. In addition to their ability to rapidly increase in population, thrips also migrate into onion fields from adjacent crops. For example, as nearby cereal crops dry down in the early summer and alfalfa fields are harvested, large populations of thrips can migrate to onions. There are a number of products registered for thrips control on onions. Many were never effective or have become ineffective due to development of resistance. Due to the label restrictions on the available effective insecticides, it is currently infeasible for producers to control thrips for the entire production season with the available insecticides in most areas of onion production.

After having reviewed the submissions, EPA determined that an emergency condition exists for eleven states (Colorado, Idaho, Michigan, Minnesota, Nevada, New York, Oregon, Texas, Utah, Washington, and Wisconsin), and that the criteria for approval of emergency exemptions are met. EPA has authorized specific exemptions under FIFRA section 18 for the use of spirotetramat on dry bulb onion for control of onion thrips (Thrips tabaci) in the 11 states listed in this unit.

As part of its evaluation of the emergency exemption applications, EPA assessed the potential risks presented by residues of spirotetramat in or on onion, dry bulb. In doing so, EPA considered the safety standard in section 408(b)(2) of FFDCA, and EPA decided that the necessary tolerance under section 408(l)(6) of FFDCA would be consistent with the safety standard and with FIFRA section 18. Consistent with the need to move quickly on the emergency exemption in order to address an urgent non-routine situation and to ensure that the resulting food is safe and lawful, EPA is issuing this tolerance without notice and opportunity for public comment as provided in section 408(l)(6) of FFDCA. Although this time-limited tolerance expires on December 31, 2014, under section 408(l)(5) of FFDCA, residues of the pesticide not in excess of the amounts specified in the tolerance remaining in or on onion, dry bulb after that date will not be unlawful, provided the pesticide was applied in a manner that was lawful under FIFRA, and the residues do not exceed a level that was authorized by this time-limited tolerance at the time of that application. EPA will take action to revoke this time-limited tolerance earlier if any experience with, scientific data on, or other relevant information on this pesticide indicate that the residues are not safe.

Because this time-limited tolerance is being approved under emergency conditions, EPA has not made any decisions about whether spirotetramat meets FIFRA's registration requirements for domestic use on dry bulb onions or whether permanent tolerances for this use would be appropriate. Under these circumstances, EPA does not believe that this time-limited tolerance decision serves as a basis for registration of spirotetramat by a State for special local needs under FIFRA section 24(c). Nor does this tolerance by itself serve as the authority for persons in any State other than the 11 states listed in this unit to use this pesticide on the applicable crops under FIFRA section 18 absent the issuance of an emergency exemption applicable within that State. For additional information regarding the emergency exemption for spirotetramat, contact the Agency's Registration Division at the address provided underFOR FURTHER INFORMATION CONTACT.

Consistent with the factors specified in FFDCA section 408(b)(2)(D), 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 expected as a result of this emergency exemption request and the time-limited tolerances for combined residues of spirotetramat and its metabolites and degradates on onion, dry bulb at 0.3 ppm. EPA's assessment of exposures and risks associated with establishing time-limited tolerances follows.

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-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 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 spirotetramat used for human risk assessment is discussed in Unit III. of the final rules published in theFederal Registerof July 9, 2008 (73 FR 39251) (FRL-8367-1) and May 18, 2011 (76 FR 28675) (FRL-8865-8). The final rule of July 9, 2008 established a number of tolerances for residues of spirotetramat, including onion, bulb, subgroup 3A-07. Subsequently, in the final rule published in theFederal Registerof May 18, 2011, EPA added a footnote to the established tolerance for onion, bulb, subgroup 3A-07 to indicate that currently there are no U.S. registrations for onions. Use on onions at that time was assessed for import tolerances only.

1.Dietary exposure from food and feed uses.In evaluating dietary exposure to spirotetramat, EPA considered exposure under the time-limited tolerances established by this action as well as all existing spirotetramat tolerances in 40 CFR 180.641. EPA assessed dietary exposures from spirotetramat 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. Such effects were identified for spirotetramat. In estimating acute dietary exposure, EPA used food consumption information from the United States Department of Agriculture (USDA) 1994-1996 and 1998 Nationwide Continuing Surveys of Food Intake by Individuals (CSFII). As to residue levels in food, EPA assumed 100 percent crop treated (PCT) and tolerance-level residues for all foods. Empirical and Dietary Exposure Evaluation Model (DEEMTM) (ver. 7.81) default processing factors were used for processed commodities. Residues in drinking water were addressed byincorporating directly in the dietary assessment the acute concentrations of spirotetramat residues in surface water estimated by the First Index Reservoir Screening Tool (FIRST) model.

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 conducted a conservative chronic dietary assessment assuming tolerance-level residues, empirical and DEEMTM(ver. 7.81) default processing factors, and 100 PCT. Drinking water was incorporated directly in the dietary assessment using the chronic concentrations for surface water.

iii.Cancer.Based on the data summarized in Unit IV.A., EPA has concluded that spirotetramat does not pose a cancer risk to humans. Therefore, a dietary exposure assessment for the purpose of assessing cancer risk is unnecessary.

iv.Anticipated residue and PCT information.EPA did not use anticipated residue and/or PCT information in the dietary assessment for spirotetramat. 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 spirotetramat in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of spirotetramat. 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 and Screening Concentration in Ground Water (SCI-GROW) models, the estimated drinking water concentrations (EDWCs) of spirotetramat for acute exposures are estimated to be 0.212 parts per billion (ppb) for surface water; and 3.96 × 10−4ppb for ground water.

For chronic exposures for non-cancer assessments, the EDWCs are estimated to be 1.37 × 10−3ppb for surface water and 3.96 × 10−4ppb for ground water.

Modeled estimates of drinking water concentrations were directly entered into the dietary exposure model.

For acute dietary risk assessment, the most conservative water concentration value of 0.212 ppb was used to assess the contribution to drinking water based on the use of spirotetramat on pome fruit (0.4 lb ai/A/year).

For chronic dietary risk assessment, the most conservative water concentration of value 1.37 × 10−3ppb was used to assess the contribution to drinking water, based on the use of spirotetramat on Christmas trees (0.32 lb ai/A/year).

3.Sources of 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). Spirotetramat 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 spirotetramat to share a common mechanism of toxicity with any other substances, and spirotetramat does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that spirotetramat 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 Web site 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 different additional SF 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 to prenatal or postnatal exposure to spirotetramat. In the rat developmental toxicity study, toxicity to offspring was observed at the same dose as maternal toxicity, which was also the limit dose. In the developmental toxicity study in the rabbit, only maternal toxicity was observed. In both reproductive toxicity studies, toxicity to offspring (decreased body weight) was observed at the same dose as parental toxicity. Therefore, no evidence of increased susceptibility of offspring was found across four relevant toxicity studies with spirotetramat.

3.Conclusion.EPA has determined that reliable data show that the safety of infants and children are adequately protected at the FQPA SF of 1X. That decision is based on the following findings:

i. The toxicity database for spirotetramat is complete except for an immunotoxicity study and a subchronic neurotoxicity study which are considered to be outstanding due to recent amendments to the data requirements in 40 CFR part 158. Despite the absence of these studies, other related studies indicate that the immunotoxicity study and subchronic neurotoxicity study are unlikely to show risks to infants and children that would warrant an additional safety factor. The only indication of possible immunotoxicity in the toxicology database for spirotetramat is a 90-day oral toxicity study in dogs that shows effects in the thymus gland, an organ of the immune system. However, the endpoint selected for risk assessment is protective against these thyroid effects, as it was based on accelerated thymus involution and decreased thyroid hormone levels in the dog. Moreover, thymus involution has been demonstrated to occur in animals when the thyroid is induced to decrease hormone levels, so it is reasonable to conclude that the thymus involution in these dogs was secondary to the thyroid effects, rather than a direct effect on the immune system. The dose at which these effects were observed was chosen as a point of departure because there was some consistency of dose and effect seen across the subchronic and chronic toxicity studies. However, the effects occurred in relatively few animals and thus selection of this endpoint is considered a very protective point of departure; it is at least tenfold lower than any other potential point of departure. With respect to immunotoxicity, no immunotoxic effects were seen in rats or mice, the species in which immunotoxicity studies are conducted. Thus, the Agency does not believe that conducting a functional immunotoxicity study in any rodent species will result in a lower POD than that currently used for overall risk assessment. For this reason and because the current POD is consideredextremely protective, an uncertainty factor (UFDB) is not needed to account for the lack of this study. Data regarding neurotoxicity is discussed in Unit III.C.3.ii.

ii. EPA has concluded that spirotetramat is not a neurotoxic chemical and there is no need for a developmental neurotoxicity study or additional UFs to account for neurotoxicity. Although a subchronic neurotoxicity study is now required as part of the revisions to 40 CFR part 158, the existing toxicological database indicates that spirotetramat is not a neurotoxic chemical in mammals. The only clinical signs at any dose in the acute neurotoxicity study were staining of the fur or perianal region with urine and decreased motor activity. The urine staining that was identified is not considered a neurotoxic effect and was likely due to a colored metabolite that was excreted into the urine or feces or to a change in the pH of the urine due to an excreted metabolite. The decreased motor activity observed is not considered evidence of neurotoxicity because there were no effects on movement or gait and there were no confirmatory findings of neurological pathology. Thus, both of these effects are considered signs of general toxicity (malaise). Further, the effects seen in the acute neurotoxicity study are not corroborated by any other study in the database. Although brain dilation was found in one dog in the one-year dog study, EPA concluded that this effect was most likely not caused by administration of spirotetramat given evidence showing this to be a congenital anomaly in the test species, and because there is no other evidence of brain pathology in the database. Finally, the conclusion that spirotetramat is not a neurotoxic chemical is supported by the fact that the acute, subchronic and developmental neurotoxcity studies available for structurally-related compounds (spirodiclofen and spiromesifen) do not show evidence of neurotoxicity in adults or young.

iii. There is no evidence that spirotetramat results in increased susceptibility inin uterorats or rabbits in the prenatal developmental studies or in young rats in the 2-generation reproduction study. There was no evidence of increased susceptibility of offspring following pre- or post-natal exposure in any study. In the rat developmental toxicity study, toxicity to offspring was observed at the same dose as maternal toxicity, which was also the limit dose. In the developmental toxicity study in the rabbit, only maternal toxicity was observed. In both reproductive toxicity studies, toxicity to offspring (decreased body weight) was observed at the same dose as parental toxicity. Therefore, no evidence of increased susceptibility of offspring was found across four relevant toxicity studies with spirotetramat.

iv. There are no residual uncertainties identified in the exposure databases. The dataset used to establish a tolerance for spirotetramat and its metabolites on onion, bulb, subgroup 3A-07 consisted of field trial data representing application rates of ∼0.26 a.i./A (Northern EU, 100 OD formulation) with a 7-day PHI. As specified by theGuidance for Setting Pesticide Tolerances Based on Field Trial DataSOP, the field trial application rates and PHIs are within 25% of the maximum label application rate and minimum label PHI, respectively. 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 spirotetramat in drinking water. These assessments will not underestimate the exposure and risks posed by spirotetramat.

EPA determines whether acute and chronic dietary pesticide exposures are safe by comparing aggregate exposure estimates to the acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA calculates the lifetime probability of acquiring cancer 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 appropriate PODs to ensure that an adequate MOE exists.

1.Acute risk.Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food and water to spirotetramat will occupy 11% of the aPAD for children 1-2 yrs old, the population group receiving the greatest exposure.

2.Chronic risk.Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to spirotetramat from food and water will utilize 93% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure. There are no residential uses for spirotetramat.

3.Short-term risk.Spirotetramat is not registered for any use patterns that would result in short-term residential exposure.

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). Spirotetramat 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 spirotetramat 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 the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, spirotetramat is not expected to pose a cancer risk to humans.

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 spirotetramat residues.

Adequate enforcement methodology (high performance liquid chromatography with tandem mass spectrometry (HPLC-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; email address:residuemethods@epa.gov.

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level. TheU.S. provided the primary review of the available toxicology studies, and Canada provided the primary review of the residue chemistry data. All of the residues of concern for tolerances and MRLs have been harmonized among Austria, Canada and the U.S. All toxicology endpoints have been harmonized, with the exception of the acute reference dose (aRfd), which has been harmonized with Canada. The Codex has not established MRLs for spirotetramat on onion, dry bulb. This time-limited tolerance is harmonized with the Canadian MRL for spirotetramat on onion, dry bulb.

Therefore, time-limited tolerances are established for combined residues of spirotetramat, including its metabolites and degradates in or on onion, dry bulb at 0.3 ppm. These tolerances expire on December 31, 2014.

This final rule establishes tolerances under sections 408(e) and 408(l)(6) of FFDCA. 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 in accordance with sections 408(e) and 408(l)(6) 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) (Pub. L.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).

Therefore, 40 CFR chapter I is amended as follows:

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://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

Under FFDCA section 408(g), 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-2011-0578 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 April 16, 2012.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. Information not marked confidential pursuant to 40 CFR part 2 may be disclosed publicly by EPA without prior notice. Submit a copy of your non-CBI objection or hearing request, identified by docket ID number EPA-HQ-OPP-2011-0578, 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 August 26, 2011 (76 FR 53372) (FRL-8884-9), 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 1F7873) by E.I. du Pont de Nemours and Company, 1007 Market Street, Wilmington, DE 19898-0001. The petition requested that 40 CFR 180.564 be amended by establishing tolerances for residues of the insecticide indoxacarb, (S)-methyl-7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)-phenyl]amino]carbonyl]indeno[1,2e] [1,3,4]oxadiazine-4a(3H)-carboxylate, its R-enantiomer, (R)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy) phenyl]amino]carbonyl]indeno [1,2-e] [1,3,4] oxadiazine-4a(3H)-carboxylate, and the metabolites: IN-JT333: Methyl 7-chloro-2,5-dihydro-2-[[[4-(trifluoromethoxy)phenyl]-amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate; IN-KT319: (E)-methyl 5-chloro-2,3,-dihydro-2-hydroxy-1-[[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]-carbonyl]hydrazono]-1H-indene-2-carboxylate; IN-JU873: Methyl 5-chloro-2,3-dihydro-2-hydroxy-1-[[[[4-(triflurormethoxy)-phenyl]amino]carbonyl]hydrazono]-1H-indene-2-carboxylate; IN-KG433: Methyl 5-chloro-2,3,-dihydro-2-hydroxy-1-[[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]carbonyl]-hydrazono]-1H-indene-2-carboxylate; and IN-KB687: Methyl [4-(trifluoromethoxy)phenyl]carbamate, in or on egg at 0.2 parts per million (ppm); poultry, fat at 0.2 ppm; poultry, meat at 0.06 ppm; and poultry, meat byproducts at 0.06 ppm. That notice referenced a summary of the petition prepared by E.I. du Pont de Nemours and Company, the registrant, which is available in the docket,http://www.regulations.gov.There were no comments received in response to the notice of filing.

Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a tolerance (the legal limit for a pesticide chemicalresidue 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 indoxacarb including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with indoxacarb follows.

In theFederal Registerof July 10, 2009 (74 FR 33159) (FRL-8424-9), EPA published a Final Rule establishing tolerances for residues of the insecticide indoxacarb in or on various beet commodities and the bushberry subgroup 13-07B. These tolerances had been requested in PP 8E7324. When the Agency conducted the risk assessment in support of the July 10, 2009 tolerance action, it also considered residues of indoxacarb, its R-enantiomer, and its metabolites IN-JT333, IN-KT319, IN-JU873, IN-KG433, and IN-KB687 in or on egg; poultry, fat; poultry, meat; and poultry, meat byproducts. These tolerances were evaluated by EPA based on the results of a previously submitted and accepted poultry feeding study; however, because of a deficiency related to a poultry storage stability study, EPA was not able to establish tolerances on egg and poultry commodities. Since that time, the registrant has provided an acceptable poultry storage stability study, which supports the establishment of tolerances on egg; poultry, fat; poultry, meat; and poultry, meat byproducts. Detailed considerations regarding EPA's resolution of these data deficiencies are discussed in the document, “Indoxacarb. Petition for the Establishment of Permanent Tolerances on Poultry Commodities and Submission of Storage Stability Data for Poultry Commodities in Response to HED Memorandum DP#297936, 9/22/04,” which is available athttp://www.regulations.govin docket EPA-HQ-OPP-2011-0578.

Since EPA considered the additional uses proposed by PP 1F7873 in its most recent risk assessments, establishing tolerances on these commodities will not change the estimated aggregate risks resulting from use of indoxacarb, as discussed in theFederal Registerof July 10, 2009 (74 FR 33159) (FRL-8424-9). In that action, EPA concluded that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to indoxacarb residues. Refer to the July 10, 2009 (74 FR 33159) (FRL-8424-9)Federal Registerdocument, available athttp://www.regulations.govin docket EPA-HQ-OPP-2008-0271, for a detailed discussion of the aggregate risk assessments and determination of safety. The findings in that action apply with equal force here and are adopted by EPA in this rulemaking. Accordingly, EPA concludes that aggregate exposure to indoxacarb will be safe for the general population, including infants and children.

Adequate enforcement methodology (high-performance liquid chromatography (HPLC)/column switching/ultraviolet (UV) method AMR 2712-93 with confirmation/specificity provided by gas chromatography (GC)/mass-selective detector method AMR 3493-95, Supplement No. 4) is available to enforce the tolerance expression.

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

In making its tolerance decisions, EPA seeks to harmonize U.S. tolerances with international standards whenever possible, consistent with U.S. food safety standards and agricultural practices. EPA considers the international maximum residue limits (MRLs) established by the Codex Alimentarius Commission (Codex), as required by FFDCA section 408(b)(4). The Codex Alimentarius is a joint U.N. Food and Agriculture Organization/World Health Organization food standards program, and it is recognized as an international food safety standards-setting organization in trade agreements to which the United States is a party. EPA may establish a tolerance that is different from a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain the reasons for departing from the Codex level.

The Codex has established MRLs for indoxacarb in or on eggs at 0.02 mg/kg; poultry meat at 0.01 mg/kg; and poultry, edible offal at 0.01 mg/kg. These MRLs are lower than the poultry tolerance levels determined appropriate for indoxacarb in the United States. The U.S. residue definition for poultry commodities includes indoxacarb, its R-enantiomer, and five metabolites, whereas the Codex residue definition includes only indoxacarb and its R-enantiomer. Because the Codex residue definition and evaluation procedures for livestock commodities differ from those of the United States harmonization of U.S. tolerances with Codex MRLs is not possible for poultry commodities.

Therefore, tolerances are established for residues of indoxacarb, (S)-methyl-7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy)-phenyl]amino]carbonyl]indeno[1,2e] [1,3,4]oxadiazine-4a(3H)-carboxylate; its R-enantiomer (R)-methyl 7-chloro-2,5-dihydro-2-[[(methoxycarbonyl)[4-(trifluoromethoxy) phenyl]amino]carbonyl]indeno [1,2-e] [1,3,4] oxadiazine-4a(3H)-carboxylate; and the metabolites: IN-JT333: Methyl 7-chloro-2,5-dihydro-2-[[[4-(trifluoromethoxy)phenyl]-amino]carbonyl]indeno[1,2-e][1,3,4]oxadiazine-4a(3H)-carboxylate; IN-KT319: (E)-methyl 5-chloro-2,3,-dihydro-2-hydroxy-1-[[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]-carbonyl]hydrazono]-1H-indene-2-carboxylate; IN-JU873: Methyl 5-chloro-2,3-dihydro-2-hydroxy-1-[[[[4-(triflurormethoxy)-phenyl]amino]carbonyl]hydrazono]-1H-indene-2-carboxylate; IN-KG433: Methyl 5-chloro-2,3,-dihydro-2-hydroxy-1-[[[(methoxycarbonyl)[4-(trifluoromethoxy)phenyl]amino]carbonyl]-hydrazono]-1H-indene-2-carboxylate; and IN-KB687: Methyl [4-(trifluoromethoxy)phenyl]carbamate, in or on egg at 0.20 parts per million (ppm); poultry, fat at 0.20 ppm; poultry, meat at 0.06 ppm; and poultry, meat byproducts at 0.06 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 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) (Pub. L. 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).

Therefore, 40 CFR chapter I is amended as follows:

The snapper-grouper fishery of the South Atlantic is managed under the Fishery Management Plan for the Snapper-Grouper Fishery of the South Atlantic Region (FMP). The FMP was prepared by the South Atlantic Fishery Management Council and is implemented under the authority of the Magnuson-Stevens Fishery Conservation and Management Act by regulations at 50 CFR part 622.

The commercial quota for golden tilefish in the South Atlantic is 282,819 lb (128,284 kg) for the current fishing year, January 1 through December 31, 2012, as specified in 50 CFR 622.42(e)(2).

Under 50 CFR 622.43(a), NMFS is required to close the commercial sector for golden tilefish when its quota has been reached, or is projected to be reached, by filing a notification to that effect with the Office of the Federal Register. NMFS has determined that the commercial quota for South Atlantic golden tilefish will have been reached by February 17, 2012. Accordingly, the commercial sector for South Atlantic golden tilefish is closed effective 12:01 a.m., local time, February 17, 2012, until 12:01 a.m., local time, January 1, 2013.

The operator of a vessel with a valid commercial vessel permit for South Atlantic snapper-grouper having golden tilefish onboard must have landed and bartered, traded, or sold such golden tilefish prior to 12:01 a.m., local time, February 17, 2012. During the closure, the bag limit and possession limits specified in 50 CFR 622.39(d)(1)(ii) and (d)(2), respectively, apply to all harvest or possession of golden tilefish in or from the South Atlantic EEZ, and the sale or purchase of golden tilefish taken from the EEZ is prohibited. The prohibition on sale or purchase does not apply to the sale or purchase of golden tilefish that were harvested, landed ashore, and sold prior to 12:01 a.m., local time, February 17, 2012, and were held in cold storage by a dealer or processor. For a person on board a vessel for which a Federal commercial or charter vessel/headboat permit for the South Atlantic snapper-grouper fishery has been issued, the sale and purchase provisions of the commercial closure for golden tilefish would apply regardless of whether the fish are harvested in state or Federal waters, as specified in 50 CFR 622.43(a)(5)(ii).

This action responds to the best available information recently obtained from the fishery. The Assistant Administrator for Fisheries, NOAA, (AA), finds that the need to immediately implement this action to close the commercial sector for golden tilefish constitutes good cause to waive the requirements to provide prior notice and opportunity for public comment pursuant to the authority set forth in 5 U.S.C. 553(b)(B), as such procedures would be unnecessary and contrary to the public interest. Such procedures would be unnecessary because the rule itself has been subject to notice and comment, and all that remains is to notify the public of the closure.

Allowing prior notice and opportunity for public comment is contrary to the public interest because of the need to immediately implement this action to protect golden tilefish since the capacity of the fishing fleet allows for rapid harvest of the quota. Prior notice and opportunity for public comment would require time and would potentially result in a harvest well in excess of the established quota.

For the aforementioned reasons, the AA also finds good cause to waive the 30-day delay in the effectiveness of this action under 5 U.S.C. 553(d)(3).

This action is taken under 50 CFR 622.43(a) and is exempt from review under Executive Order 12866.