This rule is issued pursuant to the Commodity Promotion, Research, and Information Act of 1996 (1996 Act) (7 U.S.C. 7411-7425).

As part of this rulemaking, a proposed rule was published in the Federal Register on April 9, 2009 [74 FR 16289], with a 60-day comment period which closed on June 8, 2009. Twenty-one comments were received. A second proposed rule was published in the Federal Register on February 8, 2010 [75 FR 6131] addressing the comments. In addition, a separate final rule on referendum procedures was published in the Federal Register on February 8, 2010 [75 FR 6089]. A notice delaying the referendum at the request of the industry was published in the Federal Register on March 19, 2010 [75 FR 13238]. A third proposed rule announcing the referendum was published in the Federal Register on May 5, 2011 [76 FR 25618].

The Department conducted a referendum from June 8 through June 24, 2011 to ascertain whether the persons to be covered by and assessed under the Order favored the implementation of the program prior to it going into effect. In the referendum, 88 percent of those who voted favored implementation of the Order. Producers and importers of 20,000 or more pounds of raspberries for processing or processed raspberries respectively, during the calendar year January 1 through December 31, 2010, were eligible to vote in the referendum. The referendum was conducted by mail ballot.

Since publication of the proposed rule, published February 8, 2010, the industry worked with the 484(f) Committee (Committee) of the United States International Trade Commission (USITC) which is the committee that reviews requests for changes to the statistical reporting requirements of the HTS for imports, to determine the feasibility of separating red raspberry juice and juice concentrate from all other juice and juice concentrate, red raspberry paste and purees from all other pastes and purees, and red raspberry preserves from all other fruit preserves. According to the Committee, this separation was feasible. Accordingly, the Committee approved the petition for processed red raspberry statistical breakout in the Harmonized Tariff Schedule. The new number assigned to red raspberry juice and juice concentrate is 2009.80.60.55, the new number assigned to processed red raspberry pastes and purees is 2007.99.65.10, and the new number assigned to red raspberry preserves is 2008.99.20.20, effective July 1, 2010. The aforementioned changes are reflected in this final rule. Assessment collected for imported red raspberry preserves will not begin until a conversion factor is developed.

This rule has been determined to be not significant for purposes of Executive Order 12866 and therefore has not been reviewed by the Office of Management and Budget (OMB).

This rule has been reviewed under Executive Order 12988, Civil Justice Reform. It is not intended to have retroactive effect. Section 524 of the 1996 Act provides that the 1996 Act shall not affect or preempt any other Federal or state law authorizing promotion or research relating to an agricultural commodity.

Under section 519 of the 1996 Act, a person subject to an order may file a written petition with the Department stating that an order, any provision of an order, or any obligation imposed in connection with an order, is not established in accordance with the law, and requesting a modification of an order or an exemption from an order. Any petition filed challenging an order, any provision of an order, or any obligation imposed in connection with an order, shall be filed within two years after the effective date of an order, provision, or obligation subject to challenge in the petition. The petitioner will have the opportunity for a hearing on the petition. Thereafter, the Department will issue a ruling on the petition. The 1996 Act provides that the district court of the United States for any district in which the petitioner resides or conducts business shall have the jurisdiction to review a final ruling on the petition, if the petitioner files a complaint for that purpose not later than 20 days after the date of the entry of the Department's final ruling.

This rule has been reviewed under Executive Order 13132, Federalism. This Executive Order directs agencies to construe, in regulations and otherwise, a Federal Statute to preempt State law only when the statute contains an express preemption provision. Section 524 of the 1996 Act provides that the Act shall not affect or preempt any other Federal or State law authorizing promotion or research relating to an agricultural commodity.

The WRRC and the Oregon Raspberry and Blackberry Commission (ORBC), the principal producers of processed raspberries, both administer State marketing orders, which require all producers of raspberries to pay assessments to support the health of their respective industries. Both the WRRC and ORBC invest funds into research programs at their land-grant universities and other research institutions to study disease, pest control, and varietal development. In addition to developing and funding production research, they also fund marketing and promotion programs and seek to foster education and communication between producers. However, WRRC stated that it has not been able to generate the funds necessary, nor has the ORBC or international raspberry organizations, to support the marketing efforts needed to help expand processed raspberry consumption and increase the demand for processed raspberries. In order to manage increased production, increased competition, and changing consumer habits, the WRRC believes that a more extensive marketing program is needed. The WRRC and ORBC believe that a national research and promotion program would fund the promotional aspect necessary to stay competitive and would place all domestic producers and importers on an equal playing field with each investing a fair share in promoting processed raspberries. The WRRC and ORBC will continue to fund processed raspberry research in areas not likely to be the focus of the national program.

In accordance with the 1996 Act, this rule will not preempt any State-legislated programs. Further, section 1208.52(h) of the Order provides for credit of assessments for those individuals who contribute to local, regional, or State organizations that engage in similar generic research, promotion, and information programs as partial fulfillment of assessments due to the Council subject to approval of the Secretary, for expenditure on generic research, promotion and information programs conducted within the United States.

The program is not intended to duplicate any State program. Considerable attention has been made to involve producers in discussions regarding future program development and administration and what the State commissions will look like subsequent to the implementation of a national program. It is expected that farm related activities, such as production research, will continue to be funded by the State organizations and market development functions, such as nutritional research and marketing programs, will shift to the Order.

Not only were the States informed throughout the development of the national program, they were instrumental in the processed raspberry industry's decision to institute a national program.

In 2007, representatives from the WRRC were among other raspberry industry representatives who met with AMS representatives to discuss the possibility of implementing a national processed raspberry promotion, research, and information program. WRRC representatives participated in the development of the provisions of the Order during these meetings and with direct communication with the ORBC.

In accordance with the Regulatory Flexibility Act (RFA) [5 U.S.C. 601-612], AMS is required to examine the impact of the rule on small entities. The purpose of the RFA is to fit regulatory actions to the scale of businesses subject to such actions so that small businesses will not be disproportionately burdened.

The Small Business Administration defines, in 13 CFR part 121, small agricultural producers as those having annual receipts of no more than $750,000 and small agricultural service firms (handlers and importers) as those having annual receipts of no more than $7.0 million. Under these criteria, the majority of the producers and handlers that would be affected by this Order would be considered small entities, while most importers would not. Further, an estimated ten qualified organizations certified by the Secretary for nomination purposes, would be expected to generally consist of entities reflecting such sizes also. Producers and importers of less than 20,000 pounds per year of raspberries for processing and processed raspberries respectively shall be exempt under this Order. Five organic producers and importers are also expected to be exempt from assessments. The number of entities assessed under the program would be approximately 245. Estimated revenue is expected at $1.2 million of which 43 percent is expected from imported product and 57 percent from domestic product.

According to the WRRC, in 2010, there were approximately 195 producers of raspberries for processing and 34 processors (first handlers) of processed raspberries in Oregon and Washington States, which are the principal growing areas in the United States for raspberries destined for processing. Approximately 95 percent of the producers and 100 percent of the raspberry processors qualified under the definition for small business owners. Although California is a significant producer of raspberries, virtually all harvested product is destined for the fresh market. In 2010, there were approximately 50 importers of processed raspberries. Based on the U.S. Department of Commerce, U.S. Census Bureau, Foreign Trade Statistics, in 2010 two countries accounted for 95 percent of the processed raspberries imported into the United States. These countries and their share of the imports are: Chile (78 percent) and Canada (17 percent).

The 1996 Act authorizes generic programs of promotion, research, and information for agricultural commodities. Congress found that it is in the national public interest and vital to the welfare of the agricultural economy of the United States to maintain and expand existing markets and develop new markets and uses for agricultural commodities through industry-funded, government-supervised, generic commodity promotion programs.

The WRRC submitted this Order to: (1) Develop and finance an effective and coordinated program of research, promotion, industry information, and consumer education regarding processed raspberries; (2) strengthen the position of the processed raspberry industry; and (3) maintain, develop, and expand existing markets for processed raspberries.

While the Order imposes certain recordkeeping requirements on first handlers, this information may be compiled from records currently maintained. First handlers will collect and remit the assessments on domestic raspberries for processing to the Council. First handler responsibilities will include accurate recordkeeping and accounting on all raspberries purchased or contracted for processing including the number of pounds handled, the names of their producers, and the date's raspberries were purchased. The forms require the minimum information necessary to effectively carry out the requirements of the program, and their use is necessary to fulfill the intent of the 1996 Act. Such records must be retained for at least two years. This information is already maintained as a normal business practice. In addition, most of these entities currently remit assessments under either the Washington or Oregon State programs, the additional recordkeeping and submission impact will be minimal.

There is also a minimal paperwork burden on producers. The Order requires producers to keep records and to provide information to the Council or the Department when requested. However, it is not anticipated that producers will be required to submit forms to the Council other than for nomination to the Council. If, for example, the Council needs information from a producer as part of the Council's compliance program, the information will need to be obtained through an audit of the producer's records instead of having the producer complete and submit paperwork.

In addition, there is a minimal burden on importers. The import assessments will be collected by U.S. Customs and Border Protection (Customs) at time of entry into the United States. Importers will be required to keep records and to provide information to the Council or the Secretary of Agriculture (Secretary) when requested. However, it is not anticipated that importers will be required to submit forms to the Council for assessment collection because Customs conducts recordkeeping and assessment remittance at the time of product entry into the United States. Importers who seek nomination to serve on the Council will be required to complete a background form which will be submitted to the Secretary.

Foreign producers from countries exporting a minimum of three million pounds of raspberries for processing based on a three-year average to the U.S. and at-large members seeking nomination to serve on the Council will also be required to complete a background form which shall be submitted to the Secretary.

The estimated annual cost of providing the information to the Council by an estimated 297 respondents (195 producers, 50 importers, 34 first handlers/processors, 2 foreign producers, 5 organic producers and importers, 10 certified organizations (for nomination purposes), and 1 at-large member) would be $9,141.

Section 518 of the 1996 Act provides for referenda to ascertain approval of the Order to be conducted either prior to its going into effect or within three years after assessments first begin under the Order. An initial referendum was conducted prior to putting this Order in effect. Eighty-eight percent of producers and importers who voted favored implementation of the Order.

Every seven years, the Department shall conduct a referendum to determine whether producers of raspberries for processing and importers of processed raspberries favor the continuation, suspension, or termination of the Order. In addition, the Department may conduct a referendum at any time; at the request of 10 percent or more of all eligible producers of raspberries for processing and processed raspberries importers required to pay assessments; or if the Council requests that the Secretary hold a referendum.

The United States is among the leading producers of raspberries. Raspberries are grown in 49 states and are harvested late June to mid August. The 2007 Census of Agriculture indicates that about 80 percent of the U.S. raspberry acreage was in California, Oregon, and Washington.

According to the United States Department of Agriculture's National Agricultural Statistics Service (NASS) and the Foreign Agricultural Service (FAS), in 2010, 148,010 million pounds of raspberries (fresh) with a combined value approaching $258 million (value of utilized production) were produced in California, Oregon, and Washington, the three most productive States for growing raspberries in the United States. In 2009, 173,700 million pounds were produced and utilized, at a value of almost $361 million. California's crop is predominately delivered to the fresh market, while Oregon and Washington are the principal producers of processed raspberries.

Domestic production varies from year to year due to climatic conditions and field health. Over the last fifteen years, total domestic production of raspberries delivered to processors in the United States (i.e., production utilized for processing) has increased from 47.5 million pounds in 1991 to almost 65 million pounds in 2010 with most recent years averaging approximately 64 million pounds. Washington continues to be the major supplier of processed raspberries to the domestic market, although its market share declined from 72 percent to 37 percent between 2001 and 2010. In comparison, imported processed raspberries surged from 7.5 to 53.8 million pounds from 1991 to 2005 and then decreased to 50.3 million pounds in 2010. Chile, which is the predominate importer of processed raspberries to the United States, supplied just over 24 percent of the total U.S. market in 2010.

Domestic uses of processed raspberries include further processing into juices, jellies, baked goods, and consumer retailer packs. After averaging approximately 184 million pounds for the period 2008 to 2010, approximately 194 million pounds of processed raspberries were imported into the United States and fresh raspberries within the United States were utilized for processing in 2010. These totals were calculated by using imports of frozen raspberries from FAS and NASS reports of production utilized for processing in Oregon, Washington, and California. Because of the way imports are currently reported, and because of the way NASS reports raspberry data, the totals represent the best information currently available.

The following countries are major exporters of raspberries to the United States: Canada, Chile, China, France, and Serbia. Canada and Chile represented 95 percent share of total import tonnage in the domestic United States market for 2010, with 17 and 78 percent respectively.

The same growing conditions and harvesting period apply to the Pacific Northwest and British Columbia, the major raspberry growing region in Canada. Exports of processed frozen raspberries from British Colombia to the United States ranged from 2.9 million metric tons to 5.7 million metric tons over the past five years.

Contra-season raspberry production in the southern hemisphere is primarily located in Chile, with a harvest season beginning in December and continuing into February. However, processed raspberries are imported into the United States throughout the year.

The Order authorizes a fixed assessment to be paid by producers of raspberries for processing and importers of processed raspberries at a rate of up to one cent per pound, with the initial assessment rate being one cent per pound. Imported processed raspberries covered under the program will have a quantity associated with it in either kilograms or liters. One pound is equal to .45359237 kilograms. In addition, one pound is equal to .45359237 liters of water weight. For processed red raspberry juice and juice concentrate, the Department has decided to use this conversion factor for calculating the assessment because calculating the weight of one liter of raspberry juice and juice concentrate would be costly and impractical. Therefore, the assessment rate for imported processed raspberries will be $.022 per kilogram/liter.

The factors for calculating the assessment on imported processed raspberries include the (1) HTS classification number, (2) conversion factor from pound to kilogram/liter, (3) assessment rate as established under the Order, and (4) the ratio requested by the WRRC for HTS classification numbers 2009.80.60.55 and 2007.99.65.10 to HTS code 0811.20.20.25.

Imported processed raspberries covered under the program will have a quantity associated with it in either kilograms or liters. Therefore, the Department converted the assessment rate from dollars per pound to dollars per kilogram. One cent per pound is equivalent to $.0045 per kilogram/liter. The Department then calculated the dollar per kilogram/liter assessment rate based on the ratios requested by the WRRC. For example $.022 per kilogram/liter based on a 1:1 ratio will still be $.022 per kilogram/liter. However, $.022 per kilogram/liter based on a 6.8:1 ratio, would be $.1496 per kilogram/liter.

Examples of calculating the assessment on processed red raspberry juice and juice concentrate, processed red raspberries, and red raspberries paste and purees are as follows:

To calculate the assessment for processed raspberries products in HTS codes 2007.99.65.10, the following example illustrates a typical calculation.

To calculate the assessment for processed raspberries products in HTS code 2009.80.60.55, the following example illustrates a typical calculation.

The assessment rate will be reviewed, and increased or decreased as recommended by the Council and approved by the Secretary after the first referendum is conducted as stated in § 1208.71(a). Such an increase or decrease may occur not more than once annually. Any change in the assessment rate shall be subject to rulemaking by the Department, and will be reviewed, and increased or decreased by the Secretary through rulemaking as recommended by the Council. Any change in the assessment rate shall be announced by the Council at least 30 days prior to going into effect. The maximum assessment rate authorized is one cent per pound.

At the assessment rate of up to one cent per pound, with the initial assessment rate being one cent per pound, the Council shall collect approximately $1.2 million annually based on an estimated 120 million pound supply from domestic raspberries for processing and imports of processed raspberries. The domestic supply represents approximately 57 percent of the total and imports represent 43 percent.

The Order exempts producers and importers of less than 20,000 pounds annually of raspberries for processing and processed raspberries respectively. A review of producer delivery statistics from Oregon and Washington States indicate that around 15 percent of all producers would have been exempted from assessment in 2010 from the research and promotion program based on a 20,000 pounds exemption threshold. Also, 100 percent organic producers and importers shall be exempt from assessment. Section 515 of the 1996 Act provides for the establishment of a board or council consisting of producers, importers, and others in the marketing chain as appropriate.

The Order provides for the establishment of the National Processed Raspberry Council (Council) to administer the Order under AMS oversight. The Secretary will appoint members to the Council from nominees submitted in accordance with the Order. The WRRC proposed that the Council be composed of 13 members and their alternates. The Council membership will be as follows: six producer members of raspberries for processing from States producing a minimum of three million pounds of raspberries delivered for processing; one producer member of raspberries for processing representing all other States that produce less than the minimum of three million pounds of raspberries delivered for processing; three processed raspberry importer members; two foreign producers from countries exporting a minimum of three million pounds of raspberries for processing to the U.S. based on a three-year average; and one at-large member recommended by the Council. The distribution of producer member of raspberries for processing positions among the States producing a minimum of three million pounds of raspberries shall be proportional to the average of the total pounds delivered to the processor for processing over the previous three years. The States that provide less than three million pounds will be combined into one region and will have one producer representative.

Under the Order, the Council members and alternates will serve for a term of three years and be able to serve a maximum of two consecutive terms. When the Council is first established, four producer members, two importers, one of the two foreign producers, and the at-large member and their respective alternates will be assigned initial terms of three years; and, three producer members, one importer member, and the second foreign producer and their respective alternates will serve an initial term of two years. Thereafter, each of these positions will carry a full three-year term. Members serving an initial term of two years will be eligible to serve a second three-year term to complete their eligibility. Council nominations and appointments will take place in two out of every three years. Each term of office will end on December 31, and a new term will begin on January 1.

Producers and importers will represent those entities in the United States. The United States is defined to include collectively the 50 States, the District of Columbia, the Commonwealth of Puerto Rico and the territories and possessions of the United States.

The nominations for the six producer and alternate members from States producing a minimum three year average of three million pounds of raspberries delivered for processing will be submitted to the Council in the following manner: (1) For those States that have a State raspberry commission or State marketing order, the State raspberry commission or committee will nominate producers and their alternates to serve; or (2) for those States that do not have a State raspberry commission or State marketing order, the Council will seek nominations from the State Departments of Agriculture for members and alternates from the specific States.

For those States producing a minimum three year average of three million pounds of raspberries delivered for processing that have a State raspberry commission or State marketing order, the State raspberry commission or committee nominations will be sent to the Council and placed on a ballot which will then be sent to producers in the State for a vote. The nominee for member will have received the highest number of votes cast. The person with the second highest number of votes cast will be the nominee for alternate. The persons with the third and fourth place highest number of votes cast will be designated as additional nominees for consideration by the Secretary. Once the Council has received all of the nominations from commissions or committees, the information will be submitted to the Secretary for appointment. Nominations for the initial Council will be handled by the Department. Subsequent nominations will be handled by the Council staff and shall be submitted to the Secretary not less than 90 days prior to the expiration of the term of office.

If the Department determines that there are no State raspberry commissions or State marketing orders from States producing a minimum three year average of three million pounds of raspberries delivered for processing, the Council will seek nominations from the State Departments of Agriculture for members and alternates from the specific States. The State Departments of Agriculture will have the opportunity to participate in nomination caucuses and may directly submit as a group, a single slate of nominations to the Department for the six producer positions and producer alternate positions for the initial Council. Subsequent nominations shall be submitted to the Council and will be handled by the Council staff who in turn shall submit those nominations to the Secretary not less than 90 days prior to the expiration of the term of office.

The distribution of the six producer and alternate seats will be proportional to the percentage determined by the average of the total pounds produced and delivered to processors for processing over the previous three years divided by the average total pounds produced over the previous three years. For example, if Washington State and Oregon are the only two States producing a minimum of 3 million pounds each, and Washington's previous three year average is 62.4 million pounds and Oregon's previous three year average is 6.7 million pounds with the average total pounds for the previous three years being 69.1 million pounds, Washington would have 90 percent of the production and Oregon would have 10 percent of the production. Therefore, Washington would obtain five out of the six seats and Oregon would receive one seat.

The nominations for the one raspberry producer of raspberries for processing and alternate member, who represents all other States producing less than a minimum three year average of three million pounds of raspberries delivered for processing, which constitutes a region will be submitted to the Council in the following manner: (1) For those States that have a State raspberry commission or State marketing order, the State raspberry commission or committee will nominate producers and their alternates to serve; or (2) for those States that do not have a State raspberry commission or State marketing order, the Council will seek nominations from the State Departments of Agriculture for the member and alternate from the specific States.

For those States producing less than a minimum three year average of three million pounds of raspberries delivered for processing that have a State raspberry commission or State marketing order, the State raspberry commission or committee nominations will be sent to the Council and placed on a ballot which will then be sent to producers in the region for a vote. The nominee for member will have received the highest number of votes cast. The person with the second highest number of votes cast will be the nominee for alternate. The persons with the third and fourth place highest number of votes cast will be designated as additional nominees for consideration by the Secretary. Once the Council has received all of the nominations from commissions or committees, the information will be submitted to the Secretary for appointment. Nominations for the initial Council will be handled by the Department. Subsequent nominations will be handled by the Council staff and shall be submitted to the Secretary not less than 90 days prior to the expiration of the term of office.

If the Department determines that there are no State raspberry commissions or State marketing orders from States producing less than a minimum three year average of three million pounds of raspberries delivered for processing, the Council will seek nominations from the State Departments of Agriculture for members and alternates from the specific States. The State Departments of Agriculture will have the opportunity to participate in nomination caucuses and will directly submit as a group a single slate of nominations to the Department for the producer position and the producer alternate position for the initial Council. Subsequent nominations shall be submitted to the Council and will be handled by the Council staff who in turn shall submit those nominations to the Secretary not less than 90 days prior to the expiration of the term of office.

Nominations for the three processed raspberry importer member positions and their alternates will be made by qualified national organizations representing importers. Two nominees for each member and each alternate position will be submitted to the Secretary for consideration.

All qualified national organizations representing importers will have the opportunity to participate in nomination caucuses and will submit as a group a single slate of nominations to the Secretary for the importer positions and the importer alternate positions on the Council.

Eligible organizations must submit nominations to the Department not less than 90 days prior to the expiration of the term of office. To become a qualified national organization representing importers under the Order, each such organization shall be required to meet the following criteria: (1) Any organization representing importers must represent a substantial number of importers who market a substantial volume of raspberries for processing; (2) it must have a history of stability and permanency and have been in existence for more than one year; (3) it must promote processed raspberry importers' welfare; and (4) it must derive a portion of its operating funds from importers.

If the Department determines that there are no qualified national organizations representing importers, individuals who have paid their assessments to the Council in the most recent fiscal year, or for the initial Council, those that imported processed raspberries into the U.S. in the most recent fiscal year, may directly submit nominations to the Department for the initial Council. Subsequent nominations shall be submitted to the Council and will be handled by the Council staff who in turn shall submit those nominations to the Secretary not less than 90 days prior to the expiration of the term of office.

Nominations for the two foreign producer member positions and their alternates will be made by qualified organizations representing foreign producers. Two nominees for each member and each alternate position will be submitted to the Secretary for consideration.

All qualified organizations representing foreign producers will have the opportunity to participate in nomination caucuses and will submit as a group a single slate of nominations per country to the Secretary for foreign producer positions and the foreign producer alternate positions on the Council.

Eligible organizations must submit nominations to the Department not less than 90 days prior to the expiration of the term of office. To become a qualified organization representing foreign producers under the Order, each such organization shall be required to meet the following criteria: (1) Any organization representing foreign producers must represent a substantial number of foreign producers who market or produce a substantial volume of raspberries for processing; (2) it must have a history of stability and permanency and have been in existence for more than one year; (3) it must promote processed raspberry foreign producers' welfare; (4) it must derive a portion of its operating funds from foreign producers; and (5) must be from a country exporting a minimum of three million pounds of raspberries for processing to the U.S. based on a three-year average.

If the Department determines that there are no qualified organizations representing foreign producer interests, individual foreign producers may directly submit nominations to the Department for the initial Council. Subsequent nominations shall be submitted to the Council and will be handled by the Council staff who in turn shall submit those nominations to the Secretary not less than 90 days prior to the expiration of the term of office.

In recommending the at-large member and alternate, the Council may give consideration to nutrition health professionals and others interested in the raspberry industry. Nominations for the at-large member and alternate will be conducted at a Council meeting by the Council staff and shall be submitted by the Council to the Secretary for approval not less than 90 days prior to the expiration of the term of office. Nominations for the initial Council will be handled by the Department.

The 1996 Act provides that to ensure fair and equitable representation, the composition of a board or council shall reflect the geographic distribution of the production of the agriculture commodity in the United States and the quantity or value of the agriculture commodity imported into the United States. The Order states that at least once every five years, but not more frequently than once every three years, the Council will review the geographic distribution of United States production of processed raspberries and the quantity and source of processed raspberry imports. If warranted, the Council will recommend to the Secretary that membership on the Council be altered to reflect any changes in geographic distribution of domestic raspberry production and the quantity of imports. Also, if the level of imports increases or decreases importer members and alternates may be added or reduced on the Council. However, the foreign producer seats will remain the same regardless of the volume of imports from importing countries.

The Order provides that all officers, employees, and agents of the Department and of the Council are required to keep confidential all information obtained from persons subject to the Order. This information shall be disclosed only if the Department considers the information relevant, and the information is revealed in a judicial proceeding or administrative hearing brought at the direction or on the request of the Department or to which the Department or any officer of the Department is a party. However, the issuance of general statements based on reports or on information relating to a number of persons subject to the Order shall be permitted, if the statements do not identify the information furnished by any person. Finally, the publication, by direction of the Department, of the name of any person violating the Order and a statement of the particular provisions of the Order violated by the person shall be allowed.

Recordkeeping and reporting requirements for the raspberry promotion, research, and information program shall be designed to minimize the burden on the raspberry industry.

The estimated total cost of providing information to the Council by all respondents would be $9,141. This total has been estimated by multiplying 277 total hours required for reporting and recordkeeping by $33, the average mean hourly earnings of various occupations involved in keeping this information. Data for computation of this hourly rate was obtained from the U.S. Department of Labor Statistics.

With regard to alternatives to this rule, the 1996 Act itself does provide for authority to tailor a program according to the individual needs of an industry. Provision is made for permissive terms in an order in section 516 of the 1996 Act, and other sections provide for alternatives. Section 514 of the 1996 Act provides for orders applicable to (1) producers, (2) first handlers and other persons in the marketing chain as appropriate, and (3) importers (if imports are subject to assessment). Section 516 states that an order may include an exemption of de minimis quantities of an agricultural commodity; different payment and reporting schedules; coverage of research, promotion, and information activities to expand, improve, or make more efficient the marketing or use of an agricultural commodity in both domestic and foreign markets; provision for reserve funds; provision for credits for generic activities for those individuals who contribute to other similar generic research, promotion, and information programs at State, regional or local level; and assessment of imports. In addition, section 518 of the 1996 Act provides for referenda to ascertain approval of an order to be conducted either prior to its going into effect or within three years after assessments first begin under the order. An order also may provide for its approval in a referendum to be based upon (1) a majority of those persons voting; (2) persons voting for approval who represent a majority of the volume of the agricultural commodity; or (3) a majority of those persons voting for approval who also represent a majority of the volume of the agricultural commodity. Section 515 of the 1996 Act provides for establishment of a council from among producers, first handlers, and others in the marketing chain as appropriate and importers, if importers are subject to assessment.

The WRRC and ORBC both administer State marketing orders, which require all producers of raspberries to pay assessments to support the health of their respective industries. According to WRRC, the two commissions have developed a good working relationship with each other over the years. Both the WRRC and ORBC invest funds into research programs at their land-grant universities and other research institutions to study disease, pest control, and varietal development. In addition to developing and funding production research, they also fund marketing and promotion programs and seek to foster education and communication between producers. However, the WRRC, stated that it has not been able to generate the funds necessary, nor has the ORBC or international raspberry organizations, to support the marketing efforts needed to help expand processed raspberry consumption and increase the demand for processed raspberries. In order to manage increased production, increased competition, and changing consumer habits, the WRRC believes that a more extensive marketing program is needed. The WRRC and ORBC believe that a national research and promotion program will fund the promotional aspect necessary to stay competitive and shall place all domestic producers and importers on an equal playing field with each investing a fair share in promoting processed raspberries. The Council may provide credits of assessments for those individuals who contribute to local, regional, or State organizations engaged in similar generic research, promotion, and information programs as applied to assessment due to the Council subject to approval of the Secretary, for expenditure on generic research, promotion and information programs conducted within the United States. The WRRC and ORBC will continue to fund processed raspberry research in areas not likely to be the focus of the national program.

The WRRC and ORBC programs are not able to engage raspberry production in other States or countries in a meaningful way. The program is not intended to duplicate any State program. Considerable attention has been made to involve producers in discussions regarding future program development and administration and what the State commissions would look like prior to the initial referendum. It is expected that farm related activities, such as production research, shall continue to be funded by the State organizations and market development functions, such as nutritional research and marketing programs, will shift to the Order.

The WRRC proposed that producers and importers of less than 20,000 pounds annually of raspberries for processing and processed raspberries respectively, be exempt from assessments. The WRRC also proposed that a producer who operates under an approved National Organic Program (NOP) system plan, produces only products eligible to be labeled as 100 percent organic under the NOP, and is not a split operation, be exempt from paying assessments under the Order. An importer who imports only products eligible to be labeled as 100 percent organic under the NOP, and is not a split operation, shall also be exempt from paying assessments.

There are no federal rules that duplicate, overlap, or conflict with this rule.

The Department invited comments concerning potential effects of the Order on small entities and the accuracy regarding the number and size of entities covered under the Order. We did not receive any comments as a result of the publication of the Initial Regulatory Flexibility Analysis.

In accordance with the Paperwork Reduction Act of 1995 [44 U.S.C. Chapter 35], the reporting and recordkeeping provisions generated by this rule have been preapproved by OMB, under OMB control number: 0581-0258

Title: National Processed Raspberry Promotion, Research, and Information Program.

OMB Number: 0581-0258.

Expiration Date of Approval: November 30, 2012.

Type of Request: Approval of a preapproved collection.

Abstract: The information collection requirements are essential to carry out the intent of the 1996 Act.

There will also be the additional burden on producers and importers voting in referenda. The referendum ballot, which represents the information collection requirement relating to referenda, was addressed in a separate final rule on referendum procedures which was published in the Federal Register on February 8, 2010 [75 FR 6089].

Under the program, first handlers are required to collect assessments from producers and file reports with and submit assessments to the Council. While the Order imposes certain recordkeeping requirements on first handlers, information required under the Order may be compiled from records currently maintained. Such records shall be retained for at least two years beyond the marketing year of their applicability.

Under the Order, importers are responsible to pay assessments. Importers must report the total quantity of processed raspberries imported during the reporting period and a record of each importation of such product during such period, giving quantity, date, and port of entry. Under the Order, Customs will collect assessments on imported processed raspberries and remit the funds to the Council.

An estimated 297 respondents will provide information to the Council. There will be approximately 195 producers, 50 importers, 34 first handlers/processors, 5 organic producers and importers (for exemption purposes), 2 foreign producers, 10 certified organizations (for nomination purposes), and 1 at-large member. The estimated cost of providing the information to the Council by respondents would be $9,141. This total has been estimated by multiplying 277 total hours required for reporting and recordkeeping by $33, the average mean hourly earnings of various occupations involved in keeping this information. Data for computation of this hourly rate was obtained from the U.S. Department of Labor Statistics.

The Order's provisions have been carefully reviewed, and every effort has been made to minimize any unnecessary recordkeeping costs or requirements, including efforts to utilize information already submitted under other raspberry programs administered by the Department and other state programs.

The forms require the minimum information necessary to effectively carry out the requirements of the program, and their use is necessary to fulfill the intent of the 1996 Act. Such information can be supplied without data processing equipment or outside technical expertise. In addition, there are no additional training requirements for individuals filling out reports and remitting assessments to the Council. The forms will be simple, easy to understand, and place as small a burden as possible on the person required to file the information.

Collecting information yearly will coincide with normal industry business practices. The timing and frequency of collecting information are intended to meet the needs of the industry while minimizing the amount of work necessary to fill out the required reports. The requirement to keep records for two years is consistent with normal industry practices. In addition, the information to be included on these forms is not available from other sources because such information relates specifically to individual producers, first handlers, processors, foreign producers, and importers who are subject to the provisions of the 1996 Act.

Therefore, there is no practical method for collecting the required information without the use of these forms.

The request for OMB approval of OMB No. 0581-0258 is as follows:

(1) A Background Information Form AD-755 (OMB Form No. 0505-0001).

Estimate of Burden: Public reporting for this collection of information is estimated to average 0.5 hours per response for each Council nominee.

Respondents: Producers, importers, foreign producers, and at-large nominee.

Estimated number of Respondents: 26 (52 for initial nominations to the Council, 26 in subsequent years).

Estimated number of Responses per Respondent: 1 every 3 years. (0.3).

Estimated Total Annual Burden on Respondents: 7.8 hours for the initial nominations to the Council and 3.9 hours annually thereafter.

(2) An Annual Report By Each First Handler of Processed Raspberries.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 0.5 hours per first handler reporting on processed raspberries handled.

Respondents: First handlers.

Estimated number of Respondents: 34.

Estimated number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 17 hours.

(3) An Exemption Application for Producers And Importers Who Would Be Exempt From Assessments.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 0.25 hours per producers, or importer reporting on processed raspberries produced or imported. Upon approval of an application, producers and importers will receive exemption certification.

Respondents: Exempt producers and importers.

Estimated number of Respondents: 40.

Estimated number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 10 hours.

(4) Application for Reimbursement of Assessment.

Estimate of Burden: Public reporting burden for this collection of information is estimated to average 0.25 hours per request for reimbursement.

Respondents: Producers and importers.

Estimated number of Respondents: 10.

Estimated number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 2.5 hours.

(5) A Requirement to Maintain Records Sufficient to Verify Reports Submitted Under the Order.

Estimate of Burden: Public recordkeeping burden for keeping this information is estimated to average 0.5 hours per record keeper maintaining such records.

Recordkeepers: Producers, first handlers, and importers.

Estimated number of recordkeepers: 297.

Estimated total recordkeeping hours: 148.5 hours.

(6) Application for Certification of Organizations.

Estimate of Burden: Public recordkeeping burden for this collection of information is estimated to average 0.5 hours per application.

Respondents: Importers and foreign producer organizations.

Estimated Number of Respondents: 10.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 5 hours.

(7) Nomination Appointment Form.

Estimate of Burden: Public recordkeeping burden for this collection of information is estimated to average 0.25 hours per application.

Respondents: Producers, importers, and foreign producers.

Estimated Number of Respondents: 150.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 37.5 hours.

(8) Nomination Appointment Ballot.

Estimate of Burden: Public recordkeeping burden for this collection of information is estimated to average 0.25 hours per application.

Respondents: Producers and importers.

Estimated Number of Respondents: 150.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 37.5 hours.

(9) Application For Assessments Credit.

Estimate of Burden: Public recordkeeping burden for this collection of information is estimated to average 0.25 hours per application.

Respondents: Producers.

Estimated Number of Respondents: 50.

E stimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 12.5 hours.

(10) Organic Exemption Form.

Estimate of Burden: Public recordkeeping burden for this collection of information is estimated to average 0.5 hours per exemption form.

Respondents: Producers and importers.

Estimated Number of Respondents: 5.

Estimated Number of Responses per Respondent: 1.

Estimated Total Annual Burden on Respondents: 2.5 hours.

As discussed previously, the new number assigned to red raspberry juice and juice concentrate is 2009.80.60.55, the new number assigned to processed red raspberry pastes and purees is 2007.99.65.10, and the new number assigned to red raspberry preserves is 2008.99.20.20, effective July 1, 2010. The aforementioned changes are reflected in this final rule. Assessment collected for imported red raspberry preserves will not begin until a conversion factor is developed.

As a result of the aforementioned changes, the Department has made additional changes to the Order. Section 1205.52 has been modified as follows: (1) Newly approved HTS codes have been added; (2) the factor for converting pounds to liters and pounds to kilograms has been added; (3) Table I. Processed Raspberry Products Assessment Table has been added to clearly identify the assessment rates for importers based on the conversion ratios requested by the WRRC; and (4) language has been added to ensure that assessments continue to be collected in the event that any HTS number identified in the Order is changed, replaced by another number, or added, and still falls within the definition of processed raspberries.

The Order is summarized as follows: 1208.1 through 1208.29 of the Order define certain terms, such as processed raspberries, first handler, and importer, which are used in the Order.

Sections 1208.40 through 1208.48 include provisions relating to the Council. These provisions cover establishment and membership, nominations and appointments, term of office, vacancies, alternate members, and procedures for conducting Council business, compensation and reimbursement, and powers and duties of the Council, and prohibited activities. The Council is the governing body authorized to administer the Order through the implementation of programs, plans, projects, budgets, and contracts to promote and disseminate information about processed raspberries, subject to oversight of the Secretary.

Sections 1208.50 through 1208.56 cover budget review and approval; financial statements; authorize the collection of assessments; specify how assessments would be used, including reimbursement of necessary expenses incurred by the Council for the performance of its duties and expenses incurred for the Department's oversight responsibilities; specify who pays the assessment and how; authorize the imposition of a late-payment charge on past-due assessments; outline exemption procedures; address programs, plans, and projects; require the Council to periodically conduct an independent review of its overall program; and address patents, copyrights, trademarks, information, publications, and product formulations developed through the use of assessment funds.

The assessment rate is up to one cent per pound for domestic raspberries for processing and imported processed raspberries, with the initial assessment rate being one cent per pound. The assessment rate will be reviewed, and increased or decreased as recommended by the Council and approved by the Secretary after the first referendum is conducted as stated in § 1208.71(a). Such an increase or decrease may occur not more than once annually and may not exceed the initial assessment rate of one cent per pound. Any change in the assessment rate shall be subject to rulemaking by the Department, and will be reviewed, and increased or decreased by the Secretary through rulemaking as recommended by the Council. Any change in the assessment rate shall be announced by the Council at least 30 days prior to going into effect. The maximum assessment rate authorized is one cent per pound.

The assessment rate may be raised or lowered at a rate not to exceed one cent per pound, after the initial continuance referendum which would be conducted after the program has been in operation five years. A referendum to approve the new assessment rate or for any other change is not required.

Sections 1208.60 through 1208.62 concerns reporting and recordkeeping requirements for persons subject to the Order and protect the confidentiality of information from such books, records, or reports.

Sections 1208.70 through 1208.78 describe the rights of the Secretary; address referenda; authorize the Secretary to suspend or terminate the Order when deemed appropriate; prescribe proceedings after termination; address personal liability, separability, and amendments; and provide OMB control numbers.

As previously mentioned the Department conducted a referendum among domestic producers of raspberries for processing and processed raspberry importers from June 8 through June 24, 2011. The representative period for establishing voter eligibility was from January 1 through December 31, 2010. Producers and importers of 20,000 or more pounds of raspberries for processing or processed raspberries respectively during the representative period were eligible to vote in the referendum. Eighty-eight percent of those who voted in the referendum favored implementation of the Order.

After consideration of all relevant material presented, including the initial proposal, comments received, and the referendum results, it is found that the Processed Raspberry Research, Promotion, and Information Order, authorized under the Commodity Promotion, Research, and Information Act of 1996, is consistent with and effectuates the declared policy and purpose of the 1996 Act.

It is also found that good cause exists for not postponing the effective date of this action until 30 days after publication in the Federal Register (5 U.S.C. 553) because implementation of the Order is needed as soon as possible to begin assessments under the program and to initiate the process of establishing the Council.

For the reasons set forth in the preamble, Title 7, Chapter XI of the Code of Federal Regulations is amended as follows:

I. Section 418.3 Effective Dates

The regulations in § 418.3 are applicable as follows:

• In large establishments, defined as all establishments with 500 or more employees, November 5, 2012.

• In small establishments, defined as all establishments with 10 or more employees but fewer than 500, May 8, 2013.

• In very small establishments, defined as all establishments with fewer than 10 employees or annual sales of less than $2.5 million, May 8, 2013.

The Food Safety and Inspection Service (FSIS) administers a regulatory program under the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq. ) and the Poultry Products Inspection Act (PPIA) (21 U.S.C. 451 et seq. ) to protect the health and welfare of consumers. The Agency is responsible for ensuring that the nation's commercial supply of meat and poultry is safe, wholesome, and correctly labeled and packaged.

On June 18, 2008, section 11017 of the Food, Conservation, and Energy Act of 2008, Public Law 110-246, 122 Stat 1651, 448-49, otherwise known as the 2008 Farm Bill, amended the FMIA and the PPIA to require establishments subject to inspection under these Acts that believe or have reason to believe that an adulterated or misbranded meat or poultry product received by or originating from the establishment has entered into commerce to promptly notify the Secretary with regard to the type, amount, origin, and destination of the meat or poultry product. The 2008 Farm Bill also requires that inspected establishments: (1) Prepare and maintain written procedures for the recall of all products produced and shipped by the establishment; (2) document each reassessment of the process control plans of the establishment (i.e., HACCP plans); and (3) upon request, make the procedures and reassessed control plans available for inspectors appointed by the Secretary to review and copy.

In the Federal Register of March 25, 2010 (75 FR 14361), FSIS proposed regulations to implement the new provisions of the 2008 Farm Bill. FSIS proposed to amend 9 CFR 417.4(a)(3) to require official establishments to make a written record of each reassessment of the adequacy of their HACCP plan, or to document the reasons for not making a change to their HACCP plan based on the reassessment. For annual reassessments, if an establishment determines that no changes to its HACCP plans are necessary, the establishment does not have to document the reasons for this determination. Furthermore, FSIS proposed to establish a new 9 CFR part 418, Recalls, under which official establishments would be required to prepare and maintain procedures for the recall of all meat and poultry products produced and shipped by the establishment, and to promptly notify FSIS within 48 hours if the establishment believes or has reason to believe that an adulterated or misbranded product received by or originating from the establishment has entered into commerce. Interested persons were invited to submit written comments by May 24, 2010.

After review and consideration of all comments, FSIS is finalizing, with three changes, the provisions in the March 2010 proposed rule. Specifically, the Agency is amending the proposal to require official establishments to promptly notify FSIS within 24 hours if the establishment believes or has reason to believe that an adulterated or misbranded product received by or originating from the establishment has entered into commerce. In addition, the Agency is amending the proposal to require new establishments to develop their written recall procedures at the same time as their HACCP plans in order to receive a Federal Grant of Inspection.

Also in response to comments, FSIS has decided to stagger the applicability date for 9 CFR part 418 based on establishment size. Existing large establishments, defined as all establishments with 500 or more employees, will have six months from the date of publication of this final rule in the Federal Register to prepare their written recall procedures. Existing small establishments (those with 10 or more employees but fewer than 500) and very small establishments (those with fewer than 10 employees or annual sales of less than $2.5 million) will have one year from publication of this final rule in the Federal Register to prepare their written recall procedures. These changes are discussed in detail in the Agency's responses to comments.

FSIS received 31 comments from hospitality supply companies, supply management companies, trade groups representing meat packing and processing establishments, a trade group representing the turkey industry, a trade group representing food and beverage companies, a trade group representing organic agriculture products, a representative from a state department of agriculture, a small processing plant, a rancher, a farmer, and 14 consumers.

A summary of issues raised by commenters and the Agency's responses follows.

Comment: A few comments addressed whether 48 hours is an appropriate time in which to expect official establishments that have shipped or received, or have reason to believe that they have shipped or received, adulterated or misbranded product, to notify the appropriate District Office of that situation. A consumer and a trade group representing the turkey industry stated that 48 hours is a reasonable timeframe to give establishments to notify District Offices. A trade group representing meat packing and processing establishments also stated that the proposed time period was reasonable, but was concerned that 48 hours may be an arbitrary figure. Three consumer groups and an individual consumer argued the proposed timeframe is too lax, and that establishments should notify District Offices within 24 hours if they may have shipped or received adulterated or misbranded product. One consumer group argued that allowing official establishments to wait as long as 48 hours before reporting this information to the appropriate District Office will unnecessarily delay efforts to remove adulterated or misbranded product from commerce. Another consumer group argued that 24 hours is sufficient time for establishments to notify District Offices that they may have shipped or received adulterated or misbranded product because establishments may notify the District Office by phone.

Agency's Response: FSIS agreed with commenters that 48 hours may be too long. The Agency has concluded that because notification can be made with a phone call, 24 hours is an appropriate time in which to expect official establishments that have shipped or received, or have reason to believe that they have shipped or received, adulterated or misbranded product, to notify the appropriate District Office of that situation. Therefore, the final rule requires official establishments to notify the appropriate District Office within 24 hours of learning or determining that an adulterated or misbranded product received by or originating from the establishment has entered commerce, if the establishment believes or has reason to believe that this has happened.

Comment: A few comments requested that the Agency provide more guidance on when the 48-hour period would officially begin. One comment from a consumer group argued that the proposed requirement was vague and confusing. The commenter asked that the Agency explain how much investigation an establishment owner will be required to make before the notification requirement is triggered. Another comment from a trade group representing meat packing and processing establishments recommended that the Agency work with industry on establishing the timeline. They requested that the Agency develop specific guidance that outlines a step-by-step reaction process. They also requested that FSIS consider factors such as microbial test data recovery, weekends, and Federal holidays when deciding when the 48-hour period should officially begin.

Agency's Response: The 24-hour period begins when the establishment has reason to believe that a product that is in commerce is adulterated or misbranded under the FMIA or PPIA. For example, if the results of a laboratory analysis show that raw ground beef contains E. coli O157:H7, or that a ready-to-eat product contains Listeria monocytogenes or any other pathogen, the product would be adulterated. However, there also may be situations in which laboratory results are not available, but, based on epidemiological evidence, there may be a probability of harm from consuming the product. Under these circumstances, the establishment is to consider the strength of the epidemiological evidence to determine whether there is reason to believe that the product is adulterated or misbranded.

Comment: Two comments argued that the notification requirement is “overly broad,” and that minor labeling errors do not misbrand product and should be excluded from the notification requirement. They suggested that the Agency follow the standard established for the U.S. Food and Drug Administration's (FDA's) Reportable Food Registry or incorporate a de minimis standard. The FDA standard requires notification when there is a reasonable probability that the use of, or exposure to, the article of food will cause serious adverse health consequences or death (21 U.S.C. 350(d)).

Agency's Response: FSIS did not accept suggestions to follow the standard established for the FDA's Reportable Food Registry (RFR) or to incorporate a de minimis standard. FSIS assesses the public health concern or hazard presented by a product being recalled, or considered for recall, and classifies the concern as one of the following: (1) Class I, a health-hazard situation where there is a reasonable probability that the use of the product will cause serious, adverse health consequences or death; (2) Class II, a health-hazard situation where there is a remote probability of adverse health consequences from the use of the product; or (3) Class III, a situation where the use of the product will not cause adverse health consequences. If the Agency adopted the RFR standard or a similar de minimis standard, establishments may not be required to notify FSIS about product that could trigger a Class II or Class III recall. Furthermore, the 2008 Farm Bill provisions do not provide for a de minimis standard concerning the notification requirements for establishments that may have shipped or received adulterated or misbranded product. Consistent with the statute, and because the notification requirement is a preventive measure that will allow FSIS to determine more quickly whether a recall action is necessary (including detention and seizure of product by FSIS), thereby protecting public health, the final rule requires official establishments to notify the appropriate District Office of all product that is believed to be adulterated or misbranded.

FSIS is aware, however, that there can be misbranding situations because of minor labeling deficiencies, and that these deficiencies do not create health or safety issues or impart an economic advantage. If a District Office, when notified by an establishment that it has shipped or received or may have shipped or received misbranded product, identifies the violation as one that does not create a health or safety issue or economic impact, it will contact FSIS's Labeling and Program Delivery Division (LPDD) about the misbranding situation. LPDD will then contact the establishment and work with it to resolve the situation.

Comment: Two comments submitted by consumer groups requested that the final rule require official establishments to notify both the appropriate District Office and FSIS headquarters in Washington, DC They argued that because the legislation refers to notifying the Secretary of Agriculture, and given the potential health impacts of the recall information, data should be sent to headquarters in addition to the local District Office.

Agency's Response: The Agency does not believe it is necessary for official establishments to contact both the appropriate District Office and FSIS headquarters in Washington, DC The Secretary of Agriculture has delegated to the Under Secretary for Food Safety the responsibility for exercising the functions of the Secretary of Agriculture under various statutes (Section 4(a) of Reorganization Plan No. 2 of 1953 (5 U.S.C. App.) and Section 212(a)(1) of the Department of Agriculture Reorganization Act of 1994, Public Law 103-354, 7 U.S.C. 6912(a)(1)), while the Under Secretary for Food Safety has delegated that authority to the Administrator of the Food Safety and Inspection Service (7 CFR 2.7, 2.18, and 2.53). In turn, each District Office, under the direction of a District Manager, has been given the authority to manage a farm-to-table food safety program of regulatory oversight and inspection in a district consisting of a State or several States and territories. Thus, the District Offices have the authority, and are fully competent, to receive and analyze information from official establishments about adulterated or misbranded product.

Comment: A trade group representing meat packing and processing establishments and a trade group that represents food and beverage companies noted that the proposed rule provides that establishments must notify FSIS of the destination of the adulterated or misbranded product. The two trade groups suggested that the Agency clearly state in the preamble to the final rule that while the statutory language specified notification of the “destination” of the adulterated or misbranded product, shipping establishments only have knowledge of, and therefore, need only provide notification about their direct consignees.

Agency's Response: Under this rule, establishments must provide all available information about the “destination” of adulterated or misbranded product. This rule does not create a duty to seek out new information; however, if establishments have information about the destination of adulterated or misbranded product beyond their direct consignees, they must provide it to the Agency.

Comment: Several comments expressed concerns about the security of plant recall information and whether recall plans would be subject to the Freedom of Information Act (FOIA) (5 U.S.C. 552(b)).

Agency's Response: FSIS understands the nature of these comments and that many meat and poultry establishments view the data in recall procedures as confidential commercial information. Pursuant to USDA's Freedom of Information Act (FOIA) regulations (7 CFR 1.1 et seq.), FSIS is responsible for making the determination with regard to the disclosure or nondisclosure of information in records obtained from businesses. When, in the course of responding to an FOIA request, FSIS cannot readily determine whether the information obtained from a person is confidential business information, the Agency seeks to obtain and carefully consider the views of the business and provide the business an opportunity to object to any decision to disclose the information.

Under this final rule, establishments are not required to submit their recall procedures to FSIS. They must, however, make the written recall procedures available for copying. FSIS will verify that all establishments maintain the required written recall procedures. FSIS will also protect establishments' confidential business information from public disclosure to the extent authorized under FOIA and in conformity with USDA's FOIA regulations.

Comment: Two comments questioned whether the language of the proposed rule exceeded the provisions of the Farm Bill because it requires official establishments to specify in their written recall procedures how they will decide whether to conduct a product recall, and how the establishment will effect the recall, should it decide that one is necessary.

Agency's Response: FSIS has the authority to require official establishments to specify in their written recall procedures how they will decide whether to conduct a product recall, and how the establishment will effect the recall, should it decide that one is necessary. 1 These requirements are also consistent with the legislation and with longstanding Agency guidance on recall plans. 2

Comment: Several comments suggested that the Agency execute the rule in incremental stages based on business size, similar to the plan used when HACCP was implemented. Two stated that six months to one year is a reasonable time to give establishments to develop recall procedures. One comment suggested that current establishments should be given six months to develop recall procedures, but new establishments should be required to prepare their recall procedures at the same time as their HACCP plans. Another comment recommended that large establishments be required to prepare their recall procedures as soon as possible, but that small and very small establishments be given more time to comply. Yet another comment suggested that the Agency implement the rule for large establishments and review the results for one year before requiring small and very small establishments develop recall procedures.

Agency's Response: FSIS has sought to make this rule as fair and equitable as possible, regardless of an establishment's size. Therefore, the Agency asked for comments on when, after the effective date of this final rule, written recall procedures must be completed in accordance with proposed 9 CFR 418.3. Based upon the comments received, FSIS has determined that existing large establishments will have six months from the date of publication of this final rule to implement it and prepare recall plans. To minimize the burden on small businesses, small and very small establishments will have one year from the date of publication to comply.

FSIS believes that the suggestion to require new establishments to have prepared their recall procedures at the same time as their HACCP plans in order to receive a Federal Grant of Inspection has merit. Therefore, the Agency is amending 9 CFR 304.3 and 9 CFR 381.22 to require that before being granted Federal inspection, an establishment must have developed written recall procedures as required by part 418 of Title 9, Chapter III. The Office of Outreach, Employee Education and Training has model recall plans available to industry.

Comment: Several comments supported the documenting of HACCP reassessments, as proposed. One consumer group argued that documentation is vital because it provides a needed safeguard against evasion of reassessment requirements. The commenter stated that by making records of reassessment available for official review and copying, FSIS has the ability to preempt an outbreak by identifying overlooked hazards.

Agency's Response: The Agency agrees with comments that the documenting of HACCP reassessments is beneficial. The Agency believes that documenting HACCP reassessments will facilitate verification that establishments have appropriately reassessed their HACCP plans. It will also help FSIS personnel to identify whether there are emerging hazards that the establishment has decided not to address.

Comment: One comment submitted by a trade group representing meat packing and processing establishments requested that the Agency clarify in the final rule that simple formatting or grammar changes of a HACCP plan do not need to be documented as reassessments.

Agency's Response: While establishments are required to document each reassessment of their HAACP plans, the Agency does not consider formatting and grammar changes to be reassessments.

Comment: The Agency received several comments addressing the cost of implementing the proposed rule. One consumer group argued that the cost of implementing the proposed rule is reasonable. The commenter argued that if the first-year industry costs will be $5 million dollars, that cost is far less than the billions of dollars the United States incurs as a result of foodborne illnesses per year.

A few comments from very small processors or supporters of very small processors or local processors claimed that additional regulation will be an undue financial burden on small and very small establishments. One trade group representing meat packing and processing establishments believed that FSIS's estimated initial cost is already a significant cost to many small and very small establishments, and that the actual cost could potentially be much higher. The trade group suggested that the initial cost to small and very small establishments might be $2,000; however, the trade group did not offer any data to support its claim. Another comment submitted by a consumer suggested creating waivers or exemptions for small and very small establishments.

Agency's Response: While the Agency agrees with the commenter that $2,000 in initial cost for small and very small establishments may be a significant cost, FSIS estimates that the average initial (first-year) cost of implementing this final rule for these establishments will not be $2,000 but would be between $700 and $900, with a midpoint of $800, 3 for each small or very small establishment.

Executive Orders 13563 and 12866 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. This rule has been designated a “significant regulatory action” under section 3(f) of Executive Order 12866. Accordingly, the rule has been reviewed by the Office of Management and Budget.

FSIS has carefully evaluated the comments submitted in response to the proposed rule and has concluded that it is appropriate to adopt the Preliminary Regulatory Impact Analysis and the initial Regulatory Flexibility Act (RFA) assessment as final. This Final Regulatory Impact Analysis (FRIA) and final RFA assessment have changed from the Preliminary Regulatory Impact Analysis and the initial RFA assessment that were published in the proposed rule on March 25, 2010, though the methodology remains the same.

FSIS expects that this final rule will affect about 6,300 official federally-inspected establishments that slaughter or process meat, meat products, poultry, and poultry products, based on FSIS's Performance Based Inspection System (PBIS) of 2011. Based on HACCP classification, about 400 are large establishments, 3,044 are small, and 2,856 are very small. 4

Under the current regulations, the development and maintenance of recall procedures and the written documentation of HACCP reassessments are voluntary. This final rule will make them mandatory. Costs will be incurred because about 6,300 official establishments will need to develop recall procedures and maintain written documentation of HACCP reassessments. Cost estimates are updated to reflect the most recent available data. 5

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on October 11, 2011 (76 FR 62673), and proposed to supersede AD 2010-23-26, Amendment 39-16516 (75 FR 74610, December 1, 2010). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

We gave the public the opportunity to participate in developing this AD. We considered the comment received. The commenter supports the NPRM (76 FR 62673, October 11, 2011).

We have made the following changes to this AD. These changes have not changed the intent of any provisions specified in this AD.

• Revised certain headers throughout this AD.

• Redesignated Notes 1, 2, and 3 of the NPRM (76 FR 62673, October 11, 2011) as paragraphs (g)(3), (q)(1), and (q)(2) of this AD, respectively.

• Redesignated paragraph (n) of the NPRM (76 FR 62673, October 11, 2011) as paragraph (q)(3) of this AD, and redesignated subsequent paragraphs accordingly.

• We have revised paragraphs (g), (i), (o)(1), (o)(3), (o)(4), and (o)(5) of this AD to clarify the specific actions for which the specified service information is required.

• We have revised the headings of Tables 1, 2, 3, 4, 5, and 6 of this AD to clarify the purpose of the content in those tables.

• We have revised the wording in paragraphs (q)(1), (q)(2), (q)(3), and (q)(4) of this AD (Notes 2 and 3 and paragraphs (n) and (r) of the NPRM (76 FR 62673, October 11, 2011), respectively); this change has not changed the intent of these paragraphs.

We reviewed the available data, including the comment received, and determined that air safety and the public interest require adopting the AD with the changes described previously—and minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (76 FR 62673, October 11, 2011) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (76 FR 62673, October 11, 2011).

We estimate that this AD will affect about 155 products of U.S. registry.

The actions that are required by AD 2010-23-26, Amendment 39-16516 (75 FR 74610, December 1, 2010), and retained in this AD take about 79 work-hours per product, at an average labor rate of $85 per work hour. Required parts cost about $10,270 per product. Based on these figures, the estimated cost of the currently required actions is $16,985 per product.

We estimate that it will take about 100 work-hours per product to comply with the new basic requirements of this AD. The average labor rate is $85 per work-hour. Based on these figures, we estimate the cost of the AD on U.S. operators to be $1,317,500, or $8,500 per product.

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

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

We determined that this 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 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); and

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

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

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (76 FR 62673, October 11, 2011), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

We received two reports of sun gears, part number (P/N) E3028456, and installed in reduction gearboxes, failing during operation. We also received one report of a sun gear, P/N E3037304, showing premature wear and broken gear teeth during inspection. All three gear failures occurred between 60 and 127 hours of operation time-since-new. These conditions, if not corrected, could result in failure of the sun gear and planet gears in the propeller reduction gearbox assembly, which will result in an engine in-flight shut down, possible uncontained engine failure, aircraft damage, and serious injuries. We determined that the affected PMA replacement TAATI first stage sun gears and planet gears listed in this AD, would have been installed after December 22, 2008. The affected parts are listed as follows:

First stage sun gears P/N E3028456, all serial numbers (S/Ns), and the associated planet gears.

First stage sun gears P/N E3037304, all S/Ns, and the associated planet gears.

Planet gear sets P/N E3101455-02, all S/Ns, and the associated sun gears.

Planet gear sets P/N E3101525-02, all S/Ns, and the associated sun gears.

We are issuing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.

This AD requires removal from service within 40 operating hours after the effective date of the AD, of the PMA replacement TAATI first stage sun gears and planet gears, as listed in the Discussion section above, and installed in the reduction gearbox assemblies of Pratt & Whitney Canada PT6A-38, -41, -42, -42A, -61, -64, -66, -66B, -110, -112, -114, -114A, -121, -135, and -135A series turboprop engines.

An unsafe condition exists that requires the immediate adoption of this AD. The FAA has found that the risk to the flying public justifies waiving notice and comment prior to adoption of this rule because of the short compliance time required in this AD to start the inspections. Therefore, we determined that notice and opportunity for public comment before issuing this AD are impracticable and that good cause exists for making this amendment effective in fewer than 30 days.

This AD is a final rule that involves requirements affecting flight safety, and we did not precede it by notice and opportunity for public comment. We invite you to send any written relevant data, views, or arguments about this AD. Send your comments to an address listed under the ADDRESSES section. Include “Docket No. FAA-2012-0417; Directorate Identifier 2012-NE-11-AD” at the beginning of your comments. We specifically invite comments on the overall regulatory, economic, environmental, and energy aspects of this AD. We will consider all comments received by the closing date and may amend this AD because of those comments.

We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We will also post a report summarizing each substantive verbal contact with FAA personnel concerning this AD. Using the search function of the Web site, anyone can find and read the comments in any of our dockets, including, if provided, the name of the individual who sent the comment (or signed the comment on behalf of an association, business, labor union, etc.). You may review the DOT's complete Privacy Act Statement in the Federal Register published on April 11, 2000 (65 FR 19477-78).

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 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); and

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

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

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM published in the Federal Register on April 25, 2011 (76 FR 22828). That NPRM proposed to require, for certain airplanes, replacing the seat track pivot link assemblies, seat track sections, and floor panels. For certain airplanes, that NPRM also proposed to require moving certain rows of passenger seats. For certain other airplanes, that NPRM also proposed to require inspecting certain areas of the seat tracks for damage, and corrective actions if necessary.

We reviewed the compliance times that were proposed and determined that the compliance time in paragraph (h)(1) of the NPRM (76 FR 22828, April 25, 2011) applies to all airplanes identified in paragraph (h) of this AD and the compliance time proposed in paragraph (h)(2) of the NPRM is unnecessary. We have therefore removed paragraphs (h)(1) and (h)(2) of the NPRM and revised paragraph (h) of this AD.

We gave the public the opportunity to participate in developing this AD. The following presents the comments received on the proposal (76 FR 22828, April 25, 2011) and the FAA's response to each comment. Boeing supports the NPRM.

AirTran Airways (ATA) (now owned by Southwest Airlines) and Southwest Airlines (SWA) requested that the NPRM (76 FR 22828, April 25, 2011) be withdrawn. ATA and SWA stated that the Model 737-700 series airplanes owned by ATA and transferred to SWA ownership have been or will be modified to have new B/E Aerospace seats installed in a different layout of passenger accommodation (LOPA). The LOPA for those B/E Aerospace seats does not have a seat leg fitting that spans the STA 521.45 “stay-out zone.” ATA stated that it accomplished the actions of Boeing Special Attention Service Bulletin 737-53-1286, dated November 20, 2008, or Revision 1, dated December 14, 2009, on 22 of its airplanes; those airplanes and the remaining 24 airplanes in its fleet would be modified to SWA's seat configuration before the effective date of the AD. ATA also stated that it sold three of the 49 airplanes listed in Boeing Special Attention Service Bulletin 737-25-1596, dated November 20, 2008. ATA and SWA stated that since the new seats are from a different seat manufacturer and will be installed in a different approved LOPA, the unsafe condition would no longer exist.

We disagree with the commenters' request to withdraw the proposed AD (76 FR 22828, April 25, 2011). Replacing the existing Recaro seat configuration with the B/E Aerospace configuration would address the unsafe condition while that configuration is installed. However, the approval for the Recaro seats with the LOPA that has a seat leg fitting that spans the STA 521.45 “stay-out zone” would still exist. It would be possible, for example, for an operator that has purchased one of the three airplanes that ATA sold to convert the seats and LOPA back to the Recaro seats and the related LOPA that spans the STA 521.45 “stay-out zone.” In light of this, the unsafe condition is likely to exist or develop in the affected airplanes. As a result, we are issuing this AD to eliminate the unsafe condition by requiring that seat leg fittings do not span the “stay-out zone.” The AD is the appropriate vehicle for mandating such actions. We have not changed the AD in this regard.

ATA and SWA also requested that if the NPRM (76 FR 22828, April 25, 2011) is not withdrawn, that the proposed applicability be revised to apply only to airplanes with specific Recaro seats installed in a specific configuration. SWA stated that if the airplane does not have those specific Recaro seats installed with the foot spanning the STA 521.45 “stay-out zone,” then the unsafe condition does not exist and the AD should not apply. ATA also stated that having an AD include airplanes on which the modification to a different LOPA or the applicable service bulletins has been accomplished would result in applying for an alternative method of compliance (AMOC) each time a revision to that LOPA is issued. ATA stated that issuing AMOCs each time a LOPA is revised would produce an undue burden on both the airline and the FAA.

We partially agree. The applicability statement of this AD references certain service bulletins, one of which contains conditions as part of its effectivity. Part of the applicability statement in paragraph (c) of this AD contains an indirect reference to the conditional statement that the commenters requested, i.e., “a passenger seat configuration that could result in a seat leg plunger being installed across a seat track pivot point * * *,” as described in paragraph 1.A. of Boeing Special Attention Service Bulletin 737-53-1286, Revision 1, dated December 14, 2009. Boeing Special Attention Service Bulletin 737-53-1286, Revision 1, dated December 14, 2009, is referenced in paragraphs (c)(1) (as an applicability condition) and (g) (in the identification of affected airplanes) of this AD. When an airplane has been modified so that a seat leg plunger is not installed across that specific seat track pivot point, the actions required by paragraph (g) of this AD would not be required. The other service bulletins referenced in the proposed AD (76 FR 22828, April 25, 2011) do specify specific airplanes without conditional statements on whether certain seat configurations are installed. Also, we do not consider it appropriate to include various provisions in an AD applicable only to individual airplanes or to a single operator's seat configurations or unique use of an airplane. Once we issue this AD, any person may request approval of an AMOC under the provisions of paragraph (k) of this AD. We have not changed the AD in this regard.

We have added paragraph (k)(3) to this final rule to provide operators with the option to apply for an AMOC that has been approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle Aircraft Certification Office, to make those findings.

We reviewed the relevant data, considered the comments received, and determined that air safety and the public interest require adopting the AD as proposed—except for minor editorial changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (76 FR 22828, April 25, 2011) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (76 FR 22828, April 25, 2011).

We estimate that this AD will affect 50 airplanes of U.S. registry. The following table provides the estimated costs for U.S. operators to comply with this AD.

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.

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 DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),

(3) Will not affect intrastate aviation in Alaska, 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.

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

Discussion

We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR part 39 to include an AD that would apply to the specified products. That NPRM was published in the Federal Register on November 7, 2011 (76 FR 68668). That NPRM proposed to correct an unsafe condition for the specified products. The MCAI states:

You may obtain further information by examining the MCAI in the AD docket.

We gave the public the opportunity to participate in developing this AD. We received no comments on the NPRM (76 FR 68668, November 7, 2011) or on the determination of the cost to the public.

We have revised paragraph (h)(2) of this AD to correct a typographical error. This error resulted in a reference to paragraph (c) of this AD instead of paragraph (g) of this AD.

We reviewed the available data and determined that air safety and the public interest require adopting the AD as proposed except for minor editorial changes and/or format changes. We have determined that these minor changes:

• Are consistent with the intent that was proposed in the NPRM (76 FR 68668, November 7, 2011) for correcting the unsafe condition; and

• Do not add any additional burden upon the public than was already proposed in the NPRM (76 FR 68668, November 7, 2011).

We estimate that this AD will affect 4 products of U.S. registry. We also estimate that it will take about 30 work-hours per product to comply with the basic requirements of this AD. The average labor rate is $85 per work-hour. Required parts will cost about $520,000 per product. Where the service information lists required parts costs that are covered under warranty, we have assumed that there will be no charge for these parts. As we do not control warranty coverage for affected parties, some parties may incur costs higher than estimated here. Based on these figures, we estimate the cost of this AD to the U.S. operators to be $2,090,200, or $522,550 per product.

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

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

We determined that this 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; 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 a regulatory evaluation of the estimated costs to comply with this AD and placed it in the AD docket.

You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office between 9 a.m. and 5 p.m., Monday through Friday, except Federal holidays. The AD docket contains the NPRM (76 FR 68668, November 7, 2011), the regulatory evaluation, any comments received, and other information. The street address for the Docket Operations office (telephone (800) 647-5527) is in the ADDRESSES section. Comments will be available in the AD docket shortly after receipt.

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

Throughout this document, the terms “we,” “us,” and “our” refer to EPA.

Effective June 15, 2004, EPA designated and classified the “Los Angeles and San Bernardino Counties (Western Mojave Desert)” area in California (Western Mojave Desert) under the CAA as “Subpart 2/Moderate” nonattainment for the 1997 8-hour ozone NAAQS. 1 See 69 FR 23858, at 23884 (April 30, 2004) and 40 CFR 81.305. Our classification of the Western Mojave Desert area as a “Moderate” ozone nonattainment area established a requirement that the area attain the 1997 8-hour ozone NAAQS as expeditiously as practicable, but no later than six years from the date of designation as nonattainment, i.e., June 15, 2010.

On February 14, 2008, the California Air Resources Board (CARB) submitted a request that EPA reclassify three California areas (including the Western Mojave Desert area) designated nonattainment for the 1997 8-hour ozone standard. 2 For the Western Mojave Desert ozone nonattainment area, CARB requested reclassification from “Moderate” to “Severe-17.”  3 On March 14, 2012, CARB submitted a clarification requesting that EPA reclassify the Western Mojave Desert area from “Moderate” to “Severe.”  4 Consistent with section 181(b)(3) of the CAA, we are granting the State's request and reclassifying the Western Mojave Desert area from “Moderate” to “Severe-15” nonattainment for the 1997 8-hour ozone NAAQS. 5 We are not establishing a schedule for plan submissions at this time and intend to do so in a subsequent action, if necessary.

Because the State of California does not have jurisdiction over Indian country located within its borders, CARB's request to reclassify the Western Mojave Desert area does not apply to Indian country under the jurisdiction of the Twenty-Nine Palms Band of Mission Indians of California, which is located within the boundaries of the Western Mojave Desert nonattainment area. EPA implements federal Clean Air Act programs, including reclassifications, in this area of Indian country consistent with our discretionary authority under sections 301(a) and 301(d)(4) of the Clean Air Act. EPA has consulted with the Twenty-Nine Palms Band of Mission Indians of California regarding CARB's request and the Tribe has agreed to reclassification of its tribal land within the Western Mojave Desert nonattainment area consistent with the surrounding areas under State jurisdiction. 6 Accordingly, we are reclassifying the entire Western Mojave Desert nonattainment area (both the portion under State jurisdiction and the portion under the Tribe's jurisdiction) from “Moderate” to “Severe-15” for the 1997 8-hour ozone NAAQS.

We are approving CARB's reclassification request under section 181(b)(3) of the Act, which provides for “voluntary reclassification” and states: “The Administrator shall grant the request of any State to reclassify a nonattainment area in that State in accordance with table 1 of subsection (a) of this section to a higher classification. The Administrator shall publish a notice in the Federal Register of any such request and of action by the Administrator granting the request.” The provision for voluntary reclassification has been brought forward as part of the transition from the 1-hour ozone standard to the 1997 8-hour ozone standard. See 40 CFR 51.903(b) (“A State may request a higher classification for any reason in accordance with section 181(b)(3) of the CAA”) and 40 CFR 51.903(a), Table 1. Because the plain language of section 181(b)(3) mandates that we approve such a request, EPA is granting CARB's request for voluntary reclassification under section 181(b)(3) for the Western Mojave Desert ozone nonattainment area, and EPA is reclassifying the area from “Moderate” to “Severe-15” for the 1997 8-hour ozone NAAQS. With respect to that portion of the Western Mojave Desert area that is under the jurisdiction of the Twenty-Nine Palms Band of Mission Indians of California, EPA has consulted with the Tribe and the Tribe has agreed to reclassification of the area from “Moderate” to “Severe-15” consistent with the surrounding areas under State jurisdiction. As a result of this action, Western Mojave Desert must now attain the 1997 8-hour ozone NAAQS as expeditiously as practicable, but no later than fifteen years from the date of designation as nonattainment, i.e., June 15, 2019. EPA will address in future rulemaking actions, as necessary, any issues relating to timing and content of plan submissions under this new classification.

EPA has determined that today's action falls under the “good cause” exemption in section 553(b)(3)(B) of the Administrative Procedure Act (APA) which, upon finding “good cause,” authorizes agencies to dispense with public participation where public notice and comment procedures are “impracticable, unnecessary or contrary to the public interest.” With respect to that portion of the Western Mojave Desert area that is under State jurisdiction, public notice and opportunity for comment prior to today's action are unnecessary because EPA's reclassification of the Western Mojave Desert area to “Severe-15” is mandated by the CAA and does not involve any exercise of discretion. Public notice and comment are also unnecessary with respect to our reclassification of Indian country under the jurisdiction of the Twenty-Nine Palms Band of Mission Indians of California located within the Western Mojave Desert area, because the Tribe has agreed to reclassification of these tribal lands consistent with the surrounding State lands.

Under Executive Order 12866 (58 FR 51735, October 4, 1993), this action is not a “significant regulatory action” and therefore is not subject to review by the Office of Management and Budget. With respect to lands under State jurisdiction, voluntary reclassifications under section 181(b)(3) of the CAA are based solely upon requests by the State and EPA is required under the CAA to grant them. These actions do not, in and of themselves, impose any new requirements on any sector of the economy. In addition, because the statutory requirements are clearly defined with respect to the differently classified areas, and because those requirements are automatically triggered by classification, reclassification does not impose a materially adverse impact under Executive Order 12866. With respect to Indian country, reclassifications do not establish deadlines for air quality plans or plan revisions. For these reasons, this action is also not subject to Executive Order 13211, “Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use” (66 FR 28355, May 22, 2001).

In addition, I certify that this rule will not have a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601 et seq. ). This action does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), because EPA is required to grant requests by States for voluntary reclassifications and such reclassifications in and of themselves do not impose any federal intergovernmental mandate, and because tribes are not subject to implementation plan submittal deadlines that apply to states as a result of reclassifications.

Executive Order 13175 (65 FR 67249, November 9, 2000) requires EPA to develop an accountable process to ensure “meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.” “Policies that have tribal implications” is defined in the Executive Order to include regulations that have “substantial direct effects on one or more Indian tribes, on the relationship between the Federal government and Indian tribes, or on the distribution of power and responsibilities between the Federal government and Indian tribes.” One Indian tribe (the Twenty-Nine Palms Band of Mission Indians of California) has jurisdiction over Indian country located within the boundaries of the Western Mojave Desert area. EPA implements federal Clean Air Act programs, including reclassifications, in this area of Indian country consistent with our discretionary authority under sections 301(a) and 301(d)(4) of the Clean Air Act. EPA has concluded that this final rule might have tribal implications for the purposes of Executive Order 13175 but will not impose substantial direct costs upon the Tribe, nor does it preempt Tribal law. This final rule does not affect implementation of new source review for new or modified stationary sources proposed in Indian country within the boundaries of the Western Mojave Desert area because such sources are already subject to the permitting requirements that apply in “Severe” nonattainment areas for purposes of the 1-hour ozone NAAQS. This reclassification might affect projects proposed in this area of Indian country that require Federal permits, approvals, or funding under EPA's General Conformity rule because of the lower de minimis thresholds triggered by reclassification (25 tons per year for volatile organic compounds or oxides of nitrogen). Given the potential implications, EPA contacted tribal officials to provide an opportunity for meaningful and timely input into this action. As discussed in section I of this document, on April 11, 2012, the Tribe agreed to the reclassification of its tribal lands within the Western Mojave Desert area consistent with the surrounding State lands.

This action also does not have Federalism implications because it does not have substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132 (64 FR 43255, August 10, 1999). This action does not alter the relationship or the distribution of power and responsibilities established in the Clean Air Act.

This rule also is not subject to Executive Order 13045, “Protection of Children from Environmental Health Risks and Safety Risks” (62 FR 19885, April 23, 1997), because EPA interprets Executive Order 13045 as applying only to those regulatory actions that concern health or safety risks, such that the analysis required under section 5-501 of the Executive Order has the potential to influence the regulation.

Reclassification actions do not involve technical standards and thus, the requirements of section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) do not apply. This rule does not impose an information collection burden under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq. ).

Executive Order 12898 (59 FR 7629, February 16, 1994) establishes federal executive policy on environmental justice. Its main provision directs federal agencies, to the greatest extent practicable and permitted by law, to make environmental justice part of their mission by identifying and addressing, as appropriate, disproportionately high and adverse human health or environmental effects of their programs, policies, and activities on minority populations and low-income populations in the United States. This reclassification action relates to ozone, a pollutant that is regional in nature, and is not the type of action that could result in the types of local impacts addressed in Executive Order 12898.

The Congressional Review Act, 5 U.S.C. section 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, 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 the rule in the Federal Register . A major rule cannot take effect until 60 days after it is published in the Federal Register . This action is not a “major rule” as defined by 5 U.S.C. 804(2).

Under section 307(b)(1) of the Clean Air Act, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by July 9, 2012. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this rule for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. This action may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)

Part 81, chapter I, title 40 of the Code of Federal Regulations 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 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 under FOR 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 at http://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 to http://www.epa.gov/ocspp and 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-2004-0144 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 July 9, 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-2004-0144, by one of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the online 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 the Federal Register of September 8, 2010 (75 FR 54629) (FRL-8843-3), 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 0F7687) by Stehekin, LLC, 1012 Good Lander Drive, Selah, Washington 98942. The petition requested that a tolerance exemption be established for residues of the fungicide 1-naphthaleneacetic acid (1-naphthaleneacetamide), on potatoes. That notice referenced a summary of the petition prepared by Stehekin, LLC, the registrant, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the notice of filing.

Based upon a revised petition which requested a tolerance and review of the data supporting the petition, EPA has determined that it is appropriate to establish a tolerance in association with the use of 1-naphthaleneacetic acid (1-naphthaleneacetamide) on potatoes.

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

Consistent with section 408(b)(2)(D) of FFDCA, and the factors specified in section 408(b)(2)(D) of FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure for 1-naphthalneactic acid, its salts, ester, and acetamide which are collectively referred to as naphthalene acetates (NAA) including exposure resulting from the tolerances established by this action. EPA's assessment of exposures and risks associated with NAA follows.

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

Based on structural activity relationship and metabolism data, all forms of 1-naphthaleneacetic acid, its salts, ester, and acetamide are expected to exhibit similar toxicological effects. Therefore the Agency concluded that required toxicity testing on any form should serve for all members of this group of chemicals.

Naphthalene acetates have low acute toxicity via the oral, inhalation and dermal routes of exposure. 1-Naphthaleneacetic acid is not a skin irritant or a dermal sensitizer. The 1-naphthaleneacetic acid and its sodium salt were found to be irritating to the eye. Repeated exposure oral toxicity studies in rats and dogs resulted in decreased body weights and body weight gains accompanied by decreased food consumption.

The major target organs of subchronic and chronic oral exposure were the liver, stomach and lung. Repeated oral exposure also resulted in decreased hematocrit and hemoglobin along with reduced RBC count in rats and dogs and hypocellularity of the bone marrow in dogs.

There was no developmental toxicity at the highest dose of 1-naphthaleneacetic acid tested in the rat or in the rabbit, but developmental toxicity (decreased fetal weight and minor skeletal changes) were seen in rats orally gavaged with the sodium salt.

Reproductive effects of naphthaleneacetic acid sodium salt were limited to reduced litter survival and pup weight throughout lactation in both generations of offspring in a 2-generation reproduction study.

Naphthaleneacetic acid and it's acetamide and the ethyl ester were tested for mutagenic effects in a gene mutation bacterial assay, mouse lymphoma assay, and mouse erythrocyte micronucleus assay, mouse lymphoma assay, and mouse erythrocyte micronucleus assay and were not mutagenic. Additionally 1-naphthaleneacetic acid was tested for mitotic gene conversion and dominant lethality in rats and found to be negative.

Carcinogenicity studies of NAA in mice and in rats for the 1-naphthaleneacetic acid group showed no evidence of carcinogenicity. Specific information on the studies received and the nature of the adverse effects caused by NAA as well as the no-observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in the document “Naphthalene Acetates HED Risk Assessment for Section 3 Proposed New Use on Potato Seed Pieces” at pages 10 through 14 in docket ID number EPA-HQ-OPP-2004-0144.

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, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.

A summary of the toxicological endpoints for 1-naphthaleneaetic acid used for human risk assessment is shown in Table 1 of this unit.

1. Dietary exposure from food and feed uses. In evaluating dietary exposure to NAA, EPA considered exposure under the petitioned-for tolerances as well as all existing tolerances in 40 CFR 180.155. EPA assessed dietary exposures from NAA in food as follows:

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

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

ii. Chronic exposure. In conducting the chronic dietary exposure assessment EPA used the food consumption data from the USDA 1994-1996 and 1998 CSFII. As to residue levels in food, EPA assumed tolerance level residues for all registered uses, 100% crop treated for all commodities with existing tolerances, and default processing factors.

iii. Cancer. Based on the data summarized in Unit III.A., EPA has concluded that NAA 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 percent crop treated (PCT) information. EPA did not use anticipated residue and/or PCT information in the dietary assessment for 1-naphthaleneacetic. Tolerance level residues and/or 100% CT were assumed for all food commodities.

2. Dietary exposure from drinking water. The Agency used screening level water exposure models in the dietary exposure analysis and risk assessment for NAA in drinking water. These simulation models take into account data on the physical, chemical, and fate/transport characteristics of 1-naphthaleneacetic acid. Further, information regarding EPA drinking water models used in pesticide exposure assessment can be found at http://www.epa.gov/oppefed1/models/water/index.htm .

Based on the First Index Reservoir Screening Tool (FIRST) and Screening Concentration in Ground Water (SCI-GROW) models, estimated drinking water concentrations (EDWCs) of naphthaleneacetic acetates for peak and average concentrations of naphthalene acetates in surface water are 0.02 ppm and 0.003 ppm respectively. The modeled peak and average EDWCs for ground water is 0.00002 ppm.

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

For chronic dietary risk assessment, the water concentration of value .003 ppm was used to assess the contribution to drinking water.

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

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 naphthalene acetates to share a common mechanism of toxicity with any other substances, and NAA does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has assumed that NAA 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 at http://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 safety factor when reliable data available to EPA support the choice of a different factor.

2. Prenatal and postnatal sensitivity. There is low concern (and no residual uncertainty) for prenatal and/or postnasal toxicity resulting from exposure to the NAA group of chemicals. The available data provided no indication of increased susceptibility (quantitative or qualitative) to rats or rabbits to in utero exposure to naphthalene acetates or to prenatal and postnatal exposure in rat reproduction studies.

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

i. Acceptable developmental toxicity studies in the rat and rabbit, and an acceptable reproduction study in the rat are available. Recent changes to 40 CFR part 158 require acute and subchronic neurotoxicity and immunotoxicity studies. An immunotoxicity study is not available. However, the toxicology data base for NAA does not show any evidence of treatment-related effects on the immune system and the overall weight of evidence suggests that this chemical does not directly target the immune system. Consequently, the Agency does not believe that conducting a functional immunotoxicity study will result in a lower POD than that currently used for overall risk assessment, and therefore, an additional safety factor is not needed to account for lack of this study. The toxicity database does not show any indications of neurotoxicity or neuropathology (the liver, stomach, lung, and hematological parameters are the target organs based on repeat toxicity studies in rats, mice and dogs).

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

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

iv. There are no residual uncertainties identified in the exposure databases. EPA made conservative (protective) assumptions in dietary assessment and in the ground and surface water modeling used to assess exposure to NAA in drinking water. EPA made conservative (protective) assumptions in the residential handler assessment. Post-application exposure to residents is not expected.

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

2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that chronic exposure to NAA, from food and water will utilize 2% of the cPAD for children 1-2 years old, the population group receiving the greatest exposure.

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

There is potential for short-term residential exposure to NAA from ornamental uses. Oral, dermal and inhalation exposures cannot be combined for short-term aggregate risk assessment, however, because oral exposure endpoints are not based on common toxicological effects with either dermal or inhalation endpoints. Estimated dermal and inhalation MOEs for residential exposure to naphthalene acetates are 3,800 and 58,000 respectively. These estimated exposures are greater than the target MOE of 100 and therefore not of concern. Although a POD from an oral study was used to assess residential handler inhalation risks for NAA, the Agency does not believe this assessment is under-protective of adult handlers. Inhalation MOEs calculated for residential handlers were all >58,000, thus providing an ample margin of safety to account for any uncertainties in route-to-route extrapolation.

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).

Intermediate-term exposure to NAA is not expected based on residential use patterns. Therefore, NAA is not expected to pose an intermediate-term risk.

5. Aggregate cancer risk for U.S. population. Based on the lack of evidence of carcinogenicity in two adequate rodent carcinogenicity studies, NAA 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 NAA residues.

An adequate enforcement methodology (HPLC methods (Method NAA-AM 001 and Method NAA-AM-002) for determination of NAA in plant commodities have been submitted and reviewed. These methods have been subjected to successful independent laboratory validations. Acceptable recoveries were obtained from apples, olives and olive oil fortified with NAA at the method limit of quantitation (LOQ; 0.01 ppm) and at 1.0 ppm.

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.

No Codex, Canadian, or Mexican maximum residue limits (MRLs) have been established for residues of naphthalene acetates. Therefore, there are no trade issues with this action.

The applicant's petition requested an exemption from the requirement of a tolerance for this seed potato application but upon review of submitted information, the Agency determined that a potato tolerance is needed. In lieu of providing field trial data, a theoretical calculation was provided, to show that residues of 1-naphthaleneacetic acid on potatoes will be less than the analytical method's level of quantitation (0.01 ppm) when using the label application rates on potato seed pieces. The Agency determined that a tolerance at the level of quantitation is appropriate and that an exemption is not appropriate because some residues below the level of quantitation may be present and there is toxicological concern for NAA.

Therefore, tolerances are established for residues of 1-naphthaleneacetic acid and its conjugates calculated as 1-naphthaleneacetic acid from the application of 1-naphthaleneacetic acid, its ammonium, sodium, or potassium salts, ethyl ester, and acetamide in or on food commodities as follows: in or on potato at 0.01 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, entitled Regulatory 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, entitled Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled Protection 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. 3501 et seq., nor does it require any special considerations under Executive Order 12898, entitled Federal 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. 601 et 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, entitled Federalism (64 FR 43255, August 10, 1999) and Executive Order 13175, entitled Consultation 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. 801 et 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 the Federal 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 Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Federal Insurance and Mitigation Administrator has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community.

The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

Accordingly, 44 CFR part 67 is amended as follows:

The Federal Emergency Management Agency (FEMA) makes the final determinations listed below for the modified BFEs for each community listed. These modified elevations have been published in newspapers of local circulation and ninety (90) days have elapsed since that publication. The Deputy Federal Insurance and Mitigation Administrator has resolved any appeals resulting from this notification.

This final rule is issued in accordance with section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4104, and 44 CFR part 67. FEMA has developed criteria for floodplain management in floodprone areas in accordance with 44 CFR part 60.

Interested lessees and owners of real property are encouraged to review the proof Flood Insurance Study and FIRM available at the address cited below for each community. The BFEs and modified BFEs are made final in the communities listed below. Elevations at selected locations in each community are shown.

National Environmental Policy Act. This final rule is categorically excluded from the requirements of 44 CFR part 10, Environmental Consideration. An environmental impact assessment has not been prepared.

Regulatory Flexibility Act. As flood elevation determinations are not within the scope of the Regulatory Flexibility Act, 5 U.S.C. 601-612, a regulatory flexibility analysis is not required.

Regulatory Classification. This final rule is not a significant regulatory action under the criteria of section 3(f) of Executive Order 12866 of September 30, 1993, Regulatory Planning and Review, 58 FR 51735.

Executive Order 13132, Federalism. This final rule involves no policies that have federalism implications under Executive Order 13132.

Executive Order 12988, Civil Justice Reform. This final rule meets the applicable standards of Executive Order 12988.

Accordingly, 44 CFR part 67 is amended as follows:

This document announces that, on April 13, 2012, OMB approved, for a period of six months, the information collection requirements contained in the Commission's Order, FCC 12-11, published at 77 FR 12952, March 2, 2012. The OMB Control Number is 3060-0986. The Commission publishes this document as an announcement of the effective date of the revision to §§ 54.312(b)(3), 54.313(b), 54.313(h), 54.314 and 54.320(b), and an announcement of the applicability dates of §§ 54.305(f), 54.307(b) and (c), and 54.313 (a)(1) through (a)(6) . If you have any comments on the burden estimates listed below, or how the Commission can improve the collections and reduce any burdens caused thereby, please contact Judith Boley-Herman, Federal Communications Commission, Room 1-B441, 445 12th Street SW., Washington, DC 20554. Please include the OMB Control Number, 3060-0986, in your correspondence. The Commission also will accept comments via email. Please send them to PRA@fcc.gov .

The Wireline Competition Bureau also recently released a Public Notice in WC Docket Nos. 10-90, 07-135, 05-337, 03-109; GN Docket No. 09-51; CC Docket Nos. 01-92, 96-45; WT Docket No. 10-208 that notifies Eligible Telecommunications Carriers and other stakeholders that information filed pursuant to §§ 54.313(a)(2) through (a)(6) and (h) of the Commission's rules must be filed by July 2, 2012.

To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an email to fcc504@fcc.gov or call the Consumer and Governmental Affairs Bureau at (202) 418-0530 (voice), (202) 418-0432 (TTY).

As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 3507), the FCC is notifying the public that it received OMB approval on April 16, 2012, for the information collection requirements contained in the Commission's rules at 47 CFR 54.312(b)(3), 54.313(b), 54.313(h), 54.314 and 54.320(b), and an announcement of the applicability dates of §§ 54.305(f), 54.307(b) and (c), and 54.313 (a)(1) through (a)(6).

Under 5 CFR part 1320, an agency may not conduct or sponsor a collection of information unless it displays a current, valid OMB Control Number.

No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act that does not display a current, valid OMB Control Number. The OMB Control Number is 3060-0986.

The foregoing notice is required by the Paperwork Reduction Act of 1995, Public Law 104-13, October 1, 1995, and 44 U.S.C. 3507.

The total annual reporting burdens and costs for the respondents are as follows:

OMB Control Number: 3060-0986.

OMB Approval Date: April 16, 2012.

OMB Expiration Date: April 30, 2015.

Title: Competitive Carrier Line Count Report and Self-Certification as a Rural Carrier.

Form Number: Form 525.

Respondents: Business or other for-profit, not-for-profit institutions, and state, local or Tribal Government.

Number of Respondents and Responses: 4,934 respondents; 5,048 responses.

Estimated Time per Response: .50 hours to 80 hours.

Frequency of Response: On occasion, Quarterly, Annually, Third Party Disclosure requirements.

Obligation to Respond: Required to obtain or retain benefits. Statutory authority for this information collection is contained in 47 U.S.C. 151-154, 201-206, 214, 218-220, 251, 252, 254, 256, 303(r), 332, 403, 405, and 410.

Total Annual Burden: 163,435 hours.

Total Annual Cost: N/A.

Nature and Extent of Confidentiality: The Commission is not requesting that respondents submit confidential information to the Commission. We note that the Universal Service Administrative Company (USAC), who administers the universal service program, must preserve the confidentiality of all data obtained from respondents and contributors to the universal service support program mechanisms; must not use the data except for purposes of administering the universal service support program; and must not disclose data in company-specific form unless directed to do so by the Commission. Also, respondents may request materials or information submitted to the Commission be withheld from public inspection under 47 CFR 0.459 of the Commission's rules.

Needs and Uses: In November 2011, the Commission adopted a Report and Order, FCC 11-161, 76 FR 73830, November 29, 2011, Connect America Fund; A National Broadband Plan for Our Future; Establish Just and Reasonable Rates for Local Exchange Carriers; High-Cost Universal Service Support; Developing a Unified Intercarrier Compensation Regime; Federal-State Joint Board on Universal Service; Life-line and Link-Up; and Universal Service Reform—Mobility Fund.

The order provides that existing high-cost support for price cap incumbent local exchange carriers will be frozen at 2011 levels. In addition, the order provides for up to $300 million annually in incremental support to those carriers, to be allocated by the use of a cost equation. Carriers accepting such incremental funding will be required to meet defined broadband deployment obligations. Eligible carriers will be required to notify the Commission, the universal service fund Administrator, as well as relevant state and Tribal authorities of the amount, if any, of funds they accept. Carriers accepting funding must certify that (a) the locations that will be served in satisfaction of the deployment requirement associated with its identified funds are shown as unserved by fixed terrestrial broadband on the then-current version of the National Broadband Map; (b) to the best of the carrier's knowledge, its identified locations are, in fact, unserved by fixed terrestrial broadband; (c) the carrier's current capital improvement plan did not already include plans to complete broadband deployment, without CAF Phase I incremental support, within the next three years to the locations to be counted to satisfy its deployment requirement; and (d) incremental support will not be used to satisfy any merger commitment or similar regulatory obligation. Carriers accepting funding will also be required to identify, for each location to be counted toward satisfaction of the carrier's deployment obligation, the following information: The location's census block information based on the Federal Information Processing Standard (FIPS) code, the carrier's NECA-assigned operating company code (OCN), the carrier's study area code (SAC), the wire center's eight-digit Common Language Location Identifier (CLLI) code, the latitude (to 6 decimal places), and the longitude (to 6 decimal places). Carriers accepting funding have the option of providing all of the required location-identifying information at the time they file their notice of acceptance of support, or, in the alternative, they may elect to only identify the census blocks and wire centers where they will deploy. Carriers electing this latter option must provide all required information for each location no later than one year after filing notices of acceptance for purposes of satisfying the carrier's deployment obligation. That is, carriers electing to initially provide only census block and wire center information must provide complete location information for all of their locations no later than one year after they file their notices of acceptance.

The order also adopts a rule to reduce, dollar-for-dollar, a carrier's high-cost loop support (for rate-of-return carriers) or Connect America Fund Phase I frozen high-cost support (for price cap carriers) to the extent that the carrier's local end user rate plus state regulated fees do not meet a specified urban rate floor. Accordingly, carriers will be required to report, on an annual basis, the local end user rates that fall below the specified urban rate floor, and the number of lines associated with each rate so that the universal service fund Administrator can calculate reductions in support.

The order also modifies § 54.307 of the Commission's rules, 47 CFR 54.307, (often called the “identical support rule”) and related rules, which provide that competitive eligible telecommunications carriers receive the same per-line level of support as received by incumbent LECs serving the same areas. Competitive eligible telecommunications carriers, with limited exceptions, will not continue to receive support pursuant to the identical support rule and will have their support phased down over five years. (The limited exceptions relate to certain competitive eligible telecommunications carriers serving remote parts of Alaska and a single Tribally-owned competitive eligible telecommunications carrier. For these carriers, the phasedown is delayed by five years.) As a result, the Commission will be reducing the burdens associated with a number of collections in this control number, including line count filings for competitive ETCs and incumbent LECs serving competitive areas, disaggregation plans (which permit incumbent LECs to target support for the purpose of calculating per-line support amounts), and certifications for carriers serving Tribal lands and Alaska native regions. In addition, the Commission eliminates the “own costs” exception to the interim cap for competitive ETCs. The interim cap limited the total annual amount of high-cost support competitive ETCs in any state could receive to the amount competitive ETCs in that state received in March 2008 on an annualized basis. The “own costs” exception provided that competitive ETCs that showed that they met the support threshold in the same manner as the incumbent LEC would not be subject to the cap. Eliminating the “own costs” exception does not alter the content of this information collection; it does, however, address and satisfy the terms of clearance in the May 2009 Notice of Office of Management and Budget Notice of Approval.

The order also revises the certifications that states (or ETCs that are not subject to state jurisdiction) are required to file annually with the Commission and the universal service fund Administrator to ensure that carriers use universal service support “only for the provision, maintenance and upgrading of facilities and services for which the support is intended” consistent with section 254(e) of the Act. Although the existing certifications are prospective only, the revised certification will ensure that carriers not only will use support in the next year for the intended purposes, but also have used support in the prior year for the intended purposes.

The order also eliminates eligibility for Safety Net Additive support for costs incurred after 2009. Accordingly, this collection is being revised to eliminate the requirement that carriers notify the Commission and USAC that they qualify for Safety Net Additive Support.

The order also eliminates the distinction between “rural” and “non-rural” carriers. Therefore, this collection is being revised to eliminate the reporting requirements for self-certification as a rural carrier.

The order also moves the recordkeeping requirement from 47 CFR 54.202(e) to new 47 CFR 54.320. It also increases the required document retention period from five to ten years and makes clear that carriers are subject to random compliance audits and other investigations and must make all documents and records available to the Commission, any of its Bureaus or Offices, the USF Administrator, and their respective auditors.

The order extends current federal annual reporting requirements to all ETCs, including those designated by states. Specifically, the order requires that all ETCs must include in their annual reports the information that is currently required by § 54.209(a)(1) through (a)(6)—specifically, a progress report on their five-year build-out plans; data and explanatory text concerning outages; unfulfilled requests for service; complaints received; certification of compliance with applicable service quality and consumer protection standards; and certification of its ability to function in emergency situations. All ETCs that receive high-cost support will file this information with the Commission, USAC, and the relevant state commission, relevant authority in a U.S. Territory, or Tribal government, as appropriate.

Finally, this submission eliminates the recordkeeping requirements from OMB Control Number 3060-0894. Upon OMB approval of this information collection revision, the Commission will voluntarily discontinue OMB Control Number 3060-0894.

The Commission plans to submit additional revisions or new collections for OMB review and approval to address other reforms adopted in the Order at a later date.