SUPPLEMENTARY INFORMATION:

This rule is issued under Marketing Order No. 981, as amended (7 CFR part 981), regulating the handling of almonds grown in California, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.”

The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.

The order is administered locally by the Board. Under the order, handlers are required to treat shipments of almonds to reduce the potential for Salmonella contamination, with limited exceptions. Various equipment systems must be in place and must be “validated” by the Board's TERP to ensure that treatments meet a required 4-log reduction of Salmonella in almonds destined for consumers in the United States, Canada, and Mexico. The TERP consists of four scientists, with a representative from the Food and Drug Administration serving as an ex-officio member.

In an interim final rule published in the Federal Register on June 18, 2009, and effective on June 19, 2009 (74 FR 28872, Doc. No. AMS-FV-08-0045; FV08-981-2 IFR), § 981.442 was amended by specifying that validation means that the treatment technology and equipment have been demonstrated to achieve in total a minimum 4-log reduction of Salmonella bacteria in almonds. Validation data must be both submitted to and accepted by the TERP for each piece of equipment used to treat almonds prior to its use under the program. Prior to the change, the regulation did not specify that validation data must be both submitted to and accepted by the TERP for each piece of equipment prior to its use under the program.

Final Regulatory Flexibility Analysis

Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA), the Agricultural Marketing Service (AMS) has considered the economic impact of this rule on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.

The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and the rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf. Thus, both statutes have small entity orientation and compatibility.

There are approximately 6,200 producers of almonds in the production area and approximately 100 handlers subject to regulation under the marketing order. Additionally, the Board estimates there are about 15 process authorities and 30 almond manufacturers under the Salmonella treatment program. Small agricultural producers are defined by the Small Business Administration (13 CFR 121.201) as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those whose annual receipts are less than $7,000,000.

Data for the most recently-completed crop year indicate that about 50 percent of the handlers shipped under $7,000,000 worth of almonds. Dividing average almond crop value for 2006-07 reported by the National Agricultural Statistics Service of $2.258 billion by the number of producers (6,200) yields an average annual producer revenue estimate of about $364,190. Based on the foregoing, about half of the handlers and a majority of almond producers may be classified as small entities. While data regarding the size of the process authorities and almond manufacturers is not available, it may be assumed that some process authorities and manufacturers may be classified as small entities.

This rule continues in effect the action that revised § 981.442(b)(3)(i) of the order's administrative rules and regulations specifying that the term “validation” under the Salmonella treatment program means that validation data must be both submitted to and accepted by the TERP for each piece of treatment equipment prior to its use under the program. This revision will help ensure that all treatment equipment meets the program's 4-log requirement prior to its use. Authority for this action is provided in § 981.42(b) of the order.

Regarding the overall impact of this action on the affected entities, it is expected to be minimal. Validation data had previously been submitted to the Board's TERP for review. This interim final rule simply specified that such data must be accepted by the TERP for all treatment equipment prior to its use under the program.

The Board's Food Quality and Safety Committee (committee) met prior to the board meeting to consider this change. The committee considered the alternative to this action, which maintained the status quo whereby equipment could be used under the program that had completed validation testing, but had not been accepted by the TERP. The committee, and subsequently the Board, concluded that acceptance by the TERP was important in order to help ensure that all treatment equipment consistently meets the 4-log requirement of the program.

The Board, with the expertise of various committees and subcommittees, makes recommendations regarding the revisions to the marketing order rules and regulations after consideration of all available information, including comments received by Board staff. At the meetings, the impact of and alternatives to these recommendations are deliberated. The Board and its committees and subcommittees consist of individual producers and handlers with many years of experience in the industry, who are familiar with industry practices and trends. All Board, committee, and subcommittee meetings are open to the public and comments are widely solicited. In addition, minutes of all meetings are distributed to Board, committee, and subcommittee members and others who have requested them, and are also posted on the board's Web site, thereby increasing the availability of this critical information within the industry.

This rule will not impose any additional reporting and recordkeeping requirements on California almonds handlers, process authorities, or almond manufacturers. As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies. In addition, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.

Further, the subcommittee, committee, and Board meetings where this issue was discussed were widely publicized throughout the California almond industry, and all interested persons were encouraged to attend the meetings and participate in deliberations on all issues. The issue was discussed at two Food Quality and Safety Committee meetings in April 2008 and at two Board meetings, one in April and one in May 2008. All of these meetings were public meetings, and all entities, both large and small, were able to express views on this issue.

Comments on the interim final rule were required to be received on or before August 17, 2009. No comments were received. Therefore, for the reasons given in the interim final rule, we are ( printed page 50683) adopting the interim final rule as a final rule, without change.

To view the interim final rule, go to http://www.regulations.gov/​search/​Regs/​home.html#documentDetail?​R=​09000064809d2903.

This action also affirms information contained in the interim final rule concerning Executive Orders 12866 and 12988, the Paperwork Reduction Act (44 U.S.C. Chapter 35), and the E-Gov Act (44 U.S.C. 101).

After consideration of all relevant material presented, it is found that finalizing the interim final rule, without change, as published in the Federal Register (74 FR 28872, June 18, 2009) will tend to effectuate the declared policy of the Act.