# Cooperative Inspection Programs: Interstate Shipment of Meat and Poultry Products > Briefs, arguments, decisions, and more. URL: https://www.frixlaw.com/law-library/documents/fr%3A2011-9865 ## Record - **Collection:** Federal Register - **Document type:** Rule - **Published:** May 2, 2011 - **Citation:** 76 FR 24714 ## Text DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service 9 CFR Parts 321, 332, and 381 [Docket No. FSIS-2008-0039] RIN 0583-AD37 Cooperative Inspection Programs: Interstate Shipment of Meat and Poultry Products AGENCY: Food Safety and Inspection Service, USDA. ACTION: Final rule. SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the Federal meat and poultry products inspection regulations to establish a new voluntary cooperative program under which State-inspected establishments with 25 or fewer employees will be eligible to ship meat and poultry products in interstate commerce. In participating States, State-inspected establishments selected to take part in this program will be required to comply with all Federal standards under the Federal Meat Inspection Act (FMIA) and the Poultry Products Inspection Act (PPIA). These establishments will receive inspection services from State inspection personnel that have been trained in the enforcement of the FMIA and PPIA. Meat and poultry products produced under the program that have been inspected and passed by designated State personnel will bear an official Federal mark of inspection and will be permitted to be distributed in interstate commerce. FSIS will provide oversight and enforcement of the program. DATES: Effective Date: July 1, 2011. FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Assistant Administrator, Office of Policy and Program Development, Room 350-E, Jamie L. Whitten Building, 1400 Independence Avenue, SW., Washington, DC 20250; Telephone (202) 720-2709, Fax (202) 720-2025. SUPPLEMENTARY INFORMATION: I. Background 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. ) (“the Acts”) require that FSIS protect the public by ensuring that meat and poultry products are safe, wholesome, and accurately labeled. The Acts require Federal inspection and provide for Federal regulation of meat and poultry products prepared for distribution in commerce for use as human food. Cooperative State inspection programs. Section 661 of the FMIA and 454 of the PPIA authorize FSIS to cooperate with State agencies in developing and administering their own meat or poultry products inspection programs for the inspection and regulation of products that are produced and sold solely within the State (21 U.S.C. 661 & 454). These cooperative State inspection programs are required to operate in a manner and with authorities “at least equal to,” but not necessarily identical to, the provisions set out in the FMIA and PPIA (21 U.S.C. 661 (a)(1) & 454 (a)(1)). The “at least equal to” standard is a concept that requires that State MPI Programs operate in a manner that is at least as effective as those standards adopted for the Federal inspection program. The Acts provide for FSIS to contribute up to 50 percent of the cost of the cooperative State inspection programs, as long as the State programs are effectively enforcing requirements that are “at least equal to” the Federal program (21 U.S.C. 661 (a)(3) & 454 (a)(3)). Section 11015 of Title XI of The Food, Conservation, and Energy Act of 2008 (“the 2008 Farm Bill”), enacted on June 18, 2008, amended the Acts to establish a new cooperative inspection program under which certain State-inspected establishments will be eligible to ship meat and poultry products in interstate commerce (Pub. L. 110-246, 112 Stat. 1651; 21 U.S.C. 683 and 472). The amendments to the Acts provide that the Secretary of Agriculture (FSIS by delegation), “in coordination with the appropriate State agency of the State in which the establishment is located,” may select State-inspected establishments with 25 or fewer employees to ship meat and poultry products in interstate commerce (21 U.S.C. 683 (b) and 472(b)). Inspection services for these establishments must be provided by State inspection personnel that have “undergone all necessary inspection training and certification to assist the Secretary with the administration and enforcement of [the Acts]” (21 U.S.C. 683(a)(2) and 472(a)(2)). Meat and poultry products inspected and passed by the State inspection personnel would bear a “Federal mark, stamp, tag, or label of inspection” and would be permitted to be shipped in interstate commerce (21 U.S.C. 683(b)(1) and 472(b)(1)). The law provides for the Secretary to “designate an employee of the Federal government” to “provide oversight and enforcement” of the program (21 U.S.C. 683(d)(1) and 472 (d)(1)). If the Federal employee finds that an establishment selected for the program is in violation of the Acts, he or she is required to “deselect the selected establishment or suspend inspection at the selected establishment” (21 U.S.C. 683(d)(3)(c) and 472(d)(3)(c)). The law requires that any selected establishment that FSIS “determines to be in violation of any requirement of the Act, be transitioned to be a Federal establishment” (21 U.S.C. 683(h) and 472(g)). The law provides that FSIS is to reimburse a State for costs related to the inspection of establishments in the State selected for the program “in an amount of not less than 60 percent of eligible State costs” (21 U.S.C. 683(c) and 472(c)). The law also states that FSIS “may provide grants to appropriate State agencies to assist the appropriate State agencies in helping establishments covered by this Act to transition to selected establishments” (21 U.S.C. 683(g) and 472(f)). The law is to take effect “on the date on which the Secretary, after providing a period of public comment (including through the conduct of public meetings or hearings), promulgates final regulations to carry out [section 11015]” (21 U.S.C. 683 (j)(1) and 472((i)(1)). Proposed rule. On September 16, 2009, FSIS published proposed regulations to implement the new cooperative interstate shipment program (“ Cooperative Inspection Programs: Interstate Shipment of Meat and Poultry Products,” 74 FR 47648). FSIS held two public meetings by teleconference on October 27, 2009, and November 4, 2009, to solicit comments on the proposed regulations (74 FR 54493). The comment period for the proposed rule was scheduled to close on November 16, 2009, but, in response to comments, was extended to December 16, 2009. In developing this final rule, FSIS considered all comments submitted in response to the September 2009 proposed rule, as well as those provided at the two teleconferences held in October and November 2009. Based on its analysis of the issues, and on information provided by the comments, FSIS made certain changes to the proposed regulations. Those changes are summarized below and are discussed in detail in the Agency's responses to comments. For a more detailed discussion of section 11015 of the 2008 Farm Bill and FSIS's proposed implementing regulations, refer to the September 16, 2009, proposed rule. II. Summary of Amendments to the Proposed Rule To Implement the Cooperative Interstate Shipment Program In this rulemaking, FSIS is finalizing, with some changes, the provisions in the September 2009 proposed rule. Specifically, the Agency is amending the proposal to: • Revise the standards for determining an establishment's average number of employees for purposes of the cooperative interstate shipment program to exclude employees whose duties do not involve handling the meat or poultry products produced by the establishment (9 CFR 332.3(b)(1) and (2) and 9 CFR 318.513(b)(1) and (2)); • Revise the standards for determining the average number of employees for purposes of the cooperative interstate shipment program to include uncompensated volunteers who are involved in handling the meat or poultry products produced by the establishment (9 CFR 332.3(b)(6) and 381.515(b)(6)); • Allow States that have existing cooperative agreements for a State MPI program to submit a request to enter into an agreement with FSIS for a cooperative interstate shipment program before the States have identified establishments to recommend for the cooperative interstate shipment program (9 CFR 332.4(b)(1) and 381.514(b)(1)); • Identify factors that will be considered to determine the frequency with which the FSIS selected establishment coordinator (SEC) will visit selected establishments under his or her jurisdiction (9 CFR 332.7(a) and 381.517(a)); • Give establishments that were deselected from the cooperative interstate shipment program because they are located in a State whose agreement for the program was terminated the option to either revert back to operating under the cooperative State MPI program or obtain a Federal grant of inspection (9 CFR 332.11(a) and 381.521(a)); • Allow establishments that were deselected from the cooperative interstate shipment and successfully transitioned to become Federal establishments to revert back to the State MPI program after successfully operating as a Federal establishment for a year (9 CFR 332.11(b) and 381.521(b)); • Allow establishments selected to participate in the cooperative interstate shipment program to operate under both the State MPI program for the State where the establishment is located and the new cooperative interstate shipment program. State-inspected establishments that operate under both programs must maintain an appropriate separation of time or space between operations (9 CFR 332.13 and 381.523); • Allow selected establishments that are in full compliance with the requirements of the cooperative interstate shipment program to voluntarily end their participation in the program and revert back to the State MPI program (9 CFR 332.14 and 381.514); • Codify the definition of “eligible State costs” to include those costs that a State has justified and FSIS has approved as necessary for the State to provide inspection services to selected establishments in the State (9 CFR 321.3(b) and 381.187(b)). III. Comments and Responses FSIS received approximately 90 separate comment letters in response to the September 2009 proposed regulations and approximately 5000 identical comment letters submitted by a consumer advocacy organization on behalf of private citizens. Comments submitted by consumer advocacy organizations, private citizens, State farm bureaus, trade associations representing meat processors, and a labor union representing food and commercial workers expressed general support for the proposed regulations. Comments submitted by an association of State meat and food inspection directors, an association of State Departments of Agriculture, several State Departments of Agriculture and other State agencies, farm and agriculture advocacy organizations, Congress members providing comments on behalf of the State of Wisconsin, and private citizens expressed support for the concept of a cooperative interstate shipment program but objected to several provisions in FSIS's proposed implementing regulations. Other comments submitted by FSIS inspection personnel, small federally-inspected establishments, and one consumer advocacy organization opposed any program that would permit State-inspected meat and poultry products in interstate commerce. Following is a discussion of these comments and FSIS's responses. A. Development of the proposed rule Comment: Several comments criticized FSIS for not consulting with State officials during the development of the proposed regulations. The comments stated that several States and organizations of State officials had offered to form an advisory committee to assist FSIS in developing the proposed regulations to implement the cooperative interstate shipment program. As noted by the comments, FSIS determined that such a request was not practical due to the regulatory constraints and the statutory time-line for implementing this program. The comments encouraged FSIS to work closely with State inspection officials to develop final regulations to make the program as workable as possible. One comment said that creating an environment where state regulators and federal regulators work together consistently will provide the stability the program needs to be successful for all involved. Some comments suggested that FSIS use this rulemaking as an opportunity to encourage more State involvement in addressing the nation's food safety problem. The comments encouraged FSIS to accord considerable weight to comments submitted by States with exemplary food safety inspection histories and State-inspected establishments that likewise have exemplary histories when the Agency finalizes the proposed rule. Response: FSIS appreciates the States' willingness to participate in the development and implementation of the new cooperative interstate shipment program. In developing this final rule, FSIS carefully considered the comments and suggestions submitted by the States and, as a result, the Agency made certain revisions to the proposed regulations. FSIS will work closely with the States as the Agency moves forward to implement the cooperative interstate shipment program established in this final rule. Comment: A few comments stated that the teleconference format for the two public meetings that were held in October and November of 2009 was not an appropriate way to generate comments on the proposed cooperative interstate shipment program. One comment noted that there were few comments presented during the teleconferences, which the commenter believed may be related to the format of the public meeting. One comment said that both teleconferences occurred on the same dates and times when FSIS was offering webinars for small and very small plant operators, which presented a conflict for those interested in participating in both meetings. Another comment complained that, although the commenter had registered for the teleconference and has a confirmation passcode to participate, the commenter was not allowed to speak during the meeting. Response: FSIS chose the teleconference format for the public meetings to provide individuals with easier access to the meeting, particularly those who may lack the resources or time to attend a meeting in person. FSIS will consider the comments submitted on this issue to determine how it can improve its use of the teleconference format to conduct public meetings in the future. B. General Support for and General Opposition to the Proposed Rule 1. Support for the Proposed Regulations Comment: Comments submitted by consumer advocacy organizations, private citizens, State farm bureaus, trade associations representing meat processors, and a labor union representing food and commercial workers expressed general support for FSIS's proposed regulations to implement the cooperative interstate shipment program. Some of these comments said that the language in Section 11015 of the 2008 Farm Bill reflects an agreement reached through negotiations between various national consumer organizations, the National Association of State Departments of Agriculture, the National Farmers Union, the American Federation of Government Employees, and the United Food and Commercial Workers Union. According to these comments, the language in section 11015 was carefully crafted to meet the desire of some State-inspected meat plants to enlarge their area of sales while assuring that all meat and poultry sold across state lines meet federal inspection standards. The comments commended FSIS for writing proposed regulations that closely adhere to both the intent and specific language of the legislation. One comment noted that the program established in the proposed regulations builds on existing State inspection programs and includes important enhancements that can lead to stronger State inspection programs. The comment approved of the fact that, like the statute, the proposed regulations would not permit “regulatory forum shopping.” Response: FSIS agrees that the proposed regulations are consistent with both the intent and language of the enabling legislation. The Agency also agrees that the program established in the proposed regulations will complement the existing State inspection programs. 2. Support Interstate Shipment but not the Program Proposed by FSIS Comment: Comments submitted by an organization of State Agriculture Departments, an organization of State meat inspection program Directors, several State Departments of Agriculture, State agencies, farm and agriculture advocacy organizations, and private citizens expressed support for the concept of a cooperative interstate shipment program but had concerns about FSIS's proposed regulations to implement the program. Many of these comments stated that, instead of allowing for the interstate shipment of state inspected products, FSIS's proposed regulations essentially set up another Federal inspection system under more stringent and inflexible provisions than the current Federal system. According to the comments, FSIS's proposed program fails to remove unnecessary barriers for small establishments to sell their specialty products across State lines. The comments asserted that the proposed regulations will create a regulatory system that is too burdensome for either establishments or State inspection programs, which likely means that few will take advantage of the program. To support these assertions, the comments noted that, when FSIS issued the proposed rule, the Agency estimated that approximately 60% (16 of 27) of the States with existing State MPI programs and approximately 200-600 establishments were interested in participating in the new cooperative interstate shipment program. The comments stated that after FSIS issued the proposed rule, an internal poll conducted by an organization of State official indicates that only 2 of these 27 States, each with only a handful of establishments, now find the cooperative interstate shipment proposed by FSIS to be even potentially viable. According to the comments, without a drastic revision of the proposed regulations and active FSIS participation in cooperation with the State partners, the program is unlikely to succeed. Response: After careful consideration of all comments submitted in response to the 2009 proposed rule, FSIS modified the proposed regulations to provide some added flexibility for establishments selected to participate in the cooperative interstate shipment program. For example, under this final rule, selected establishments that are in full compliance with the program will be permitted to voluntarily end their participation in the program. This final rule will also permit selected establishments to operate under both the cooperative interstate shipment program and the State's MPI program if they maintain an appropriate separation of time or space between operations. The Agency believes that these modifications, which are discussed in more detail in the Agency's response to comments, will provide additional incentive for some establishments to participate in the program. 3. Oppose any Program That Would Allow Interstate Shipment of State-Inspected Product Comment: Comments submitted by FSIS inspection personnel, small federally-inspected meat and poultry processing establishments, and a consumer advocacy organization objected to any program that would permit state-inspected meat and poultry products to be shipped in interstate commerce. According to many of these comments, meat and poultry products produced in State-inspected establishments do not undergo the same level of inspection as products produced in Federal-inspected facilities, and many State MPI programs are not truly “at least equal to” the Federal inspection program. A few comments referenced a 2006 Office of Inspector General Audit Report of State-inspected meat and poultry programs that the comments said found that some State-inspected facilities had failed to operate in a sanitary manner and that FSIS had not provided consistent oversight of existing State MPI programs. Response: As required by law, the cooperative interstate shipment program established under this final rule will operate under the same standards imposed under the Federal inspection program. Thus, meat and poultry products produced in State-inspected establishments selected for the cooperative interstate shipment program will undergo the same level of inspection as products produced in federally-inspected facilities. With respect to the comment that many State MPI programs are not truly “equal to” the Federal inspection program, each year the FSIS OPEER Federal State Audit Branch reviews the State cooperative MPI programs and their requirements to verify that each State program “at least equal to” the Federal program. These comprehensive reviews consist of an annual review of the State MPI program's self assessment submission and an on-site review to verify the State's self-assessment submission. The onsite reviews are scheduled at a minimum, once every three years. Based on the self assessment documents received during FY 2009, FSIS determined that all of the 27 State MPI programs provided adequate documentation to support that they have implemented and can maintain MPI programs “at least equal to” the Federal program. FSIS determined that all of the 11 State MPI programs reviewed on-site were enforcing requirements “at least equal to” those imposed under the Federal Acts. In its 2006 audit of the FSIS's cooperative State MPI programs, the OIG provided recommendations to strengthen FSIS's review of these programs. FSIS provided management decisions in response to the 2006 OIG audit recommendations, which were accepted by OIG. The Agency has implemented the 2006 management decisions. Comment: One comment stated that State-inspected establishments should not be allowed to ship products interstate because the States do not have the money or staff to provide the inspection that the Federal government does. Another comment maintained that Federal inspectors undergo more extensive training than State inspection personnel and, therefore, unlike State inspectors, are continuously expanding their knowledge bases. Response: As discussed in greater detail below, to qualify for the cooperative interstate shipment program, States with cooperative State MPI programs will need to demonstrate that they have staffing sufficient to conduct the same inspection activities in establishments operating under the cooperative interstate shipment program that FSIS conducts in official Federal establishments. The States will also need to demonstrate that the designated State personnel have been properly trained in Federal inspection methodology. FSIS will not enter into an agreement for a cooperative interstate shipment program with States that are unable to meet these conditions. Comment: One comment submitted by a consumer advocacy organization said that while the commenter does not support State-inspected meat and poultry for either intrastate or interstate commerce, it understands that Congress amended the FMIA and PPIA to establish the cooperative interstate shipment program, and that FSIS is required to develop regulations to implement the law. The comment urged the Agency to put into place a system whereby establishments that participate in the program are held to the identical Federal standards and practices as those establishments under Federal inspection and that the Agency maintain strict oversight of such a program. Response: The cooperative interstate shipment program established in these final regulations will be a State inspection program under which designated State-personnel enforce Federal food safety standards. As required by law, FSIS will provide oversight and enforcement of the program. Comment: Several comments submitted by FSIS inspection personnel and small federally-inspected meat and poultry processors maintained that instead of establishing cooperative interstate shipment program, FSIS should require that State-inspected establishments that desire to ship their meat and poultry products in interstate commerce come under Federal inspection. One comment submitted by a small federally-inspected establishment explained that as a small company, it decided to obtain a Federal grant of inspection as an investment for the future of its business. The comment noted that the establishment did this to allow for interstate sales of its products and that the same option is available today for any company willing to make a similar investment. The comment asserted that to provide for a level playing field, all small companies that want to sell their products across state lines should be required to go through the same process and obtain a Federal grant of inspection. Response: Section 11015 of the 2008 Farm Bill amended the FMIA and PPIA to establish the cooperative interstate shipment program. The amendments require that FSIS issue final regulations to implement the new program. Once the new program becomes effective, small State-inspected establishments that are interested in selling meat or poultry products across State lines will have the option to operate as a selected establishment under the cooperative interstate shipment program or as an official Federal establishment. An establishment that ships products across States lines must comply with all Federal standards regardless of the inspection program that it chooses to operate under. Comment: One comment said that the cooperative interstate shipment program is not necessary because the Talmadge/Aiken program serves the same purpose. Response: The Talmadge-Aiken program and the cooperative interstate shipment program serve different purposes. Under the Talmadge-Aiken program, FSIS enters into a separate agreement with a State agency for the State program to conduct meat, poultry, or egg products inspection or other regulatory activities on behalf of FSIS. Establishments that participate in the Talmadge-Aiken program operate under a Federal grant of inspection. Under the cooperative interstate shipment program, FSIS enters into a separate agreement with a State agency to enforce Federal food safety standards at State-inspected establishments. Establishments that participate in the cooperative interstate shipment program are not Federal establishments operating under a Federal grant of inspection. Comment: Comments submitted by a few FSIS inspection personnel opposed the proposed cooperative interstate shipment stated because the commenters believe that the program will result in a reduction in the Federal inspection force. The comments stated that under such a program, small federally-inspected establishments will want to drop their Federal grant of inspection and produce products under State-inspection, thereby taking jobs that would otherwise belong to Federal employees and giving them to State employees. Response: Under the law and implementing regulations, establishments that operate under the Federal inspection program are ineligible to participate in the cooperative interstate shipment program. The new program is limited to certain small and very small State-inspected establishments. Thus, the cooperative interstate shipment program will have little effect on Federal inspection personnel. Comment: One comment objected to allowing the interstate shipment of state-inspected products because, according to the comment, FSIS will no longer have control or jurisdiction over some meat and poultry products in interstate commerce. The comment noted that a State's jurisdiction is limited to the State's borders. The comment asked what would happen if product produced by a State-inspected establishment is implicated in a food safety issue resulting in a recall. Response: Under the law, FSIS is responsible for providing oversight and enforcement of the cooperative interstate shipment program. Therefore, if an establishment operating under the cooperative interstate shipment program distributes meat or poultry products that present a food safety hazard or that need to be recalled for other reasons, FSIS will coordinate with the State MPI program to ensure that such product is removed from commerce. FSIS will be responsible for the overall coordination of the recall and for verifying that recalled product that has been shipped interstate has been removed from commerce. C. Establishment Participation—Conditions for Eligibility and Standards for Determining Average Number of Employees The proposed rule prescribed conditions that State-inspected establishments would be required to meet to become eligible to participate in the cooperative interstate shipment program. Consistent with the law, among these proposed conditions were that an establishment be in compliance with all Federal inspection requirements under the FMIA, PPIA, and their implementing regulations, and that the establishment employ, on average, no more than 25 individuals. The proposed rule also included proposed standards for determining the average number of employees, which, for the most part, reflect applicable methods used by the Small Business Administration (SBA) to calculate the number of employees for a small business concern. FSIS received several comments on the proposed conditions for establishment eligibility and the proposed standards for determining the average number of employees. 1. Compliance With Federal Standards Comment: Some comments agreed that State-inspected establishments should be required to comply with Federal standards to be eligible for the cooperative interstate shipment program. The comments stated that many small and very small establishments have managed to conform to, and operate successfully under, the requirements of the Federal inspection system. Two comments noted that data obtained from FSIS's PBIS in 2007 show that 51 percent (2,878 of 5,603) of all federally-inspected establishments have 10 or fewer employees and 80% have 50 or fewer employees. The comments also noted that all establishments that prepare or process meat and poultry products have always had the opportunity to ship their products in interstate commerce provided that they apply for and receive a Federal grant of inspection. The comments stated that small and very small establishments now under Federal inspection have invested time and money to comply with all Federal regulations and to operate under Federal standards. The comments asserted that while the new cooperative interstate shipment program is intended to offer establishments operating under their State inspection program an opportunity to broaden their distribution, any establishment that ships meat or poultry products in interstate commerce can and should meet Federal food safety standards. Other comments stated that requiring that State-inspected establishments comply with Federal food safety standards in order to be eligible for the cooperative interstate shipment program will establish unfair barriers for small plants to participate in the program. The comments urged FSIS to provide small State-inspected establishments with greater flexibility in achieving food safety standards. One comment from a small State-inspected establishment stated that it cannot afford Federal inspection. The comment noted that establishments operating under the State MPI system are required to adhere to very strict food safety standards but, unlike the Federal system, State inspection personnel are also available to help the small and very small establishments with education and training. Response: The amendments to the Acts in section 11015 of the 2008 Farm Bill require that State-inspected establishments be in compliance with all Federal standards in order to be eligible for the cooperative interstate shipment program. The provisions in the Acts that establish the cooperative interstate shipment program define an “eligible establishment” as an establishment that is in compliance with both “* * * the State inspection program of the State in which the establishment is located” and “[the FMIA or PPIA], including the rules and regulations issued under [the FMIA or PPIA]” (21 U.S.C. 472(a)(3) and 683(a)(3)). The Senate Conference Committee report on the bill that established the cooperative interstate shipment program also makes clear that establishments selected for the program “* * * must fully follow [the FMIA or PPIA], its regulations, notices, directives and policies just as would be required of a Federal establishment” (S. Rep. No. 220, 110th Cong., 1st Sess. (2007), pp. 211-214). Thus, requiring that State-inspected establishments comply with Federal food safety standards to become eligible to participate in the cooperative interstate shipment program is consistent with both the language and intent of section 11015 of the 2008 Farm Bill. FSIS's Office of Outreach, Employee Education, and Training (OOEET) will provide technical resources, information, and guidance to small and very-small State establishments that are interested in becoming eligible to participate in the cooperative interstate shipment program. 2. Determining Average Number of Employees a. Proposed standard: All individuals, both supervisory and non-supervisory, employed by the establishment on a full-time, part-time, or temporary basis are to be counted when calculating the total number of employees. Comment: Several comments stated that for purposes of the cooperative interstate shipment program, an establishment's average number of employees should be based only on those directly involved in the preparation or processing of meat and poultry products. The comments noted that many small and very small establishments conduct operations other than the processing of meat or poultry products, such as grocery stores, convenience stores, or other retail outlets. According to the comments, employees that do not perform duties related to the meat or poultry processing operations of the business should not be included when calculating the average number of employees. One comment suggested that FSIS consider basing the “value” associated with the employee on the workers compensation code that the employer designates. The commenter said that it could give FSIS a simple way of determining which workers are associated with the meat processing part of the business and which employees offer other roles for the company, such as administrative workers or retail clerks. Other comments said that all establishment personnel, including those not involved in the actual production of meat and poultry products, should be counted when calculating the average number of employees. One comment noted that the law specifically states that supervisory and nonsupervisory employees are to be counted when calculating the average number of employees. The comment maintained that this indicates that if Congress had intended to exclude certain employees from the calculation, it would have expressly stated so in the law. The comment urged FSIS to require that temporary and part-time employees, regardless of their position in the establishment, be counted when determining the average number of employees. Response: Although the law limits participation in the cooperative interstate shipment program to State-inspected establishments that employ, on average, 25 or fewer employees, it does not distinguish between employees involved in an establishment's meat or poultry processing operations from those that are not. Counting all individuals employed by the establishment would ensure that participation in the cooperative interstate shipment program is limited to very small and certain small establishments. Counting only employees directly involved in the preparation or processing of meat and poultry products would create a more flexible standard that would expand the number of potentially eligible establishments to include those that have a small number of employees that work in meat or poultry processing but a larger number of employees that work in other areas of their business. The 2008 amendments to the Acts give FSIS the authority to define “average number of employees” for purposes of the cooperative interstate shipment program, but they also make clear that the program is intended for State-inspected establishments that employ a limited number of individuals. Therefore, FSIS is adopting a standard for calculating the average number of employees that provides some flexibility for establishments that conduct operations other than meat or poultry processing, but that also clearly distinguishes those employees that are to be counted for purposes of the interstate shipment program from those that are not. Therefore, instead of counting all individuals employed by the establishment as proposed, under this final rule, an establishment's average number of employees will be calculated by counting all individuals employed by the establishment, excluding the employees that do not come into contact with the meat or poultry products produced by the establishment. For example, if the owner of a gas station produces beef jerky and sells it at the gas station, the employees that are involved in producing the jerky, as well as those that work as cashiers and sell the product, will be counted. The mechanics that work on the cars, however, will not be. Employees that perform solely administrative functions and that do not handle meat or poultry products will also not be counted. When an establishment conducts multiple operations, it is sometimes difficult to distinguish employees associated with the meat or poultry operations from those that are not. For example, an individual employed as a cashier at an establishment's deli operations may also slice and package meat or poultry products produced by the establishment. The standard adopted in this final rule clearly distinguishes employees whose duties are associated with the meat or poultry products produced by an establishment from those that are not. It also ensures that the cooperative interstate shipment program will remain limited to certain small and very small establishments, as intended. b. Proposed standard: Part-time and temporary employees are to be counted the same as full-time employees. Comment: Several comments, most submitted by consumer advocacy organizations and one submitted by a food and commercial workers union, agreed with the proposed standard to count part-time and temporary workers as full-time workers for purposes of qualifying for the cooperative interstate shipment program. The comments noted that most very small establishments have few full-time employees, and many do not operate every day. The comments maintained that counting part-time and temporary employees the same as full time employees is an effective means to assure the cooperative interstate shipment program serves the entities it was intended to serve. According to the comment, failing to count part-time and temporary employees in the average number of employees would permit substantially larger entities to participate in a program that was designed to serve very small local establishments. Some of these comments noted that during negotiations with the States, consumer advocacy groups reluctantly agreed to the States' request for a program with a 25 employee limit. According to the comment, none of the groups involved in the negotiations ever agreed to anything larger than 25 employees. The comments said that the primary reason that many consumer advocacy organizations had opposed the House interstate shipment bill was because the bill contained a 50 employee limit, which, according to the comment, would have expanded the number of establishments in the new cooperative program far beyond what was intended. One comment stated that, although the program's 25 employee limit is reasonable, the commenter would have preferred a limit of 10 employees, which is similar to the current FSIS definition for very small establishments. Several other comments, most submitted by State Departments of Agriculture and other State agencies, disagreed with the proposed standard to count part-time and temporary workers as full time employees. The comments stated that such a standard seems excessive and does not provide an accurate depiction of an establishment's actual number of employees. The comments noted that many small establishments in small towns hire part-time employees who work as little as a few hours a week. According to the comments, to count such employees as full-time would contradict and undercut the rural development intentions of the enabling legislation. One comment stated that in some rural areas, especially those with small and very small establishments, meat processing has a seasonal component that provides part-time seasonal work for rural residents. The comments noted that during each part of the day, an establishment may have only 25 employees on site, even if the total number of part-time and fulltime employees employed overall during the day exceeds 25. The comments suggested that part-time and temporary workers be counted on the basis of “full-time equivalents” or “FTEs,” i.e., based on the ratio of their work-hours to those of a full-time year-round employee. The comments said that part-time and temporary employees should be grouped together and counted based on the number of hours they work each week during the year, with 40 hours per week being considered an FTE. Several comments suggested formulas for calculating the number of employees based on FTEs. Response: After considering the comments, FSIS has decided to adopt the proposed standard to count temporary and part time employees the same as full-time employees. For purposes of its regulatory programs, FSIS defines small and very small establishments based on SBA criteria. A standard that counts part-time and temporary workers the same as full-time workers reflects the SBA methods for calculating the average number of employees for a small business concern and is thus consistent with FSIS's overall approach for defining small and very small establishments. 1 1 See 13 CFR 121.105 and 121.106 for SBA methods to calculate the number of employees of a business concern where the size standard in number of employees. As noted by the comments, several very small establishments have few full-time employees, and many do not operate every day. A standard that is based on the SBA criteria that counts part-time and temporary employees the same as full time employees allows these establishments to hire seasonal workers while ensuring that only very small and certain small establishments are eligible to participate in the program. Comment: Several comments stated that the standards for determining the average number of employees need to allow for more flexibility in counting temporary seasonal workers. The comments noted that small and very small establishments often have fluctuation in their employees during certain parts of the year, such as during holiday and hunting seasons, and that the term “seasonal” will have different meanings in different areas of the country. Some comments noted some establishments hire extra employees to help with seasonal activities that are not related to the processing of amenable species, such as processing game meat or for busy times in their retail shops around holidays. The comments suggested that seasonal employees be counted based on FTE. As an example, the comments explained that a seasonal employee who works full-time for 3 months would be a 25% FTE and should be counted as one quarter of an employee. One comment asserted that seasonal employees should not be counted at all when calculating the average number of employees. The comment suggested that the final rule define a seasonal employee as an employee that works for the establishment ninety or fewer days in a calendar year. Response: When Congress amended the FMIA and PPIA to establish the cooperative interstate shipment program, it intended for FSIS to interpret the term average “…to provide some flexibility to these selected plants that require seasonal employees for certain parts of the year, as long as the increase in employees are [sic] manageable by the establishment and the increase in employees does not undermine food safety standards” (S. Rep. No. 220, 110th Cong., 1st Sess., pp. 211-214 (2007)). As discussed below, under the proposed rule, selected establishments may temporarily employ more than 25 employees during busy seasons, as long as the average number of employees continues to be 25 and the number of employees does not exceed 35. Thus, a standard that counts temporary seasonal employees the same as full-time employees will allow selected establishments to hire seasonal employees while ensuring that the number of employees remains manageable by the establishment, as Congress intended. FSIS disagrees with the comment that stated that seasonal employees should not be counted at all. Such an approach would be inconsistent with the language and intent of the statute. c. Proposed standard: The total number of employees cannot exceed 35 at any given time, regardless of the average number of employees. Comment: Some comments stated that the proposed standard that provides that the total number of employees can never exceed 35 individuals at any given time, regardless of the average number of employees, is a reasonable upper limit for selected establishments to remain eligible to participate in the program. One comment stated that such a limit is reasonable if FSIS does not count part-time and temporary employees the same as full time. Other comments asserted that FSIS should not limit the number of employees working at a selected establishment at any given time if the establishment maintains an average of 25 employees or fewer. The comments stated that while section 11015 of the 2008 Farm Bill requires that the average number of employees not exceed 25, the law does not prohibit a selected establishment from ever, over the course of a year, having more than 35 employees. The comments stated that in many small establishments there may be “spikes” in employee numbers during busy periods, but the overall average number of employees is under 25. The comments asserted that, as written, the proposed rule excludes such establishments from participating in the interstate shipment program. According to the comments, section 11015 was not intended to exclude these establishments. The comments suggested that FSIS revise the proposed rule to ensure that these establishments remain eligible for the program. One comment disagreed with the proposed 35 employees limit because, according to the comment, allowing selected establishment to have 35 employees during seasonal shifts represents, at minimum, a 40% increase in establishment personnel. The comment argued that the higher number of employees represents a huge increase in production that could overwhelm a very small establishment's production systems, which could result in contaminated food entering commerce. The comment noted that if an establishment routinely employs 5 people and then increases this number to 10 or 20 during a certain timeframe, it will have a 100% or 400% increase in employees. The comment maintained that this level of increase is not manageable and is not what Congress intended. The comment suggested that instead of limiting the total number of employees to 35 at any given time, FSIS should cap at 20% the increase in the number of employees that an establishment may use during a seasonal shift. The comment acknowledged that the commenter does not have data to support this number, but stated that it stands to reason that a sudden increase in production could significantly affect the dynamics within an establishment and overwhelm the system. According to the comment, small and very small establishments have HACCP plans for a production process at a certain level that would not necessarily support a significantly higher level of production. The comment pointed out that FSIS did not provide any data to support the proposed 35 employee cap. One comment stated that FSIS should not allow more than 25 employees in selected establishments at any given time. The comment noted that section 11015 requires that establishments that consistently employ more than 25 employees but fewer than 35 employees transition to Federal establishments within three years of the enactment date. The comment stated that this provision indicates that Congress recognized that establishments that ship product in interstate commerce and that have more than 25 employees should be under Federal inspection. Response: While the 2008 amendments to the Acts do not specifically prohibit selected establishments from ever having more than 35 employees, the Senate report described above indicates that Congress intended that there be some limits on the number of employees working at a selected establishment at any given time. As explained in the preamble to the proposed rule, FSIS proposed that the number of employees working in a selected establishment never exceed 35 at any given time because the law allows FSIS to select for the cooperative interstate shipment program establishments that employed more than 25 but fewer than 35 employees as of June 18, 2008, the date the law was enacted (21 U.S.C. 683(b)(3)(B) and 472(b)(3)(B)). To remain in the program, these establishments must employ fewer than 25 employees on average 3 years after the effective date of this final rule. Thus, while Congress did not intend to “* * * routinely allow selected establishments to employ above 25 or more employees,” the fact that the law provides for some selected establishments to initially employ up to 35 individuals demonstrates that a temporary increase in the number of employees of up to 35 individuals, as long as the average number of employees remains 25 or fewer, is consistent with the language and intent of the Acts. As noted above, when Congress established the cooperative interstate shipment program, it intended to provide some flexibility to establishments that require seasonal employees to meet consumer demands for certain parts of the year. The 20% cap on the increase in the number of employees suggested by one of the comments would greatly restrict the number of temporary workers that a selected establishment would be allowed to hire during busy seasons. For example, an establishment that regularly employs five employees on average would be permitted to hire only one temporary employee during its busy seasons. Many small and very small establishments operate on an intermittent or seasonal basis and are accustomed to adjusting their operations to temporarily increase production without undermining food safety standards. FSIS has concluded that restricting the increase in employees to 20% is unlikely to provide the flexibility that many very small selected establishments will need to meet seasonal demands for their products. d. Proposed standards: Volunteers who receive no compensation are not considered employees. Comment: One comment disagreed with the proposed standard that provides that volunteers are not considered employees. The comment stated as a food safety measure, uncompensated volunteers who are engaged in meat or poultry product processing should be considered employees for the purpose of the cooperative interstate shipment program. Response: FSIS agrees with this comment and has revised the standards for counting employees to include as employees, volunteers that perform duties that involve handling the meat or poultry products produced by the establishment. D. State Participation: “The Same as” Standard for Inspection Services Provided to Selected Establishments The proposed regulations provide that States interested in establishing an agreement for a cooperative interstate shipment program are required to submit a request for such an agreement to FSIS through the FSIS district office that covers the State. The proposed rule also provided that, in their requests, States are required to include documentation to demonstrate that they are able to provide the necessary inspection services to selected establishments in the State and conduct any related activities that would be required under a cooperative interstate shipment program. The preamble to the proposed rule explained that to meet this requirement, the statute requires that States demonstrate that the inspection service that they provide to selected establishments in the State will be “the same as,” rather than “at least equal to” those provided under the Federal inspection program. FSIS received a significant number of comments on the proposed “same as” standard. 1. Support for “the same as” Standard Comments submitted by consumer advocacy organizations, meat processor trade associations whose members mainly operate under the Federal inspection system, a union representing food and commercial workers, two pork producer trade associations, and some private citizens expressed support for the proposed “same as” standard. Comment: The comments that supported the proposed “same as” standard agreed that the language and intent of the enabling statute require that the cooperative interstate shipment program operate under standards that are the “same as” the Federal inspection system and not the “at least equal to” standard that applies to State MPI programs. The comments believed that all meat and poultry products shipped in interstate commerce should be required to comply with uniform Federal food safety standards rather then multiple State standards. The comments stated that it is especially important for State-inspected establishments that participate in the new program to be in compliance with all Federal standards because the meat and poultry products produced by these establishments will bear a Federal mark of inspection. One comment stated that requiring that selected establishments that voluntarily request the opportunity to participate in a cooperative interstate shipment program operate in a manner that is the “same as” federally-inspected establishments is not only consistent with the provisions and intent of the law, but also ensures that the food safety standards established in the FMIA, PPIA, and their implementing regulations are applied uniformly to all meat and poultry products that are distributed in interstate commerce. The comment encouraged FSIS to retain the proposed “same as” standard to first and foremost ensure the safety of meat and poultry products distributed in interstate commerce, but also to ensure equity in the marketplace. The comment added that this fundamental proposition, that the playing field be level for all companies engaging in interstate commerce, was a critical element in securing passage of the statutory provisions that authorized the cooperative interstate shipment program. The comment asserted that the program must not provide an unfair advantage to small companies that will not, or cannot, make the commitments necessary to comply with Federal food safety requirements. Two comments stated that requiring that State-inspected products produced under the cooperative interstate shipment program comply with all Federal requirements is essential for maintaining domestic and international markets for U.S. meat and poultry products. Other comments said that consumers expect that products carrying the Federal mark of inspection comply with Federal standards for meat and poultry inspection. The comments stated that establishments that are not held to all aspects of the Federal requirements should not be entitled to apply the Federal mark of inspection on their products. One comment that supported the “same as” standard noted that although establishments operating under a State MPI inspection program receive inspection services that are “at least equal to” the Federal inspection program, the methodology employed by FSIS is a critical part of the effectiveness of the Federal food safety system. The comment asserted that, as such, it is essential for States that participate in the cooperative interstate shipment program to follow Federal inspection methodology when providing inspection services to selected establishments. Response: FSIS agrees that the “same as” standard is consistent with the language and intent of the statutes. The issues raised by the comments demonstrate why it is important for the cooperative interstate shipment program to operate under standards that are “the same as” those imposed under the Federal meat and poultry products inspection programs. 2. Opposed to “same as” standard Several comments submitted by State Departments of Agriculture and other State agencies, as well as organizations representing these entities, objected to the proposed “same as” standard. Some farm and rural community advocacy organizations, cattle producer organizations, a trade association representing small meat processors, and an animal welfare advocacy organization also opposed the proposed standard. Comment: Several comments that objected to the proposed “same as” standard claimed that such a standard is not authorized by law. These comments asserted that the Acts, as amended by the 2008 Farm Bill, do not contain any language that would require that the inspection services that States provide to selected establishments be “the same as” or “identical to” the inspection services provided under the Federal program. The comments maintained that such an interpretation is an extrapolation of the language that does not exist in the statute. The comments noted that under the 2008 Farm Bill amendments, the term “eligible establishment” refers to an establishment that is “in compliance with” the Acts. The comments also noted that these amendments authorize the SEC to “ensure that selected establishments are operating in a manner that is consistent with * * *” the Acts (21 U.S.C. 472(d)(3)(A), 683(d)(3)(A)). The comments argued that these provisions indicate that if Congress had intended to require that the State program be “the same as” or “identical to” to the Federal program, it would have specifically said so in the statute. The comments also noted that the 2008 Farm Bill did not amend the provisions in the FMIA and PPIA that provide for cooperative State MPI programs that are “at least equal” to the Federal program. According to the comments, the fact that Congress did not amend these provisions demonstrates that State programs that are “at least equal to” the Federal program are in compliance with the Acts. Response: The language in the FMIA and PPIA, as amended by the 2008 Farm Bill, is clear: Congress provided that the cooperative interstate shipment program would operate under standards that are “the same as” those imposed under the Federal program. The 2008 amendments to the FMIA and PPIA provide that to be eligible for the cooperative interstate shipment, State-inspected establishments must be in compliance with both the State's MPI program and “* * * the requirements of this chapter, including the rules and regulations issued under this chapter” (21 U.S.C. 472(a)(3) and 683(a)(3)). As used in the statutes, the term “this chapter” refers to the FMIA at 21 U.S.C Chapter 12, and the PPIA at 21 U.S.C. Chapter 10. The 2008 amendments also require that the State personnel designated to provide inspection services under the program undergo “* * * all necessary training and certification to assist * * * in the administration and enforcement of this chapter, including the rules and regulations issued under this chapter” (21 U.S.C. 472(a)(2) and 683(a)(2)). The 2008 amendments allow a meat or poultry product inspected by designated State personnel to bear a Federal mark of inspection and be shipped in interstate commerce if the product “* * * qualifies for the mark * * * under the requirements of this chapter” (21 U.S.C. 472(b)(1)(A) and 683(b)(1)(A)). The Senate Conference Committee report on the bill that established the cooperative interstate shipment program provides that “* * * establishments selected for the [cooperative interstate shipment] program * * * must fully follow [the FMIA or PPIA], its regulations, notices, directives and policies just as would be required of a Federal establishment” (S. Rep. No. 220, 110th Cong., 1st Sess. (2007), pp. 211-214). The report also provides that “* * * [t]he inspection personnel of the State that will inspect the selected establishment must have undergone all the necessary training to carry out the requirement of [the Acts], [their] regulations, notices directives and policies, just as required of a Federal inspector.” Thus, both the statute and the Committee report make clear that Congress intended for the cooperative interstate shipment program to operate under standards that are “the same as” those imposed under the Federal inspection program. FSIS agrees with the comments that stated that the 2008 Farm Bill did not amend the provisions in the FMIA and PPIA that provide for cooperative State MPI programs that are “at least equal” to the Federal program. However, FSIS disagrees that this means that State programs that are “at least equal to” the Federal program are in compliance with all requirements of the Acts for purposes of the cooperative interstate shipment program. Under the FMIA and PPIA, establishments operating under an “at least equal to” State MPI program are permitted to produce meat or poultry products solely for distribution within the State where the establishment is located (21 U.S.C. 454(a)(1) and 661(a)(1)). Thus, State programs that are “at least equal to” the Federal program are in compliance with the Acts only if the establishments operating under these programs prepare and ship products solely for use within the State where they are located. Comment: One comment asked whether the proposed rule requires that a State's entire MPI program must be “identical to” the Federal program for the State to qualify for the cooperative interstate shipment program. Response: No, a State's entire MPI program does not need to be identical to the Federal program for the State to qualify for the cooperative interstate shipment program. To qualify for the program, a State must demonstrate that the inspection services that it will provide to selected establishments in the State will be “the same as” those provided under the Federal inspection program. States that participate in the cooperative interstate shipment program may continue to operate an “at least equal to” State MPI program for establishments that produce meat and poultry products solely for distribution within the State. Comment: Several comments stated that the interstate shipment program's legislative history demonstrates that Congress intended for the program to operate under the “at least equal” standard required for the existing cooperative State MPI programs. According to the comments, the conference reports for the House and Senate versions of interstate shipment legislation indicate that Congress adopted the Senate version of the bill because the House version would have required that States implement meat and poultry inspection programs “identical to” the Federal inspection system. The comments maintained that the legislative intent was to provide current State facilities with a viable route to ship State product interstate. The comments said that the requirement for State plants to be “identical to” or “same as” a federal plant radically deviates from this. Response: The comments are correct in that Congress did adopt the Senate version of the legislation that established the cooperative interstate shipment program. However, FSIS disagrees that the Senate version was adopted to permit State-inspected establishments operating under an “at least equal to” standard to ship meat and poultry products in interstate commerce. Section 11103 of the House version of the 2008 Farm Bill would have amended the FMIA and PPIA to replace the existing “at least equal to” cooperative State MPI program with a new program that would have authorized FSIS to approve, and enter into cooperative agreement with, only those State MPI programs that adopt standards identical to those imposed under the Federal program (H. Rep. 110-256, 110th Cong., 1st Session, pp. 184-191). Under the House version, all State-inspected establishments would have been required to comply with Federal standards, the State mark of inspection would have been deemed an official mark, and all State-inspected establishments would have been allowed to ship meat or poultry products in interstate commerce. The Senate bill, which was the version adopted in the 2008 Farm Bill, supplements, but does not replace, the existing State MPI programs. The Senate version provides an option under which State-inspected establishments that have, on average, 25 or fewer employees, will be permitted to ship their meat or poultry products in interstate commerce. Under the Senate version, State-inspected establishments are required to comply with all Federal standards to be eligible to participate in the cooperative interstate shipment program, and designated State personnel must be trained to enforce Federal food safety standards. Under the Senate version, State-inspected establishments that choose not to participate in the cooperative interstate shipment program may continue to operate under the “at least equal to” State MPI program and ship their products within the States where they are located. Comment: Some comments claimed that in the past, FSIS itself concluded that it was unrealistic for States to maintain MPI programs that are “the same as” or “identical to” FSIS's program. The comments noted that in 2003, the Agency provided an option for the States to claim that their meat and poultry inspection programs were “same as” or “identical to” FSIS inspection as part of the Agency's annual review in which it verifies that State MPI programs are “equal to” the Federal program. The comments said that in 2006, FSIS reached the conclusion that it was logistically impossible for State programs to maintain a true “same as” or “identical to” status, so the Agency removed this option from the State Self Assessment Manual forms. The comments asserted that if only a few years ago FSIS acknowledged that it is impossible for State MPI programs to be the “same as” Federal programs, proposing such a standard now will effectively prevent States from qualifying for a cooperative interstate shipment program. Response: FSIS has stated that “at least equal to” does not require that States operate their cooperative MPI programs in a manner that is “the same as” or “identical to” the FSIS program or does not prohibit States from establishing safeguards that the States believe to be more effective than those employed by FSIS. The law does not require that the cooperative State MPI programs operate under standards “identical to” the Federal program. As noted above, the cooperative interstate shipment program will supplement the existing State MPI programs, not replace them. Thus, while States that participate in the cooperative interstate shipment program will need to provide the same inspection services to selected establishments that FSIS provides to federally-inspected establishments, States may also continue to operate their cooperative State MPI programs in a manner that is “at least equal to” the Federal program. Comment: Several comments noted that a foreign country must demonstrate that its inspection system is “equivalent” to the U.S. inspection system before FSIS will permit establishments located in the foreign country to import meat and poultry products into the United States. These comments asserted that requiring that States operate their cooperative interstate shipment programs under standards that are the “same as” those required under the Federal program subjects the States to a stricter and less flexible standard than the standard applied to foreign countries. One comment maintained that while the commenter does not support the equivalent standard for foreign facilities, there is no justification for discriminating against domestic establishments under the jurisdiction of State inspection programs by requiring that they meet more rigid standards than those imposed on foreign establishments. Response: The equivalence standard applied to imported meat and poultry products and the “same as” standard applied to meat and poultry products produced under the cooperative interstate shipment program reflect the relevant provision in the FMIA and PPIA. The FMIA and PPIA require that FSIS treat as equivalent to a U.S. requirement alternative measures proposed by an exporting country if the country provides scientific evidence or other information, in accordance with risk assessment methodologies agreed to by FSIS and the exporting country, to demonstrate that the alternative measure achieves the level of protection that is appropriate for the United States (21 U.S.C. 620(e)(1)(B), 466(d)(2)(A)). These provisions reflect the U.S. Government's obligation under the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures (the SPS Agreement) to accept the sanitary measures of an exporting Member country as equivalent if the exporting member demonstrates that its sanitary measures attain the same level of protection (Article 4.1, “Agreement on the Application of Sanitary and Phytosanitary Measures). FSIS evaluates foreign food regulatory systems for equivalence through document reviews, on-site audits, and port-of-entry reinspection of products at the time of importation (9 CFR part 327 and 381 subpart T). Comment: Several comments asserted that it is unnecessary to require that the inspection services that States provide to selected establishments be the “same as” inspection services provided under the Federal program because most States have incorporated the Federal requirements into their State MPI programs. The comments stated that, according to FSIS's 2008 report on its review of the State MPI programs, these State programs have demonstrated that they can implement the Federal laws and regulations in a manner that is “at least equal to,” and thus, “in compliance with” the Federal standards without operating under a program that is “the same as” the Federal inspection program because of the smaller staff size and other administrative aspects of the State programs. Response: As noted throughout this document, the 2008 amendments to the Acts require that the inspection services that States provide to selected establishments be “the same as” those provided under the Federal inspection program. The Senate report also makes clear that State inspection personnel are “* * * to carry out the Federal requirements of the [the Acts], [their] regulations, notices directives and policies, just as required of a Federal inspector” (S. Rep. No. 110-220, 110th Cong., 1st Sess. (2007), pp 211-214). Thus, FSIS disagrees that State programs that have implemented the Federal laws and regulations in a manner that is “at least equal to” the Federal inspection program are “in compliance with” the Federal standard for purposes of the cooperative interstate shipment program. The law clearly requires that the inspection services that designated State personnel provide to selected establishments in States participating in the cooperative interstate shipment program be “the same as” those provided under the Federal program. Comment: Several comments claimed that under the “at least equal to” standard, some States have implemented requirements for food safety and consumer protection that are stricter than those provided for under the Federal Acts. According to these comments, many States have processes for the review and evaluation of product labels that do more than FSIS's generic label process to ensure that the labels of meat and poultry products properly inform consumers about the product, its weight and its ingredients. The comments also noted that while FSIS currently does not have the authority to levy civil penalties for violations of the Federal Acts, many States have the authority to impose civil penalties against violators of State meat and poultry inspection laws. Some comments stated that while FSIS allows the slaughter and sale of up to 20,000 farm raised chickens annually to restaurants and retail markets without benefit of inspection, many State programs do not permit this activity. The comment claimed that requiring States to operate their MPI programs in a manner that is “identical to” the Federal program could force the States to lower their standards. One comment stated that some states impose humane handling and slaughter requirements that go above and beyond those required by Federal law. Another comment said that some States have stricter cold storage requirements than FSIS. Response: As discussed above, the cooperative interstate shipment program established in this final rule supplements rather than replaces the existing State MPI programs. States that participate in the cooperative interstate shipment program may continue to operate their “at least equal to” State MPI programs for meat and poultry products produced and sold solely within the State. Thus, this final rule does not affect requirements for labeling, civil fines, poultry inspection, humane handling, or cold storage that States have adopted as part of their cooperative State MPI programs. Comment: In the preamble to the proposed rule, FSIS explained that to qualify for a cooperative interstate shipment program, States will need to demonstrate that they have the authority under State law to provide the necessary inspection services to selected establishments in the State (74 FR 47652). Some comments noted that if the final regulations require that inspection services provided to selected establishments be the “the same as” those provided under the Federal inspection system, many States will not be able to immediately change their laws to make them identical to the Federal inspection laws. One comment noted that the ability of States interested in the new program to change their rules and adopt FSIS regulations will depend on the process the State program must follow in order to make those changes. Other comments noted that each State has its own legislative process and some State legislatures do not meet every year. One comment noted that, although the State programs are “equal to” the Federal inspection system, the terminology and precise phrasing in the laws and regulations differ, and that State administrative systems vary. Response: As discussed above, the cooperative interstate shipment program supplements the existing State MPI programs. Therefore, States are not required to amend all State inspection laws to make them identical to the Federal requirements. States interested in participating in the cooperative interstate shipment program will need to demonstrate that they have the necessary legal authority to enforce Federal food safety standards in selected establishments in the State. As noted by the comments, State laws and regulations differ, and each State has its own legislative process. Some States may already have the necessary legal authority to participate in the cooperative interstate shipment program, while others may need to make legislative changes to provide for any additional authority that they may need. Comment: Some comments asserted that the main focus of any program that provides for the interstate shipment of State-inspected products should be on the safety of the products produced in the selected establishments, not on administrative procedures for the inspection program. According to the comments, if States are required to operate their cooperative interstate shipment programs in a manner that is the “same as” the Federal program, the focus of these programs will be on the administrative procedures of the State instead of food safety. The comments stated that regulatory requirements can be met through different means and that it is not practical or effective for a State program to operate under the exact same procedures prescribed in the Federal system. The comments suggested that an effective alternative would be to allow States to work within the existing “equal to” framework to develop food safety activities focused on problems specific to their establishments. The comments stated that the “at least equal to” standard is well accepted and has been effective in ensuring that State MPI inspection programs are comparable to the Federal program. Response: As explained above, the law does not provide for the cooperative interstate shipment program to operate within the existing “at least equal to” framework. Under the 2008 amendments to the Acts, meat or poultry produced in selected establishments are permitted to bear a Federal mark of inspection and be shipped in interstate commerce only if designated State personnel find that such product qualify for a Federal mark (21 U.S.C. 683(b)(1)(a) and 472(b)(1)(a)). While products that are inspected and passed under a State's “at least equal” MPI program qualify for a State mark, these products are not eligible for a Federal mark. Comment: Some comments complained that FSIS's proposed regulations would require that States maintain two separate inspection systems, one that is “identical to” the Federal program and one that is “equal to” the Federal program. The comments said that adding an entirely new State inspection system to comply with the “same as” standard will add an extra layer of cost for the States. According to the comments, many States would need to hire additional laboratory staff to perform different methodology and complete documentation the same as FSIS. The comments also said that States would need funds to train inspectors and purchase Federal computers, and that overall State administrative costs would increase because office staff, accountants, supervisors, and managers would need to manage two systems. One comment urged FSIS to fully consider the impact that the “same as” standard will have on the administrative aspects of the State inspection programs. Response: In the Preliminary Regulatory Impact Analysis (PRIA) to the proposed interstate shipment rule, FSIS acknowledged that States that choose to participate in the cooperative interstate shipment program may need to make certain modifications to their inspection program to provide inspection services to selected establishments in the State (74 FR 47657). The Agency also acknowledged that the inspection costs under the new program may differ from the costs of the existing State MPI program. As required by law, if Congress provides the necessary funding for the cooperative interstate shipment program, FSIS will reimburse States for costs related to the inspection of selected establishments in the State in an amount not less than 60 percent of eligible State cost. FSIS has updated its analysis of the State costs in the Final Regulatory Impact Analysis (FRIA) for this final rule. As noted by the comments, the cooperative interstate shipment program established in the proposed rule may require that States maintain two separate inspection programs, one that is “the same as” the Federal program and one that is “equal to” the Federal program. States that enter into cooperative agreements under the Talmadge-Aiken program to provide Federal inspection services to Federal establishments on behalf of FSIS are also required to maintain two separate inspection systems—one under the cooperative State “at least equal to” MPI program and the other under the cooperative Talmadge-Aiken program. Thus, FSIS does not believe that the cost to administer two separate cooperative inspection programs will prevent States that are interested in participating in the cooperative interstate shipment program from doing so. 3. “Same as” Computer Systems and Forms In the preamble to the proposed rule, FSIS explained that to qualify for a cooperative interstate shipment program, the Agency expects States to demonstrate that they can provide the necessary equipment for State personnel to provide the same inspection services to selected establishment that FSIS provides to official establishments, including computers and supplies for collecting regulatory product samples (74 FR 47652). Comment: A number of comments said that this statement could be interpreted to mean that State programs must obtain and use the same computers and computer programs that are used by FSIS personnel. The comments requested that FSIS clarify its expectations with regard to the type of computers and information systems the States will need to have in place to qualify for a cooperative interstate shipment program. Some of these comments noted that many States currently use State-issued laptops computers and have developed systems that have been determined “equal to” FSIS to track and report inspection activities and other required data. One comment noted that some States have developed their own data-driven systems that mimic the Federal System, but that also allow State program personnel access to State licensing information and to view and conduct other inspection activities in facilities that are not related to meat and poultry. According to the comment, States with their own information systems are able to tailor FSIS inspection activities, which are geared towards use in larger establishments, to be effective in very small establishments. Response: To qualify for the cooperative interstate shipment program, States will need to have computer programs and information systems that are “the same as” those used by FSIS to administer the Federal inspection program. Assuming that Congress provides the necessary funding, FSIS will allow States that do not have the necessary information systems to purchase from the Agency federally-procured computers and the necessary computer programs. FSIS will reimburse the States for 60% of their eligible costs to obtain the necessary computers and software. FSIS does not intend to reimburse more than 60% of the States' costs unless Congress directs it, and provides the money for it to do so. Comment: Some comments stated that if FSIS expects States to have information systems that are identical to those used under the Federal system, some States will need to maintain two computer systems to participate in the program because the Federal computer system does not allow any State program loads, and the Federal systems cannot be operated on a computer other than a federally-sourced computer. One comment noted that federally-procured computers generally cost more than State-procured ones, and the Federal computers would only be used on a limited basis by State personnel that work in selected establishments. Response: As noted above, to provide the necessary inspection services under the cooperative interstate shipment program, States that participate in the program will need to use computer programs that are “the same as” those used by FSIS to administer the Federal inspection program. Thus, if the Federal computer programs cannot be operated on State-sourced computers, the State may need to purchase new computers from FSIS. As a result, some States will need to maintain two computer systems to participate in the cooperative interstate shipment program. Comment: One comment asked if states participating in the cooperative interstate shipment program will have access to all of the Federal data programs, like eADRS, Assurance Net and FSIS intranet. Another comment stated that FSIS did not explain how requiring that States have identical computer systems in order to participate in the cooperative interstate shipment program will further food safety and compliance with the Acts. Response: States that participate in the cooperative interstate shipment program will have access to the computer programs that are necessary to provide inspection services that are “the same as” those provided under the Federal program. The computer systems used by States to administer the cooperative interstate shipment program need to be “the same as” those used under the Federal program to ensure that selected establishments are meeting all food safety standards that are “the same as” rather than “at least equal to” standards imposed under the Federal program. Comment: Some comments asked whether the forms used by States operating under a cooperative interstate shipment need to be identical to the Federal forms that FSIS uses under its inspection program. According to one comment, State inspection programs frequently do not have access to Federal forms and, therefore, most have developed their own forms. The comment stated that, if States are required to maintain forms that are identical to the Federal forms, many States will need to manage two different sets of documentation to participate in the cooperative interstate shipment program. Response: To provide the necessary inspection services to selected establishments participating in the cooperative interstate shipment program, States will need to use forms that are the same as those used under the Federal inspection program. FSIS's OOEET will assist the States to obtain the necessary forms. 4. “Same as” Training for Designated State Personnel The preamble to the proposed rule stated that to qualify for a cooperative interstate shipment program, States will need to demonstrate that designated State personnel have been properly trained in Federal inspection methodology (74 FR 7652). The preamble also explained that FSIS offers training courses in Federal inspection methodology to State inspection personnel and that States that are interested in participating in a cooperative interstate shipment program will be responsible for making arrangements for their inspection personnel to attend these courses. Comment: Several comments stated that FSIS-sponsored training is costly, lengthy, and almost always requires travel out of State for extended periods of time. The comments suggested that, instead of requiring designated State personnel to attend FSIS training, the Agency should allow States to provide training that is “equal to” FSIS's training program. The comments explained that such training would include equivalent content as FSIS training but could be administered by the individual States, other State programs, FSIS or other qualified entities. Response: The law does not provide for training that is “equal to” FSIS's training program or that includes equivalent content. The 2008 amendments to the Acts require that designated State personnel under go “* * * all necessary inspection training and certification to assist the [FSIS Administrator] in the administration and enforcement of [the Acts], including rules and regulations issued under [the Acts]” (21 U.S.C. 683(a)(2)and 472(a)(2)). As stated in the Senate Committee report, this means that the designated State personnel “* * * must have undergone all the necessary training to carry out the requirements of [the Acts], [their] regulations, notices, directives and policies, just as required of a Federal inspector” (S. Rep. No. 220, 110th Cong., 1st Sess. (2007), pp. 211-214) Thus, the law clearly requires that the training in Federal inspection methodology provided to designated State personnel be “the same as” the training provided to FSIS inspection personnel. As noted in the preamble to the proposed cooperative interstate shipment rule, FSIS offers training courses in Federal inspection methodology to State inspection personnel. FSIS's OOEET will coordinate with States participating in the cooperative interstate shipment program to provide the necessary training for designated State personnel. Comment: Some comments stated that many States conduct their own training courses, which are subject to oversight by FSIS. The commenters noted that these State courses often present the identical material that FSIS presents in its training courses. The comments suggested that FSIS consider these State courses as acceptable training for designated State personnel. Response: Although some States may be providing training that includes the same content as the training provided by FSIS, designated State personnel will need to complete FSIS-sponsored training for the State to qualify for the cooperative interstate shipment program. FSIS-sponsored training courses will ensure that designated State personnel receive the necessary training to carryout the requirements of the Federal Acts, “just as required of a Federal inspector,” as intended by Congress. Comment: One comment asked whether State personnel will need to complete their training before the State begins its cooperative interstate shipment program. Some comments stated that State programs cannot afford the travel costs associated with sending already trained state inspectors to additional training. One comment suggested that FSIS make any required training for State inspectors available through on-line courses at no charge to the States. Two comments asked whether FSIS would be covering training and training-related expenses. Response: As noted above, the preamble to the proposed rule explained that to qualify for the program, States would need to demonstrate, among other things, that designated State personnel have been properly trained in Federal inspection methodology. This means that when a State submits a request to FSIS for a cooperative interstate shipment program, the State must demonstrate either that its designated State personnel have completed the necessary training in Federal inspection methodology or that such personnel will have completed such training before they begin to provide inspection services to selected establishments in the State. As previously noted, FSIS currently offers courses in Federal inspection methodology to State inspection personnel. States that are interested in participating in a cooperative interstate shipment program will be responsible for making arrangements for their inspection personnel to attend these courses. FSIS's OOEET will coordinate with the States to help make the necessary training available to designated personnel in the State. For example, if a State has a significant number of designated personnel that need to be trained Federal inspection methodology, FSIS could arrange to conduct training courses at a location within the State so that all designated State personnel can attend. As it does for training costs associated with the State MPI program, FSIS will reimburse States for any eligible training costs associated with the cooperative interstate shipment program, including necessary travel costs. However, instead of reimbursing the State for 50% of the eligible costs, FSIS will reimburse 60% of a State's eligible costs associated with training designated State personnel. As discussed above, for a State to qualify for the cooperative interstate shipment program, its designated State personnel will need to attend FSIS-sponsored training in person. Thus, FSIS will not be providing the required training through on-line courses as suggested by the comment. The Agency may, however, make supplemental training materials available on-line. 5. “Same as” Laboratory Testing and Analysis The preamble to the proposed rule explained that to qualify for an interstate shipment program, States will need to demonstrate that the laboratory services that they intend to use to analyze regulatory product samples from selected establishments are capable of conducting the same chemical, microbiological, physical, and pathology testing as are required under the Federal meat and poultry products inspection programs (74 FR 47652). The preamble also explains that FSIS's Office of Public Health Science (OPHS) will provide laboratory audit assistance to the State to verify that the methodologies used by a State's laboratory services to analyze samples from selected establishments are capable of producing the same results as the methodologies used by FSIS laboratories. Comment: Some comments agreed that State-inspected establishments participating in the cooperative interstate shipment program should be subject to the same regulatory sampling programs as those established in the Federal inspection program. One comment stated that positive results on pathogen and residue testing on products produced in selected establishments should lead to the same regulatory actions that federally-inspected establishments are subjected to. Two comments stated that they were encouraged by the requirements for regulatory sampling and laboratory analysis described in the proposed rule. The comments stated that a robust residue, microbiological, and pathological analysis capability will assure accuracy of these test results, which, according to the comments, is essential for maintaining foreign markets. Response: The comments present valid reasons for requiring that the selected establishments participating in the cooperative interstate shipment program be subject to the same regulatory sampling required under the Federal program. Comment: Several comments requested that FSIS clarify its expectations with regard to the laboratory services used by States to analyze samples under the cooperative interstate shipment program. Many comments specifically asked whether FSIS expects these laboratories to be (International Organization for Standards) ISO accredited. Several comments expressed concern that if FSIS requires laboratories that analyze samples for the cooperative interstate shipment program to be ISO accredited, some laboratories will have to abandon perfectly acceptable procedures, or possibly more up-to-date procedures, to perform the methodology executed at the FSIS laboratories. The comments also said that some states would need to hire additional personnel to perform the increased paperwork with no additional benefit in the quality or quantity of tests performed. Response: The laboratory services that States use to analyze samples collected under the cooperative interstate shipment must be capable of producing the same results as FSIS's laboratories. Therefore, to demonstrate that the laboratory services used by a State are sufficient for the State to qualify for the cooperative interstate shipment program, the State will need to show that the laboratory is accredited by an internationally recognized organization that accredits food testing laboratories against the ISO 17025 “General Requirements for the Competence of Testing and Calibration Laboratories” and AOAC “Guidelines for Laboratories Performing Food Microbiological and Chemical Analyses of Food and Pharmaceuticals Testing” written by the Analytical Laboratory Accreditation Criteria Committee (ALACC). The assessment body that FSIS uses, the American Association for Laboratory Accreditation (A2LA), is the sole organization that incorporates ALACC into their program requirements. State labs would need to use A2LA or another accrediting body that incorporates ALACC and is a signatory and in good standing to the Mutual Recognition Arrangements of the International Laboratory Accreditation Cooperation (ILAC). The laboratory will also need to use the protocols for analytical tests required for FSIS regulatory activities on meat and poultry products described in the FSIS Chemistry, Microbiological, and Pathology Laboratory Guidebooks. However, if the laboratory that a State intends to use to analyze samples for the cooperative interstate shipment program is unable to follow an FSIS method as written, the State may submit a justification to FSIS that: (1) Explains why the laboratory is unable to follow the FSIS methodology and (2) describes the modifications that the laboratory intends to make to the FSIS methodology. FSIS will evaluate the State's justification to determine whether the modification of FSIS methodology is minimal and supportable through validation or other evidence. FSIS will allow a State to use the modified method if the Agency determines that methodology is consistent with the original FSIS protocol and the State's method is capable of achieving results that are consistent with the corresponding FSIS method. To assist the States in developing laboratory services that are “the same as” those provided under the Federal inspection program, FSIS is adopting a “phased in” approach for the States to become ISO 17025 accredited. OPHS has developed a Quality Assurance (QA) checklist based on ISO 17025 and ALACC criteria. It is not as extensive as ISO 17025, but contains minimum QA practices that laboratories should follow to be able to defend their results. The checklist is included as an appendix in FSIS's guidance for “at least equal to” State MPI programs. States that use services from laboratories that are not ISO 17025 accredited but that can demonstrate that the laboratories meet the laboratory criteria in the FSIS QA checklist will be permitted to participate in the cooperative interstate shipment program if they agree to actively seek and obtain ISO accreditation within two years. However, if the laboratory fails to actively seek or does not obtain the necessary accreditation, FSIS will terminate the State's cooperative agreement for the interstate shipment program. FSIS is developing materials to assist States whose laboratory services are pursuing ISO accreditation to meet the requirements to become accredited. States may also use an outside laboratory to analyze samples collected under the cooperative interstate shipment program if the outside laboratory has the necessary accreditation. States that currently use laboratories with active ISO 17025 accreditations will need to submit the necessary documentation for FSIS to verify that the laboratories are ISO accredited and meet ALACC food laboratory requirements as assessed by an appropriate accreditation body. To remain eligible for the programs, States will need to demonstrate, through documented third-party audits or other appropriate documentation, that their laboratories are maintaining their accreditation and are continuing to use methods described in FSIS Laboratory Guidebooks. Comment: One comment asserted that instead of conducting the same number and type of sampling that is conducted under FSIS's sampling programs, the Agency should allow States to develop sampling programs that reflect the same number of samples over the broad spectrum of meat products produced under the cooperative interstate shipment program. According to the comment, States may very well conduct more sampling or more comprehensive sampling than Federal programs. The comment also suggested that FSIS provide States with production data to guide them in selecting the same number or more samples based on the same volumes under FSIS inspection programs. Response: To qualify for the cooperative interstate shipment program States must, at a minimum, collect and analyze the same number and type of regulatory product samples from selected establishments as are collected and analyzed under FSIS's inspection sampling program. If they have met the sampling requirements provided for in FSIS's regulatory sampling programs, States may collect additional samples or conduct additional analyses if they choose to do so. FSIS will provide guidance to States in determining the appropriate number of samples that they will need to collect to be the same as the Federal regulatory sampling program. Comment: Some comments noted that establishing a national laboratory program to analyze samples collected under the cooperative interstate shipment program would be more economically viable than requiring that each State program conduct a laboratory program that is “the same as” FSIS's. According to the comments, it is economically unreasonable for States to set up and maintain equipment necessary for running extremely rare samples. Response: States that do not have the laboratory capability to conduct the necessary sampling and analyses required under the cooperative interstate shipment program are permitted to submit samples collected under the cooperative interstate shipment program to an outside laboratory that does. The States may rely on the sample results obtained from an outside laboratory if the State, in coordination with FSIS's OPHS, has verified that the laboratory has the necessary accreditation and is capable of producing the same results obtained by FSIS's laboratories. Comment: One comment stated that the level of oversight that FSIS intends to have over State laboratories under the cooperative interstate shipment program is unnecessary. The comment suggested that, if FSIS intends to oversee the analysis of samples collected from selected establishments, it should offer to analyze all samples from eligible establishments at FSIS laboratories at no cost to the State program. Response: FSIS does not intend to oversee the analysis of samples collected from selected establishments. The Agency intends to consult with the States to verify that the laboratories that States use to analyze samples from selected establishments are capable of producing the same results as FSIS's laboratories. Comment: One comment included a number of questions that the commenter requested FSIS address before the Agency issues the final rule to implement the cooperative interstate shipment program. The questions are as follows: • Will the kidney inhibition swab (KIS) test for detecting antimicrobial drug residues be required in establishments selected for the program, or will other tests be acceptable? • If KIS is necessary, will every facility be required to have an incubator, or can samples be sent to the state laboratory, requiring only one incubator? • If an establishment decides to participate in both the cooperative program and the state inspection program, would the sampling program required by FSIS be sufficient, or would they also have to participate in the State's sampling program? • Could the selected establishments be put into the FSIS sampling program, with FSIS sending sample requests and supplies, and the samples analyzed at Federal labs? • What process must be followed if a state's laboratory wants to request audit help? • Will the recommendations of the auditor be the official required adjustments the lab must make to allow the state to participate in the program? Response: As noted above, the laboratory services that a State uses to analyze samples under the cooperative interstate shipment program must use methods that are capable of producing results that are “the same as” those obtained from the methods used by FSIS's laboratories. Therefore, the KIS test for detecting antimicrobial drug residues used by FSIS is the acceptable test. Samples may be sent to and analyzed by the State laboratory if FSIS has evaluated and approved any minor modifications to the procedures described in the FSIS Laboratory Guidebooks. If an establishment participates in both the cooperative interstate shipment program and the cooperative State MPI program, the sampling conducted under the cooperative interstate shipment program must be “the same as” the sampling conducted under the Federal program, while the samples collected under the State MPI program must meet standards that are “at least equal to” the Federal program. States that participate in the cooperative interstate shipment program are responsible for scheduling, collecting and analyzing samples required under the program. FSIS will not collect or analyze regulatory samples for the cooperative interstate shipment program. The SEC assigned to the State will facilitate the process for the State to obtain the necessary audit assistance from FSIS's OPHS. As noted above, OPHS will provide guidance and advice on laboratory accreditation requirements. However, the laboratories themselves will be responsible for obtaining the necessary ISO accreditation. 6. Related Activities Comment: Some comments requested that FSIS clarify what States need to do to demonstrate they are able to “conduct any related activities that would be required under a cooperative interstate shipment program,” as required under the proposed regulations. The comments said that the final rule must specifically describe the “related activities” required under the cooperative agreement or else the Agency should remove this statement. One comment said that requiring that States conduct “related activities” adds requirements for a State program that are outside of what is authorized by the enabling statute, and is both unclear and unnecessary. The comment said that FSIS should not be attempting to impose ancillary requirements on the States through the cooperative agreement process. According to the comment, the State's ability to provide inspection service to selected establishments in accordance with the statute is all that is authorized and, therefore, all that is necessary. Response: The term “related activities” refers to any activities that are necessary to ensure that the inspection services provided to selected establishments are “the same as” the inspection services provided to Federal establishments. Such activities include, but are not limited to, scheduling, collecting and analyzing regulatory samples, issuing export certificates for establishments that will be exporting products to foreign countries, and verifying that selected establishments are humanely handling livestock in connection with slaughter. E. Additional Conditions for State Participation In addition to requiring that a State's requests for an interstate shipment program include documentation to demonstrate that it is capable of providing the necessary inspection services to selected establishments in the State, the proposed regulations also require that, in its request, the State must agree to: (1) Provide FSIS with access to the results of all laboratory analyses conducted on product samples from selected establishments in the State; (2) inform the SEC for the State of any laboratory results that indicate that a product produced in a selected establishment may be adulterated or may otherwise present a food safety concern; and (3) if necessary, cooperate with FSIS to transition selected establishments in the State that have been deselected from a cooperative interstate shipment program to become official establishments (proposed 9 CFR 332.4(b)(3) and 381.187(b)(3)). The proposed regulations also provide that when States submit their requests for an interstate shipment program, they must include a list of establishments that have requested to participate in the program and that the State recommends for initial selection into the program (proposed 9 CFR 332.4(b)(1) and 381.187(b)(1)). Comment: Two comments suggested that FSIS remove the provision in the proposed regulations that requires that States give FSIS access to the results of all laboratories analyses conducted at selected establishments. The comments stated that such a requirement is unnecessary because the States are also required to notify the SEC of results that indicate that a product produced in a selected establishment may be adulterated or may otherwise present a food safety hazard. Response: Although the States are required to notify the SEC of laboratory results that indicate that a product produced in a selected establishment may be adulterated or present a food safety hazard, the SEC or other FSIS personnel also need to have access to the results of the laboratory analyses conducted on products produced in selected establishments to verify that these establishments are operating in a manner that complies with the Acts. Comment: One comment stated that, as written, the proposed requirement that States give FSIS “access” to all laboratory results could be interpreted as requiring that FSIS have electronic access, via a particular system, to the results of testing conducted by State programs. According to the comment, when an integrated electronic system for data sharing is developed, funded, and implemented, State programs will share laboratory results with FSIS electronically. The comment maintained that the cooperative interstate shipment program should not unintentionally limit the methods by which analytical results are shared with FSIS before an electronic system is fully operational. Response: The regulations do not prescribe the methods by which States are required to share their analytical results with FSIS. States may share analytical results with FSIS electronically or they may provide hard copies. The only requirement is that they give FSIS access to these results upon request. Comment: One comment said that the proposed requirement that the State notify the SEC when laboratory results indicate that a product from a selected establishment may be “adulterated or may otherwise present a food safety concern” is overly broad and redundant. The comment asserted that any product that presents a food safety concern is, by definition, adulterated. The comment suggested that FSIS delete the phrase “may otherwise present a food safety concern” in the final regulations. Response: There may be instances in which a product presents a food safety concern but it is unclear as to whether the product is adulterated under the FMIA or PPIA. For example, a preliminary laboratory result may indicate that a product that has been distributed in commerce is contaminated with a pathogen but the laboratory needs to complete the analysis to confirm these results. The SEC needs to be made aware of these situations to verify that the establishment and States have responded to the preliminary result in a manner that complies with the Federal Acts and implementing regulations. Comment: One comment stated that, instead of requiring that a State's request for a cooperative interstate shipment program include a list of establishments that have submitted requests to participate in the program and that the State recommends for the program, the final regulations should permit States to submit a request for a cooperative interstate shipment program before they have identified establishments interested in being selected for the program. According to the comment, this would allow the State and Federal programs to work out any issues with their relationship before offering the program to establishments. Response: FSIS agrees with this comment. The Agency has modified the regulations to require that a State's request for a cooperative interstate shipment program include a list of establishments that have submitted a request to participate in the program, if any. This will allow States to request an agreement for a cooperative interstate shipment program before they have identified establishments interested in participating in the program. However, FSIS will only reimburse States for 60% of their eligible costs to administer the program if, after entering into a cooperative agreement, establishments in the State are selected for, and participate in, the program. Comment: A few comments stated that, in addition to verifying that States have sufficient authority, resources, personnel, training, sampling capability and laboratory capacity to provide the necessary inspection services to selected establishments in the State, FSIS will also need to monitor budget issues in participating States on an ongoing basis to ensure that States continue to have sufficient resources to participate in the program. The comments noted that many State governments are under financial duress and have had to make budget cuts in their State inspection programs. One comment said that even though FSIS is required to reimburse States for at least 60% of their eligible costs associated with the cooperative interstate shipment program, the Agency will need to verify that States interested in participating in the new program will be able to meet Federal inspection regulatory requirements during these hard economic times. Response: States that enter into an agreement with FSIS for a cooperative interstate shipment program will be required to prepare annual budgets to cover the costs for the cooperative interstate shipment program, maintain complete accounting records, and conduct all other financial accountability activities just as they do for the State MPI program. FSIS will terminate a State's agreement for a cooperative interstate shipment program if the State does not have sufficient finances to comply with all aspects of the cooperative interstate shipment program. F. Selection Process Under the proposed regulations, State-inspected establishments that are interested in participating in the cooperative interstate shipment program must apply for the program through their State (proposed 9 CFR 332.5(a)(1) and 381.515(a)(1)). If a State determines that an establishment operating under the State's meat or poultry products inspection program qualifies for selection into a cooperative interstate shipment program, and the State is able and willing to provide the necessary inspection services to the establishment, the State is to submit its evaluation of the establishment through the FSIS District Office that covers the State (74 FR 47653). The proposed rule provides that the FSIS Administrator, in coordination with the State, will decide whether to select the establishment for the program (proposed 9 CFR 332.5(b) and 381.151(b)). Comment: Some comments said that the State inspection program is the government entity best suited to begin the process of selecting establishments for the cooperative interstate shipment program. According to the comments the States, not the FSIS Administrator, should be responsible for selecting establishments to participate in the program. The comments suggested that after initiating the selection process, the State program could collaborate with the FSIS SEC, who can visit the establishments that are under consideration for selection into the cooperative interstate shipment program. Response: FSIS agrees that the States are best suited to begin the process of determining which establishments in the State are eligible for selection to the cooperative interstate shipment program. Therefore, the proposed rule requires that establishments interested in participating in the cooperative interstate shipment program apply for the program through the State in which they are located (proposed 9 CFR 332.5(a) and 381.515(a). After the State recommends establishments for the program, the law requires that the FSIS Administrator coordinate with the State to select establishments for the program (21 U.S.C. 683(b)(1) and 472(b)(1)). Comment: One comment argued that the regulations do not need to include a process for selecting establishments to participate in the cooperative interstate shipment program because establishments operating under the State MPI programs are already under an inspection system that provides for food safety in a manner that is “at least equal to” the Federal inspection program. According to the comment, there is no need for selection because the entire State program has already been approved. Response: The law requires that the FSIS Administrator, in coordination with the State, select establishments to participate in the new cooperative interstate shipment program (21 U.S.C. 683(b) and 472(b)). There is nothing in the law to indicate that establishments operating under the existing State MPI programs have already been approved for the cooperative interstate shipment program. Therefore, these final regulations include procedures for selecting establishments for the program. Comment: One comment suggested that the final rule require that selected establishments undergo an on-site review by FSIS at least 30 days before they become eligible to participate in the cooperative interstate shipment program. The comment noted that such a review would help to guarantee that selected establishments that wish to ship their meat products in interstate commerce are in compliance with Federal law. Response: The preamble to the proposed rule explained that, as part of the selection process, the SEC assigned to a State, in coordination with the State, will verify that each establishment in the State that has applied to participate in a cooperative interstate shipment program is in compliance with all Federal standards (74 FR 47653). To verify such compliance, the SEC will coordinate with the State to conduct on-site reviews of each establishment that has applied, and that the State recommends, for selection into the program. Comment: One comment said that FSIS should better explain how establishments may be selected for the cooperative interstate shipment program. Response: The preamble to the proposed rule provides a detailed description of the proposed selection process. FSIS is adopting that process in this final rule. As proposed, State-inspected establishments that are interested in participating in a cooperative interstate shipment program will be required to apply for the program through the State agency that administers the State MPI program. States are responsible for establishing their own application procedures. The State will then evaluate the establishment to determine whether it qualifies for selection. To qualify for selection to the cooperative interstate shipment program, an establishment must: • Have the appropriate number of employees; • Not be ineligible for a cooperative interstate shipment program 2 ; 2 Examples of establishments that are ineligible for the cooperative interstate shipment program include official Federal establishments, establishments located in a State that has a State MPI program, establishments in violation of the FMIA or PPIA, establishments that are the subject of a transition to become a Federal plant, and establishments located in a State without a State MPI program. • Be in compliance with all requirements under the State inspection program; and • Be in compliance with all Federal meat or poultry products inspection requirements. If a State determines that an establishment operating under the State's MPI program qualifies for selection into a cooperative interstate shipment program, and the State is able and willing to provide the necessary inspection services to the establishment, the State is to submit its evaluation of the establishment through the FSIS District Office that covers the State. The FSIS Administrator, in coordination with the State, will then decide whether to select the establishment for the program. In deciding whether to select an establishment that the State has recommended for the cooperative interstate shipment program, the Administrator will consider whether the establishment qualifies for the program and whether the Agency has the resources that it needs to provide the required oversight of the establishment if it is selected for the program. Before an establishment can be selected, the SEC, in coordination with the State, must verify, through record reviews and on-site visits, that the establishment is in compliance with all Federal inspection requirements under the FMIA, PPIA, and their implementing regulations in title 9, chapter III, of the CFR. G. Mark of Inspection and Official Number The proposed regulations require that inspection services for selected establishments be provided by design [Text truncated at 120,000 characters. The full text is on the page linked above.] --- Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2011-9865. Public record. Not legal advice.