The Regulatory Plan
The Department of Agriculture, consistent with its reputation as the "people's Department," will pursue regulations that enhance and protect the quality of American agriculture, assist and promote America's farmers and ranchers, and benefit the lives of all Americans. USDA will remain vigilant to ensure the safety of our Nation's food supply and to address the potential threats posed by bioterrorism.
¤ Farmers, ranchers, and other USDA customers will find significant changes in all aspects of regulations that govern their interaction with the Department and its programs. Farm credit, a mainstay of the Nation's rural economy, is being significantly streamlined by the merger of cumbersome loan-making regulations with forms and certifications simplified to facilitate the application process. Existing forms and procedures are also being reviewed for their applicability to electronic submission and collection. The Department is undertaking a number of actions in the regulation of commodities that will increase efficiency, improve customer service, and reduce intervention in markets.
¤ USDA will develop new regulations and review existing ones that address the potential threats posed by domestic outbreaks of exotic animal diseases such as Foot-and-Mouth Disease (FMD) and Bovine Spongiform Encephalopathy (BSE).
¤ In the area of food safety, the Department will continue to refine existing regulations to assist industry in implementing a consistent, science-based process control system while developing new regulations that address emerging and exotic threats to the safety of the Nation's meat, poultry, and egg products supply.
¤ The Department is also improving the regulations that serve rural communities. Regulations are being streamlined and simplified so that they will be more customer friendly while providing for more efficient and effective program management.
¤ Nutrition programs are being improved to strengthen dietary quality by providing a wider variety of food packages to children and low-income participants while also improving the efficiency and integrity of program operations.
Reducing Paperwork Burden on Farmers
The Department has made substantial progress in implementing the goal of the Paperwork Reduction Act of 1995 to reduce the burden of information collection on the public. The Government Paperwork Elimination Act (GPEA) is leading all agencies in the Department to evaluate how they conduct business and migrate toward electronically oriented methods. The Farm Service Agency, Natural Resources Conservation Service, Rural Development, and Risk Management Agency are also working to implement the Freedom to E-File Act. Freedom to E-File directs the agencies, to the maximum extent practicable, to modify forms into user-friendly formats with user instructions and permits those forms to be downloaded and submitted via facsimile, mail, or similar means. As a result, producers should have the capability to electronically file forms and all other documentation if they so desire. Underlying these efforts will be analyses to identify and eliminate redundant data collections and streamline collection instructions. The end result of implementing both of these pieces of legislation will be better service to our customers so that they can choose when and where to conduct business with USDA.
The Role of Regulations
The programs of the Department are diverse and far reaching, as are the regulations that attend their delivery. Regulations codify how the Department will conduct its business, including the specifics of access to, and eligibility for, USDA programs. Regulations also specify the behavior of State and local governments, private industry, businesses, and individuals that is necessary to comply with their provisions. The diversity in purpose and outreach of our programs contributes significantly to the USDA being near the top of the list of departments that produce the largest number of regulations annually. These regulations range from nutrition standards for the school lunch program, to natural resource and environmental measures governing national forest usage and soil conservation, to regulations protecting American agribusiness (the largest dollar value contributor to exports) from the ravages of domestic or foreign plant or animal pestilence, and they extend from farm to supermarket to ensure the safety, quality, and availability of the Nation's food supply. Many regulations function in a dynamic environment, which requires their periodic modification. The factors determining various entitlement, eligibility, and administrative criteria often change from year to year. Therefore, many significant regulations must be revised annually to reflect changes in economic and market benchmarks. Almost all legislation that affects departmental programs has accompanying regulatory needs, often with a significant impact. The Federal Agriculture Improvement and Reform Act of 1996 (the 1996 Act), the Farm Bill of 1996, Public Law 104-127, had considerable regulatory consequences. This key legislation affects most agencies of USDA and resulted in the addition of new programs, the deletion of others, and modification to still others. In addition, the "Agricultural Risk Protection Act of 2000," Public Law 106-224, provides further assurances that agricultural programs will continue to achieve long-term improvements, particularly in reforms to the crop insurance programs. This legislation also provides for improvements in market loss and conservation assistance, crop and livestock disease pest protection, marketing program enhancements, child nutrition program measures, pollution control, and research and development for biomass.
Major Regulatory Priorities
Five agencies are represented in this regulatory plan. They include the Farm Service Agency, the Food and Nutrition Service, the Food Safety and Inspection Service, the Animal and Plant Health Inspection Service, and the Agricultural Marketing Service. This document represents summary information on prospective significant regulations as called for in Executive Order 12866. A brief comment on each of the five agencies appears below, which summarizes the Agency mission and its key regulatory priorities. The Agency summaries are followed by the regulatory plan entries.
Farm Service Agency
Mission: The Farm Service Agency (FSA) administers contract commodity, conservation, farm loan, commodity purchase and emergency loan, and disaster programs as prescribed by various statutes. The Agency's objective is to support farming certainty and flexibility, ensure compliance with highly erodible land, farm conservation and wetland protection requirements, and to assist owners and operators of farms and ranches to conserve and enhance soil, water, and related natural resources.
Priorities: FSA's priority for 2002 will be to continue to emphasize service to our customers. As Administration initiatives and changes in law require revisions to the Agency's regulations, the Agency's focus will be to implement the changes in such a way as to provide benefits for, while minimizing program complexity and regulatory burden for, program participants. As regulations are revised for program changes, opportunities will be taken to clarify, simplify, and reduce confusion whenever possible. The FSA regulations that operate the contract commodity programs, such as production flexibility contracts and marketing assistance loans, were revised a few years ago to remove the link between income support payments and farm prices and provide for seven annual payments. More changes to the laws governing those programs and the related regulations changes are anticipated in 2002. However, the Agency's ability to promote new policy initiatives when implementing these regulations is limited, due to the need to adhere to legislative intent. Therefore, due to their economic magnitude, they are noted here to acknowledge their significance in the overall USDA regulatory plan but are not further listed in the body of the plan that appears below.
A primary mission of FSA is to administer commodity payment and commodity marketing assistance loan programs. Generally, these programs are authorized by the 1996 Act with respect to the 1996 through 2002 crop years. Accordingly, FSA envisions no major changes in the last year of the regulations used to administer these programs but anticipates major initiatives once legislation is enacted which would authorize such programs for the 2003 and subsequent crops.
FSA is committed to the Paperwork Reduction Act of 1995's goal of reducing the information collection burden on the public. FSA is streamlining its farm loan-making and servicing regulations and reducing the information collection burden associated with the programs. FSA plans to reduce the number of CFR parts containing its farm loan program regulations by approximately 70 percent. In addition, FSA hopes to achieve a significant reduction in the total number of CFR pages by removing administrative provisions and internal policy and eliminating duplicative material. Furthermore, FSA intends to improve the clarity of the farm loan program regulations by following the guidelines established in the Plain Language in Government Writing Initiative.
As part of this project, all farm program regulations and internal Agency directives will be completely rewritten. All application processes and information collections will be reviewed, and unnecessary or redundant requirements will be eliminated. All forms associated with the programs were reviewed and assigned to one of the following categories:
¤ Prepared by the public;
¤ Prepared by the Agency, reviewed by the public; or
¤ Internal agency use only.
FSA will concentrate on streamlining forms assigned to the first category to reduce public burden. In addition, a data base was developed listing each field contained on the forms. This information will be used to identify duplicate collections and ensure consistency in terminology.
FSA has completed the streamlining of the Guaranteed Loan Program, Indian Tribal Land Acquisition Loan Program, and portions of the direct loan program. The balance of the direct loan program will be published in three separate rulemaking packages. A final rule streamlining the loan-making process for emergency loans should be published by the end of the 2001 calendar year. A proposed rule streamlining the loan-making process for farm ownership and operating loans and servicing of direct loans will be published in the spring of 2002. A proposed rule streamlining special loan programs, including boll weevil eradication, drainage and irrigation, and grazing associations is planned for the fall of 2002.
Finally, FSA is a full participant in the USDA Electronic Access Initiative and is taking the lead on the implementation of the Government Paperwork Elimination Act. All FSA information collections, forms, and procedures are reviewed for their applicability to electronic submission and collection.
Food and Nutrition Service
Mission: FNS increases food security and reduces hunger in partnership with cooperating organizations by providing children and low-income people access to food, a healthful diet, and nutrition education in a manner that supports American agriculture and inspires public confidence.
Priorities: In addition to responding to provisions of legislation authorizing and modifying Federal nutrition assistance programs, FNS' 2002 regulatory plan supports the broad goals and objectives in the Agency's strategic plan, which include:
¤ Improved nutrition of children and low-income people. This goal represents FNS' efforts to improve nutrition by providing access to program benefits (Food Stamps, WIC food vouchers, commodities, and State administrative funds), nutrition education, and quality meals and other benefits. It includes three major objectives: 1) improved food security, which reflects nutrition assistance benefits issued to program participants; 2) improved ability of FNS program participants to make healthy food choices, which represents our efforts to improve nutrition knowledge and behavior through nutrition education and breastfeeding promotion; and 3) improved nutritional quality of meals, food packages, commodities, and other program benefits, which represents our efforts to ensure that program benefits meet the appropriate nutrition standards to effectively improve nutrition for program participants.
In support of this goal, FNS plans to propose a rule mandated under Public Law 106-387 to increase food stamp benefits for household with high shelter costs and to make it easier for low-income working families to receive food stamps and own a reliable vehicle. The Agency also plans a proposed rule to amend regulations governing food packages provided in WIC to improve their variety and consistency with the Dietary Guidelines for Americans and to increase the nutritional adequacy of food packages for those with special medical needs.
¤ Improved Stewardship of Federal Funds. This goal represents FNS' ongoing commitment to maximize the accuracy of benefits issued, maximize the efficiency and effectiveness of program operations, and minimize participant and vendor fraud. It includes two major objectives: 1) improved benefit accuracy and reduced fraud, which represents the Agency's effort to reduce participant and Agency errors and to control Food Stamp and WIC trafficking and participant, vendor, and administrative Agency fraud, and 2) improved efficiency of program administration, which represents our efforts to streamline program operations and improve program structures as necessary to maximize their effectiveness.
In support of this goal, FNS plans to publish a final rule making changes in Child and Adult Care Food Program (CACFP) rules designed to improve management and financial integrity in this important program. FNS also plans to publish a final rule, mandated under the Personal Responsibility and Work Opportunity Reconciliation Act of 1996 and the Balanced Budget Act of 1997, which is designed to provide State agencies that administer the Food Stamp Program greater flexibility to support personal responsibility and independence and encourage work.
Food Safety and Inspection Service
Mission: The Food Safety and Inspection Service (FSIS) is responsible for ensuring that meat, poultry, and egg products in commerce are safe and not adulterated or misbranded.
Priorities: Since the mid-1990's, FSIS has been reviewing its regulations to eliminate duplication of and inconsistency with its own and other agencies' regulations and to convert "command-and-control" regulations to performance standards. The review effort is directed, in particular, at improving the consistency of the regulations with the Agency's pathogen reduction and hazard analysis and critical control point (PR/HACCP) regulations. HACCP is a science-based process control system for producing safe food products. FSIS-inspected meat and poultry establishments are required to develop and implement HACCP plans incorporating the controls the establishments have determined are necessary and appropriate to produce safe products. Under the HACCP regulations, establishments assume the responsibility for producing meat and poultry products that are safe, but they are able to tailor their control systems to their particular needs and processes and to take advantage of the latest technological innovations.
FSIS is continuing to revise its numerous command-and-control regulations, which prescribe the exact means establishments must use to ensure the safety of their products. Some of these regulations specify precise time-and-temperature combinations for processing meat, poultry, or egg products. Others require the prior approval by FSIS of equipment and procedures, in effect assigning to the Agency the responsibility for determining the means used by establishments to comply with the regulations. As a general matter, such command-and-control regulations are incompatible with HACCP because they deprive plants of the flexibility to innovate, and they undercut the clear delineation of responsibility for food safety.
In addition to undertaking regulatory amendments based on the results of its review activities, FSIS has been developing regulations for emergency use. Such regulations are an outcome of the Agency's proactive, risk-based policy toward emerging and exotic threats to the safety of the Nation's meat, poultry, and egg product supply.
Following are some of the Agency's recent and planned initiatives to convert command-and-control regulations to performance standards, to streamline and simplify the regulations, and to make the meat, poultry products, and egg products inspection regulations more consistent with the pathogen reduction and HACCP systems final rule:
FSIS has proposed a rule clarifying requirements for meat produced using advanced recovery systems by replacing the compliance program parameters in the current regulations with non-compliance criteria for bone solids, bone marrow, and neural tissue. Establishments would have to have process control procedures in place before labeling or using the product derived by use of such systems.
FSIS has proposed a rule to establish food safety performance standards for all processed ready-to-eat meat and poultry products and partially heat-treated meat and poultry products that are not ready-to-eat.
FSIS plans to propose generic Eshcerichia coli process control criteria based on the sponge method of sampling, for cattle, wine, and geese slaughtering establishments and for turkey slaughtering establishments based on both the sponge and the whole-bird rinse sampling methods. The Agency also plans to propose updated Salmonella performance standards for all market classes of cattle and swine.
FSIS will propose removing from the poultry products inspection regulations the requirement for ready-to-cook poultry products to be chilled to 40 degrees or below within certain time periods according to the weight of the dressed carcasses.
In addition, FSIS will be proposing to require federally inspected egg product establishments to develop and implement HACCP systems and sanitation standard operating procedures. The Agency will be proposing pathogen reduction performance standards for pasteurized egg products. Further, the Agency will be proposing to remove requirements for approval by FSIS of egg-product plant drawings, specifications, and equipment prior to use and to end the system for pre-marketing approval of labels for egg products.
Besides the foregoing initiatives, FSIS has proposed requirements for the nutrition labeling of ground or chopped meat and poultry products and single-ingredient products. This proposed rule would require nutrition labeling, on the label or at the point-of-purchase, for themajor cuts of single-ingredient, rawproducts and will require nutrition information on the label of ground or chopped products.
Finally, FSIS is planning to propose stand-by emergency procedures for dealing with any occurrences of bovine spongiform encephalopathy (BSE), known as mad-cow disease, to prevent any meat or meat products of animals affected by BSE from entering commerce. To date, no cases of BSE have been found in the United States herd. Any final rule that may be developed after the proposal would become effective when and if a native case of BSE is detected in the United States.
Animal and Plant Health Inspection Service
Mission: The major part of the mission of the Animal and Plant Health Inspection Service (APHIS) is to protect U.S. animal and plant resources from destructive pests and diseases. APHIS conducts programs to prevent the introduction of exotic pests and diseases into the United States and monitors and manages pests and diseases existing in this country. These activities enhance agricultural productivity and competitiveness and contribute to the national economy and the public health.
Priorities: APHIS is reviewing its existing regulations and developing new regulatory initiatives to ensure that a comprehensive framework is in place to address the threats posed by exotic and endemic animal diseases. Prompted in part by recent outbreaks of foot-and-mouth disease elsewhere in the world, APHIS is developing a proposed rule to amend its regulations for the cooperative control and eradication of animal diseases to ensure their adequacy with regard to the valuation of animals and materials, as well as the payment of indemnity, should an outbreak of foot-and-mouth disease occur in the United States. APHIS has also published, or is developing, proposed and final rules pertaining to the group of neurological diseases known as transmissible spongiform encephalopathies, which includes scrapie (a disease of sheep and goats), bovine spongiform encephalopathy (BSE, which affects cattle), and chronic wasting disease (a disease of deer and elk). APHIS has recently established an expanded regulatory program incorporating interstate movement restrictions and compensation for scrapie, strengthened its restrictions on the importation of ruminant-derived animal products that present a risk of introducing BSE, and is in the early stages of developing a cooperative eradication program for chronic wasting disease. In addition, APHIS, in coordination with the Department's Food Safety and Inspection Service, has begun developing an advance notice of proposed rulemaking to solicit public comment on BSE-related issues, including mandatory testing of down/dead/dying animals and requirements for the disposal of the carcasses of such animals.
APHIS documents published in the Federal Register and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at www.aphis.usda.gov /ppd/rad/webrepor.html.
Agricultural Marketing Service
Mission: The Agricultural Marketing Service (AMS) facilitates the marketing of agricultural products in domestic and international markets, while ensuring fair trading practices and promoting a competitive and efficient marketplace to the benefit of producers, traders, and consumers of U.S. food and fiber products.
Priorities: (1) AMS is proposing to develop a Lamb Promotion, Research, and Information Order (Order). The proposed Order, if implemented, would establish an industry-funded program that would be subject to a referendum within 3 years after assessments begin under the Order. The proposed Order provides for an assessment of one-half per pound of live lambs sold to be paid by producers, seedstock producers, feeders, and exporters and remitted to a 12-member industry board by the first handler or exporter. The program would generate an estimated $3 million annually, all from the domestic lamb industry. Importers of lamb would not be assessed.
(2) AMS plans to amend the National Organic Program (NOP) to add practice standards for Organic Certification of Wild Captured Aquatic Animals. The Organic Foods Production Act states that an organic certification program be established for producers and handlers of agricultural products that have been produced using organic methods. The NOP has been reviewing organic certification of fish including wild captured and aquaculture operations in response to a FY 2000 congressional mandate to develop regulations for the certification of seafood. The NOP has engaged in public meetings and workshops and conducted public comment proceedings on this subject. The NOP considers it advantageous to proceed with a proposed rule for wild capture operations prior to issuing a proposed rule for aquaculture systems because of the significant impact that wild capture standards will have on the production and use of fish meal confined systems.
(3) AMS published in the Federal Register on July 13, 2001, a proposed rule implementing the Hass Avocado Promotion, Research, and Information Order (Order) and a proposed rule containing referendum procedures for the program. Under the proposed Order, producers and importers would pay an assessment to the proposed Hass Avocado Board (Board). The Board would use the assessment collected to conduct a promotion, research, and information program to maintain, develop, and expand markets for Hass avocados in the United States. The comment period ended August 27, 2001. On August 28, 2001, AMS published a notice extending the comment period until September 12, 2001, due to several requests that were received. AMS plans to publish a final rule before the end of this calendar year.
AMS Program Rulemaking Pages. Most of AMS' rules as published in the Federal Register are available on the Internet at: www.ams.usda.gov/rulemaking. This site also includes commenting instructions and addresses, links to news releases and background material, and comments received so far on various rules.
1. ¤ ESTABLISHING A LAMB PROMOTION, RESEARCH, AND INFORMATION ORDER (LS-01-12)
Agency:
USDA—Agricultural Marketing Service (AMS)
Priority:
Other Significant
Legal Authority:
7 USC 7401 through 7425
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
7 CFR 1280
Legal Deadline:
None
Abstract:
The Agricultural Marketing Service (AMS) is planning to issue a proposed rule establishing an industry-funded promotion, research, and information program for lamb and lamb products including pelts but excluding wool and wool products. In response to an invitation published in the Federal Register to submit proposals for a Lamb Promotion, Research, and Information (Order), AMS received a proposal from the lamb industry.
Statement of Need:
The United States sheep industry has identified this program as a key to its future viability. Due to the negative impact on producer prices caused by high levels of imports, the sheep industry has sought Government assistance and is seeking to fund this self-help program to improve industry profitability. A $100 million trade adjustment assistance package has been provided based on a Presidential Proclamation. The proposed Lamb Promotion, Research, and Information Program would be a self-help program funded through assessments on sales of live lambs. The assessments would be paid by producers, feeders, and lamb slaughters.
Summary of Legal Basis:
Section 512(b) of the Commodity Promotion, Research, and Information Act (Act) of 1996 indicates that the purpose of the Act is to authorize the Secretary to establish programs of promotion, research, and information for agricultural commodities to strengthen their position in domestic and foreign markets. Section 514 of the Act provides that to carry out the purpose of the Act, the Secretary may issue orders applicable to producers of an agricultural commodity and others in the marketing chain.
Alternatives:
Not issue a proposed Order.
Anticipated Cost and Benefits:
The proposed program would generate approximately $3 million annually for promotion, research, and information activities designed to benefit the sheep and lamb industry. These funds would be generated from assessments on sales of lamb paid by producers, feeders, and lamb slaughters. The Department of Agriculture costs associated with the implementation and oversight of the program would be reimbursed from the assessments collected under the program. The activities funded under the program would likely increase the demand for lamb and lamb products and have a positive impact on producer profitability.
Risks:
None.
| Action | Date | FR Cite |
| NPRM | 12/00/01 |
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Federal
Agency Contact:
Ralph L. Tapp
Chief, Marketing Programs Branch, Livestock and Seed Division
Department of Agriculture
Agricultural Marketing Service
Room 2624
P.O. Box 96456, Room 2748-So. Bldg.
Washington, DC 20090-6456
Phone: 202 720-1115
RIN:
0581-AC06
2. HASS AVOCADO PROMOTION, RESEARCH, AND INFORMATION ORDER (FV-01-705)
Agency:
USDA—AMS
Priority:
Other Significant
Legal Authority:
7 USC 7801 to 7813
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
7 CFR 1219
Legal Deadline:
None
Abstract:
Under the Hass Avocado Promotion, Research, and Information Order, Hass avocado producers and importers will pay an assessment of 2.5 cents per pound on Hass avocados produced and imported into the U.S. The funds will be used by the Hass Avocado Board to increase demand for Hass avocados in the U.S.
Statement of Need:
The Agricultural Marketing Service (AMS) is proposing an industry-funded research, promotion, industry information, and consumer information program for Hass avocado. A proposed program—the Hass Avocado Research, Promotion, and Consumer Information Order (Order)—was submitted to AMS by the California Avocado Commission. In addition, Mexican, Chilean, and New Zealand producers and associations submitted partial proposals. Under the proposed order, producers and importers would pay an initial assessment of 2.5 cents per pound of Hass domestic and imported avocados to the Hass Avocado Board (Board). The Board would be appointed by the Secretary of Agriculture to conduct research, promotion, industry information, and consumer information needed for the maintenance, expansion, and development of domestic markets for Hass avocados. The purpose of the program is to increase consumption of Hass avocados in the United States.
Summary of Legal Basis:
The proposed Order is issued under the Hass Avocado Research, Promotion, and Consumer Information Act (Pub.L. 104-127), enacted on October 23, 2000.
Alternatives:
Not issue a proposed Order.
Anticipated Cost and Benefits:
The proposed Order would authorize assessments on producers (to be collected by first handlers) and on importers (collected by Customs) of Hass avocados at an initial rate of 2.5 cents a pound. Exports of domestic Hass avocados are exempt from assessment. At the initial rate of assessment, about $10 million will be collected to administer the program—about 65 percent from domestic production and 35 percent from imports. All costs of program administration, including conducting the program, AMS oversight, and collection of assessments by Customs will be covered by the collected assessments.
Risks:
None.
| Action | Date | FR Cite |
| NPRM | 07/13/01 | 66 FR 36869 |
| NPRM Comment Period End | 08/27/01 | |
| Final Action | 12/00/01 |
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Margaret B. Irby
Assistant Branch Chief
Department of Agriculture
Agricultural Marketing Service
Stop 0244, Fruit & Vegetable Programs
14th & Independence Avenue SW
Washington, DC 20250-0244
Phone: 202 720-9915
Fax: 202 205-2800
Email: margaret.irby@usda.gov
RIN:
0581-AB92
3. ¤ FOOT-AND-MOUTH DISEASE; PAYMENT OF INDEMNITY
Agency:
USDA—Animal and Plant Health Inspection Service (APHIS)
Priority:
Other Significant
Legal Authority:
21 USC 111; 21 USC 114 to 114a; 21 USC 134a to 134h
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
9 CFR 53
Legal Deadline:
None
Abstract:
APHIS is proposing to amend its regulations for the cooperative control and eradication of livestock or poultry diseases. These changes would provide APHIS with much needed flexibility in responding in an effective manner in the event of an outbreak of foot-and-mouth disease so that eligible claimants may be compensated while at the same time protecting the U.S. livestock and poultry population from the further spread of this highly contagious disease.
Statement of Need:
APHIS has recently reviewed these regulations to determine their sufficiency should an occurrence of foot-and-mouth disease occur in the United States. This review has been prompted, in part, by the series of outbreaks of foot-and-mouth disease that have taken place in the United Kingdom and elsewhere around the world. Based on this review, APHIS has determined that changes to the regulations are needed with regard to the valuation of animals and materials, as well as the payment of an indemnity to those persons who suffer loss of property as a result of foot-and-mouth disease.
Summary of Legal Basis:
The Secretary of Agriculture, either independently or in cooperation with States or political subdivisions, farmers' associations and similar organizations, and individuals, is authorized to control and eradicate any communicable diseases of livestock or poultry and contagious or infectious diseases of animals that, in the opinion of the Secretary, constitute an emergency and threaten the livestock industry of the country, including the payment of claims growing out of destruction of animals (including poultry), and of materials affected by or exposed to any such disease, in accordance with such regulations as the Secretary may prescribe (21 U.S.C. 114a).
Alternatives:
The proposed rule would comprise several regulatory changes, each of which is intended to facilitate the control and eradication of foot-and-mouth disease, should an outbreak of this disease occur in the United States. Reasonable alternatives to the proposed rule would be to (1) not make any changes at all or (2) to provide alternative levels of compensation.
Anticipated Cost and Benefits:
The proposed rule is expected to affect livestock operations and Federal and State government agencies. The vast majority of livestock operations are small entities. The potential costs and benefits would depend upon the degree of compensation provided should a compensation alternative be chosen.
Risks:
The changes contained in the proposed rule would be particularly important in facilitating early and effective intervention should an outbreak of foot-and-mouth disease occur in the United States. An effective response in the early stages of such an outbreak greatly reduces the risk of the disease's wider dissemination.
| Action | Date | FR Cite |
| NPRM | 12/00/01 | |
| NPRM Comment Period End | 02/00/02 |
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Additional Information:
APHIS documents published in the Federal Register and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at www.aphis.usda.gov /ppd/rad/webrepor.html.
Agency Contact:
Dr. Mark Teachman
Senior Staff Veterinarian, Emergency Programs, VS
Department of Agriculture
Animal and Plant Health Inspection Service
Unit 41
4700 River Road
Riverdale, MD 20737-1231
Phone: 301 734-8073
RIN:
0579-AB34
4. ¤ CHRONIC WASTING DISEASE IN ELK; INTERSTATE MOVEMENT RESTRICTIONS AND PAYMENT OF INDEMNITY
Agency:
USDA—APHIS
Priority:
Other Significant
Legal Authority:
21 USC 111 to 114a-1; 21 USC 120 to 121; 21 USC 125; 21 USC 134b
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
9 CFR 55; 9 CFR 81
Legal Deadline:
None
Abstract:
APHIS is proposing to establish minimum requirements for the interstate movement of farmed elk and to provide indemnity for the depopulation of farmed elk that have been infected with, or exposed to, chronic wasting disease (CWD).
Statement of Need:
CWD has been confirmed in free-ranging deer and elk in a limited number of counties in northeastern Colorado and southeastern Wyoming and has also been diagnosed in farmed elk herds in South Dakota, Nebraska, Oklahoma, Montana, and Colorado. The proposed rule is intended to prevent the spread of, and perhaps eliminate altogether, CWD in farmed elk herds in the United States. APHIS believes that establishing restrictions on the interstate movement of infected and exposed farmed elk, coupled with the payment of some level of indemnity for infected and exposed animals, will encourage elk producers who are not yet engaging in surveillance activities to begin doing so. To date, the level of support from States and the farmed elk industry for such a program has been high. Without a Federal program in place to depopulate infected and exposed animals, the movement of infected elk into new herds and States with no known infection will continue or may even accelerate. APHIS needs to take action to document the prevalence of the disease and to prevent its further spread.
Summary of Legal Basis:
The Secretary of Agriculture, either independently or in cooperation with States or political subdivisions, farmers' associations and similar organizations, and individuals, is authorized to control and eradicate any communicable diseases of livestock or poultry and contagious or infectious diseases of animals that, in the opinion of the Secretary, constitute an emergency and threaten the livestock industry of the country, including the payment of claims growing out of destruction of animals (including poultry), and of materials affected by or exposed to any such disease, in accordance with such regulations as the Secretary may prescribe (21 U.S.C. 114a).
Alternatives:
APHIS has identified two alternatives to the proposed rule. The first—to maintain the status quo—was rejected because it would not address the animal disease risks associated with CWD. The second option would have been to provide financial and technical assistance to the elk industry for continuation and expansion of a variety of herd management practices to reduce or eliminate CWD. Although this option may be less costly than the option chosen by APHIS (i.e., the proposed rule), this option was not selected because it would not advance CWD eradication as quickly or effectively as the chosen option. However, APHIS will continue to work with industry to develop voluntary herd management practices to preserve and increase the reduction in CWD levels that the proposed program is expected to achieve.
Anticipated Cost and Benefits:
The presence of CWD in elk causes significant economic and market losses to U.S. producers. Recently Canada has begun to require, as a condition for importing U.S. elk into Canada, that the animals be accompanied by a certificate stating that the herd of origin is not located in Colorado or Wyoming, and CWD has never been diagnosed in the herd of origin. The Republic of Korea recently suspended the importation of deer and elk and their products from the United States and Canada. The domestic prices for elk are severely affected by fear of CWD; it is extremely difficult for producers to sell elk that are associated with any hint of exposure to CWD.
Risks:
Aggressive action in controlling this disease now will decrease the chance of having to deal with a much larger, widespread, and costly problem later, such as the situation with bovine spongiform encephalopathy ("mad cow disease") in Europe. Although there is currently no evidence that CWD is linked to disease in humans, or in domestic animals other than deer and elk, a theoretical risk of such a link exists.
| Action | Date | FR Cite |
| NPRM | 01/00/02 | |
| NPRM Comment Period End | 03/00/02 |
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Additional Information:
APHIS documents published in the Federal Register and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at www.aphis.usda.gov /ppd/rad/webrepor.html.
Agency Contact:
Dr. Lynn Creekmore
Staff Veterinarian/Wildlife Diseases Liaison, NAHPS, VS
Department of Agriculture
Animal and Plant Health Inspection Service
4101 Laporte Avenue
Fort Collins, CO 80521
Phone: 970 266-6128
RIN:
0579-AB35
5. SPECIAL SUPPLEMENTAL NUTRITION PROGRAM FOR WOMEN, INFANTS, AND CHILDREN (WIC): REVISIONS IN THE WIC FOOD PACKAGES
Agency:
USDA—Food and Nutrition Service (FNS)
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
42 USC 1786
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
7 CFR 246
Legal Deadline:
None
Abstract:
This proposed rule will amend regulations governing the WIC food packages to disallow low-iron WIC formulas in food packages for infants; revise the maximum monthly allowances and minimum requirements for certain WIC foods; revise the substitution rates for certain WIC foods and allow additional foods as alternatives; make technical adjustments in all of the food packages to accommodate newer packaging and physical forms of the WIC foods; add vegetables as a food category in Food Packages III-VII for women and children; require that State agencies make available the full maximum foods allowed in each package; revise the criteria for developing State agency proposals for alternative food packages to accommodate participant food preferences more effectively; revise the purpose, content, and requirements for Food Package III; and address general provisions that apply to all the food packages. These revisions will improve the likelihood that WIC recipients achieve the food servings recommendations of the Dietary Guidelines for Americans and nutritional recommendations, providing WIC participants with a wider variety of foods, accommodating newer packaging and physical forms of WIC foods, and providing WIC State agencies with greater flexibility in prescribing food packages, especially to accommodate participants with hardships or cultural/food preferences. (99-006)
Statement of Need:
While WIC has been successful in many areas, obesity and inappropriate dietary patterns have become equal, if not greater, problems for many in WIC's target population. WIC food packages and nutrition education are the chief means by which WIC affects the dietary quality and habits of participants. Results of a recent WIC study found that the supplemental food package is consistently ranked by pregnant and postpartum women as the leading positive attribute of the program. Therefore, revised food packages, which will foster greater consistency with the Dietary Guidelines for Americans, are an appropriate response to further increase the positive effects of the program among the WIC eligible population.
The overarching objective of this rule is to improve disease prevention and nutritional status by improving dietary quality and nutritional adequacy of the WIC food packages by:
1. Improving the manner in which the nutrients lacking in the target population's diet are provided by revising food packages to reflect more closely the Dietary Guidelines for Americans as represented by the diet recommendations of the Food Guide Pyramid; and
2. Increasing the nutritional adequacy of the WIC food packages for medically needy participants.
Summary of Legal Basis:
The WIC Program was established to provide nutritious supplemental foods, nutrition education, and referrals to related health and social services to low-income pregnant, breastfeeding, and non-breastfeeding postpartum women, infants, and children up to age 5. Section 17 of the Child Nutrition Act of 1966 (as amended, 42 U.S.C. 1786) clearly established the WIC Program as a supplemental nutrition program designed to provide nutrients determined by nutritional research to be lacking in the diets of the WIC target population. WIC law requires that, to the extent possible, the fat, sugar, and salt content of WIC foods be appropriate. The law gives substantial latitude to the Department in designing WIC food offerings but obligates the Department to prescribe foods that effectively and economically supply the target nutrients.
Alternatives:
None.
Anticipated Cost and Benefits:
None.
Risks:
This rule is intended to improve the nutritional status and dietary patterns of the WIC target population, as a response to the threat of increasing risk factors for nutrition-related diseases—obesity, diabetes, coronary heart disease, stroke, and cancer, to name a few—in the WIC eligible population.
| Action | Date | FR Cite |
| NPRM | 05/00/02 | |
| NPRM Comment Period End | 08/00/02 | |
| Final Action | 02/00/03 | |
| Final Action Effective | 06/00/03 |
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
State, Local, Tribal, Federal
Federalism:
This action may have federalism implications as defined in EO 13132.
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
RIN:
0584-AC90
6. ¤ FOOD STAMP PROGRAM: VEHICLE AND MAXIMUM EXCESS SHELTER EXPENSE DEDUCTION PROVISIONS OF PUBLIC LAW 106-387
Agency:
USDA—FNS
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
PL 106-387
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
7 CFR 272.1; 7 CFR 273.8; 7 CFR 273.9
Legal Deadline:
None
Abstract:
This proposed rule will (1) implement a revision of the Food Stamp Program's resource eligibility standards regarding vehicle ownership and (2) set the maximum excess shelter expense deduction for fiscal year 2001 and, for future years, index it to the Consumer Price Index. (01-006)
Statement of Need:
This rule is necessary to implement revisions to the Food Stamp Program's resource eligibility standards regarding vehicle ownership and maximum excess shelter expense deduction.
Summary of Legal Basis:
All provisions of this proposed rule are mandated by Public Law 106-387.
Alternatives:
The alternative would be not to revise current rules, which have been superseded by changes brought about by Public Law 106-387.
Anticipated Cost and Benefits:
Low-income households will benefit by claiming larger income deductions for shelter expenses, thereby obtaining higher food stamp benefits. The new vehicle ownership provisions will make more low-income households eligible for food stamps and make it easier for them to own a reliable vehicle. States will benefit by having more flexibility and simpler administrative options for determining the effect of vehicle ownership upon food stamp eligibility.
Risks:
Not implementing this proposed rule would ignore the mandates contained in Public Law 106-387.
| Action | Date | FR Cite |
| NPRM | 02/00/02 | |
| NPRM Comment Period End | 04/00/02 | |
| Final Action | 11/00/02 | |
| Final Action Effective | 01/00/03 |
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
State, Local
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
RIN:
0584-AD13
7. CHILD AND ADULT CARE FOOD PROGRAM: IMPROVING MANAGEMENT AND PROGRAM INTEGRITY
Agency:
USDA—FNS
Priority:
Other Significant
Legal Authority:
42 USC 1766; PL 103-448; PL 104-193; PL 105-336
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
7 CFR 226
Legal Deadline:
None
Abstract:
This rule amends the Child and Adult Care Food Program (CACFP) regulations. The changes in this rule result from the findings of State and Federal program reviews and from audits and investigations conducted by the Office of Inspector General. This rule will revise: State agency criteria for approving and renewing institution applications; program training and other operating requirements for child care institutions and facilities; State- and institution-level monitoring requirements; and criteria for terminating agreements with institutions and day care homes. This rule also includes changes that are required by the Healthy Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the Personal Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub. L. 104-193), the William F. Goodling Child Nutrition Reauthorization Act of 1998 (Pub. L. 105-336), the Agricultural Risk Protection Act of 2000 (Pub. L. 106-224), and the Grain Standards and Warehouse Improvement Act of 2000 (Pub. L. 106-472).
The changes are designed to improve program operations and monitoring at the State and institution levels and, where possible, to streamline and simplify program requirements for State agencies and institutions. (95-024)
Statement of Need:
In recent years, State and Federal program reviews have found numerous cases of mismanagement, abuse, and in some instances, fraud by child care institutions and facilities in the CACFP. These reviews revealed weaknesses in management controls over program operations and examples of regulatory noncompliance by institutions, including failure to pay facilities or failure to pay them in a timely manner; improper use of program funds for non-program expenditures; and improper meal reimbursements due to incorrect meal counts or to mis-categorized or incomplete income eligibility statements. In addition, audits and investigations conducted by the Office of Inspector General (OIG) have raised serious concerns regarding the adequacy of financial and administrative controls in CACFP. Based on its findings, OIG recommended changes to CACFP review requirements and management controls.
Summary of Legal Basis:
Some of the changes proposed in the rule are discretionary changes being made in response to deficiencies found in program reviews and OIG audits. Other changes codify statutory changes made by the Healthy Meals for Healthy Americans Act of 1994 (Pub. L. 103-448), the Personal Responsibility and Work Opportunities Reconciliation Act of 1996 (Pub. L. 104-193), the William F. Goodling Child Nutrition Reauthorization Act of 1998 (Pub. L. 105-336), the Agricultural Risk Protection Act of 2000 (Pub. L. 106-224), and the Grain Standards and Warehouse Improvement Act of 2000 (Pub. L. 106-472).
Alternatives:
In developing the proposal, the Agency considered various alternatives to minimize burden on State agencies and institutions while ensuring effective program operation. Key areas in which alternatives were considered include State agency reviews of institutions and sponsoring organization oversight of day care homes.
Anticipated Cost and Benefits:
This rule contains changes designed to improve management and financial integrity in the CACFP. When implemented, these changes would affect all entities in CACFP, from USDA to participating children and children's households. These changes will primarily affect the procedures used by State agencies in reviewing applications submitted by, and monitoring the performance of, institutions which are participating or wish to participate in the CACFP. Those changes which would affect institutions and facilities will not, in the aggregate, have a significant economic impact.
Data on CACFP integrity is limited, despite numerous OIG reports on individual institutions and facilities that have been deficient in CACFP management. While program reviews and OIG reports clearly illustrate that there are weaknesses in parts of the program regulations and that there have been weaknesses in oversight, neither program reviews, OIG reports, nor any other data sources illustrate the prevalence and magnitude of CACFP fraud and abuse. This lack of information precludes USDA from estimating the amount of money lost due to fraud and abuse or the reduction in fraud and abuse the changes in this rule will realize.
Risks:
Continuing to operate the CACFP under existing provisions of the regulations that do not sufficiently protect against fraud and abuse in CACFP puts the program at significant risk. This rule includes changes designed to strengthen current program regulations to reduce the risk associated with the program.
| Action | Date | FR Cite |
| NPRM | 09/12/00 | 65 FR 55103 |
| NPRM Comment Period End | 12/11/00 | |
| Interim Final Rule | 07/00/02 | |
| Interim Final Rule Effective | 08/00/02 |
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
State, Local
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
RIN:
0584-AC24
8. FOOD STAMP PROGRAM: WORK PROVISIONS OF THE PERSONAL RESPONSIBILITY AND WORK OPPORTUNITY RECONCILIATION ACT OF 1996 AND THE FOOD STAMP PROVISIONS OF THE BALANCED BUDGET ACT OF 1997
Agency:
USDA—FNS
Priority:
Economically Significant. Major under 5 USC 801.
Legal Authority:
PL 104-193
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
7 CFR 273.7; 7 CFR 273.22
Legal Deadline:
None
Abstract:
This proposed rule will implement revisions to the Food Stamp Program's work and employment and training requirements, as well as new provisions for a work supplementation or support program and an employment initiative program. (96-025)
Statement of Need:
This rule is necessary to implement revisions to the Food Stamp Program's work requirements.
Summary of Legal Basis:
All provisions of this proposed rule are mandated by Public Law 104-193 and the Balanced Budget Act of 1997.
Alternatives:
The alternative is not to revise current rules. This is not practical. The current rules have been superseded by changes brought about by Public Law 104-193.
Anticipated Cost and Benefits:
None.
Risks:
None.
| Action | Date | FR Cite |
| NPRM | 12/23/99 | 64 FR 72196 |
| NPRM Comment Period End | 02/22/00 | |
| Final Action | 12/00/01 |
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
State, Local
Agency Contact:
Sharon Ackerman
Agency Regulatory Officer
Department of Agriculture
Food and Nutrition Service
Room 910
3101 Park Center Drive
Alexandria, VA 22302
Phone: 703 305-2246
Fax: 703 605-0220
Email: sheri.ackerman@fns.usda.gov
RIN:
0584-AC45
9. POULTRY INSPECTION: REVISION OF FINISHED PRODUCT STANDARDS WITH RESPECT TO INGESTA
Agency:
USDA—Food Safety and Inspection Service (FSIS)
Priority:
Economically Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
21 USC 451 to 470 et seq
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
9 CFR 381
Legal Deadline:
None
Abstract:
FSIS is seeking to clarify its Poultry Inspection regulations regarding visible ingesta on poultry carcasses and parts. A preliminary regulatory impact analysis conducted by FSIS determined that costs to achieve a zero tolerance for ingesta far outweighed benefits. This action was precipitated by a civil suit filed against USDA.
Statement of Need:
FSIS is seeking to clarify the regulations respecting visible ingesta on poultry carcasses and parts. In 1997, FSIS issued a final rule removing the process tolerance level for fecal contamination on poultry carcasses, in effect, adopting a zero process tolerance for poultry fecal matter. During the comment period on the final rule, several commenters supported a zero tolerance for ingesta. As a result, FSIS solicited comments and information on ingesta to determine whether there was a need for additional regulatory measures regarding ingesta. No comments were received. Lacking any information to suggest the current tolerance standards were inadequate, FSIS let stand the current process tolerance for ingesta contamination. However, partly in view of a civil suit, now dismissed, that alleged disparate regulation of the meat and poultry industries by FSIS and challenged the existing process tolerance for ingesta contamination of poultry carcasses, FSIS is issuing an ANPRM to determine how it should proceed on this issue.
Summary of Legal Basis:
This action is authorized under the Poultry Products Inspection Act (21 U.S.C. 451-470).
Alternatives:
No action.
Anticipated Cost and Benefits:
FSIS is seeking information and data from the public about the costs of establishing any of several alternative tolerance levels for ingesta and the effects on operations of large and small poultry establishments. In addition, we are soliciting comments on the availability of new technology that would reduce the levels of contamination of birds. FSIS is interested in having information on new research that identifies microbial hazards and determines whether or not their presence results in pathogen contamination of the poultry.
Risks:
None.
| Action | Date | FR Cite |
| ANPRM | 07/00/02 |
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN:
0583-AC77
10. PERFORMANCE STANDARDS FOR BACON
Agency:
USDA—FSIS
Priority:
Other Significant
Legal Authority:
21 USC 601 et seq; 21 USC 451 et seq
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
9 CFR 424.22(b)
Legal Deadline:
None
Abstract:
FSIS is proposing to revise the regulatory provisions concerning the production and testing of bacon (9 CFR 424.22(b)). FSIS is proposing to remove provisions that require the Agency to test bacon for nitrosamines and to remove provisions that prescribe the substances and amounts of such substances that must be used to produce bacon. FSIS is proposing to replace these provisions with performance standards that establishments producing bacon must meet. To meet these proposed performance standards, the process used would be required to limit the presence of nitrosamines when the product is cooked. Under the hazard analysis and critical control points (HACCP) system, establishments would incorporate the proposed performance standards into their HACCP plans.
Statement of Need:
FSIS is proposing to replace restrictive provisions concerning the processing of bacon with a performance standard. The proposed performance standard concerns limiting the presence of volatile nitrosamines in bacon products. The Agency is also proposing to remove provisions that require the Agency to sample and test bacon for the presence of nitrosamines. These proposed changes are necessary to make the bacon regulations consistent with those governing Hazard Analysis and Critical Control Point (HACCP) systems.
Summary of Legal Basis:
Under the Federal Meat Inspection Act (21 U.S.C. 601-695) a meat or meat food product is adulterated "if it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case the substance is not an added substance, such article shall not be considered adulterated under this clause if the quantity of such substance in or on such article does not ordinarily render it injurious to health" (21 U.S.C. 601(m)(1)). Volatile nitrosamines are deleterious because carcinogenic and, though not added directly to bacon, they may be produced when the bacon is fried. Processors can control the levels of nitrosamines that may be present when the product is fried by controlling the levels of nitrite and nitrosamine inhibitors that are used in the bacon curing process. In 1978, USDA stated that nitrosamines present at confirmable levels in bacon after preparation for eating were deemed to be adulterative. FSIS still maintains that bacon with confirmable levels of nitrosamines after preparation for eating is adulterated. In this proposed rule, processors would control the levels of nitrosamines by complying with a performance standard.
Alternatives:
No action; performance standards for all types of bacon (not just pumped bacon, as proposed); removal of the FSIS testing provisions without converting prescriptive regulations to performance standard.
Anticipated Cost and Benefits:
Because FSIS is proposing to convert existing regulations to a performance standard and is not proposing any new requirements for establishments producing bacon, FSIS does not anticipate that this proposed rule would result in any significant costs or benefits. Bacon-processing establishments whose HACCP plans do not address nitrosamines as hazards reasonably likely to occur may incur some costs. Also, establishments that choose to test their products for nitrosamines may incur some costs. Because this rule provides establishments the flexibility to develop new procedures for producing bacon, this rule may result in profits to processors who develop cheaper means of producing product or who develop a product with wide consumer appeal.
Risks:
None.
| Action | Date | FR Cite |
| NPRM | 07/00/02 |
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN:
0583-AC49
11. EGG AND EGG PRODUCTS INSPECTION REGULATIONS
Agency:
USDA—FSIS
Priority:
Economically Significant. Major status under 5 USC 801 is undetermined.
Unfunded Mandates:
Undetermined
Legal Authority:
21 USC 1031 to 1056
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
9 CFR 590.570; 9 CFR 590.575; 9 CFR 590.146; 9 CFR 590.10; 9 CFR 590.411; 9 CFR 590.502; 9 CFR 590.504; 9 CFR 590.580; 9 CFR 591; ...
Legal Deadline:
None
Abstract:
The Food Safety and Inspection Service (FSIS) is proposing to require shell egg packers and egg products plants to develop and implement Hazard Analysis and Critical Control Points (HACCP) systems and Sanitation Standard Operating Procedures (SOPs). FSIS also is proposing pathogen reduction performance standards that would be applicable to pasteurized shell eggs and egg products. Plants would be expected to develop HACCP systems that ensure products meet the pathogen reduction performance standards. Finally, FSIS is proposing to amend the Federal egg and egg products inspection regulations by removing current requirements for prior approval by FSIS of egg products plant drawings, specifications, and equipment prior to their use in official plants. The Agency also plans to eliminate the prior label approval system for egg products.
The actions being proposed are part of FSIS's regulatory reform effort to improve FSIS's egg and egg products food safety regulations, better define the roles of Government and the regulated industry, encourage innovations that will improve food safety, remove unnecessary regulatory burdens on inspected egg products plants, and make the egg and egg products regulations as consistent as possible with the Agency's meat and poultry products regulations. FSIS is also taking these actions in light of changing inspection priorities and recent findings of salmonella in pasteurized egg products.
Statement of Need:
FSIS is proposing to require egg products plants to develop and implement HACCP systems and Sanitation Standard Operating Procedures (SSOPs). FSIS also is proposing a pathogen reduction performance standard that would be applicable to pasteurized egg products. Plants would be expected to develop HACCP systems that ensure egg products meet the lethality required by the pathogen reduction performance standard. In addition, FSIS is proposing to amend the Federal shell egg and egg products inspection regulations by removing current requirements for approval by FSIS of egg product plant drawings, specifications, and equipment prior to their use in official (FSIS-inspected) plants. Finally, the Agency plans to eliminate the pre-marketing label approval system for egg products but to require safe-handling labels on shell eggs and egg products.
The actions being proposed are part of FSIS's regulatory reform effort to improve FSIS's shell egg and egg products food safety regulations, better define the roles of Government and the regulated industry, encourage innovations that will improve food safety, remove unnecessary regulatory burdens on inspected egg products plants, and make the shell egg and egg products regulations as consistent as possible with the Agency's meat and poultry products regulations. FSIS also is taking these actions in light of changing inspection priorities and recent findings of Salmonella in pasteurized egg products.
This proposal is directly related to FSIS's PR/HACCP initiative.
Summary of Legal Basis:
This proposed rule is authorized under the Egg Products Inspection Act (21 U.S.C. 1031-1056). It is not the result of any specific mandate by the Congress or a Federal court.
Alternatives:
A team of FSIS economists and food technologists is conducting a cost-benefit analysis to evaluate the potential economic impacts on the public, the egg products industry, and FSIS of several alternatives. These alternatives include: (1) taking no regulatory action; (2) requiring all inspected egg products plants to develop, adopt, and implement written Sanitation SOPs and HACCP plans; and (3) converting to a lethality-based pathogen reduction performance standard many of the current highly prescriptive egg products processing requirements. The team will consider the effects of a uniform, across-the-board standard for all egg products; a performance standard based on the relative risk of different classes of egg products; and a performance standard based on the relative risks to public health of different production processes.
Anticipated Cost and Benefits:
FSIS is analyzing the potential costs of this proposed rulemaking to industry, to FSIS and to other Federal agencies, to State and local governments, to small entities, and to foreign countries. The expected costs to industry will depend on a number of factors. These costs include the required lethality, or level of pathogen reduction, and the cost of HACCP plan and SSOP development, implementation, and associated employee training. The pathogen reduction costs will depend on the amount of reduction sought and in what classes of product, product formulations, or processes.
Relative enforcement costs to FSIS and FDA may change because the two agencies share responsibility for inspection and oversight of the egg industry and a common farm-to-table approach for shell egg and egg products food safety. Other Federal agencies and local governments are not likely to be affected.
FSIS has cooperative agreements with six States and the Commonwealth of Puerto Rico under which they provide inspection services to egg processing plants under Federal jurisdiction. FSIS reimburses the States for staffing costs and expenses for full-time State inspectors. HACCP implementation may result in a reduction of staffing resource requirements in the States and a corresponding reduction of the Federal reimbursement. As a result, some States may decide to stop providing inspection services and convert to Federal inspection of egg products plants.
Egg and egg product inspection systems of foreign countries wishing to export eggs and egg products to the U.S. must be equivalent to the U.S. system. FSIS will consult with these countries, as needed, if and when this proposal becomes effective.
This proposal is not likely to have a significant impact on small entities. The entities that would be directly affected by this proposal would be the approximately 75 federally inspected egg-processing establishments, most of which are small businesses, according to Small Business Administration criteria. If necessary, FSIS will develop compliance guides to assist these small firms in implementing the proposed requirements.
The impacts on the FSIS budget will be influenced by the alternatives proposed and industry responses. Most likely, fewer FSIS inspection personnel will be required over time as more uniform inspection practices are employed among the meat, poultry, and egg products industries.
Potential benefits associated with this rulemaking include: Improvements in human health due to pathogen reduction; improved utilization of FSIS inspection program resources; and cost savings resulting from the flexibility of egg products plants in achieving a lethality-based pathogen reduction performance standard. Once specific alternatives are identified, economic analysis will identify the quantitative and qualitative benefits associated with each.
Human health benefits from this rulemaking are likely to be small because of the low level of (chiefly post-processing) contamination of pasteurized egg products. In light of recent scientific studies that raise questions about the efficacy of current regulations, however, it is likely that measurable reductions will be achieved in the risk of foodborne illness.
Risks:
FSIS believes that this regulatory action may result in a further reduction in the risks associated with egg products. The development of a lethality-based pathogen reduction performance standard for egg products, replacing command-and-control regulations, will remove unnecessary regulatory obstacles to, and provide incentives for, innovation to improve the safety of egg products.
To assess the potential risk-reduction impacts of this rulemaking on the public, an interagency panel of scientific and technical experts is conducting a risk management analysis. The panel has been charged with identifying the lethality requirement sufficient to ensure the safety of egg products and the alternative methods for implementing the requirement. The egg products processing and distribution module of the Salmonella enteritidis Risk Assessment, made public June 12, 1998, will be appropriately modified to evaluate the risk associated with the regulatory alternatives.
| Action | Date | FR Cite |
| NPRM | 12/00/01 |
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses, Governmental Jurisdictions
Government Levels Affected:
None
Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN:
0583-AC58
12. PATHOGEN REDUCTION; HAZARD ANALYSIS AND CRITICAL CONTROL POINTS (HACCP) SYSTEMS; ADDITIONS TO GENERIC E. COLI CRITERIA
Agency:
USDA—FSIS
Priority:
Other Significant
Legal Authority:
21 USC 601 to 695; 21 USC 451 to 470
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
9 CFR 310; 9 CFR 381
Legal Deadline:
None
Abstract:
FSIS is proposing to add generic E. coli criteria to the regulations. In addition, FSIS is proposing to revise the terms used to identify and define certain classes of product listed in the Salmonella tables.
FSIS is proposing to delay making the proposed criteria and standards applicable for 1 year for small establishments and for 2 years for very small establishments.
Statement of Need:
FSIS is proposing to update its pathogen reduction (PR)/Hazard Analysis and Critical Control Point (HACCP) System regulations by adding generic Eschericha coli (E. coli) criteria for cattle, swine, and goose carcasses based on the sponging method of sample collection and for turkey carcasses based on the sponging and rinse methods of sample collection. FSIS is also proposing new pathogen reduction performance standards for Salmonella in cattle, swine, young turkey, and goose carcasses by the sponging method and fresh pork sausage by direct sampling. The new cattle performance standard would replace the existing Salmonella performance standards for steers/heifers and cows/bulls. The new swine standard would replace the existing standard for hogs. These new standards apply to all market classes of cattle and swine, respectively.
The National Academy of Sciences and the National Advisory Committee on Microbiological Criteria for Foods are examining the Salmonella performance standards and generic E. coli criteria. FSIS will take into account their findings and concerns before issuing rules on this matter.
In addition, FSIS is proposing to revise the terms used to identify and define certain classes of product listed in the Salmonella tables to more accurately reflect the products sampled in the baseline studies that are the basis for the standards. The Agency also intends to correct some errors in the E. coli and Salmonella tables and to change the footnotes to the tables for greater clarity.
These changes would ensure that the pathogen reduction performance standards and process control criteria applying to products and establishments regulated by FSIS are appropriate and accurate. The additional performance standards for Salmonella and criteria for E. coli will help establishments to improve process controls for certain classes of raw product. Improved process controls will help reduce pathogens on certain raw products and may result in the reduction of foodborne illness. The provision of E. coli criteria based on the sponge method of sampling would provide affected establishments with flexibility in complying with the rule.
In addition to the need to update and add flexibility to existing PR/HACCP requirements, the rule is needed to help address the market failure associated with the consumer's lack of information about pathogens that may be present in certain classes of meat and poultry products and to help meet the commitments made by FSIS in its PR/HACCP and associated regulatory reform initiatives.
Summary of Legal Basis:
This action is authorized under the Federal Meat Inspection Act (21 U.S.C. 601-695) and the Poultry Products Inspection Act (21 U.S.C. 451-470).
Alternatives:
No action.
Anticipated Cost and Benefits:
The costs of the proposal are estimated to be in the $18 million to $20 million range and are attributable to the need for some firms to modify their processes to meet the new standards.
Benefits would accrue from reductions in pathogen levels, which in turn, might lead to reductions in foodborne illness. There is, however, a great deal of uncertainty associated with the human health benefits estimates, including data reflecting a decline in foodborne illness after implementation of the PR/HACCP regulations, because of the lack of prevalence data for the period before and after implementation of the regulations.
Risks:
None.
| Action | Date | FR Cite |
| NPRM | 07/00/02 |
Regulatory Flexibility Analysis Required:
No
Government Levels Affected:
None
Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN:
0583-AC63
13. ¤ ELIMINATION OF CHILLING TIME AND TEMPERATURE REQUIREMENTS FOR READY-TO-COOK POULTRY (SECTION 610 REVIEW)
Agency:
USDA—FSIS
Priority:
Other Significant
Legal Authority:
21 USC 451 to 470
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
9 CFR 381.66
Legal Deadline:
None
Abstract:
FSIS is proposing to eliminate the time and temperature requirements for chilling ready-to-cook poultry carcasses and giblets. The Agency is taking this action because the requirements are inconsistent with the Agency's Pathogen Reduction/Hazard Analysis and Critical Control Point (HACCP) System regulations, with its final rule further restricting retained water in raw meat and poultry, and with the Agency's regulatory reform program. Moreover, because of these regulations, the meat and poultry industries receive disparate regulatory treatment: No regulations that apply to the chilling of poultry apply to the chilling of meat. This proposal responds to longstanding petitions by industry trade associations.
Statement of Need:
This proposed rule addresses Federal regulations that are inconsistent with the PR/HACCP regulations because they restrict the ability of poultry processors to choose appropriate and effective measures to eliminate, reduce, or control biological hazards identified in their hazard analyses. The regulations also complicate efforts by establishments to comply with the terms of the January 9, 2001, final rule further restricting the amount of water that may be retained in raw meat or poultry products after post-evisceration processing; some establishments may have to use chilling procedures that result in higher levels of retained water in carcasses than may be necessary to achieve the same food safety objective. For example, establishments that operate automated chillers may have to subject poultry carcasses to higher agitation rates or longer dwell times in the chillers. Also, as discussed above, the time/temperature chilling regulations for poultry result in disparate regulatory treatment of the meat and poultry industries.
Summary of Legal Basis:
This regulatory action is authorized under the Poultry Products Inspection Act (21 U.S.C. 451-470).
Alternatives:
FSIS evaluated five regulatory alternatives: (1) taking no regulatory action; (2) replacing the command-and-control requirements with a performance standard; (3) requiring meatpackers, as well as poultry processors, to comply with such a performance standard; (4) requiring all establishments that prepare raw meat or poultry products or handle, transport, or receive the products in transportation to comply with a performance standard; or (5) removing the command-and-control requirements from the poultry products inspection regulations. The Agency chose the fifth alternative.
Anticipated Cost and Benefits:
Poultry processors would gain the flexibility to choose the best processing techniques and procedures for achieving production efficiencies, meeting HACCP food safety objectives, and preventing economic adulteration of raw product with retained water in amounts greater than unavoidable for food-safety purposes. They would be able to operate with a wider range of chilling temperatures consistently with the requirements of the PR/HACCP regulations. The poultry products industry could achieve energy efficiencies resulting in annual savings of as much as $2.8 million.
The industry could also reduce carcass "dwell times" in immersion chillers and thereby reduce the amount of water absorbed and retained by the carcasses. The reduction in dwell time might enable some establishments, particularly those currently operating at the throughput capacity of their chillers, to increase production by installing additional evisceration lines. Poultry establishments would therefore be able to operate more efficiently to provide consumers with product that is not adulterated.
FSIS also would gain some flexibility by being able to reallocate some inspection resources from measuring the temperature of chilled birds to such activities as HACCP system verification.
This proposed rule would directly impose no new costs on the regulated industry. It would relieve burdens arising from the disparate impacts of the current regulations on the meat and poultry industries.
Risks:
None
| Action | Date | FR Cite |
| NPRM | 02/00/02 |
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
Businesses
Government Levels Affected:
None
Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN:
0583-AC87
14. ¤ EMERGENCY REGULATIONS TO PREVENT MEAT FOOD AND MEAT PRODUCTS THAT MAY CONTAIN THE BSE AGENT FROM ENTERING COMMERCE
Agency:
USDA—FSIS
Priority:
Economically Significant. Major status under 5 USC 801 is undetermined.
Legal Authority:
21 USC 601 et seq
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
Not Yet Determined
Legal Deadline:
None
Abstract:
FSIS is proposing to amend the meat inspection regulations to add emergency regulations to prevent meat and meat food products that may contain the bovine spongiform encephalopathy (BSE) agent from entering commerce. The emergency regulations would become effective when, and if, BSE is diagnosed in native cattle in the United States. The proposed regulations provide for periodic review by FSIS to determine their effectiveness and to evaluate the need to modify or remove some measures or impose additional measures.
Statement of Need:
FSIS is proposing to amend the meat inspection regulations to add provisions to prevent meat and meat products that may contain the BSE agent from entering commerce in the event that BSE is diagnosed in native cattle in the U.S. Any final rule that is developed as a result of this proposal will become effective when, and if, a native case of BSE is detected in the U.S.
BSE is a chronic, degenerative, neorological disorder of cattle. Worldwide, there have been more than 178,000 cases since the disease was first diagnosed in 1986 in Great Britain. There have been no cases of BSE detected in the United States despite 10 years of active surveillance for the disease. Recent laboratory and epidemiological research indicate that there is a causal association between BSE and variant Creutzfeldt-Jakob Disease (vCJD), a slow degenerative disease that affects the central nervous system of humans. Like BSE, vCJD has not been detected in the United States. Both BSE and vCJD are always fatal.
Although BSE has not been detected in the U.S., USDA policy in regard to BSE has been to be proactive and preventive. Therefore, FSIS is proposing these regulations so that the Agency will have an immediate regulatory response in the event that BSE is detected in the U.S. Once finalized, the proposed measures will be incorporated in the meat inspection regulations but would only become effective when, and if, BSE is detected in native cattle.
Summary of Legal Basis:
Under the Federal Meat Inspection Act (21 U.S.C. 601-695), FSIS issues regulations governing the production of meat and meat food products. The regulations, along with FSIS inspection programs, are designed to ensure that meat food products are safe, not adulterated, and properly marked, labeled, and packaged.
Alternatives:
As an alternative to the proposed requirements, FSIS considered taking no action. FSIS rejected this option because, as previously mentioned, USDA policy in regard to BSE has been to be proactive and preventive. Publishing a proposed rule will inform the public of the type of regulatory response it can expect from FSIS when, and if, BSE is detected in native cattle.
In addition to the proposed requirements, FSIS is considering taking actions prior to the detection of BSE in the U.S. to minimize human exposure to materials from cattle that could potentially contain the BSE agent. The measures under consideration are targeted at the materials of cattle that are most likely to contain the BSE agent, if such animals have been infected with BSE, and those cattle that have consumed feed prohibited by Food and Drug Administration's (FDA) regulations (i.e., mammalian meat and bone meal in ruminant feed).
Anticipated Cost and Benefits:
None.
Risks:
Although vCJD is a rare condition, the symptoms are severe, and it is always fatal. This proposed rule is intended to reduce the risk of humans developing vCJD in the U.S. in the event BSE is detected in native cattle. The measures proposed by FSIS are intended to minimize human exposure to materials from cattle that could potentially contain the BSE agent. In April 1998, USDA entered into a cooperative agreement with Harvard University's School of Public Health to conduct a risk analysis to assess the potential pathways for entry into U.S. cattle and the U.S. food supply, to evaluate existing regulations and policies, and to identify any additional measures that could be taken to protect human and animal health. FSIS will use the findings of the risk assessment to evaluate the level of risk reduction associated with the proposed measures.
Unlike bacterial and viral pathogens that may be found in or on meat food products, the BSE agent cannot be destroyed by conventional methods, such as cooking or irradiation. Also, although it is rare, vCJD, the human disease associated with exposure to the BSE agent, is generally more severe than the human illnesses associated with exposure to bacterial and viral pathogens. Thus, if BSE were detected in the U.S., additional measures to reduce the risk of human exposure to the BSE agent are necessary to protect public health.
| Action | Date | FR Cite |
| NPRM | 09/00/02 |
Regulatory Flexibility Analysis Required:
Yes
Small Entities Affected:
Businesses
Government Levels Affected:
Undetermined
Federalism:
Undetermined
Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN:
0583-AC88
15. MEAT PRODUCED BY ADVANCED MEAT/BONE SEPARATION MACHINERY AND RECOVERY SYSTEMS
Agency:
USDA—FSIS
Priority:
Economically Significant
Legal Authority:
21 USC 601 to 695
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
9 CFR 301.2; 9 CFR 318.24 (Revision); 9 CFR 320.1(b)(10)
Legal Deadline:
None
Abstract:
In 1994, the Food Safety and Inspection Service amended its regulations to recognize that product resulting from advanced meat/bone separation machinery comes within the definition of meat when recovery systems are operated to assure that the characteristics and composition of the resulting product are consistent with those of meat. Subsequent compliance problems and other concerns have made it apparent that the regulations are inadequate to prevent misbranding and economic adulteration. Therefore, FSIS is developing a rule to clarify the regulations and supplement the rules for assuring compliance.
Statement of Need:
In 1998, FSIS proposed to clarify the meat inspection regulations regarding mechanically separated meat contained in a final rule issued in December 1994. The proposed rule would replace the present compliance program parameters with non-compliance criteria for bone and bone-related material. The proposed rule would require, as a prerequisite to labeling or using product derived by mechanically separating skeletal muscle tissue from cattle bones as meat, that establishments implement and document procedures for ensuring that their production process is in control. FSIS intends to issue a final rule in the first quarter of 2002 that prohibits central nervous system tissue in meat produced by advanced meat separation and recovery systems.
Summary of Legal Basis:
This action is authorized under the Federal Meat Inspection Act (21 U.S.C. 601-695).
Alternatives:
No action.
Anticipated Cost and Benefits:
Although the 1998 proposed rule was determined to be not economically significant, FSIS restudied the projected costs using data from various FSIS data bases and other sources to develop an improved estimate of the benefits and costs of implementing the final rule. To date, it appears that the final rule will not be economically significant, but data evaluation continues. The benefit of publishing a rule that prohibits central nervous system tissue is that the meat industry would be producing a product that is not misbranded or economically adulterated.
Risks:
None.
| Action | Date | FR Cite |
| NPRM | 04/13/98 | 63 FR 17959 |
| NPRM Comment Period End | 06/12/98 | |
| Final Action | 02/00/02 |
Regulatory Flexibility Analysis Required:
Undetermined
Government Levels Affected:
None
Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN:
0583-AC51
16. PERFORMANCE STANDARDS FOR ON-LINE ANTIMICROBIAL REPROCESSING OF PRE-CHILL POULTRY CARCASSES
Agency:
USDA—FSIS
Priority:
Other Significant
Legal Authority:
21 USC 451 to 470
CFR Citation: (To search for a specific CFR, visit the Code of Federal Regulations.)
9 CFR 381; 9 CFR 424
Legal Deadline:
None
Abstract:
This rule is proposing to allow, on a voluntary basis, the on-line reprocessing of pre-chill poultry carcasses that are accidentally contaminated with digestive tract contents during slaughter. The treated carcasses must meet pre-chill performance standards that are substantially lower than the current performance standard and criteria.
Statement of Need:
On December 1, 2000, FSIS issued a proposed rule to permit on-line antimicrobial reprocessing of pre-chill poultry carcasses on a voluntary basis. It is estimated that approximately 90 poultry slaughter establishments are now engaged in on-line processing. Permitting pre-chill poultry to be reprocessed on-line rather than off-line yields great benefits to industry and reduces microbial loads on visibly contaminated and visibly clean birds.
Summary of Legal Basis:
This action is authorized by the Poultry Products Inspection Act (21 U.S.C. 456 et seq.) Exercise of the Secretary of Agriculture's functions under this Act has been delegated to the Under Secretary for Food Safety (7 CFR 2.18) and by the Under Secretary to the Administrator of FSIS (7 CFR 2.53).
Alternatives:
Executive Order 12866 requires that FSIS identify and assess alternative forms of regulation. FSIS considered two alternatives to this proposed rule: (1) not proposing to allow for the on-line reprocessing of contaminated carcasses and (2) proposing to require plants to perform on-line reprocessing of pre-chill contaminated carcasses and establishing specific numerical performance standards that the reprocessed poultry must meet using a mandated antimicrobial treatment or process. FSIS rejected both alternatives for the reasons explained below.
Failing To Propose
FSIS is committed to reducing the levels of microbial pathogens in poultry products. On-line reprocessing of poultry in commercial trials using solutions of TSP/chlorine and acidified sodium chlorite has been shown to be a highly effective method of reducing the microbial levels of raw poultry to levels substantially below the performance standards and criteria established by the pathogen reduction/HACCP final rule.
Mandating Procedures, Materials, and Methods
FSIS is proposing to give all establishments the option of adopting on-line reprocessing of visibly contaminated birds. By not mandating that all plants adopt on-line reprocessing, FSIS is recognizing that there are other solutions to reducing bacterial loads that may be more appropriate and cost-effective for small plants. There are many possible solutions for pathogen reduction of raw poultry and poultry products, and the industry continues to seek out new products and equipment that will be effective.
Pathogen reduction is central to the FSIS food safety strategy. However, eliminating as many prescriptive or command-and-control regulations as possible also is an important part of the overall strategy for updating and improving inspection in light of HACCP. Therefore, there will be no mandate proposed for establishments to use TSP or any other substance as the antimicrobial reprocessing aid. Various substances have undergone trials to determine their potential as antimicrobial processing agents. Such substances include acidified sodium chlorite; organic acids such as lactic, acetic, and formic acids; chlorine dioxides; and ozone. Plants will be free to use other products that have demonstrated their efficacy in reducing levels of microorganisms in in-plant commercial trials. This is consistent with the Agency's strategy of encouraging the industry to take advantage of new technology to reduce the risks associated with the consumption of meat and poultry products.
Anticipated Cost and Benefits:
The economic impact of this rule is likely to be minimal because of the voluntary nature of the practice this proposal would authorize. An establishment will use on-line reprocessing if it is consistent with the objectives of the firm, conforms with plant configuration, provides increased efficiency in achieving product standards, improves product characteristics, and other factors. The poultry industry is highly competitive; an increase in product price by a single producer is likely to result in a loss of market share. A firm is not likely to purchase new equipment that will increase overall production costs or reduce profits.
The cost for a poultry plant to adopt an acceptable on-line reprocessing system will vary from plant to plant and will be contingent on the location, physical structure, and age of the plant and the adaptability of the equipment. Available information indicates that the capital cost per line ranges from $10,000 to more than $55,000, with an average cost of $35,600, which is close to the manufacturer's estimate for a single line cost of $30,000.
Operating costs associated with on-line reprocessing systems also can vary significantly as a result of plant size, number of lines, processing capacity, plant configuration, and other factors. Rhodia estimates that the TSP application cost will be about 0.2 cents per pound for an average chicken slaughter plant. The application of other antimicrobial substances may vary slightly in cost. Plant data suggest that total annual operating costs, which include labor, water softener, TSP, and water, are very close to the manufacturer's estimate. Available information suggests annual operating costs of about $125,000 per line for an average plant. Costs associated with off-line reprocessing would be expected to decline following installation of on-line reprocessing equipment because of reduced labor and other operating requirements. Available data suggest the decrease in operating costs because of reduced off-line reprocessing is about $70,000 per line, somewhat more than half of the increase in operating costs associated with TSP on-line reprocessing. The available plant information suggests that about two-thirds of the plants would not experience any change in sewage treatment. The remaining third would be required to perform additional treatment at the plant to meet discharge limits. Two-thirds of the plants would show no change in water use, while the remaining plants will have to increase use by 1 to 2 gallons per bird, or about 10 percent.
For the average plant, the net present value of capital costs and the net change in operating costs of TSP on-line reprocessing is about $1.2 million over a 10-year period using a discount rate of 7 percent. Based on the assumptions that the average plant processes about 200,000 birds per day, that an average bird has a dressed weight of 3.6 pounds, and the plant operates an average of 255 days per year over the next 10 years, the increase in total production costs is slightly more than .2 cents per pound. The capital costs amortized over a 10-year period are minimal on a per pound basis. The costs to the poultry processing industry would accrue to plants engaged in slaughter, either exclusively or in combination with processing. In 1996, there were 281 federally inspected plants of this description. Only one Federal-State cooperative inspection plant is currently engaged in poultry slaughter. If all such plants voluntarily install an on-line reprocessing system, the total cost to the poultry industry would be about $345 million over a 10-year period.
Risks:
The cost of a TSP on-line reprocessing system represents an insignificant portion of the retail price per pound of poultry. If there is any increase in the retail price of poultry, it will be modest and offset by consumer confidence that the product presents lower microbial risks.
| Action | Date | FR Cite |
| NPRM | 12/01/00 | 65 FR 75187 |
| NPRM Comment Period End | 01/30/01 | |
| Final Action | 03/00/02 |
Regulatory Flexibility Analysis Required:
No
Small Entities Affected:
No
Government Levels Affected:
None
Agency Contact:
Daniel L. Engeljohn
Director, Regulations and Directives Development Staff
Department of Agriculture
Food Safety and Inspection Service
Washington, DC 20250
Phone: 202 720-5627
RIN:
0583-AC73