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USDA/FSIS RIN: 0583-AB93 Publication ID: Fall 1996 
Title: Elimination of Prior Approval Requirements for Establishment Drawings and Specifications, Facilities Equipment, and Certain Partial Quality Control Programs 
Abstract: The Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat and poultry products inspection regulations by removing current requirements for FSIS approval of facilities and equipment prior to their use in official establishments. Establishments would be held accountable for meeting existing regulations for facilities and equipment and for preventing conditions that would tend to adulterate meat, meat food, and poultry products. FSIS is also proposing to end its prior approval of most voluntary, plant-operated partial quality control (PQC) programs, which are used by establishments to control certain kinds of food processing and product characteristics. Establishments would be encouraged to develop and implement quality control programs without first receiving permission from the Agency to do so and without having to rely on Agency guidance in operating them. 
Agency: Department of Agriculture(USDA)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
CFR Citation: 9 CFR 304    9 CFR 308    9 CFR 317    9 CFR 318    9 CFR 319    9 CFR 381   
Legal Authority: 21 USC 451 et seq    21 USC 601 et seq   

Statement of Need: This action is being taken as part of the continuing Reinventing Government initiative to streamline and modernize the meat and poultry inspection regulations, to reduce reliance on command-and-control regulations in favor of science-based prevention measures and performance standards, and to encourage innovations that will improve food safety.

Summary of the Legal Basis: Under the Federal Meat Inspection Act (21 USC 601 et seq.) and the Poultry Products Inspection Act (21 USC 451 et seq.), FSIS issues regulations governing the production of meat and poultry products prepared for distribution in interstate commerce. The Agency also issues regulations concerning the sanitation conditions under which such products are prepared.

Alternatives: Alternatives to removing requirements for facilities and equipment prior approvals include development by FSIS of detailed standards to be published in booklets with periodic updates, recognizing industry organizations as prior approval authorities, and establishing general performance standards similar to FDA-recognized good manufacturing practices. FSIS has chosen the option of proposing general performance standards. Industry would be free to set up technical assistance organizations. For PQC prior approvals, the alternatives to removing requirements were market sampling, mandating additional in-plant controls, sampling of finished products for chemical analysis, and general requirements, and a performance standard option was the one chosen.

Anticipated Costs and Benefits: Costs of this proposed rulemaking to the Agency and the regulated industry would be minimal because the rulemaking would remove administrative burdens. Benefits include annual current-dollar cost savings or avoidance to FSIS of nearly $3 million and to industry of at least $40,000 for blueprint submissions that are no longer required, plus additional, substantial uncalculated benefits because there would no longer be production delays arising from prior approval of facilities, equipment, and PQC programs.

Risks: This rulemaking could induce reduced health and safety risks to the public by providing industry with additional flexibility to innovate, which the command-and-control approach of prior-approval regulation has not encouraged.

Timetable:
Action Date FR Cite
NPRM  05/02/1996  61 FR 19578   
NPRM Comment Period End  07/01/1996    
Comment Period Extended to  09/09/1996  61 FR 35990   
Final Action  02/00/1997    
Regulatory Flexibility Analysis Required: Yes  Government Levels Affected: None 
Small Entities Affected: Businesses 
Included in the Regulatory Plan: Yes 
Agency Contact:
Patricia F. Stolfa
Assistant Deputy Administrator, Regulations and Inspection
Department of Agriculture
Food Safety and Inspection Service
Office of Policy, Program Development, and Evaluation,
Washington, DC 20250-3700
Phone:202 205-0699