[Federal Register Volume 60, Number 101 (Thursday, May 25, 1995)] [Notices] [Pages 27714-27715] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 95-12883] ----------------------------------------------------------------------- DEPARTMENT OF AGRICULTURE Food Safety and Inspection Service [Docket No. 95-015N] Guidelines for Preparing and Submitting Experimental Protocols for In-Plant Trials of New Technologies and Procedures AGENCY: Food Safety Inspection Service, USDA. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food Safety and Inspection Service has issued Directive 10,700.1, establishing guidelines for preparing and submitting experimental protocols for in-plant research or trials of new technologies and procedures in federally inspected meat and poultry plants. This notice summarizes Directive 10,700.1 and announces its availability to interested persons. ADDRESSES: To obtain a copy of FSIS Directive 10,700.1, ``Guidelines for Preparing and Submitting Experimental Protocols for In-Plant Trials of New Technologies and Procedures,'' contact Ms. Diane Moore, Docket Clerk, room 4352, South Agriculture Building, Food Safety and Inspection Service, U.S. Department of Agriculture, Washington, DC 20250, (202) 720-3813. FOR FURTHER INFORMATION CONTACT: Dr. Pat Basu, Director, Technology Assessment and Research Coordination Division, Science and Technology, Food Safety and Inspection Service, U.S. Department of Agriculture, room 302, Annex Building, 300 12th Street SW., Washington, DC 20250, (202) 720-8623. SUPPLEMENTARY INFORMATION: Background The Food Safety and Inspection Service (FSIS) periodically issues directives that either explain internal administrative policies and procedures or, as in the case of Directive 10,700.1, clarify FSIS regulations and procedures regarding meat and poultry product safety and inspection. While these directives are intended for FSIS inspectors and other employees, they are also regularly sent to other interested persons, including meat and poultry plant management, trade associations, and State and local governments. To ensure that all interested persons are aware of the substance and availability of this directive, FSIS is publishing this notice. Directive 10,700.1 As part of its comprehensive strategy to reduce the occurrence and numbers of pathogenic organisms in meat and poultry for the purpose of reducing the incidence of foodborne illness associated with consumption of those products, FSIS has proposed a series of new requirements applicable to all federally inspected meat and poultry plants (``Pathogen Reduction; Hazard Analysis and Critical Control Points (HACCP) Systems''; February 3, 1995, 60 FR 6774-6889). In order to meet the requirements proposed in that document, the meat and poultry industries may find it useful to develop innovative technologies and procedures that more effectively protect meat and poultry products from microbiological [[Page 27715]] and other hazards. FSIS is committed to fostering such innovation. In the past few years, innovative technologies and procedures have been developed by the meat and poultry industry and allied enterprises to enhance industry productivity and profitability. FSIS believes that industry innovation should also be directed to improving food safety. FSIS intends as part of its comprehensive long-term food safety strategy to increase the incentives for such innovation by establishing public health-driven targets, guidelines, and standards that establishments will be held accountable for meeting. Also, FSIS is redoubling its efforts to facilitate experimentation in the meat and poultry industries. Specifically, FSIS is encouraging in-plant experimentation, which both aids in the development of new production and processing techniques and provides the requisite confirmation that new technologies and procedures are efficacious, practical, and manageable in commercial plant environments. FSIS has reviewed its policies and procedures governing review and approval of in-plant experimentation with the intention of simplifying them to the maximum extent possible, while ensuring that important safety and efficacy issues are considered. As a result, on April 11, 1995, FSIS issued Directive 10,700.1, ``Guidelines for Preparing and Submitting Experimental Protocols for In-Plant Trials of New Technologies and Procedures.'' Directive 10,700.1 explains that a written proposal and protocol must be submitted to FSIS, reviewed, and approved prior to any in-plant research or demonstration of technologies and procedures that could affect product safety, worker safety, environmental safety, or inspection procedures. The written proposal and protocol must contain a statement of purpose, a scientific literature review, including data from laboratory studies supporting further in-plant trials, a detailed description of the research methodology to be used, and other administrative information. Also, proposals for research on technologies or procedures that could alter inspection procedures, affect food safety, or are to be approved for general use must include a detailed study design and a commitment to submit final research results. Applicants must submit proposals and protocols at least 60 days before any experiments begin, so that FSIS may have adequate time to both review the proposal and notify, if necessary, the local FSIS inspection staff who would observe the approved experiment. FSIS will not approve any proposal or protocol for in-plant experimentation that could result in an increased risk for the public and accordingly has placed certain restrictions on experiments involving the artificial contamination of food products. For example, in experiments where researchers artificially contaminate carcasses with fecal material that may contain human pathogens, any products from these carcasses must be removed from commercial channels or reconditioned to be wholesome and fit for sale. Also, in tests where researchers artificially contaminate carcasses with surrogate organisms that approximate the growth or spread of human pathogens, trimming of treated areas followed by an antimicrobial wash is required before product can be moved into commerce. Furthermore, while FSIS will not approve experiments that unreasonably interfere with our inspection responsibilities, requests for modest changes in inspection during an experiment will be considered on a case-by-case basis. FSIS requires that certain proposal and protocol submissions include approvals from other agencies. If any chemical reagents or other such materials are to be used in an experiment, those materials must have been approved by Food and Drug Administration. Also, certain proposals for experiments that may affect worker safety must be accompanied by appropriate regulatory citations or by written approval from the Environmental Protection Agency (EPA) and/or the Occupational Safety and Health Administration. And, some proposals for experiments that may impact environmental safety must be accompanied by approvals from EPA. During approved in-plant experimentation, FSIS reserves the right to have on-site observers present and to review interim data. Should unexpected safety concerns arise at any time, for example, if food products affected by the experiment are in violation of food safety statutes or present an increased risk to the public, FSIS will require termination of the experiment. FSIS also reserves the right to have an approved proposal, as well as experimental results, reviewed by outside parties, as long as proprietary rights are safeguarded. Further, FSIS reserves the right to request the ``raw'' data initially collected from the experiment when evaluating the results of in-plant experiments. FSIS has established a new unit, the Technology Assessment and Research Coordination Division (TARCD), which will function as the single point of entry for in-plant research protocols and experimental results. TARCD will perform the initial review of proposals for acceptability and completeness and then forward the proposals to teams within FSIS for technical review. TARCD also will be responsible for conveying results from FSIS technical reviews to the researchers requesting approval for in-plant experiments. TARCD will similarly coordinate the review of results and facilitate the policy decision process. Proposals and protocols that are unapproved or in the approval process will be unavailable to the public. Approved proposals and protocols will be available and on file in the FSIS Freedom of Information Act (FOIA) reading room. FSIS will ensure FOIA protection for proprietary information contained in proposals and protocols available to the public. Development and dissemination of these guidelines, as well as the establishment within FSIS of a single office for receiving proposed protocols for in-plant research, is intended to encourage the technological and procedural innovation necessary to enhance food safety within the meat and poultry industries. Done at Washington, DC on May 19, 1995. Michael R. Taylor, Acting Under Secretary for Food Safety. [FR Doc. 95-12883 Filed 5-24-95; 8:45 am] BILLING CODE 3410-DM-P