[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]



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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.

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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]
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