[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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