[Federal Register: May 15, 2000 (Volume 65, Number 94)]
[Notices]
[Page 30952-30956]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15my00-30]
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Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
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[[Page 30952]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. 00-014N]
Announcement of and Request for Comment Regarding Industry
Petition on Hazard Analysis and Critical Control Point (HACCP)
Inspection
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice; opportunity to comment.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is requesting
comment on a petition that asks FSIS to amend sections of the Hazard
Analysis and Critical Control Point (HACCP) regulations ``to increase
the effectiveness'' of the HACCP system and to make the regulations
more consistent with the HACCP principles published in 1997 by the
National Advisory Committee on Microbiological Criteria for Food
(NACMCF). The petition is set out in this Federal Register notice. The
petition was submitted by a group of trade associations. It contains no
data or examples to support the requests it makes. In addition to
comments from the public, FSIS will solicit comment from the members of
the National Advisory Committee on Meat and Poultry Inspection (NACMPI)
at its May 16-17, 2000, meeting.
DATES: Comments are due July 14, 2000.
ADDRESSES: Send comments in triplicate to USDA, FSIS Docket Room,
Docket No. 00-014N, Room 102 Cotton Annex, 300 12th Street, SW,
Washington, DC 20250-3700.
FOR FURTHER INFORMATION CONTACT: Philip Derfler, Deputy Administrator,
Office of Policy, Program Development and Evaluation, Food Safety and
Inspection Service, U.S. Department of Agriculture (202) 720-2709.
SUPPLEMENTARY INFORMATION:
Background
On July 25, 1996, FSIS published a final rule in the Federal
Register, entitled ``Pathogen Reduction; Hazard Analysis and Critical
Control Point Systems'' (61 FR 38806), requiring that federally
inspected meat and poultry establishments implement HACCP systems to
address hazards that are reasonably likely to occur in their
operations. This rule requires that all federally inspected meat and
poultry plants develop and implement written sanitation standard
operating procedures (sanitation SOPs); mandates that meat and poultry
slaughter plants conduct microbial testing for generic E. coli to
verify the adequacy of their process controls; requires that all meat
and poultry plants develop and implement a system of preventive
controls known as HACCP to improve the safety of their products; and
sets pathogen reduction performance standards for Salmonella that
slaughter plants and plants producing raw ground products must meet.
When FSIS issued this final rule, it was aware that the rule would
bring about major changes in the way plants operate and in how FSIS
conducts its inspections. To account for this impact, the
implementation of the rule was phased in over a three-year period that
concluded January 25, 2000. Also, to assist the industry in preparing
for the implementation of HACCP, FSIS provided extensive technical
assistance and guidance and held numerous public meetings to receive
input from all stakeholders.
Petition
FSIS received a petition dated December 30, 1999, signed by the
following organizations: The American Meat Institute, American
Association of Meat Processors, National Chicken Council, National Food
Processors Association, National Meat Association, National Turkey
Federation, and the North American Meat Processors. The petition
requests that FSIS amend sections of the HACCP regulations in order,
according to the petition, to increase the effectiveness of the HACCP
system and to make the regulations more consistent with the HACCP
principles published in 1997, by the National Advisory Committee on
Microbiological Criteria for Food (NACMCF).
The petitioners contend that FSIS has too narrowly interpreted its
rulemaking and ignores the ``* * * commonsense approach needed to make
HACCP successful.'' In particular, they point out that there are other
components of a HACCP system that the Agency should recognize, such as
good manufacturing practice (GMP) programs (referred to as prerequisite
programs), and that FSIS does not permit prerequisite programs to
address food safety concerns. In 61 FR 38805, FSIS stated that it
expected the HACCP plan to be a stand-alone document addressing food
safety.
The petitioners also suggest that FSIS change some of the
definitions contained in the HACCP regulations. Specifically, they
suggest the following definition changes:
1. Delete the term and definition for ``food safety hazard'' and
replace it with the term ``hazard.'' A ``hazard'' would be defined as
``a biological, chemical or physical agent that is reasonably likely to
cause illness or injury in the absence of its control.''
2. Change the definition of ``hazard analysis'' to ``the process of
collecting and evaluating information on hazards associated with the
food under consideration to decide which are significant and must be
addressed in the HACCP plan.''
3. Define ``severity'' as ``the seriousness of the effect(s) of a
hazard.''
4. Define ``shipped'' as ``a product has been shipped if it has
been sold to a third party and is not under the direct or effective
control of the inspected establishment. Products have not been shipped
in circumstances such as when the product is still owned by the
inspected establishment, whether stored at the inspected establishment
or at another storage location, as well as when the product is moving
from one facility to another that is owned by the same person or
company.'' The petitioners also suggest that throughout the regulations
the word ``shipped'' should replace the phrase ``enters commerce.''
5. Lastly, the petitioners request that FSIS amend 9 CFR 417.6(e)
to provide that a HACCP system may be found to be inadequate only when
adulterated product has been shipped. Currently, the regulations state
that the system may be found inadequate when adulterated product is
produced or shipped.
As part of the Agency's continued efforts to involve all
stakeholders in
[[Page 30953]]
issues related to the HACCP regulation and its implementation, FSIS is
publishing the petition in this Federal Register notice. FSIS is also
publishing this petition as part of its on-going efforts to keep
stakeholders updated and informed about the Agency's activities. The
Agency is working on a separate rulemaking related to the petition
process, to more clearly define the requirements to be contained in a
petition for changing the FSIS regulations.
Questions
FSIS is seeking public comment on the following questions about the
petition:
1. The industry petition relies mainly on the NACMCF document and
does not provide any data or examples to support its request. Is there
any information that would support taking any of the actions requested
in the petition?
2. Would amending 9 CFR 417.2(a) in the manner suggested in the
petition result in regulations that provide the level of public health
protection required by the Federal Meat Inspection Act and the Poultry
Products Inspection Act?
3. Should FSIS consider regulatory modifications that would
acknowledge the prerequisite programs concept of NACMCF?
4. Do FDA regulations, such as the GMP regulations, offer an
approach that FSIS should consider? How would such an approach fit
within the HACCP concept? How would FSIS implement such an approach?
5. What will be the effects of making FSIS and FDA HACCP regulatory
requirements dissimilar?
6. Should the changes suggested in the industry petition be
considered in light of the views expressed on HACCP by Codex and by
other countries?
The Text of the Petition
Petition for Rulemaking Amendments to Pathogen Reduction; Hazard
Analysis Critical Control Point (HACCP); Final Rule
The member companies of the trade associations (the associations)
identified below support the adoption of Hazard Analysis Critical
Control Point (HACCP) as the best system available for enhancing the
safety of meat and poultry products. Through this petition, the
associations seek amendments that will contribute to the evolution and
effectiveness of HACCP. Although some adjustments can be made to the
inspection system administratively, certain amendments to the Pathogen
Reduction; Hazard Analysis Critical Control Point Systems final rule
(the Rule) published by the Food Safety and Inspection Service (FSIS or
the agency) on July 25, 1996 (61 FR 38806) will be required to
accomplish these objectives.
Although HACCP implementation to date has been largely successful,
disputes over ``technical'' non-conformances with certain elements of
the Rule have arisen that have adversely affected the overall success
of HACCP, without contributing to protection of consumers.\1\ In that
regard, amending the rule would reduce the occurrence of these
unproductive instances and help focus future activities of the industry
and the agency on issues that are vital to consumer protection.
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\1\ Although HACCP implementation will not be completed
throughout the meat and poultry industry until next January, nearly
80 percent of meat and poultry production already occurs under HACCP
systems. This experience suggests strongly, that the time is now to
discuss ways to improve an HACCP-based inspection system.
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Background
HACCP is a preventive system of hazard control, the inherent value
of which is widely acknowledged. In that regard, the HACCP system has
provided a framework for establishing more effective food safety
measures. Nearly 15 years ago, the National Academy of Sciences (NAS)
recognized the importance of incorporating HACCP into the meat and
poultry inspection system and encouraged FSIS to move quickly to apply
the HACCP system. \2\
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\2\ Meat and Poultry Inspection--The Scientific Basis of the
Nation's Program, National Academy Press, 1985 (pp. 134-135).
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The seven principles of HACCP, as revised by the National Advisory
Committee on Microbiological Criteria for Foods (NACMCF) in 1997,
provide the basis for contemporary interpretations of the HACCP system.
Those principles are:
1. Conduct a hazard analysis.
2. Determine the critical control points.
3. Establish critical limits.
4. Establish monitoring procedures.
5. Establish corrective actions.
6. Establish verification procedures.
7. Establish recordkeeping and documentation procedures. \3\
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\3\ The NACMCF streamlined the principles in a report adopted
August 14, 1997. That report reversed principles six and seven from
the original order established by NACMCF to the order presented
above. See Hazard Analysis and Critical Control Point Principles and
Application Guidelines (hereinafter the Guidelines), J. of Food
Protection, Vol. 61, No. 6, at 762-775, 1998.
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Through the application of these principles, simple production
processes can be accommodated. Similarly, highly sophisticated
procedures, even those that may pose some degree of risk can also be
accommodated, assuming that the appropriate critical control points are
identified and measurement criteria are established.
These principles purportedly provide the basis for the agency's
Rule. The Rule as written, however, deviates from the intended
application of these principles in several important ways. It is
because the Rule as implemented by the agency does not adhere in its
entirety to the principles of HACCP that this petition is submitted.
The Rule and industry's adoption of HACCP have fundamentally
changed many aspects of food safety practices and inspection. HACCP
requires acceptance by industry that it is responsible for ensuring the
safety of products it produces. That concept, and the challenges it
presents, has been accepted by industry.
The Rule also has required adjustments within the agency's
inspection program. Companies' HACCP control activities occur in
establishments under some form of continuous inspection and a wide
range of enforcement sanctions remains available to FSIS. Indeed, the
Rule has, in effect, expanded that capability through provisions
permitting withholding actions in the event an establishment's HACCP
plan is deemed to be inadequate. Under HACCP, however, inspection
emphasis was to have shifted away from the application of subjective
criteria and toward monitoring of specific, quantitative benchmarks.
HACCP should result in a food inspection system with a much higher
level of private and public cooperation. Ideally, under HACCP
government and industry would find themselves working together to
monitory food safety compliance, with the goal of providing the safest
possible meat and poultry supply.
Discussion
The Rule Is Written and Interpreted Too Narrowly
An important component of HACCP is the requirement that a written
HACCP plan be developed for all products in accordance with HACCP
principles. That plan should identify the hazards associated with the
product, identify the critical control points in the process, establish
quantitative monitoring procedures to assure compliance and corrective
actions, and provide effective documentation of compliance. A HACCP
plan is, however, only one part of a plant's overall food safety
system. Other integral components of that system include Sanitation
Standard
[[Page 30954]]
Operating Procedures (SSOPs), and various good manufacturing practices
and other prerequisite programs (hereinafter collectively prerequisite
programs) that are needed to form the foundation for the HACCP
system.\4\
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\4\ Prerequisite programs have been identified as the foundation
upon which a HACCP plan is built. See ``The Role of Prerequisite
Programs in Managing a HACCP System,'' Dairy, Food and Environmental
Sanitation, Vol. 18, No. 7 at 418-423, July 1998.
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Unfortunately, the agency has elected only to recognize the
sanitation part of these other components of establishments' food
safety systems. For example, a beef plant typically controls
temperature according to prerequisite programs to preserve product
quality. Although this is a necessary program for meeting quality
criteria, FSIS has apparently taken the posisiton that establishments
must also incorporate product temperature controls into their HACCP
plans. This position has resulted essentially in government mandated
critical control points (CCPS)--contrary to the agencys often repeated
statement that companies develop and operate their own HACCP plans and
are responsible for the same. The role of prerequisite programs is a
central question that needs to be addressed through a dialogue with the
agency to determine the appropriate role for prerequisite programs as a
component of a plant's operating system.
This mandate arises out of the agency's refusal to acknowledge
prerequisite programs and other important food safety systems as very
important, integral components of an establishment's food safety
system. The agency specifically points to the ``in the absence of those
controls'' language it incorporated into section 417.2(a)(1) of the
Rule. The agency's interpretation of the Rule's language is unduly
narrow and ignores the commonsense approach needed to make HACCP
successful.
Notwithstanding the problems encountered to date, the Rule can be
amended to enable the agency to consider the other important aspects of
an establishment's food safety system, such as prerequisite programs.
Rather than continue to implement a regulation that the agency
interprets as forcing FSIS to ignore certain elements of a plant's
program, the Rule should be amended to permit the agency to consider
those other components when determining whether an establishment's
HACCP plan is adequate. As discussed below, prerequisite programs will
influence the likelihood that a food safety hazard will occur and,
therefore, should be acknowledged by the Agency.
Such an amendment will benefit the agency, the regulated industry,
and most significantly will enhance food safety. In that regard, the
agency will be better able to determine whether a company's HACCP plan
is adequate, enabling the agency to apply its limited resources to
situations in which the integrity of the food inspection system may be
compromised. Similarly, regulated companies will be better able to
direct their resources to address circumstances that involve legitimate
food safety issues, rather than including additional and often
unnecessary provisions in their HACCP plans in order to accommodate the
current interpretation of HACCP contained in the rule. Making the
system operate more efficiently benefits all interested parties,
including consumers who benefit from lower prices and also benefit from
the fact that a less complicated, less duplicative system contributes
to a more effective system from a food safety standpoint.
The Definition and Interpretation of a Food Safety Hazard Should Be
Amended
The Rule's definition of ``food safety hazard'' is inconsistent
with the definition of hazard provided by the NACMCF. Currently, the
Rule defines a ``food safety hazard'' as any ``biological, chemical, or
physical property that may cause a food to be unsafe for human
consumption.'' \5\ The NACMCF, however, developed a tighter, more
appropriate defintion of ``hazard'' in its 1997 report.\6\
Specifically, NACMCF defines a ``hazard'' as a ``biological, chemical,
or physical agent that is reasonably likely to cause illness or injury
in the absence of its control.'' \7\ This definition will facilitate
development of HACCP plans that focus on food safety, while encouraging
firms to utilize prerequisite programs.
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\5\ 9 CFR sec. 417.1.
\6\ FSIS cross-references hazard and food safety hazard in the
Rule. See 9 CFR sec. 417.1.
\7\ See Hazard Analysis and Critical Control Point Principles
and Application Guidelines, National Advisory Committee on
Microbiological Criteria for Foods, at 6 (August 14, 1997).
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The Guidelines include a thorough discussion of that definition
and, in that regard, provide that the purpose of a hazard analysis ``is
to develop a list of hazards which are of such significance that they
are reasonably likely to cause injury or illness if not effectively
controlled.'' \8\ The Guidelines provide that each identified potential
hazard should be evaluated, giving consideration to its severity and
likely occurrence. That consideration should also include the food, its
method of preparation, transportation, storage, and the persons likely
to consume the product.\9\ Also included in these considerations would
be the influence of prerequisite programs on the likely occurrence of
the hazard under consideration. In short, the Guidelines make clear
that significance, based on a variety of factors, is an integral part
of determining whether a potential hazard is, in fact, a hazard that
should be addressed in a HACCP plan.\10\
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\8\ Id. at 12-13.
\9\ Id. at 12.
\10\ Indeed, the Guidelines provide that hazards identified in
one facility may not be significant in another plant for the same or
similar product. Id. at 14.
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The Rule, however, is not written, nor interpreted, in a manner
consistent with the NACMCF Guidelines. The Rule provides a much broader
definition of ``hazard'' because it identifies as a ``hazard'' those
properties that may cause a food to be unsafe, regardless of whether
the hazard is ``significant'' in terms of actually presenting a risk to
human health. This interpretation has led to confusion regarding what
should be covered in HACCP plans and how to make this determination.
This problem could be addressed by changing the Rule's definition of
``hazard.'' The NACMCF definition and interpretation of a ``hazard,''
is more precise and consistent with the principles of HACCP because it
provides useful guidance for identifying those properties that, when
all factors are considered, present a significant risk of illness or
injury.
Prior to the implementation date for HACCP in the very large
plants, the agency published the first of several notices that, in
effect, dictate the adoption or establishment of hazards, without
engaging in the necessary hazard analysis with respect to the
significance and severity of those hazards. For example, in November
1997 FSIS published a notice telling establishments that zero tolerance
for visible fecal material was a food safety standard and that FSIS
would be determining compliance before the application of
interventions. FSIS stated in the notice that visible fecal was a
vehicle for microbial contamination. However, an establishment
employing microbial interventions would typically set the critical
control point at the intervention, not prior to it. In a situation such
as this the visible contamination would need to be minimized but would
not be the most critical point in the system. This notice, in effect,
dictated the presence of CCPs in the production process, as well as its
positioning.
[[Page 30955]]
Immediately following large plant implementation the agency
published a notice that effectively abandoned the concepts underlying
HACCP in favor of a command and control regulatory system. Ultimately,
the agency issued letters to numerous federally inspected facilities
effectively dictating CCPs when a hazard analysis conducted by those
plants, consistent with the NACMCF model for conducting such an
analysis, indicated that the hazard was not of sufficient significance
and severity to warrant its control through the HACCP plan. Finally,
more recently, the agency has again insisted on dictating the presence
and positioning of CCPs in plants that manufacture raw ground and not
ground products.
Implementing the change recommended by this petition would address
this problem and would benefit the agency, consumers, and the regulated
industry. As previously discussed, such a change would enable the
agency to focus its resources in a more efficient and effective manner
and would enhance food safety by doing so. Accordingly, the Rule should
be amended to adopt the definition of ``hazard'' as set forth by the
NACMCF and abide by the NACMCF's intent with regard to conducting a
hazard analysis.
The Rule Does Not Adequately Address When a Product Is Within an
Establishment's Control
The Rule does not provide adequate guidance as to when a product
has left the producing facility's control. The agency's interpretation
of the Rule fails to acknowledge that products can be within an
establishment's control even when the product is outside the physical
boundaries of an establishment. For example, product on a company-owned
or contracted truck is still under that company's control, as is
product still owned by the establishment but held in a cold storage
warehouse away from the production facility. FSIS has, on several
occasions, contended that product was no longer within the
establishment's control once it left the production facility's loading
dock. Indeed, the agency has taken that position even when the product
was stored on tractor-trailers still on the physical plant compound.
The Rule should be amended to define, for purposes of compliance
with the HACCP regulations, when a product is shipped. In that regard,
product should be deemed to have been shipped for purposes of HACCP
compliance when it has been sold to another entity and is no longer in
the direct or effective control of the producing establishment. For
example, when product owned by the establishment is stored at a cold
storage warehouse and is still subject to movement at the direction of
the establishment it should be deemed to be in the establishment's
control.
The Provision Regarding Inadequate Plans Should Be Amended
The Rule provides that a plant's HACCP plan may be deemed to be
inadequate when ``adulterated product is produced or shipped.'' That
provision however, is too draconian and should be amended to delete the
reference to ``produced.''
The checks built into a HACCP plan are intended to identify not
only when the production process is working as intended, but also to
alert an establishment when the process has not met the critical limits
relevant to the identified CCPs. A HACCP plan operating, as intended,
will alert a company when a critical limit has not been met for one of
many reasons that can, over the course of time, be expected to occur.
In some cases, that will result in the production of ``adulterated''
product as that term is defined in the Federal Meat Inspection Act and
the Poultry Products Inspection Act. What is relevant for purposes of
compliance with the Rule is whether administration of the HACCP plan
resulted in the company being able to detect the problem, as well as
enabling the company to take corrective action.
A plant's operation should not be in jeopardy when it identifies a
problem, as its plan is designed to do--even though adulterated product
has been produced. The Rule, however, puts the agency in the position
of taking action and deciding that an establishment's HACCP plan is
inadequate when adulterated product is produced, even if the company
caught the problem before any product left the plant's control. If the
system is working a company should not be penalized. At a minimum, no
plan should be deemed to be inadequate for deviations detected by the
company in pre-shipment review. Numerous examples of such technical
non-conformances can be cited and such instances have encumbered the
agency and industry in resource intensive discussions that do not
enhance public health protection. By modifying the Rule the squandering
of valuable inspection resources can be avoided.
Specific Action Requested
The undersigned organizations request that the FSIS HACCP
regulations be amended as set forth below.
Amend section 417.2(a)(1) to read as follows: ``Every official
establishment shall conduct, or have conducted for it, a hazard
analysis to develop a list of hazards that are of such severity and
significance that they are reasonably likely to cause injury or illness
if not effectively controlled. Hazards that are not reasonably likely
to cause injury or illness do not require further consideration within
a HACCP plan. The hazard analysis shall consider the ingredients and
raw materials, each step in the process, product storage and
distribution, and final preparation and use by the consumer.''
Amend section 417.1 to include several necessary definitions to
ensure consistency with the recommendations of the NACMCF. In that
regard the following amendments should be promulgated.
<bullet> Delete the term food safety hazard and provide the
following definition of hazard: ``A biological, chemical, or physical
agent that is reasonably likely to cause illness or injury in the
absence of its control.''
<bullet> Provide the following definition of hazard analysis: ``The
process of collecting and evaluating information on hazards associated
with the food under consideration to decide which are significant and
must be addressed in the HACCP plan.''
<bullet> Provide the following definition of severity: ``The
seriousness of the effect(s) of a hazard.''
<bullet> Provide the following definition of shipped: ``A product
has been shipped if it has been sold to a third party and is not under
the direct or effective control of the inspected establishment.
Products have not been shipped in circumstances such as when the
product is still owned by the inspected establishment, whether stored
at the inspected establishment or at another storage location, as well
as when the product is moving from one facility to another that is
owned by the same person or company.''
Amend section 417.3 to provide when product produced pursuant to a
HACCP plan has been shipped for purposes of compliance with the rule.
Specifically, section 417.3(b)(3) should be amended by striking the
words ``enters commerce'' and inserting in lieu thereof ``is shipped.''
Amend section 417.6(e) to provide that a HACCP system may be found
to be inadequate when adulterated product has been shipped.
Specifically, section 417.6(e) should be amended by striking ``produced
or.''
[[Page 30956]]
Conclusion
Amendments to the Rule as suggested by this Petition will advance
the interests of government, industry, and the consuming public. The
Food Safety and Inspection Service should proceed without further delay
toward adoption of these amendments. With regard specifically to
prerequisite programs, the undersigned organizations intend to engage
the agency in discussions to develop the appropriate consideration of
these programs within a comprehensive system for managing food safety,
quality, and wholesomeness.
Certification
The undersigned certifies that, to the best of his knowledge and
belief, the Petition includes all information and views on which the
Petition relies, and that it includes representative data and
information known to the Petitioners that are unfavorable to the
Petitioners.
Respectfully submitted,
American Meat Institute
American Association of Meat Processors
National Chicken Council
National Food Processors Association
National Meat Association
National Turkey Federation
North American Meat Processors
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to better ensure
that minorities, women, and persons with disabilities are aware of this
notice, FSIS will announce it and provide copies of this Federal
Register publication in the FSIS Constituent Update. FSIS provides a
weekly FSIS Constituent Update, which is communicated via fax to over
300 organizations and individuals. In addition, the update is available
on-line through the FSIS web page located at http://www.fsis.usda.gov.
The update is used to provide information regarding FSIS policies,
procedures, regulations, Federal Register notices, FSIS public
meetings, recalls, and any other types of information that could affect
or would be of interest to our constituents/stakeholders. The
constituent fax list consists of industry, trade, and farm groups,
consumer interest groups, allied health professionals, scientific
professionals, and other individuals that have requested to be
included. Through these various channels, FSIS is able to provide
information to a much broader, more diverse audience. For more
information and to be added to the constituent fax list, fax your
request to the Congressional and Public Affairs Office, at (202) 720-
5704.
Done at Washington, DC, on: May 8, 2000.
Thomas J. Billy,
Administrator.
[FR Doc. 00-12156 Filed 5-12-00; 8:45 am]
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