[Federal Register Volume 69, Number 246 (Thursday, December 23, 2004)]
[Proposed Rules]
[Pages 76884-76886]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28083]
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 417
[Docket No. 04-017N]
HACCP Reassessment for Slaughterers of Young Calves
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice of proposed rule; request for comments.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is publishing
this document to inform slaughterers of young calves, including those
marketed, slaughtered, and labeled as ``veal,'' of the need for such
firms to reassess their Hazard Analysis and Critical Control Point
(HACCP) System, including prerequisite programs, with respect to
[[Page 76885]]
animal drug residues and the use of unapproved new animal drugs. FSIS
is concerned about the widespread, illegal use of drug implants in
young calves that was discovered in 2004. The discovery of this illegal
use represents a change that would affect the hazard analysis and could
alter the HACCP plans, of establishments that slaughter young calves.
Therefore, under the HACCP regulations, any establishment that
slaughters young calves, including those marketed, slaughtered, and
labeled as veal, must, as part of its calendar year 2005 annual
reassessment of its HACCP plans, determine whether unapproved new
animal drugs are hazards reasonably likely to occur in its process if
it has not previously done so. If the reassessment results in a
determination that animal drug residues, including unapproved new
animal drugs, are food safety hazards reasonably likely to occur, these
hazards must be addressed in the establishment's HACCP plan.
FSIS invites comments on the matters presented in this document.
The comments will be used by FSIS to inform further policy development
on animal drug residues.
DATES: The Agency must receive comments by February 22, 2005.
ADDRESSES: FSIS invites interested persons to submit comments on this
notice. Comments may be submitted by any of the following methods:
Mail, including floppy disks or CD-ROM's, and hand- or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture, Food Safety and Inspection Service, 300 12th Street, SW.,
Room 102, Cotton Annex, Washington, DC, 20250.
All submissions received must include the Agency name and docket
number 04-017N.
All comments submitted in response to this notice, as well as
research and background information used by FSIS in developing this
document, will be available for public inspection in the FSIS Docket
Room at the address listed above between 8:30 a.m. and 4:30 p.m.,
Monday through Friday. The comments also will be posted on the Agency's
Web site at http://www.fsis.usda.gov/OPPDE/rdad/FRDockets.htm.
FOR FURTHER INFORMATION CONTACT: Carole Thomas, Technical Analysis
Staff, Office of Policy, Program, and Employee Development, FSIS, U.S.
Department of Agriculture, 1400 Independence Avenue, SW., Room 405,
Cotton Annex, Washington, DC, 20250-3700, (202) 205-0210.
SUPPLEMENTARY INFORMATION:
Background
FSIS administers a regulatory program under the Federal Meat
Inspection Act (FMIA) (21 U.S.C. 601 et seq.) to protect the health and
welfare of consumers by preventing the processing and distribution of
meat products that are unwholesome, adulterated, or misbranded or
otherwise unfit for human food. In pursuit of its goal of reducing the
risk of foodborne illness from meat products to the maximum extent
possible, FSIS issued final regulations on July 25, 1996, mandating the
development and implementation of Pathogen Reduction and Hazard
Analysis and Critical Control Point (HACCP) Systems by Federally
inspected establishments (61 FR 38806). These regulations require that
federally inspected establishments take preventive and corrective
measures at each stage of the food production process where food safety
hazards occur.
During routine ante-mortem and post-mortem inspections in late
March 2004, FSIS inspection program personnel discovered drug implants
in animals that were presented for slaughter as veal. For the purpose
of this notice, FSIS considers young calves to be bovine food animals,
weighing 400 pounds or less (carcass weight, hide-on) with
characteristics of immature cattle, and ``veal'' to be young calves
with a non-functioning rumen. (FSIS is aware that the Agricultural
Marketing Service, USDA, has specific characterizations of what type of
animal can be marketed as veal and calf. While FSIS intends to engage
in rulemaking to establish a regulatory definition for veal, FSIS
believes that it is in the best interest of public health to issue this
reassessment notice now.)
Subsequently, FSIS learned that the use of growth promoting
implants was a widespread practice within the veal industry. However,
the Food and Drug Administration (FDA) has not approved growth
promoting implants for use in food animals presented for slaughter as
veal and considers their use to be a violation of the Federal Food,
Drug, and Cosmetic Act (FFDCA).
On April 2, 2004, FDA made publicly available on its Web site,
http://www.fda.gov/cvm/guidance/guide172.doc, ``Guidance for Industry--
Use of Unapproved Hormone Implants in Veal Calves.'' This document
provided guidance on the appropriate disposition of veal calves that
had been implanted with unapproved new animal drugs and made clear that
such use is illegal.\1\ On April 5, 2004, FSIS, in the interest of
public health, issued FSIS Notice 23-04, ``FSIS Verification of Veal
Calves with Implants.'' This notice informed FSIS inspection program
personnel of FDA's determination that the use of growth promoting
implants in non-ruminating veal calves is a violation of the FFDCA and
advised that veal calves could be passed for food only if they met the
criteria specified in the notice.
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\1\ U.S. Department of Health and Human Services, Food and Drug
Administration, Center for Veterinary Medicine. April 2, 2004.
Guidance for Industry--Use of Unapproved Hormone Implants in Veal
Calves.
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The criteria set forth in FSIS Notice 23-04 expired on June 6,
2004. Therefore, on June 3, 2004, FSIS issued FSIS Notice 31-04,
``Verification of Implant Usage in Non-Ruminating Calves.'' This notice
provides instructions for inspection program personnel to use when they
suspect the use of growth promoting implants in non-ruminating veal
calves. On July 16, 2004, FDA and FSIS jointly issued a letter to the
American Veal Industry, as well as to other trade associations,
reiterating that the practice of implanting food animals that are to be
marketed as ``veal'' with growth promoting implants is illegal, and
that those animals and their parts are subject to not being granted the
mark of inspection.\2\
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\2\ U.S. Department of Agriculture, Food Safety and Inspection
Service; Food and Drug Administration, Center for Veterinary
Medicine. July 16, 2004.
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Under the FMIA, the term ``adulterated'' (21 U.S.C. 601(m)) applies
to any carcass, part thereof, meat or meat food product if it bears or
contains (by reason of administration of any substance to the live
animal or otherwise) any added poisonous or added deleterious substance
which may make such product unfit for food (see 601(m)(2)(A)). An
unapproved new animal drug may be considered a deleterious substance.
If administered to a live animal, the presence of that substance could
render the product in which it is found, that is, the edible tissues of
the animal, unfit for human food and thus adulterated.
Under the authority of the FFDCA, FDA determines whether or not new
animal drugs proposed for use in food animals by the drug sponsor are
safe for use. This determination includes consideration of whether
there will be unsafe residues of the drug in the tissues that are used
for human food. To ensure that there are not unsafe residues, FDA
establishes and codifies tolerance levels for residues of such drugs.
If FDA has not received a new
[[Page 76886]]
drug application from the drug sponsor, and has not established and
codified a tolerance level for the drug, the use of such drugs is
illegal.
FDA has not evaluated the safety of growth promoting implants in
non-ruminating young calves. Therefore, FSIS cannot determine when the
edible tissues from animals to whom such substances have been
administered are not unfit for human food. If FSIS cannot make this
determination, it cannot determine when the edible product from those
animals that have been administered the unapproved new animal drug are
not adulterated, and thus it cannot apply the mark of inspection to
such products.
HACCP Systems
9 CFR 417.2(a) requires establishments to conduct a hazard analysis
to determine what food safety hazards are reasonably likely to occur in
their process and to identify the preventive measures that the
establishment can apply to control those hazards. The hazards may occur
before, during, or after entry into the establishment. FSIS has
identified drug residues as possible food safety hazards (9 CFR
417.2(a)(3)).
Section 417.2(a)(1) states that a food safety hazard that is
reasonably likely to occur is one for which a prudent establishment
would establish control measures because it historically has occurred,
or because there is a reasonable possibility that it will occur in the
particular type of product being processed, in the absence of those
controls. Whenever a hazard analysis reveals that one or more hazards
are reasonably likely to occur in the production process, the
regulations require that the establishment develop and implement a
written HACCP plan that includes specific control measures for each
hazard so identified (417.2(b) (1) and (c)).
Requirement and Basis for Reassessment
Section 417.4(a)(3) states that every establishment shall reassess
the adequacy of its HACCP plan at least annually and whenever any
changes occur that could affect the hazard analysis or alter the HACCP
plan. The finding that new animal drugs have been knowingly
administered, on a widespread basis, to a production class of animals
in which their use is not approved, represents information that could
alter the hazard analysis, and ultimately the HACCP plan, of any
establishment that slaughters animals of that class, in this case young
calves, for human food. Therefore, establishments that slaughter young
calves, including those young calves marketed, slaughtered, and labeled
as ``veal,'' need to consider the hazard presented by the illegal use
of animal drugs in the animals they slaughter, and what actions they
should take to control it if they determine that it is reasonably
likely to occur, as a result of their reassessments.
If reassessment results in a determination by the establishment
that a residue of an unapproved new animal drug is a food safety hazard
that is reasonably likely to occur, this hazard must be addressed in
the establishment's HACCP plan. However, FSIS recognizes that some
slaughterers employ measures to ensure that they do not purchase food
animals for slaughter with violative animal drug residues. These
slaughterers should consider incorporating these measures into their
HACCP plans or prerequisite programs.
FSIS Actions To Enforce and Facilitate Compliance With the Reassessment
The Agency intends to instruct inspection program personnel to
verify, as part of the Agency's verification of the 2005 hazard
analysis reassessment, that establishments that slaughter young calves
have considered the hazard of illegal residues. Before performing that
verification, inspection program personnel will ensure that all
establishments that slaughter young calves are aware that the Agency
has issued this notice. They will also ensure that those establishments
that have not yet reassessed their HACCP plans, based on the relevant
FSIS findings discussed earlier, begin their reassessment. By looking
into establishments' reassessment actions before the time that the
establishments are required to complete their reassessments, FSIS will
ensure that all establishments slaughtering young calves, including
establishments that are considered small and very small businesses, and
those that may not belong to a trade association, are aware of this
notice.
Paperwork Reduction Act
FSIS has reviewed the paperwork and recordkeeping requirements in
this notice in accordance with the Paperwork Reduction Act and has
determined that the paperwork requirements for the regulations that
require establishments that slaughter calves to reassess their HACCP
Plans have already been accounted for in the Pathogen Reduction/HACCP
Systems information collection approved by the Office of Management
Budget (OMB). The OMB approval number for the Pathogen Reduction/HACCP
Systems information collection is 0583-0103.
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that the
public and in particular minorities, women, and persons with
disabilities, are aware of this notice, FSIS will announce it on-line
through the FSIS Web page located at http://www.fsis.usda.gov.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, recalls, and other types of
information that could affect or would be of interest to our
constituents and stakeholders. The update is communicated via Listserv,
a free e-mail subscription service consisting of industry, trade, and
farm groups, consumer interest groups, allied health professionals,
scientific professionals, and other individuals who have requested to
be included. The update also is available on the FSIS Web page.
Through Listserv and the Web page, FSIS is able to provide
information to a much broader, more diverse audience.
Done at Washington, DC, on December 20, 2004.
Barbara J. Masters,
Acting Administrator.
[FR Doc. 04-28083 Filed 12-22-04; 8:45 am]
BILLING CODE 3410-DM-P