[Federal Register: December 23, 2004 (Volume 69, Number 246)]
[Proposed Rules]               
[Page 76884-76886]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


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.



    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.

    \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 

    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\

    \2\ U.S. Department of Agriculture, Food Safety and Inspection 
Service; Food and Drug Administration, Center for Veterinary 
Medicine. July 16, 2004.

    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 
    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 
    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 

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]