[Federal Register Volume 67, Number 215 (Wednesday, November 6, 2002)]
[Proposed Rules]
[Pages 67572-67573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-28373]
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Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
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Federal Register / Vol. 67, No. 215 / Wednesday, November 6, 2002 /
Proposed Rules
[[Page 67572]]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 589
[Docket No. 02N-0273]
RIN 0910-AC37
Substances Prohibited From Use in Animal Food or Feed; Animal
Proteins Prohibited in Ruminant Feed
AGENCY: Food and Drug Administration, HHS.
ACTION: Advance notice of proposed rulemaking.
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SUMMARY: The Food and Drug Administration (we) is soliciting
information and views on some potential changes to its current
regulation prohibiting the use of certain proteins in ruminant animal
feed. We put this regulation in place to prevent the spread through
animal feed of the agent of bovine spongiform encephalopathy (BSE) were
it to enter the United States. In this regulation we determined that
protein derived from mammalian tissues for use in ruminant feed is a
food additive under the Federal Food, Drug, and Cosmetic Act (the act),
and that use of certain mammalian proteins in ruminant feed causes the
feed to be adulterated under the act. We are considering revising this
regulation, and therefore we are asking the public for comment on
certain possible modifications to the rule. This information may be
used to help draft a proposed rule in the near future.
DATES: Submit written or electronic comments by February 4, 2003.
ADDRESSES: Submit written or electronic comments to the Dockets
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to
http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Linda Huntington, Executive
Secretariat, Office of the Commissioner (HF-40), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4443.
SUPPLEMENTARY INFORMATION:
I. Background
We published the regulation, ``Substances Prohibited From Use in
Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed,'' (21
CFR 589.2000) in the Federal Register of June 5, 1997 (62 FR 30936).
On October 30, 2001, we held a public hearing in Kansas City, MO to
hear views from the public on the adequacy of the present BSE feed
regulation. We specifically invited comments, both oral and written, on
17 questions about ways the rule and its enforcement might be improved
to achieve its original objectives of preventing the establishment and
amplification of BSE in the United States. We appreciate the efforts of
the many organizations and individuals who took the time to express the
views of various segments of the animal feed industry, regulatory
agencies, concerned consumers, and consumer organizations on the
adequacy of the present feed rule.
Shortly after the public hearing, the U.S. Department of
Agriculture (USDA) released a report prepared by the Harvard Center for
Risk Analysis (http://www.aphis.usda.gov/oa/bse/) on the findings of a
major 3-year initiative to develop a risk assessment model that allows
evaluation of the impact of various risks and potential pathways for
exposure of U.S. cattle and U.S. citizens to the BSE agent. The
assessment of the present situation in the United States using this
model concluded that, due to control measures already in place, the
risk to U.S. cattle and to U.S. consumers from BSE is very low. The
model also demonstrated that certain new control measures could reduce
the small risk even further.
USDA's BSE surveillance program supports the findings of the
Harvard study that measures implemented by the U.S. Government, such as
early import restrictions and the feed ban, have been effective in
preventing the entrance and establishment of BSE in the U.S. cattle
population. The USDA surveillance program, which has been in place
since May 1990 and which targets the highest risk cattle population,
has found no cases of BSE to date. Although BSE has not been detected
in the United States, the U.S. Government's response to BSE has always
been proactive and preventive. Therefore, USDA and FDA are interested
in exploring measures that could further reduce the already small risk
that BSE will enter and become established in the United States. To
that end, FDA is once again asking for information from the affected
industries and the public on several ways that the animal feed
regulation could be strengthened.
II. Agency Request for Information
We are soliciting information and comments from those with interest
and expertise in any of the following five aspects of the BSE feed
regulation:
1. Excluding Brain and Spinal Cord From Rendered Animal Products
The Harvard risk assessment identified removal of high risk
tissues, such as brain, spinal cord, gut, and eyes, from human food and
rendered material for animal feed, as a way to dramatically reduce the
potential exposure of cattle and humans to the BSE agent. In response
to the Harvard study, USDA's Food Safety Inspection Service is
considering rulemaking to ban high risk tissues obtained from certain
populations of cattle (also called specified risk materials or SRMs)
from use in human food. Should USDA publish such a proposal, FDA may
also propose that SRMs be prohibited from going into rendered material.
Therefore, FDA is asking for comments on the following questions:
[sbull] Should high risk materials, such as brain and spinal cord
from ruminants 2 years of age and older, be excluded from all rendered
products?
[sbull] How feasible would it be for the rendering industry to
implement such an exclusion?
[sbull] What will be the adverse and positive impacts (economic,
environmental, health, etc.) resulting from a brain and spinal cord
exclusion?
2. Use of Poultry Litter In Cattle Feed
In some parts of the country where cattle are raised in proximity
to large poultry production areas, poultry litter, composed of excreta,
bedding, spilled feed, and feathers, may be used as a feed ingredient
for cattle. The Harvard risk assessment said that the risk from the use
of poultry litter as a feed supplement should be investigated
[[Page 67573]]
further. For example, if the spilled feed contained ruminant protein,
would this practice represent a significant break in the feed
regulations? In order to further investigate possible risk, FDA is
seeking information on the following questions:
[sbull] How extensive is the use of poultry litter in cattle feed
in the United States?
[sbull] What is the level of feed spillage in poultry litter?
[sbull] What are the methods used to process poultry litter before
inclusion in animal feed?
[sbull] What will be the adverse and positive impacts (economic,
environmental, health, etc.) resulting from banning poultry litter in
ruminant feed?
3. Use of Pet Food In Ruminant Feed
Under the current regulation, pet food for retail sale is exempt
from the labeling requirement and need not bear the caution statement
``Do not feed to cattle or other ruminants.'' However, if the pet food
products are sold or are intended for sale as distressed or salvage
items, then, under Sec. 589.2000(d)(4), such products must state, ``Do
not feed to cattle or other ruminants.'' In order to assure that
salvaged pet food is not used in ruminant feed despite the requirement
that it be labeled with the caution statement, FDA is asking for
comments on the following questions.
[sbull] Should pet food for retail sale be labeled with the
statement ``Do not feed to cattle or other ruminants.''?
[sbull] What would be the adverse and positive impacts (economic,
environmental, health, etc.) of such a labeling requirement?
4. Preventing Cross-Contamination
The Harvard risk assessment and the FDA public hearing identified
cross-contamination of feed and facilities as a possible BSE risk. The
current animal feed regulation permits feed and feed ingredients for
ruminant animals to be processed in facilities that also process
prohibited proteins. The rule requires that those firms handling both
prohibited and nonprohibited material have a system in place and a
written plan to prevent cross-contamination. We provided suggestions in
the preamble to the final rule and in the small entity compliance
guides on ways to prevent carry-over in shared equipment. Small entity
compliance guides include: No. 67--Renderers; No. 68--Protein Blenders,
Feed Manufacturers, and Distributors; No. 69--Feeders of Ruminant
Animals With On-Farm Feed Mixing Operations; No. 70--Feeders of
Ruminant Animals Without On-Farm Feed Mixing Operations; and No. 76--
Questions and Answers, BSE Feed Regulation. You may see the small
entity compliance guides on the Center for Veterinary Medicine (CVM)
Internet site at http://www.fda.gov/cvm or by calling the CVM
Communications Staff at 301-594-1755. For feed mills, these suggestions
were based on medicated feed good manufacturing practices (GMPs) and
included physical cleaning, flushing, or sequencing. For renderers, we
suggested flushing, using one complete change of operating volume of
the entire system.
The rule requires that those firms handling both prohibited and
nonprohibited material have a system in place and a written plan to
prevent cross-contamination. The only way to be sure that there is
absolutely no potential for carry-over of, or cross-contamination with,
prohibited material is to use completely separate facilities. We are
interested in information on control measures, other than dedicated
facilities, that apply specifically to transmissible spongiform
encephalopathy (TSE) agents and in information on whether such measures
can prevent carry-over of prohibited material. The agency is asking for
comments on the following questions:
[sbull] Are there practical ways, other than dedicated facilities,
for firms to demonstrate that the level of carry-over could not
transmit BSE to cattle or other ruminants? If so, what is the safe
level of carry-over in a feed mill; and
[sbull] What is the scientific rationale used to establish this
safe level?
[sbull] What steps are firms currently taking to prevent cross-
contamination of prohibited protein into ruminant feed, and what are
the costs of those steps?
5. Elimination of the Plate Waste Exemption
The current regulation contains an exemption that permits
``inspected meat products which have been cooked and offered for human
food and further heat processed for feed (such as plate waste and used
cellulosic food casings)'' to be fed to ruminants. Although the Harvard
study concluded that plate waste posed a minimal risk, FDA wishes to
reconsider this exemption and is seeking information on the following
questions.
[sbull] To what extent is plate waste used in ruminant feed?
[sbull] What is the composition of plate waste, and what are its
sources?
[sbull] How is plate waste processed before inclusion in ruminant
feed?
[sbull] What would be the adverse and positive impacts (economic,
environmental, health, etc.) from excluding plate waste from ruminant
feed?
III. Comments
You may submit written or electronic comments regarding the advance
notice of proposed rulemaking (ANPRM) by February 4, 2003, to the
Dockets Management Branch (see ADDRESSES). Please submit two copies of
any comments, except that individuals may submit one copy. Identify
your comments with the docket number found in brackets in the heading
of this document. You may see received comments in the Dockets
Management Branch reading room between 9 a.m. and 4 p.m., Monday
through Friday, except Federal holidays.
You may submit comments electronically on the Internet at: http://www.fda.gov/dockets/ecomments. On this Internet site, select ``02N-
0273'' and follow the directions.
This ANPRM is issued under sections 201, 402, 409, and 701 of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 342, 348, and 371)
and under the authority of the Commissioner of Food and Drugs.
Dated: November 4, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-28373 Filed 11-5-02; 8:45 am]
BILLING CODE 4160-01-S