[Federal Register: November 6, 2002 (Volume 67, Number 215)]
[Proposed Rules]               
[Page 67572-67573]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

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.


[[Page 67572]]


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.


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 

Secretariat, Office of the Commissioner (HF-40), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-4443.


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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 

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 
    [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 

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 
    [sbull] To what extent is plate waste used in ruminant feed?
    [sbull] What is the composition of plate waste, and what are its 
    [sbull] How is plate waste processed before inclusion in ruminant 
    [sbull] What would be the adverse and positive impacts (economic, 
environmental, health, etc.) from excluding plate waste from ruminant 

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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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]