[Federal Register Volume 61, Number 94 (Tuesday, May 14, 1996)]
[Proposed Rules]
[Pages 24253-24256]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-12081]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. 96N-0135]
RIN 0910-AA91


Substances Prohibited From Use in Animal Food or Feed; Protein 
Derived From Ruminants 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 (FDA) is soliciting comments 
on the issue of using protein derived from ruminants (e.g., cattle, 
sheep, goats, mule deer, and elk) in ruminant feed. Animal feed 
containing protein derived from ruminants may contain the disease agent 
that causes transmissible spongiform encephalopathy (TSE) in animals. 
Epidemiological evidence gathered in the United Kingdom (U.K.) suggests 
a link between an outbreak of ruminant TSE, specifically bovine 
spongiform encephalopathy (BSE) and feeding animals protein derived 
from ruminants. In addition information from the U.K. also suggests 
that exposure to BSE may explain some of the recent cases of variant 
Creutzfeldt-Jakob disease (v-CJD) in the U.K. This action is being 
taken to protect the health of animals and to reduce any risk which 
might be faced by humans. FDA is requesting scientific and economic 
information and other comments relating to the prohibition of ruminant 
protein in ruminant feed.

DATES: Written comments by June 13, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: George Graber, Center For Veterinary 
Medicine (HFV-220), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1724.

SUPPLEMENTARY INFORMATION:

I. Background

     In the Federal Register of August 29, 1994 (59 FR 44584) FDA 
issued a proposed rule declaring that specified offal from adult (more 
than 12 months of age) sheep and goats is not generally recognized as 
safe for use in ruminant feed and is an unapproved food additive when 
added to ruminant feed. The proposed rule defined ``specified offal'' 
as any tissue from the brain, spinal cord, spleen, thymus, tonsil, 
lymph nodes, or intestines of sheep or goats, or any processed product 
that is reasonably expected to contain specified offal. Processed 
products that may contain specified offal include, but are not limited 
to, meat meal, meat and bone meal, animal byproduct meal, meat 
byproducts, glandular meal, and cooked bone meal. Accordingly, in the 
absence of an approved food additive regulation or investigational 
exemption, the use in ruminant feed of ingredients containing specified 
offal from adult sheep or goats would cause the feeds to be considered 
adulterated within the meaning of the Federal Food, Drug, and Cosmetic 
Act (the act). FDA proposed the action because the specified offal may 
contain the agent that causes scrapie, a TSE of sheep and goats. Since 
the proposal was issued, the agency has been evaluating the comments 
submitted on the proposal, monitoring the scientific advances made in 
understanding the interrelationships among the animal TSE's, and 
participating in a number of national and international task force/
symposia to better understand the BSE epidemic. The actions that would 
have been prohibited in the proposed rule are considered in this 
advance notice of proposed rulemaking. If it is determined that some 
action is necessary, the agency believes issuing an advance notice of 
proposed rulemaking (ANPRM) will hasten that process.
    In the U. K., scrapie has been epidemiologically associated with 
the occurrence of BSE, another form of TSE. The initial cases of BSE 
may have been the result of feeding supplements to cattle that were 
contaminated with prions from scrapie-infected sheep offal. Prions are 
highly resistant to procedures that modify or destroy nucleic acids. 
(Refs. 1 and 2). Prions are believed by many scientists to be the 
agents responsible for TSE's, and they appear to be modified forms of 
normal proteins.
    BSE has been diagnosed in over 155,600 head of cattle from almost 
33,000 herds in the U.K. No cases of BSE have been diagnosed in the 
United States. BSE is postulated to have been spread in the U.K. among 
cattle by the feeding of processed ruminant protein to cattle. A July 
1988 U.K. ban on this feeding practice has resulted in a steady 
reduction in the number of cases of BSE detected in cattle, with the 
new cases occurring mainly in animals born before the ban was fully 
implemented.
    Ten cases of CJD have been identified in the U.K. in recent months 
with a new neuropathological profile. Other consistent features that 
are unusual include the young age of the cases (16 to 39 years old at 
onset of clinical signs), clinical findings, and the absence of the 
electroencephalogram features typical for CJD. Similar cases have not 
been identified in other countries in the European surveillance system. 
These 10 cases appear to represent a new variant of CJD (v-CJD), which 
may be unique to the U.K. The appearance of these 10 cases of v-CJD 
raises the possibility that they are causally linked to BSE. Although 
this may be the most plausible explanation for these cases, a link with 
BSE cannot be confirmed on the basis of this evidence alone. (Ref. 3). 
Sporadic occurrences of spongiform encephalopathy in humans are known 
to occur at a rate of 1 to 2 per million population worldwide. A group 
of international experts convened in April 1996 by the World Health 
Organization concluded that there is no definite link between BSE and 
v-CJD, but that circumstantial evidence suggests exposure to BSE may be 
the most likely explanation. Among other recommendations, the group 
recommended that all countries should

[[Page 24254]]

ban the use of ruminant tissues in ruminant feed (Ref. 4).

II. Issues for Comment

    No cases of BSE have been diagnosed in the United States. Despite 
the fact that there is no problem with BSE in the United States, the 
agency believes it would be prudent to solicit information and receive 
comments on this issue. Therefore, the agency is assessing whether to 
provide that protein derived from ruminants is not generally recognized 
as safe for use as a ruminant feed or prior sanctioned for such and is 
a food additive subject to section 409 of the act (21 U.S.C. 348). 
Absent a determination that it is safe for use as a food additive under 
section 409 of the act, the use in ruminant feed of ingredients 
containing protein derived from ruminants would cause the feed to be 
adulterated. Ruminant-derived protein could be defined as any feed 
ingredient that is reasonably expected to contain proteinaceous 
material that derives from ruminant species. Processed feed ingredients 
that may contain ruminant-derived protein include, but are not limited 
to, products meeting the following animal feed definitions: animal 
byproduct meal, blood meal, cooked bone meal, glandular meal, meat and 
bone meal, meat byproducts, and meat meal. The agency is prepared to 
consider the exclusion of specific ruminant products from the 
prohibition, such as milk products, blood products, fetal bovine serum, 
and gelatin based on appropriate and adequate scientific information 
which demonstrates no infectivity.
    In addition, the agency is considering labeling requirements for 
ruminant-derived proteins for enforcement purposes.

III. Agency Request for Information

    FDA is soliciting comments on all aspects of this ANPRM, and 
specifically requests comments on the following issues:
    1. The occurrence in the United States of TSE's in animals.
    2. Scientific information on how TSE's occur and are spread among 
animals and among humans and what vectors might be involved.
    3. Scientific information on the ecology of TSE agents, and the 
epidemiology, etiology, and pathogenesis of TSE diseases.
    4. Scientific information supporting the exclusion of any ruminant-
derived proteins from the proposed prohibition.
    5. Establishment of Hazard Analysis and Critical Control Points 
(HACCP) for the rearing of ruminants, and rendering or other processing 
of ruminant derived feed ingredients, that may reduce the need to 
prohibit the feeding of ruminant protein to ruminants.
    6. Details of rendering or processing practices that may inactivate 
the TSE agents and information and evidence which shows that these 
practices are effective.
    7. Data on the amount of material affected by this ruminant protein 
to ruminant feed prohibition, specifically: (a) The total volume of the 
processed feed ingredients that may contain ruminant-derived protein 
which were produced in the United States in recent years, (b) details 
of the total volume used for each of these ingredients in the rations 
of the various animals in the United States, (c) information on the 
percentage of the diet each ingredient

[[Page 24255]]

typically comprises for each species and what percentage of the total 
volume is fed to each species, and (d) other information.
    8. Economic and environmental adverse consequences or benefits 
resulting from a ruminant protein to ruminant feed prohibition on: (a) 
The farmer/producer, (b) the slaughter operation, (c) the rendering 
industry, (d) the public, (e) the feed manufacturer, (f) other parties 
that may be affected.
    9. Potential mitigating factors that would lessen the economic and 
environmental impact of the prohibition, specifically: (a) 
Identification of nonfeed uses of products containing ruminant-derived 
protein, (b) development of rendering or processing processes that 
would allow the safe feed use of a portion of the prohibited feed 
ingredient, (c) alternate disposal methods, and (d) other mitigating 
factors.
    10. Descriptive and incremental cost data for incremental tasks 
required by the proposed change with respect to person-hours, type of 
labor (professional, technical, and clerical), type of equipment to be 
purchased, disposal costs, capital expenditures, loss of current 
markets, expansion of alternative markets, etc.
    11. Estimates of the average total cost of compliance (including 
any expected reporting and recordkeeping costs) for both large and 
small businesses in each affected industry segment. Descriptions and 
numbers of small businesses affected in each sector.
    12. Information which identifies and explains effective alternative 
policy actions which would minimize any negative economic effects on 
small businesses and the affected industry as a whole.
    13. Estimates of the level of compliance with the voluntary ban on 
feeding ruminant protein to ruminants announced by the livestock 
industry on March 29, 1996.
    14. Information on restrictions placed upon beef or sheep imports 
by foreign countries that would directly affect U.S. beef or sheep 
producers.
    15. Identification of potential analytical methods that may be used 
in detecting ruminant proteins in feed.
    16. Labeling requirements (i.e., declaring the source of the animal 
protein; a prohibition of use statement).
    17. Development of antemortem tests to accurately determine if an 
animal has a TSE.
    18. Alternate actions the agency could take to prevent the spread 
of TSE's among ruminants.

IV. Comments

    Interested persons may, on or before June 13, 1996, submit to the 
Dockets Management Branch (address above), written comments regarding 
this ANPRM. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. 
Received comments may be seen in the office above between 9 a.m. and 4 
p.m., Monday through Friday.
    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.




[[Page 24256]]



VI. References

    The following references have been placed on display in the Dockets 
Management Branch (address above) and may be seen by interested persons 
between 9 a.m. and 4 p.m., Monday through Friday.
    1. Prusiner, S. B. , ``Novel Proteinaceous Infectious Particles 
Cause Scrapie,'' Science, 216:136-144, 1982.
    2. Stahl, N. and S. B. Prusiner, ``Prions and Prion Proteins,'' 
FASEB Journal, 5:2799-2807, 1991.
    3. Will, R. G. et al., ``A New Variant of Creutzfeldt-Jakob 
Disease in the UK,'' Lancet, 347, 921-925, 1996.
    4. WHO press release, April 3, 1996, ``International Experts 
Propose Measures to Limit Spread of BSE and Reduce Possible Human 
Risk from Disease.''

    Dated: May 8, 1996.
David A. Kessler,
Commissioner of Food and Drugs.
Donna E. Shalala,
Secretary of Health and Human Services.
[FR Doc. 96-12081 Filed 5-9-96; 2:16 pm]
BILLING CODE 4160-01-F