[Federal Register Volume 62, Number 74 (Thursday, April 17, 1997)]
[Proposed Rules]
[Pages 18728-18730]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10132]


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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; Animal 
Proteins Prohibited in Ruminant Feed; Draft Rule; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Availability of draft rule.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft rule that would provide that animal protein 
derived from mammalian tissues is a food additive subject to certain 
provisions in the Federal Food, Drug, and Cosmetic Act. The agency is 
making this draft available because of the complex scientific and 
regulatory issues involved regarding transmissible spongiform 
encephalopathies and ruminant feeds. The agency invites the public to 
submit comments with questions and concerns about the draft.

DATES: Written comments must be received in the Dockets Management 
Branch by 4:30 p.m. d.s.t. April 28, 1997.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857, or you may fax the comments to 301-594-3215.

FOR FURTHER INFORMATION CONTACT: George A. (Bert) Mitchell, Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-5587.

SUPPLEMENTARY INFORMATION: In the Federal Register of January 3, 1997 
(62 FR 552), FDA published a proposed rule that would prohibit the use 
of protein derived from ruminant and mink tissues in ruminant feeds. 
The agency took this action due to concerns about the

[[Page 18729]]

possible effects if transmissible spongiform encephalopathies, 
especially bovine spongiform encephalopathy, were to be spread through 
animal feed. (See the preamble to the January 3, 1997, proposal for a 
full discussion of this issue.) After considering the comments on the 
proposal, given the complex issues involved, the agency has decided to 
make this draft available to the general public under Secs. 10.40(f) 
and 10.80(d)(2). These provisions allow the agency to make this draft 
available for discussion of questions and concerns about the draft. In 
this instance, FDA is conducting this discussion by inviting written 
comments with questions and concerns about the draft which will be 
addressed in any final rule that is published. The agency emphasizes 
that the draft rule does not represent final agency action or the 
agency's final decision on this regulation.
    Interested persons may, on or before April 28, 1997, submit to the 
Dockets Management Branch (address above) written comments regarding 
this draft rule. 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.

    Dated: April 15, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
    The text of the draft rule is set forth below:
    For the reasons discussed in the preamble, FDA hereby issues a 
draft rule that would amend 21 CFR part 589 as follows:

PART 589--SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED

    1. The authority citation for 21 CFR part 589 continues to read as 
follows:

    Authority: Secs. 201, 402, 409, 701 of the Federal Food, Drug 
and Cosmetic Act (21 U.S.C. 321, 342, 348, 371).
    2. New Sec. 589.2000 is added to subpart B to read as follows:


Sec. 589.2000  Animal proteins prohibited in ruminant feed.

    (a) Definitions. (1) Protein derived from mammalian tissues 
means any protein-containing portion of mammalian animals, 
excluding: Blood and blood products; gelatin (including amino acids 
and dicalcium phosphate derived from gelatin); inspected and 
processed meat products which have been cooked and offered for human 
consumption (plate waste and used cellulosic food casings); milk 
products (milk and milk proteins); and any product whose only 
mammalian protein consists entirely of porcine protein.
    (2) Renderer means any firm or individual that processes 
slaughter byproducts, animals unfit for human consumption, or meat 
scraps. The term includes persons who collect such materials and 
subject them to minimal processing, or distribute them to firms 
other than renderers (as defined here) whose intended use for the 
products may include animal feed. The term includes renderers that 
also blend animal protein products.
    (3) Blender means any firm or individual which obtains processed 
animal protein from more than one source or from more than one 
species, and subsequently mixes (blends) or redistributes an animal 
protein product.
    (4) Feed manufacturer includes manufacturers of complete and 
intermediate feeds intended for animals, and includes on-farm in 
addition to off-farm feed manufacturing and mixing operations.
    (5) Nonmammalian protein includes proteins from nonmammalian 
animals.
    (6) Distributor includes distributors of complete and 
intermediate feeds intended for animals.
    (7) Ruminant means any member of the order of animals which has 
a stomach with four chambers (rumen, reticulum, omasum, and 
abomasum) through which feed passes in digestion. The order 
includes, but is not limited to, cattle, buffalo, sheep, goats, 
deer, elk, and antelopes.
    (b) Food additive status. The Food and Drug Administration has 
determined that protein derived from mammalian tissues for use in 
ruminant feed is a food additive subject to section 409 of the 
Federal Food, Drug, and Cosmetic Act (the act). The use or intended 
use in ruminant feed of any material that contains protein derived 
from mammalian tissues causes the feed to be adulterated and in 
violation of the act, unless it is the subject of an effective 
notice of claimed investigational exemption for a food additive 
under Sec. 570.17 of this chapter.
    (c) Requirements for renderers that are not included in 
paragraph (e) of this section. (1) Renderers that manufacture 
products that contain or may contain protein derived from mammalian 
tissues and that are intended for use in animal feed shall take the 
following measures to ensure that materials identified in paragraph 
(b) of this section are not used in the feed of ruminants:
    (i) Label the materials as follows: ``Do not feed to cattle or 
other ruminants''; and
    (ii) Maintain records sufficient to track the materials 
throughout their receipt, processing, and distribution and make the 
copies available for inspection and copying by the Food and Drug 
Administration.
    (2) Renderers described in paragraph (c)(1) of this section will 
be exempted from the requirements of paragraphs (c)(1)(i) and 
(c)(1)(ii) of this section if they:
    (i) Use exclusively a manufacturing method that has been 
validated by the Food and Drug Administration to deactivate the 
agent that causes transmissible spongiform encephalopathy (TSE) and 
whose design has been made available to the public;
    (ii) Use routinely a test method that has been validated by the 
Food and Drug Administration to detect the presence of the agent 
that causes TSE's and whose design has been made available to the 
public. Products found to contain the agent that causes TSE's shall 
be labeled ``Not for Use in Animal Feed.'' Records of the test 
results shall be made available for inspection by the Food and Drug 
Administration; or
    (iii) Use exclusively a method for controlling the manufacturing 
process that minimizes the risk of the TSE agent entering the 
product and whose design has been made available to the public and 
validated by the Food and Drug Administration.
    (3) Renderers described in paragraph (c)(1) of this section will 
be exempted from the requirements of paragraph (c)(1)(ii) of this 
section if they use a permanent method, approved by FDA, to make a 
mark indicating the presence of the materials. If the marking is by 
the use of an agent that cannot be detected on visual inspection, 
the renderer must use an agent whose presence can be detected by a 
method that has been validated by the Food and Drug Administration 
and whose design has been made available to the public.
    (d) Requirements for protein blenders, feed manufacturers, and 
distributors that are not included in paragraph (e) of this section. 
(1) Protein blenders, feed manufacturers, and distributors that 
manufacture, blend, process, and distribute products that contain or 
may contain protein derived from mammalian tissues shall comply with 
paragraph (c)(1) of this section.
    (2) Protein blenders, feed manufacturers, and distributors, 
shall be exempt from paragraphs (d)(1) of this section if they:
    (i) Purchase animal products from renderers that certified 
compliance with paragraph (c)(2) of this section or purchase such 
materials from parties that certify that the materials were 
purchased from renderers that certified compliance with paragraph 
(c)(2); or
    (ii) Comply with the requirements of paragraph (c)(2) of this 
section where appropriate.
    (3) Protein blenders, feed manufacturers, and distributors shall 
be exempt from paragraph (c)(1)(ii) of this section if they:
    (i) Purchase animal protein products that are marked in 
accordance with paragraph (c)(3) of this section or purchase such 
materials from renderers that certified compliance with paragraph 
(c)(3) of this section, or purchase such materials from parties that 
certify that the materials were purchased from renderers that 
certified compliance with paragraph (c)(3) of this section; or
    (ii) Comply with the requirements of paragraph (c)(3) of this 
section where appropriate.
    (4) Pet food products that are sold or are intended for sale at 
retail are exempt from the labeling requirements in paragraphs (c) 
and (d) of this section. However, if the pet food products are sold 
or are intended for sale as distressed or salvage items for possible 
use in ruminant feed, then such products shall be labeled in 
accordance with paragraphs (c) or (d) of this section, as 
appropriate.
    (5) Copies of certifications as described in paragraphs (d)(2) 
and (d)(3) of this section,

[[Page 18730]]

shall be made available for inspection and copying by the Food and 
Drug Administration.
    (e) Requirements for persons that intend to separate mammalian 
and nonmammalian materials. (1) Renderers, protein blenders, feed 
manufacturers, distributors, haulers and others that manufacture, 
process, blend and distribute both protein products derived from 
mammalian tissues or feeds containing such products, and protein 
products from other animal tissues or feeds containing such 
products, and that intend to keep those products separate shall:
    (i) Comply with paragraphs (c)(1) or (d)(1) of this section as 
appropriate except that the labeling requirement shall apply only to 
products derived from mammalian (other than pure porcine) tissues or 
feeds containing such products;
    (ii) In the case of a renderer, obtain nonmammalian or pure 
porcine materials only from single-species facilities;
    (iii) Provide for measures to avoid commingling or cross-
contamination:
    (A) Maintain separate equipment or facilities for the 
manufacture, processing, or blending of such materials; or
    (B) Use clean-out procedures or other means adequate to prevent 
carry-over of protein derived from mammalian tissues into animal 
protein or feeds that may be used for ruminants; and
    (iv) Maintain written procedures specifying the clean-out 
procedures or other means, and specifying the procedures for 
separating mammalian (other than pure porcine) materials from 
nonmammalian materials from the time of receipt until the time of 
shipment.
    (2) Renderers, blenders, feed manufacturers, and distributors 
will be exempted from appropriate requirements of paragraph (e)(1) 
of this section, if they meet the appropriate criteria for exemption 
under paragraphs (c)(2) or (c)(3), and paragraphs (d)(2) or (d)(3) 
of this section.
    (f) Requirements for establishments and individuals that are 
responsible for feeding ruminant animals. Establishments and 
individuals that are responsible for feeding ruminant animals shall 
maintain copies of purchase invoices and labeling for all feeds 
containing animal protein products received, and make the copies 
available for inspection and copying by the Food and Drug 
Administration.
    (g) Adulteration and misbranding. (1) Animal protein products, 
and feeds containing such products, that are not in compliance with 
paragraphs (c) through (f) of this section, excluding labeling 
requirements, will be deemed adulterated under section 402(a)(2)(C) 
or (a)(4) of the act.
    (2) Animal protein products, and feeds containing such products, 
that are not in compliance with the labeling requirements of 
paragraphs (c) through (f) of this section will be deemed misbranded 
under section 403(a)(1) of the act.
    (h) Inspection; records retention. (1) Records that are to be 
made available for inspection and copying, as required by this 
section, shall be kept for a minimum of 2 years.
    (2) Written procedures required by this section shall be made 
available for inspection and copying by the Food and Drug 
Administration.
[FR Doc. 97-10132 Filed 4-15-97; 3:17 pm]
BILLING CODE 4160-01-F