[Federal Register Volume 66, Number 194 (Friday, October 5, 2001)]
[Proposed Rules]
[Pages 50929-50931]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-25108]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. 01N-0423]


Substances Prohibited From Use in Animal Food or Feed; Animal 
Proteins Prohibited in Ruminant Feed; Public Hearing; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public hearing; request for comments..

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public 
hearing in Kansas City, MO, to solicit information and views on its 
present animal feeding regulation. The purpose of the rule is to help 
prevent the establishment and amplification of the agent(s) of bovine 
spongiform encephalopathy (BSE) in the U.S. cattle herd through feed 
and thereby help minimize any risks from such agent(s) to animal or 
human health. FDA recognizes that much new information has emerged on 
BSE and new variant Creutzfeldt-Jakob Disease (vCJD) since the rule 
went into effect in 1997. FDA is therefore requesting information and 
views from individuals and organizations on the present rule and 
whether changes in the rule or other additional measures are necessary. 
The agency is particularly interested in soliciting comments and views 
from individuals, industry, consumer groups, health professionals, and 
researchers with expertise in BSE and related animal and human 
diseases.

DATES: The hearing will be held on October 30, 2001, from 9 a.m. to 5 
p.m. central time and will be open to the public throughout its 
entirety. The hearing will be adjourned from 12 noon to 1 p.m. for 
lunch. FDA will reserve the hour from 4 p.m. to 5 p.m. for those who 
have not registered to present orally at the meeting to make oral 
presentations to the panel. Those individuals or organizations that 
wish to register to present orally at the hearing must register by 4:30 
p.m. eastern time on October 23, 2001. Send registration information to 
the contact person. Written comments regarding the matters before this 
panel are welcome at anytime; however, the official record of the 
hearing will remain open to receive written comments until November 21, 
2001.

ADDRESSES: The public hearing will be held at the Westin Crowne Center 
Hotel, One Pershing Rd., Kansas City, MO. Those wishing to present 
orally at the hearing must submit a written notice of participation to 
Linda Grassie at the address or fax number listed in For Further 
Information Contact section. To submit electronic comments go to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm.
    Individuals and organizations wishing to submit written comments on 
these issues to the panel, but who do not wish to present orally to the 
panel, should submit their written comments to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Written comments are to be identified with 
Docket No. 01N-0423.
    Information specified in this notice can be received by calling 
301-594-5000 or sending a self-addressed stamped envelope with your 
request to the contact person listed below.

FOR FURTHER INFORMATION CONTACT: Linda Grassie, Center for Veterinary 
Medicine (HFV-12), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-3796, FAX 301-827-4065, e-mail 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of June 5, 1997 (62 FR 30936), FDA issued a 
final rule amending its final regulations to provide that animal 
protein derived from mammalian tissues for use in ruminant feed is a 
food additive subject to certain provisions in the Federal Food, Drug, 
and Cosmetic Act. The final rule established at Sec. 589.2000 (21 CFR 
589.2000) a flexible system of controls, including a number of 
exemptions, designed to ensure that ruminant feed does not contain most 
mammalian tissue proteins and to encourage innovation in such controls. 
FDA issued this regulation to protect animal and

[[Page 50930]]

human health in the United States. The final rule was intended to help 
prevent the establishment and amplification of BSE in the U.S. cattle 
herd through feed, and thereby help minimize any risk from the agent(s) 
of BSE to animals or humans health.
    This rule has now been in effect for 4 years. Federal, State, and 
private sector entities have conducted an intensive campaign to educate 
livestock producers and all sectors of the animal feed industry on the 
purpose of the rule and the requirements for compliance with the rule. 
Since 1997, FDA and State feed inspectors have conducted over 10,000 
inspections of cattle producers and firms involved in the manufacture 
of animal feeds. The inspectors found approximately 78 percent of these 
firms to be in compliance with this rule. Upon re-inspection, 
inspectors found approximately 90 percent of the firms to be in 
compliance with the rule. In addition, there have been incidents in 
which feed containing prohibited materials has been fed to cattle. To 
date, there is no evidence that this feed contained prohibited proteins 
that were infected with the agent(s) of BSE. All known instances of 
feeding violations involved animal protein from countries free of BSE.
    To date, there has been no evidence of BSE or vCJD in the United 
States. Nonetheless, since the promulgation of this rule, BSE has 
spread and is now found in most countries of western and central Europe 
and, pending final confirmation, Japan. New efforts this year to 
contain the spread of the epidemic in Europe have included, among other 
policies, a ban on feeding most animal protein to farmed animals.

II. Scope of the Hearing

    There are many evolving, complex scientific and public health 
issues involved in the effort to prevent the establishment and 
amplification of the agent(s) of BSE in the U.S. cattle herd and to 
reduce the risk to American public health from the agent(s) of BSE. In 
light of these issues, FDA is soliciting broad public participation and 
comment on issues regarding whether new measures are necessary in 
addition to FDA's present animal feeding rule at Sec. 589.2000 and 
regarding the compliance with that rule to date. Because of the spread 
of BSE beyond the United Kingdom, and because of the compliance 
experience to date with the 1997 rule, FDA believes it would be prudent 
to solicit information and views on the present rule and if there are 
ways in which this rule and its enforcement might be further improved 
to meet its original objectives or any new objective(s) that may now be 
appropriate to consider.
    Since 1997, FDA has received numerous unsolicited suggestions from 
many individuals and groups regarding this rule. These have ranged from 
making no changes to the rule to completely banning the use of all 
animal proteins in the feeding of all animals. In addition, there have 
been many suggestions that would fall between these two positions.
    The agency encourages individuals, industry, consumer groups, 
health professionals, and researchers with particular expertise in this 
area, as well as other interested persons, to respond to this notice. 
The agency strongly encourages persons who cannot attend the hearing to 
send information and views relevant to the topics and questions listed 
below in this document to the Dockets Management Branch (address 
above). Comments should be identified with Docket No. 01N-0423.
    FDA is soliciting information and comments on all aspects of the 
present feeding rule at Sec. 589.2000 and specifically requests 
comments on the following questions. For each question, FDA is 
requesting information and comments on the impact on public health and 
on both animal feed and human food safety, on any increased business 
costs that might result from such changes, and any suggestions on ways 
to minimize any potential increased costs or any relevant environmental 
concerns associated with such changes. Individuals and organizations 
may address as many of the following questions as they wish. It is not 
expected that all participants will address all questions.
    1. What additional enforcement activities, if any, regarding the 
present rule are needed to provide adequate public health controls? Are 
there other suggestions for ways to improve compliance with the rule?
    2. Is the present rule at Sec. 589.2000 adequate to meet its 
intended objectives? If not, what are its inadequacies? Are there 
additional objectives that this rule should now address? If so, what 
are these new objectives?
    3. Should the present FDA ban on the use of certain mammalian 
proteins in ruminant feed be broadened? If so, what should the new 
parameters of use be? Should the rule be broadened beyond ruminant 
feed? Beyond mammalian protein?
    4. Should FDA require dedicated facilities for the production of 
animal feed containing mammalian protein to decrease as much as 
possible the possibility of comingling during production?
    5. Should FDA require dedicated transportation of animal feed 
containing mammalian protein to decrease as much as possible the 
possibility of comingling during transport?
    6. In order to improve production practices and increase assurance 
of compliance with the rule, should FDA require FDA licensing of 
renderers and other firms/facilities engaged in the production of 
animal feed containing mammalian protein?
    7. Should FDA revoke or change any/all of the current exclusions 
for certain products allowed in the current rule at 
Sec. 589.2000(a)(1)?
    8. Should FDA add to the list of prohibited material in ruminant 
feed (i.e., add to the definition of ``protein derived from mammalian 
tissues'') poultry litter and other recycled poultry waste products?
    9. Should FDA remove the exemption for pet foods from labeling with 
the precautionary statements?
    10. Should FDA extend its present recordkeeping requirements beyond 
1 year? If so, how many years?
    11. Should FDA change its rule to require labeling of protein-
containing feed to specify what type(s) of mammal was used in the 
production of the protein, e.g. ``porcine MBM'', ``bovine MBM''.
    12. In order to make the statement clearer, should the required 
cautionary statement on the label of products that contain protein 
derived from mammalian tissues and that are intended for use in animal 
feed be changed to read: ``Do not feed to cattle, sheep, goats, bison, 
elk, or deer.''?
    13. What new information is available on potential efficient, 
accurate analytical methods that may be used in detecting mammalian 
proteins, especially the prohibited mammalian proteins, in feed and 
what should the sampling parameters of such a program be?
    14. Regarding enforcing compliance with the rule, what further 
authorities, if any, would be desirable in order to enforce the rule 
adequately (civil monetary penalties?, others?)
    15. Regarding helping to increase compliance with the rule, what 
role, if any, should public or private certification programs play?
    16. Regarding the import of feed, what should the restrictions on 
such import be (country specific? comparison between domestic and 
foreign controls?)
    17. Are there any other additional measures necessary to guard 
against BSE and vCJD in the United States?

[[Page 50931]]

III. Notice of Hearing Under 21 CFR Part 15

    The Commissioner of Food and Drugs is announcing that the public 
hearing will be held in accordance with part 15 (21 CFR part 15). The 
presiding officer will be the Commissioner of Food and Drugs or his 
designee. A panel of government employees with relevant expertise will 
accompany the presiding officer.
    Persons who wish to participate in the part 15 hearing must file a 
written or facsimile notice of participation with Linda Grassie 
(address or fax number above) by 4:30 p.m. eastern time on October 23, 
2001. To ensure timely handling, the outer envelope should be clearly 
marked with Docket No. 01N-0423 and the statement ``Animal Feed Rule 
Hearing.'' Groups should submit two copies. The notice of participation 
should contain the speaker's name, address, telephone number, fax 
number, business affiliation, if any, a brief summary of the 
presentation, and approximate amount of time requested for the 
presentation.
    The agency requests that persons or groups having similar interests 
consolidate their presentations and present them through a single 
representative. FDA will allocate the time available for the hearing 
among the persons who properly file notices of participation. FDA will 
reserve the hour from 4 p.m. to 5 p.m. for those who have not 
registered to present orally at the meeting to make oral presentations 
to the panel.
    After reviewing the notices of participation and accompanying 
information, FDA will schedule each appearance and notify each 
participant by mail, telephone, or fax, of the time allotted to the 
person and the approximate time the person's presentation is scheduled 
to begin. The hearing schedule will be available at the hearing. After 
the hearing, the schedule will be placed on file in the Dockets 
Management Branch (address above) under Docket No. 01N-0423.
    In order to facilitate the efficiency of the hearing process, 
presenters at the hearing should indicate the format in which their 
presentations will be made so that appropriate visual aids can be made 
available. Presenters should note that a hardcopy version of their 
presentations should be submitted to FDA on the day of the hearing for 
inclusion in the official record of the hearing.
    Under Sec. 15.30(f), the hearing is informal and the rules of 
evidence do not apply. The presiding officer and any panel members may 
question any person during or at the conclusion of their presentation. 
No participant may interrupt the presentation of another participant.
    Public hearings under part 15 are subject to FDA's policy and 
procedures (part 10 (21 CFR part 10, subpart C)) for electronic media 
coverage of FDA's public administrative proceedings. Under Sec. 10.205, 
FDA permits persons, subject to certain limitations, to videotape, 
film, or otherwise record FDA's public administrative proceedings, 
including presentations by participants. The hearing will be 
transcribed as required in Sec. 15.30(b).
    Any disabled persons requiring special accommodations in order to 
attend the hearing should direct those needs to the contact person 
listed above.
    To the extent that the conditions for the hearing, as described in 
this notice, conflict with any provisions set out in part 15, this 
notice acts as a waiver of those provisions as specified in 
Sec. 15.30(h).

IV. Request for Comments

    To permit time for all interested persons to submit data, 
information, or views on this subject, interested persons may submit to 
the Dockets Management Branch written comments for this hearing at any 
time; however, the official record of the hearing will remain open to 
receive written comments until November 21, 2001. Such written comments 
can be submitted to the Dockets Management Branch (HFA-305), Animal 
Feed Rule Hearing, Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852, or FAX written comments to the Dockets 
Management Branch, Animal Feed Rule Hearing, 301-827-6870. Two copies 
of any comments are to be submitted, except individuals should submit 
one copy. Comments are to be identified with Docket No. 01N-0423.

V. Transcripts

    Transcripts of the hearing will be available for review at the 
Dockets Management Branch (address above) approximately 30 days 
following the hearing and at http://www.fda.gov.; also orders can be 
placed with Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857.

    Dated: October 1, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-25108 Filed 10-4-01; 8:45 am]
BILLING CODE 4160-01-S