[Federal Register Volume 74, Number 78 (Friday, April 24, 2009)]
[Rules and Regulations]
[Pages 18626-18628]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-9466]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 589

[Docket No. FDA-2002-N-0031] (formerly Docket No. 2002N-0273)
RIN 0910-AF46


Substances Prohibited From Use in Animal Food or Feed; 
Confirmation of Effective Date of Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; confirmation of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is confirming the 
effective date of April 27, 2009, for the final rule that published in 
the Federal Register of April 25, 2008 (73 FR 22720), entitled 
``Substances Prohibited From Use in Animal Food or Feed.'' The agency 
is also establishing a compliance date of October 26, 2009, for this 
rule in order to allow additional time for renderers to comply with the 
new requirements. This additional time will also give other affected 
persons, including cattle producers and packers, more time to identify 
appropriate methods for disposing of material prohibited from use in 
animal feed by this rule.

DATES: Effective Date: The effective date of the final rule published 
in the Federal Register of April 25, 2008 (73 FR 22720), is April 27, 
2009.
    Compliance Date: The compliance date is October 26, 2009.

FOR FURTHER INFORMATION CONTACT: Burt Pritchett, Center for Veterinary 
Medicine (HFV-222), Food and Drug Administration, 7519 Standish Pl., 
Rockville, MD 20855, 240-453-6860, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of April 25, 2008, FDA published a final 
rule entitled ``Substances Prohibited From Use in Animal Food or Feed'' 
(referred to herein as the April 25, 2008, final rule), that would 
become effective 1 year after the April 27, 2009, date of publication. 
These measures were established to further strengthen existing 
safeguards against bovine spongiform encephalopathy (BSE). FDA recently 
became aware that some affected persons are experiencing difficulties 
modifying their operations to comply with the new requirements 
contained in the April 25, 2008, final

[[Page 18627]]

rule and, therefore, may not be in full compliance by the April 27, 
2009, effective date. Accordingly, in the Federal Register of April 9, 
2009 (74 FR 16160) (referred to herein as the April 9, 2009, proposal), 
FDA published a proposal that would delay the effective date of the 
April 25, 2008, final rule for 60 days and provided a period for public 
comment on this proposal of 7 days.

II. Comments

    The agency received comments from over 400 organizations and 
individuals on the April 9, 2009, proposal. Many comments were received 
from state and national cattle producer organizations, as well as from 
individual cattle producers. A large number of individual consumers 
also submitted comments. Comments were also received from renderers, 
meat processors, dairy organizations, and State agriculture agencies.
    Those opposed to a delay of the effective date primarily cited a 
heightened risk of BSE to U.S. consumers and the U.S. cattle herd from 
imports of live Canadian cattle, particularly those cattle over 30 
months of age. Most of these comments also noted that the current U.S. 
feed ban implemented in 1997 is comparable to the initial Canadian feed 
ban, also implemented in 1997, which, according to these comments, has 
proven to be ineffective at preventing the spread of BSE in Canada. 
This position was echoed in the many comments received from persons 
concerned with Creutzfeldt-Jakob Disease.
    Those in favor of a delay of the effective date cited the need for 
more time to identify alternative methods of disposal of cattle 
material prohibited in animal feed (CMPAF) from slaughter and dead 
stock cattle in areas of the country where rendering services are 
curtailed or no longer available because of the rule. Some renderers 
and dead stock haulers commented that they were choosing to discontinue 
picking up dead cattle due to difficulties complying with the new rule. 
Many of the comments suggested that the proposed 60-day delay was not 
adequate with some comments suggesting delays of 6 months to 1 year. 
Also, a number of comments asked that the effective date be delayed 
indefinitely until the carcass disposal problem was more fully 
resolved. Several comments urged FDA to work with other Government 
agencies to develop a disposal plan for CMPAF and dead stock cattle 
before implementing the rule.

III. Discussion

    FDA continues to believe that the new measures contained in the 
April 25, 2008, final rule are necessary to further strengthen existing 
safeguards against BSE. The underlying bases for these new measures 
were fully considered through the notice and comment rulemaking 
process. (See the October 6, 2005, proposed rule (70 FR 58570) and the 
April 25, 2008, final rule).
    The April 9, 2009, proposal to delay the effective date was issued 
solely for the purpose of considering whether a delay should be 
provided to allow time to address concerns that some entities were not 
adequately prepared to comply with the April 25, 2008, final rule and 
that adequate alternative carcass disposal methods had not been 
developed. Therefore, any delay in the implementation of this rule is 
intended to help address these concerns and is not intended to signal 
that the agency is reconsidering the final rule. Based on the 
significant number of comments that oppose delaying the effective date 
of the April 25, 2008, final rule due to public and animal health 
concerns, FDA is confirming the original April 27, 2009, effective date 
of the final rule. However, although the final rule is effective on 
April 27, 2009, FDA has decided to establish a compliance date of 
October 26, 2009, for those who need it, to help address the compliance 
and implementation concerns.
    In its rulemaking, FDA acknowledged that alternative disposal 
methods for CMPAF and dead stock cattle would be needed for a 
substantial volume of material that would be diverted from animal feed 
use by the new requirements. Accordingly, the rule provided a 12-month 
delayed effective date to allow sufficient time to arrange for 
alternative disposal. Where services to remove brain and spinal cord 
will not be available, such arrangements might include composting dead 
stock cattle, or disposing of dead stock cattle in landfills. To some 
extent, we believe the rendering, livestock, meat, and animal feed 
industries have addressed many of the compliance and carcass disposal 
challenges and are prepared to meet the April 27, 2009, effective date 
of the final rule.
    By affirming the April 27, 2009, effective date, renderers can 
begin putting the new BSE safeguards into place by removing the 
prohibited cattle materials from the animal feed chain. However, it is 
apparent from the comments that a significant number of other 
stakeholders will not be ready to deal effectively with the new 
regulation when it goes into effect on April 27, 2009. In particular, 
smaller entities such as dead stock haulers, small meat processors, and 
some livestock producers have only recently become aware that their 
current disposal arrangements will no longer be available, or will be 
available at increased cost, as a result of the April 25, 2008, final 
rule. In addition, comments from certain State agencies have indicated 
that adequate alternative measures have not yet been developed for 
disposing of animal carcasses, particularly in areas where rendering is 
limited or may no longer be available. Generally, the disposal of 
animal carcasses is regulated at the State and local level. For 
example, State law may dictate whether dead animals can be buried or 
composted, or whether an incinerator needs to be approved before one is 
built. Furthermore, some landfill operators have indicated that they do 
not intend to accept dead animals or CMPAF because they consider it to 
be hazardous material. FDA has consulted with the Environmental 
Protection Agency (EPA) on this issue and EPA has recently published a 
statement on its Web site stating that, under the Resource Conservation 
and Recovery Act (RCRA), EPA considers CMPAF to be solid waste, not 
hazardous waste (http://www.epa.gov/epawaste/nonhaz/municipal/landfill/cattle.htm). (FDA has verified the Web site address, but FDA is not 
responsible for any subsequent changes to the Web site after this 
document publishes in the Federal Register.)
    Based on a consideration of all comments received in response to 
the April 9, 2009, proposal, FDA believes the most appropriate action 
is to confirm the April 27, 2009, effective date, and delay compliance 
until October 26, 2009. Confirming the April 27, 2009, effective date 
conveys the agency's clear intent to move forward with the 
implementation of the new measures. As stated previously, some affected 
parties are prepared to begin implementation. Providing for a 6-month 
delay for compliance acknowledges the significant number of affected 
stakeholders who will require more time to comply with the new 
regulation or adjust to the loss of rendering service. For renderers, 
who are directly impacted by this regulation, this means modifying 
their operations to effectively separate and dispose of CMPAF. For 
cattle producers, who are also impacted by this regulation, this may 
mean finding alternative means of disposing of dead stock cattle if 
rendering services are no longer available to them.

[[Page 18628]]

    FDA acknowledges that carcass disposal problems exist in certain 
states or regions and that developing and implementing adequate 
solutions to these problems is challenging. Furthermore, FDA recognizes 
that in certain circumstances it may be particularly challenging to 
address such disposal problems by the October 26, 2009, compliance 
date. FDA intends to finalize the Draft Small Entities Compliance Guide 
for Renderers that was issued on November 26, 2008. In addition, FDA 
intends to engage in further outreach to the rendering industry, 
pertinent State agencies, and others affected by the rule. FDA is 
committed to working with all affected parties to the extent possible 
to assist efforts in mitigating the impacts associated with 
implementation of the rule.

IV. Conclusion

    At this time, the agency is confirming the April 27, 2009, 
effective date of the final rule published in the Federal Register of 
April 25, 2008, entitled ``Substances Prohibited From Use in Animal 
Food or Feed.'' The agency is also establishing a compliance date of 
October 26, 2009, for this rule in order to allow additional time for 
affected persons to comply with the new requirements.

    Dated: April 21, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-9466 Filed 4-22-09; 11:15 am]
BILLING CODE 4160-01-S