[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