Friday, April 25, 2008
Substances Prohibited From Use in Animal Food or Feed [Docket No.
2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 589
[Docket No. 2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46
Substances Prohibited From Use in Animal Food or Feed
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the agency's
regulations to prohibit the use of certain cattle origin materials in the
food or feed of all animals. These materials include the following: The
entire carcass of bovine spongiform encephalopathy (BSE)-positive cattle;
the brains and spinal cords from cattle 30 months of age and older; the
entire carcass of cattle not inspected and passed for human consumption that
are 30 months of age or older from which brains and spinal cords were not
removed; tallow that is derived from BSE-positive cattle; tallow that is
derived from other materials prohibited by this rule that contains more than
0.15 percent insoluble impurities; and mechanically separated beef that is
derived from the materials prohibited by this rule. These measures will
further strengthen existing safeguards against BSE.
DATES: This final rule is effective April 27, 2009. The Director of the
Office of the Federal Register approves the incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain publication
in new 21 CFR 589.2001 effective April 27, 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:
Table of Contents
I. Introduction II. Comments on the Proposed Rule A. General Comments B.
Comments on Proposed New Sec. 589.2001--Cattle Materials Prohibited in
Animal Food or Feed C. Comments on Proposed Amendments to Sec.
589.2000--Animal Proteins Prohibited in Ruminant Feed III. Description of
the Final Rule A. Definitions B. Requirements C. Recordkeeping and Access
Requirements D. Changes to Sec. 589.2000--Animal Proteins Prohibited in
Ruminant Feed IV. Analysis of Economic Impacts A. Summary of Final
Regulatory Impact Analysis B. Cost Effectiveness of Final Rule and
Alternatives C. Need for Regulation D. Benefits E. Costs F. Government Costs
G. Sensitivity Analysis H. Regulatory Flexibility Analysis V. The Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) VI. Paperwork
Reduction Act of 1995 VII. Environmental Impact VIII. Federalism IX.
References
I. Introduction
snip...see different commentors and replies back ;
(Comment 6) A few comments asked FDA to recognize that the USDA 18- month
surveillance snapshot may not be an accurate indication of BSE prevalence in
the United States. Specifically, because the BSE cases to date are likely
clustered in time and location, USDA's surveillance results may
underestimate the true risk.
(Response) FDA stated in the preamble to the proposed rule that the
detection of one BSE case in over 418,000 samples analyzed under USDA's
enhanced surveillance program at the time of the publication of the proposed
rule indicates that the prevalence of BSE is very low in the U.S. cattle
population. FDA notes that USDA has conducted surveillance for BSE since
1990. A July 20, 2006, USDA report entitled ``An Estimate of the Prevalence
of BSE in the United States'' supports FDA's qualitative statement of a very
low prevalence of BSE in the United States (Ref. 3). According to the
report, a model developed in Europe was used to calculate U.S. BSE
prevalence from two BSE cases detected in 735,213 samples collected over a
7-year period ending in March 2006. Results of this analysis support a
conclusion that the prevalence of BSE in the U.S. cattle population is less
than one infected animal per million adult cattle. FDA remains confident in
the two models used by USDA. The most likely values calculated by these
models for the estimated number of cases were 4 or 7 infected animals out of
42 million adult cattle. USDA's analysis was submitted to the scrutiny of a
peer review process, and the expert panel agreed with the appropriateness of
USDA's assumptions and the factors it considered, as well as with the
estimate of BSE prevalence.
(Comment 7) One comment noted that the effectiveness of the feed ban,
especially at the farm level, is not known.
(Response) Inspection results indicate that compliance by U.S. animal feed
industry is high. However, FDA agrees that it is very difficult to assess
compliance with the ruminant feed rule at the farm level. FDA believes
excluding certain cattle-derived risk materials from all animal feed
channels will minimize any residual risks from on- farm misfeeding.
(Comment 8) Two comments indicated that the agency's feed control measures
for ensuring compliance with the 1997 ruminant feed rule have been
inadequate, citing a Government Accountability Office (GAO) study as
evidence.
(Response) FDA disagrees with these comments. FDA believes its enforcement
activities are adequate for ensuring industry compliance with the 1997
ruminant feed rule. The agency's response to the GAO's study can be found in
Appendix VI of the GAO's report (Ref. 4).
(Comment 9) One comment speculated that, in some species, atypical BSE might
be more pathogenic than typical BSE.
(Response) FDA is not aware of any scientific evidence that atypical BSE is
[[Page 22724]]
more pathogenic than typical BSE. Therefore, the agency believes that the
controls in this final rule are appropriate.
full text ;
http://edocket.access.gpo.gov/2008/08-1180.htm
========================PLEASE NOTE TSS 2008=====================
***2008 Atypical forms of BSE have emerged which, although rare, appear to
be more virulent than the classical BSE that causes vCJD.
Pierluigi Gambetti, MD Director, National Prion Disease Pathology
Surveillance Center
Stephen M. Sergay, MB, BCh President, American Academy of Neurology
Progress Report from the National Prion Disease Pathology Surveillance
Center An Update from Stephen M. Sergay, MB, BCh & Pierluigi Gambetti, MD
April 3, 2008
http://www.aan.com/news/?event=read&article_id=4397&page=72.45.45
=======================PLEASE NOTE TSS 2008======================
April 25, 2008
Strengthening Beef Safety
The Food and Drug Administration (FDA) has issued a final regulation barring
certain cattle materials from all animal feed, including pet food. FDA
regulates animal feed and drugs. The U.S. Department of Agriculture (USDA)
regulates meat. Together the agencies enforce regulations that ensure that
specific risk materials are kept out of the human food supply.
http://www.fda.gov/consumer/updates/beefsafety042508.html
Greetings again,
IS this strengthening beef safety, or dangling another carrot out in front
of the consumer $$$
*** DO NOT forget what was originally promised years ago !!!
Press Release FOR IMMEDIATE RELEASE Monday, Jan. 26, 2004 FDA Press Office
301-827-6242
Expanded "Mad Cow" Safeguards Announced to Strengthen Existing Firewalls
Against BSE Transmission HHS Secretary Tommy G. Thompson today announced
several new public health measures, to be implemented by the Food and Drug
Administration (FDA), to strengthen significantly the multiple existing
firewalls that protect Americans from exposure to the agent thought to cause
bovine spongiform encephalopathy (BSE, also known as mad cow disease) and
that help prevent the spread of BSE in U.S. cattle.
snip...please see full text ;
http://madcowfeed.blogspot.com/2008/04/substances-prohibited-from-use-in.html
TSS
Substances Prohibited From Use in Animal Food or Feed [Docket No.
2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 589
[Docket No. 2002N-0273] (Formerly Docket No. 02N-0273) RIN 0910-AF46
Substances Prohibited From Use in Animal Food or Feed
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is amending the agency's
regulations to prohibit the use of certain cattle origin materials in the
food or feed of all animals. These materials include the following: The
entire carcass of bovine spongiform encephalopathy (BSE)-positive cattle;
the brains and spinal cords from cattle 30 months of age and older; the
entire carcass of cattle not inspected and passed for human consumption that
are 30 months of age or older from which brains and spinal cords were not
removed; tallow that is derived from BSE-positive cattle; tallow that is
derived from other materials prohibited by this rule that contains more than
0.15 percent insoluble impurities; and mechanically separated beef that is
derived from the materials prohibited by this rule. These measures will
further strengthen existing safeguards against BSE.
DATES: This final rule is effective April 27, 2009. The Director of the
Office of the Federal Register approves the incorporation by reference in
accordance with 5 U.S.C. 552(a) and 1 CFR part 51 of a certain publication
in new 21 CFR 589.2001 effective April 27, 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:
Table of Contents
I. Introduction II. Comments on the Proposed Rule A. General Comments B.
Comments on Proposed New Sec. 589.2001--Cattle Materials Prohibited in
Animal Food or Feed C. Comments on Proposed Amendments to Sec.
589.2000--Animal Proteins Prohibited in Ruminant Feed III. Description of
the Final Rule A. Definitions B. Requirements C. Recordkeeping and Access
Requirements D. Changes to Sec. 589.2000--Animal Proteins Prohibited in
Ruminant Feed IV. Analysis of Economic Impacts A. Summary of Final
Regulatory Impact Analysis B. Cost Effectiveness of Final Rule and
Alternatives C. Need for Regulation D. Benefits E. Costs F. Government Costs
G. Sensitivity Analysis H. Regulatory Flexibility Analysis V. The Small
Business Regulatory Enforcement Fairness Act of 1996 (SBREFA) VI. Paperwork
Reduction Act of 1995 VII. Environmental Impact VIII. Federalism IX.
References
I. Introduction
snip...see different commentors and replies back ;
(Comment 6) A few comments asked FDA to recognize that the USDA 18- month
surveillance snapshot may not be an accurate indication of BSE prevalence in
the United States. Specifically, because the BSE cases to date are likely
clustered in time and location, USDA's surveillance results may
underestimate the true risk.
(Response) FDA stated in the preamble to the proposed rule that the
detection of one BSE case in over 418,000 samples analyzed under USDA's
enhanced surveillance program at the time of the publication of the proposed
rule indicates that the prevalence of BSE is very low in the U.S. cattle
population. FDA notes that USDA has conducted surveillance for BSE since
1990. A July 20, 2006, USDA report entitled ``An Estimate of the Prevalence
of BSE in the United States'' supports FDA's qualitative statement of a very
low prevalence of BSE in the United States (Ref. 3). According to the
report, a model developed in Europe was used to calculate U.S. BSE
prevalence from two BSE cases detected in 735,213 samples collected over a
7-year period ending in March 2006. Results of this analysis support a
conclusion that the prevalence of BSE in the U.S. cattle population is less
than one infected animal per million adult cattle. FDA remains confident in
the two models used by USDA. The most likely values calculated by these
models for the estimated number of cases were 4 or 7 infected animals out of
42 million adult cattle. USDA's analysis was submitted to the scrutiny of a
peer review process, and the expert panel agreed with the appropriateness of
USDA's assumptions and the factors it considered, as well as with the
estimate of BSE prevalence.
(Comment 7) One comment noted that the effectiveness of the feed ban,
especially at the farm level, is not known.
(Response) Inspection results indicate that compliance by U.S. animal feed
industry is high. However, FDA agrees that it is very difficult to assess
compliance with the ruminant feed rule at the farm level. FDA believes
excluding certain cattle-derived risk materials from all animal feed
channels will minimize any residual risks from on- farm misfeeding.
(Comment 8) Two comments indicated that the agency's feed control measures
for ensuring compliance with the 1997 ruminant feed rule have been
inadequate, citing a Government Accountability Office (GAO) study as
evidence.
(Response) FDA disagrees with these comments. FDA believes its enforcement
activities are adequate for ensuring industry compliance with the 1997
ruminant feed rule. The agency's response to the GAO's study can be found in
Appendix VI of the GAO's report (Ref. 4).
(Comment 9) One comment speculated that, in some species, atypical BSE might
be more pathogenic than typical BSE.
(Response) FDA is not aware of any scientific evidence that atypical BSE is
[[Page 22724]]
more pathogenic than typical BSE. Therefore, the agency believes that the
controls in this final rule are appropriate.
full text ;
http://edocket.access.gpo.gov/2008/08-1180.htm
========================PLEASE NOTE TSS 2008=====================
***2008 Atypical forms of BSE have emerged which, although rare, appear to
be more virulent than the classical BSE that causes vCJD.
Pierluigi Gambetti, MD Director, National Prion Disease Pathology
Surveillance Center
Stephen M. Sergay, MB, BCh President, American Academy of Neurology
Progress Report from the National Prion Disease Pathology Surveillance
Center An Update from Stephen M. Sergay, MB, BCh & Pierluigi Gambetti, MD
April 3, 2008
http://www.aan.com/news/?event=read&article_id=4397&page=72.45.45
=======================PLEASE NOTE TSS 2008======================
April 25, 2008
Strengthening Beef Safety
The Food and Drug Administration (FDA) has issued a final regulation barring
certain cattle materials from all animal feed, including pet food. FDA
regulates animal feed and drugs. The U.S. Department of Agriculture (USDA)
regulates meat. Together the agencies enforce regulations that ensure that
specific risk materials are kept out of the human food supply.
http://www.fda.gov/consumer/updates/beefsafety042508.html
Greetings again,
IS this strengthening beef safety, or dangling another carrot out in front
of the consumer $$$
*** DO NOT forget what was originally promised years ago !!!
Press Release FOR IMMEDIATE RELEASE Monday, Jan. 26, 2004 FDA Press Office
301-827-6242
Expanded "Mad Cow" Safeguards Announced to Strengthen Existing Firewalls
Against BSE Transmission HHS Secretary Tommy G. Thompson today announced
several new public health measures, to be implemented by the Food and Drug
Administration (FDA), to strengthen significantly the multiple existing
firewalls that protect Americans from exposure to the agent thought to cause
bovine spongiform encephalopathy (BSE, also known as mad cow disease) and
that help prevent the spread of BSE in U.S. cattle.
snip...please see full text ;
http://madcowfeed.blogspot.com/2008/04/substances-prohibited-from-use-in.html
TSS