FDA Issues Final Guidance for Renderers on BSE, TSE, SRMs

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CVM Update April 30, 2009

FDA Issues Final Guidance for Renderers on Substances Prohibited From Use in Animal Food or Feed

The Food and Drug Administration (FDA) today issued a final guidance document, “Small Entities Compliance Guide for Renderers – Substances Prohibited from use in Animal Food or Feed,” to provide guidance on the requirements of the final rule published in the Federal Register of April 25, 2008. This rule will further protect consumers against bovine spongiform encephalopathy (BSE), otherwise known as ‘mad cow disease.’

The purpose of the guidance document is to help rendering firms comply with the rule that became effective April 27, 2009. The guidance should also help slaughter facilities and farms supplying offal and dead livestock to the renderers understand their obligations under the rule. A copy of the final guidance can be found at http://www.fda.gov/cvm/Guidance/guide195.pdf.

The added measure of excluding high-risk materials from all animal feeds addresses risks associated with accidental feeding of such material to cattle, which could occur through cross-contamination of ruminant feed with non-ruminant feed or feed ingredients during manufacture and transport, or through misfeeding of non-ruminant feed to ruminants on the farm.

Comments on this guidance may be submitted any time to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be submitted electronically at http://www.regulations.gov. All written comments should be identified with Docket No. FDA-2008-D-0597.

For additional information on BSE and the final rule, please see: http://www.fda.gov/cvm/bsetoc.html.

For questions regarding this final document, please contact Shannon Jordre at FDA’s Center for Veterinary Medicine, 240-276-9229, [email protected].

--------------------------------------------------------------------------------

Issued by: FDA, Center for Veterinary Medicine, Communications Staff, HFV-12 7519 Standish Place, Rockville, MD 20855 Telephone: (240) 276-9300 FAX: (240) 276-9115 Internet Web Site: http://www.fda.gov/cvm

http://www.fda.gov/cvm/CVM_Updates/BSEUpdate043009.htm

#195

GUIDANCE FOR INDUSTRY

SMALL ENTITIES COMPLIANCE GUIDE

FOR RENDERERS—SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED

Submit comments on this guidance at any time. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Comments may also be submitted electronically on the Internet at http://www.regulations.gov. All written comments should be identified with Docket No. FDA-2008-D-0597.

For questions regarding this guidance document, contact Shannon Jordre, Division of Compliance (HFV-230), U.S. Food and Drug Administration, Center for Veterinary Medicine, 7519 Standish Place, MPN-4, Rockville, MD 20855, (240) 276-9229.

Additional copies of this guidance document may be requested from the Communications Staff, HFV-12, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, and may be viewed on the Internet at http://www.fda.gov/cvm.

U.S. Department of Health and Human Services Food and Drug Administration Center for Veterinary Medicine April 30, 2009

CONTAINS NON-BINDING RECOMMENDATIONS

Page 2

TABLE OF CONTENTS

I. BACKGROUND.......................................................................................................................3

II. PURPOSE.................................................................................................................................3

III. AGING CATTLE.....................................................................................................................6

IV. BRAIN AND SPINAL CORD REMOVAL............................................................................7

V. RECORDKEEPING..................................................................................................................8

VI. MARKING REQUIREMENTS.............................................................................................10

VII. WASTEWATER FROM RENDERING...............................................................................11

VIII. TALLOW............................................................................................................................12

IX. ENFORCEMENT...................................................................................................................14

CONTAINS NON-BINDING RECOMMENDATIONS

Page 3

GUIDANCE FOR INDUSTRY

SMALL ENTITIES COMPLIANCE GUIDE

FOR RENDERERS—SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED1

This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

I. BACKGROUND

On April 25, 2008, FDA published a final rule in the Federal Register, entitled “Substances Prohibited from Use in Animal Food or Feed” (73 FR 22719). See also 74 FR 18626; April 24, 2009. This final rule established a new regulation at 21 CFR 589.2001 entitled, “Cattle materials prohibited in animal food or feed to prevent the transmission of bovine spongiform encephalopathy” and, amended the previously existing ruminant feed regulation at 21 CFR 589.2000 entitled, “Animal proteins prohibited in animal feed.” FDA has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996 (Public Law 104-121). This document is intended to provide guidance on the requirements of Title 21, Code of Federal Regulations, new Section 589.2001, and amended Section 589.2000.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word “should” in Agency guidances means that something is suggested or recommended, but not required.

II. PURPOSE

WHAT IS THE PURPOSE OF REGULATION 589.2001?

1 This guidance has been prepared by the Office of Surveillance and Compliance in the Center for Veterinary Medicine at the Food and Drug Administration.

CONTAINS NON-BINDING RECOMMENDATIONS

Page 4

This regulation is designed to further strengthen existing safeguards against the establishment and amplification of Bovine Spongiform Encephalopathy (BSE), sometimes referred to as “Mad Cow Disease,” through animal feed. The regulation prohibits the use of certain cattle origin materials in the food or feed of all animals.

The following materials are prohibited in all animal feed by the new rule:

* The entire carcass of 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 effectively removed or otherwise effectively excluded;

*Tallow that is derived from other materials prohibited by this rule that contain more than 0.15 percent insoluble impurities;

and

*Mechanically separated beef that is derived from the materials prohibited by this rule. Throughout the regulation, these materials are referred to as “cattle materials prohibited in animal feed” or CMPAF. If you (i.e., renderers) receive, manufacture, blend, process, or distribute any of these materials, you must comply with the provisions of this regulation (21 CFR 589.2001(c)(2)).

ARE THERE ANY CATTLE MATERIALS SPECIFICALLY EXEMPTED FROM THIS REGULATION?

Yes. The following materials do not fall under the definition of CMPAF:

*Tallow derivatives (as defined in the regulation (See 21 CFR 589.2001(b)(6)).

*Tallow that is derived from material containing the brains and spinal cords of cattle 30 months of age and older if such tallow contains no more than 0.15 percent insoluble impurities.

*Cattle materials (as defined in the regulation (See 21 CFR 589.2001(b)(vi)(C))) from a foreign country that has received designation by FDA as not being subject to the new regulation.

CONTAINS NON-BINDING RECOMMENDATIONS

Page 5

WHAT IS THE DIFFERENCE BETWEEN CATTLE MATERIAL PROHIBITED IN ANIMAL FEED (CMPAF) AND SPECIFIED RISK MATERIAL (SRM)?

SNIP...PLEASE SEE FULL TEXT HERE ;

http://www.fda.gov/cvm/Guidance/guide195.pdf


see full text ;


Thursday, April 30, 2009

FDA Issues Final Guidance for Renderers on Substances Prohibited From Use in Animal Food or Feed CVM Update Back April 30, 2009



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