E9-10034. Guidance for Industry: Small Entities Compliance Guide for Renderers-Substances Prohibited From Use in Animal Food or Feed; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry #195 entitled “Small Entities Compliance Guide for Renderers—Substances Prohibited From Use in Animal Food or Feed” This small entities compliance guide aids renderers in complying with the requirements of the final rule published in the Federal Register of April 25, 2008 (73 FR 22720). FDA's goal is to strengthen existing safeguards to prevent the spread of bovine spongiform encephalopathy (BSE) in U.S. cattle and to reduce the risk of human exposure to the BSE agent.

DATES:

Submit written or electronic comments on agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests.

Submit written comments on the guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:

Shannon Jordre, Center for Veterinary Medicine (HFV-230), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-9229, [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of November 26, 2008 (73 FR 72062), FDA published the notice of availability for a draft guidance entitled “Small Entities Compliance Guide for Renderers—Substances Prohibited From Use in Animal Food or Feed” giving interested persons until January 26, 2009, to comment on the draft guidance. FDA received several comments on the draft guidance and those comments were considered as the guidance was finalized. FDA received a number of comments that were outside the scope of the draft guidance, and thus those comments were not addressed in the final version.

The comments raised a number of questions including the following:

• Inquiries from an industry organization regarding the difference between cattle materials prohibited in animal feed (CMPAF) and specified risk materials (SRM);
• Industry requests for clarification on the provisions of the regulation concerning insoluble impurity standards for tallow and how to achieve compliance;
• Whether a certificate of analysis is necessary for each shipment of tallow;
• Whether edible tallow must meet the 0.15 percent insoluble impurities standard for use in ruminant feed, and if so whether this requirement is consistent with FDA's requirement that tallow for human food and cosmetics be free of prohibited material or contain less than 0.15 percent insoluble impurities;
• Whether the impurity standard applies to blended fats and oils;
• Whether a renderer can be held responsible for the impurity level in tallow after it is delivered to a customer's storage tanks;
• Whether the new regulation applies to cattle material fed to mink; and finally,
• A request to use the word “effective” in the guidance when referring to the removal of brains and spinal cords of cattle.

FDA has responded to these comments and concerns in the question and answer portion of the final guidance. The guidance announced in this notice finalizes the draft guidance dated November 25, 2008.

II. Significance of Guidance

This level 1 guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on the topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR 589.2001 have been approved under OMB control number 0910-0627.

IV. Comments

Submit written requests for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

V. Electronic Access

Persons with access to the Internet may obtain the guidance at either http://www.fda.gov/​cvm or http://www.regulations.gov.

Dated: April 27, 2009.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.