06-9927. Draft Animal Cloning Risk Assessment; Proposed Risk Management Plan; Draft Guidance for Industry; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of, and is requesting comment on, a draft risk assessment on animal cloning. FDA's Center for Veterinary Medicine (CVM) developed this draft risk assessment to evaluate the health risks to animals involved in the process of cloning and to evaluate the food consumption risks that may result from edible products derived from animal clones or their progeny. FDA is also announcing the availability of, and is requesting comment on, a proposed risk management plan for animal clones and their progeny. The proposed risk management plan takes into account the risks identified in the draft risk assessment and sets out proposed measures that FDA might use to manage those risks. In addition, FDA is announcing availability of draft guidance for industry #179 for public comment. This draft guidance describes FDA's recommendations regarding the use of edible products from animal clones and their progeny in human food or in animal feed.

DATES:

Submit written or electronic comments on the draft risk assessment document, the proposed risk management plan, and the draft guidance for industry by April 3, 2007. FDA will accept comments, data, and information after the deadline, but to ensure consideration by the agency in any final documents, comments must be received by this date. Comments on agency guidance documents are welcome at any time.

ADDRESSES:

Submit written requests for single copies of the draft risk assessment, proposed risk management plan, or the draft guidance for industry to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send a self-addressed, adhesive label to assist that office in processing your request. Submit written comments on the draft risk assessment, proposed risk management plan, or draft guidance for industry to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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.fda.gov/​dockets/​ecomments. See the SUPPLEMENTARY INFORMATION section for electronic access to the documents.

FOR FURTHER INFORMATION CONTACT:

Larisa Rudenko, Center for Veterinary Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-453-6842, e-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

I. Background

In July 2001, FDA's CVM issued an update on livestock cloning (available at http://www.fda.gov/​cvm/​CVM_​Updates/​clones.htm) and indicated its intention to work with stakeholders to assess potential risks presented by cloning food-producing animals. It also requested that companies voluntarily refrain from introducing animal clones, their progeny, or their food products (such as milk or meat) into the human or animal food supply, pending completion of the risk assessment process. The public participation phase of this process begins with the release of draft documents entitled “Animal Cloning: A Draft Risk Assessment,” “Animal Cloning: Proposed Risk Management Plan for Clones and Their Progeny,” and “Draft Guidance for Industry #179: Use of Edible Products From Animal Clones or Their Progeny for Human Food or Animal Feed.”

Among the goals of our draft risk assessment were the determination of whether somatic cell nuclear transfer (SCNT), the process used to produce the clones being considered in the risk assessment, poses any unique risks to animals involved in cloning relative to other assisted reproductive technologies, and whether foods derived from animal clones or their progeny pose consumption risks greater than those posed by foods derived from their conventional counterparts. It specifically does not consider risk issues that may be posed by genetically engineered animals.

The draft risk assessment has been peer reviewed in accordance with the Office of Management and Budget's Information Quality Peer Review Bulletin. The peer reviewers' comments and the agency's response to them are posted on the Internet with the draft risk assessment (see the Electronic Access section of this document).

The proposed risk management plan describes proposed measures that the agency might use to address animal health and food consumption risks identified in the draft risk assessment that are within the agency's purview. It also describes the agency's plans with regard to issues that are not within the agency's authority to manage (e.g., ethics) regarding animal cloning.

The draft guidance for industry describes FDA's recommendations regarding the introduction of edible products from animal clones and their progeny into the food and feed supply. FDA will consider information received during the comment period in its preparation of a final risk assessment. To that end, FDA requests that any producers or breeders of clones who have additional data on the health of the clones or their progeny or composition of food products (i.e., meat or milk) derived from clones or their progeny share those data with us. Additionally, the agency reiterates that the release of these draft documents does not affect its request to industry to continue to refrain from introducing food products from clones and their progeny into the marketplace.

II. Significance of Guidance

The draft guidance for industry is a level 1 draft guidance that is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance represents the agency's current thinking on the topic. The draft guidance document does not create or confer any rights for or on any person and will not operate to bind FDA or the public. Alternative methods may be used as long as they satisfy the requirements of the applicable statutes and regulations.

III. Comments

Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments regarding the draft risk assessment document, the proposed risk management plan, and the draft guidance for industry. For convenience in reviewing the comments, FDA requests that comments be separately identified as to which document they address. 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.

IV. Electronic Access

Persons with access to the Internet may obtain the documents at http://www.fda.gov/​cvm/​cloning.htm. In an effort to better ensure broad awareness of this Federal Register notice, FDA will announce it and make copies available through the FDA Dockets Listserv (http://www.fda.gov/​ohrms/​dockets/​FDAMAIL/​DMBemaillist.htm). To be added to any of FDA's free e-mail subscription services go to http://www.fda.gov. Click on “Subscribe to FDA's E-mail Lists,” then follow the instructions provided.

Dated: August 18, 2006.

Jeffrey Shuren,

Assistant Commissioner for Policy.