05-11407. Prevention of Salmonella Enteritidis in Shell Eggs During Production; Extension of Comment Period

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Proposed rule; extension of comment period.

SUMMARY:

The Food and Drug Administration (FDA) is extending to July 25, 2005, the comment period for the document that appeared in the Federal Register of May 10, 2005 (70 FR 24490). In the document, FDA reopened the comment period until June 9, 2005, for the agency's proposed rule entitled “Prevention of Salmonella Enteritidis in Shell Eggs During Production” that published in the Federal Register of September 22, 2004 (69 FR 56824). FDA reopened the comment period to receive comment and other information regarding industry practices and programs that prevent Salmonella Enteritidis (SE)-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into laying hen houses. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

DATES:

Submit written or electronic comments by July 25, 2005.

ADDRESSES:

You may submit comments, identified by Docket No. 2000N-0504, by any of the following methods:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
• Agency Web site: http://www.fda.gov/​dockets/​ecomments. Follow the instructions for submitting comments on the agency Web site.
• E-mail: [e-mail]. Include Docket No. 2000N-0504 in the subject line of your e-mail message.
• FAX: [phone].
• Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

Instructions: All submissions received must include the agency name and docket number or regulatory information number for this rulemaking. All comments received will be posted without change to http://www.fda.gov/​ohrms/​dockets/​default.htm, including any personal information provided. For detailed instructions on submitting comments and additional information on the rulemaking process, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document.

Docket: For access to the docket to read background documents or comments received, go to http://www.fda.gov/​ohrms/​dockets/​default.htm and insert the relevant docket number, 2000N-0504, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Lou Carson, Center for Food Safety and Applied Nutrition (HFS-032), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2130.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of May 10, 2005, FDA reopened the comment period until June 9, 2005, for the agency's proposed rule entitled “Prevention of Salmonella Enteritidis in Shell Eggs During Production” that published in the Federal Register of September 22, 2004. FDA reopened the comment period to receive comment and other information regarding industry practices and programs that prevent SE-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into laying hen houses. Specifically, FDA requested additional comment and supportive data or other information on the following questions:

1. How many pullet growing facilities are there in the United States? What is the range in the number of houses on those facilities?

• What percentage of pullet growers are under programs or have practices aimed at preventing SE-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into layer hen houses?
• Do State or regional Egg Quality Assurance Programs include provisions to prevent SE-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into layer hen houses? How effective have the pullet programs (whatever the programs entail—cleaning, testing, etc.) been in reducing the prevalence of SE in layer flocks? How is effectiveness measured?

2. During pullet rearing, what programs or industry practices are currently taken to prevent SE-monitored chicks from becoming infected by SE during the period of pullet rearing until placement into layer hen houses?

• Are pullets, or their environment, tested for SE between the time they are procured as chicks and the time they enter layer houses? If so, when? When tested, approximately how often do pullets or pullet environments test positive? What happens after a positive test?
• Is vaccination used as a preventive measure, if so, when and how?
• What cleaning and disinfecting practices are common?
• Are measures taken to reduce the prevalence of rodents and pests in the pullet rearing houses?

Interested persons were given until June 9, 2005, to submit comments and supportive data or other information.

The agency has received requests for an extension of the reopened comment period. The requests conveyed concern that the current 30-day comment period does not allow sufficient time to develop meaningful responses for submission.

FDA has considered the requests for additional time to submit comments and is extending the reopened comment period for an additional 45 days, until July 25, 2005. The agency believes that a 45-day extension allows adequate time for interested persons to submit comments without significantly delaying the agency's progress in publishing a final rule. However, the agency does not anticipate granting any further extensions of the reopened comment period.

II. Comments

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. Identify comments 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.

Dated: June 1, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.