2016-09367. Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin; Request for Scientific Data, Information, and Comments; Extension of Comment ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice; request for comments and for scientific data and information; extension of comment period.

SUMMARY:

The Food and Drug Administration (FDA or we) is extending the comment period for the notice entitled “Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin; Request for Scientific Data, Information, and Comments” that appeared in the Federal Register of March 4, 2016. The notice requested scientific data, information, and comments that would assist in the development of a risk assessment for produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin (including raw manure). We are taking this action for an extension to allow interested persons additional time to submit comments.

DATES:

Submit either electronic or written comments by July 5, 2016.

ADDRESSES:

You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:

• Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov.
• If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).

Written/Paper Submissions

Submit written/paper submissions as follows:

• Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”

Instructions: All submissions received must include the Docket No. FDA-2016-N-0321 for “Risk Assessment of Foodborne Illness Associated With Pathogens From Produce Grown in Fields Amended With Untreated Biological Soil Amendments of Animal Origin; Request for Scientific Data, Information, and Comments.” Received comments will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

• Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.fda.gov/​regulatoryinformation/​dockets/​default.htm.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in the heading of this document, 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:

Jane Van Doren, Center for Food Safety and Applied Nutrition (HFS-005), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-402-2927.

SUPPLEMENTARY INFORMATION:

In the Federal Register of March 4, 2016 (81 FR 11572), we published a notice entitled “Risk Assessment of Foodborne Illness Associated with Pathogens from Produce Grown in Fields Amended with Untreated Biological Soil Amendments of Animal Origin; Request for Scientific Data, Information, and Comments.” The notice requested scientific data, information, and comments that would assist us in our plan to develop a risk assessment for produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin (BSAAO) (including raw manure). The risk assessment will evaluate and, if feasible, quantify the risk of human illness associated with consumption of produce grown in fields or other growing areas amended with untreated biological soil amendments of animal origin that are potentially contaminated with enteric pathogens, such as Escherichia coli O157:H7 or Salmonella. The risk assessment also will evaluate the impact of certain interventions, such as use of a time interval between application of the soil amendment and crop harvest, on the predicted risk. The risk assessment is intended to inform policy decisions with regard to produce safety.

We received multiple requests for an extension of the comment period. The requests conveyed concern that the original 60-day comment period does not allow sufficient time to provide the scientific data, information, and comments described in the notice. We have considered the requests and are extending the comment period for the notice until July 5, 2016. We believe that a 60-day extension allows adequate time for interested persons to submit comments without significantly delaying rulemaking on these important issues.

Dated: April 18, 2016.

Leslie Kux,

Associate Commissioner for Policy.