Document ID: FDA-2016-N-0321-0015
Agency: fda
Document Type: Notice
Title: 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 Period
Posted Date: 2016-04-22T04:00Z

[Federal Register Volume 81, Number 78 (Friday, April 22, 2016)]
[Notices]
[Pages 23733-23734]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-09367]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0321]

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 Period

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

[[Page 23734]]

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.
[FR Doc. 2016-09367 Filed 4-21-16; 8:45 am]
 BILLING CODE 4164-01-P