Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability; Extension of the Comment Period, 24693-24694 [2013-09762]

Download as PDF Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Proposed Rules II. Paperwork Reduction Act of 1995 Interested persons may either submit electronic comments regarding the information collection to oira_submission@omb.eop.gov or fax written comments to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285. All comments should be identified with the title ‘‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.’’ III. Request for Comments Interested persons may submit either electronic comments regarding the proposed rule to http:// www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. 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, and will be posted to the docket at http:// www.regulations.gov. Dated: April 22, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–09761 Filed 4–24–13; 11:15 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 117 [Docket No. FDA–2012–N–1258] Draft Qualitative Risk Assessment of Risk of Activity/Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability; Extension of the Comment Period AGENCY: Food and Drug Administration, HHS. Notification; extension of comment period. ACTION: The Food and Drug Administration (FDA or we) is extending the comment period for a document that we made available for public comment by notification in the Federal Register of January 16, 2013. We are taking this action to make the comment period for the draft RA conform to the comment period for proposed rules entitled ‘‘Current Good Manufacturing Practice and Hazard erowe on DSK2VPTVN1PROD with PROPOSALS-1 SUMMARY: VerDate Mar<15>2010 14:46 Apr 25, 2013 Jkt 229001 Analysis and Risk-Based Preventive Controls for Human Food’’ (the proposed preventive controls rule) and ‘‘Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption’’ (the proposed produce safety rule). Elsewhere in this issue of the Federal Register, we are announcing a 120-day extension of the comment period for the proposed preventive controls rule and the proposed produce safety rule. DATES: The comment period for the document published January 16, 2013, at 78 FR 3824, reopened March 13, 2013, at 78 FR 15894, is extended. Submit either electronic or written comments by September 16, 2013. ADDRESSES: Submit electronic comments to http:// www.regulations.gov. Submit written comments to Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety and Applied Nutrition (HFS–300), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240– 402–2166. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of January 16, 2013 (78 FR 3824), we published a notification with a 30-day comment period announcing the availability of, and requesting comment on, a document entitled ‘‘Draft Qualitative Risk Assessment of Risk of Activity/ Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm.’’ The purpose of the draft RA is to provide a science-based risk analysis of those activity/food combinations that would be considered low risk. Interested persons were originally given until February 15, 2013, to comment on the draft RA. We conducted this draft RA to satisfy requirements of the FDA Food Safety Modernization Act (FSMA) (Pub. L. 111–353) to conduct a science-based risk analysis and to consider the results of that analysis in rulemaking that is required by FSMA. In the Federal Register of January 16, 2013 (78 FR 3824), we announced that we had used the results of the draft RA to propose to exempt certain food facilities (i.e., those that are small or very small businesses that are engaged only in specific types of on-farm manufacturing, processing, packing, or holding activities identified in the draft RA as low-risk activity/food combinations) from the proposed PO 00000 Frm 00005 Fmt 4702 Sfmt 4702 24693 requirements of the Federal Food, Drug, and Cosmetic Act for hazard analysis and risk-based preventive controls (the proposed preventive controls rule). Interested persons were originally given until May 16, 2013, to comment on the proposed preventive controls rule. We previously received requests to allow interested persons additional time to comment on the draft RA. Two requesters had considered that the comment period for the draft RA should conform to the comment period of the proposed preventive controls rule. (One of these requesters further requested that the comment period conform to that of the proposed produce safety rule, which published in the Federal Register of January 16, 2013 (78 FR 3504), and other major rulemakings that we would be conducting under FSMA but were not yet published.) We considered the requests and reopened the comment period for the draft RA until May 16, 2013—i.e., the same date as that for the proposed preventive controls rule and the proposed produce safety rule (Federal Register of March 13, 2013, 78 FR 15894). We have now received comments requesting an extension of the comment period on the proposed preventive controls rule and the proposed produce safety rule. Each request conveyed concern that the current 120-day comment period does not allow sufficient time to develop a meaningful or thoughtful response to those proposed rules. We have considered the requests and, elsewhere in this issue of the Federal Register, we are granting a 120-day extension of the comment period for those proposed rules. We are extending the comment period for the draft RA for 120 days to continue to make the comment period for the draft RA conform to the comment period for the proposed preventive controls rule and the proposed produce safety rule. II. Request for Comments Interested persons may submit either electronic comments regarding the draft RA to http://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. 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, and will be posted to the docket at http:// www.regulations.gov. E:\FR\FM\26APP1.SGM 26APP1 24694 Federal Register / Vol. 78, No. 81 / Friday, April 26, 2013 / Proposed Rules Dated: April 22, 2013. Leslie Kux, Assistant Commissioner for Policy. Executive Summary I. Purpose of the Regulatory Action [FR Doc. 2013–09762 Filed 4–24–13; 11:15 am] BILLING CODE 4160–01–P DEPARTMENT OF DEFENSE Office of the Secretary 32 CFR Part 60 [Docket ID DOD–2008–OS–0128] RIN 0790–AI40 Family Advocacy Command Assistance Team (FACAT) Office of the Under Secretary of Defense for Personnel and Readiness, DoD. ACTION: Proposed rule. AGENCY: This part updates Department of Defense (DoD) policy and responsibilities and prescribes procedures for the implementation and use of the FACAT in accordance with 10 U.S.C. 1794. It is DoD policy to provide a safe and secure environment for DoD personnel and their families by promoting the prevention, early identification, and intervention in all allegations of child abuse and neglect. DATES: Comments must be received by June 25, 2013. ADDRESSES: You may submit comments, identified by docket number and/or RIN number and title, by any of the following methods: • Federal Rulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. • Mail: Federal Docket Management System Office, 4800 Mark Center Drive, East Tower, Suite 02G09, Alexandria, VA 22350–3100. Instructions: All submissions received must include the agency name and docket number or Regulatory Information Number (RIN) for this Federal Register document. The general policy for comments and other submissions from members of the public is to make these submissions available for public viewing on the Internet at http://www.regulations.gov as they are received without change, including any personal identifiers or contact information. erowe on DSK2VPTVN1PROD with PROPOSALS-1 SUMMARY: FOR FURTHER INFORMATION CONTACT: Mary Campise, 571–372–5346. SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 14:46 Apr 25, 2013 Jkt 229001 To establish DoD policy, assign responsibilities, and prescribe procedures for implementation and use of the multi-disciplinary Family Advocacy Command Assistant Team to respond to allegations of child sexual abuse in DoD-sanctioned childcare and youth activities. a. The need for the regulatory action and how the action will meet that need. Child sexual abuse allegations in DoD-sanctioned childcare and youth activities require a coordinated community response between law enforcement, child protection agencies, and the setting from which the allegation arose. Local teams who may not be sufficiently resourced to conduct large scale investigations and coordinate an effective multi-level response can request the deployment and support of the FACAT to foster cooperation among the DoD, other Federal agencies, and responsible civilian authorities when addressing allegations of child sexual abuse in DoD-sanctioned activities; promote timely and comprehensive reporting of all allegations; and actively seek prosecution of alleged perpetrators to the fullest extent of the law. b. Succinct statement of legal authority for the regulatory action (explaining, in brief, the legal authority laid out later in the preamble). Section 1794 of title 10, United States Code (U.S.C.) requires the Secretary of Defense to maintain a special task force to respond to allegations of widespread child abuse at a military installation. The task force shall be composed of personnel from appropriate disciplines, including, medicine, psychology, and child development. This task force will provide assistance to the commander of the installation, and to parents at the installation, to effectively deal with the allegations. II. Summary of the Major Provisions of the Regulatory Action in Question a. This regulatory action establishes a DoD multi-disciplinary Family Advocacy Command Assistant Team (FACAT) to support local installation personnel in responding to extrafamilial child sexual abuse allegations in DoD sanctioned childcare and youth activities. b. The deployment of the FACAT provides a coordinated and comprehensive DoD response to assist the Military Department upon DoD Component request to address allegations when local resources are limited. PO 00000 Frm 00006 Fmt 4702 Sfmt 4702 c. The goal of the FACAT is to foster cooperation among the DoD, other Federal agencies, and responsible civilian authorities when addressing allegations of extrafamilial child sexual abuse in DoD-sanctioned activities, to ensure the timely and comprehensive reporting of all incidents to the appropriate authorities, and to seek prosecution of alleged perpetrators to the fullest extent of the law when appropriate. III. Costs and Benefits The benefit to the Department and to the public is to provide safe and secure environments for children of DoD personnel and their families by promoting a coordinated community response to allegations of child sexual abuse arising in DoD-sanctioned childcare and youth activities settings. The deployment of the FACAT to support local communities ensures that alleged offenders are identified, assessed, investigated, and prosecuted to the full extent of the law. Further, the multidisciplinary and well-coordinated approach promotes the identification of all potential child victims and provides a safe and secure setting for these children to be interviewed, assessed, and supported. Per Section 1794 of Title 10, United States Code, this rule has an internal reporting requirement that will cost the Department of Defense $600 annually. Costs for this program include salaries of government employees, training costs of approximately $30,000 every three years, and up to $15,000 to deploy a FACAT of five team members per response. There were no FACATs deployed in FY 2011, and there was one FACAT deployed in FY 2010. The cost of the FY 2010 deployment was approximately $7,500. Executive Order 12866, ‘‘Regulatory Planning and Review’’ and Executive Order 13563, ‘‘Improving Regulation and Regulatory Review’’ It has been certified that 32 CFR part 60 does not: (1) Have an annual effect on the economy of $100 million or more or adversely affect in a material way the economy; a section of the economy; productivity; competition; jobs; the environment; public health or safety; or State, local, or tribal governments or communities; (2) Create a serious inconsistency or otherwise interfere with an action taken or planned by another Agency; (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs, or the rights and obligations of recipients thereof; or E:\FR\FM\26APP1.SGM 26APP1

Agencies

[Federal Register Volume 78, Number 81 (Friday, April 26, 2013)]
[Proposed Rules]
[Pages 24693-24694]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-09762]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 117

[Docket No. FDA-2012-N-1258]


Draft Qualitative Risk Assessment of Risk of Activity/Food 
Combinations for Activities (Outside the Farm Definition) Conducted in 
a Facility Co-Located on a Farm; Availability; Extension of the Comment 
Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the 
comment period for a document that we made available for public comment 
by notification in the Federal Register of January 16, 2013. We are 
taking this action to make the comment period for the draft RA conform 
to the comment period for proposed rules entitled ``Current Good 
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive 
Controls for Human Food'' (the proposed preventive controls rule) and 
``Standards for the Growing, Harvesting, Packing, and Holding of 
Produce for Human Consumption'' (the proposed produce safety rule). 
Elsewhere in this issue of the Federal Register, we are announcing a 
120-day extension of the comment period for the proposed preventive 
controls rule and the proposed produce safety rule.

DATES: The comment period for the document published January 16, 2013, 
at 78 FR 3824, reopened March 13, 2013, at 78 FR 15894, is extended. 
Submit either electronic or written comments by September 16, 2013.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written comments to Division of Dockets Management (HFA-305), 
Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, 
MD 20852.

FOR FURTHER INFORMATION CONTACT: Jenny Scott, Center for Food Safety 
and Applied Nutrition (HFS-300), Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-2166.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of January 16, 2013 (78 FR 3824), we 
published a notification with a 30-day comment period announcing the 
availability of, and requesting comment on, a document entitled ``Draft 
Qualitative Risk Assessment of Risk of Activity/Food Combinations for 
Activities (Outside the Farm Definition) Conducted in a Facility Co-
Located on a Farm.'' The purpose of the draft RA is to provide a 
science-based risk analysis of those activity/food combinations that 
would be considered low risk. Interested persons were originally given 
until February 15, 2013, to comment on the draft RA.
    We conducted this draft RA to satisfy requirements of the FDA Food 
Safety Modernization Act (FSMA) (Pub. L. 111-353) to conduct a science-
based risk analysis and to consider the results of that analysis in 
rulemaking that is required by FSMA. In the Federal Register of January 
16, 2013 (78 FR 3824), we announced that we had used the results of the 
draft RA to propose to exempt certain food facilities (i.e., those that 
are small or very small businesses that are engaged only in specific 
types of on-farm manufacturing, processing, packing, or holding 
activities identified in the draft RA as low-risk activity/food 
combinations) from the proposed requirements of the Federal Food, Drug, 
and Cosmetic Act for hazard analysis and risk-based preventive controls 
(the proposed preventive controls rule). Interested persons were 
originally given until May 16, 2013, to comment on the proposed 
preventive controls rule.
    We previously received requests to allow interested persons 
additional time to comment on the draft RA. Two requesters had 
considered that the comment period for the draft RA should conform to 
the comment period of the proposed preventive controls rule. (One of 
these requesters further requested that the comment period conform to 
that of the proposed produce safety rule, which published in the 
Federal Register of January 16, 2013 (78 FR 3504), and other major 
rulemakings that we would be conducting under FSMA but were not yet 
published.) We considered the requests and reopened the comment period 
for the draft RA until May 16, 2013--i.e., the same date as that for 
the proposed preventive controls rule and the proposed produce safety 
rule (Federal Register of March 13, 2013, 78 FR 15894).
    We have now received comments requesting an extension of the 
comment period on the proposed preventive controls rule and the 
proposed produce safety rule. Each request conveyed concern that the 
current 120-day comment period does not allow sufficient time to 
develop a meaningful or thoughtful response to those proposed rules. We 
have considered the requests and, elsewhere in this issue of the 
Federal Register, we are granting a 120-day extension of the comment 
period for those proposed rules. We are extending the comment period 
for the draft RA for 120 days to continue to make the comment period 
for the draft RA conform to the comment period for the proposed 
preventive controls rule and the proposed produce safety rule.

II. Request for Comments

    Interested persons may submit either electronic comments regarding 
the draft RA to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. 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, and will be posted to the docket at http://www.regulations.gov.


[[Page 24694]]


    Dated: April 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-09762 Filed 4-24-13; 11:15 am]
BILLING CODE 4160-01-P