Draft Qualitative Risk Assessment of Risk of Activity/Animal Food Combinations for Activities (Outside the Farm Definition) Conducted in a Facility Co-Located on a Farm; Availability; Extension of Comment Period, 6116-6117 [2014-02112]
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6116
Federal Register / Vol. 79, No. 22 / Monday, February 3, 2014 / Proposed Rules
CIVIL MONETARY PENALTIES AUTHORITIES ADMINISTERED BY FDA AND ADJUSTED MAXIMUM PENALTY AMOUNTS—
Continued
U.S.C. section
Former
maximum
penalty
amount
(in dollars)
360pp(b)(1) .........................
355,000
Date of
last penalty
figure or
adjustment
Assessment method
For any related series of violations ......................................
Adjusted
maximum
penalty
amount
(in dollars)
2013
375,000
2008
2013
11,000
130,000
42 U.S.C.
263b(h)(3) ...........................
300aa–28(b)(1) ...................
1 Not
11,000
120,000
adjusted.
3. In § 17.5, revise paragraph (a) to
read as follows:
■
§ 17.5
Complaint.
(a) The Center with principal
jurisdiction over the matter involved
shall begin all administrative civil
money penalty actions by serving on the
respondent(s) a complaint signed by the
Office of the Chief Counsel attorney for
the Center and by filing a copy of the
complaint with the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. For a civil
money penalty action against retailers of
tobacco products, the complaint may be
signed by any Agency employee
designated by the Chief Counsel.
*
*
*
*
*
Dated: January 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–02149 Filed 1–31–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 507
[Docket No. FDA–2013–N–1043]
Draft Qualitative Risk Assessment of
Risk of Activity/Animal Food
Combinations for Activities (Outside
the Farm Definition) Conducted in a
Facility Co-Located on a Farm;
Availability; Extension of Comment
Period
mstockstill on DSK4VPTVN1PROD with PROPOSALS
Per violation ..........................................................................
Per occurrence .....................................................................
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 we made available for public
SUMMARY:
VerDate Mar<15>2010
16:26 Jan 31, 2014
Jkt 232001
comment in the Federal Register of
October 29, 2013 (78 FR 64428) (the
draft RA). We are taking this action to
make the comment period for the draft
RA conform to the comment period for
proposed rule entitled ‘‘Current Good
Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive
Controls for Food for Animals’’ (the
proposed preventive controls rule for
food for animals).
DATES: FDA is extending the comment
period on the draft RA. Submit either
electronic or written comments by
March 31, 2014.
ADDRESSES: You may submit comments,
identified by Docket No. FDA–2013–N–
1043 by any of the following methods:
Electronic Submissions
Submit electronic comments in the
following way:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the
following ways:
Mail/Hand delivery/Courier (for paper
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 No. FDA–2013–N–1043. All
comments received may be posted
without change to https://
www.regulations.gov, including any
personal information provided. For
additional information on submitting
comments, see the ‘‘Request for
Comments’’ heading of the
SUPPLEMENTARY INFORMATION.
Docket: For access to the docket to
read background documents or
comments received, go to https://
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
PO 00000
Frm 00015
Fmt 4702
Sfmt 4702
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Kim
Young, Center for Veterinary Medicine,
Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 240–
276–2207.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 29,
2013, we published a notification with
a 120-day comment period announcing
the availability of, and requesting
comment on, a document entitled ‘‘Draft
Qualitative Risk Assessment of Risk of
Activity/Animal Food Combinations for
Activities (Outside the Farm Definition)
Conducted in a Facility Co-Located on
a Farm’’ (the draft RA). The purpose of
the draft RA is to provide a sciencebased risk analysis of those activity/
animal food combinations that would be
considered low risk.
We conducted this draft RA to satisfy
requirements of the FDA Food Safety
Modernization Act (FSMA) 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 October 29,
2013, we announced that we had used
the results of the draft RA to propose to
exempt certain animal 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/animal 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 February 26, 2014, to comment on
the proposed preventive controls rule.
FDA has received requests for an
extension of the comment period on the
proposed preventive controls rule for
E:\FR\FM\03FEP1.SGM
03FEP1
Federal Register / Vol. 79, No. 22 / Monday, February 3, 2014 / Proposed Rules
food for animals to allow interested
persons an opportunity to consider the
interrelationship between this proposed
rule and the proposed rules entitled
‘‘Foreign Supplier Verification Programs
for Importers of Food for Humans and
Animals’’ (78 FR 45729, July 29, 2013)
and ‘‘Accreditation of Third-Party
Auditors/Certification Bodies to
Conduct Food Safety Audits and to
Issue Certifications’’ (78 FR 45782, July
29, 2013). We have considered the
requests, and elsewhere in this issue of
the Federal Register, we are granting an
extension of the comment period to
March 31, 2014, for the proposed
preventive controls rule. We are
extending the comment period for the
draft RA to March 31, 2014, to continue
to make the comment period for the
draft RA conform to the comment
period for the proposed preventive
controls rule.
II. Request for Comments
Interested persons may submit either
electronic comments regarding the
proposed rule to https://
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 https://
www.regulations.gov.
Dated: January 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–02112 Filed 1–31–14; 8:45 am]
BILLING CODE 4160–01–P
ENVIRONMENTAL PROTECTION
AGENCY
DEPARTMENT OF DEFENSE
40 CFR Part 1700
[EPA–HQ–OW–2013–0469; FRL–9903–49–
OW]
mstockstill on DSK4VPTVN1PROD with PROPOSALS
RIN 2040–AD39
Uniform National Discharge Standards
for Vessels of the Armed Forces—
Phase II
Environmental Protection
Agency and Department of Defense.
ACTION: Proposed rule.
AGENCY:
The U.S. Environmental
Protection Agency (EPA) and the U.S.
Department of Defense (DoD) are
SUMMARY:
VerDate Mar<15>2010
16:26 Jan 31, 2014
Jkt 232001
proposing performance standards for
certain discharges incidental to the
normal operation of a vessel of the
Armed Forces into the navigable waters
of the United States, the territorial seas,
and the contiguous zone. The proposed
standards would reduce the adverse
environmental impacts associated with
the discharges, stimulate the
development of improved pollution
control devices, and advance the
development of environmentally sound
ships by the Armed Forces. The
proposed standards are designed to be
consistent with the effluent limitations
included in the recently issued National
Pollutant Discharge Elimination System
(NPDES) general permit for discharges
incidental to the normal operation of a
non-military vessel.
DATES: Comments must be received on
or before April 4, 2014.
ADDRESSES: Submit your comments,
identified by Docket No. EPA–HQ–OW–
2013–0469, by one of the following
methods:
Federal eRulemaking Portal: https://
www.regulations.gov. Follow on-line
instructions for submitting comments.
Mail: Send an original and one copy
of your comments and enclosures
(including references) to EPA Water
Docket, U.S. Environmental Protection
Agency, Mail Code: 2822–IT, 1200
Pennsylvania Avenue NW., Washington,
DC 20460, Attention Docket No. EPA–
HQ–OW–2013–0469.
Hand Delivery: EPA Water Docket,
EPA Docket Center, EPA West Building,
Room 3334, 1301 Constitution Avenue
NW., Washington, DC 20004, Docket
No. EPA–HQ–OW–2013–0469.
Deliveries to the docket are accepted
only during their normal hours of
operation: 8:30 a.m. to 4:30 p.m.,
Monday through Friday, excluding legal
holidays. For access to docket materials,
call (202) 566–2426, to schedule an
appointment.
Email: ow-docket@epa.gov; Attention
Docket No. EPA–HQ–OW–2013–0469.
To ensure that EPA can properly
respond to comments, commenters
should cite the paragraph(s) or
section(s) in the proposed rule to which
each comment refers. Commenters
should use a separate paragraph for each
issue discussed, and must submit any
references cited in their comments. If
you submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment. Electronic
files should avoid any form of
encryption and should be free of any
defects or viruses.
Instructions: Direct your comments to
docket ID number EPA–HQ–OW–2013–
PO 00000
Frm 00016
Fmt 4702
Sfmt 4702
6117
0469. EPA’s policy is that all comments
received will be included in the docket
without change and may be made
available on-line at https://
www.regulations.gov, including any
personal information provided, unless
the comment includes information
claimed to be Confidential Business
Information (CBI) or other information
whose disclosure is restricted by statute.
Do not submit information that you
consider to be CBI or otherwise
protected through https://
www.regulations.gov. The Federal
https://www.regulations.gov Web site is
an ‘‘anonymous access’’ system, which
means EPA will not know your identity
or contact information unless you
provide it in the body of your comment.
If you send an email comment directly
to EPA without going through https://
www.regulations.gov, your email
address will be automatically captured
and included as part of the comment
that is placed in the public docket and
made available on the Internet. If you
submit an electronic comment, EPA
recommends that you include your
name and other contact information in
the body of your comment and with any
disk or CD–ROM you submit. If EPA
cannot read your comment due to
technical difficulties and cannot contact
you for clarification, EPA may not be
able to consider your comment.
Electronic files should avoid any form
of encryption and should be free of any
defects or viruses. For additional
instructions on submitting comments,
go to the SUPPLEMENTARY INFORMATION
section of this document.
Docket: The electronic version of the
public docket is available through the
Federal Docket Management System
(FDMS) found at https://
www.regulations.gov. You may use the
FDMS to view public comments, access
the index listing of the contents of the
official public docket, and access those
documents in the public docket that are
available electronically. Once at the
Web site, enter the appropriate Docket
ID No. in the ‘‘Search’’ box to view the
docket. Certain types of information will
not be placed in the EPA dockets.
Information claimed as CBI and other
information whose disclosure is
restricted by statute, which is not
included in the official public docket,
will not be available for public viewing
in EPA’s electronic public docket. EPA
policy is that copyrighted material will
not be placed in EPA’s electronic public
docket but will be available only in hard
copy in the official public docket.
Although not all docket materials may
be available electronically, you may still
access any of the publicly available
E:\FR\FM\03FEP1.SGM
03FEP1
]]>Agencies
[Federal Register Volume 79, Number 22 (Monday, February 3, 2014)]
[Proposed Rules]
[Pages 6116-6117]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02112]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 507
[Docket No. FDA-2013-N-1043]
Draft Qualitative Risk Assessment of Risk of Activity/Animal Food
Combinations for Activities (Outside the Farm Definition) Conducted in
a Facility Co-Located on a Farm; Availability; Extension of 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 we made available for public comment in
the Federal Register of October 29, 2013 (78 FR 64428) (the draft RA).
We are taking this action to make the comment period for the draft RA
conform to the comment period for proposed rule entitled ``Current Good
Manufacturing Practice and Hazard Analysis and Risk-Based Preventive
Controls for Food for Animals'' (the proposed preventive controls rule
for food for animals).
DATES: FDA is extending the comment period on the draft RA. Submit
either electronic or written comments by March 31, 2014.
ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-1043 by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov. Follow the
instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Mail/Hand delivery/Courier (for paper 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 No. FDA-2013-N-1043. All comments received may be posted
without change to https://www.regulations.gov, including any personal
information provided. For additional information on submitting
comments, see the ``Request for Comments'' heading of the SUPPLEMENTARY
INFORMATION.
Docket: For access to the docket to read background documents or
comments received, go to https://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: Kim Young, Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855, 240-276-2207.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 29, 2013, we published a
notification with a 120-day comment period announcing the availability
of, and requesting comment on, a document entitled ``Draft Qualitative
Risk Assessment of Risk of Activity/Animal Food Combinations for
Activities (Outside the Farm Definition) Conducted in a Facility Co-
Located on a Farm'' (the draft RA). The purpose of the draft RA is to
provide a science-based risk analysis of those activity/animal food
combinations that would be considered low risk.
We conducted this draft RA to satisfy requirements of the FDA Food
Safety Modernization Act (FSMA) 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 October 29, 2013, we announced that we
had used the results of the draft RA to propose to exempt certain
animal 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/animal 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 February 26, 2014, to comment on the proposed preventive controls
rule.
FDA has received requests for an extension of the comment period on
the proposed preventive controls rule for
[[Page 6117]]
food for animals to allow interested persons an opportunity to consider
the interrelationship between this proposed rule and the proposed rules
entitled ``Foreign Supplier Verification Programs for Importers of Food
for Humans and Animals'' (78 FR 45729, July 29, 2013) and
``Accreditation of Third-Party Auditors/Certification Bodies to Conduct
Food Safety Audits and to Issue Certifications'' (78 FR 45782, July 29,
2013). We have considered the requests, and elsewhere in this issue of
the Federal Register, we are granting an extension of the comment
period to March 31, 2014, for the proposed preventive controls rule. We
are extending the comment period for the draft RA to March 31, 2014, to
continue to make the comment period for the draft RA conform to the
comment period for the proposed preventive controls rule.
II. Request for Comments
Interested persons may submit either electronic comments regarding
the proposed rule to https://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 https://www.regulations.gov.
Dated: January 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02112 Filed 1-31-14; 8:45 am]
BILLING CODE 4160-01-P
