Draft Guidance for Industry on Voluntary Third-Party Certification Programs for Foods and Feeds; Availability, 39704-39705 [E8-15715]
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Federal Register / Vol. 73, No. 133 / Thursday, July 10, 2008 / Notices
Dated: July 2, 2008.
Maryam I. Daneshvar,
Reports Clearance Officer, Centers for Disease
Control and Prevention.
[FR Doc. E8–15749 Filed 7–9–08; 8:45 am]
BILLING CODE 4163–18–P
Carl
Rubenstein, Wilson-Fish Program
Manager, Office of Refugee
Resettlement, Aerospace Building, 8th
Floor West, 901 D Street, SW.,
Washington, DC 20447. Telephone:
202–205–5933.
FOR FURTHER INFORMATION CONTACT:
Dated: July 1, 2008.
David H. Siegel,
Acting Director, Office of Refugee
Resettlement.
[FR Doc. E8–15633 Filed 7–9–08; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
BILLING CODE 4184–01–P
Office of Refugee Resettlement
Office of Refugee Resettlement,
Administration for Children and
Families.
ACTION: Single-Source Program
Expansion Supplement.
jlentini on PROD1PC65 with NOTICES
AGENCY:
CFDA#: 93.583.
Legislative Authority: The Refugee Act
of 1980 as amended, Wilson-Fish
Amendment, 8 U.S.C. 1522(e)(7);
section 412(e)(7)(A) of the Immigration
and Nationality Act.
Amount of Award: $1,312,414
supplement for current year.
Project Period: 09/30/2005–09/29/
2010.
Justification for the Exception to
Competition: The Wilson-Fish program
is an alternative to the traditional Stateadministered welfare system for
providing integrated assistance and
services to refugees, asylees, Amerasian
Immigrants, Cuban and Haitian
Entrants, and Trafficking Victims. San
Diego County is one of 12 sites that has
chosen this alternative approach.
The supplemental funds will allow
the grantee, Catholic Charities Diocese
of San Diego, to provide refugee cash
assistance through the end of this fiscal
year to eligible refugees (and others
eligible for refugee benefits) under the
San Diego Wilson-Fish Program.
The primary reason for the grantee’s
supplemental request is a higher
number of arrivals than anticipated
when the grantee’s budget was
submitted and approved last year. The
Refugee Act of 1980 mandates that the
Office of Refugee Resettlement (ORR)
reimburse States and Wilson-Fish
projects for the costs of cash and
medical assistance for newly arriving
refugees. Since 1991, ORR has
reimbursed States and Wilson-Fish
agencies for providing cash and medical
assistance to eligible individuals during
their first eight months in the United
States.
Hence, the supplement is consistent
with the purposes of the Wilson-Fish
Program, the Refugee Act of 1980, and
ORR policy.
VerDate Aug<31>2005
16:58 Jul 09, 2008
Jkt 214001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–D–0381]
Draft Guidance for Industry on
Voluntary Third-Party Certification
Programs for Foods and Feeds;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Voluntary ThirdParty Certification Programs for Foods
and Feeds.’’ This draft guidance
describes the general attributes FDA
believes a voluntary third-party
certification program should have in
order to help ensure its certification is
a reliable reflection that the foods and
feeds from certified establishments are
safe and meet applicable FDA
requirements.
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
written or electronic comments on the
draft guidance by September 8, 2008.
ADDRESSES: Submit written comments
on the draft guidance to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to https://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance
document.
DATES:
FOR FURTHER INFORMATION CONTACT:
Sharon Lindan Mayl, Food and Drug
Administration, 5600 Fishers Lane (HF–
11), Rockville, MD 20857, 301–827–
3360.
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Voluntary Third-Party Certification
Programs for Foods and Feeds.’’ This
draft guidance is issued in response to
the recommendations contained in the
Action Plan for Import Safety: A
Roadmap for Continual Improvement
(Action Plan) issued on November 6,
2007, by the Interagency Working Group
on Import Safety (Working Group)
established by Executive Order 13439,
as well as FDA’s Food Protection Plan
released on the same date. Both those
plans emphasize certification as a way
to help verify the safety of products
from a growing food establishment
inventory, both domestic and foreign.
In the Federal Register of April 2,
2008 (73 FR 17989), FDA issued a notice
requesting comments on the use of
third-party certification programs for
foods and animal feeds. FDA received
approximately 70 comments in response
to that notice. The comments were
generally supportive of the use of thirdparty certification programs. Many
encouraged FDA to recognize such
programs as a way to increase
participation and improve the safety
and security of foods.
This draft guidance, when finalized,
will represent FDA’s current thinking
on the certification process and will
describe the general attributes FDA
believes a voluntary third-party
certification program should have in
order to provide FDA with confidence
in that program. If FDA has such
confidence, we may choose to recognize
the program and provide incentives for
establishments to obtain certification by
recognized certification programs.
Recognition in this context means that
FDA has determined that certification
may be a reliable reflection that the
foods from the certified establishment
are safe and meet applicable FDA
requirements. Such recognition would
be tailored to particular categories of
products and would occur in a separate
document that builds upon the general
attributes set forth in this document.
Therefore, this draft guidance is
intended as one of the steps in FDA’s
future recognition of one or more
voluntary third-party certification
programs for particular product types.
To further that process, FDA is also
announcing, in a separate notice issued
in this Federal Register, a voluntary
pilot program for third-party
certification bodies that certify foreign
processors of aquacultured shrimp. This
pilot is intended to gather technical and
operational information that will assist
E:\FR\FM\10JYN1.SGM
10JYN1
Federal Register / Vol. 73, No. 133 / Thursday, July 10, 2008 / Notices
FDA in determining its infrastructure
needs, as well as the process for
evaluating third-party certification
programs. The criteria for selection for
that pilot are based upon the attributes
set forth in the draft guidance.
As with the pilot, the 12 attributes
discussed in the draft guidance are
intended to provide a model that could
be tailored for particular categories of
products and incorporated by FDA as it
recognizes third-party certification
programs for those products. These
attributes incorporate such things as the
authority of the certification body to
adequately inspect the establishments
seeking certification, qualifications, and
training for the third-party inspectors,
self-assessment of the certification
programs and its inspectors, elements of
an effective inspection program,
notification to FDA, and preventing
conflicts of interest. While FDA invites
comments on all aspects of the draft
guidance, FDA is particularly interested
in receiving comments on this list of
attributes for the certification program.
More specifically, we would like to
know whether there are some attributes
that should be removed or added and
whether the draft guidance provides
sufficient information about each
attribute. We are also interested in
knowing how this list compares with
existing, well-accepted guidelines or
requirements for certification programs.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent FDA’s current thinking on
Voluntary Third-Party Certification
Programs for Foods and Feeds. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
jlentini on PROD1PC65 with NOTICES
II. Comments
The draft guidance is being
distributed for comment purposes only
and is not intended for implementation
at this time. Interested persons may
submit to the Division of Dockets
Management (see ADDRESSES) written or
electronic comments regarding the draft
guidance. Submit a single copy of
electronic comments or two paper
copies of any mailed comments, except
that individuals may submit one paper
copy. Comments are to be identified
with the docket number found in the
brackets in the heading of this
document. A copy of the draft guidance
and received comments are available for
public examination in the Division of
VerDate Aug<31>2005
16:58 Jul 09, 2008
Jkt 214001
Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Please note that on January 15, 2008,
the FDA Division of Dockets
Management Web site transitioned to
the Federal Dockets Management
System (FDMS). FDMS is a
Government-wide, electronic docket
management system. Electronic
comments or submissions will be
accepted by FDA only through FDMS at
https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/oc/guidance/
thirdpartycert.html or https://
www.regulations.gov.
Dated: July 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and
Planning.
[FR Doc. E8–15715 Filed 7–9–08; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2008–N–0382]
Voluntary Third-Party Certification
Programs for Imported Aquacultured
Shrimp; Notice of Pilot Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is seeking thirdparty certification bodies that certify
foreign processors of aquacultured
shrimp for compliance with FDA’s
Seafood Hazard Analysis and Critical
Control Point (HACCP) regulations to
volunteer to participate in a pilot
program to be conducted by FDA’s
Center for Food Safety and Applied
Nutrition (CFSAN) and Office of
Regulatory Affairs (ORA). The goal of
the pilot program is to gather technical
and operational information that will
assist FDA in determining its
infrastructure needs, as well as the
process for evaluating third-party
certification programs, in order to assist
FDA in moving towards broader
recognition of voluntary third-party
certification programs, including thirdparty certification programs for
aquacultured shrimp, at a later time.
DATES: Submit written and electronic
requests to participate in the pilot
program by August 25, 2008.
ADDRESSES: Submit written requests to
participate in the pilot program to the
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
39705
Center for Food Safety and Applied
Nutrition (HFS–325), Food and Drug
Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740. Submit
electronic requests to participate to
aquaculture@fda.hhs.gov. We strongly
encourage interested persons to
electronically submit their request to
participate.
FOR FURTHER INFORMATION CONTACT:
Brett Koonse, Center for Food Safety
and Applied Nutrition (HFS–325), Food
and Drug Administration, 5100 Paint
Branch Pkwy., College Park, MD 20740,
301–436–1700.
SUPPLEMENTARY INFORMATION:
I. Background
Ensuring the safety of food for human
and animal use is a shared
responsibility between the public and
private sectors. FDA has the authority to
establish regulatory standards, inspect
facilities, and take action if there are
violations, but it is primarily the
responsibility of industry to ensure that
foods products intended for human and
animal consumption in the United
States are safe and meet applicable FDA
standards. An increasing number of
establishments that sell foods to the
public, such as retailers and food
service providers, are independently
requesting, as a condition of doing
business, that their suppliers, both
foreign and domestic, become certified
as meeting safety (as well as quality)
standards. In addition, domestic and
foreign suppliers (such as producers, comanufacturers, or re-packers) are
increasingly looking to third-party
certification programs to assist them in
meeting U.S. requirements.
On July 18, 2007, the President issued
Executive Order 13439 to establish the
Interagency Working Group on Import
Safety (Working Group). On November
6, 2007, the Working Group released an
‘‘Action Plan for Import Safety: A
Roadmap for Continual Improvement’’
(Action Plan) (https://
www.importsafety.gov/report/
actionplan.pdf). The Action Plan
contains 14 broad recommendations and
50 specific short- and long-term action
steps to better protect consumers and
enhance the safety of the increasing
volume of imports entering the United
States. The Action Plan stresses the
importance of the private sector’s
responsibility for the safety of its
products and the importance of ongoing
private-sector mechanisms and
experience as a basis for ongoing,
substantive public-private collaboration.
The public and private sectors have a
shared interest in import safety, and
substantive improvement will require
E:\FR\FM\10JYN1.SGM
10JYN1
]]>Agencies
[Federal Register Volume 73, Number 133 (Thursday, July 10, 2008)]
[Notices]
[Pages 39704-39705]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-15715]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0381]
Draft Guidance for Industry on Voluntary Third-Party
Certification Programs for Foods and Feeds; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Voluntary
Third-Party Certification Programs for Foods and Feeds.'' This draft
guidance describes the general attributes FDA believes a voluntary
third-party certification program should have in order to help ensure
its certification is a reliable reflection that the foods and feeds
from certified establishments are safe and meet applicable FDA
requirements.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by September 8, 2008.
ADDRESSES: Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to https://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.
FOR FURTHER INFORMATION CONTACT: Sharon Lindan Mayl, Food and Drug
Administration, 5600 Fishers Lane (HF-11), Rockville, MD 20857, 301-
827-3360.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Voluntary Third-Party Certification Programs for Foods and
Feeds.'' This draft guidance is issued in response to the
recommendations contained in the Action Plan for Import Safety: A
Roadmap for Continual Improvement (Action Plan) issued on November 6,
2007, by the Interagency Working Group on Import Safety (Working Group)
established by Executive Order 13439, as well as FDA's Food Protection
Plan released on the same date. Both those plans emphasize
certification as a way to help verify the safety of products from a
growing food establishment inventory, both domestic and foreign.
In the Federal Register of April 2, 2008 (73 FR 17989), FDA issued
a notice requesting comments on the use of third-party certification
programs for foods and animal feeds. FDA received approximately 70
comments in response to that notice. The comments were generally
supportive of the use of third-party certification programs. Many
encouraged FDA to recognize such programs as a way to increase
participation and improve the safety and security of foods.
This draft guidance, when finalized, will represent FDA's current
thinking on the certification process and will describe the general
attributes FDA believes a voluntary third-party certification program
should have in order to provide FDA with confidence in that program. If
FDA has such confidence, we may choose to recognize the program and
provide incentives for establishments to obtain certification by
recognized certification programs. Recognition in this context means
that FDA has determined that certification may be a reliable reflection
that the foods from the certified establishment are safe and meet
applicable FDA requirements. Such recognition would be tailored to
particular categories of products and would occur in a separate
document that builds upon the general attributes set forth in this
document. Therefore, this draft guidance is intended as one of the
steps in FDA's future recognition of one or more voluntary third-party
certification programs for particular product types.
To further that process, FDA is also announcing, in a separate
notice issued in this Federal Register, a voluntary pilot program for
third-party certification bodies that certify foreign processors of
aquacultured shrimp. This pilot is intended to gather technical and
operational information that will assist
[[Page 39705]]
FDA in determining its infrastructure needs, as well as the process for
evaluating third-party certification programs. The criteria for
selection for that pilot are based upon the attributes set forth in the
draft guidance.
As with the pilot, the 12 attributes discussed in the draft
guidance are intended to provide a model that could be tailored for
particular categories of products and incorporated by FDA as it
recognizes third-party certification programs for those products. These
attributes incorporate such things as the authority of the
certification body to adequately inspect the establishments seeking
certification, qualifications, and training for the third-party
inspectors, self-assessment of the certification programs and its
inspectors, elements of an effective inspection program, notification
to FDA, and preventing conflicts of interest. While FDA invites
comments on all aspects of the draft guidance, FDA is particularly
interested in receiving comments on this list of attributes for the
certification program. More specifically, we would like to know whether
there are some attributes that should be removed or added and whether
the draft guidance provides sufficient information about each
attribute. We are also interested in knowing how this list compares
with existing, well-accepted guidelines or requirements for
certification programs.
The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on Voluntary Third-
Party Certification Programs for Foods and Feeds. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.
II. Comments
The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding the draft guidance. Submit a
single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in the brackets in
the heading of this document. A copy of the draft guidance and received
comments are available for public examination in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at https://www.regulations.gov.
III. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/oc/guidance/thirdpartycert.html or https://
www.regulations.gov.
Dated: July 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15715 Filed 7-9-08; 8:45 am]
BILLING CODE 4160-01-S
