[Federal Register Volume 73, Number 133 (Thursday, July 10, 2008)]
[Notices]
[Pages 39705-39708]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15713]


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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.

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SUMMARY:  The Food and Drug Administration (FDA) is seeking third-party 
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 third-party 
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 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 [email protected]. 
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, co-manufacturers, 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) (http://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

[[Page 39706]]

the careful collaboration of the entire importing community.
    Recommendation 2 of the Action Plan is to ``verify compliance of 
foreign producers with United States safety and security standards 
through certification.'' Third-party certification can augment the 
Federal Government's and the importing community's ability to help 
ensure that products imported into the United States meet U.S. safety 
and security standards. The Action Plan states ``[f]or foreign 
producers, the ability to participate in voluntary certification 
programs could allow products from firms that comply with U.S. safety 
and security standards to enter the United States more quickly. This 
would facilitate trade, while allowing federal departments and agencies 
to focus their resources on products from non-certified firms or for 
which information suggests there may be safety or security concerns. 
This would allow federal departments and agencies to more effectively 
target their resources.''
    Action Steps 2.2 and 2.4 of the Action Plan call for the 
recognition or development of voluntary third-party certification 
programs, based on risk, for foreign producers of certain products who 
export to the United States and the creation of incentives for foreign 
firms to participate in voluntary certification programs and for 
importers to purchase only from certified firms.
    In conjunction with the Action Plan, on November 6, 2007, FDA 
released its Food Protection Plan (FPP), a comprehensive strategy 
designed to bolster efforts to better protect the Nation's food supply 
(http://www.fda.gov/oc/initiatives/advance/food/plan.html). The FPP is 
a three-part plan that uses science and a risk-based approach of 
prevention, intervention and response to ensure the safety of domestic 
as well as imported foods eaten by American consumers. The FPP 
emphasizes certification as a way to help verify the safety of products 
from a growing food establishment inventory, both foreign and domestic.
    On April 2, 2008, FDA published a notice in the Federal Register 
(73 FR 17989) requesting comments by May 19, 2008, on the use of third-
party certification programs for foods and animal feeds. The notice was 
FDA's first step in soliciting public input in the design and 
development or recognition of voluntary third-party certification 
programs.
    In order to assist FDA in moving towards broader recognition of 
third-party certification programs, FDA is now seeking voluntary 
participants for a third-party certification pilot program for 
aquacultured shrimp. This pilot program is the next step in gathering 
technical and operational information that will assist FDA in 
determining its infrastructure needs. The information from this pilot 
also will assist with subsequent steps, such as developing the process 
for evaluating third-party certification programs should FDA decide to 
recognize voluntary third-party certification programs and to consider 
certification in its decision making. Certification might be 
considered, for example, in decision making regarding determination of 
establishment inspection priorities, entry admissibly, field exam and 
sampling priorities, ``may proceed'' rates, and requests by firms to 
have their products removed from an import alert. If FDA were to 
recognize third-party certification programs, we would do so on a 
product-by-product basis. We would also provide an opportunity for both 
foreign and domestic certification bodies to voluntarily seek FDA 
recognition and for foreign and domestic establishments to voluntarily 
seek certification.

II. Voluntary Third-Party Certification Pilot Program

A. Scope and Selection Attributes

    FDA is seeking a limited number of third-party certification bodies 
(such as private, non-government entities, other Federal government, 
State government, and foreign government agencies) that currently 
certify foreign processors of aquacultured shrimp for compliance with 
FDA's Seafood HACCP regulations to volunteer to participate in the 
pilot program. Participants in the pilot program will be asked to 
provide FDA with technical feedback on the pilot.
    A limited number of voluntary participants are needed for the pilot 
program. The agency will use its discretion in choosing participants 
for Phase II of the pilot (see following discussion) from those who 
apply during Phase I of the pilot based on the following attributes:
    1. Authority of the Certification Body. The certification body 
should have the authority to perform inspection activities, collect and 
evaluate records, collect and analyze samples, and assess and report on 
compliance as necessary to ensure certification standards and 
requirements are met and maintained.
    2. Qualification and Training for Inspectors. The certification 
body should ensure that its inspectors are adequately trained to 
perform their work assignments. Such training includes course work, 
field work, and continuing education.
    3. Elements of an Effective Inspection Program. The certification 
body should ensure that its inspectors are consistently using 
established, widely-recognized standards when performing inspections. 
The inspector should prioritize and target the elements of producing, 
manufacturing, processing, packing, and holding that pose the greatest 
risk to human and/or animal health. The certification body should have 
written policies and procedures describing the protocol to be used by 
all inspectors during an inspection. During an inspection, inspectors 
should verify that the establishments and products meet and maintain 
certification criteria that include the following:
     The processor is in compliance with applicable FDA 
regulatory requirements for food, including FDA's Seafood HACCP 
regulations;
     If appropriate, the processor has in place, and 
effectively executes, management systems that ensure the safety of all 
shrimp products, from production to distribution, as applicable, 
including the feed used, the hatchery, the growing area, harvesting, 
processing, and transportation. This may include a preventive control 
program for farms (e.g., Good Aquaculture Practices, Best Management 
Practices, farmer training along with farm inspections), a verification 
program (e.g., an effective testing scheme to ensure products are free 
of unapproved drugs, chemicals, and pathogens), a traceability program, 
or recall and follow-up procedures in case of an outbreak or illness 
associated with a product.
    4. Inspection Audit Program. The third-party certification body 
should conduct audits of its inspections to assess the effectiveness of 
the inspections and sample collections and to ensure the competency and 
consistency of its inspectors.
    5. Cooperation with FDA and Other Appropriate Government Officials 
When Safety Problems Occur. The certification body should cooperate as 
necessary with FDA and other appropriate government authorities if the 
certification body discovers a situation in which there is a reasonable 
probability that U.S. consumers may consume or be exposed to a food 
product that could cause serious adverse health consequences or death 
to humans or animals, whether the contamination or problem was caused 
intentionally or unintentionally. Such cooperation may include 
notification to relevant agencies inside and outside of the United 
States, where the food is sold or distributed. Moreover, when FDA has 
reliable information from the Centers for

[[Page 39707]]

Disease Control and Prevention (CDC) or other reliable sources about a 
health risk associated with an FDA-regulated food product and FDA is 
conducting a traceback of a product, FDA may request information from 
the certification body regarding the supply chain. Such information may 
be requested based on preliminary information that an establishment 
under the certification program may be implicated. The certification 
body should provide FDA with this information in a timely manner. Such 
information would be disclosed (or protected from disclosure) in 
accordance with applicable laws and policies.
    6. Compliance and Corrective Action. The certification body should 
have strategies, procedures, and actions to ensure the establishments 
and products it certifies comply with FDA laws and regulations and 
otherwise meet certification standards, to take action when there is 
non-compliance, and to evaluate the effectiveness of corrective action 
programs.
    7. Industry Relations. At a minimum, the certification body should 
provide establishments seeking certification with information about 
current FDA requirements and guidances.
    8. Resources. The certification body should have sufficient 
resources, such as technological tools and infrastructure, to carry out 
its certification program.
    9. Self-Assessment of Overall Certification Program. In addition to 
auditing the inspection program, the certification body should assess 
the effectiveness of the certification program as a whole.
    10. Laboratories. The certification body should have access to 
laboratory services to support the program functions. The laboratories 
should be accredited by an accreditation body operating in accordance 
with International Organization for Standardization (ISO) standard 120/
IEC 17011, General requirements for Accreditation bodies accrediting 
conformity assessment bodies.
    11. Notifications to FDA. The certification body should promptly 
notify FDA of problems or changes that can affect product safety or 
security. We expect prompt notification of the following:
    a. Safety Issues. The certification body should immediately notify 
FDA if an inspector finds or discovers a situation in which there is a 
reasonable probability that U.S. consumers may consume or be exposed to 
a food that could cause serious adverse health consequences or death to 
humans or animals. This information may pertain to intentional or 
unintentional contamination. The certification body should provide 
detailed information that describes the extent and nature of the 
problem and allows us to identify the product and source, including 
traceability records.
    b. Fraud. The certification body should promptly notify FDA if it 
has information that the establishment or any of its officers or 
employees engages in any fraudulent acts related to foods, including 
providing false information to the certification body or any inspectors 
acting on its behalf.
    c. Criminal Acts. The certification body should promptly notify FDA 
if it has information that the establishment or any of its officers or 
employees has been convicted of a crime relating to foods or any crime 
involving false statements, fraud, or dishonesty.
    12. Conflict of Interest. The certification body and its inspectors 
should be free from conflicts of interest.
    These attributes are described in greater detail in a draft 
guidance issued today entitled, ``Voluntary Third Party Certification 
Programs for Foods and Feeds'' (http://www.fda.gov/oc/guidance/thirdpartycert.html or http://www.regulations.gov). The draft guidance 
is being distributed for comment purposes only and is not intended for 
implementation at this time. Certification bodies interested in 
participating in this pilot should review the draft guidance.
    Favorable consideration will be given to third-party certification 
bodies that: (1) Currently certify foreign shrimp processors for 
controls designed to ensure the safety of the product from production 
through distribution, in addition to compliance with FDA's Seafood 
HACCP regulations; (2) certify processors of aquacultured shrimp in 
countries that export significant amounts of aquacultured shrimp to the 
United States; and/or (3) are accredited or are in the process of 
becoming accredited by a recognized accreditation body.

B. Pilot Program and FDA Audit

    The pilot program will be conducted in two phases. Phase I begins 
with the issuance of this document and will run through December 2008. 
During Phase I, FDA will receive and evaluate requests to participate 
in the pilot, including conducting paper audits to determine whether 
applicants have the attributes described in this document. During the 
paper audit, applicants will be asked to provide FDA with a list of 
inspectors for the products covered under this pilot and the 
inspectors' locations. In addition, applicants may be asked to provide 
FDA with other documents such as certification or recertification audit 
reports and product sampling results.
    Phase II will begin in December 2008 with notification of the 
applicants that have been selected for participation. During Phase II, 
which will run through June 2009, FDA will conduct onsite audits of 
third-party certification programs by accompanying certain inspectors 
during certification and/or recertification inspections. FDA will also 
conduct targeted sampling of imported shrimp products. FDA may elect to 
increase the ``may proceed'' rate during Phase II for shrimp products 
from certified establishments, if warranted based on information 
generated as a result of participation in the pilot. FDA's decision 
would be made on a case-by-case basis.
    The pilot program will not preclude FDA, U.S. Customs and Border 
Protection, or other agencies from inspecting or taking other action 
with respect to any firm or imported product. Further, FDA may 
terminate a certifying body's participation in the pilot at any time 
for any reason.

C. Duration

    FDA plans to conduct the pilot program for a period of 12 months, 
beginning in July 2008. Either phase of the pilot program may be 
extended or shortened as appropriate.

D. Submission of Requests to Participate

    Written requests to participate in the pilot program should be 
submitted to the Center for Food Safety and Applied Nutrition (HFS-
325), Food and Drug Administration, 5100 Paint Branch Pkwy., College 
Park, MD 20740. Electronic requests to participate should be submitted 
to [email protected]. We strongly encourage interested persons to 
electronically submit their request to participate. Written and 
electronic requests to participate in the pilot program should be 
submitted to FDA by August 25, 2008.
    The request to participate should include the following 
information:
    1. The docket number found in brackets in the heading of this 
document;
    2. The applicant's name, telephone number, address, and e-mail 
address;
    3. A signed statement indicating the following:
    a. The certification body, its inspectors, and any subcontractors 
that might be used (e.g., laboratories, sampling services) agree to 
participate in the pilot program and are free from any conflict of 
interest;

[[Page 39708]]

    b. The certification body agrees to undergo an FDA audit of its 
certification program, and supply information requested by FDA for the 
evaluation of the participant's certification program or of products 
certified under the program; and
    c. The certification body agrees to: (i) Immediately notify FDA if 
an inspector finds or discovers a situation in which there is a 
reasonable probability that U.S. consumers may consume or be exposed to 
a food that could cause serious adverse health consequences or death to 
humans or animals; (ii) promptly notify FDA if it has information that 
the establishment or any of its officers or employees engages in any 
fraudulent acts related to foods, including providing false information 
to the certification body or any inspectors acting on its behalf; and 
(iii) promptly notify FDA if it has information that the establishment 
or any of its officers or employees has been convicted of a crime 
relating to foods or any crime involving false statements, fraud, or 
dishonesty.
    4. The name and address of each certified foreign aquaculture 
shrimp farming and/or processing facility that has agreed to 
participate in the pilot and to be available for an FDA audit and a 
description of the products certified;
    5. A detailed written description of the extent to which the 
applicant's certification program conforms to the 12 attributes listed 
previously; and
    6. Any accreditation the applicant may have from an accreditation 
body operating in accordance with the International Organization for 
Standardization (ISO) standard ISO/IEC 17011, General requirements for 
accreditation bodies accrediting conformity assessment bodies, or 
information confirming that the applicant is in the process of becoming 
accredited by such an accreditation body.
    FDA notes that statements made to FDA as part of this pilot are 
subject to the provisions of 18 U.S.C. 1001, which provides for 
criminal penalties for anyone who, among other things, makes a 
materially false, fictitious, or fraudulent statement to the U.S. 
government.

E. Evaluation of Pilot Program

    FDA intends to evaluate the pilot program based on several factors, 
including, but not limited to, the extent to which certification 
provides adequate assurances of the safety of aquacultured shrimp from 
certified establishments, FDA's ability to accurately and efficiently 
evaluate third-party certification programs, and FDA's current ability 
and future needs to operationalize the recognition of third-party 
certification programs and the utilization of certification in agency 
decision making. After FDA evaluates the pilot program, the agency may 
extend, modify, or terminate the pilot program.
    As noted previously, FDA will take the results of the pilot program 
into consideration in future decisions of whether to provide incentives 
for voluntary certification, including considering whether to adjust 
the ``may proceed'' rate for imports, and/or begin the process to 
recognize voluntary third-party certification programs for aquacultured 
shrimp or other food or feed on a non-pilot basis.

    Dated: July 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15713 Filed 7-9-08; 8:45 am]
BILLING CODE 4160-01-S