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On November 6,
2007, the Interagency Working Group on Import Safety (Working
Group), established by Executive
Order 13439, issued an Action Plan for Import
Safety: A roadmap for continual improvement (Action
Plan). The Action Plan is based on the principles
of prevention, intervention, and response and 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.
- Prevention: Prevent harm in the first place. The
U.S. government must work with the private sector and foreign
governments to adopt an approach to import safety that
builds safety into the manufacturing and distribution processes. This
effort will reduce the risks to consumers from otherwise
dangerous imported products.
- Intervention: Intervene when risks are identified. Federal,
state, local and foreign governments, along with foreign
producers and the importing community, must adopt more
effective techniques for identifying potential product
hazards. When problems are discovered, government officials
must act swiftly, and in a coordinated manner, to seize,
destroy or otherwise prevent dangerous goods from advancing
beyond the point-of-entry. For foreign countries, taking
steps to ensure the safety of products exported to the
United States will benefit them by facilitating trade.
- Response: Respond rapidly after harm has occurred. In
the event that an unsafe import makes its way into domestic
commerce, swift actions must be taken to limit potential
exposure and harm to the American public.
Since the release of the Action Plan, the FDA has collaborated with many partners to improve the safety of imported products. The following is a list of FDA accomplishments since issuance of the Action Plan.
Prevention
- Signed Memoranda of Agreement (MOA) with China. FDA
signed two MOAs with China and held bilateral talks with
the Chinese regulatory agencies to work towards creation
of a certification program to help ensure items exported
to the United States meet Department of Health and Humans
Services (HHS) and FDA safety standards. Additionally,
these MOA’s provide a streamlined process for facilitating
FDA inspections conducted in China. This aspect of
the agreement has already proven effective in giving FDA
prompt access to conduct inspections.
- Issued Report on the Use of Standards. FDA
issued its Annual Report on the Use of Standards by the
Agency. This report describes the Agency’s involvement
in standards setting activities during 2007.
- Expanded FDA’s International Outreach. FDA
provided a briefing to Washington, DC-based foreign embassy
personnel on FDA actions under the Action Plan and the
FDA Food Protection Plan. Additionally, FDA
discussed import safety with counterparts from Australia,
New Zealand, the European Union, India, Vietnam, and several
other countries. These discussions support new capacity
building, new bilateral agreements, and continued efforts
to expand FDA’s foreign presence.
- Released Self-Assessment Tools for Industry. FDA
worked domestically with industry to strengthen existing
safety standards by releasing self-assessment
tools for industry to minimize the risk of intentional
contamination of food and cosmetics.
- Participated in Food and Agriculture Organization
(FAO)/World Health Organization (WHO) Activities. FDA
participated in FAO/WHO activities to establish the Scientific
Basis for International Standards and Guidance for Residues,
Chemical Contaminants and Pathogens in Fresh Produce,
Seafood, and Other Commodities. This included the completion
of a risk assessment on Vibrio parahaemolyticus, which
can cause gastrointestinal illness in humans.
- Participated in the Codex Alimentarius Commission
(Codex) Activities to Promote International Food Safety
Standards and Guidance Through Codex Alimentarius. FDA
provided the U.S. Delegate or Alternate delegate to 14
Codex Committees including those that developed standards
in the areas of food hygiene, food additives, contaminants,
nutrition, food labeling, biotechnology, and food import
and export inspection and certification systems.
- Participated in the WHO International Medical
Products Anti-Counterfeiting Task Force (IMPACT). FDA
provided the U.S. Delegate or Alternate delegate to the
WHO IMPACT which aims to build coordinated action across
and between countries in order to halt the production,
trading and selling of counterfeit medical products around
the globe. IMPACT is a coalition comprised of all the
major anti-counterfeiting players, including: international
organizations, non-governmental organizations, medicines
regulatory authorities, enforcement authorities, associations
representing pharmaceutical manufacturers, wholesalers,
health professionals and patients.
- Published Draft Compliance Policy Guide (CPG)
on Listeria Monocytogenes. FDA published a draft
CPG on Listeria monocytogenes and held a public meeting
to solicit public comment and encourage discussion on
the CPG.
- Issued Draft Guidance for Industry on Control
of Listeria Monocytognenes. The draft
guidance is intended to assist processors in controlling
Listeria monocytogenes in the food processing environment
during the manufacture of refrigerated or frozen, ready-to-eat
foods. The draft guidance for industry, when finalized,
will complement FDA’s current good manufacturing
practices regulations.
- Issued Fresh-Cut Produce Guidance. FDA
issued guidance on Fresh-Cut Produce to advise industry
on how to limit contamination of fresh cut fruits and vegetables.
- Issued Amended Interim Final Rule on Use of Materials
Derived from Cattle in Human Food and Cosmetics. FDA
issued an amended interim final rule that permits the
agency to designate a country as not subject to certain
bovine spongiform encephalopathy (BSE)-related restrictions
upon written request and if the country demonstrates
and provides supporting documentation that it’s
current controls make such restrictions unnecessary.
- Issued
a Federal Register Notice for Food and Feed Third Party
Certification Programs. FDA
issued a Federal Register notice that sought public comment
on the existence and use of third-party certification
programs to better understand how they can be used to
help to ensure that food products are safe, secure, and
meet FDA requirements.
- Provided Technical Assistance
to China. FDA
provided training on regulatory requirements and technical
assistance training to Chinese regulatory agencies.
- Hired Leadership for an FDA Office
in China. FDA
received approval and has hired leadership for a new FDA
office in China.
- Provided Technical Assistance
to South Africa. FDA’s
Office of Cosmetics and Colors (OCAC) in the Center for
Food Safety and Applied Nutrition participated in a U.S.
Department of Agriculture/Foreign Agriculture Service workshop
for South African regulators and industry representatives. OCAC
gave a seminar on regulatory requirements for marketing
cosmetics in the United States, which included specific
information on imports and labeling.
- Establishing
an FDA Presence in India. An
FDA delegation visited Indian counterparts to discuss requirements
for an FDA presence in India. Results are promising
for future collaboration.
- Continued International
Cooperation on Cosmetics Regulation (ICCR). FDA
continued to participate in ICCR activities, including
strengthening the mechanisms for participating cosmetics
regulatory authorities to keep each other apprised of
emerging product-related safety issues.
- Issued
a Federal Register Notice on Animal Feed Safety. FDA
issued a Federal Register notice for a public meeting
to present changes to the Animal Feed Safety System project
and the ranking of feed hazards according to the risk
they pose to animal and public health.
- Issued Final Rule on Substances Prohibited from
Use in Animal Food or Feed. FDA issued
a final rule to expand protections against bovine spongiform
encephalopathy (BSE) by prohibiting certain material
in all animal feed that can carry the agent that causes
BSE.
- Participated
in HHS Delegation to Vietnam. FDA
accompanied an HHS delegation to Vietnam to discuss a cooperative
arrangement with the Ministry of Health covering food,
feed, and medical products.
- Establishing an FDA Presence in the Middle East. The
FDA Commissioner traveled to Jordan to explore expanding
FDA”s presence in the Middle East.
- Coordinated
Food Safety Exchange of Information. FDA
led the Security and Prosperity Partnership of North America
Health Working Group with Canada and Mexico to coordinate
and exchange information on food safety investigations
and follow-up activities.
- Negotiated a Plan to
Leverage Inspectional Resources. The
FDA negotiated a plan for leveraging inspectional resources
of the European Union. The initial effort is to establish
a pilot program to coordinate inspection planning.
- Protected
American Consumers from Potentially Harmful Products. Between
November 7, 2007 and May 20, 2008, HHS/FDA refused admission
of 8,543 entry lines, each line representing a distinct
product type, that appeared to be adulterated, misbranded,
processed under insanitary conditions, or unapproved
new drugs. The refusal of these potentially harmful products
prevented them from being distributed to the American
public.
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- Collaborated on an Inter-Agency Agreement to
Determine the Survivability of Bacillus Anthracis (causative
agent of anthrax). FDA entered into an
agreement with the U.S. Department of Agriculture and
the Department of Homeland Security to determine the
survivability of Bacillus anthracis in processed liquid
egg products, which includes whole eggs, egg yolks, and
egg whites.
- Established a Memorandum of Understanding
(MOU) to Develop Forensic Tools. FDA entered
into a MOU with the Department of Homeland Security to
develop forensic tools to allow the identification and
differentiation of individual strains of food borne bacteria.
- Modernized
FDA’s Mission Accomplishments
and Regulatory Compliance Services (MARCS). The
MARCS program manages the integration, re-engineering,
and enhancement of the legacy systems that support FDA
field activities. MARCS was recently upgraded to include
International Mail Courier information collection and
photographic capture of parcels and contents.
- Enabled
Single Sign-On for Import Systems. The
FDA enabled a single sign-on capability for the Field Accomplishments
and Compliance Tracking System and the Operational and
Administrative System for Import Support. By not
having to log on to multiple systems, it will be easier
for Agency staff to use these systems in accomplishing
their work.
- Improved Interagency Interaction. Representatives
from Customs and Border Protection, Department of Justice,
U.S. Department of Agriculture, Department of Commerce,
Consumer Protection Safety Commission, FDA, Environmental
Protection Agency, and Department of Transportation held
a series of meetings to identify ways to improve upon agency
interaction during the cargo clearance process and to maximize
the sharing of critical data among agencies.
- Developed
a Platform for Rapid Detection of Pathogens in Food. FDA
developed a rapid detection method using flow cytometry
to identify E. coli and Salmonella in food. This system
is being used in poultry processing facilities to detect
and prevent bacterial contamination during food processing.
- Approved the Use of Cetylpyridinium Chloride
(CPC) as an Antimicrobial Agent. FDA approved
CPC as an antimicrobial agent applied in solution to
raw poultry carcasses to prevent contamination with Salmonella
or E. coli.
- Developed a Cell-Based Cytotoxicity Assay. FDA
developed a cell-based cytotoxicity assay to assess the
biological activity of the bioterrorism agents, ricin and
abrin, in infant formulas, fruit juices and yogurt. This
assay can be used to assess other chemicals that may be
used by terrorists to contaminate the food supply.
- Developed a Flow Cytometry Based System. In
collaboration with outside parties, FDA developed a flow
cytometry based system which uses probes to identify bacteria
according to genus, species, or serotype (e.g. differentiating
normal E. coli from E. coli O157), depending on the level
of specificity desired. This system has been successfully
commercialized and is being used in poultry processing
facilities to detect and prevent bacterial contamination.
- Employed a New Detection Method for Salmonella. FDA
is using genetic analysis to identify hundreds of Salmonella
enterica strains from seafood imports. The analysis provides
information that can be used to trace more quickly outbreaks
of Salmonellaenterica and implement surveillance programs
to ensure the safety of imported seafood.
- Developed a New Detection
Method for Mycotoxins. FDA
developed a method to detect mycotoxins in distiller’s
grains.
- Portable X-Ray Fluorescence (XRF)
Devices. FDA
has developed the analytical capabilities using handheld
XRF devices to detect lead and other heavy metals in a
variety of products and media. More than 80 elements can
be rapidly screened that could be extended to the field
and used in remote sites outside the laboratory. To
date a cadre of investigators and analysts has been trained
to screen a variety of products.
- Upgraded eLEXNET
Portal Collaboration and User Interface Tools. FDA
has upgraded the Electronic Laboratory Exchange Network
(eLEXNET) user interface to more effectively provide information
and stimulate interactive information exchange amongst
users. eLEXNET
is a seamless, integrated, web-based information network
that allows health officials at multiple government agencies
engaged in food safety activities to compare, share and
coordinate laboratory analysis findings. This network
provides the necessary infrastructure for an early warning
system that identifies potentially hazardous foods and
enables health officials to assess risks and analyze
trends.
- Developed a Real-Time Polymerase
Chain Reaction Assay for the Detection of Salmonella and E.coli
in multiple food matrices. FDA developed a method
which was AOAC International validated to rapidly screen
large numbers of samples for Salmonella and E.coli in 24 hours.
FDA has also developed a method to rapidly screen large
numbers of samples within 30 hours.
- Issued a Compliance
Program for Select Imported Biologic Regulated Products
(CP 7342.007). FDA
issued a comprehensive compliance program for select
biologic imports (http://www.fda.gov/cber/cpg/7342007.htm). The
new compliance program gives the Field comprehensive
instructions for reviewing import entries of select biologic
products. It outlines what regulatory requirements
apply and what steps to take if a product does not comply.
- Expedited
Entry of Stem Cells for Transplantation. The
FDA, Customs and Border Protection, and the National Marrow
Donor Program entered into an agreement for expedited entry
of hematopoietic stem cells for transplantation. Hematopoietic
stem cells are used for transplantation into immuno-compromised
individuals, particularly those individuals who have cancer
and require donated stem cell transplant material as part
of their treatment protocol.
- Responded to Adverse
Events Associated with Heparin. After
discovering an increase in adverse reactions to certain
heparin sodium products, FDA designed, validated, and publicized
test methods for analyzing heparin for contamination. FDA
began inspections of domestic and foreign facilities and
suppliers to determine the presence and cause of the contamination,
map the supply route of contaminated products, and gauge
the inspected firms' compliance with current good manufacturing
practices. Working relationships developed through
the Memoranda of Agreement with China helped speed and
facilitate HHS/FDA visas and inspections in responding
to the heparin crisis. HHS/FDA was joined in the
facilities by representatives from the Chinese State Food
and Drug Administration and continues to have conversations
with them as they conduct their testing so that any findings
are shared.
- Completed PREDICT Pilot.
The PREDICT prototype for improved, risk-based electronic
screening of imports was pilot tested using seafood entries
at five ports in metropolitan Los Angeles. The test
was successful. Using
PREDICT, the "hit rate" of violative findings
for field exams increased to 7.0% from 3.7%. For
samples, the violation rate increased to 19.3% from
14.4%. FDA is now expanding the prototype to
include automated database lookups with regards
to marketing status, and to add more types of
products for PREDICT screening.
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- Collaborated with States. FDA held a
conference call with the State Commissioners of Agriculture
and Health to discuss collaboration between the states
and the Agency regarding food safety. The FDA Commissioner
announced that a 50-State meeting will be held to develop
implementation strategies for the implementation of the
Food Protection Plan, the Action Plan, and the FDA Amendments
Act (FDAAA) between federal, state, and local partners
- Issued Federal Register Notices for Pharmaceutical Serialization, Track and Trace, and Authentication. FDA published
two Federal Register (FR) notices pursuant to section
913 of the FDA Amendments Act of 2007 to seek public
comment on standards for pharmaceutical serialization,
track and trace, and authentication, as well as to seek
public comment on technologies
used for track and trace and authentication of pharmaceuticals. Track-and-trace
technologies can be used as anti-counterfeiting and anti-diversion
tools by tracking a product throughout the supply chain.
- Developed a Recall Template. FDA
developed a template for public notification of recalls
and presented it to the FDA Risk Communications Advisory
Committee.
- Issued a Request for Applications for states interested in establishing Food Hazard Rapid Response Teams (RRT). The goal of developing and sustaining an RRT is in concert with long-term goals to enhance the food inspection and foodborne illness response programs, to increase the ability to inspect and obtain compliance for firms in their jurisdiction involved in the processing, manufacturing, distribution, transportation and warehousing of food, verify compliance with the State laws and regulations, good manufacturing practices, food defense, and other food protection requirements.
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