[Federal Register: April 2, 2008 (Volume 73, Number 64)]
[Notices]
[Page 17987-17989]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ap08-70]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0188]
Food Protection Plan; Outreach Activities; Opportunity for Public
Comment
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that it
is establishing a public docket to receive information and comments
related to its comprehensive Food Protection Plan (the Plan) released
in November 2007. The new Plan presents a robust strategy to protect
the nation's food supply from both unintentional contamination and
deliberate attack. FDA is establishing this docket for the purpose of
soliciting comments from its stakeholders on the Plan and the questions
set forth in this notice.
DATES: Submit written or electronic comments by July 31, 2008.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://
www.regulations.gov. To ensure timelier processing of comments, FDA is
no longer accepting comments submitted to the agency by e-mail. All
comments to FDA on the Plan should be submitted through the docket.
FOR FURTHER INFORMATION CONTACT: Kari Barrett, Office of the
Commissioner (HF-60), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20852, 301-827-9831, FAX: 301-827-2866.
SUPPLEMENTARY INFORMATION:
I. Background
For more than 100 years, FDA has protected the health of Americans
by ensuring the safety of the food supply (other than meat, poultry,
and processed egg products that are regulated by the U.S. Department of
Agriculture). Every day across the country people eat out, buy
groceries, cook meals for their families, and feed their pets.
Americans expect that all their food will be safe, and FDA plays a
critical role in making sure this is true. Specifically, FDA is
responsible for the safety of 80 percent of all food sold in the United
States.
The U.S. food supply is one of the safest in the world. Current
trends in the food industry promise better nutrition and wider choices
for consumers. At the same time, new trends in demographics,
consumption, food production technology, and business practices all
pose challenges for maintaining this safe food supply. For example,
consumers today want the convenience of opening a bag of salad that is
already prepared. In the past a single head of lettuce that was
contaminated may have resulted in one family being ill. Now, a
contaminated head of lettuce may be processed with many others and be
placed into bags of convenience salad that many consumers can buy.
These bags of salad, if contaminated, could result in hundreds of
illnesses.
The supply of food consumed in the United States is increasingly
imported, introducing a greater challenge for improving the information
FDA has regarding conditions under which food is produced in foreign
countries. The United States trades with over 150 countries and
territories with products coming into over 300 U.S. ports. Fifteen
percent of the food supply by volume in the United States is imported.
Sixty percent of fresh fruits and vegetables are imported. More than 75
percent of seafood is imported. Although many foreign countries have
well developed regulatory systems to ensure food safety, others have
systems that may not be able to ensure food safety to the same degree.
FDA also faces the challenge of foodborne illnesses caused by known
hazards as well as new threats. In 1999, the Centers for Disease
Control and Prevention estimated that there were approximately 76
million cases per year of illness from foodborne agents in the United
States, with 325,000 hospitalizations and 5,000 deaths. Foodborne
illnesses are caused by more than 200 different foodborne pathogens
(agents that can cause illness) of which we are aware. The variety of
agents associated with foodborne illness has steadily grown over the
last few decades, and there is every probability that this list will
continue to increase. In addition, the recent incident in which
vegetable protein products were contaminated with melamine was a
deliberate act for economic gain. Although this was not considered an
act of terrorism, it resulted in the sickness and death of cats and
dogs.
Another important challenge is effective communication. FDA,
States, and industry receive food safety
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information in various ways, such as consumer complaints, inspection
data, positive test results, adverse event reports and other reports of
illness. FDA is committed to improving information flow to improve
detection and response to signs of trouble. These challenges call for a
new approach to protecting our food supply from unintentional and
deliberate contamination. In May 2007, the Secretary of Health and
Human Services and the Commissioner of Food and Drugs charged FDA with
developing a comprehensive and integrated FDA Food Protection Plan to
keep pace with these changes. FDA issued the Plan in November 2007. The
Plan outlines a strategy to strengthen an already safe food system for
humans and animals, and builds upon advances in science and technology
to safeguard the nation's food supply. The Plan represents a proactive
approach that uses science and modern technology to identify potential
hazards ahead of time. By preventing most harm before it can occur,
enhancing our intervention methods at key points in the food production
system, and strengthening our ability to respond immediately when
problems are identified, FDA can provide a food protection framework
that helps keep the American food supply safe.
The Plan provides a comprehensive and integrated strategy that
encompasses three core elements: Prevention, intervention, and
response. The prevention element includes promoting increased corporate
responsibility so that food problems do not occur in the first place.
By comprehensively reviewing food supply vulnerabilities and developing
and implementing risk reduction measures with industry and other
stakeholders, FDA can best address critical weaknesses. The
intervention element focuses on risk-based inspections, sampling, and
surveillance at high risk points in the food supply chain from
production to consumption. These interventions must verify that the
preventive measures are in fact being implemented, and done so
correctly. The response element bolsters FDA's emergency response
efforts by increasing the speed and efficiency of response. It includes
improved communication and coordination with other Federal, State, and
local government agencies and industry during and after emergencies.
When there is an emergency, there is a need to respond quickly and to
communicate clearly with consumers and other stakeholders.
FDA is committed to strengthening the nation's food protection
system through implementation of this Plan. The Plan incorporates
several crosscutting principles including:
Focus on risks over a product's life cycle from production
to consumption;
Target resources to achieve maximum risk reduction;
Address both unintentional and deliberate contamination;
and
Use science and modern technology systems.
In addition, the Plan includes key steps under each of the three
core elements including:
1. Prevention:
Promote increased corporate responsibility to prevent
foodborne illnesses;
Identify food vulnerabilities and assess risks; and
Expand the understanding and use of effective mitigation
measures.
2. Intervention:
Focus inspections and sampling based on risk;
Enhance risk-based surveillance; and
Improve the detection of food system ``signals'' that
indicates contamination.
3. Response:
Improve immediate response; and
Improve risk communications to the public, industry, and
other stakeholders.
The strategy outlined in the Plan involves, in part, the agency
actively pursuing input from its stakeholders. The agency will be
conducting various formal and informal outreach activities with its
domestic and international stakeholders. The objective of this notice
is to provide stakeholders an opportunity to comment on the Plan. To
help achieve this objective, stakeholders are encouraged to review and
comment on the Plan found at http://www.fda.gov/oc/initiatives/advance/
food.html. In particular, FDA is interested in comments addressing the
following questions:
Core Element #1: Prevention
1.1 What are best practices, and what are the principal benefits of
and challenges to implementing the key prevention steps in the Plan?
How do these vary by stakeholder (e.g., producers, manufacturers,
retailers, consumers, Federal/State government, and foreign countries)?
1.2 What, if any, significant gaps are there in the key prevention
steps and the associated FDA actions listed in the Plan?
1.3 In targeting resources to achieve maximum risk reduction
through prevention the Plan focuses on high risk identification. What,
if any, are the limitations to this approach? What criteria should the
agency consider in defining high risk? What are specific areas of
modeling, analysis, and research likely to significantly advance high
risk identification? How would these areas of work promote effective
and efficient high risk identification? What would be the key
challenges to implementation?
1.4 What are potential data sources other than FDA data to inform
the risk based approach? What are the obstacles to obtaining such data?
1.5 The Plan proposes new legislative authorities to strengthen
FDA's ability to prevent food problems. They include: (1) Allowing FDA
to require controls against intentional adulteration by terrorists or
criminals at points of high vulnerability in the food chain, (2)
authorizing FDA to issue additional preventive controls for high-risk
foods, and (3) requiring FDA facilities to renew their FDA registration
every 2 years and allowing FDA to modify the registration categories.
What would be the principal benefits and limitations of each of these
proposed authorities? In implementing these proposed authorities, how
could the benefits be best leveraged and the limitations mitigated?
Core Element #2: Intervention
2.1 What are best practices, and what are the principal benefits
and challenges to implementing the key intervention steps in the Plan?
How do these vary by stakeholder (e.g., producers, manufacturers,
retailers, consumers, Federal/State government, and foreign countries)?
2.2 What, if any, significant gaps are there in the key
intervention steps and the associated FDA actions listed in the Plan?
2.3 In targeting resources to achieve maximum risk reduction
through intervention the Plan focuses on risk-based surveillance. What,
if any, are the limitations to this approach? What are specific
strategies likely to significantly advance effective risk-based
surveillance? How would these strategies promote effective and
efficient risk-based surveillance? What would be the key challenges to
implementation?
2.4 The Plan proposes legislative authority for FDA to accredit
highly qualified third parties for food inspections. What would be the
principal benefits and limitations of an accreditation program? What
criteria should a third party meet to qualify as an accrediting
organization?
2.5 Concerning imports, the Plan proposes legislative authority to
require electronic import certification for shipments of designated
high risk products. It also proposes legislative authority to refuse
admission of imported food if FDA inspection is
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delayed, limited, or denied. What would be the principal benefits and
limitations of these proposals? In implementing these proposals how
could the benefits be best leveraged and the limitations mitigated?
Core Element #3: Response
3.1 What are the best practices, and what are the principal
benefits and challenges to implementing the key response steps in the
Plan? How do these vary by stakeholder (e.g., producers, manufacturers,
retailers, consumers, Federal/State government, and foreign countries)?
3.2 What, if any, significant gaps are there in the key response
steps and the associated FDA actions listed in the plan?
3.3 The Plan proposes two new legislative authorities to strengthen
FDA's response capability: (1) Empowering FDA to issue a mandatory
recall of food products when voluntary recalls are not effective, and
(2) providing FDA enhanced access to food records during emergencies.
What would be the principal benefits and limitations of each of these
proposed authorities? In implementing these proposed authorities, how
could the benefits be best leveraged and the limitations mitigated?
II. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
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 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.
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
through FDMS only.
Dated: March 26, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-6833 Filed 4-1-08; 8:45 am]
BILLING CODE 4160-01-S