[Federal Register Volume 73, Number 64 (Wednesday, April 2, 2008)]
[Notices]
[Pages 17987-17989]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-6833]


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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

[[Page 17988]]

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