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March 3, 2005
FDA is requesting comments and scientific data and information that would assist the agency in its plans to conduct a risk assessment for Listeria monocytogenes in smoked finfish (smoked finfish risk assessment), and evaluate the provisions of the 2001 Food Code that address preventive controls for L. monocytogenes in retail and foodservice establishments. The purpose of the smoked finfish risk assessment is to ascertain the impact on public health from the reduction and/or prevention of L. monocytogenes growth and recontamination during the manufacturing and/or processing of hot- and cold-smoked finfish. The smoked finfish risk assessment and the evaluation of the Food Code provisions for preventive controls for L. monocytogenes in retail and foodservice establishments support the agency's commitment to the Listeria Action Plan (revised 2003) that FDA and the Centers for Disease Control and Prevention (CDC) developed to reduce L. monocytogenes illnesses associated with the consumption of ready-to-eat (RTE) foods.
The request went on Advanced Display at the Federal Register today. Comments and scientific data and information may be submitted 60 days after publication in the Federal Register. Submit written comments and scientific data and information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments, data, and information to Dockets Open for Comment. Include the docket number, 2005N-0065, CFSAN 200510, with comments.
For further information, please contact Dr. Sherri B. Dennis, Center for Food Safety and Applied Nutrition (HFS-06), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1903.
FDA announced a draft revision of the Compliance Policy Guide (CPG) Section 110.310 to provide guidance to FDA and Customs and Border Protection (CBP) staff regarding:
FDA is issuing the revisions to the CPG as level 1 draft guidance consistent with FDA's good guidance practices regulation § 10.115 (21 CFR 10.115). The draft revisions to the CPG represent the agency's current thinking on its enforcement policy concerning prior notice. It does not create or confer any rights for or on any person and does not operate to bind FDA, or the public. The revisions to the CPG are found in section C, items 7 and 8.
FDA is considering taking these steps while the prior notice final rule is under development to provide additional flexibility in filing prior notice when, due to the geography, the only practical transportation route available for the shipment is through the United States and when there is a prior notice violation because the prior notice does not include the 6-digit HTS code for the article of food.
Submit written comments on the draft revisions to the CPG by April 2, 2005, to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to Dockets Open for Comment. Be sure to reference Docket No. 2003D-0554. For further information contact Domenic Veneziano, Office of Regulatory Affairs (HFC-100), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 703-621-7809.
FDA has awarded a task order to IFT to consult with subject-area specialists and prepare a report on issues related to the manufacturing of foods that may become unintentionally contaminated with the eight major food allergens (i.e., milk, egg, fin fish, shellfish, tree nuts, peanuts, wheat, and soybeans). The new task order was awarded under an existing contract titled "Analysis and Review of Topics in Areas of Food Safety, Food Security, Food Processing, and Human Health." The work under this new task order requires that IFT consult with qualified individuals who have subject-area expertise and specialization to examine practices that result in foods becoming unintentionally contaminated with major food allergens during manufacturing. This evaluation shall address such contamination from two perspectives--where shared production lines and dedicated production lines are used. The report will also cover approaches that industry currently uses to control allergen contamination in foods, including information on the efficacy of these different approaches, as well as the research needed to study the control of allergens in the food manufacturing and distribution environment. For additional information, please contact Mr. Donald Kautter, Jr., at 301-436-1629.
To help reduce the risk of an attack on the food supply, the U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (DHHS) have joined forces to provide a food security awareness training program.
The training targets individuals who play an important role in defending our nation's food from attack: federal, state, local, and tribal food-industry regulators; school food authorities; and nutrition assistance program operators and administrators. Representatives from the food industry and other individuals essential in responding to a food emergency due to an intentional attack-such as law enforcement, public health, and homeland security officials-are also encouraged to participate.
The program was developed jointly by the USDA's Food Safety and Inspection Service, Food and Nutrition Service, and Agricultural Marketing Service and DHHS' Food and Drug Administration. In conjunction with the food security awareness training, some of the individual agencies participating are also offering training on specific actions their workforce and partners should take to ensure the security of the food supply.
USDA and DHHS recognize the importance of closely coordinating the efforts of all involved parties to protect the food supply. This food security awareness training is just one example of how those departments are committed to defending the nation's food supply by working together.
Through food security training, USDA and DHHS are ensuring that critical security information reaches key audiences, so those audiences are prepared to prevent attacks against our nation's food supply.
For more information on this course, please check with the agencies' websites: for USDA, Food Safety and Inspection Service (FSIS), Agricultural Marketing Service, or Food, Nutrition, and Consumer Services; for FDA, Food Security Training.
The 13th annual FDA Science Forum will be held April 27-28, 2005, at the Washington Convention Center in Washington, DC. This year's theme is Advancing Public Health through Innovative Science.
Each year since 1993, the FDA Science Forum has served as a comprehensive training program, and as a vehicle to communicate and promote issues relating to scientific development and associated regulatory concerns. This annual event showcases FDA's scientific achievements, facilitates discussions on topics of interest to FDA and its stakeholders, promotes both internal and external collaborations, and recognizes outstanding research and science-based review performance with Scientific Achievement Awards.
This is the only forum where scientists from all disciplines and organizational components of FDA meet to share data, knowledge, and ideas on the science-based mission of the Agency. The Science Forum also features presentations by leaders of the academic and public health communities, and thereby provides an excellent environment for the open discussion of emerging science, technology, and methodologies, as well as how they can be used to meet the Nation's public health needs.
Open to the public, the 2005 Forum is designed to bring FDA scientists together with representatives from other components of DHHS, industry, academia, government agencies, consumer and patient advocacy groups, Congress, international constituents, and many other stakeholders. This meeting offers a valuable opportunity for academia and industry to learn about FDA research, collaboration opportunities, and regulatory priorities.
Additional information about the Science Forum and online registration are available at
2005 FDA Science Forum.
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Office of Food Safety, Defense, and Outreach |
CFSAN Web site: http://www.cfsan.fda.gov/ |
