Dr. Michiel van Schothorst, retired Vice President of Food Safety Affairs for Nestlé in Vevey, Switzerland, will keynote the annual “John H. Silliker Lecture” at the 2005 Annual Meeting of the International Association for Food Protection (IAFP). He will address “Managing the Safety of Internationally Traded Food" on Wednesday, August 17th, at the Baltimore Marriott Waterfront Hotel beginning at 3:45 PM.

An internationally acclaimed scientist, Dr. Schothorst was a member of the Permanent Food Safety Advisory Panel of the World Health Organization from 1986 - 2002, participating in the Codex Food Hygiene Committee from 1968 - 2002. He was also a member of the International Commission on the Microbiological Specification for Foods from 1973 - 2003, and served as secretary from 1992 - 2003.

Sponsored by Silliker, Inc. the annual series lecture commemorates the distinguished career and scientific contributions of company founder, Dr. John H. Silliker.

For more information contact: John Williams, SILLIKER, Inc.   708/ 957 7878

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Homewood, IL – June 2005 – Dr. Ann Marie McNamara, Vice President of Food Safety and Scientific Affairs for Silliker, Inc., was recently appointed by U.S. Agriculture Secretary Mike Johanns to serve on the National Advisory Committee on Microbiological Criteria for Foods (NACMCF).

NACMCF provides scientific advice on public health issues relative to the safety and wholesomeness of the U. S. food supply. In addition, the committee assists in the development of microbiological criteria and reviews, evaluates epidemiological and risk assessment data, and reviews methodologies for assessing microbiological hazards.

A renowned scientist with over 17 years of industry and regulatory experience, Dr. McNamara joined Silliker, Inc. in 2003 after serving as Corporate Vice President of Food Safety and Technology for the Sara Lee Corporation. From 1992 to 1999, she served as Director of Microbiology for the Office of Public Health and Science (USDA FSIS). She was influential in several food safety initiatives, and received the Secretary of Agriculture’s “Superior Service Award” five times in her seven years at USDA.

“It is a great honor to be chosen to serve on NACMCF with all of the new and highly accomplished appointees,” said Dr. McNamara. “ I am looking forward to continuing the tremendous work the committee has performed over the past three decades.”

Established in 1988, NACMCF serves the U.S. Departments of Agriculture (Food Safety and Inspection Service), Health and Human Services (Food and Drug Administration and Centers for Disease Control and Prevention), Commerce (National Marine Fisheries Service) and Defense. Committee members, 30 scientific experts representing disciplines related to health and food safety issues, serve two-year terms and normally meet two to three times a year.

For more information contact: John Williams, SILLIKER, Inc.   708/ 957 7878

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FDA also issues draft guidance regarding records access

12/6/04 - The U.S. Food and Drug Administration (FDA) today issued final regulations on the establishment and maintenance of records to protect the U.S. human food and animal feed supply in the event of credible threats of serious adverse health consequences or death to humans or animals. FDA also issued draft guidance to FDA staff and industry, which details the internal procedures the agency will follow before requesting access to records.

This final regulation implements section 306 of the Bioterrorism Act, which directs the HHS Secretary to issue regulations requiring persons who manufacture, process, pack, transport, distribute, receive, hold, or import food to establish and maintain records. These records identify the immediate previous source of all food received, as well as, the immediate subsequent recipient of all food released.

"These records will be crucial for FDA to deal effectively with food-related emergencies, such as deliberate contamination of food by terrorists," said Dr. Lester M. Crawford, Acting FDA Commissioner. "The ability to trace back will enable us to get to the source of contamination. The records also enable FDA to trace forward to remove adulterated food that poses a significant health threat in the food supply."

The final regulation is the fourth regulation designed to increase the safety and security of the U.S. human and animal food supply under the authority of the "Public Health Security and Bioterrorism Preparedness and Response Act of 2002" (the Bioterrorism Act).

The record retention period for human foods ranges from six months to two years depending on the shelf life of the food. Records for animal food, including pet food, must be retained for one year. The maximum record retention requirement for transporters of all types of food is one year.

Records must be retained at the establishment where the activities covered in the records occurred or at a reasonable accessible location. To minimize the burden on food companies affected by the final rule, companies may keep the required information in any format, paper or electronic. All businesses covered by this rule must comply within 12 months from the date the rule is published in the Federal Register, except small and very small businesses. Small businesses (11-499 full-time equivalent employees (FTEs)) must comply within 18 months from this date, and very small businesses (10 or fewer FTEs) have to comply within 24 months from this date.

When FDA has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, any records or other information to which FDA has access must be available for inspection and copying as soon as possible, not to exceed 24 hours from time of receipt of the official request. The records access authority applies both to records required to be established and maintained by the final rule, or any other records a covered entity may keep to comply with federal, state, or local law or as a matter of business practice.

The Bioterrorism Act allows FDA to bring a civil action in federal court to enjoin the persons who fail to comply with this rule. FDA also can seek criminal actions in federal court to prosecute persons who fail to establish and maintain records, as required by the final rule.

FDA has already issued three other final regulations under the Bioterrorism Act, which are in effect. They cover:

• Registration foreign and domestic food facilities;

• Prior notice of food shipments imported or offered for import into the U.S.; and

• Administrative detention, so that food products that might pose a threat of serious adverse health consequences or death may be detained.

FDA will be holding seven public meetings in January and February 2005 to explain the requirements of the final rule to interested parties and answer questions.

As mandated by the Bioterrorism Act of 2002, the U.S. Food and Drug Administration (FDA) proposed four regulations to enhance its authority to protect the nation’s food supply against terrorist threats or similar food safety emergencies. On October 9, FDA announced the release of interim final rules for the Registration of Food Facilities, and the Prior Notice of Imported Food Shipments.

Under the interim final rule for prior notice of food imports, firms will be required to provide advance notice of food shipments, which would allow the FDA to effectively target inspections of imported foods. Within the interim final rule, FDA removed the unpopular provision of the proposed rule that required prior notice by “noon the day before arrival.” Based on input provided by the food industry, the Agency modified this requirement to allow for various modes of transportation. The interim final rule stipulates that firms must provide notification in no fewer than “two hours before arrival by land via road; four hours before arrival by air or by land via rail; or eight hours before arrival by water."

The second interim final rule released this week concerned new requirements for the registration of all domestic and foreign food facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States by December 12, 2003. The FDA expects approximately 420,000 facilities will register in the Agency’s first complete roster of foreign and domestic food facilities.

In order to streamline the registration process, FDA will accept registration that is submitted via the Internet, surface mail, fax, or CD-ROM by mail. Beginning October 16, FDA will accept electronic registration via the Internet. The free online registration process could be completed in 15 minutes.

Since the Agency issued the regulations as interim final rules, FDA will use enforcement discretion for up to four months beyond the effective date of December 12, 2003. FDA has provided a 75-day comment period on the interim rules, and plans to reopen the comment period in March 2004 for 30 days.

The final versions of the registration and prior notice rules reflect the numerous comments submitted to the Agency by the food industry, bioterrorism experts, national security agents, and law enforcement agencies. In statements released this week, the National Food Processors Association and other food industry associations expressed support for the interim final rules and rulemaking process.

“It is important to recognize that the regulations build upon an already strong food security system,” commented John R. Cady, President and CEO of the National Food Processors Association (NFPA). “Industry communication and education will be the key to ensuring compliance with these new requirements.”

“GMA and its member companies are pleased that FDA appears to have given a great deal of consideration to making the bioterrorism regulations workable," said GMA Vice President of Federal Affairs Susan Stout. "These interim rules are an example of what can be accomplished when the government engages all stakeholders to create regulations that meet the needs of FDA, the food industry, and consumers to further protect the food supply without creating overly burdensome requirements."

The interim final rules were published in the Federal Register on October 10.

Contact us to find out how Silliker can help you implement a total food safety program.