FDA COMPLETES REVIEW OF HOW AGENCY EVALUATES HARMFUL CHEMICALS IN PRODUCTS

FROM:  U.S. FOOD AND DRUG ADMINISTRATION 

FDA Takes Steps to Strengthen Program to Assess the Safety of Chemicals in Foods, Other Products

August 28, 2014

The U.S. Food and Drug Administration has completed a review of how the agency evaluates the harmful effects of chemicals in foods, cosmetics, dietary supplements, animal food/feed and veterinary drugs. Based on the findings, the agency is taking steps to strengthen internal processes.

The chemical safety assessment review is the first of three planned strategic reviews being conducted under the direction of the FDA’s Office of Foods and Veterinary Medicine (OFVM). The other two focus on nutrition and microbiological laboratory programs.

The FDA conducted the chemical safety assessment review in order to ensure that the agency is making the most effective and efficient use of its chemical safety resources. The review focused on the scientific capacity and management of the program’s multiple elements across the Center for Food Safety and Applied Nutrition (CFSAN) and the Center for Veterinary Medicine (CVM). Initiated in 2012, the review included interviews of current and former FDA employees involved in all aspects of the agency’s chemical safety assessment program, as well as senior managers from other U.S. government agencies experienced in chemical safety assessment, and five listening sessions conducted by CFSAN with internal and external stakeholders on OFVM’s overall chemical safety assessment program. In addition, four outside consultants, all of whom are considered experts in the field, and who had previously held senior management positions dealing with chemical safety assessment in the Federal government, met with OFVM and senior CFSAN managers to discuss the interview and listening session reports. Based on this discussion and their review of the interview and listening session reports, each consultant also made his or her own written recommendations for OFVM’s chemical safety program.

Working groups were formed in CFSAN and CVM to review all the reports and consultant recommendations. The issues and recommendations identified in the workgroup reports fall into three overarching categories (Science, Communication and Collaboration, and Training and Expertise).

Among the review’s most significant outcomes: the centers, led by CFSAN, will develop a process for updating FDA’s Toxicological Principles for the Safety Assessment of Food Ingredients (also called the “Redbook”), so that it reflects current science. Additionally, the centers will jointly develop a process to ensure consistency of methodologies used for safety and risk assessments within and across offices at CFSAN, and between CFSAN and CVM.

COMPLAINT FILED AGAINST MICHIGAN CHEESE FACTORY FOR DISTRIBUTING ADULTERATED CHEESE PRODUCTS

FROM:  U.S. JUSTICE DEPARTMENT 

Friday, August 8, 2014

United States Files Enforcement Action Against Michigan Cheese Company and Owners to Stop Distribution of Adulterated Cheese Products

A civil complaint was filed today in federal court in Michigan against S. Serra Cheese Company of Clinton Township, Michigan, and its owners, Stefano and Fina Serra, to prevent the distribution of adulterated cheese, announced Assistant Attorney General Stuart F. Delery of the Justice Department’s Civil Division.

S. Serra Cheese Company manufactures and distributes several varieties of Italian cheeses, such as ricotta, provolone, mozzarella and primo sale.  The complaint alleges that the company’s Italian cheeses are manufactured in insanitary conditions, and that the company’s procedures are inadequate to ensure the safety of its products.  The department filed the injunction action in the Eastern District of Michigan at the request of the U.S. Food and Drug Administration (FDA).

“The presence of potentially harmful pathogens in food and processing facilities poses a serious risk to the public health,” said Assistant Attorney General Delery.  “The Department of Justice will continue to bring enforcement actions against food manufacturers who do not follow the necessary procedures to comply with food safety laws.”

According to the complaint, two FDA inspections performed in 2013 revealed that the company’s cheese is adulterated within the meaning of the Food, Drug and Cosmetic Act because it is prepared, packed or held under insanitary conditions in which it may have become contaminated with filth or rendered injurious to health.  The complaint alleges, for example, that the company repeatedly failed to reduce the risk of contamination from two potentially dangerous types of bacteria: Escherichia coli (E. coli) and Listeria innocua (L. innocua).

Although the strains of E. coli found in cheese samples collected from the company’s facility were n on-pathogenic, their presence indicates that the facility is insanitary and contaminated with filth.  In addition, t he presence of L. innocua indicates insanitary conditions and a work environment that could support the growth of L. monocytogenes, an organism that poses a life-threatening health hazard because it is the causal agent for the disease listeriosis, a serious encephalitic disease.  The presence of L. innocua in the company’s facility demonstrates the potential for the presence of L. monocytogenes in the same processing environment.

According to the complaint, the FDA’s most recent inspection in November 2013 revealed insanitary conditions, including the presence of generic, non-pathogenic E. coli and L. innocua and the absence of effective monitoring and sanitation controls in accordance with the current Good Manufacturing Practice requirements for food under federal law.  For example, cleaning and sanitizing operations for utensils and equipment were not performed in a manner that protects against contamination of food and food contact surfaces.

FDA previously inspected the facility in January 2013.  According to the complaint, at that time, FDA inspectors discovered a number of Good Manufacturing Practice deficiencies.  For example, FDA inspectors noted that the facility was not constructed in such a manner as to allow floors to be adequately cleaned and to be kept clean and in good repair.  The FDA inspectors also observed that the company failed to store raw materials in a manner that protects against contamination.

The government is represented by Trial Attorney Dan Baeza of the Civil Division’s Consumer Protection Branch and Assistant U.S. Attorney Peter Caplan for the Eastern District of Michigan, with the assistance of Assistant Chief Counsel for Enforcement Christopher Fanelli of the Food and Drug Division, Office of General Counsel, Department of Health and Human Services.

A complaint is merely a set of allegations that, if the case were to proceed to trial, the government would need to prove by a preponderance of the evidence.