• Submitters of Active FCNs Will Receive Objection Letters if the Government Shuts Down, FDA's Keefe Says at Keller and Heckman Conference
  • September 27, 2013
  • Law Firm: Keller Heckman LLP - Washington Office
  • If a government shutdown occurs at the end of FY 2013 (September 30, 2013), the Food and Drug Administration (FDA) will send formal objection letters to submitters of pending food contact notifications (FCNs), effectively denying them because the Agency would not have sufficient funds to operate the FCN program and, thus, would not be able to meet the statutory requirement that FCNs be acted upon within 120 days, said Dennis M. Keefe, Ph.D., Director of FDA’s Office of Food Additive Safety (OFAS), Center for Food Safety and Applied Nutrition (CFSAN). Speaking September 18, 2013, at Keller and Heckman’s 14th Annual Food Packaging Law Seminar, he added that companies that had received objection letters would have to resubmit the FCNs once the shutdown is over.

    Explaining that OFAS is responsible for the safety of food ingredients—including premarket reviews of food additive petitions, color additive petitions, generally recognized as safe (GRAS) notices, biotechnology notices, and FCNs—and the post-market monitoring of food ingredients, Dr. Keefe stated that OFAS’s resources are allocated overwhelmingly to food contact-related issues. OFAS conducts premarket reviews of food-contact materials to the tune of approximately 100 FCNs a year; Dr. Keefe reported that OFAS also handled 240 Freedom of Information Act (FOIA) requests during FY 2012, or 70% of the total FOIA requests submitted to CFSAN that year.

    Dr. Keefe told the seminar attendees that training videos on the use of FDA’s electronic portal, including one on submitting FCNs, will be available on FDA’s website by the end of the month. [The training videos were posted on FDA’s website on September 25.] He also encouraged the use of the pre-notification consultation (PNC) process prior to submitting a FCN. Dr. Keefe explained that the Agency recently compared FCNs submitted with and without a PNC, and found that FCNs that had started with a PNC tended to be much more successful.

    OFAS to Release Some Redacted FCN Submissions under Transparency Initiative

    FDA currently is conducting an FCN transparency initiative. Discussing this initiative, Dr. Keefe stated, “Our interactions and decisions must be transparent.” This transparency builds the public trust and it allows industry to better understand the process, he added. He noted one of the challenges of the FCN program is that the process is very opaque to the public; Dr. Keefe said that the Agency is trying to find a way to make the process more transparent within the statutory confines of the program. Explaining, he said that FCNs don’t come to light until a substance is cleared.

    (According to FDA’s Food Contact Notification (FCN) Transparency Initiative, OFAS is piloting a project to proactively release the redacted, FDA-generated review memoranda and FDA FORM 3480s from industry-submitted FCNs. According to FDA’s website, “This pilot intends to process and post documents for 20 FCNs, and to determine the best way to do this while meeting requirements of the Freedom of Information Act (FOIA) and Section 508.”)

    Emphasizing that OFAS is driven by the desire to obtain and use the best science, Dr. Keefe discussed the development of a Chemical Evaluation and Risk Estimation System (CERES), an area of scientific innovation that will enable FDA to leverage available data through computational and predictive methods for pre- and post-market monitoring of packaging materials and direct food additives. Models are being developed that will be used to help OFAS make decisions in the future. “Our intent is to make at least a portion of this publicly available on the web,” Dr. Keefe said, adding, “Stay tuned, this is an exciting area.”

    Dr. Keefe also discussed several areas that will be addressed in a forthcoming update to the Chemistry Guidance for FCN submissions. The Guidance will include updates to the migration study protocols and a section on high pressure processing. Dr. Keefe stated that FDA is now using for infant exposures a 6.3 kg body weight and a food intake of 900 grams per day. He said that FDA also is looking at the elderly as a sensitive sub-population. Dr. Keefe noted that FDA is conducting an internal review of low molecular weight oligomers. Finally, he also told attendees to expect a final version of the Draft Guidance on assessing the effects of significant manufacturing process changes by the end of the year.

    Lastly, Dr. Keefe spoke on the topic of interagency collaboration. In particular, OFAS is working with the U.S. Department of Agriculture’s (USDA) Food Safety Inspection Service (FSIS), particularly in the antimicrobial area (he added that OFAS is seeing an uptick in the number of FCN submissions for antimicrobial substances). If, for example, a company submits an FCN for an antimicrobial application, Dr., Keefe explained that OFAS will inform the company that it also needs to notify FSIS so OFAS and FSIS can conduct concurrent reviews. Apart from FSIS, OFAS also is considering sharing toxicology data with EPA.