October 7, 2015
TO: JPA Members
FROM: Patricia Faison
JPA Regulatory Update: FDA Publishes Strategy for FSMA Training; Vermont Genetically Engineered Food Labeling; Court to Hear Arguments in Vermont GE Food Labeling Case; Senate Agriculture Committee Hearing on Biotechnology; FDA Revises Process Filing Forms for Acidified and Low-Acid Canned Foods; FDA to Review GMA Petition to Allow Certain PHOs in Foods; FDA Announces New Food Emergency Exercises
FDA Publishes Strategy for FSMA Training
JPA has been providing updates regarding the FDA's efforts to implement the provisions of the FDA Food Safety Modernization Act (FSMA). The FDA recently published a Consituent Update, available here, announcing the Agency's strategy for facilitating training related to FSMA. According to the FDA, "The FSMA Training Strategy outlines those options and formats, in addition to introducing the partners in government, industry and academia who are working with the FDA on the development and delivery of training to the global community of food suppliers." The Training Strategy is available here.
In part, the Produce Safety Alliance (PSA), Food Safety Preventive Controls Alliance (FSPCA), and Sprout Safety Alliance (SSA) are developing training programs to help food businesses (foreign and domestic) understand the requirements of the preventive controls regulations (for human and animal foods) and the forthcoming Produce Safety rule. The Alliances are developing model, standardized curricula that are intended to meet the needs of, and be used by, the majority of those affected by the FSMA rules.According to the FDA, these groups are composed of representatives from the government, including FDA, USDA, and state regulatory agencies, the food industry, and academia. Training will also be provided by other parties.
JPA will continue to monitor and provide updates, as information becomes available.
Vermont Genetically Engineered Food Labeling Law
JPA has been providing updates regarding Vermont’s law to mandate the labeling of genetically engineered (GE) foods, which becomes effective on July 1, 2016. Earlier this year, JPA members were notified that the state had issued the GE food labeling regulations, available here.
The Vermont Attorney General’s Office recently issued a guidance, available here, pertaining to the labeling regulation. According to the Attorney General, the guidance provides insight on how the law will be interpreted and enforced. The guidance, formatted as an annotated version of the Rule, responds to numerous questions posed by the public.
JPA will continue to monitor and provide updates, as information becomes available.
Court to Hear Arguments in Vermont GE Food Labeling Case
In 2014, JPA members were notified that the Grocery Manufacturers Association (GMA), Snack Food Association (SFA), International Dairy Foods Association (IDFA) and the National Association of Manufacturers (NAM) filed a lawsuit in federal court to prohibit Vermont from implementing the GE food labeling law (Act 120). Members were also notified that this coalition had also requested a preliminary injunction to prevent Vermont from implementing the law until the lawsuit had been settled but a court had subsequently dismissed the coalition’s motion for preliminary injunction. Most recently, JPA members were notified that the coalition had filed an appeal to reverse the lower court’s ruling.
According to an article recently published on FoodNavigator-USA.com, available here, a hearing will be held in federal court on October 8, 2015 to hear arguments by the Grocery Manufacturers Association (GMA) and Vermont’s Attorney General regarding the motion for preliminary injunction. According to the article, a representative of GMA noted that time is running out to stop the law from being implemented, as the judges will not likely rule on the injunction for weeks or even months.
While legislation ("Safe and Accurate Food Labeling Act") to preempt states from implementing mandatory genetically engineered food labeling laws was passed in the House of Representatives earlier this year, a companion bill has not yet been introduced in the Senate.
JPA will continue to monitor and provide updates, as information becomes available.
Senate Agriculture Committee Hearing on Biotechnology
The U.S. Senate Committee on Agriculture, Nutrition and Forestry will hold a hearing October 21, 2015 on the “federal regulation of agriculture biotechnology with perspectives from producers and consumers.” The notice of the hearing is available here.
FDA Revises Process Filing Forms for Acidified and Low-Acid Canned Foods
In September 2013, JPA notified members of the Food and Drug Administration’s (FDA’s) plans to modernize the process filing forms (paper and electronic) that are required to be submitted by manufacturers of acidified and low-acid canned foods. The Agency requested comments from stakeholders on the four new forms. The new forms will replace the old process filing forms, Forms FDA 2541a and 2541c.
The FDA recently issued a Constituent Update, available here, announcing the forms have been revised and sent to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act. The Agency also published the new forms, which can be accessed via the links below. Juices (e.g., eggplant juice, carrot juice) are mentioned on the forms.
- Form FDA 2541d – Food Process Filing for Low-Acid Retorted Method
- Form FDA 2541e – Food Process Filing for Acidified Method
- Form FDA 2541f – Food Process Filing for Water Activity/Formulation Control Method
- Form FDA 2541g – Food Process Filing for Low-Acid Aseptic Systems
JPA will continue to monitor and provide updates, as information becomes available.
FDA to Review GMA Petition to Allow Certain PHOs in Foods
In August 2015, JPA notified members that the FDA had issued a declaratory order announcing the Agency’s final determination that partially hydrogenated oils (PHOs) are not generally recognized as safe (GRAS) for use in any human food. The FDA established June 18, 2018 as the compliance date to allow, in part, products to be reformulated to remove PHOs or to allow companies to submit a food additive petition. Members were subsequently notified that the Grocery Manufacturers Association (GMA) had submitted a food additive petition to the FDA requesting that the Agency allow low-level uses of PHOs in certain food categories, including salad dressings and sauces.
According to a press release recently published by GMA, available here, the FDA has decided to accept the petition for review. GMA stated, “FDA’s acceptance of our food additive petition marks the beginning of the agency’s formal review process and we look forward to working with the FDA on achieving approval for these proposed low-level uses of PHOs. Our petition shows that the proposed PHO uses are as safe as the naturally occurring trans fat present in the normal diet.”
JPA will continue to monitor and provide updates as information becomes available.
FDA Announces New Food Emergency Exercises
The FDA recently published a Constituent Update, available here, announcing the Agency is making available two new food emergency exercises titled “Wat’er You Thinking” and “Foul Fodder,” to help public health and other officials prepare for a food-related emergency. One exercise involves the possible contamination of a local water supply and the other exercise pertains to a tampering incident with animal food. The exercises are available here.
As always, please contact me with questions or comments.
Patricia Faison
(404) 252 - 3663