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Industry News and Press: Regulatory Updates

January 2018 Regulatory Update

Wednesday, January 31, 2018   (0 Comments)
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from December 12, 2017 through January 11, 2018. Please contact Seth Mailhot, Leah Ziemba, or Paulette Morgan for additional information on regulatory issues that may impact upon your business.

The January 2018 Regulatory Update includes FDA Terminates Food Advisory Committee, USDA Egg Product Inspection Proposal, Food Safety and Inspection Service (FSIS) Contaminants in Food Public Meeting, Food Safety Modernization Act (FSMA) Updates; Other Developments of Interest


On December 13, 2017, FDA announced the termination of the Food Advisory Committee, which was established on March 6, 1992.  FDA noted that, over the past several years, the Committee had not met frequently and it could no longer justify the effort and expense of maintaining the Committee. FDA noted further that its Science Board or its Risk Communication Advisory Committee could address relevant food issues in the future, augmented as needed by subject matter experts serving as temporary members on either of those committees. It remains to be seen whether this termination will stand.   


On January 9, 2018, the U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) announced a proposed rule to amend egg products inspection regulations by "requiring official plants that process egg products to develop Hazard Analysis and Critical Control Points (HACCP) systems and Sanitation Standard Operating Procedures (Sanitation SOPs) and to meet other sanitation requirements consistent with the meat and poultry regulations.” FSIS Press Release (see link below).    Egg products will be required to be produced "in such a manner that the finished product is free of detectable pathogens.” (see link).  The proposed rule is designed to support consistency and modernization, allow a better fit for a plant’s particular facility and equipment, and promote innovative means of enhancing food safety. The link to the press release below also contains a link to the proposed rule.  >>Read more


On Thursday, February 22, 2018, the Food Safety and Inspection Service (FSIS) will hold a public meeting from 1:00 to 4:00 p.m. to provide information and receive public commons on agenda items and U.S. positions to be discussed at the 12th Session of the Codex Committee on Contaminants in Food (CCCF) of the Codex Alimentarius Commission (Codex) to be held in the Netherlands, March 12-16, 2018.  See the link below for registration information and a list of issues to be discussed at the Public Meeting.  >>Read more



FDA Announces Intention to Exercise Enforcement Discretion for Certain FSMA Rules

On January 4, 2018, FDA announced that it intends to exercise enforcement discretion for certain FSMA rules.  The agency announced the issuance of a guidance for industry, "Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs: Guidance for Industry” outlining the enforcement discretion policy.  

Recognizing that, due to the fundamental change to food safety brought about by FSMA and the resulting challenges to manufacturers, farmers and other stakeholders, certain changes are needed, FDA Commissioner Scott Gottlieb, M.D., issued a statement on the enforcement discretion guidance. He indicated that the provisions that FDA does not intend to enforce relate to "aspects of the ‘farm’ definition, requirements related to written assurances from a manufacturer’s customers, requirements for importers of food contact substances, and requirements related to certain human food by-products for use as animal food.”  (See link below).  >>Read more

The Guidance concerns certain provisions of four of FDA’s seven foundational rules that are part of the implementation of FSMA;  1) "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food”; 2) "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals”; 3) "Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; and 4) "Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption.” See the link below to the Guidance and also the link to FDA fact sheets for more information.  >>Read more (1 of 3)  >>Read more (2 of 3)  >>Read more (3 of 3)

FDA Commissioner Statement on Food Recalls

On December 26, 2017, FDA Commissioner Scott Gottlieb, M.D., issued a statement on efforts being made to improve the food recall process. The Commissioner discusses concerns with the statistics in the Office of Inspector General’s report on recalls and notes that the Agency intends to issue guidance on recall communications in the first half of 2018. Also referenced was the progress of the Strategic Coordinated Oversight of Recall Execution ("SCORE”) Team, which we discussed in an earlier Regulatory Update.  In early 2018, we can expect to see additional policy statements focused, in part, on the timeliness and scope of information about food recalls made available to the public.  >>Read more

FDA Commissioner Talks About Lab Accreditation

On December 14, 2017, FDA Commissioner Scott Gottlieb included a brief post on FDA Voice concerning the agency’s steps to improve oversight of food safety.  One step that FDA intends to take is to propose a rule on lab accreditation.  As noted in the post, this rule "would establish a program to accredit labs to do food safety testing and to require that these accredited labs be used in certain situations.”  >>Read more


Food and Cosmetic Export Certificate Application Process

On January 2, 2018, FDA announced the opportunity for 60 days for public comments on the proposed collection of information concerning the Food and Cosmetic Export Certificate Application Process.  FDA noted that firms exporting products from the United States seek a "certificate” from FDA to present in countries into which they desire to export products.  FDA’s Center for Food Safety and Applied Nutrition (CFSAN) issues such certificates.  Generally, the certificates are intended to signify that the product to be exported is marketed in the United States or otherwise eligible for export and that there are no enforcement actions pending with FDA.  A certificate may be sought electronically via the Certificate Application Process, within FDA Industry Systems or by contacting CFSAN for assistance.  FDA has eliminated paper-based forms and expanded the electronic options for providing facility and product information. Respondents to the collection of information include firms interested in exporting U.S.-manufactured food and cosmetic products to countries requiring export certificates.  >>Read more

Child Nutrition Programs

On December 14, 2017, the Food and Nutrition Service, USDA, published a Request for Information, with a comment period ending February 12, 2018, concerning crediting and the National School Lunch Program, School Breakfast Program, Child and Adult Care Food Program, and Summer Food Service Program (Child Nutrition Programs), administered by USDA Food and Nutrition Service (FNS).  To claim Federal reimbursement, "Child Nutrition Program operators must serve meals and snacks that meet the minimum meal pattern requirements of the respective Program.” Crediting "is the process designed by FNS to specify how individual food items contribute to the Child Nutrition Programs’ meal patterns.”  The Request for Information is designed to help FNS determine how the crediting system can "best address today’s evolving food and nutrition environment, as well as to offer first-rate customer service to those operating and benefitting from the Child Nutrition Programs.”   All interested stakeholders are invited to comment.  >>Read more

FDA’s Consultation Procedures for Foods Derived From New Plant Varieties

On December 13, 2017, FDA announced the opportunity for 60 days for public comment on the proposed collection of information regarding FDA’s consultation procedures for foods derived from new plant varieties.  The collection of information supports information in FDA’s "Guidance on Consultation Procedures:  Foods Derived from New Plant Varieties” and in Form FDA 3665 entitled "Final Consultation for Food Derived From a New Plant Variety (Biotechnology Final Consultation).”  As stated in the Notice, "FDA recommends that producers who use biotechnology in the manufacture or development of foods and food ingredients work cooperatively with FDA to ensure that products derived through biotechnology are safe and comply with all applicable legal requirements” and, in support of that recommendation has "instituted a voluntary consultation process with industry” described in the Guidance. Respondents to the collection of information include developers of new plant varieties intended for food use.  >>Read more

Reminder: FDA Issues Draft Guidance, "Menu Labeling:  Supplemental Guidance for Industry”  

As noted in our last two updates, on November 9, 2017, FDA issued a Draft Guidance, "Menu Labeling: Supplemental Guidance for Industry.” The draft guidance is intended to addresses concerns raised by stakeholders regarding the implementation of nutrition labeling for foods sold in covered establishments.* FDA announced that it "includes expanded and new interpretations of policy, and identifies places where FDA intends to be more flexible in its approach.” 82 FR 50236.  The draft guidance "addresses calorie disclosure signage for self-service foods, including buffets and grab-and-go foods; reasonable basis, and the criteria for considering the natural variation of foods; various methods for providing calorie disclosure information, including those for pizza; compliance and enforcement; and criteria for distinguishing between menus and other information presented to the consumer.”  The date for compliance with the menu labeling final rule is May 7, 2018.  >>Read more

Reminder: FDA Issues Draft Guidance on "Best Practices for Convening a GRAS Panel”

As noted in our last update, on November 15, 2017, FDA published a draft guidance, "Best Practices for Convening a GRAS Panel,” intended to assist those persons convening a panel of experts ("GRAS panel”) to evaluate whether the available scientific data, information, and methods establish that a substance is safe under the conditions of its intended use in human food or animal food in relation to the generally recognized as safe (GRAS) provision of the federal Food, Drug and Cosmetic Act. The draft guidance provides best practices to identify the appropriate members of such a panel, address conflict of interest issues, and consider other suggested steps and strategies with respect to such panels. Public comments should be submitted by May 15, 2018.  >>Read more

Reminder: FDA Issues Draft Guidance Regarding Foreign Food Establishment Inspections 

FDA issued its draft Guidance for Industry, "Refusal of Inspection by a Foreign Food Establishment or Foreign Government” with a publication date of December 12, 2017. This draft guidance illuminates FDA’s position on when it may consider that a foreign food establishment of foreign government has refused to permit an inspection.  There is a 75-day notice period for comments ending February 25, 2018.  >>Read more

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