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Industry News and Press: Regulatory Updates

February 2018 Regulatory Update

Monday, March 5, 2018   (0 Comments)
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from January 11, 2018 through February 15, 2018.  Please contact Seth Mailhot, Leah Ziemba, or Paulette Morgan for additional information on regulatory issues that may impact upon your business.

The February 2018 Regulatory Update includes several MUST READ updates, including FDA Draft Guidance on Notification of Recalls, FDA/USDA 2017 Food Code Guidance to Reduce Foodborne Illness, The FDA Issues FIVE Food Safety Modernization Act (FSMA) Guidances on a Single Day; Other Developments of Interest.


On January 17, 2018, FDA issued a Draft Guidance entitled "Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C.” This Draft Guidance is a must-read as it not only explains FDA’s public warning policy and its posting of recalls in the FDA Enforcement Report, but also provides guidance as to the circumstances under which companies should issue public warnings, who prepares the warnings, what information should and should not be contained in the warning, and how warnings should be distributed and displayed. This Draft Guidance covers all FDA-regulated products, including foods.  Comments should be submitted by March 20, 2018.  >>Read more


On February 12, 2018, the U.S. Food and Drug Administration announced the release of the 2017 edition of the FDA Food Code.  The Food Code is intended to provide government and industry with guidance that is both practical and science-based to reduce the risk of foodborne illness.  FDA encourages the adoption of the Food Code by state governments and other authorities in order to help maintain a safe food supply.  FDA noted the following as significant changes in the 2017 edition:

  • "Revised requirement for the Person in Charge (PIC) to be a Certified Food Protection Manager (CFPM) (Section 2-102.12)

  • Added a new section that addresses the use of bandages, finger cots or finger stalls (Section 2-401.13)

  • Harmonized cooking time/temperature parameters for intact and non-intact meat and poultry in accordance with guidance from the U.S. Department of Agriculture’s Food Safety and Inspection Service (USDA-FSIS) (Section 3-401.11)

  • Updated procedures for retail food establishment operations to continue during an extended water or electrical outage if a written emergency operation plan has been pre-approved by the Regulatory Authority, immediate corrective action taken and the Regulatory Authority has been notified upon implementation of the plan (Section 8-404.11).”

>>2017 Edition of the Food Code


Small Entity Guidance Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: What You Need To Know About the Food and Drug Administration Regulation; Small Entity Compliance Guide; Availability

On January 24, 2018, FDA announced the availability of a small entity compliance guide intended to help small entities comply with the final rule entitled "Foreign Supplier Verification Programs for Importers of Food for Humans and Animals.” The final rule, announced in the Federal Register on November 27, 2015, requires importers to perform certain risk-based activities to verify that food produced by their foreign suppliers has been produced in a manner that meets applicable U.S. safety standards, including the preventive controls or produce safety regulations, as applicable, and allergen labeling. The Foreign Supplier Verification Programs (FSVP) regulation, unless an exemption applies, is applicable to all food imported or offered for import in the U.S. >>Read more

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals; Draft Guidance for Industry; Availability 1/25/18; Comments due by May 25, 2018 - MUST READ

This Draft Guidance is in question and answer format, and is intended to assist importers in understanding Foreign Supplier Verification Programs (FSVP) requirements.  Topics covered include, among others, who much comply with the FSVP regulations, what relevant terms mean, U.S. agent or representative questions, and specific situations that may apply to importers under various circumstances.  To ensure consideration of your comments, they should be submitted by May 25, 2018.  >>Read more 

Foreign Supplier Verification Programs Draft Guidance for Industry: Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in 21 CFR part 112 or the Preventive Controls Requirements in part 117 or 507 - MUST READ

This Draft Guidance is intended to assist in determining the adequacy of processes, procedures or other actions taken to meet the "same level of public health protection” (SLPHP) language used in both the Foreign Supplier Verification Programs (FSVP) regulation and the Produce Safety regulation. The Draft Guidance "identifies certain points to consider that a competent authority, a farm, a facility, an importer, or other relevant entity should take into consideration when evaluating whether a measure that is different from that required under part 112 or the preventive controls requirements in part 117 or 507 meets the SLPHP threshold under the FSVP or Produce Safety regulations.” 83 FR 3447.  FDA intends to apply these points as well to its evaluations as to whether the SLPHP requirements have been met.  Again, comments should be submitted by May 25, 2018.  >>Read more 

Supply-Chain Program for Human Food Products: Hazard Analysis and Risk-Based Preventive Controls for Human Food: Draft Guidance for Industry

FDA published the final rule establishing 21 CFR Part 117, "Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food,” in the Federal Register of September 17, 2015.  This chapter in the Draft Guidance for Industry: Hazard Analysis and Risk-Based Preventive Controls for Human Food, Chapter 15, is entitled "Supply-Chain Program for Human Food Products.” It provides an overview of the requirements for a supply-chain program and provides guidance on such topics as the responsibilities of the receiving facility, using approved suppliers, determining appropriate supplier verification activities, conducting supplier verification activities for raw materials and other ingredients, onsite audits, documentation of the supply-chain program, and compliance dates.  >>Read more 

Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities: Guidance for Industry; Availability

This Guidance for Industry explains FDA’s intent to exercise enforcement discretion with respect to the application of the Foreign Supplier Verification Programs (FSVP) regulation to importers of grains imported into the United States as raw agricultural commodities (RACs) "that are solely engaged in the storage of grain intended for further distribution or processing and grain importers that do not take physical possession of the grain they import, but instead arrange for the delivery of the grain to others for storage, packing, or manufacturing/processing (such as certain commodity brokers with respect to the FSVP regulation).” FDA webpage, see link below, and, also see link below to the Guidance.  >>Read more (1 of 2)  >>Read more (2 of 2)

Hazard Analysis and Risk-Based Preventive Controls for Food for Animals Guidance for Industry 

In January 2018, FDA’s Center for Veterinary Medicine issued a guidance entitled "Hazard Analysis and Risk-Based Preventive Controls for Food for Animals” to provide guidance on developing a food safety plan that complies with PCAF (animal food preventive controls) requirements.  Covered topics include guidance:

  • "the biological, chemical (including radiological), and physical agents that are known or reasonably foreseeable hazards in manufacturing, processing, packing, and holding of animal food 

  • the components of a food safety plan and the importance of each component 
  • how to conduct a hazard analysis and develop a food safety plan for the animal food that you produce

  • identifying preventive controls for biological, chemical, and physical hazards associated with animal food and how to apply those preventive controls 

  • preventive control management components (i.e., monitoring, corrective actions and corrections, and verification (including validation)) [and]

  • the recordkeeping requirements associated with the food safety plan and implementation of the food safety plan.”

Guidance, p. 8.  The guidance document covers "facilities that manufacture, process, pack, or hold food intended for all animal species including food-producing animals (e.g., livestock, poultry, and aquaculture species), companion animals (e.g., dogs, cats, horses, and guinea pigs), laboratory animals, and animals maintained in zoological parks. ‘Animal food’ means food for animals other than man and includes pet food, animal feed, and raw materials and ingredients (see 21 CFR 507.3).”  Guidance, p.7.  >>Read more


FDA and USDA Agree to Further Cooperation on Food Oversight - MUST READ

On January 30, 2017, the USDA and FDA made a joint announcement at the White House that they had entered into a Formal Agreement to bolster collaboration between the two agencies with respect to food oversight.  The agencies are focused on further cooperation, efficiencies and effectiveness, focusing on produce safety and biotechnology, among other subjects.  >>Read more

Agency Information Collection Activities; Proposed Collection; Comment Request; Irradiation in the Production, Processing, and Handling of Food (Notice); January 26, 2018

FDA announced an opportunity for public comment on the proposed collection of certain information by the Agency. This notice solicits comments on the information collection provisions of the agency’s requirements for food irradiation processors. Respondents to the information collection are businesses engaged in the irradiation of food.  >>Read more

FDA Extends Comment Period for Proposed Rule To Revoke Regulation Authorizing Health Claims on Relationship between Soy Protein and Coronary Heart Disease

As noted in our October-November 2017 Update, on October 31, 2017, FDA published a proposed rule to revoke its regulation authorizing the use of health claims on the relationship between soy protein and coronary heart disease on the label or in the labeling of foods. FDA announced that it is taking this action based on its review of the totality of publicly available scientific evidence currently available and its tentative conclusion that such evidence does not support its previous determination that there is significant scientific agreement (SSA) among qualified experts for a health claim regarding the relationship between soy protein and reduced risk of coronary heart disease. Comments were to close in January 2018, but FDA has extended the comment period to March 19, 2018.

Reminder - Food Safety and Inspection Service to Hold Public Meeting on Codex Committee Session on Contaminants in Food

On Thursday, February 22, 2018, the Food Safety and Inspection Service (FSIS) will hold a public meeting in College Park, Maryland from 1:00 to 4:00 p.m. to provide information and receive public comments 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.  There is also a dial in number available.  >>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

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

As noted in our recent 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 recent updates, 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

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