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Industry News and Press: Regulatory Updates

January 2017 Regulatory Update

Tuesday, February 28, 2017   (0 Comments)
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These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from January 1 through 31, 2017. Please contact Seth Mailhot, Leah Ziemba, or Paulette Morgan for additional information on regulatory issues that may impact upon your business.



4) Genome Editing in New Plant Varieties Used for Foods  >>Read more

5) Regulation of Intentionally Altered Genomic DNA in Animals  >>Read more

 
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THE JANUARY 20, 2017 WHITE HOUSE MEMORANDUM HALTING OR POSTPONING REGULATORY ACTION

The Memorandum instructed that:
  • No regulations are to be sent to the Office of the Federal Register ("OFR”) until the required review and approval.

  • Regulations that have been sent to the OFR, but have not yet been published in the Federal Register are to be withdrawn in order to be reviewed and approved.

  • For regulations that have been published in the OFR, but have not taken effect, their effective dates are to be temporarily postponed for 60 days from January 20, 2017, for the purpose of review of questions of fact, law, and policy raised by the regulations.  Where appropriate and as permitted by law, consideration is to be given for proposing a rule for notice and comment to delay the effective date beyond the 60-day period, and potentially proposing further notice-and-comment rulemaking.
 



Calling for the Repeal of Two Existing Regulations Prior to Promulgation of A New Regulation 

Executive Order 13771 provided the following regulatory cap for fiscal year 2017, among other provisions:
  • Unless prohibited by law, when an executive department or agency (agency) publicly proposes for notice and comment or otherwise promulgates a new regulation, it must identify at least two existing regulations to be repealed.

  • The total incremental cost of all new regulations, including repealed regulations, to be finalized shall be no greater than zero, unless otherwise required by law or consistent with written advice by the Director of the Office of Management and Budget.
 
 
There were a number of recent U.S. Food and Drug Administration (FDA) Final Rules with effective dates preceding the Memorandum.  Some of these rules have compliance dates that will occur after the cutoff period established in the Memorandum.  See, e.g., Food Labeling; Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments; Extension of Compliance Date (publication and effective date of December 30, 2016 extending compliance date to May 5, 2017). It is unclear whether some of these recent rules will be withdrawn based on the Memorandum.  In addition, any pending proposed rules will be delayed until the new administration appoints individuals authorized to approve such regulatory actions.  Based on the definition of what constitutes a regulatory action, this Memorandum will also affect guidance documents and similar agency actions, such as the examples provided below.  Finally, it is not known which existing regulations might be subject to the repeal provisions of Executive Order 13771.  Note that comments can generally be submitted after the comment period closes, but they may not be considered, i.e., before work begins on a final guidance. 

Some examples of recent regulatory actions with the potential to be affected by the regulatory freeze include the following:  

  • Interim Final Rule - Food Labeling: Health Claims; Dietary Saturated Fat and Cholesterol and Risk of Coronary Heart Disease  (Publication and Effective Date December 19, 2016 – Comments Close March 6, 2017)

  • Proposed Rule – Food Safety and Inspection Service: Revision of the Nutrition Facts Labels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed  (Publication Date  January 19, 2017; Comments Close March 20, 2017) 

  • Proposed Rule - Use of the Term "Healthy” in the Labeling of Human Food Products; Request for Information and Comments; Extension of Comment Period (Publication Date December 30, 2016 - Comment Period extended to April 26, 2017)

  • Proposed Rule - Reference Amount Customarily Consumed for Flavored Nut Butter Spreads and Products That Can Be Used To Fill Cupcakes and Other Desserts, in the Labeling of Human Food Products; Request for Information and Comments (Publication Date November 2, 2016 – Comments Close  January 3, 2017) 

  • Compliance With and Recommendations for Implementation of the Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption for Sprout Operations; Draft Guidance for Industry; Availability – Draft Guidance; Proposed Rule (Publication Date January 23, 2017 – Comments Close July 24, 2017)

  • Control of Listeria monocytogenes in Ready-To-Eat Foods: Revised Draft Guidance for Industry; Availability – Revised Draft Guidance; Proposed Rule (Publication Date January 17, 2017 – Comments Close July 26, 2017)

  • Fruit Juice and Vegetable Juice as Color Additives in Food; Draft Guidance for Industry; Availability – Draft Guidance; Proposed Rule (Publication Date December 14, 2016 – Comments Close February 13, 2017)

  • Preparation of Food Contact Notifications for Food Contact Substances in Contact With Infant Formula and/or Human Milk; Draft Guidance for Industry; Availability (Publication Date December 9, 2016 – Comments Close February 7, 2017)

  • Substantiation for Structure/Function Claims Made in Infant Formula Labels and Labeling: Draft Guidance for Industry; Reopening of the Comment Period  (Publication Date November  21, 2016 – Comment Period Reopened until February 21, 2017)

  • Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry; Availability – Draft Guidance; Proposed Rule (Publication Date October 31, 2016 – Comments Close May 1, 2017) 

  • Classification of Activities as Harvesting, Packing, Holding, or Manufacturing/Processing for Farms and Facilities; Draft Guidance for Industry; Availability  -Draft Guidance; Proposed Rule (Publication Date August 25, 2016 – Comments Close February 21, 2017)

  • Hazard Analysis and Risk-Based Preventive Controls for Human Food; Draft Guidance for Industry; Availability – Draft Guidance; Proposed Rule (Publication Date August 24, 2016 - Comments Close February 21, 2017)


Given the sweeping effect of the Memorandum and Executive Order 13771, the implementation of several laws could very well be delayed.  Most significant for the food industry are regulations implementing the remaining parts of the FDA Food Safety Modernization Act and the GMO Labeling Bill.

Senate Bill 764, sometimes referred to as the "GMO Labeling Bill” signed into law by President Obama on July 29, 2016, which amended The Agricultural Marketing Act of 1946 to add Subtitle E (National Bioengineered Food Disclosure Standard) and Subtitle F (Labeling of Certain Foods), provided that within two (2) years of the date of its enactment, the Secretary of Agriculture shall "(1) establish a national mandatory bioengineered food disclosure standard with respect to any bioengineered food and any food that may be bioengineered; and (2) establish such requirements and procedures as the Secretary determines necessary to carry out the standard.”

A Task Force working on this law has indicated that it will conduct two studies and has taken other steps in furtherance of promulgating regulations.  It is unclear at this time to what extent the GMO labeling regulations will ultimately be delayed as a result of the Memorandum and Executive Order 13771.       
 
 
 
Request for Comments (Center for Food Safety and Applied Nutrition) 

On January 19, 2017, an FDA Notice was published in the Federal Register announcing the establishment of a docket for comments on the use of genome editing techniques to produce new plant varieties that are used for human or animal food, "Genome Editing in New Plant Varieties Used for Foods; request for Comments.”  FDA intends to "continue offering consultations for developers of new plant varieties, including those produced using genome editing, in order to help developers ensure that applicable safety and legal questions are resolved prior to market.”  The comment period, including on specific questions included in the Notice, extends to April 19, 2017.
 
 
 
REGULATION OF INTENTIONALLY ALTERED GENOMIC DNA IN ANIMALS
Draft Guidance for Industry; Availability (Center for Veterinary Medicine) 

This draft guidance revises GFI #187 entitled "Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs.”  This guidance is "intended to clarify that, unless otherwise excluded[], the altered genomic DNA in an animal (referred to in this document as ‘animals with intentionally altered genomic DNA’) that is intended to affect the structure or function of the body of the animal, or in some cases, to diagnose, cure, mitigate, treat, or prevent disease in the animal, meets the drug definition in section 201(g) of the FD&C Act.” Comments are requested, in particular, on specified questions.  (Publication Date January 19, 2017 - Comments Close April 19, 2017) 

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