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Industry News and Press: Regulatory Updates

May-June 2018 Regulatory Update

Tuesday, July 10, 2018   (0 Comments)
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from May 4, 2018 through June 8, 2018.  Please contact Seth Mailhot, Leah Ziemba, or Emily Lyons for additional information on regulatory issues that may impact upon your business. Special thanks to associate Taylor Fritsch and summer associate Jecoliah Williams for their assistance in putting together this update. 

The May-June 2018 Regulatory Update includes several MUST READ updates, including FDA Extends Deadline for Compliance with Partially Hydrogenated Vegetable Oil Phase, USDA Issues Guidance on Livestock Slaughter and Processing Exemptions, FDA Issues Small Entity Compliance Guidance on Registration of Food Facilities, Food Safety Modernization Act (FSMA) Updates, Other Developments of Interest


FDA Extends Deadline for Compliance with Partially Hydrogenated Vegetable Oil (PHO) Phase-Out   

After FDA revoked the Generally Recognized as Safe (GRAS) status of partially hydrogenated vegetable oils (PHOs) for use in food in June of 2015, the food industry filed a food additive petition requesting that FDA continue to allow specific limited uses of PHOs as a (1) solvent, carrier, or a component of flavoring agents; (2) processing aid or component of a processing aid; and (3) pan release agent for baked goods. FDA recently denied that petition, citing that the petition did not provide sufficient information to guarantee the safety of the requested uses.

In order to provide food manufacturers more time to phase out the use of all PHOs in foods, FDA has extended the compliance date for the three petitioned uses and clarified the compliance date for all other uses of PHOs in foods. For the three petitioned uses only, food manufacturers will now have until June 18, 2019 to reformulate products and phase out the use of PHOs—a one-year extension beyond the original deadline. Additionally, companies will now have until January 1, 2021 to exhaust their inventories of food products containing those PHOs that were manufactured prior to the new June 18, 2019 deadline. For non-petitioned uses, the extension does not apply; instead, FDA clarified that manufacturing of food with any other use of PHOs must cease prior to June 18, 2018, but companies can distribute and sell through their inventories of those foods until January 1, 2020. Ultimately, no foods on the market should contain any PHOs after January 1, 2021, or they will be deemed ‘adulterated’ and subject to FDA enforcement.

Learn more about the status of PHOs in Michael Best’s Food and Beverage Alert.  >>FDA announcement

USDA Issues Guidance on Livestock Slaughter and Processing Exemptions - MUST READ

In late May, the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) issued guidance for determining whether a livestock slaughter or processing firm is exempt from the inspection requirements of the Federal Meat Inspection Act. FSIS currently requires an inspection of all establishments where cattle, goat, swine, or sheep are slaughtered or processed for sale, unless one of the exemptions (detailed at 9 C.F.R. Part 303) applies.

The recent guidance is intended to aid processors in making an initial determination whether their operations might be exempt from FSIS inspection. These businesses include: 

  • Small and very small slaughter or processing establishments wishing to provide custom exempt services to owners of livestock; 
  • Retail stores making sales directly to consumers at a single location or at satellite stores owned or operated by the retail store; 
  • Restaurants selling or serving ready-to-eat (RTE) meals to individual consumers; 
  • Caterers delivering or serving RTE meals to individual consumers; 
  • Restaurant central kitchens sending RTE meals to their satellite restaurant locations or vending machines; 
  • Businesses that are a combination of a retail store and a restaurant; 
  • Internet advertisers, marketers, and brokers of meat or meat food products to consumers; 
  • Firms using common couriers to transport meat or meat food products to consumers; and 
  • Farmers wishing to engage in direct purchase agreements with school food service authorities for livestock slaughtered and prepared under State or Federal inspection. 

View the Federal Register notice hereFSIS will accept comments on the guidance document until July 24, 2018.

FDA Issues Small Entity Compliance Guidance on Registration of Food Facilities - MUST READ

The Federal Food, Drug, and Cosmetic Act requires domestic and foreign food facilities engaged in manufacturing, processing, packing, or holding of food for human or animal consumption in the United States to register with the FDA. To reflect changes in the food facility registration regulations, FDA has issued new guidance intended to help small entities comply with these food facility registration regulations, set forth in 21 C.F.R. Part 1. 

The new guidelines explain which types of facilities are required to register, when and how to do that, and the information that is needed to register. The guide also explains the consequences for facilities that fail to register or to renew their registration as required. In addition, it explains when FDA can suspend a facility’s registration and the effect of a suspension order.

>>FDA update


FDA and USDA Coordinate on Produce Safety

FDA and USDA have announced a collaborative effort to align the USDA Harmonized Good Agricultural Practices Audit Program (USDA H-GAP) with the requirements of FDA’s Produce Safety Rule under the FSMA. While the requirements of both programs are not identical, numerous technical components in the FDA Produce Safety Rule are covered in the USDA H-GAP Audit Program, including areas such as biological soil amendments; sprouts; domesticated and wild animals; worker training; health and hygiene; and equipment, tools, and buildings. The alignment will help farmers by enabling them to assess their food safety practices as they prepare to comply with the Produce Safety Rule. However, the USDA audits are not a substitute for FDA or state regulatory inspections.

The announcement builds on a formal agreement signed earlier this year outlining plans to increase interagency coordination regarding produce safety, inspections of dual-jurisdiction facilities, and biotechnology activities.

>>FDA announcement

FDA Data Dashboard Now Includes FSMA Data Search for Supply-chain Requirements - MUST READ

FDA continues to expand its Data Dashboard platform to make it easier for stakeholders to access information regarding supply-chain requirements under various FMSA regulations. Now, FDA has improved the Supplier Evaluation Resources page to allow importers and manufacturers/processors to search multiple data bases at the same time for compliance and enforcement information related to specific firms. As a result of this change, Dashboard users need only conduct a single search to reach information regarding warning letters, import refusal, and import alerts, as well as a variety of other firm-specific information.

>>FDA Data Dashboard     >>FDA update 


FDA Update on Efforts to Advance Biotechnology Innovation

In May, FDA formed a New Biotech Working Group, comprised of representatives from multiple FDA centers and offices, to evaluate scientific developments in genome editing for animals and food crops and to develop risk-based assessments. According to FDA, an Action Plan is forthcoming which will "lay out the steps [FDA] intends to take to ensure a flexible regulatory framework for evaluating the safety of products that also supports plant and animal biotechnology innovation.”

View the blog post here.  

Recent USDA Appointments

In the last month, the Trump Administration has moved to fill several food safety leadership roles at USDA:

  • On May 4, 2018, President Trump nominated Dr. Mindy Brashears to be the USDA undersecretary for food safety. Brashears is currently a professor of food safety and public health and the director of the International Center for Food Industry Excellence at Texas Tech University. Brashears is awaiting Senate confirmation. View the press release here.

  • On May 11, 2018, U.S. Secretary of Agriculture Sonny Perdue appointed Bruce Summers as administrator of USDA’s Agricultural Marketing Service (AMS). Summers has worked in a number of key leadership roles at AMS for more than 30 years, and most recently served as acting administrator. View the press release here.

  • On May 11, 2018, Secretary Purdue appointed Carmen Rottenberg and Paul Kiecker as administrator and deputy administrator of FSIS, respectively. Rottenberg most recently served as deputy administrator for FSIS, and since August 2017, as acting deputy undersecretary for USDA’s Office of Food Safety. Paul Kiecker has been serving as acting administrator for FSIS since August 2017. View the press release here.

Reminder – USDA National Bioengineered (BE) Labeling Standard Proposal

As noted in our April-May Update, USDA released a proposed rule on May 3, 2018, establishing a national bioengineered (BE) food disclosure standard. Comments on the proposal must be submitted to USDA by July 3, 2018.

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