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Industry News and Press: Regulatory Updates

July & August 2017 Regulatory Update

Monday, August 14, 2017   (0 Comments)
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from July 1 through 30 and early August, 2017. Please contact Seth Mailhot, Leah Ziemba, or Paulette Morgan for additional information on regulatory issues that may impact upon your business.

The July & August 2017 Regulatory Update 
includes Senate Appropriations for the FDA; Food Safety Modernization Act (FSMA) Updates; Developments of Interest


$5.2 Billion for FDA

On July 20, 2017, the Senate Appropriations Committee submitted its Report accompanying Bill (S. 1603), approving FY 2018 appropriations for FDA.  Overall appropriations for FDA total $5.2 billion, an increase over FY 2017 of $491 million. The Overview and Summary of the bill explains that "[t]he discretionary programs and activities of USDA and FDA that are supported by this bill include high priority responsibilities entrusted to the Federal Government and its partners to protect human health and safety, contribute to economic recovery, and achieve policy objectives strongly supported by the American people… this bill provides annual funding for programs familiar to all Americans such as protecting food safety through the Food Safety and Inspection Service and the Food and Drug Administration….” The Committee recommendation "does not include proposed user fees for food facility registration and inspection [and other specified user fees] …. None of these user fee proposals have been authorized by Congress.”  The Report expresses concerns and recommendations on a number of specific food-related topics, including nutritional labeling, Food Safety Modernization Act (FSMA) clarification for small farms, and the FDA seafood advisory, see beginning p. 87.  >>Read more



FDA Announces 2018 Rates for Certain Domestic and Foreign Facility Reinspections, Recall Order Failures and Importer Reinspections

Recently published in the Federal Register was the July 25, 2017 Notice of FDA’s fiscal year (FY) 2018 rates for certain domestic and foreign facility reinspections, failures to comply with recall orders, and importer reinspections authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Food Safety Modernization Act (FSMA) effective on October 1, 2017 through September 30, 2018.  82 FR 35954 (August 2, 2017).  The Notice reflected FDA’s continued recognition that "for small businesses the full cost recovery of FDA reinspection or recall oversight could impose severe economic hardship, [and therefore] FDA intends to consider reducing certain fees for those firms.”  Further noted was that "FDA does not intend to issue invoices for reinspection or recall order fees until FDA publishes a guidance document outlining the process through which firms may request a reduction in fees.”  Fee rates in this Notice will be used to determine any importer reinspection fees assessed in FY 2018.  The Notice, see link below, includes the rates that will be assessed.  For additional information, see FDA’s 2011 Guidance for Industry "Implementation of the Fee provisions of Section 107 of the FDA Food Safety Modernization Act,” which includes questions and answers on the implementation of the fee provisions of Section 107 of FSMA, link below.  

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FDA Issues Guidances on Certain FSMA Regulation Exemptions

A primary focus of FDA under FSMA is preventing food safety issues. Regulations issued by FDA under FSMA provide certain exemptions related to juice, low-acid canned foods and seafood regulations. FDA had previously established various preventive control type regulations, including, for example, the juice HACCP (Hazard Analysis and Critical Control Point) regulation, which requires juice processors "to identify food safety hazards that are reasonably likely to occur with the products they process and to develop plans for the control of those hazards,” as well as "requiring importers of certain juice products to comply with requirements designed to help ensure that these imported products are processed in accordance with the juice HACCP regulation.” See FDA website background on Juice HACCP Regulation.  Several of the regulations FDA issued under FSMA provide for exemptions related to the Juice HACCP Regulation.  On August 7, 2017, FDA issued a Guidance for Industry addressing these exemptions and FSMA regulations:  Guidance for Industry:  Juice HACCP and the FDA Food Safety Modernization Act (August 2017).  This was one of three guidances issued on August 7, 2017 addressing these types of exemptions and FSMA regulations.  The other two guidances are: Guidance for Industry:  Low-Acid Foods Packaged in Hermetically Sealed Containers (LACF) Regulation and the FDA Food Safety Modernization Act (August 2017); and Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act (August 2017).  See links to each of the three guidances below. 

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FDA Awards Funding to States for Implementation of FSMA’s Produce Safety Rule

On July 19, 2017, FDA announced that it is awarding $30.9 million in funding to support 43 states in the continued implementation of FSMA’s produce safety rule.  A statement issued by Commissioner Gottlieb pronounced it the "largest allocation of funds to date, made available by the FDA to help state agencies support FSMA produce safety rule implementation and develop state-based produce safety programs.”  >>Read more



On July 25, 2017, FDA’s blog, FDA Voice, posted an article encouraging consumers to contact the Federal Trade Commission or FDA about problems with dietary supplements and providing guidance on how to make such reports.  >>Read more


Comment Period Remains Open - FSIS Proposed Rule for PRC Export of Poultry Products to U.S. – Comments by August 15, 2017

On June 16, 2017, the Food Safety and Inspection Service (FSIS) published a proposed rule to amend the poultry products inspection regulations to list the PRC (People’s Republic of China) as eligible to export to the United States poultry products from birds slaughtered in the PRC. Currently, the PRC is eligible to export processed poultry products to the United States if the products are derived from poultry slaughtered in the United States or in other countries eligible to slaughter and export poultry to the United States. FSIS has reviewed the PRC's laws, regulations, and poultry slaughter inspection system and concluded that the PRC's poultry slaughter inspection system is equivalent to the system that the United States has established under the Poultry Products Inspection Act (PPIA) and its implementing regulations. Comments must be received on or before August 15, 2017.  >>Read more

Comment Period Remains Open - FSIS Updated Compliance Guidelines – Salmonella and Other Pathogens – Comments by August 15, 2017

The Food Safety and Inspection Service (FSIS) is announcing the availability of two updated compliance guidelines to "assist small and very small meat and poultry establishments to understand and comply with the regulatory requirements associated with the destruction of Salmonella and other pathogens (lethality) in ready-to-eat (RTE) products and the control of pathogen growth in heat-treated RTE and not-ready-to-eat (NRTE) products during cooling and hot-holding (stabilization).  FSIS is including the time-temperature tables and cooling options in these guidelines that were previously in Appendices A and B, originally made available in 1999, along with new recommendations establishments can use to achieve lethality and stabilization of these products.”  Comments by August 15, 2017 are also sought.  >>Read more


Comment Period Remains Open - New FSIS Guidance on Imports – Comments by September 5, 2017

The Food Safety and Inspection Service (FSIS) has announced a guidance for importing meat, poultry, and egg products into the United States. "This guidance is intended to help U.S. importers, customs brokers, official import inspection establishments, egg products plants, and other interested parties understand and comply with FSIS import requirements.”  FSIS is also seeking comments on the Guidance with comments to be submitted on or before September 5, 2017.  >>Read more

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