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Industry News and Press: Regulatory Updates

June 2017 Regulatory Update

Tuesday, July 25, 2017   (0 Comments)
  
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These Regulatory Updates are brought to you by Michael Best & Friedrich. 

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



The June 2017 Regulatory Update 
includes Nutrition Facts and Menu Labeling compliance date; FSMA updates for water requirements for produce, 3rd Party Certification, Engaging Stakeholders; New Developments 

Nutrition Facts and Menu Labeling Compliance Date Extension

On June 13, 2017, the FDA announced its intention to extend the compliance date for the Nutrition Facts Label final rules and indicated that it will provide details of the extension through a Federal Register Notice at a later date.   Menu labeling final rule for certain restaurant and retail establishments was extended from May 5, 2017 to May 7, 2018.  


FSMA  Update

a. FDA Announces Intent to Extend Compliance Date for Agricultural Water Requirements in the Produce Safety Rule after exploring ways to simplify FSMA’s agricultural water standards. 

b. FDA Launches Website for Accredited Third-Party Certification Program for organizations to apply to be recognized as a third-party accreditation body, a voluntary program established by FSMA.  

c. FDA Announces Stakeholder Engagement as a Top Priority for the evolution of FSMA.  


Other Developments of Interest

a. Sprout Operations – Comment period open until July 24, 2017

b. Control of Listeria Monocytogenes - Comment period open until July 17, 2017

c. FSIS Proposed Rule for PRC Export of Poultry Products to U.S. – Comment period open until August 15, 2017  

d. FSIS Compliance Guidelines for Salmonella and Other Pathogens – Comment period open until August 15, 2017

e. New FSIS Guidance on Imports – Comment period open until September 5, 2017 

 
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NUTRITION FACTS AND MENU LABELING COMPLIANCE DATE EXTENSION

On May 20, 2016, the FDA announced the new Nutrition Facts and Supplement Facts Label. The new label was designed to assist consumers in making better informed food choices.  The compliance date for the new label was set for July 26, 2018, with an additional year for manufacturers with annual food sales of less than $10 million.  On June 13, 2017, the FDA announced its intention to extend the compliance date for the Nutrition Facts Label final rules and indicated that it will provide details of the extension through a Federal Register Notice at a later time.  FDA stated that the extension would give industry more time to comply and minimize the amount of time that consumers would see both old and new labels in the marketplace. >>Read more


Comment Period Extended Following Compliance Date Extension - Disclosure of Certain Nutrition Information in Certain Restaurants and Retail Food Establishments (Menu Labeling) 

In December 2014, FDA published a final rule requiring disclosure of certain nutrition information for standard menu items in certain restaurants and retail food establishments, now codified at 21 CFR § 101.11. An interim final rule extended the compliance date for the final rule from May 5, 2017 to May 7, 2018.  The compliance date was extended to enable FDA to consider further reducing the regulatory burden or increasing flexibility while achieving regulatory objectives, consistent with the Administration’s policiesIn the interim final rule, FDA requested comments on several specific questions on how FDA "might further reduce the regulatory burden or increase flexibility while continuing to achieve [its] regulatory objectives to provide consumers with nutrition information so that they can make informed choices for themselves and their families.” Comments are now due by August 2, 2017.  >>Read more


FSMA DEVELOPMENTS

FDA Announces Intent to Extend Compliance Date for Agricultural Water Requirements in the Produce Safety Rule (PSR) of the Food Safety Modernization Act (FSMA)

FDA, after earlier this year announcing its exploration of ways to simplify FSMA’s agricultural water standards, announced its intention to extend the compliance dates for agricultural water requirements in the PSR (other than for sprouts). Stakeholders had informed FDA of the complexities of the requirements and attendant difficulties. The length of the extension is under consideration.  >>Read more 

FDA Launches Website for Accredited Third-Party Certification Program

On June 21, 2017, FDA launched a website for organizations to apply to be recognized as a third-party accreditation body to implement the Accredited Third-Party Certification program, a voluntary program established by FSMA.  Those accreditation bodies that are recognized by FDA will be able to accredit third-party certification bodies (third-party auditors). As explained by FDA, "[t]hese accredited certification bodies will conduct food safety audits of foreign food entities and, based on their audit findings, may issue certifications of those entities and the foods for humans and animals that they produce. Such certifications may be used to help establish eligibility for participation in the Voluntary Qualified Importer Program (VQIP), which was also established by FSMA. VQIP offers expedited review and entry of food for eligible participants. In addition, FDA can require that an imported product be certified in specific circumstances to prevent a potentially harmful food from entering the U.S.”  Private third parties, and foreign governments and agencies may apply via the web-based application and payment of a user fee. >>Read more


FDA Emphasizes Stakeholder Engagement as a Top Priority

On June 26, 2017, FDA published a Constituent Update discussing the importance of stakeholder engagement in the context of the implementation of FSMA.  The Q&A, "Our Strategy for Engaging Stakeholders,” gives interesting insights into the evolution of FSMA and the implementation process.  >>Read more



OTHER DEVELOPMENTS OF INTEREST

Sprout Operations - Comment Period Remains Open until July 24, 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)  >>Read more


Control of Listeria Monocytogenes - Comment Period Remains Open until July 17, 2017

Draft Guidance for Industry: Control of Listeria monocytogenes in Ready-To-Eat Foods  (Publication Date January 2017; Comments close July 17, 2017)  >>Read more


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


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

 

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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