February–March 2019 Regulatory Update


These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from February 14 through April 5, 2019.  Please contact Leah Ziemba or Paul Benson for additional information on regulatory issues that may impact your business. 

The February–March 2019 Regulatory Update includes several MUST READ updates: 

FDA AND USDA UPDATES

  • FDA Commissioner Scott Gottlieb Resigns, Cautions Food Industry Against Resisting Sodium Targets (MUST READ)
  • USDA and FDA Announce Formal Agreement for Regulating Cell-Cultured Meat Products (MUST READ)
  • FSIS Releases Guideline for Industry Response to Consumer Adulteration or Misbranding Complaints

 

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

  • FDA Will Exercise Enforcement Discretion under the Produce Safety Rule for Wine Grapes, Hops, Pulse Crops, and Almonds (MUST READ)
  • FDA Issues Updated Draft Guidance on Mitigation Strategies to Protect Foods against Intentional Adulteration (MUST READ)
  • FDA Finalizes New Compliance Dates for Agricultural Water Requirements
  • FDA Releases "Strategy for the Safety of Imported Food”

 

OTHER DEVELOPMENTS OF INTEREST

  • FDA Releases Biotech Plan, Deactivates Import Restriction on GE Salmon FDA Issues
  • Proposed Rule Amending Allowable Levels of Added Fluoride in Bottled Water

 
FDA AND USDA UPDATES

FDA Commissioner Scott Gottlieb Resigns, Cautions Food Industry Against Resisting Sodium Targets (MUST READ)

Last month, FDA Commissioner Scott Gottlieb announced that he would step down from his post as FDA commissioner after nearly two years leading the agency.  The Trump Administration appointed Dr. Norman (Ned) Sharpless acting commissioner beginning April 8. Dr. Sharpless previously served as director of the National Cancer Institute.

Gottlieb took a particular interest in nutrition and food policy topics during his tenure.  His time at FDA saw the introduction of updates to the nutrition facts label, restaurant menu labeling, and voluntary sodium reduction targets.

And on those short-term voluntary sodium reduction targets, Gottlieb provided the food industry with some unsolicited advice as he departed the agency in a recent interview with POLITICO.

"If the packaged food industry wants to start a lobbying campaign against voluntary guidelines, I think they risk ending up with multiple regimes in different states and municipalities. Then they're going to be looking for federal legislation and preemption,” Gottlieb said.  The guidance is now in the final clearance stage at FDA and should be released within the next month to six weeks, POLITICO reported.

 

USDA and FDA Announce Formal Agreement for Regulating Cell-Cultured Meat Products

USDA and FDA recently announced a formal agreement describing how the agencies will regulate cell-cultured food products from cell lines of livestock and poultry. According to the agencies, the agreement "describes the formal oversight roles and responsibilities for both agencies and how the agencies will collaborate to regulate the development and entry of these products into commerce.”

Under the agreement, FDA will oversee pre-harvest development and production activities, including oversight for the proliferation and differentiation of cells and ensuring compliance with CGMPs and preventive controls. Regulatory authority will transfer to USDA-FSIS at the time of harvest. FSIS will conduct inspections "in establishments where cells cultured from livestock and poultry subject to the [Federal Meat Inspection Act and Poultry Products Inspection Act] are harvested, processed, packaged or labeled.” FSIS will also oversee labeling of livestock or poultry products from the cultured cells of livestock or poultry. 

The agreement also states the agencies’ intent to develop a more detailed joint framework or standard operating procedure to facilitate shared regulatory oversight related to the harvest of biological material.

Read the agreement

 

FSIS Releases Guideline for Industry Response to Consumer Adulteration or Misbranding Complaints

Last month, FSIS announced the availability of a guideline setting forth best practices for FSIS-regulated facilities responding to customer complaints of adulterated and misbranded meat and poultry products.  In general, FSIS rules require FSIS-regulated establishments to notify FSIS when it believes or has reason to believe that an adulterated or misbranded meat, meat food, poultry, or poultry product received by or originating from the establishment has entered commerce.

Comments on the guideline should be submitted on or before May 10, 2019.  As part of this obligation, FSIS recommends that establishments develop a program to receive and process customer complaints.  The guideline makes recommendations to establishments on developing a customer compliant program.

Read the guideline

 

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

FDA Will Exercise Enforcement Discretion under the Produce Safety Rule for Wine Grapes, Hops, Pulse Crops, and Almonds (MUST READ)

In late March, FDA issued final guidance announcing that the agency does not intend to enforce the requirements of the FSMA Produce Safety Rule as they apply to entities growing, harvesting, packing and holding wine grapes, hops, pulse crops, and almonds.  The guidance explains that the agency made this decision after considering the unique production circumstances and intended uses of these crops reduces risks associated with these crops.  The Produce Safety Rule did not include these crops on a list of produce items considered to be exempt from the rule as "Rarely Consumed Raw,” but invited stakeholder comment and interaction with the agency.  After interaction with growers and other stakeholders, the agency does not intend to enforce the Produce Safety Rule apply to entities growing, harvesting, packing and holding these commodities and plans to pursue further rulemaking as appropriate.

Read the final guidance here

 

FDA Issues Updated Draft Guidance on Mitigation Strategies to Protect Foods against Intentional Adulteration (MUST READ)

FDA issued an updated draft guidance to help industry develop and implement a food defense plan (FDP) in accordance with the FSMA Intentional Adulteration Rule.  The updated guidance document supersedes a previous version issued last June. Among other things, the extensive guidance document sets out the components of the FDP, how to conduct a vulnerability assessment, and how to identify and implement mitigation strategies.  

Unless a facility is classified as "Very Small,” "Small,” or is otherwise exempt, the compliance date for the FSMA Intentional Adulteration rule is July 26, 2019.  Small facilities have an additional year (until July 27, 2020) and very small facilities an additional two years (until July 26, 2021) to comply.  Under the Intentional Adulteration Rule, a "small business” means a business (including subsidiaries and affiliates) that employing fewer than 500 full-time equivalent employees.  A "very small business” means a business "averaging less than $10,000,000, adjusted for inflation, per year, during the 3-year period preceding the applicable calendar year in sales of human food plus the market value of human food manufactured, processed, packed, or held without sale.”

To ensure consideration, comments should be submitted by July 5, 2019.  FDA will hold a public meeting on the guidance document on April 17, 2019.

Read the draft guidance here

 

FDA Finalizes New Compliance Dates for Agricultural Water Requirements

FDA recently finalized a rule extending the compliance dates for the agricultural water requirements of the FSMA Produce Safety Rule.

The new compliance dates are as follows:

  • January 26, 2022 for large farms (average annual monetary value of produce sold over the last three years is more than $500,000)
  • January 26, 2023 for small farms (average annual monetary value of produce sold over the last three years is no more than $500,000)
  • January 26, 2024 for very small farms (average annual monetary value of produce sold over the last three years is no more than $250,000)  

This rule does not change the compliance dates for sprout operations, nor does it provide an exemption from compliance with other provisions of the Produce Safety Rule or other FSMA rules.  In a release, FDA explained that it extended the compliance dates to provide FDA time to consider "how best to protect public health while addressing widespread concerns about the complexity of the agricultural water requirements and the practicality of implementing them across a wide variety of farms, water sources and uses.”

Read the final rule

 

FDA Releases "Strategy for the Safety of Imported Food”

In early March, FDA announced what it describes as a "multi-layered approach” to ensuring the safety of imported food.  As part of its implementation of FSMA, the agency notes that it has developed prevention-based standards applicable to both foreign and domestic food growers, manufacturers, processors, packers, and holders.  FDA recently released its "Strategy for the Safety of Imported Food.”  The strategy document describes how FDA is integrating new import oversight tools with existing efforts.

Read the strategy here

 

OTHER DEVELOPMENTS OF INTEREST

FDA Releases Biotech Plan, Deactivates Import Restriction on GE Salmon

FDA recently announced a new Plant and Animal Biotechnology Innovation Action Plan, a "comprehensive framework for the efficient development of safe biotechnology products.”  At the same time, FDA also announced that it was deactivating a 2016 import alert that prevented GE salmon from entering the U.S.  In 2015, FDA approved an application related to AquAdvantage salmon, a GE Atlantic salmon product, after determining that the salmon met statutory requirements for safety and effectiveness under the Federal Food, Drug, and Cosmetic Act.  Despite that approval, Congress directed FDA to not allow the product into commerce until a labeling standard had been developed, a requirement that FDA now believes given USDA’s development of the National Bioengineered Food Disclosure Standard.  Accordingly, FDA has deactivated the relevant import alert that prevented GE salmon from entering the United States.

Learn more here

 

FDA Issues Proposed Rule Amending Allowable Levels of Added Fluoride in Bottled Water

On April 3, FDA issued a proposed rule limiting the allowable level of fluoride in packaged bottled water to 0.7 milligrams/liter when fluoride is added to the bottled water by the manufacturer.  The standard applies when the manufacturer adds any fluoride to the bottled water, regardless of how much fluoride was present in the source water.  The proposed rule does not impact the allowable levels of fluoride in bottled water to which the manufacturer does not add any fluoride (i.e., the fluoride comes exclusively from the source water).  FDA’s proposed rule is designed to sync FDA regulations for packaged bottled water with fluoridation standards issued by the U.S. Public Health Service in 2015. 

Read the proposed rule

 

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