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Industry News and Press: Regulatory Updates

September-October 2018 Regulatory Update

Wednesday, October 31, 2018   (0 Comments)
These Regulatory Updates are brought to you by Michael Best & Friedrich. 

This Regulatory Update includes information from September 2018 through October 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 September-October 2018 Regulatory Update includes:

  • FDA Seeks Input on Use of Dairy Names on Plant-Based Foods
  • FSIS Establishes Criteria for Poultry Line Speed Waiver
  • FDA to Share Retailer Information during Human and Animal Food Recalls (MUST-READ)
  • FDA Releases FY 2016 Pesticide Monitoring Program Results
  • Food Safety Modernization Act Updates (MUST-READ)
  • Other Developments of Interest




FDA Use of Dairy Names on Plant-Based Foods 

The FDA has requested comments on the use of dairy terms such as "milk,” "yogurt,” and "cheese” on plant-based foods and beverages.  This effort is part of FDA’s Nutrition Innovation Strategy, which seeks to empower consumers to make better and more informed decisions about their diets and health.   Specifically, how plant-based products are used, how dairy terms are understood by consumers when used on plant-based products, consumers’ understanding of the nutritional characteristics of plant-based foods, how they are different from traditional dairy foods, and how the nutritional qualities compare to each other.  

FDA will use these comments to develop a guidance document that addresses labeling of plant-based products with names that include the names of dairy foods.   

>>FDA announcement

Comments can be submitted to FDA via on or before November 27, 2018.

Recall Fees FSIS Establishes Criteria for Poultry Line Speed Waiver

The U.S. Department of Agriculture (USDA) announced additional criteria for poultry slaughter plants to gain a waiver to run line speeds faster than the current limit of 140 birds per minute.  FSIS will consider factors such as whether plants are complying with good commercial practices, which requires that the poultry be slaughtered in a manner that will result in thorough bleeding.  FSIS also announced that the 20 young chicken establishments already operating under line speed waivers must meet the new criteria to be eligible for the waiver.

This announcement is a follow up to an FSIS announcement from February 2018 that established other criteria to operate poultry a poultry slaughter line at speeds of up to 175 birds per minute.  The waiver request must, among others, show the plant meets specific Salmonella performance standards requirements, establishes compliance with NPIS requirements, demonstrates a history of regulatory requirements, and demonstrates that new equipment, technologies, or procedures that allow the establishment to operate at faster line speeds will maintain or improve food safety. 

The criteria to obtain a poultry line speed waiver can be reviewed here

FDA to Share Retailer Information during Human and Animal Food Recalls

In late September, FDA announced it will reveal retailer information when a food is subject to a recall, particularly in Class I recalls where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals. FDA has not released this information in the past because it could potentially reveal confidential supply chain information.

As part of the announcement, FDA issued draft guidance that describes the circumstances under which FDA will publicly disclose recall locations that may be have sold or distributed the recalled food. FDA intends that this effort will provide consumers with "actionable information” for protecting themselves from recalled products.

>>FDA announcement

Individuals interested in providing comments on the draft guidance can submit them to FDA by November 26, 2018.

FDA Releases FY 2016 Pesticide Monitoring Program 

As part of its surveillance for food contaminants, FDA recently released results of its annual Pesticide Monitoring Program.  FDA tested for 711 pesticides and industrial chemicals across 7,413 total samples. In previous years, the majority of samples were below the tolerance levels set by the U.S. Environmental Protection Agency. For the first time, FDA tested for glyphosate and glufosinate in corn, soybeans, milk and eggs. Of the 760 samples tested, all of the corn and soybean samples were below the tolerance levels set by EPA and there were no detectable levels of glyphosate or glufosinate in the milk or egg samples. 

>>FDA announcement



FDA Reminder: It’s Time to Register Your Food Facility

In August 2018, the FDA released a guidance to help food facilities comply with the facility registration requirements. The document includes questions and answers to clarify the registration requirements.  U.S. and foreign food facilities are required to renew their registration with the FDA every even-numbered year between October 1 and December 31 to indicate the types of foods produced or held at each facility. FDA uses this information, when necessary, to provide quick and targeted responses to food-related emergencies stemming from accidental or intentional contamination or adulteration.

To register with FDA or find more information about registration, visit the Registration of Food Facilities page on the FDA website.

FDA Opens Voluntary Qualified Importer Program (VQIP) Application Portal 

On October 1, FDA opened the Voluntary Qualified Importer (VQIP) application portal. VQIP is a voluntary fee-based program that provides expedited review and importation of human and animal foods into the U.S. for applicants who achieve and maintain a high level of control over the safety and security of their supply chains. To participate in VQIP, importers must meet certain eligibility requirements, such as ensuring that the facilities of their foreign supplier are certified under the Accredited Third-Party Certification Program. 

>>Portal Access

>>FDA announcement

FDA Issues Guidance Document on Preventive Control Rules for "Qualified Facilities” 

Recently, FDA issued two guidance documents to help food facilities subject to the preventive controls for human and animal food rules determine if they meet the definition of a "qualified facility.” Under the Preventive Control Rules, qualified facilities are exempt from the hazard analysis and risk-based preventive controls requirements, and instead are subject to modified requirements. 

Facilities that meet the definition of qualified facility must submit a form to FDA attesting that it is controlling potential hazards associated with its food or complying with applicable non-federal food safety laws and regulations. The form must be submitted to FDA by December 17, 2018, if the qualified facility began manufacturing, processing, packing, or holding human food before September 17, 2018 or December 16, 2019, if the facility began manufacturing, processing, packing, or holding animal food before September 17, 2019. In 2020, the attestation form will be submitted during the food facility biennial registration renewal period that begins on October 1 and ends on December 31.

>>FDA announcement

FDA: Pilot Program for Two-Tier Preventive Controls for Human Food Inspections under FSMA 

FDA recently announced that it will engage in a pilot program to evaluate the benefits of two-tier inspections for some aspects of the Preventive Controls for Human Food (PCHF) rule.  In order to improve efficiency of inspections, FDA is inviting food companies with multiple facilities that implement centrally developed supply-chain programs and recall plans to apply to participate in the two-tier inspections. 

Companies interested in participating in the pilot must notify FDA of their desire to participate no later than October 31, 2018. 

>>FDA announcement



California Amends Slack Fill Law

Slack-fill is the void space in packaging resulting from a difference between the volume of packaging and the volume of product. Assembly Bill 2632, which was recently signed into law by Governor Jerry Brown, creates several new exemptions to California’s slack fill law.  These changes are anticipated to provide additional relief from slack fill litigation that has flooded the courts in recent years. 

To learn more about this development, view the Michael Best Client Alert

FDA Removes Use of Styrene as Flavoring or Adjuvant

FDA has amended the food additive regulations to no longer provide for the use of styrene as a flavoring substance and adjuvant for use in food because these uses have been abandoned.

>>Learn more

FDA Removes Clearance for Six Synthetic Flavoring Substances

Based upon a citizen petition, FDA announced it has amended the food additive petitions for benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine.  FDA explained that this action was being taking under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act as the petitioners provided evidence that these substances caused cancer in animals.

>>Learn more

FDA Updates Food Additive Regulation for Vitamin D3 in Food

FDA has proposed to amend the food additive regulation for Vitamin D3 to replace the current Reference Daily Intake (RDI) percentage values of calcium in 100 percent fruit juices and fruit juice drinks with absolute values and to update the reference for vitamin D3 specifications.

Objections to this amendment are due to FDA by October 22, 2018. 

>>Learn more

U.S. Progress on Several Trade Agreements

NAFTA 2.0: In October, President Trump announced that the U.S., Mexico, and Canada reached an agreement to replace the North American Free Trade Agreement (NAFTA).  The new agreement, U.S.-Mexico-Canada Agreement, contains several provisions that benefit the food and agriculture sector. 

Japan: President Trump and Japanese Prime Minister Abe yesterday announced plans to begin trade negotiations for a bilateral agreement.  Food will be included in the talks, but the leaders said they will cap market access at levels negotiated in the Trans-Pacific Partnership. 

Korea: In late September, the U.S. and Korea entered into a new trade agreement. The new United States-Republic of Korea Free Trade Agreement includes several provisions that will assist in the exporting food to Korea such as addressing sanitary and phytosanitary measures and other technical barriers to trade.

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