December 2018– February 2019 Regulatory Update

These Regulatory Updates are brought to you by Michael Best & Friedrich. 
This Regulatory Update includes information from December 20, 2018 through February 13, 2019. Please contact Leah Ziemba or Emily Lyons for additional information on regulatory issues that may impact your business.

The December 2018– February 2019 Regulatory Update includes several MUST READ updates:

 

FDA AND USDA UPDATES

  • Impact of the Federal Government Shutdown on Food Companies (MUST READ)
  • FDA Issues Technical Amendments for Nutrition Facts Labeling Regulation
  • FDA Announced Uniform Compliance Dates for Food Labeling Regulations
  • USDA FSIS Eliminates Certain Hog Carcass Cleaning Requirements

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

  • FDA Issues Final Guidance on Public Warnings and Notification of Food Recalls (MUST READ)
  • Produce Safety Rule Inspections Begin Soon (MUST READ)

OTHER DEVELOPMENTS OF INTEREST

  • FDA Recognizes Three Hemp-Seed Derived Ingredients as GRAS
  • USDA-FSIS Issues Aggregate Salmonella and Campylobacter Data for Poultry
  • USDA-FSIS Updates Microbiology Laboratory Guidebook

 


 
FDA AND USDA UPDATES

Impact of the Federal Government Shutdown on Food Companies (MUST READ)

About one fourth of the federal agencies were affected by a lapse in Congressional funding for 35 days this winter.  During the pendency of the shutdown, USDA and FDA operated under significantly reduced functions as most activities were limited to those that involved protecting national security or public health.  Congress has passed a funding bill that will keep these agencies open until the financial year ends in September.  

FDA: According to the Department of Health and Human Services shutdown plan, approximately 41% of FDA employees were furloughed from December 22, 2019 until January 25, 2019.  The majority of the staff that was affected by the shutdown came from the food safety and nutrition programs as most of the drug and tobacco programs were able to maintain some operations due to user fees collected in FY 2018.

With this reduced staff, FDA continued certain vital activities, to the extent permitted by the law, that were critical to ensuring public health and safety.  The food related activities included response to emergencies; managing high-risk food recalls; pursued criminal enforcement work and civil investigations related to imminent threats to human health or life; conducted for cause inspections of regulated facilities and surveillance of adverse events reports for issues that could cause a human health risk; reviewed imported foods; and responded to other critical public health issues, such as outbreaks related to foodborne illnesses.

FDA was unable to support most of its routine regulatory and compliance activities for foods and paused routine inspections, nutrition work, review of GRAS petitions, as well as certain ongoing research activities.  However, due to the concern over food safety, FDA recalledhundreds of government workers to conduct inspections at "high-risk” food facilities.  

USDA: According to the USDA shutdown plan, approximately, approximately 38% of USDA employees were furloughed.  The majority of the staff affected were involved in trade and foreign affairs, nutrition, rural development, and research programs. 

In general, the Food Safety Inspection Service (FSIS) continued certain functions necessary to protect public health such as recall management, outbreak investigations, and import reviews.  However, unlike FDA, FSIS continued in-plant inspections during the shutdown.  FSIS also continued outbreak investigations and recall management functions.  However, FSIS had extremely limited staff to conduct label review and approvals resulting in significant delays for food companies attempting to seek temporary label approvals.

Certain Agricultural Marketing Service (AMS) programs continued to operate because they are funded through user fees, assessments, mandatory appropriations, or reimbursements such as the meat, poultry, and dairy grading programs, Perishable Agricultural Commodities Act program, Milk Marketing Administration, and Research and Promotion programs.  However, AMS was unable to operate the National Organic Program and the Standardization, Transportation and Market Development programs.

What to Expect with the Government Reopened:  Now that the government has reopened, USDA and FDA have gone back to their normal operations.  The agencies have also been busy prioritizing matters that accumulated since December 22, 2018.  For example, FSIS has indicated expect current delays of label review of 26–29 business days and has outlined several steps food companies can take to streamline the label review. 

 

FDA Issues Technical Amendments for Nutrition Facts Labeling Regulation

FDA recently issued technical amendments to the final rule revising the nutrition labeling requirements.  These technical amendments restore provisions that were inadvertently omitted when the new regulations were published, corrects errors in FDA’s sample Nutrition Facts Label and Supplemental Facts Panel formats, and update cross references that were not updated when the final rules were issued.

Reminder: The compliance date for updating the Nutrition Facts and Supplement Facts label is January 1, 2020, for manufacturers with $10 million or more in annual food sales.  Manufacturers with less than $10 million in annual food have until January 1, 2021 to comply.

Learn more about the Technical Corrections

 

FDA Announces Uniform Compliance for Food Labeling Regulations

The FDA announced that January 1, 2022 is the uniform compliance date for final food labeling regulations that are issued in calendar years 2019 and 2020.  All foods subject to the uniform compliance date must comply with the labeling regulation when the food is initially introduced into commerce on or after January 1, 2022.  Occasionally, FDA announces uniform compliance dates for labeling regulations to minimize the economic impact of label changes. 

Learn more about the uniform compliance date

 

USDA FSIS Eliminates Certain Hog Carcass Cleaning Requirements

FSIS has issued a final rule that removes the requirements for the cleaning of hog carcasses before an incision is made prior to evisceration.  FSIS decided to remove the cleaning requirements because other regulations require carcass cleaning, the maintenance of sanitary conditions, and the prevention of introducing hazards reasonably likely to occur during the slaughter process.  According to FSIS, removing the cleaning requirements will enable hog slaughter establishments to adopt more efficient, effective procedures to ensure carcasses are free from contamination.   

Read the final rule here

 

 

FOOD SAFETY MODERNIZATION ACT (FSMA) UPDATES

FDA Issues Final Guidance on Public Warnings and Notification of Food Recalls (MUST READ)

FDA has issued final guidance regarding public warning and notification of recalls.  The guidance document outlines circumstances when a company should issue a public warning about a voluntary recall, describes the timeframe for companies to issues a warning, discussed what information should be included in the warning, and details the situations where FDA may take action to issue its own public warning.

In a statement accompanying the guidance, FDA Commissioner Scott Gottlieb stated the final guidance demonstrates FDA’s increased interest in public notification of recalls as well as increasing the publicizing of recalls.    

Read the final recall guidance here

 

Produce Safety Rule Inspections Begin Soon (MUST READ)

In a recently issued statement, FDA Commissioner Scott Gottlieb affirmed that the Produce Safety Rule inspections will being this spring.  Last year, FDA chose to delay routine inspections to allow for more time for industry and regulator training on the rule.  The announcement indicates that routine inspections for large farms (those will more than an average $500,000 in produce sales during the previous 3-year period) will commence this spring.

FDA has also launched a Produce Inspections Web Page that has resources available to assist farms and those regulated by the Produce Safety rule.  The webpage includes a new fact sheet with information on what farms should expect of their first inspection.  It also includes new documents to be used during Produce Safety inspections, including the recently developed inspectional observation form and a procedure for dispute mitigation and resolution.

 

 

OTHER DEVELOPMENTS OF INTEREST

FDA Recognizes Three Hemp-Seed Derived Ingredients as GRAS

FDA recently completely its evaluation of three hemp-seed derived ingredients, hulled hemp seed, hemp seed protein powder, and hemp seed oil, and has concluded that they are generally recognized as safe (GRAS).  Even with these GRAS conclusions, FDA still prohibits the use of cannabis, cannabidiol (CBD), and tetrahydrocannabinol (THC) in food.

Learn more here

 

USDA-FSIS Issues Aggregate Salmonella and Campylobacter Data for Poultry

FSIS recently issued updated aggregate data that outlines the progress of poultry processing facilities on meeting pathogen reduction performance standards for Salmonella and Campylobacter.  This information is shared to provide industry and other stakeholders timely updates about progress being made to reduce contamination in poultry.

View the data here

 

USDA-FSIS Updates Microbiology Laboratory Guidebook

FSIS has decided to update its Microbiology Laborite Guidebook, which outlines the analytical tests required for use by FSIS to evaluate regulatory samples in meat, poultry, and egg products.  These changes intend to implement more efficient, modern pathogen detection methods for Salmonella species, Listeria monocytogenes, and E. coli  (STEC).

View the updated Guidebook here

 

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