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Industry News and Press: Regulatory Updates

May 2017 Regulatory Update

Tuesday, June 27, 2017   (0 Comments)
  
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The May 2017 Regulatory Update includes the following topics. Click on the link for the complete regulatory update.

 

1. THE FDA Voice Blog Post
The FDA created a team to assist the FDA across the country to make decisions for mandatory product recalls based on the preventive controls outlined in FSMA. The team is called SCORE (Strategic Coordinated Oversight of Recall Execution).  Links to the FDA Voice blog and FDA SCORE webpage are provided.  

 

2. FSMA Update
The FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is final, and the first compliance dates began May 30, 2017. This includes the responsibility of importers to verify that their foreign suppliers have adequate preventive controls to ensure the production of food that is safe and complies with US Food Safety Standards. Compliance dates for importers subject to the FSVP rule vary. 

3. Other Developments of Interest   

a. Compliance Date Extended for Disclosure of Certain Nutrition Information in Certain Restaurants and Retail Food Establishments

b. Open Comment Periods:  Use of Genome Editing Techniques to Produce New Plant Varieties for Human or Animal Food; Sprout Operations; Listeria Control in RTE



This Regulatory Update includes information from May 1 through 31, 2017. Please contact Seth Mailhot, samailhot@michaelbest.com, Leah Ziemba, lhziemba@michaelbest.com, or Paulette Morgan, pjmorgan@michaelbest.com, for additional information on regulatory issues that may impact upon your business.
 
 
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FDA VOICE BLOG: THE ROLE OF SCORE IN PROTECTING PEOPLE FROM UNSAFE FOODS

A May 24, 2017 FDA Voice blog post talks about food safety in the past year and the important role of the SCORE team in protecting food safety.  SCORE (Strategic Coordinated Oversight of Recall Execution) is a team of key senior leaders that become involved with the most challenging recall situations.  This team helps support the FDA’s field staff and district offices across the country and is designed to make decisions quickly about the best steps to take with respect to a recall.   The co-chairs are William Correll, director of the Office of Compliance in the FDA’s Center for Food Safety and Applied Nutrition (CFSAN), and Douglas Stearn, director of the Office of Enforcement and Import Operations in FDA’s Office of Regulatory Affairs (ORA).  In the May 24th blog post for FDA Voice, and on the FDA SCORE webpage, links to each of which are found below, the co-chairs discuss the background of SCORE, how it works, some of the challenges the team has faced, and what options are available to address issues that SCORE confronts.

The May 24th article noted that one example of how SCORE works is that "SCORE can drive agency action if the company is not acting aggressively enough to recall their products, and can push for use of administrative or judicial remedies.  We now have FDA compliance, enforcement, and field leaders at the table, reviewing cases every week or more often, as needed.  Science and medical officers are engaged in the conversation, as are field investigators, and lawyers.”  >>Read more

Generally, the FDA’s district offices are the ones that first work with companies in a recall situation. However, the district office can bring an issue to the attention of SCORE, and then SCORE decides whether further investigation is warranted or whether there is sufficient evidence to take action, for example, issue a mandatory recall where a voluntary recall is not being instituted.  The Food Safety Modernization Act (FSMA) authorized FDA to issue mandatory recalls when a company does not voluntarily recall unsafe food after a request by FDA to implement a recall.  A mandatory recall is one of the options that SCORE may recommend where evidence meets the SAHCODA standard (a hazard is reasonably likely to cause serious adverse health consequences or death to humans or animals).  "The bottom line is that there is an expectation that the company will be taking immediate steps to remove potentially harmful or implicated food from the market, and ensuring prevention of contamination. If their safeguards have failed, companies have the responsibility to act, not only to rectify their system for prevention but, more immediately, to do something about the food that they already delivered into the marketplace. Time matters in these kinds of situations.”  >>Read more 

FDA recognizes that most companies will voluntarily recall a product where a specific lot of contaminated food has been found, but that "[t]he complexity comes in trying to ascertain what more might be contaminated than a specific lot and over what range of time.”  See link to FDA SCORE webpage above.  The enforcement options that SCORE considers include FSMA enforcement tools, including the suspension of a food facility’s registration, administrative detention to keep foods out of the marketplace, and mandatory recall, as well as judicial proceedings, such as seizures and injunctions.  With respect to FSMA preventive controls, FDA has announced that "[t]he system of preventive controls required by FSMA will result in more environmental monitoring through specimen collection as a verification tool for food processors to ensure that their control measures are working. This testing will likely identify more potential hazards before they actually result in contaminated food on the market.”  >>Read more

 

 

IMPORT REQUIREMENTS OF THE FOOD SAFETY MODERNIZATION ACT

The Food Safety Modernization Act (FSMA), which was signed into law on January 4, 2011, granted FDA new authorities and mandates for the protection of the food supply, including for prevention, inspection and compliance, response to food-based problems, and enhanced collaboration with other government agencies.  One of the areas FSMA governs is imports.  FDA has recognized that FSMA gave it "unprecedented authority” to "better ensure that imported products meet U.S. standards and are safe for U.S. consumers.”  These new authorities include the responsibility of importers to verify that their foreign suppliers have adequate preventive controls to ensure the production of food that is safe, the establishment of a program for qualified third parties to certify that foreign food facilities comply with U.S. food safety standards, the authority to require that high-risk imported foods be accompanied by a credible third-party certification as a condition of entry, a voluntary program for importers providing for expedited review and entry of foods from participating importers, and the authority to deny entry of food from a foreign facility if FDA is denied access by the facility or the country in which it is located.

The FSMA rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals is final, and the first compliance dates began May 30, 2017. Compliance dates for importers subject to the FSVP rule vary based upon:

 

             


OTHER DEVELOPMENTS OF INTEREST

Compliance Date Extended for 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. FDA is extending 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 policies.  A sixty-day comment period commenced May 4, 2017. >>Read more

Comment Period Remains Open Until June 19, 2017 for Use of Genome Editing Techniques to Produce New Plant Varieties for Human or Animal Food.

We note again for our readers that the comment period extends until June 19, 2017 for "Genome Editing in New Plant Varieties Used for Foods” (Center for Food Safety and Applied Nutrition) regarding the use of genome editing techniques to produce new plant varieties that are used for human or animal food, "Genome Editing in New Plant Varieties Used for Foods; Request for Comments.”  FDA intends to continue offering consultations for developers of new plant varieties to help developers ensure that applicable safety and legal questions are resolved prior to market.  The comment period, including on specific questions included in the Notice, extends to June 19, 2017.  >>Read more

 Comment Period Remains Open

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)

Comment Period Remains Open

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

 


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

Please contact Seth Mailhot, Leah Ziemba, or Paulette Morgan for additional information on regulatory issues that may impact upon your business.

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