Laws and Regulations Committee Update – December 11 – 13, 2019

Federal Register

Food Safety and Inspection Service


Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Focus Group Research to Inform Consumer Food Safety Education and Outreach

Filed on: 12/11/2019 at 8:45 am Scheduled Pub. Date: 12/12/2019

FR Document:2019-26694 PDF 11 Pages (249 KB) Permalink


December 10, 2019 – FDA underscores that consumers should not use drugs, dietary supplements and devices recalled from Basic Reset and Biogenyx following consent decree for federal violations

Warning Letters

Posted DateIssue DateCompanyIssuing OfficeSubject
12/10/201911/20/2019Hill’s Pet Nutrition Inc.Office of Human and Animal Foods Division II WestInterstate Commerce/Food/Adulterated
12/10/201911/20/2019Prolifix Nutrition, LLCOffice of Human and Animal Foods Division IV WestCGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated
12/10/201911/22/2019Friendly’s Manufacturing and Retail LLCOffice of Human and Animal Food Operations East – Division 1CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated
12/10/201911/18/2019Valley Proteins, Inc.Division of Human and Animal Food Operations East II (HAFE2)New Animal Drug/Adulterated



Product RecalledDate of Recall
119-2019 Ruiz Food Products, Inc. Recalls Frozen Sausage Breakfast Burrito Products due to Possible Foreign Matter ContaminationDec 10, 2019


FDA Releases Annual Summary Report on Antimicrobials Sold or Distributed in 2018 for Use in Food-Producing Animals


USDA Releases 2018 Annual Pesticide Data Program Summary


  • Petition Submitted by Center for Food Safety(Dec 4, 2019) 
    The petition requests that FSIS take certain actions with respect to the National Residue Program.
  • FSIS Response Acknowledging Receipt of Petition (Dec 9, 2019)

National Academies


Innovations in the Food System: Exploring the Future of Food: Proceedings of a Workshop—in Brief


FDA’s New Report on Antibiotics in Farm Animals Adds Urgency to Fight for Responsible Antibiotics Use


  • Did you know that there’s an office at the FDA that conducts investigations of animal food-occurring outbreaks? Join us Dec. 12 for the FDA Grand Rounds to learn all about the Veterinary Laboratory Investigation and Response Network. Register here!
  • Federal health officials report 8 illnesses in 3 states caused by E. coli O157-H7, likely linked to Fresh Express Sunflower Crisp chopped salad kits. FDA is still investigating. We do not yet know if this is related to other ongoing outbreak investigations


  • Investigators working to identify factors that caused contamination. DO NOT EAT romaine lettuce grown in #Salinas, California growing region.
  • #OUTBREAK UPDATE: #FDA@CDCgov, working w/ Wisconsin @DHSWI & @widatcp to investigate multi-state outbreak of E. coli O157:H7 infections linked to romaine lettuce from Salinas.


  • FDA continues to investigate a multistate outbreak of hepatitis A linked to blackberries purchased between Sept. 9 & Sept. 30 from Fresh Thyme Farmers Market or Woodman’s Market in 11 states; @CDCgov reports an increase in the case count to 18.
  • FDA publishes the 2018 summary report on antimicrobials sold or distributed for use in food-producing animals @FDAanimalhealth  To help understand what the report means and how to interpret the data, check out our FAQs.



  • Have you ever wondered how products are imported into the U.S., or what #imports are flagged from entry into the states? FDA’s job of protecting imports has increased 5-10 % annually for the last decade, and that % keeps rising. LEARN MORE:

December 12, 2019

Federal Register

Food Safety and Inspection Service


Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Small Meat Processor Study

Filed on: 12/12/2019 at 8:45 am Scheduled Pub. Date: 12/13/2019

FR Document:2019-26882 PDF  8 Pages (214 KB) Permalink



DateBrandProduct DescriptionTypeReason/ProblemCompany
12/10/2019CATSMO LLCCold Smoked Salmon (whole fillets and specialty cuts)Food & Beverages, Fish, Foodborne IllnessListeria monocytogenesCATSMO LLC


USDA Clarifies that Nicholas Allen Continues to Challenge his Responsibly Connected Status to Allens Inc. for PACA Violations

USDA Restricts PACA Violators in California and Virginia from Operating in the Produce Industry

USDA Issues Packers and Stockyards Complaint against Merle Olson, d.b.a. Olson Cattle Co.


NAD Finds Format of RXBAR Front Labels Not Misleading, Communicates Substantiated Claims about the Core Ingredients of an RXBAR

Food and Water Watch

USMCA is a New NAFTA and an Assault on Food, Air, and Water



  • Planning to buy your family and friends makeup or other cosmetics this holiday season? Be sure to check the ingredients before you buy. For cosmetics safety information and resources, visit:


  • #ICYMI FDA continues to investigate a multistate outbreak of #hepatitis A linked to #blackberries purchased between Sept. 9 & Sept. 30 from Fresh Thyme Farmers Market or Woodman’s Market in 11 states; @CDCgov reports an increase in the case count to 18.

December 13, 2019


Statement on new findings and current status of the romaine lettuce E. coli O157:H7 outbreak investigation


AGENCY: USDA-FNSRIN: 0584-AE72Status: Concluded
TITLE: Streamlining Program Requirements and Improving Integrity in the Summer Food Service Program
** COMPLETED: 12/12/2019COMPLETED ACTION: Consistent with Change


Now Available: Winter Scoop Newsletter


  • Progress is being made, and the FDA is actively investigating other traceback leads identified to determine if we can triangulate a more precise location of the contamination. We will provide updates to the public as further information becomes available.
  • Our investigation remains a complicated work in progress, and it is too soon to draw definitive conclusions. However, FDA, CDC and our state partners have identified a common grower between each of the outbreaks, which is a notable development.
  • We’ve been tracking three separate outbreaks caused by three different strains of E. coli O157:H7.
  • UPDATE: Today, #FDA is providing an update on our investigation of an outbreak of E. coli O157:H7 illnesses linked to romaine lettuce.
  • “While we can’t prevent every outbreak from happening, by sharing and learning from others, we can limit consumers’ exposure to pathogens.” – @FrankYiannasFDA


  • Visited the Costco Poultry Facility in Fremont, NE w/ @GovRicketts. It’s a modern facility w/ investments in tech & food safety, but I was most impressed by their commitment to the local economy through building a network of producers in the state & hiring workers from NE & IA.
  • Our mission at USDA is to put our farmers first and to be the most efficient, effective, and customer service driven department. We do that by listening to what our customers have to say, and it was great to see what @FBNFarmers is doing to help amplify the stories of farmers.
  • We’re seeing more & more the digitization of agriculture, so it’s vital to connect to a community that can be a reliable source of info. But it’s just as vital to share what’s worked for you & maybe what hasn’t. The practice of sharing data-driven info can help all producers.
  • Farmers and producers are in a highly competitive market — data analytics are key to survival. The @FBNFarmers‘ two main principles of “farmers first” and “transparency and fairness” help folks meet challenges head on through careful analysis and data driven farming.


  • I am pleased to announce that Dr. Stephen M. Hahn has been confirmed as 24th Commissioner of Food & Drugs. As an experienced physician, published researcher & health care leader, I know he will successfully lead FDA in its critical task of protecting & promoting public health.


  • Holiday dinner guests will be over before you know it. If you plan to serve hot foods in a slow cooker or warming tray, keep your food thermometer close by. Hot foods should be kept at an internal temperature 140 °F. This temp keeps bacteria at bay 
  • FDA is providing an update on the E. coli outbreaks linked to romaine lettuce from Salinas, CA. Illnesses are subsiding and we will continue to provide information from the investigation as it becomes available

@FDAMedia·       ROMAINE UPDATE: Illnesses are subsiding, FDA continues to investigate and advise consumers to avoid romaine lettuce from Salinas, CA. FDA will continue to provide information as it becomes available


  • FDA continues to recommend NOT EATING romaine if the label indicates the lettuce was grown in #Salinas
  • To date, investigation efforts for all 3 outbreaks have indicated a common grower in Salinas. FDA, @CDCgov & state partners will conduct investigations at this farm. Washington:  Fresh Express Sunflower Crisp Chopped Salad Kits
  • FDA continues to investigate cause of E.coli outbreak linked to #romaine lettuce from #Salinas, CA. Plus investigating two other E. coli outbreaks linked to (1) romaine lettuce in Washington state & (2) Fresh Express Sunflower Crisp Chopped Salad Kits.