Laws and Regulations Committee Update 1/14 – 1/16, 2019

January 14, 2019

AMS

USDA Cites Farmers Best of NYC Inc in New York for PACA Violations

@SGottliebFDA

• THREAD – SHUTDOWN UPDATE: The lapse in funding represents one of the most significant operational challenges in FDA’s recent history. But as an agency, we’re committed to fulfilling our consumer protection mandate, to the best of our abilities, under our current configuration.
• We analyzed activities with close input from senior career leaders & public health experts. Our plans always included activities to address immediate threats to human life & safety. But as lapse continues we’re evaluating additional activities we need to except to prevent threats
• FDA determined after careful analysis and in close consultation with senior career leaders and public health experts that the following activities should be considered excepted, unpaid work because they’re necessary to identify and respond to threats to safety of human life:
• The additional activities may be considered excepted work during a shutdown. Given the prolonged shutdown and compounding risk as time accrues; FDA is working to operationalize additional activities that exceed what we’ve done in past shutdown situations. Activities include:
•  Expanded inspection activities beyond “for-cause” inspections to also include foreign and domestic food, drug, medical, device and pharmacy compounding surveillance inspections focused on the highest risk products and facilities;
• Expanded monitoring and analysis by the Coordinated Outbreak and Response Evaluation (CORE) Network to include additional food safety and foodborne illness outbreak surveillance, detection, and response activities;
• Surveillance sampling of imported high-risk foods, drugs, and devices, and the logistical coordination and laboratory support for allowable inspections and evaluation;
• Expanded monitoring and evaluating medical device adverse event and malfunction reports to include additional types of medical devices;
• Expanded activities related to surveillance and response for recalls (including Class I and Class II) as necessary to identify and respond to threats to the safety of human life;
• It is not business as usual at FDA. Many key functions aren’t getting done. But we’re focused on maintaining core activities that directly impact consumer safety and save lives. My priority is to our consumer protection mission and the people executing mission critical functions
• In the coming days, we’ll update on some additional activities that the #FDA plans to continue undertaking, especially activities related to veterinary health issues that have a direct impact on human life and safety.

@FrankYiannasFDA

• A new Era of Smarter Food Safety is dawning. Food Safety will increasingly be people-led, technology-enabled (w technologies such as low-cost #sensors, #IoT, #blockchain, & #AI). A new Era of Smarter Food Safety is dawning. Food Safety will increasingly be people-led, technology-enabled (w technologies  such as low-cost #sensors, #IoT, #blockchain, & #AI).
• THREAD: During this partial lapse in funding, @US_FDA is committed to focusing resources, as permitted by law, on areas of highest potential risk to consumers. https://www.newsy.com/stories/fda-halts-most-us-food-safety-inspections-during-shutdown/
• While food inspections are critical, they are always a snapshot. This re-emphasizes the need to resume work–after the shutdown–to fully implement the Food Safety Modernization Act (FSMA).
• At the heart of FSMA is the idea that the nation’s food safety system must be transformed into one that’s based on #prevention.
• FSMA requires the food industry to systematically put controls in place to prevent contamination, rather than place an over-reliance on trying to catch faulty procedures or contamination after the fact through inspections & testing, although both remain important tools for FDA.

January 15, 2019

@SGottliebFDA

• UPDATE ON FOOD INSPECTIONS AND OTHER INSPECTION ACTIVITY: The response from our outstanding field force and inspectorate has been overwhelming and outstanding. They’re among the finest, most dedicated professionals in our federal workforce and we’re grateful for their service ->
• We re-starting high risk food inspections as early as tomorrow. We’ll also do compounding inspections this week. And we started sampling high risk imported produce in the northeast region today. We’ll expand our footprint as the week progresses. Our teams are working.
• This work is being done by an inspectorate that’s largely going unpaid. These men and women are the tip of the spear in our consumer protection mission. They’re the very front line. And they’re on the job. The entire nation owes them gratitude. I’m inspired by their dedication.
• With the support of our dedicated field force, we’re recalling hundreds of furloughed colleagues to conduct inspections of high risk food facilities and other entities; working on mostly unpaid inspection assignments, led by #FDA‘s outstanding inspectorate https://www.nbcnews.com/
• Behind the efforts of our dedicated field force, we’ll be restarting inspections of high risk food and medical product facilities as early as tomorrow. And sampling assignments at ports of entry re-started today. https://www.bloomberg.com/
• This was a major functional accomplishment amidst one of the biggest operational challenges in FDA’s modern history and it was fully enabled by the leadership of FDA’s field force and the colleagues who serve the country on the front lines of that mission. https://www.nytimes.com/
• #FDA is alerting pet owners not to feed their dogs certain A+ Answers Straight Beef Formula because it may be contaminated with Salmonella. Specifically, Lot 2018 20/08 20, tested positive for Salmonella by Nebraska state officials. Salmonella can be harmful to humans and animals. The company recalled the product from distribution and retail locations in Nebraska late last month but has not recalled the product nationwide. Read more here: https://go.usa.gov/xEjGn .

@FrankYiannasFDA

• Food Safety Leadership is first & foremost a commitment to protect & serve others. Grateful for the team @US_FDA & their unwavering commitment to protect consumers. #service #duty #protect https://www.politico.com/story/2019/01/14/fda-food-safety-inspections-shutdown-1084170

CVM

FDA Cautions Pet Owners Not to Feed One Lot of A+ Answers Straight Beef Formula for Dogs Due to Salmonella

FDA

Recalls

GAO

SNAP: Actions Needed to Better Measure and Address Retailer Trafficking

NTP

NTP Update – January 2019

@FDArecalls

• RXBAR Recalls Certain Varieties of Bars Due to a Potential Undeclared Peanut Allergen http://dlvr.it/QwmZNl
• Voluntary Recall Notice of El Guapo Chile Habanero and Chile Pasilla-Ancho Pouches Due to Unlabeled Peanut Allergen http://dlvr.it/QwmZNB

January 17, 2019

@Scott Gottlieb, M.D.

• THREAD: Some of the dedicated FDA staff of our Office of Regulatory Affairs at work, unpaid, in our Philadelphia lab. We’ve restarted high risk food sampling assignments and other critical surveillance activity. Among many hardships our people are overcoming right now ….
• one of the hardest challenges is to find yourself on furlough. All of our colleagues are critical; all do critical work to advance public health. I highly value each and every one of you, the institution depends on all of you….
• You’re valued each day. But it’s even more the case that in moments of challenge, when some of our work stops, that your critical role becomes so obvious. FDA can’t achieve its full mission without each of you; whether you’re exempt, excepted, or on furlough. We’re one FDA.

@FrankYiannasFDA

•  During the partial shutdown, @US_FDA continues to promptly respond to recalls. RXBAR Recalls Certain Varieties of Bars Due to a Potential Undeclared Peanut Allergen. More info at https://www.fda.gov/safety/recalls/ucm629527.htm …

January 18, 2019

FSIS

Recalls

@SGottliebFDA

• @US_FDA continues to take actions to prevent future foodborne outbreaks through surveillance sampling. Here, an #FDA Consumer Safety Officer in Nogales, AZ, collects a sample of fresh produce (sweet peppers) to be analyzed by an FDA laboratory for microbiological contamination.
• THREAD: We appreciate US PIRG’s interest in the safety of the nation’s food system and we always welcome a larger conversation on the topic. Public health is our top priority and FDA is working hard to ensure the U.S. food supply remains among the safest in the world.
• While we agree with the premise that prevention is always better than a corrective action, such as executing a recall, there should be caution in using recall numbers alone as the sole metric for gauging long-term performance trends in food safety.
• Dramatic improvements in new tools to detect foodborne pathogens has likely resulted in an increased # of recalls. The complexity of supply chain for foods has also increased so one contaminated ingredient can trigger many recalls, which can affect the overall number of recalls.
• FDA ensures that recalls by companies – voluntary or involuntary – are initiated, overseen, and completed promptly and effectively, and that consumers have timely, actionable information to protect themselves and their families.
• Even during the lapse in funding, we’re continuing to support recalls as necessary to identify and respond to threats to the safety of human life, and activities for the surveillance and inspection of high-risk foods.
• Over the past year, #FDA has made several key policy changes to improve and modernize its food recall processes — with a focus on providing more meaningful information to consumers.
• More actions to improve our recall policies are planned, including ways to further improve our ability to track and trace products through the supply chain. We’ll continue to communicate on these efforts in the coming year.