Laws and Regulations Committee Update 12/19-12/21, 2018

Federal Register

Food and Drug Administration

Rules

Food Labeling:

Revision of the Nutrition and Supplement Facts Labels; Technical Amendments

Filed on: 12/19/2018 at 8:45 am Scheduled Pub. Date: 12/21/2018

FR Document: 2018-27431 PDF 35 Pages (1.75 MB) Permalink

Uniform Compliance Date for Food Labeling Regulations

Filed on: 12/19/2018 at 8:45 am Scheduled Pub. Date: 12/20/2018

FR Document: 2018-27429  PDF 8 Pages (106 KB) Permalink

Food and Nutrition Service

Notices

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

Generic Clearance to Conduct Formative Research or Development of Nutrition Education and Promotion Materials and Related Tools and Grants for Food and Nutrition Service Population Groups

Filed on: 12/19/2018 at 8:45 am Scheduled Pub. Date: 12/20/2018

FR Document: 2018-27443 PDF 6 Pages (102 KB) Permalink

Animal and Plant Health Inspection Service

Notices

Charter Renewals:

General Conference Committee of the National Poultry Improvement Plan

Filed on: 12/19/2018 at 8:45 am Scheduled Pub. Date: 12/20/2018

FR Document: 2018-27480  PDF 2 Pages (5.27 KB) Permalink

FDA

Statement from FDA Commissioner Scott Gottlieb, M.D. on the FDA’s 2017 report on declining sales/distribution of antimicrobial drugs for food animals, a reflection of improved antimicrobial stewardship

USDA

USDA Releases 2017 Annual Pesticide Data Program Summary, U.S. Food Supply is Among the Safest in the World

FSIS

Recalls

Product Recalled	Date of Recall	Retail Distribution List
123-2018 Russ Davis Wholesale, Inc. Recalls Chicken Wrap Products due to Misbranding and Undeclared Allergens	Dec 18, 2018	Dec 18, 2018

AMS

Referendum Ends December 31, 2018 on Proposed Amendments to the Walla Walla Sweet Onion Marketing Order

CVM

FDA Releases Annual Summary Report on Antimicrobials Sold or Distributed in 2017 for Use in Food-Producing Animals Showing Declines for Past Two Years

OMB

AGENCY: USDA-FNS	RIN: 0584-AE57	Status: Concluded
TITLE:Supplemental Nutrition Assistance Program: Requirements for Able-Bodied Adults Without Dependents
STAGE: Proposed Rule	ECONOMICALLY SIGNIFICANT: Yes
** RECEIVED DATE: 12/18/2018	LEGAL DEADLINE: None
** COMPLETED: 12/18/2018	COMPLETED ACTION: Consistent without Change

@FrankYiannasFDA

• Between 2016 & 2017, @US_FDA reports there was a 33% decline in domestic sales & distribution of all medically important antimicrobials intended for use in food-producing animals. #progress
• More than 4% of Americans have food allergies. Keep this in mind when preparing #holiday treats. https://www.youtube.com/watch?v=PXxZlcrGFP0 … #foodsafety

@ScottliebFDA

• New technology such as genomic interrogation of human and food samples are enabling us to better identify outbreaks. The tools for doing more effective track and trace to isolate contaminated products and implement more targeted recalls need to catch up
• 1/2 New #FDA report from @FDAanimalhealth shows sales for antimicrobials used in food producing animals is declining.  This news highlights that our collaborative work with stakeholders on antimicrobial stewardship is making a significant impact: https://go.usa.gov/xEczK
• 2/2 Our report covers 2017 sales, the year following the implementation of GFI #213. In September, #FDA’s Center for Veterinary Medicine kicked off its 5-year action plan, including additional steps we will take to foster antimicrobial stewardship in veterinary settings.

@FDAanimalhealth

• Check out our 5-year action plan to see what we’re doing to further antimicrobial stewardship in veterinary settings: https://go.usa.gov/xEx2z
• Optimizing how antimicrobial drugs are used & limiting their use to only when necessary to treat, control, or prevent disease will help to preserve the effectiveness of these drugs for fighting disease in both humans & animals.

December 21, 2018

Federal Register

Food and Drug Administration

Notices

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

Medicated Feed Mill License Application

Filed on: 12/21/2018 at 8:45 am Scheduled Pub. Date: 12/26/2018

FR Document: 2018-27812 PDF 7 Pages (34.2 KB) Permalink

Agricultural Marketing Service

Rules

Decreased Assessment Rates:

Kiwifruit Grown California

Filed on: 12/21/2018 at 8:45 am Scheduled Pub. Date: 12/26/2018

FR Document: 2018-27888 PDF 15 Pages (336 KB) Permalink

Animal and Plant Health Inspection Service

Notices

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

Importation of Tomatoes from Certain Central American Countries

Filed on: 12/21/2018 at 8:45 am Scheduled Pub. Date: 12/26/2018

FR Document: 2018-27940 PDF 4 Pages (98.5 KB) Permalink

Environmental Protection Agency

Rules

Pesticide Tolerance Exemptions:

Chlorate

Filed on: 12/21/2018 at 8:45 am Scheduled Pub. Date: 12/26/2018

FR Document: 2018-27908 PDF 20 Pages (346 KB) Permalink

Notices

Pesticide Experimental Use Permits; Applications

Filed on: 12/21/2018 at 8:45 am Scheduled Pub. Date: 12/26/2018

FR Document: 2018-27917 PDF 4 Pages (360 KB) Permalink

Pesticide Product Registrations:

Applications for New Active Ingredients

Filed on: 12/21/2018 at 8:45 am Scheduled Pub. Date: 12/26/2018

FR Document: 2018-27911 PDF 4 Pages (177 KB) Permalink

Applications for New Uses

Filed on: 12/21/2018 at 8:45 am Scheduled Pub. Date: 12/26/2018

FR Document: 2018-27910 PDF 5 Pages (87.7 KB) Permalink

Pesticides:

Petition Seeking Rulemaking or a Formal Agency Interpretation for Planted Seeds Treated with Systemic Insecticides

Filed on: 12/21/2018 at 8:45 am Scheduled Pub. Date: 12/26/2018

FR Document: 2018-27780 PDF 4 Pages (81.2 KB) Permalink

International Trade Administration

Notices

Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Certain Frozen Warmwater Shrimp from India

Filed on: 12/21/2018 at 8:45 am Scheduled Pub. Date: 12/26/2018

FR Document: 2018-27862 PDF 4 Pages (86.5 KB) Permalink

FDA

FDA warns about safety risks of teething necklaces, bracelets to relieve teething pain or to provide sensory stimulation

Statement from FDA Commissioner Scott Gottlieb, M.D., on signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds

Notice of Agency Information Collection Activities; Substances Prohibited from Use in Animal Food or Feed; Animal Proteins Prohibited in Ruminant Feed

• December 21, 2018; 83 FR 65681

FDA Responds to Three GRAS Notices for Hemp Seed-Derived Ingredients for Use in Human Food

GRAS Notices

GRAS No.	Substance	Date of Closure	FDA’s Letter
765	Dehulled hemp seed	Dec 20, 2018	FDA has no questions (in PDF)8 (278 kB)
771	Hemp seed protein	Dec 20, 2018	FDA has no questions (in PDF)9 (484 kB)
778	Hemp seed oil	Dec 20, 2018	FDA has no questions (in PDF)10 (434 kB)

Recalls

Date	Brand	Product Description	Reason/ Problem	Company
12/20/2018	Inspired Organics	Organic almond butter, Organic Peanut Butter, Organic Tahini Butter	potential contamination of Listeria monocytogenes	Inspired Organics, LLC

USDA

USDA Provides School Meal Flexibility, Feeds Disaster Victims and More in 2018

Statement of Secretary Perdue on President Trump’s Signing of the Farm Bill

APHIS

APHIS’ 2018 Accomplishments Support American Producers and Protect U.S. Agriculture

Secretary Perdue Statement on United Nations’ Designation of 2020 as International Year of Plant Health

NAD

Advertising Claims About Insulin Sensitivity, Other Health Benefits of AstraGin Dietary Supplement Permanently Discontinued Following NAD Inquiry.

Miller Lite Can Claim “More Taste” than Bud Light and Michelob Ultra, Says NAD; Recommends Changes To Its “Know Your Beer” Campaign.

@SGottliebFDA

• Teething necklaces and jewelry have become popular among parents and caregivers who want to provide relief for children’s teething pain and sensory stimulation for children with special needs. We’re concerned about risks we’ve observed with these products
• The amount of antibiotics purchased to treat animals that are raised for the meat, dairy, and egg supply fell by 33 percent last year
• [*retweet @AFFI*] The Food and Beverage Issues Alliance led by AFFI and @AmericanBakers met for the final time this year to exchange dialogue about nutrition and food safety topics important to FDA. We thank former FDA Senior Advisor, Stephen Ostroff for his leadership & welcome @FrankYiannasFDA!
• [*retweet @maggiemfox*]New agriculture bill legalizes hemp. That doesn’t mean it’s unregulated, the @US_FDA @SGottliebFDA says
• My statement on the signing of the Agriculture Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds and new steps we plan to take: http://go.usa.gov/xEaPX
• THREAD: Today, the Agriculture Improvement Act which changes certain federal authorities relating to hemp was signed into law. However, it explicitly preserves FDA’s current authority to regulate products containing cannabis or cannabis-derived compounds: https://go.usa.gov/xEaPX
• In preserving these authorities, Congress recognized #FDA’s important public health role for products it regulates & allows us to continue enforcing the law to protect patients and the public while also providing potential pathways for cannabis and cannabis-derived products.
• In short, we treat products containing cannabis and cannabis-derived compounds as we do any other FDA-regulated products — they’re subject to the same authorities and requirements as products containing any other substance. This is true regardless of the source of the substance.
• We’ll continue to take action against products being unlawfully marketed and that create risks for consumers. We also recognize the potential opportunities that cannabis and cannabis-derived compounds could offer and acknowledge the significant interest in these possibilities
• Given the public interest and Congress’ interest in fostering the development of appropriate hemp products, we intend to hold a public meeting in the near future for stakeholders to share experiences/challenges with these products, incl. info/views on the safety of such products