Laws and Regulations Committee Update – August 13 – 17, 2021

August 13, 2021

Federal Register

Food and Drug Administration

Notices

International Drug Scheduling:

Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; 4F-MDMB-BICA (4F-MDMB-BUTICA); Brorphine; Metonitazene; Eutylone (bk-EBDB); BMDP (3,4-Methylenedioxy-N-benzylcathinone); Kratom (mitragynine, 7-hydroxymitragynine); Phenibut; Reopening Comment Period

Filed on: 08/11/2021 at 4:15 pm Scheduled Pub. Date: 08/16/2021

FR Document: 2021-17498  PDF 4 Pages (74 KB)  Permalink

Animal and Plant Health Inspection Service

Rules

Definitions of the European Union and the United Kingdom

Filed on: 08/13/2021 at 8:45 am Scheduled Pub. Date: 08/16/2021

FR Document: 2021-16900  PDF 33 Pages (329 KB)  Permalink

HHS

Secretary Becerra to Require COVID-19 Vaccinations for HHS Health Care Workforce

[Note: vaccine requirement would cover IHS, NIH, and members of the U.S. Public Health Service Commissioned Corps. FDA workforce does not appear to be included at this time]

FDA

Recalls

DateBrandProduct DescriptionTypeReason for RecallCompany
08/12/2021MarketsideChocolate Candy Cookie CakeFood & Beverages, Allergens, Bakery Product/MixMay contain undeclared peanutsJimmy’s Cookies LLC

New GRAS Notices

GRN No.Substance
1004Maltosyltrehalose syrup
1003Bifidobacterium longum subsp. infantis M-63
1002Bifidobacterium breve strain MCC1274
1001Myoglobin preparation from a strain of Pichia pastoris expressing the myoglobin gene from Bos taurus
1000Phycocyanin-rich extract of Galdieria sulphuraria (G. sulphuraria strain “FCC3424”)
999Enzyme-modified steviol glycosides
998Corn bran arabinoxylan
997Chitosan and beta-1,3-glucans from white button mushrooms (Agaricus bisporus)
996Synthetic amorphous silica
995β-glucans from Antrodia cinnamomea strain ATCC 200183
994Miracle fruit (Synsepalum dulcificum), in pulp, powder, or protein forms
993L-carnitine-L-tartrate
992White mulberry (Morus alba Linn) leaf extract
991Chitonase enzyme preparation produced by Bacillus subtilis
990Short-chain fructooligosaccharides
989Bacillus subtilis expressing a modified gene encoding a variant of the wild-type subtilisin from B. clausii
988Lactobacillus fermentum LfQi6

USDA

Biden-Harris Administration Announces Availability of Up To $500 Million in Emergency Rural Health Care Funds Under the American Rescue Plan

[Note: Funding Will Expand Access to COVID-19 Vaccines, Health Care Services and Food Assistance in Rural America]

FSIS

Notices

NumberTitleDate
32-21Posting of Additional Informational DashboardsAug 11 2021

[Note: This notice announces the availability of additional informational dashboards, posted to IPP Help and the public webpages, for FSIS Directive 5000.1, Verifying an Establishment’s Food Safety System, FSIS Directive 5300.1, Managing the Establishment Profile in the Public Health Information System, and FSIS Directive 7310.5, Presence of Foreign Material in Meat or Poultry Products.  These dashboards provide key information from each of these directives and links to available resources.]

APHIS

General Conference Committee of the National Poultry Improvement Plan Meeting

FNS

The Thrifty Food Plan: What It Is and Why It Matters

[Note: At the direction of Congress and with the support of President Biden as part of the administration’s Build Back Better initiative, USDA is re-evaluating the Thrifty Food Plan (TFP) to ensure that it reflects the cost of a practical, nutritious, budget-conscious diet.]

Twitter

@SecVilsack

  • I want to thank Senator Amy Klobuchar, Senator Tina Smith, & Rep. Angie Craig for a warm Minnesota welcome today. Important discussions with producers around drought challenges, the next Farm Bill, the climate crisis, & the work USDA is doing on the Packers and Stockyards Act.
  • [retweet @amyklobuchar] Across Minnesota, fields are drying up and farmers can’t feed their herds. I joined  @SecVilsack, @SenTinaSmith, @RepAngieCraig today in Cannon Falls to discuss how we can support farmers and ranchers during the drought. Working together, we can get through this.

@FDArecalls

  • Jongu 4308 Issues Voluntary Nationwide Recall of Hydro Pineapple Burn Due to the Presence of Undeclared Sibutramine https://go.usa.gov/xFyJ5
  • Frito-Lay Issues Limited Voluntary Recall on Undeclared Milk in Wavy Lay’s Original Potato Chips Distributed in North Carolina, South Carolina and Virginia https://go.usa.gov/xFyJW

@FDAfood

  • Sign up today for “Exploring the Science Surrounding the Safe Use of Bioactive Ingredients in Infant Formula: Considerations for an Assessment Framework.” This 2-day virtual workshop is sponsored by  @NICHD_NIH and  @US_FDA . https://go.usa.gov/xFVT2 Registration is required.
  • The workshop will focus on the functional state-of-the-science of biologically active human milk components and analogs and the implications for safety assessments when used in infant formula. https://bit.ly/3AAU7z0
  • A new episode of FDA’s TechTalk Podcast is now available. The discussion centers on whole genome sequencing #WGS and its potential to transform food safety with food safety and public health experts from  @APHL @WesternGrowers @HealthNYGov Listen here: https://go.usa.gov/xFyfx

@FDA_ORA

  • Job Alert! #FDAORA is recruiting for Consumer Safety Officers GS-9 nationwide. This position serves as FDA rep on human and animal foods, drugs, medical devices, medical products, and imports. APPLY TODAY: https://go.usa.gov/xFV4f #FDAJobs

August 16, 2021

Federal Register

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 08/16/2021 at 8:45 am Scheduled Pub. Date: 08/17/2021

FR Document: 2021-17548  PDF 3 Pages (89.5 KB)  Permalink

[Note: information collection related to waiver of inspection and weighing requirements for high quality grain]

Animal and Plant Health Inspection Service

Notices

Environmental Assessments; Availability, etc.:

BASF Corporation; Determination of Nonregulated Status of Plant-Parasitic Nematode-Protected and Herbicide Tolerant Soybean

Filed on: 08/16/2021 at 8:45 am Scheduled Pub. Date: 08/17/2021

FR Document: 2021-17558  PDF 6 Pages (116 KB)  Permalink

Environmental Protection Agency

Rules

Tolerance Exemption:

C10-C18-Alkyl dimethyl amine oxides

Filed on: 08/16/2021 at 8:45 am Scheduled Pub. Date: 08/17/2021

FR Document: 2021-17450  PDF 14 Pages (127 KB)  Permalink

Federal Crop Insurance Corporation

Rules

Common Crop Insurance Regulations:

Dry Pea Crop Insurance Provisions and Dry Beans Crop Insurance Provisions

Filed on: 08/16/2021 at 8:45 am Scheduled Pub. Date: 08/17/2021

FR Document: 2021-17300  PDF 2 Pages (79.8 KB)  Permalink

FDA

Recalls

DateBrandProduct DescriptionTypeReasonCompany
08/14/2021Genji Pacific LLC.sushi containing cocktail shrimpFood & BeveragesSalmonellaGenji Pacific LLC.
08/14/2021Mai Franchising Inc.sushi containing cocktail shrimpFood & BeveragesSalmonellaMai Franchising Inc.
08/14/2021Mai Cuisine Inc.Shrimp Tempura Kabuki RollFood & BeveragesSalmonellaMai Cuisine Inc.
08/13/2021Various: Big River, 365, Seacove, Ahold, Censea, First Street, Meijer and othersFrozen cooked, peeled and deveined, tail on shrimpFood & BeveragesPotential to be contaminated with SalmonellaAvanti Frozen Foods Pvt. Ltd
08/13/2021Simply NourishFrozen dog foodAnimal & Veterinary, Pet Food, Food & Beverages, Pet FoodDue to elevated levels of Vitamin DWet Noses Natural Dog Treat Company

FSIS

Constituent Update – August 13, 2021

CVM

FDA to Host Virtual Listening Session on the Oversight of Pet Food

Twitter

@FrankYiannas

  • [retweet @LGMAnews] From @US_FDA ‘s latest TechTalk podcast on Whole Genome Sequencing:  “Food safety is a race between our ability to detect foodborne illness and our ability to prevent it.” –  @FrankYiannasFDA

@SecVilsack

  • The President’s plan is working. The percentage of families with children who reported that they sometimes or often did not have enough to eat fell by 24% after the child tax credit payments. That’s progress.

August 17, 2021

Federal Register

Animal and Plant Health Inspection Service

Notices

Importation of Fresh Citrus Fruit from Australia into the Continental United States

Filed on: 08/17/2021 at 8:45 am Scheduled Pub. Date: 08/18/2021

FR Document: 2021-17709  PDF 12 Pages (118 KB)  Permalink

Environmental Protection Agency

Rules

Pesticide Tolerances:

Fluensulfone

Filed on: 08/17/2021 at 8:45 am Scheduled Pub. Date: 08/18/2021

FR Document: 2021-17682  PDF 10 Pages (116 KB)  Permalink

APHIS

APHIS Revising the Animal and Animal Product Import Regulations to Reflect the Exit of the United Kingdom from the European Union

Availability of Draft Environmental Documents for Petition to Deregulate Soybean Developed Using Genetic Engineering

USDA

USDA Modernizes the Thrifty Food Plan, Updates SNAP Benefits

Twitter

@FrankYiannasFDA

  • [RT @LGMAnews]: From @US_FDA‘s latest TechTalk podcast on Whole Genome Sequencing: “Food safety is a race between our ability to detect foodborne illness and our ability to prevent it.” – @FrankYiannasFDA

@FDAfood

  • As a general guide, 20% DV or more of a nutrient per serving is considered high. 5% DV or less of a nutrient per serving is considered low. Learn what the #NewNutritionFacstLabel has to say. http://go.usa.gov/xFmpz
  • Consuming too much added sugars can make it difficult to meet nutrient needs while staying within calorie limits. Learn more about reading the #NewNutritionFactsLabel. http://go.usa.gov/x6BBU