Laws and Regulations Committee Update – July 12 – 15, 2021

July 12, 2021

Federal Register

Consumer Product Safety Commission

Notices

Complaint:

Thyssenkrupp Access Corp.

Filed on: 07/12/2021 at 8:45 am

Scheduled Pub. Date: 07/13/2021

FR Document: 2021-14819  PDF 22 Pages (147 KB)  Permalink

Environmental Protection Agency

Rules

Pesticide Tolerances:

Fluxapyroxad

Filed on: 07/12/2021 at 8:45 am

Scheduled Pub. Date: 07/13/2021

FR Document: 2021-14708  PDF 11 Pages (121 KB)  Permalink

FDA

FDA and USDA Collaborate to Present Webinars on FSMA Produce Safety Rule to Produce Exporters in Latin America

July 9, 2021 – FDA In Brief: FDA Issues Systems Recognition Draft Guidance

[Note: addresses the FDA’s oversight of foods imported from countries covered by a Systems Recognition Arrangement, specifically adjustments to activities that include inspections, screening and sampling.  Systems recognition is a partnership between the FDA and a foreign regulatory counterpart (referred to as participating agency or agencies), in which the agencies have concluded that they operate comparable regulatory programs that yield similar food safety outcomes.]

FDA Issues Systems Recognition Draft Guidance

FDA Issues Industry Guidance on Oversight of Food Products Covered by Systems Recognition Arrangements

USDA

USDA Announces $500 Million for Expanded Meat & Poultry Processing Capacity as Part of Efforts to Increase Competition, Level the Playing Field for Family Farmers and Ranchers, and Build a Better Food System

[Brief Summary: This is one of several key steps that USDA will take to increase competition in agricultural markets, pursuant to President Biden’s Executive Order on promoting competition and as part of USDA efforts to build a more resilient supply chain and better food system. USDA is also holding meatpackers accountable by revitalizing the Packers and Stockyards Act, issuing new rules on “Product of USA” labels, and developing plans to expand farmers’ access to new markets. . . . This is a once in a generation opportunity to transform the food system so it is more resilient to shocks, delivers greater value to growers and workers, and offers consumers an affordable selection of healthy food produced and sourced locally and regionally by farmers and processors from diverse backgrounds.]

FSIS

Constituent Update – July 9, 2021

AMS

New USDA Grading Dashboard Expands Access to Data

GAO

Priority Open Recommendations on U.S. Department of Agriculture

Twitter

@US_FDA

  • Systems recognition assessments focus not only on the ability of food safety systems to help ensure food safety, but also on the ability of food safety authorities to identify, address and contain issues and outbreaks that may arise.
  • FDA uses these assessments to help ensure that consumers are confident that their food is safe, whether produced in the U.S. or elsewhere.

@DrWoodcockFDA

  • Ensuring the safety of food imported into the U.S. is an FDA priority. A Systems Recognition Arrangement (SRA) between the  @US_FDA and a foreign regulatory counterpart like we have with Australia, Canada, and New Zealand contributes to a safer global food supply.

@FrankYiannasFDA

  • Today, FDA released draft guidance that addresses its oversight of foods imported from countries covered by a Systems Recognition Arrangement, specifically adjustments to inspections, screening and sampling. https://go.usa.gov/x6zsC
  • This guidance advances our New Era of Smarter Food Safety initiative and reflects FDA’s larger effort to take a risk-based approach to food safety, consistent with the FDA Food Safety Modernization Act.
  • We will be able to leverage regulatory partners’ food safety systems, reallocate resources in a more risk-based manner and improve and expand information sharing on food safety issues that would benefit U.S. consumers and the global food supply.

@SecVilsack

@TheJusticeDept

July 14, 2021

Federal Register

Agricultural Marketing Service

Rules

Increased Assessment Rate:

Grapes Grown in a Designated Area of Southeastern California

Filed on: 07/14/2021 at 8:45 am Scheduled Pub. Date: 07/15/2021

FR Document: 2021-14731  PDF 17 Pages (109 KB)  Permalink

Food and Nutrition Service

Notices

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

Special Supplemental Nutrition Program for Women, Infants and Children; Food Delivery Portal

Filed on: 07/14/2021 at 8:45 am Scheduled Pub. Date: 07/15/2021

FR Document: 2021-15051  PDF 8 Pages (142 KB)  Permalink

Food Safety and Inspection Service

Rules

Inspection of Yak and Other Bovidae, Cervidae, and Camelidae Species

Filed on: 07/14/2021 at 8:45 am Scheduled Pub. Date: 07/15/2021

FR Document: 2021-15062  PDF 13 Pages (146 KB)  Permalink

Proposed Rules

Establishing a Uniform Time Period Requirement and Clarifying Related Procedures for the Filing of Appeals of Agency Inspection Decisions or Actions

Filed on: 07/14/2021 at 8:45 am Scheduled Pub. Date: 07/15/2021

FR Document: 2021-14947  PDF 21 Pages (178 KB) Permalink

Notices

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

Overtime and Holiday Inspection Fees for Small and Very Small Establishments

Filed on: 07/14/2021 at 8:45 am Scheduled Pub. Date: 07/15/2021

FR Document: 2021-15012  PDF 7 Pages (113 KB)  Permalink

Overtime and Holiday Inspection Fee Reductions for Small and Very Small Establishments

Filed on: 07/14/2021 at 8:45 am Scheduled Pub. Date: 07/15/2021

FR Document: 2021-15011  PDF 22 Pages (209 KB)  Permalink

FDA

One Year Later, the New Era of Smarter Food Safety Blueprint Makes Inroads in FDA’s Public Health Mission

CVM GFI #261 – Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs

Warning Letters

Posted DateIssue DateCompanyIssuing OfficeSubject
07/13/202106/15/2021Rong Shing Trading NY Inc.Division of Northeast ImportsForeign Supplier Verification Program (FSVP)
07/13/202106/08/2021Sobh Import, Inc.Division of Northern Border ImportsForeign Supplier Verification Program (FSVP)
07/13/202107/01/2021Biomedical Research Laboratories, LLCOffice of Human and Animal Food Operations –West Division 5New Drug/Misbranded
07/13/202106/29/2021Kuiyi International Inc.Division of West Coast ImportsForeign Supplier Verification Program (FSVP)
07/13/202106/10/2021Natural Hope Herbals, LLCDivision of Human and Animal Food Operations East IINew Drug/Misbranded

Dockets

FDA-2021-P-0653 – Petition by Environmental Defense Fund and others requesting  FDA take more aggressive action to protect consumers from per- and poly-fluoroalkyl substances (PFAS) by banning all forms that biopersist in the human body.  We specifically request that FDA comply with the FFDCA and its implementing regulations by:

  • Revoking the effectiveness of all FCNs that contain a member of either the LC-PFAS or the SCPFAS classes as an ingredient, manufacturing byproduct, impurity, breakdown product or metabolite pursuant to 21 C.F.R. § 170.105;
  • Evaluating its food additive or GRAS regulations at 21 C.F.R. Parts 172 to 188 and removing any approvals that contain a member of either the LC or SC-PFAS classes;
  • Issuing a regulation in 21 C.F.R. Part 189 banning use of SC-PFAS and LC-PFAS in food contact materials whether packaging or food handling equipment; and
  • Requiring that industry provide sufficient information to affirmatively demonstrate that all PFCs, including all PFAS that are not in the SC-PFAS or LC-PFAS classes, their impurities, byproducts, and metabolites do not biopersist or may cause cancer by non-genomic means in order for their continued use in food contact materials to remain authorized. If the evidence is not provided, then FDA should remove all approvals and authorizations. In case FDA determines that their uses are safe, the companies must submit an environmental assessment evaluating the impacts from production, processing, use, recycling, and disposal of these substances per the National Environmental Policy Act.

AMS

USDA Announces Reopening of Pecan Marketing Order Continuance Referendum

AMS Announces Upgrades to its Agricultural Transportation Open Data Visualization Platform

USDA

USDA to Provide Pandemic Assistance to Livestock Producers for Animal Losses

Twitter

@FrankYiannasFDA

  • One year later, the New Era of Smarter Food Safety is making inroads into advancing FDA’s Public Health Mission.
  • While the pandemic shaped our work, it didn’t stop it.  Here’s a glimpse into work underway in 2021.  Together, we’re creating a safer, smarter, and more traceable food system. https://fda.gov/media/150619/download

@DrWoodcockFDA

  • FDA’s New Era blueprint, along with our Data Modernization and Resiliency Roadmap for Inspections plans, are components of a #OneFDA approach to protecting consumers and the public health. #FDAVoices

July 15, 2021

Federal Register

Agricultural Marketing Service

Rules

Continuance Referendum:

Blueberry Promotion, Research, and Information Order

Filed on: 07/15/2021 at 8:45 am Scheduled Pub. Date: 07/16/2021

FR Document: 2021-15160  PDF 5 Pages (84 KB)  Permalink

FDA

Investigations of Foodborne Illness Outbreaks | FDA (Updated 7/14 to include Cyclospora, E. Coli, and Salmonella outbreaks)

Recalls

DateBrand NameProductProduct TypeRecall Reason
07/14/20215000 Years Foods, Inc.Kimchi ProductsFood & BeveragesPotential Listeria monocytogenes contamination
07/14/2021Neutrogena, AveenoSunscreenDrugsTesting identified low levels of benzene

Twitter

@FrankYiannasFDA

  • “If you do not know how to ask the right question, you discover nothing.” – W. Edwards Deming Thanks @QAMagazine for asking good questions, so we can advance ‘food safety culture’ as a legitimate subset of the profession …. not as tag-line or slogan. magazine.qualityassurancemag.com/article/may-june-2021/a-qa-with-frank-yiannas.aspx
  • FDA & @USDA offering webinars in English & Spanish on FSMA’s Produce Safety Rule & Foreign Supplier Verification Program. Outreach to the produce industry, farms in the U.S. & abroad is core to our New Era for Smarter Food Safety Blueprint. Register: https://go.usa.gov/x6uqk
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