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
July 9, 2021 – FDA In Brief: FDA Issues Systems Recognition Draft Guidance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FDA Issues Systems Recognition Draft Guidance
USDA
[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
@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
- To shift the balance of power back to the people, USDA will invest in building more, better, and fairer markets for producers and consumers alike. https://usda.gov/media/press-releases/2021/07/09/usda-announces-500-million-expanded-meat-poultry-processing
- The time is now to protect small and independent farmers and ranchers from excessive concentration and unfair practices.
@TheJusticeDept
- Justice Department Issues Statement on the U.S. Department of Agriculture’s Efforts to Invest in Competition in the Meatpacking Industry https://www.justice.gov/opa/pr/justice-department-issues-statement-us-department-agriculture-s-efforts-invest-competition
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
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
CVM GFI #261 – Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs
Warning Letters
Posted Date | Issue Date | Company | Issuing Office | Subject |
07/13/2021 | 06/15/2021 | Rong Shing Trading NY Inc. | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
07/13/2021 | 06/08/2021 | Sobh Import, Inc. | Division of Northern Border Imports | Foreign Supplier Verification Program (FSVP) |
07/13/2021 | 07/01/2021 | Biomedical Research Laboratories, LLC | Office of Human and Animal Food Operations –West Division 5 | New Drug/Misbranded |
07/13/2021 | 06/29/2021 | Kuiyi International Inc. | Division of West Coast Imports | Foreign Supplier Verification Program (FSVP) |
07/13/2021 | 06/10/2021 | Natural Hope Herbals, LLC | Division of Human and Animal Food Operations East II | New 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
@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
Date | Brand Name | Product | Product Type | Recall Reason |
07/14/2021 | 5000 Years Foods, Inc. | Kimchi Products | Food & Beverages | Potential Listeria monocytogenes contamination |
07/14/2021 | Neutrogena, Aveeno | Sunscreen | Drugs | Testing identified low levels of benzene |
@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