Laws and Regulations Committee Update – August 17 – 19, 2020
August 17, 2020
Federal Register
Agricultural Marketing Service
Proposed Rules
Continuance Referendum:
Mango Promotion, Research and Information Order
Filed on: 08/17/2020 at 8:45 am Scheduled Pub. Date: 08/18/2020
FR Document: 2020-16295 PDF 6 Pages (78.7 KB) Permalink
Animal and Plant Health Inspection Service
Proposed Rules
National List of Reportable Animal Diseases
Filed on: 08/17/2020 at 8:45 am Scheduled Pub. Date: 08/18/2020
FR Document: 2020-17339 PDF 2 Pages (57.2 KB) Permalink
FDA
FSIS
Aug 14, 2020 | PDF
- USDA to Hold Public Meeting on Salmonella: State of the Science
- FSIS and Vermont Sign Cooperative Interstate Shipment Agreement
- Updated Guidelines for Foodborne Disease Outbreak Response Now Online
- FSIS to Post Updated Dataset on Import Refusals
- Tips for Faster Label Approval Process
- Reminder: FSIS to Host Webinar on Labeling Claims on Aug. 18
- FSIS to Post Next Set of Establishment-Specific Datasets
OMB
| AGENCY: USDA-FNS | RIN: 0584-AE63 | Status: Concluded |
| TITLE: Taking Administrative Actions Pending Freedom of Information Act (FOIA) Processing | ||
| STAGE: Final Rule | ECONOMICALLY SIGNIFICANT: No | |
| RECEIVED DATE: 05/11/2020 | LEGAL DEADLINE: None | |
| ** COMPLETED: 08/14/2020 | COMPLETED ACTION: Consistent with Change |
@FrankYiannasFDA
- · True then. True still today. There is no evidence of food or food packaging being associated with the transmission of the virus that causes COVID-19.
- · UPDATE on the investigation of Cyclospora illnesses tied to bagged salads. It’s important because we deployed a new method developed & validated by the FDA and found the parasite in agricultural water for the first time in the field. https://go.usa.gov/xfF4t
- · Future use of this method may aid understanding of this parasite in the environment & it could help prevent future outbreaks. We look forward to continuing our work with partners in science & the produce industry in our shared efforts to protect consumers. #SmarterFoodSafety
- · [retweet @wrcefs] Great read: How current outbreak investigations are conducted & a look ahead to upcoming proposed rules. FDA & CDC Use Technological Advancements to Investigate Multistate Outbreak of Cyclospora Illnesses Linked to Bagged Salads https://www.fda.gov/news-events/press-announcements/fda-and-cdc-use-technological-advancements-investigate-multistate-outbreak-cyclospora-illnesses
@SteveFDA
- · Today, @US_FDA issued an EUA to @Yale for its SalivaDirect #COVID19 diagnostic test, providing flexibility for processing saliva samples and a groundbreaking step to increasing capacity and efficiency in testing. https://fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-yale-school-public-health
- · Today’s authorization is another example of @US_FDA working with test developers to bring innovation to market and ensuring access to testing for everyone in the US to help address the #COVID19 pandemic.
August 18, 2020
FDA
Warning Letters
| Posted Date | Issue Date | Company | Issuing Office | Subject |
| 08/17/2020 | 08/14/2020 | SilveryGuy | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
AMS
USDA Settles a Packers and Stockyards Case with Beken Livestock Inc., Resulting in a $7,900 Penalty
APHIS
USDA Confirms SARS-CoV-2 in Mink in Utah
CVM
FDA Releases NARMS Strategic Plan, Announces October 2020 NARMS Virtual Public Meeting
@US_FDA
- · FDA and the @FTC jointly issued a warning letter to a company called the SilveryGuy for selling fraudulent COVID-19 related products. There are currently no FDA-approved products to prevent or treat #COVID19
August 19, 2020
Federal Register
Environmental Protection Agency
Rules
Pesticide Tolerances:
Fludioxonil
Filed on: 08/19/2020 at 8:45 am Scheduled Pub. Date: 08/20/2020
FR Document: 2020-17155 PDF 13 Pages (114 KB) Permalink
Proposed Rules
Pesticides:
Exemptions of Certain Plant-Incorporated Protectants Derived from Newer Technologies
Filed on: 08/19/2020 at 8:45 am Scheduled Pub. Date: 08/20/2020
FR Document: 2020-17158 PDF 3 Pages (86.2 KB) Permalink
Proposal to Add Chitosan to the List of Active Ingredients Permitted in Exempted Minimum Risk Pesticide Products
Filed on: 08/19/2020 at 8:45 am Scheduled Pub. Date: 08/20/2020
FR Document: 2020-17698 PDF 3 Pages (85.6 KB) Permalink
FDA
Recalls
| Date | Brand | Product | Type | Reason for Recall | Company |
| 08/18/2020 | Nuuxsan, Modesa, more | Hand Sanitizer | Drugs, | Undeclared Methanol | ALBEK de Mexico S.A. de C.V. |
| 08/18/2020 | Yacana | Yacana Hand Sanitizer, 70% Alcohol | Drugs, | Potential Presence of Methanol (Wood Alcohol) and sub-potent ethanol | Grupo Yacana México S.A.S de C.V. |
Warning Letters
| Posted Date | Issue Date | Company | Issuing Office | Subject | Response Letter Date | Closeout Letter Date |
| 08/18/2020 | 08/05/2020 | Winter Gardens Quality Foods, Inc. | Division of Human and Animal Food Operations East II | Food Labeling/Misbranded | 08/18/2020 | 08/05/2020 |
| 08/18/2020 | 08/10/2020 | Pero Family Farms Food Company, LLC | Division of Human and Animal Food Operations East IV | Food Labeling/Misbranded | 08/18/2020 | 08/10/2020 |
GRAS Notices
| GRN No. | Substance | Date of closure | FDA’s Letter |
| 862 | Algal oil (40% docosahexaenoic acid) from Schizochytrium sp. strain ONC-T18 | Jun 15, 2020 | FDA has no questions (in PDF)8 (748 kB) |
| 887 | Menaquinone-7 | Jun 12, 2020 | FDA has no questions (in PDF)9 (472 kB) |
| 897 | 2-O-fucosyllactose | Jun 12, 2020 | FDA has no questions (in PDF)10 (715 kB) |
FSIS
Recalls
| Product Recalled | Date of Recall |
| 020-2020 Faribault Foods Inc. Recalls Canned Soup Product Due to Misbranding and Undeclared Allergens | Aug 18, 2020 |
APHIS
Availability of Petition for Deregulation of American Chestnut Developed Through Genetic Engineering
CISA
Version 4.0 – CISA’s Guidance on Essential Critical Infrastructure Workers
@US_FDA
- · OUTBREAK UPDATE: Additional recalls have been initiated by companies that sold onions or products containing recalled onions. The FDA has published this list of Recalls of Food Products Associated with Onions from Thomson International, Inc. http://go.usa.gov/xfVaR.
- · @US_FDA @USDAFoodSafety and @CDCgov have added to the list of products containing recalled #onions from Thomson International, Inc. If/when more products are identified and recalled we will update our list > http://go.usa.gov/xfm3n
@FrankYiannasFDA
- · #FDA Announcement Regarding #Cyclospora Illness Investigation Showcases New Technology and Previews Coming Changes #HealthcareLaw http://ow.ly/TVnK50B2K @KellerandHeck
@FDAanimalhealth
- · Today, FDA released the National Antimicrobial Resistance Monitoring System Strategic Plan: 2021-2025 and Announced the October 2020 NARMS Virtual Public Meeting. https://go.usa.gov/xfzZN