Laws and Regulations Committee Update – April 13 – 15, 2020
Federal Register
Notices
- Guidance:
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Stability Testing of New Veterinary Drug Substances and Medicinal Products in Climatic Zones III and IV
Filed on: 04/13/2020 at 8:45 am Scheduled Pub. Date: 04/14/2020
FR Document: 2020-07752 PDF 7 Pages (106 KB) Permalink
- Request for Information:
Vaping Products Associated With Lung Injuries
Filed on: 04/13/2020 at 8:45 am Scheduled Pub. Date: 04/14/2020
FR Document: 2020-07748 PDF 5 Pages (98 KB) Permalink
FDA
Coronavirus (COVID-19) Update: Daily Roundup April 10, 2020
Recalls
| Date | Brand Name | Product Description | Product Type | Recall Reason | Company |
| 04/10/2020 | Whole Foods Market | Minestrone Soup | Food & Beverages, | Undeclared milk | Whole Foods Market |
Warning Letters
| Posted Date | Issue Date | Company Name | Issuing Office | Subject |
| 04/10/2020 | 04/09/2020 | Earthley Wellness dba Modern Alternative Mama LLC | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
FSIS
Constituent Updates
Apr 10, 2020 | PDF
- FSIS Posts Updated Dataset on Import Refusals
- COVID-19 FAQs
- Establishment-Specific Datasets Now Available
Recalls
| Product Recalled | Date of Recall |
| 008-2020 Jowett Farms Corporation Recalls Pork Products Produced without Benefit of Import Inspection | Apr 10, 2020 |
| 007-2020 Conagra Brands, Inc. Recalls Frozen Not-Ready-to-Eat Chicken Bowl Products Due to Possible Foreign Matter Contamination | Apr 10, 2020 |
AMS
USDA Lifts PACA Reparation Sanctions on Texas Produce Business
USDA Cites Bucks Fresh Produce LLC in Texas for Failure to Provide Access to Records
USDA Issues a Default Decision Against Christopher Matthew Klaiber for Violations of the Packers and Stockyards Act
USDA Issues a Default Decision Against Kyle Sorrels for Violations of the Packers and Stockyards Act
@FrankYiannasFDA
- RT @pewtrusts: How can we prevent foodborne illnesses from reoccurring? By conducting root cause analyses, explains @FrankYiannasFDA.
- RT @FoodEng: FDA Issues COVID-19 Best Practices on Food Handling, Health
- RT @FoodEng: FDA issues social distancing guidance for food processing plants to fight spread of COVID-19 What processors should do when following the CDC recommendation is not possible
April 15, 2020
Federal Register
Agricultural Marketing Service
Notices
2020/2021 Rates Charged for AMS Services
Filed on: 04/15/2020 at 8:45 am Scheduled Pub. Date: 04/16/2020
FR Document: 2020-08106 PDF 12 Pages (289 KB) Permalink
Animal and Plant Health Inspection Service
Notices
- Decision to Authorize the Importation of Fresh Sand Pears from Japan into the United States
Filed on: 04/15/2020 at 8:45 am Scheduled Pub. Date: 04/16/2020
FR Document: 2020-08030 PDF 12 Pages (248 KB)Permalink
- Petition for Determination:
Nonregulated Status for Maize Genetically Engineered for the Production of Phytase Enzyme; Agrivida, Inc.
Filed on: 04/15/2020 at 8:45 am Scheduled Pub. Date: 04/16/2020
FR Document: 2020-08065 PDF 5 Pages (178 KB) Permalink
Notices
- Color Additive Certification Requests and Recordkeeping
Filed on:04/15/2020 at 8:45 am Scheduled Pub. Date: 04/16/2020
FR Document: 2020-08054 PDF 8 Pages (36.1 KB) Permalink
- Establishing and Maintaining a List of U.S. Manufacturers/Processors of Feed Additives, Premixes, Compound Feed, Distillers’ Dried Grains, and Distillers’ Dried Grains with Solubles for Use with Animals with Interest in Exporting to The People’s Republic of China
Filed on: 04/15/2020 at 8:45 am Scheduled Pub. Date: 04/16/2020
FR Document: 2020-08007 PDF 6 Pages (104 KB) Permalink
Food Safety and Inspection Service
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals
Filed on: 04/15/2020 at 8:45 am Scheduled Pub. Date: 04/16/2020
FR Document: 2020-08018 PDF 8 Pages (136 KB) Permalink
FDA
Food Safety & COVID-19 Q&A (4 new Q&As posted yesterday addressing “Food Supply,” “Social Distancing, Disinfecting & Other Precautions,” and “Workers Testing Positive”)
Coronavirus (COVID-19) Update: Daily Roundup April 14, 2020
Recalls
| Date | Brand Name | Product | Product Type | Recall Reason | Company |
| 04/14/2020 | Sun Hong Foods | Enoki Mushrooms | Food & Beverages, | Potential to be contaminated with Listeria monocytogenes | Sun Hong Foods, Inc. |
| 04/14/2020 | Guan’s Mushroom Co. | Enoki Mushroom | Food & Beverages, Foodborne Illness | Potential Listeria monocytogenes | Guan’s Mushroom Co. |
| 04/14/2020 | H&C Food Inc. | Enoki mushrooms | Food & Beverages, Foodborne Illness | Potential to be contaminated with Listeria monocytogenes | H&C Food Inc. |
Warning Letters
| Posted Date | Issue Date | Company Name | Issuing Office | Subject |
| 04/14/2020 | 03/31/2020 | KetoKerri LLC | Center for Food Safety and Applied Nutrition | New Drug/Labeling/Misbranded |
| 04/14/2020 | 04/01/2020 | David Rosen Bakery Supplies Inc. DBA David Rosen Company | Division of Northeast Imports | Foreign Supplier Verification Program (FSVP) |
| 04/14/2020 | 04/03/2020 | Macduff Shellfish -Scotland- Ltd | Center for Food Safety and Applied Nutrition (CFSAN) | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions |
| 04/14/2020 | 04/13/2020 | The GBS dba Alpha Arogya India Pvt Ltd | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
| 04/14/2020 | 04/13/2020 | Gaia Arise Farms Apothecary | Center for Drug Evaluation and Research | CDER | Unapproved Products Related to the Coronavirus Disease 2019 (COVID-19) |
FSIS
AskFSIS
- Documenting noncompliance for direct product contamination
- Industry Help Videos for the Public Health Inspection System (PHIS) Establishment Administrator role
- Industry Help Videos for the Public Health Inspection System (PHIS) Export Applicant role
- Export Applicant enrollment in the Public Health Inspection System (PHIS)
- ndustry e-Authentication Enrollment
- Industry Help Videos for the Public Health Inspection System (PHIS) Plant Management role
APHIS
APHIS Authorizes Importation of Fresh Citrus Fruit from China
@SteveFDA
- FDA & @FTC issued warning letters to 3 sellers of fraudulent #COVID19 products – Herbs of Kedem, The GBS dba Alpha Arogya India Pvt Ltd, & Gaia Arise Farms Apothecary – as part of the agency’s effort to protect both people & pets.
@foodsafetygov
- Baking at home more? Remember, raw flour, batter, and dough are NOT ready-to-eat. Flour must be thoroughly cooked or baked before eating to prevent foodborne illnesses. https://go.usa.gov/xpnHU #IsolationBaking