In This Week’s Edition:
- FDA Updates Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water
- USDA Consumer Communication: Bring Food Safety to Your Summer Vacation
- General Conference Committee of the National Poultry Improvement Plan and 45th Biennial Conference
- Final Rule on Indirect Food Additives: Obsolete Plasticizers
- FDA Denial of Food Additive Petition on Phthalates
- FDA CORE Outbreak Investigation Status Update
- FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
- FDA Import Alerts
- FDA Warning Letters
FDA Updates Protocol for the Development and Registration of Treatments for Preharvest Agricultural Water
Two updates have been made since the protocol was first released in July 2020:
- FDA announced that they had worked with EPA to update the protocol to allow companies and other agricultural water stakeholders to use non-GLP (Good Laboratory Practice) data in their submissions, provided that the submissions accurately represent how the study differs from the GLP standards in the 40 CFR 160.12 statement of non-compliance.
- FDA again worked with the EPA to amend the contact time in the protocol, changing it from a maximum of 1-minute to “up to 5 minutes.” This change is being made to meet the current need scientifically and practically.
- This action is consistent with the FDA’s commitment to a New Era of Smarter Food Safety, and fulfills one of the action items in the 2020 Leafy Green STEC Action Plan.
USDA Consumer Communication: Bring Food Safety to Your Summer Vacation
USDA wants to make sure your summer festivities are food safe. Whether you’re grilling burgers, camping, or having a picnic, everyone should always remember to practice proper handwashing and use a food thermometer. After observing that consumer behavior in test kitchens revealed that people are skipping basic food safety practices, USDA is concerned that consumers are not doing enough to reduce the risk of foodborne illness. USDA encourages all Americans to follow these food safety tips to keep you and your family foodborne illness free this summer:
- Wash Your Hands
- Use a Food Thermometer
- Avoid Cross Contamination
Read more here.
General Conference Committee of the National Poultry Improvement Plan and 45th Biennial Conference
USDA has issued notice of a meeting of the General Conference Committee of the National Poultry Improvement Plan (NPIP) and the NPIP’s 45th Biennial Conference, which was originally scheduled to take place in 2020 but was postponed due to the COVID-19 pandemic. The General Conference Committee meeting will be held on Tuesday, June 7, 2022, from 1:30 p.m. to 6 p.m. The General Session of the Biennial Conference will begin on Wednesday, June 8, 2022, at 7:30 a.m. and end no later than Friday, June 10, 2022, at 2:30 p.m.
Final Rule on Indirect Food Additives: Obsolete Plasticizers
FDA is amending the food additive regulations to no longer provide for the use of 25 plasticizers in various food contact applications because these uses have been abandoned. FDA has taken this action in response to a food additive petition submitted by the Flexible Vinyl Alliance.
Denial of Food Additive Petition
FDA is denying a food additive petition (FAP 6B4815) submitted by Natural Resources Defense Council, et al., requesting that the agency amend or revoke specified regulations to no longer provide for the food contact use of 28 ortho-phthalates.
FDA CORE Outbreak Investigation Status Update
This week’s updates are:
- For the investigation with reference number 1064, the total adverse event reports increased to 558.
- The outbreak of Norovirus linked to the consumption of Raw Oysters has ended and FDA’s investigation has closed. Outbreaks associated with shellfish are managed by the FDA Division of Seafood Safety, not CORE Response Teams. This outbreak was included here for the convenience of the consumer and has been removed from the table.
- For the investigation of Cronobacter illnesses linked to powdered infant formula the Event Status has been changed to Ended. On May 12, 2022, CDC announced that its investigation is closed, with no additional related cases identified. Although CORE is no longer investigating this incident, the FDA established an Incident Management Group (IMG) on April 1, 2022, to continue to work on supply chain and food safety issues.
- For the outbreak of Listeria monocytogenes (reference #1040), the Investigation Status is now Closed as of May 18, 2022, because there is not enough evidence to identify a vehicle. The Outbreak Status is listed as Ongoing because the most recent date an illness began is April 20, 2022, and it can take several weeks to months for someone to have symptoms of listeriosis after being infected. CDC will continue to monitor for additional illnesses and the investigation will be transferred back to a CORE Response Team if new illnesses are reported and new information is available to investigate.
FSIS Updates Lists of Foreign Establishments Eligible to Export to U.S.
FDA Import Alerts
The latest FDA import alerts include pesticides, salmonella, facilities not in compliance with FSVP.
FDA Warning Letters
Moonlight Vapers |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Vapor Arts LLC d/b/a Main Street Vapor Co. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Evans Farms Feed |
CGMP/Food for Animals/Prepared, Packed or Held Under Insanitary Conditions/Adulterated |
The Vapor Gypsy, LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
El Dorado Imports Inc |
Foreign Supplier Verification Program (FSVP) |
Specialty Process Labs LLC |
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
Lempira Distribution LLC |
Foreign Supplier Verification Program (FSVP) |
Red Shield Reserve Inc. |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
Colorful Products Corporation |
CGMP/Finished Pharmaceuticals/Adulterated |
Triple J Fresh, LLC |
Foreign Supplier Verification Program (FSVP) |
LECS USA Inc. |
Foreign Supplier Verification Program (FSVP) |
Fres Co, LLC |
Foreign Supplier Verification Program (FSVP) |
Vaporwave LLC |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |