FDA Announces Effort to Recognize Third Party Food Safety Audit Standards for FSMA Compliance
FDA is launching a voluntary pilot program to evaluate alignment of private third-party food safety audit standards with the food safety requirements in two regulations under the FDA Food Safety Modernization Act (FSMA) – the Preventive Controls for Human Food (PC Human Food) and the Produce Safety rules. This pilot program will help both FDA and industry better understand how to determine whether these standards align with FDA regulations, a goal that is consistent with the New Era of Smarter Food Safety Blueprint. The Blueprint, published on July 13, 2020, explains that the Agency is looking to explore how reliable third-party audits can help ensure food safety, including the use of audit data in risk-prioritization for FDA regulatory activities. More information here.
FSIS Publishes Final Egg Products Inspection Act Rule
The final rule requires official plants that process egg products to develop and implement Hazard Analysis and Critical Control Point (HACCP) Systems and Sanitation Standard Operating Procedures (Sanitation SOPs) and to meet other sanitation requirements consistent with FSIS’s meat and poultry regulations. The rule is available here. Background information is here.
FDA Webinar on New Era of Smarter Food Safety Replay Available
The webinar was held on October 26 and the replay is available here.
APHIS Recognizes Regions of Switzerland as Newcastle Disease-Free
Neuchâtel and Ticino have been recognized as Newcastle Disease-Free. More information here.
AMS Referendum to Continue South Florida Avocado Marketing Order
The referendum will be conducted from November 30 through December 21, 2020.
FDA Resources for Areas Flooded by Hurricane Zeta
The resources for human food are here and animal food are here.
FSIS Updates Directive on Safe and Suitable Ingredients Used in the Production of Meat, Poultry and Egg Products
The directive contains the latest updates to the list of substances that may be used in the production of meat, poultry, and egg products.
AMS Proposes Termination of Certain Consumer Produce Standards
AMS has proposed to terminate the consumer standards for Italian sprouting broccoli, fresh carrots, celery stalks, husked corn on the cob, fresh kale, fresh spinach leaves, Brussels sprouts, fresh parsnips, fresh turnips, and beet greens. AMS states the industry has not fully adopted the standards.
FNS Publishes Final Rule on Commodity Supplemental Food Program
The rule codifies statutory requirements included in section 4102 of the Agriculture Improvement Act of 2018 (Pub. L. 115-334, the 2018 Farm Bill). Section 4102 established a statutory definition for the term “certification period” and established that certification periods for CSFP participants must be not less than one year and not more than three years. The rule also revises 7 CFR 247 per section 4102 of the Agriculture Act of 2014 (Pub. L. 113-79, the 2014 Farm Bill), which amended CSFP eligibility requirements and phased out individuals who do not meet the new requirements.
AMS Updates Grade Standards for Texas Oranges and Grapefruit; Other States
Details here.
FSIS Updates List of Foreign Establishments Eligible to Export to the U.S.
Latest FDA Import Alerts
The latest FDA import alerts are available here and include misbranding, allergens, products from firms who have refused FDA inspection and more.
Latest FDA Warning Letters:
Posted Date |
Company |
Issuing Office |
Subject |
10/28/2020 |
Predator Nutrition |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
10/28/2020 |
Peterson Research Laboratories LLC |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
10/28/2020 |
Beepothecary LLC |
Center for Food Safety and Applied Nutrition (CFSAN) |
Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
10/27/2020 |
Everything Aquatic |
Center for Veterinary Medicine |
Unapproved New Animal Drug Products |
10/27/2020 |
KVK-Tech, Inc. |
Division of Pharmaceutical Quality Operations I |
CGMP/Finished Pharmaceuticals/Adulterated |
10/27/2020 |
Shilpa Medicare Limited |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Adulterated |
10/27/2020 |
Ramar International Corporation |
Division of Human and Animal Food Operations West V |
CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated/L. monocytogenes |
10/27/2020 |
Quimica Magna de Mexico, S.A. de C.V. |
Center for Drug Evaluation and Research | CDER |
CGMP/Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated |
10/27/2020 |
OCM Group USA Inc. |
Division of West Coast Import |
Foreign Supplier Verification Program (FSVP) |
10/27/2020 |
Mr Frags, LLC |
Center for Veterinary Medicine |
Unapproved Chloroquine Phosphate Product |
Please contact Erik Lieberman at elieberman@usfoodimports.com for additional information. |