IFSAC Annual Report on Sources of Foodborne Illness Released
The U.S. Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS), U.S. Food and Drug Administration (FDA) and Centers for Disease Control (CDC) have released the 2017 Interagency Food Safety Analytics Collaboration (IFSAC) report. The report is created to understand sources of foodborne illness in the United States. IFSAC collects and analyzes outbreak data to produce an annual report with estimates of foods responsible for foodborne illnesses caused by pathogens. The report estimates the degree to which four pathogens – Salmonella, E. coli O157, Listeria monocytogenes, and Campylobacter – and specific foods and food categories are responsible for foodborne illnesses.
The updated estimates, combined with other data, may help shape agency priorities and inform the creation of targeted interventions that can help to reduce foodborne illnesses caused by these pathogens.
FSIS Releases Revised Directive on Prestamping Imported Product
The FSIS directive provides instructions to inspection program personnel (IPP) on how to verify that official import inspection establishments meet requirements for prestamping imported meat (which includes Siluriformes fish) and poultry products with the official inspection legend. The directive has been updated to include information about approving prestamping procedures among other things.
Retail Nutrition Labeling Reminder: Par-Baked and Thawed Bakery Items Need Nutrition Facts Panels
Items that are not processed or prepared in retail establishments including par-baked breads, cookies and pastries, frozen cakes that are thawed and placed out for sale, and deli salads prepared and pre-portioned in a central kitchen are required to have Nutrition Facts Panels. If the nutritional profile of the item is changed at retail (e.g. adding icing and nuts to a par-baked cinnamon roll) it is not subject to Nutrition Facts Panel labeling but may be subject to menu labeling requirements. Please see below from FDA guidance:
N94. Question: Could FDA provide additional guidance on what foods sold in delis and bakeries are exempt? Answer: This exemption is based on 3 primary criteria: 1) when the food is consumed, 2) the location in which the food is processed and prepared, and 3) the extent to which the food is processed and prepared (i.e., must be ready-to-eat and of the type served in restaurants). Bakeries and delis that sell foods for immediate consumption (e.g., where the deli or bakery has facilities for customers to sit and consume the food on the premises) are considered analogous to restaurants and all foods sold in such establishments are exempt under 101.9(j)(2). When foods are not for immediate consumption, they may be exempt if they meet all of the criteria listed in 101.9(j)(3). That is, when the food is ready-to-eat and is processed and prepared primarily on the premises of the establishment from which it is sold, it is exempt – regardless of how it is sold (i.e., from behind a counter or in pre-portioned packages from a self-service shelf). However, if the food is not primarily processed and prepared on-site, nutrition labeling is required. To meet the criteria for being “primarily processed and prepared on-site”, the food must be augmented on site in a manner that changes the nutrient profile of the food i.e., filling, icing, enrobing. Washing and garnishing with nuts, onions or seeds would fall under the definition of “primarily processed and prepared” if the added foods change the nutrition profile of the finished product. Custom cakes are exempt. If pre-formed dough, pre scaled/molded and par baked dough are merely proofed and baked or simply thawed, the product is considered to be “standardized” and nutrition labeling is required. Foods which are not prepared on premises and that are portioned to consumer specifications on-site are not required to have nutrition labeling (e.g., 1 lb of potato salad; 2 lb cheese, 1 lb assorted cookies, 5 rolls). However, if these items are packaged and offered for sale in another section of the store (e.g., refrigerator case; self service bins), nutrition labeling is mandatory. [101.9(j)(3)(iv)]
[CFSAN Food Labeling Booklet, 1994]
FSIS Releases Audit Report on Croatia
The report is available here.
Country Code for Burma Replaced in ACE
The Automated Commercial Environment (ACE) CBP and Trade Automated Interface Requirements (CATAIR) Appendix B has been updated. The code BU (Burma) was removed from the list of country codes. MM (Myanmar) is the valid code for that country.
FSIS Leadership Changes
Roberta Wagner, Assistant Administrator of the Office of Policy and Program Development (OPPD), will be retiring from the FSIS in November.
Terri Nintemann will be taking Roberta’s place as the new Assistant Administrator of OPPD. Terri has been with FSIS since 2003, and has held various leadership positions throughout the agency, most recently serving as Assistant Administrator of the Office of Planning, Analysis and Risk Management (OPARM).
Janet Stevens will become the Assistant Administrator of OPARM. Before joining OPARM, Janet served as FSIS’ Chief Information Officer for 11 years.
Nathan Greenwell will be acting as Deputy Assistant Administrator of OPARM. He joined FSIS in 2015 and has been serving as Director of the Data Analysis Staff. Prior to joining OPARM, Nathan was a mathematical statistician for the National Highway Traffic Safety Administration.
AMS Renews Substance Exemptions for National Organic Program
The list of exemptions is available here.
Changes to FSIS National Poultry Improvement Plan Program Standards
The amendments add and update definitions of H5/H7 low pathogenicity avian influenza (LPAI) (exposed) and H5/H7 LPAI (infected); clarify and amend the testing protocol for Mycoplasma by allowing use of molecular-based examination procedures and update and clarify salmonella isolation procedures among other things. The NPIP is available here. More information here.
FSIS Releases Directive on Manufacture of Animal Food or Uninspected Articles at Official Establishments
The directive (6300.1 Rev. 2) provides instructions to inspection program personnel (IPP) regarding their responsibilities in an official establishment that manufactures animal food or similar uninspected articles in the edible product department. FSIS is revising this directive because the Agency has issued a final rule removing the prescriptive regulatory requirements in 9 CFR 318.12 and 381.152 that govern the manufacture of uninspected products in edible product areas of official establishments and prohibit official establishments from manufacturing such products outside the hours of inspection. These amendments make the regulations at 9 CFR 318.12 and 381.152 consistent with the Hazard Analysis and Critical Control Point (HACCP) and sanitation regulations (9 CFR part 416 and 417).
Barcodes in Lieu of Shipping Marks Pilot Program for Fresh Meat Products from Australia
The notice provides instructions to inspection program personnel (IPP) for applying the official import mark of inspection for shipments of fresh meat products exported to the United States from establishments in Australia with barcodes in lieu of shipping marks on shipping containers.
FSIS Updates Lists of Establishments from Canada Eligible to Export to U.S.
Latest FDA Warning Letters
The latest FDA warning letters are:
DATE |
COMPANY |
ISSUING OFFICE |
SUBJECT |
10/08/2019 |
Herbal Healer Academy, Inc. |
Division of Human and Animal Food Operations West III |
Unapproved New Drugs/Misbranded |
10/08/2019 |
Orama Hookah Corporation |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/08/2019 |
Prime Hookah Incorporated |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/08/2019 |
Compuzone, Inc. d/b/a Vaping Zone |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/08/2019 |
Texas Smoke Accessories/Luxury Lites |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/08/2019 |
Bisket Vapes, LLC |
CTP Division of Promotion, Advertising & Labeling (SCRB-A ) |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/08/2019 |
Misty Mountain Vapors, LLC |
CTP Division of Promotion, Advertising & Labeling (SCRB-A ) |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/08/2019 |
Harold Brey & Sons Inc. |
Division of Human and Animal Food Operations East I |
Food/Egg/Prepared Packed or Held Under Insanitary Conditions/Adulterated |
10/08/2019 |
Hans Kissle Company, LLC |
Division of Human and Animal Food Operations East I (HAFE1) |
CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions |
10/08/2019 |
NuCare Pharmaceuticals Inc |
Center for Drug Evaluation and Research |
Failure to Comply with Drug Listing Requirements/Misbranded |
10/08/2019 |
Centennial Vapor |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/08/2019 |
Premium eJuice USA LLC d/b/a Vapor Lab |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/08/2019 |
IronVapin |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/08/2019 |
Hakooh LLC |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/08/2019 |
UltraUK Group d/b/a Ultra Vape |
CTP Division of Promotion, Advertising & Labeling (SCRB-A ) |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/08/2019 |
Ibitta Enterprises, Inc. |
Division of Human and Animal Food Operations West V |
CGMP/Dietary Supplement/Adulterated/Misbranded |
10/08/2019 |
Delaware Vapor |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/08/2019 |
Hookah Design, LLC d/b/a Fumo Design, LLC |
Center for Tobacco Products |
Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded |
10/08/2019 |
Family Fertility Center |
Division of Biological Products Operations II |
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) |
Please contact Erik Lieberman at elieberman@usfoodimports.com or (202) 765-1800 if you have questions or would like additional information. |