Laws and Regulations Committee Update 1/22 – 1/24, 2018
January 22, 2018
Federal Register
Health and Human Services Department
Proposed Rules
Protecting Statutory Conscience Rights in Health Care; Delegations of Authority
Filed on: 01/19/2018 at 11:15 am Scheduled Pub. Date: 01/26/2018
FR Document: 2018-01226 PDF 216 Pages (1.04 MB) Permalink
Guidance:
Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
Filed on: 01/22/2018 at 08:45 am Scheduled Pub. Date: 01/23/2018
FR Document: 2018-01126 PDF 6 Pages (106 KB) Permalink
Least Burdensome Provisions: Concept and Principles; Extension of Comment Period
Filed on: 01/22/2018 at 08:45 am Scheduled Pub. Date: 01/23/2018
FR Document: 2018-01122 PDF 5 Pages (33.4 KB) Permalink
FDA
Recalls
Date | Brand Name | Product Description | Reason/ Problem | Company |
01/21/2018 | Zero For Him | Dietary Supplement | Salmonella | Break Ventures / California Basics |
01/21/2018 | Arthri-D | Dietary Supplement | Salmonella | Arthri-D, LLC |
01/19/2018 | Ottogi | Rice Cake Soup | Undeclared milk | Ottogi America, Inc. |
01/19/2018 | JustFoodForDogs | Dog Food | Listeria monocytogenes | JustFoodForDogs |
@FDAFood, @FDA_ORA, @SGottliebFDA
- Ottogi America, Inc. Issues Allergy Alert on Undeclared Milk in Rice Cake Soup http://dlvr.it/QBw7bb
- FDA’s Special Agents/@TheJusticeDept: Owner of seafood company charged in Atlantic blue crab scam https://go.usa.gov/xnvsF
- 2018 events where FDA will be at discussing #WGS – whole genome sequencing of food borne pathogens #GenomeTrakr https://go.usa.gov/xnwja
- @US_FDA announced new guidance for public warnings of recalls. First in a series of policy steps we’ll take this year to further improve recall process. Read more: http://go.usa.gov/xnw3c
- For the latest info on @FDA shutdown plans and our efforts to ensure critical activities continue during the lapse in funding, see https://go.usa.gov/xnwV6
FSIS
USDA Announces Proposed Rule to Modernize Swine Inspection
Swine Modernization Radio Actualities
FSIS Compliance Guideline: Modernization of Swine Inspection System
- USDA Announces a Proposed Rule to Modernize Swine Slaughter Inspection Systems
- FSIS Expands Ceftiofur Method
- Webinar on Salmonella categories
- FSIS Upgrades PHIS Reports on the FSIS Website
Recall Update
Product Recalled | Date of Recall | Retail Distribution List |
004-2018 Café Spice GCT Inc., Recalls Ready-To-Eat Chicken Salad Products Due to Misbranding and an Undeclared Allergen | Jan 18, 2018 | Jan 19, 2018 |
askFSIS
Halal, Zabiha Halal, or Kosher product label that bears a foreign language
Work-in-progress (WIP) product labeling
Labeling of work-in-process (WIP) meat and poultry for further processing
Registration of Meat and Poultry Handlers
AMS
02/22 to 02/23 Agricultural Outlook Forum
January 23, 2018
Federal Register
Health and Human Services Department
Proposed Rules
Protecting Statutory Conscience Rights in Health Care; Delegations of Authority
Filed on: 01/19/2018 at 11:15 am Scheduled Pub. Date: 01/26/2018
FR Document: 2018-01226 PDF 216 Pages (1.04 MB) Permalink
Environmental Protection Agency
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Pesticide Data Call-in Program
Filed on: 01/23/2018 at 08:45 am Scheduled Pub. Date: 01/24/2018
FR Document: 2018-01269 PDF 4 Pages (198 KB) Permalink
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Supplemental Nutrition Assistance Program Waivers
Filed on: 01/23/2018 at 08:45 am Scheduled Pub. Date: 01/24/2018
FR Document: 2018-01279 PDF 5 Pages (105 KB) Permalink
FDA
Warning Letters
Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
01/10/2018 | USA Labs AKA Power Source Distributors, Inc AKA USA Sport | Cincinnati District Office | New Drug/Misbranded | Not Issued * |
01/05/2018 | Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc. | Seattle District Office | New Drug/Labeling/Misbranded | Not Issued * |
12/29/2017 | PT. GALAXY NUSA DUA | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated | Not Issued * |
12/21/2017 | Optimum Bioenergy International Corp. | San Francisco District Office | CGMP/Dietary Supplement/Adulterated/Misbranded | Not Issued * |
12/19/2017 | Neilsen Seafood | Cincinnati District Office | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
Recalls
Date | Brand Name | Product Description | Reason/ Problem | Company |
01/22/2018 | Sun Noodle | Tonkotsu Ramen | Undeclared Fish | Sun Noodle |
01/22/2018 | Several Brands | Cheeses, breads, and desserts | Undeclared Soy, Egg, Wheat, and Milk | Productos Pacheco Inc. |
@FDAFood, @FDA_ORA, @SGottliebFDA
- Sun Noodle – New Jersey – Issues Allergy Alert on Undeclared Fish in Tonkotsu Ramen http://dlvr.it/QCLXpk
- Ottogi America, Inc. Issues Allergy Alert on Undeclared Milk in Rice Cake Soup http://dlvr.it/QBw7bb
- Be assured, during #shutdown, thousands of dedicated #FDA employees were still on the job ensuring security of food and medical product supply; protecting public safety. We’re grateful for all of our employees’ for their dedication; proud of our mission https://go.usa.gov/xnwAf
- #TuesdayTip: #FDAORA has identified 300+ #weightloss products marketed as #dietarysupplements that contain undeclared active drug ingredients. See the list and protect yourself from #healthfraud: https://go.usa.gov/xnNcG
askFSIS
Antimicrobial intervention in slaughter operation
CSPI
Biotechnology and Biosafety Policy Under the Trump Administration: The Devil Will Be in the Details
January 24, 2018
Federal Register
Proposed Rules
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Small Entity Compliance Guide
Filed on: 01/24/2018 at 08:45 am Scheduled Pub. Date: 01/25/2018
FR Document: 2018-01300 PDF 5 Pages (29.7 KB) Permalink
Guidance:
Application of the Foreign Supplier Verification Program Regulation to Importers of Grain Raw Agricultural Commodities
Filed on: 01/24/2018 at 08:45 am Scheduled Pub. Date: 01/25/2018
FR Document: 2018-01298 PDF 7 Pages (32.6 KB) Permalink
Considerations for Determining Whether a Measure Provides the Same Level of Public Health Protection as the Corresponding Requirement in the Code of Federal Regulations or the Preventive Controls Requirements
Filed on: 01/24/2018 at 08:45 am Scheduled Pub. Date: 01/25/2018
FR Document: 2018-01296 PDF 8 Pages (114 KB) Permalink
Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
Filed on: 01/24/2018 at 08:45 am Scheduled Pub. Date: 01/25/2018
FR Document: 2018-01297 PDF 7 Pages (106 KB) Permalink
Hazard Analysis and Risk-Based Preventive Controls for Human Food
Filed on: 01/24/2018 at 08:45 am Scheduled Pub. Date: 01/25/2018
FR Document: 2018-01299 PDF 6 Pages (103 KB) Permalink
@FDAFood, @FDA_ORA, @SGottliebFDA
- Products Pacheco Inc Issues Allergy Alert For Undeclared Wheat, Soy, Egg, Milk and Undeclared Artificial Coloring in its Bakery Products http://dlvr.it/QCR6VZ
- Sun Noodle – New Jersey – Issues Allergy Alert on Undeclared Fish in Tonkotsu Ramen http://dlvr.it/QCLXpk
- Break Ventures/California Basics Recalls “Zero For Him” 150ct Lot#1710-638 Because of Possible Health Risk http://dlvr.it/QCBW3R
- #TuesdayTip: #FDAORA has identified 300+ #weightloss products marketed as #dietarysupplements that contain undeclared active drug ingredients. See the list and protect yourself from #healthfraud: https://go.usa.gov/xnNcG
FSIS
Product Recalled | Date of Recall | Retail Distribution List |
005-2018 Perdue Foods LLC Recalls Chicken Products due to Misbranding and Undeclared Allergens | Jan 23, 2018 | To be posted |
- FSIS to Resume Posting of Individual Salmonella Category Status for Poultry Carcass Establishments
- FSIS Posts Aggregate Results for Chicken Parts, Comminuted Poultry and Poultry Carcasses Tested for Salmonella and Campylobacter
askFSIS
AMS
USDA Cites J&R Fresh Produce LLC in Florida for PACA Violations
Grow Your Business, Apply to Sell Local Goods at the USDA Farmers Market
FTC