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
FDA 2018 Shutdown Information
FDA Investigates Multistate Outbreak of Salmonella Infections Linked to Sprouts Served at Certain Jimmy John’s Restaurants
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
Compliance Guideline for Training Establishment Employees under the New Swine Slaughter Inspection System
Jan 19, 2018 | PDF
- 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
White HousePress Briefing by OMB Director Mick Mulvaney and Legislative Affairs Director Marc Short on the Potential Government Shutdown
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
FDA Releases FSMA Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Animal Food
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 |
Jan 23, 2018 | PDF
- 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
If a pizza-like product contains 1% cooked meat sausage and 1% cooked poultry meat, is the product amenable?
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
Bollman Hat Company Settles with FTC, Agrees to Stop Making Deceptive ‘Made in USA’ and Certification Claims
Statement by Acting FTC Chairman Maureen K. Ohlhausen Regarding Announcement of the President’s Intent to Nominate Her to the U.S. Court of Federal Claims
FTC Publishes Inflation-Adjusted Civil Penalty Amounts