Laws and Regulations Committee Update 1/22 – 1/24, 2018

January 25, 2018 in Federal Register Updates

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

Food and Drug Administration

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

Food and Nutrition Service

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

Food and Drug Administration

Proposed Rules

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals: Small Entity Compliance Guide