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

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

DateBrand NameProduct DescriptionReason/ ProblemCompany
01/21/2018Zero For Him  Dietary Supplement  SalmonellaBreak Ventures / California Basics
01/21/2018Arthri-D  Dietary Supplement  SalmonellaArthri-D, LLC
01/19/2018Ottogi  Rice Cake Soup  Undeclared milkOttogi America, Inc.
01/19/2018JustFoodForDogs Dog Food  Listeria monocytogenesJustFoodForDogs

@FDAFood, @FDA_ORA, @SGottliebFDA

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 RecalledDate of RecallRetail Distribution List
004-2018 Café Spice GCT Inc., Recalls Ready-To-Eat Chicken Salad Products Due to Misbranding and an Undeclared AllergenJan 18, 2018Jan 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 DateCompany NameIssuing OfficeSubjectClose Out Date
01/10/2018USA Labs AKA Power Source Distributors, Inc AKA USA SportCincinnati District OfficeNew Drug/MisbrandedNot Issued *
01/05/2018Coenzyme A, Inc. dba Coenzyme-A Technologies, Inc.Seattle District OfficeNew Drug/Labeling/MisbrandedNot Issued *
12/29/2017PT. GALAXY NUSA DUACenter for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/AdulteratedNot Issued *
12/21/2017Optimum Bioenergy International Corp.San Francisco District OfficeCGMP/Dietary Supplement/Adulterated/MisbrandedNot Issued *
12/19/2017Neilsen SeafoodCincinnati District OfficeSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsNot Issued *

Recalls

DateBrand NameProduct DescriptionReason/ ProblemCompany
01/22/2018Sun Noodle  Tonkotsu Ramen  Undeclared FishSun Noodle
01/22/2018Several Brands  Cheeses, breads, and desserts  Undeclared Soy, Egg, Wheat, and MilkProductos Pacheco Inc.

@FDAFood, @FDA_ORA, @SGottliebFDA

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

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

FSIS

Product RecalledDate of RecallRetail Distribution List
005-2018 Perdue Foods LLC Recalls Chicken Products due to Misbranding and Undeclared AllergensJan 23, 2018To 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

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