Laws and Regulations Committee Update 1/12 – 1/18, 2018

January 12, 2018

Federal Register

Food and Drug Administration

Proposed Rules

Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease

Filed on: 01/12/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018

FR Document: 2018-00683  PDF 5 Pages (32.1 KB)  Permalink

Animal and Plant Health Inspection Service

Notices

Affirmation of Addition of Treatments for Aircraft: Certain Hitchhiking Pests

Filed on: 01/12/2018 at 08:45 am Scheduled Pub. Date: 01/16/2018

FR Document: 2018-00569  PDF 4 Pages (25 KB)  Permalink

Determinations: Classical Swine Fever Status of Mexico

Filed on: 01/12/2018 at 08:45 am Scheduled Pub. Date: 01/16/2018

FR Document: 2018-00576  PDF 5 Pages (167 KB)  Permalink

FDA

Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap

Recalls

DateBrand NameProduct DescriptionReason/ ProblemCompany
01/11/2018Sundae Shoppe  Raspberry Cream Bars  Listeria monocytogenesFieldbrook Foods Corporation
01/11/2018Mary B’s®  Biscuits  Listeria monocytogenesHom/Ade Foods, Inc

@FDAFood, @FDA_ORA, @SGottliebFDA

  • #RECALL Fieldbrook Foods ice cream bars & orange cream bars produced in 2017 w/plant code: 362677 possible #Listeria under a variety of brand names (Lucerne, Kroger, etc.)  https://go.usa.gov/xndbb 
  • Gilster – Mary Lee Corp. Issues a Recall For Undeclared Milk Allergen in Essential Everyday® Chicken Coating  http://dlvr.it/Q9rLN8 
  • Folic acid, long used to fortify some enriched grains, helps moms-to-be by adding a B vitamin to their diet. This may help prevent neural tube defects. Last year FDA approved this addition to corn masa flour. Learn more for  #FolicAcidAwarenessWeek https://go.usa.gov/xnpvF 

FNS
FNS-640 SY 2016-17 Reporting Guidance

January 16, 2018

Federal Register

Agricultural Marketing Service

Proposed Rules

Meeting of the National Organic Standards Board

Filed on: 01/16/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018

FR Document: 2017-28170  PDF 4 Pages (14.5 KB)  Permalink

National Organic Program: National List of Allowed and Prohibited Substances (Crops, Livestock and Handling)

Filed on: 01/16/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018

FR Document: 2017-28172  PDF 99 Pages (535 KB)  Permalink

Notices

United States Standards for Grades of Pork Carcasses

Filed on: 01/16/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018

FR Document: 2018-00627  PDF 3 Pages (158 KB)  Permalink

Animal and Plant Health Inspection Service

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Specimen Submission

Filed on: 01/16/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018

FR Document: 2018-00694  PDF 4 Pages (98.4 KB)  Permalink

List of Regions Affected by Highly Pathogenic Avian Influenza:

Addition of the Philippines

Filed on: 01/16/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018

FR Document: 2018-00696  PDF 3 Pages (8.55 KB)  Permalink

Food and Drug Administration

Proposed Rules

Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease

Filed on: 01/12/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018

FR Document: 2018-00683  PDF 5 Pages (32.1 KB)  Permalink

Notices

Veterinary Feed Directive

Filed on: 01/16/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018

FR Document: 2018-00676  PDF 10 Pages (123 KB)  Permalink

FDA

FDA Extends Comment Period for Proposed Rule to Revoke Authorized Health Claim Regarding Soy Protein and Coronary Heart Disease

FDA Denies Qualified Health Claim Petition for Intake of Vitamin D to Reduce the Risk of Multiple Sclerosis in Healthy People 

Recalls

DateBrand NameProduct DescriptionReason/ ProblemCompany
01/13/2018Hiland Dairy, Tampico  Orange Juice, Citrus Punch  products may contain milk proteinHiland Dairy

@FDAFood, @FDA_ORA, @SGottliebFDA

FSIS

Jan 12, 2018 | PDF

  • USDA Announces Proposed Rule to Amend Egg Products Inspection Regulations
  • FSIS Announces Webinar for Posting Individual Salmonella Category Status for Poultry Carcass Establishments
  • FSIS Announces Webinar for Trading Partners, Foreign Establishments and Importers
  • 2018 Rate Changes for the Basetime, Overtime, Holiday and Laboratory Services Rates
  • Establishment Specific Datasets Now Available
  • FSIS Posts Updated Dataset on Import Refusals


AMS

USDA Announces National Peanut Board Appointments

APHIS

APHIS Recognizes Mexico as Free of Classical Swine Fever

January 17, 2018

OIRA

AGENCY: USDA-FNSRIN: 0584-AE57Status: Pending Review
TITLE: Supplemental Nutrition Assistance Program: Requirements and Services for Able-Bodied Adults Without Dependents
STAGE: PreruleECONOMICALLY SIGNIFICANT: No
** RECEIVED DATE: 01/16/2018LEGAL DEADLINE: None  

FDA

Warning Letters

Letter Issue DateCompany NameIssuing OfficeSubjectClose Out Date
12/29/2017Transbuana International ExpressCenter for Food Safety and Applied NutritionSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsNot Issued *

@FDAFood, @FDA_ORA, @SGottliebFDA

  • FDA Commissioner discusses transparency and the availability of FDA data, including: #FDAORA data dashboard and weekly enforcement reports https://go.usa.gov/xnvgz 
  • #RECALL Check your freezer! FDA advises consumers not to eat recalled Coconut Tree Brand Frozen Shredded Coconut because the product has the potential to cause  #salmonellosishttps://go.usa.gov/xnvBA 
  • Salmonella Outbreak: 25 people in 9 states sick. Check your home for recalled Coconut Tree Brand frozen Shredded Coconut.  http://bit.ly/2DbcD3y 
  • Bellisio Foods, Inc. Issues Allergy Alert Regarding Certain Michelina’s Fettuccine Alfredo Packages Due to Potential Presence of Undeclared Soy http://dlvr.it/QBVjkQ 
  • #FDA’S 2018 STRATEGIC POLICY ROADMAP: Priorities include helping consumers make better and more informed decisions when it comes to diets and health. All part of the FDA’s Healthy Innovation, Safer Families http://go.usa.gov/xndZa 

askFSIS

Electronic Records Maintained on Computers

KIS™ testing

DOAs in a Poultry Slaughter Establishment

AMS

USDA Announces Popcorn Board Appointments

USDA Lifts PACA Reparation Sanctions on Washington Produce Business

The National Academies

Academy Honors 19 for Major Contributions to Science

January 18, 2018

Federal Register

Agriculture Department (see also Consumer Product Safety CommissionEnvironmental Protection AgencyHealth and Human Services Department)

Rules

Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects

Filed on: 01/17/2018 at 04:15 pm Scheduled Pub. Date: 01/22/2018

FR Document: 2018-00997  PDF 72 Pages (344 KB)  Permalink

Agriculture Department

Proposed Rules

Withdrawal of Certain Proposed Rules and Other Proposed Actions; Correction

Filed on: 01/18/2018 at 08:45 am Scheduled Pub. Date: 01/19/2018

FR Document: 2018-00893  PDF 2 Pages (84.9 KB)  Permalink

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 01/18/2018 at 08:45 am Scheduled Pub. Date: 01/19/2018

FR Document: 2018-00879  PDF 4 Pages (90 KB)  Permalink

Environmental Protection Agency

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals:

Cross-Media Electronic Reporting Rule

Filed on: 01/18/2018 at 08:45 am Scheduled Pub. Date: 01/19/2018

FR Document: 2018-00939  PDF 4 Pages (197 KB)  Permalink

Recordkeeping and Reporting of the Production, Import, Export, Destruction, Transhipment, and Exempted Uses of Ozone-Depleting Substances

Filed on: 01/18/2018 at 08:45 am Scheduled Pub. Date: 01/19/2018

FR Document: 2018-00938  PDF 8 Pages (215 KB)  Permalink

Environmental Impact Statements; Availability, etc.: Weekly Receipts

Filed on: 01/18/2018 at 08:45 am Scheduled Pub. Date: 01/19/2018

FR Document: 2018-00929  PDF 2 Pages (5.98 KB)  Permalink

Food and Drug Administration

Proposed Rules

Guidance: Public Warning and Notification of Recalls

Filed on: 01/18/2018 at 08:45 am Scheduled Pub. Date: 01/19/2018

FR Document: 2018-00918  PDF5 Pages (29.2 KB)  Permalink

  • The draft guidance, when finalized, will establish official guidance for industry and FDA staff regarding the use, content, and timing of public warnings and public notification of recalls under part 7 (21 CFR Part 7). The draft guidance is part of a larger effort FDA is undertaking to give additional guidance to industry and FDA staff regarding the execution and oversight of voluntary recalls under part 7.

FDA

FDA to Expedite Release of Recall Information

  • FDA has decided that the public would benefit by having recall information about FDA-regulated products as soon as possible, even though further evaluation remains to be done. Moving forward, FDA will include “not-yet-classified” recalls of human drugs, foods, and veterinary products in the weekly Enforcement Report, even while classification work is still ongoing.

Recalls

DateBrand NameProduct DescriptionReason/ ProblemCompany
01/17/2018Palmer Bakery Delights  Sea Salt Caramel Hearts  Undeclared PeanutsPalmer Candy Company

@FDAFood, @FDA_ORA, @SGottliebFDA

askFSIS

Maintaining a Physical Inspection Presence

AMS

USDA Reopens the Comment Period for Proposed Revisions to the Pork Grade Standards

FTC

FTC Posts Blog on Voices for Liberty Video Project

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