Laws and Regulations Committee Update 4/5 – 4/6, 2018

April 5, 2018

Federal Register

Food and Drug Administration

Notices

Meetings:

Science Board to the Food and Drug Administration Advisory Committee

Filed on: 04/05/2018 at 08:45 am Scheduled Pub. Date: 04/06/2018

FR Document: 2018-07105  PDF 4 Pages (82.5 KB)  Permalink

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 04/05/2018 at 08:45 am Scheduled Pub. Date: 04/06/2018

FR Document: 2018-07043  PDF 5 Pages (117 KB)  Permalink

Animal and Plant Health Inspection Service

Rules

Imports:

Lemons from Chile into the Continental United States

Filed on: 04/05/2018 at 08:45 am Scheduled Pub. Date: 04/06/2018

FR Document: 2018-07073  PDF 15 Pages (194 KB)  Permalink

Agricultural Marketing Service

Rules

Subpart Nomenclature Change; Technical Amendment

Filed on: 04/05/2018 at 08:45 am Scheduled Pub. Date: 04/06/2018

FR Document: 2018-06882  PDF 21 Pages (267 KB)  Permalink

Proposed Rules

Mango Promotion, Research and Information Order:

Amendment to Include Frozen Mangos

Filed on: 04/05/2018 at 08:45 am Scheduled Pub. Date: 04/06/2018

FR Document: 2018-06968  PDF 46 Pages (254 KB)  Permalink

Marketing Orders:

Spearmint Oil Produced in the Far West; Salable Quantities and Allotment Percentages for the 2018-2019 Marketing Year

Filed on: 04/05/2018 at 08:45 am Scheduled Pub. Date: 04/06/2018

FR Document: 2018-06973  PDF 30 Pages (379 KB)  Permalink

FDA

Final Rule: Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor’s Name and Address 

Recalls

DateBrand NameProduct DescriptionReason/ProblemCompany
04/04/2018BuenasGrated coconutSalmonellaGlobal Commodities Corporation

AskFSIS

Humane Handling Livestock

FSIS Directive 6100.1 – Use of Electrical Prods #4

FSIS Directive 6100.1 Use of Electric Prod #1

SSOPs voluntary slaughter

@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls

  • The #FDA Coordinated Outbreak Response & Evaluation (CORE) Network streamlines and strengthens FDA’s efforts to prevent, detect, investigate, respond to & learn from incidents/outbreaks. MORE: https://go.usa.gov/xnS9f 
  • Kratom recall update: Since FDA’s first-ever mandatory recall order, the company’s counsel has informed #FDA that they’ve agreed to recall their products. We’ll continue to monitor the situation and resulting recall to ensure full compliance with the order https://go.usa.gov/xQgpr 
  • FDA announced new plans for getting better information on food packages & how we are looking for ways to simplify ingredient lists. #FDANutritionInnovation http://go.usa.gov/xQYdv 
  • DYK #FDAORA issues weekly Enforcement Reports of recalled products once they are classified? Products may be listed prior to classification when FDA determines the firm’s removal or correction of a marketed product(s) meets the definition of a recall. https://go.usa.gov/xnJDr 
  • Concerned about #foodrecalls & #outbreaks? Watch our Twitter feed, sign up for emails, or check our up-to-date list. https://www.fda.gov/Safety/Recalls/default.htm …
  • Global Commodities Corporation Recalls Buenas Grated Coconut due to Possible Health Risk http://dlvr.it/QNSf15 
  • When a food company says their product is #healthy #natural what does that mean? We’ll be updating the criteria to make these claims #FDANutritionInnovation http://go.usa.gov/xQYdv

April 6, 2018

Federal Register

Food and Drug Administration

Proposed Rules

Color Additive Petitions:

Aker BioMarine

Filed on: 04/06/2018 at 08:45 am Scheduled Pub. Date: 04/09/2018

FR Document: 2018-07155  PDF 5 Pages (27.5 KB)  Permalink

Notices        

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 04/06/2018 at 08:45 am Scheduled Pub. Date: 04/09/2018

FR Document: 2018-07147  PDF 14 Pages (131 KB)  Permalink

Filed on: 04/06/2018 at 08:45 am Scheduled Pub. Date: 04/09/2018

FR Document: 2018-07146  PDF 2 Pages (85.5 KB)  Permalink

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

Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic

Filed on: 04/06/2018 at 08:45 am Scheduled Pub. Date: 04/09/2018

FR Document: 2018-07154  PDF 4 Pages (84.9 KB)  Permalink

Petition to Request Exemption from 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements

Filed on: 04/06/2018 at 08:45 am Scheduled Pub. Date: 04/09/2018

FR Document: 2018-07156  PDF 7 Pages (35 KB)  Permalink

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 04/06/2018 at 08:45 am Scheduled Pub. Date: 04/09/2018

FR Document: 2018-07149  PDF 4 Pages (88.3 KB)  Permalink

Filed on: 04/06/2018 at 08:45 am Scheduled Pub. Date: 04/09/2018

FR Document: 2018-07160  PDF 4 Pages (112 KB)  Permalink

Filed on: 04/06/2018 at 08:45 am Scheduled Pub. Date: 04/09/2018

FR Document: 2018-07211  PDF 4 Pages (98.8 KB)  Permalink

Animal and Plant Health Inspection Service

Proposed Rules

National Poultry Improvement Plan and Auxiliary Provisions

Filed on: 04/06/2018 at 08:45 am Scheduled Pub. Date: 04/09/2018

FR Document: 2018-07076  PDF 34 Pages (330 KB)  Permalink

Notices

Meetings:

General Conference Committee of National Poultry Improvement Plan and 44th Biennial Conference

Filed on: 04/06/2018 at 08:45 am Scheduled Pub. Date: 04/09/2018

FR Document: 2018-07075  PDF 2 Pages (152 KB)  Permalink

AskFSIS

Can a food falling into the voluntary program category be labeled both “as consumed” and “as packaged”?

When can dual declarations be made?

Would it be useful for labels of products that are exempt to carry a disclaimer such as “not intended for retail sale” or “for further processing”?

Can values representing more than one cooking procedure be shown in optional columns?

FSIS Directive 12,600.2 – Holiday Work

askFSIS Submittal Instructions

SSOPs voluntary slaughter

FSIS Directive 12,600.2 – Formulation and Assembly Activities

Under the Small Business Exemption, are the Companies or the Products Exempted?

Verification Activities for the Prohibition of Air-Injection Stunning

APHIS

APHIS Publishes Final Rule to Allow the Importation of Fresh Lemons from Chile into the Continental United States Under a Systems Approach

AMS

USDA Lifts PACA Reparation Sanctions on California Produce Business

USDA Announces Seasonal Volume Control for 2017–18 Crop Year Cranberries

National Toxicology Program

ICCVAM Public Forum – May 24, 2018

NTP Update – April 2018 now available

@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls

  • Spring is here and could mean trips to your local farmer’s market! How do you safely pick and clean your produce? #FDAORA is serving up the correct way: https://go.usa.gov/xnJBM 
  • Recall of Certain Lots of Izzy’s Maple Nut Ice Cream Due to Undeclared Peanuts http://dlvr.it/QNYqkt