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

April 6, 2018 in Federal Register Updates

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

Date	Brand Name	Product Description	Reason/Problem	Company
04/04/2018	Buenas	Grated coconut	Salmonella	Global 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