News Article

Laws and Regulations Committee Update 12/22 - 12/27, 2017

Posted on December 28, 2017

Blog: Association of Food & Drug Officials (AFDO)

December 22, 2017

Federal Register

FDA

Proposed Rules

Animal Food Additive Petitions:

Akzo Nobel Surface Chemistry AB

Filed on: 12/22/2017 at 08:45 am Scheduled Pub. Date: 12/26/2017

FR Document: 2017-27789 PDF 5 Pages (105 KB) Permalink

Zinpro Corp.; Reopening of the Comment Period

Filed on: 12/22/2017 at 08:45 am Scheduled Pub. Date: 12/26/2017

FR Document: 2017-27785 PDF 5 Pages (33.1 KB) Permalink

Environmental Protection Agency

Tolerance Exemptions:

2-Propenoic acid, 2-methyl-, dodecyl ester, polymer with 1-ethenyl-2-pyrrolidinone and a-(2-methyl-1-oxo-2-propen-1-yl)-w-methoxypoly(oxy-1,2-ethanediyl)

Filed on: 12/22/2017 at 08:45 am Scheduled Pub. Date: 12/26/2017

FR Document: 2017-27805 PDF 13 Pages (322 KB) Permalink

FDA

Drug Products Labeled as Homeopathic: Guidance for FDA Staff and Industry

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
12/20/2017	Meijer	Package products containing apple slices	Listeria monocytogenes	Meijer

FSIS

FSIS Reaches Key Milestones in Protecting Public Health

PFP Enterprises LLC Recalls Ground Beef Products Due to Misbranding and An Undeclared Allergen

FNS

USDA Expands Flexibility, Encourages Program Integration in SNAP Administration

APHIS

APHIS Proposes Updates for Avian Influenza Virus Elimination Flat Rate for Floor-Raised Poultry

Food and Water Watch

Farming on Maryland’s Eastern Shore: From Traditional Family Agriculture to Corporate Industry

December 27, 2017

Federal Register

Proposed Rules

Food Additive Petitions (Animal Use): Akzo Nobel Surface Chemistry AB

Filed on: 12/26/2017 at 08:45 am Scheduled Pub. Date:12/27/2017

FR Document: 2017-27840 PDF 5 Pages (34 KB) Permalink

Ø FDA is reopening the comment period to allow additional time for comments on the environmental impacts of this petition. This petition seeks to amend the food additive regulations to provide for the safe use of glyceryl polyethylene glycol (15) ricinoleate as an emulsifier in animal food that does not include food for dogs, cats, vitamin premixes, or aquaculture.

FDA

Statement from FDA Commissioner Scott Gottlieb, M.D. on efforts to support more efficient and effective food recalls
Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
12/19/2017	Maine Natural Health, Inc.	New York District Office	CGMP/Dietary Supplement/Adulterated/Misbranded	Not Issued *
12/15/2017	Gold Star Smoked Fish Corp.	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
12/14/2017	BrainAlert, LLC	Seattle District Office	CGMP/Dietary Supplement/Adulterated/Misbranded	Not Issued *
12/14/2017	Eden’s Answers Inc. and Sprigs Life Inc.	Cincinnati District Office	Unapproved New Drugs/Misbranded	Not Issued *
12/13/2017	Dynamic Technical Formulations	Atlanta District Office	CGMP/Dietary Supplement/Adulterated/Misbranded	Not Issued *
11/16/2017	Naturefield Company Limited	Center for Food Safety and Applied Nutrition	Juice/HACCP/Adulterated	Not Issued *

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
12/22/2017	Fresh Pak, Michigan, and Aunt Mid’s	Packaged products containing apple slices	Listeria monocytogenes	Fresh Pak Inc.
12/22/2017	AuroMedics	Linezolid Injection	Particulate contamination (mold)	AuroMedics Pharma
12/22/2017	Nodine's Smokehouse, Inc.	Smoked Salmon 1.5 lbs, 8 oz	Listeria monocytogenes	Nodine's Smokehouse, Inc.
12/22/2017	HT Traders	Mini Biscotti – Triple Chocolate	Undeclared Almonds and Hazelnuts	Harris Teeter
12/21/2017	Springfield Smoked Fish	Smoked fish products	Listeria monocytogenes	Springfield Smoked Fish

OMB-OIRA

Department of Agriculture

AGENCY: USDA-AMS	RIN: 0581-AD54	Status: Pending Review
TITLE: National Bioengineered Food Disclosure Standard
STAGE: Proposed Rule	ECONOMICALLY SIGNIFICANT: Yes
** RECEIVED DATE: 12/26/2017	LEGAL DEADLINE: None


AGENCY: USDA-FSIS	RIN: 0583-AC58	Status: Concluded
TITLE: Egg Products Inspection Regulations
STAGE: Proposed Rule	ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 06/10/2017	LEGAL DEADLINE: None
REVIEW EXTENDED
COMPLETED: 12/21/2017	COMPLETED ACTION: Consistent with Change

FSIS

Product Recalled	Date of Recall	Retail Distribution List
131-2017 Swift Beef Company Recalls Beef Stew Products Due to Possible Foreign Matter Contamination \| En Español	Dec 26, 2017