News Article

Laws and Regulations Committee Update 11/6 - 11/9, 2017

Posted on November 09, 2017

Blog: Association of Food & Drug Officials (AFDO)

November 6, 2017

Federal Register

Food and Drug Administration

Rules

Listing of Color Additives Exempt from Certification; Calcium Carbonate

Filed on: 11/06/2017 at 08:45 am Scheduled Pub. Date: 11/07/2017

FR Document: 2017-24194 PDF 16 Pages (129 KB) Permalink

Animal and Plant Health Inspection Service

Proposed Rules

Importation, Interstate Movement, and Environmental Release of Certain Genetically Engineered Organisms; Withdrawal

Filed on: 11/06/2017 at 08:45 am Scheduled Pub. Date: 11/07/2017

FR Document: 2017-24202 PDF 4 Pages (163 KB) Permalink

FDA

FDA Issues Guidance to Allow “Co-Manufacturers” Additional Time to Implement Certain Supply-Chain Program Requirements
Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
11/03/2017	DSD Merchandisers, Inc.	Dark Chocolate Almond Products	Undeclared Milk	DSD Merchandisers, Inc.

FSIS

Nov 03, 2017 | PDF

Identifying Regulatory Reform Initiatives at USDA

Update to FSIS Public Health Partners Web Page

AskFSIS

Trimming and Washing of Exposed Beef Parts

Noncompliance Record (NR)

Who in FSIS Office of Field Operations Documents Noncompliance?

Number of Noncompliance Records (NR)

USDA
USDA to Re-engage Stakeholders on Revisions to Biotechnology Regulations

AMS

USDA Files Action Against Olympic Wholesale Produce Inc. in Illinois for Alleged PACA Violations

USDA Files Action Against Huxtable’s Kitchen Inc. in California for Alleged PACA Violations

GIPSA
Nebraska Beef, Ltd. Assessed $7,500 Civil Penalty (PDF; 43KB)

Matt Anderson, d/b/a Matt Anderson Cattle Assessed $2,000 Civil Penalty (PDF; 43KB)

November 7, 2017

FDA

FY 2015 Pesticide Analysis Demonstrates Residue Levels Remain Low

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
10/31/2017	Stanley Brothers Social Enterprises, LLC	Los Angeles District Office	New Drug/Misbranded/ Cannabidiol(CBD) products	Not Issued *
10/31/2017	Green Roads of Florida LLC	San Juan District Office	New Drug/Misbranded/Cannabidiol(CBD) products	Not Issued *
10/31/2017	Natural Alchemist	Los Angeles District Office	New Drug/Misbranded/Cannabidiol(CBD) products	Not Issued *
10/31/2017	That's Natural	Los Angeles District Office	New Drug/Misbranded/Cannabidiol(CBD) products	Not Issued *

USDA

USDA Files Action Against Olympic Wholesale Produce Inc. in Illinois for Alleged PACA Violations

USDA Files Action Against Huxtable’s Kitchen Inc. in California for Alleged PACA Violations

FSIS

Recalls

Product Recalled	Date of Recall	Retail Distribution List
117-2017 CC Kitchens LLC Recalls Meat and Poultry Products Produced Without Benefit of Inspection \| En Español	Nov 02, 2017	Nov 04, 2017
116-2017 Chelsea Food Services Firm Recalls Pork and Chicken Products Due To Possible Listeria Contamination \| En Español	Nov 01, 2017	Nov 06, 2017

FTC

FTC Releases Draft Strategic Plan for Fiscal Years 2018 to 2022

NIH-ODS

Now Available: 2017 ODS Practicum Videos

November 8, 2017

Federal Register

Food and Drug Administration

Proposed Rules

Guidance: Menu Labeling

Filed on: 11/07/2017 at 11:15 am Scheduled Pub. Date: 11/09/2017

FR Document: 2017-24246 PDF 6 Pages (198 KB) Permalink

Color Additive Petitions: Colorcon, Inc.

Filed on: 11/08/2017 at 08:45 am Scheduled Pub. Date: 11/09/2017

FR Document: 2017-24421 PDF 2 Pages (77.9 KB) Permalink

Ø Colorcon, Inc., proposed that the color additive regulations be amended by expanding the permitted uses of synthetic iron oxide as a color additive to include use in dietary supplement tablets and capsules

Notices

Health and Diet Survey, as Used by Food and Drug Administration

Filed on: 11/08/2017 at 08:45 am Scheduled Pub. Date: 11/09/2017

FR Document: 2017-24409 PDF 4 Pages (86.3 KB) Permalink

Infant Formula Recall Regulations

Filed on: 11/08/2017 at 08:45 am Scheduled Pub. Date: 11/09/2017

FR Document: 2017-24410 PDF 6 Pages (96 KB) Permalink

Federal Trade Commission

Proposed Rules

Energy Labeling

Filed on: 11/08/2017 at 08:45 am Scheduled Pub. Date: 11/09/2017

FR Document: 2017-24381 PDF 27 Pages (698 KB) Permalink

FDA

FDA Issues Menu Labeling Guidance, Utilizing Q&A Format and Graphics to Address Concerns, Offer Solutions, and Provide Flexibility

Statement from FDA Commissioner Scott Gottlieb, M.D., on a practical approach to ensuring timely implementation of FDA’s menu labeling rule

Draft Guidance for Industry: Menu Labeling Supplemental Guidance

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
11/02/2017	Create-A-Pack Foods, Inc.	Minneapolis District Office	CGMP/Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements/Adulterated	Not Issued *
10/26/2017	Bluegrass Proteins, Inc.	Minneapolis District Office	CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions	Not Issued *
10/25/2017	Finnerty Dairy	Chicago District Office	Illegal Drug Residue	Not Issued *
10/13/2017	Biomin Industries, Inc.	Denver District Office	Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded	Not Issued *
08/18/2017	Threeline Imports, Inc.	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
11/07/2017	Nature's Touch	Frozen Green Beans	Listeria monocytogenes	Nature's Touch Frozen Foods LLC

USDA

USDA Files Action Against Forest City Weingart Produce Co. in Ohio for Alleged PACA Violations

Connecticut Firm Posts $100,000 Employment Bond

askFSIS

Slaughter or Processing of Multiple Species in the Same Production Day

OEHHA

DARTIC Meeting and Availability of Hazard Identification Materials for Chlorpyrifos and n-Hexane

Ø Chlorpyrifos and n-hexane will be considered for possible listing by the DARTIC at its next meeting. Chlorpyrifos will be considered for possible listing based on the developmental toxicity endpoint. n-Hexane will be considered for possible listing based on the developmental, male and female reproductive toxicity endpoints. Wed, 11/29/2017 - 10:00am to 5:00pm

CSPI

FDA Provides Guidance to Industry on Menu Labeling Compliance

Defense Department Should Not Function as “Alt-FDA”

November 9, 2017

Federal Register

Agricultural Marketing Service

Rules

National Organic Program: Organic Livestock and Poultry Practices

Filed on: 11/09/2017 at 08:45 am Scheduled Pub. Date: 11/14/2017

FR Document: 2017-24675 PDF 6 Pages (170 KB) Permalink

Ø The Organic Livestock and Poultry Practices (OLLP) final rule amends the organic livestock and poultry production requirements of the USDA organic regulations by adding new provisions for livestock handling and transport for slaughter and avian living conditions; and expands and clarifies existing requirements covering livestock care and production practices and mammalian living conditions. AMS is delaying the effective date of the final rule published in the Federal Register on January 19, 2017 (OLPP final rule), until May 14, 2018.

Rules

Food Additives Permitted in Feed and Drinking Water of Animals: Ammonium Formate and Formic Acid

Filed on: 11/09/2017 at 08:45 am Scheduled Pub. Date: 11/13/2017

FR Document: 2017-24366 PDF 8 Pages (110 KB) Permalink

Ø FDA is amending food additive regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of formic acid and ammonium formate. Formic acid and formate salts from all added sources cannot exceed 1.2 percent of complete feed when multiple sources of formic acid and its salts are used in combination

FDA

Canadian Food Inspection Agency and United States Food and Drug Administration sign a Memorandum of Understanding to facilitate sharing of scientific information and collaborative research projects (MOU)

FSIS

Recalls

Product Recalled	Date of Recall	Retail Distribution List
118-2017 Nestle Prepared Foods Company Recalls Pork and Beef Products Due To Misbranding and Undeclared Allergens	Nov 08, 2017	Nov 08, 2017