News Article

Laws and Regulations Committee 12/18 - 12/22, 2017

Posted on December 22, 2017

Blog: Association of Food & Drug Officials (AFDO)

December 18, 2017

Federal Register

Environmental Protection Agency

Rules

Tolerance Exemptions: Amine salt of styrene acrylic polymer, ammonium salt

Filed on: 12/18/2017 at 08:45 am Scheduled Pub. Date: 12/19/2017

FR Document: 2017-27300 PDF 12 Pages (316 KB) Permalink

Proposed Rules

Pesticide Petitions: Residues of Aluminum tris (O-ethylphosphonate) In or On Fruit, Citrus, Group 10-10

Filed on: 12/18/2017 at 08:45 am Scheduled Pub. Date: 12/19/2017

FR Document: 2017-27099 PDF 5 Pages (87.3 KB) Permalink

Reporting Requirements for the TSCA Mercury Inventory: Mercury

Filed on: 12/18/2017 at 08:45 am Scheduled Pub. Date: 12/19/2017

FR Document: 2017-27217 PDF 2 Pages (79.5 KB) Permalink

FDA

Knoxville Man Sentenced for Conspiring to Defraud the FDA

@FDAfood, @FDA_ORA, @US_FDA

Ø Today, #IFSAC released its report analyzing 2013 outbreak data to estimate specific pathogens responsible for #foodborne illnesses @USDAFoodSafety @CDCgov https://go.usa.gov/xnnSS
Ø #FDAORA issues #warningletter to North Carolina ready-to-eat salad manufacturer for #listeria bacteria in the facility: https://go.usa.gov/xn8s2
Ø #RECALL Blue Pearl All Natural Male Enhancement Supplement by Marmex Corp. FDA analysis has found the product contains the drug #sildenafil, which could have adverse interaction with other medicines. https://go.usa.gov/xnn5r
Ø #FSMA rule for #producesafety is final - establishing science-based minimum standards for safe growing, harvesting, packing, & holding of #fruitsandveggies grown for human consumption. http://go.usa.gov/xRMGe

FSIS

Recalls

Product Recalled	Date of Recall
129-2017 Piller's Fine Foods Recalls Ready-To-Eat Salami and Speck Products due to Possible Salmonella Adulteration \| En Español	Dec 16, 2017

Dec 15, 2017 | PDF

FSIS to Resume Posting of Individual Salmonella Category Status for Poultry Carcass Establishments
Fiscal Year 2017 Meat and Poultry Inspection Program Review Results Available
FSIS Posts Updated Dataset on Import Rejections
FSIS Posts Aggregate Results for Chicken Parts, Comminuted Poultry and Poultry Carcasses Tested for Salmonella and Campylobacter
FSIS Announces Change on Assessing Antimicrobial Sensitivity for Enterococcus
USDA Provides Tips to Keep Holiday Food Safe at Home or When Traveling
Interagency Food Safety Analytics Collaboration: Release of a New Report on Foodborne Illness Source Attribution Estimates for 2013
FSIS Suspends Pulsed-field Gel Electrophoresis Analysis for Listeria monocytogenes

askFSIS

E. coli Intervention and Non-intact Raw Beef Products

Final Rule “Records To Be Kept by Official Establishments and Retail Stores That Grind Raw Beef Products”

FSIS Directive 6100.1 - Use of Electrical Prods #4

Donating Sample Product

FTC
FTC Publishes Staff Report on Exploratory Research Examining Consumer Recognition of Paid Search and Native Advertising Online

FTC Approves Final Consent Order in Moonlight Slumber, LLC Advertising Case

OEHHS

Proposition 65: Issuance of Safe Use Determinations for Diisononyl Phthalate (DINP) in Interface Glasbac® and Glasbac®RE Modular Carpet Tiles

Ø The California Environmental Protection Agency’s Office of Environmental Health Hazard Assessment (OEHHA) is the lead agency for the implementation of the Safe Drinking Water and Toxic Enforcement

Proposition 65: Chemicals Listed Effective December 15, 2017 as Known to the State of California to Cause Reproductive Toxicity: Chlorpyrifos and n-Hexane

Ø Both chemicals were considered by the Developmental and Reproductive Toxicant Identification Committee (DARTIC) in its official capacity as the “state’s qualified experts” at a public meeting held on November 29, 2017.

Proposition 65: Meeting Synopsis and Slide Presentations from the Developmental and Reproductive Toxicant Identification Committee Meeting Held on November 29, 2017

Ø Chlorpyrifos and n-Hexane will be added to the Proposition 65 list.

NAD

NAD Finds Church & Dwight Can Support Certain Claims for ‘Slide’ Cat Litter; Recommends Company Modify, Discontinue Demonstration

Eufy Says It Has Permanently Discontinued Claims for Robotic Vacuum Challenged by iRobot

NAD Recommends Alcon Laboratories Discontinue Certain Claims for ‘Clear Care’ Products, Including Certain ‘Natural Tears’ Claims

NIH Office of Dietary Supplements

Now Available: Proceedings of 2016 Iron Workshop

Now Available: 2017 ODS Practicum Videos

NTP

NTP Update - December 2017 now available

December 19, 2017

Federal Register

Agricultural Marketing Service

Rules

Rules of Practice and Procedures to Formulate or Amend a Marketing Agreement or a Marketing Order, or Certain Research and Promotion Orders; Correction

Filed on: 12/19/2017 at 08:45 am Scheduled Pub. Date: 12/20/2017

FR Document: 2017-27401 PDF 2 Pages (74.1 KB) Permalink

FDA

FDA Provides Information on the Use of Medically Important Antimicrobials in Bees

@FDAfood, @FDA_ORA, @US_FDA

· Fish are protein-rich & can help with your child's growth & development. Best choices are lower in mercury: https://go.usa.gov/xNwrV
· Marmex Corp Issues Voluntary Nationwide Recall Of Blue Pearl All Natural Male Enhancement Supplement, Due To Undeclared Sildenafil http://dlvr.it/Q5rfn5
· Gottlieb: I’m deeply troubled by the unlawful marketing of Coco Loko and Legal Lean, especially since they’re so easily accessible by minors. There are health consequences to snorting any powder, not to mention the societal dangers of promoting drug abuse. https://go.usa.gov/xnRUz
· FDA posted a warning letter to the marketers and distributors of Legal Lean Syrup, a drink, and Coco Loko, a “snortable” chocolate powder, for selling unapproved new drugs and misbranded drugs as alternatives to street drugs https://go.usa.gov/xnRPn

AMS

USDA Announces National Watermelon Promotion Board Appointments

FNS

USDA Selects Kansas State University to Improve Child Nutrition Safety

The National Academics

Statement by NAS, NAE, and NAM Presidents on Report of Banned Words at CDC

December 20, 2017

Federal Register

Environmental Protection Agency

Notices

Registration Reviews: Neonicotinoid Risk Assessments; Neonicotinoid Benefits Assessments

Filed on: 12/20/2017 at 08:45 am Scheduled Pub. Date: 12/21/2017

FR Document: 2017-27520 PDF 7 Pages (361 KB) Permalink

FDA

Recalls

Date	Brand Name	Product Description	Reason/ Problem	Company
12/19/2017	Springfield Smoked Fish	Smoked fish products	Listeria monocytogenes	Springfield Smoked Fish
12/19/2017	Spice Time and Spice Supreme	Beef Flavored Bouillon Cube products	Undeclared soy and Wheat	Gel Spice Company, Inc.
12/19/2017	Apple Ridge	Gala, Fuji, Honeycrisp and Golden Delicious apples	Listeria monocytogenes	Jack Brown Produce, Inc.

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
12/13/2017	GnuPharma Corp.	Dallas District Office	CGMP/Dietary Supplement/Adulterated/Misbranded	Not Issued *
12/08/2017	K & S Food Center LLC	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
09/15/2017	Grandma's Herbs	Denver District Office	New Drug/Misbranded	Not Issued *
07/26/2017	Madison One Acme Inc	Los Angeles District Office	Unapproved New Drugs/Misbranded	Not Issued *
07/21/2017	Amafruits	Chicago District Office	New Drug/Misbranded	Not Issued *
07/06/2017	Professional Botanicals, Inc.	Denver District Office	Dietary Supplement/Promotional Claims False & Misleading/Adulterated/Misbranded	Not Issued *

@FDAfood, @FDA_ORA, @US_FDA

· Did you know that #FDA’s “Hazard Guide” - or roadmap for fisherman and processors - plays a key role in keeping you safe from contaminated seafood? MORE: https://go.usa.gov/xnZrv
· #FridayFact: In 2016, @TheJusticeDept and #USMarshals conducted four seizures of adulterated products on behalf of FDA. MORE: https://go.usa.gov/xnWCW

askFSIS

Donating retail exempt meat or poultry product

December 21, 2017

Federal Register

Agricultural Marketing Service

Proposed Rules

Honey Packers and Importers Research, Promotion, Consumer Education and Industry Information Order; Change in Producer Eligibility Requirements and Implementation of Charges for Past Due Assessments

Filed on: 12/21/2017 at 08:45 am Scheduled Pub. Date: 12/22/2017

FR Document: 2017-27526 PDF 19 Pages (266 KB) Permalink

Food Safety and Inspection Service

Notices

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

Common or Usual Name for Raw Meat and Poultry Products Containing Added Solutions

Filed on: 12/21/2017 at 08:45 am Scheduled Pub. Date: 12/22/2017

FR Document: 2017-27637 PDF 8 Pages (187 KB) Permalink

Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery

Filed on: 12/21/2017 at 08:45 am Scheduled Pub. Date: 12/22/2017

FR Document: 2017-27638 PDF 10 Pages (93.4 KB) Permalink

Meetings:

Codex Alimentarius Commission: Codex Committee on Contaminants in Food

Filed on: 12/21/2017 at 08:45 am Scheduled Pub. Date: 12/22/2017

FR Document: 2017-27631 PDF 10 Pages (238 KB) Permalink

FDA

FDA Clarifies Approved Free-Choice Feeding Options for Anaplasmosis Control in Cattle

GRAS Notices

GRN No. (sorted Z-A)	Substance	FDA's Letter
748	Tomato powder	Pending
747	Calcium lactate	Pending
746	Maltogenic amylase from Geobacillus stearothermophilus produced in Bacillus subtilis	Pending
745	Steviol glycosides consisting primarily of rebaudioside M	Pending
744	Steviol glycosides consisting primarily of rebaudioside M	Pending
743	β-galactosidase from Papiliotrema terrestris	Pending
742	Duckweed (subfamily Lemnoideae) powder	Pending
741	Dimethyl ether	Pending

@FDAfood, @FDA_ORA, @US_FDA

· Don't get a RAW DEAL by eating raw cookie dough this holiday season! Keep yourself and your family safe by following this #FDAORA consumer update: https://go.usa.gov/xnZ4T
· #FDAORA & @FDAFood collaborate to implement #FSMA: Hear from #foodsafety experts & investigators about the Produce Safety Network, a collaborative effort to implement the #producesafety rule and prevent #foodborneillness associated w/produce: https://go.usa.gov/xnQMP
· #RECALL - Gel Spice Company, Inc. Issues #allergy alert on undeclared #soy and #wheat In Spice Time & Spice Supreme Beef Flavored Bouillon Cube Products. http://dlvr.it/Q6lWZx

FSIS

FSIS Reaches Key Milestones in Protecting Public Health

AMS

Expanding U.S. Commodity Markets Top Priority for USDA’s Agricultural Market Service

USDA Announces Cattlemen’s Beef Promotion and Research Board Appointments

APHIS

APHIS’ 2017 Accomplishments Support American Producers and Protect U.S. Agriculture

Food and Water Watch

EPA Gives Monsanto an Early Holiday Present

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