November 29, 2018

Federal Register

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 11/29/2018 at 8:45 am Scheduled Pub. Date: 11/30/2018

FR Document: 2018-26027 PDF 4 Pages (90.4 KB) Permalink

• Ø Relating to specimen submissions under the Animal Health Protection Act (AHPA)

Filed on: 11/29/2018 at 8:45 am Scheduled Pub. Date: 11/30/2018

FR Document: 2018-26036 PDF 4 Pages (114 KB) Permalink

• Ø Relating to medical qualifications of applicants to FSIS Food Inspector, Consumer Safety Inspector, or Veterinary Medical Officer positions

Animal and Plant Health Inspection Service

Notices

Environmental Impact Statements; Availability, etc.:

Cattle Fever Tick Control Barrier in South Texas

Filed on: 11/29/2018 at 8:45 am Scheduled Pub. Date: 11/30/2018

FR Document: 2018-26068 PDF 3 Pages (82.7 KB) Permalink

Environmental Protection Agency

Notices

Registration Review:

Draft Human Health and/or Ecological Risk Assessments for Several Pesticides; Availability

Filed on: 11/29/2018 at 8:45 am Scheduled Pub. Date: 11/30/2018

FR Document: 2018-26086 PDF 8 Pages (243 KB) Permalink

FDA

FDA warns consumers to avoid Rhino male enhancement products found at retailers because of undeclared and potentially dangerous drug ingredients

FDA Adds Resources to Assist Food Facilities with This Year’s Biennial Registration Renewal

Salmonella Linked to Tahini

Recalls

Date	Brand	Product Description	Reason/Problem	Company
11/28/2018	ANF	Lamb and Rice Dry Dog Food	Elevated Levels of Vitamin D	ANF, Inc
11/28/2018	Sprout Creek Farm	Kinkead raw cows' milk cheese	Listeria monocytogenes	Sprout Creek Farm, Inc.

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
09/07/2018	The Delano Company, Inc. dba LifeLink	Los Angeles District Office	Unapproved New Drugs/Misbranded	Not Issued *

AMS

USDA Settles a Case with Enumclaw Sales Pavilion Inc., Resulting in a $1,600 Penalty

USDA Settles a Case with Flying N Cattle Exchange Resulting in a $3,500 Penalty

FNS

FY 2019 Technology Innovation Grants (TIG)

FY 2019 Administrative Review and Training Grants

NAD

NAD Recommends Eli Nutrition Discontinue Certain Challenged Claims for TummyZen Dietary Supplement; Advertiser to Appeal to NARB

NAD Recommends Dermatology Industry Discontinue Sun Protection Claims for the Companies’ Dietary Supplement Products

NAD Recommends Novahue LLC Discontinue Sun Protection Claims for the Companies’ Novahue Skin Dietary Supplement Product

National Academies

New IAP Report Urges Reliance on Science to Develop Sustainable Food and Agricultural Systems

@SGottliebFDA, @FDArecalls

• Ø Certain uses of science should be judged intolerable, and cause scientists to be cast out. The use of CRISPR to edit human embryos or germ line cells should fall into that bucket. Anything less puts the science and the entire scientific enterprise at risk. https://www.biocentury.com/bc-extra/politics-policy/2018-11-28/%E2%80%98tepid%E2%80%99-response-crispr-embryo-editing-could-lead- …
• Ø We’re warning to consumers not to buy various Rhino male enhancement products disguised as supplements due to hidden drug ingredients. These products are often found at convenience stores and online retailers and can be hazardous to patient health. https://go.usa.gov/xP685
• Ø More than 25 products have been marketed with variations of the name Rhino. #FDA will continue to pursue regulatory and criminal actions against the producers and distributors of these products in an effort to protect consumer health. https://go.usa.gov/xP68w
• Ø #FDA updated its web page on the romaine linked E. coli outbreak to provide more specific information to consumers about the counties of concern in the Central Coast growing regions of northern and central CA https://go.usa.gov/xPFbu
• Ø #FDA has been conducting a traceback investigation, reviewing shipping records and invoices to trace the supply of romaine from the place where ill people were exposed to the place where that romaine was grown.
• Ø We have had boots on the ground collecting environmental, soil, and water samples for laboratory analysis to identify whether they contain E. coli since last week. Should positive samples be identified, we will update the public promptly.
• Ø Romaine harvested from locations outside of the CA regions identified in the investigation does not appear to be related to the current outbreak. Our advice for consumers remains and we will continue to update our investigation as we learn more.

Sprout Creek Farm Recalls “Kinkead” Cheese due to Possible Health Risk http://dlvr.it/QsLkMg

November 30, 2018

Federal Register

Food and Nutrition Service

Notices

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

Federal-State Supplemental Nutrition Programs Agreement

Filed on: 11/30/2018 at 8:45 am Scheduled Pub. Date: 12/03/2018

FR Document: 2018-26128 PDF 6 Pages (168 KB) Permalink

• Ø Relating to WIC, FMNP and SNAP reporting burdens

FDA

FDA’s Global Efforts to Protect Patients and Consumers from Unsafe Products

Recalls

Date	Brand	Product Description	Reason/Problem	Company
11/29/2018	Elm Pet Foods	Pet Food	Elevated levels of Vitamin D	ELM Pet Foods

FSIS

Recalls

Product Recalled	Date of Recall	Retail Distribution List
116-2018 165368 C. Corporation Recalls Pork Products Due to Possible Listeria Contamination | En Español	Nov 20, 2018	Nov 30, 2018

OMB

AGENCY: USDA-AMS	RIN: 0581-AD54	Status: Concluded
TITLE: National Bioengineered Food Disclosure Standard
STAGE: Final Rule	ECONOMICALLY SIGNIFICANT: Yes
RECEIVED DATE: 08/31/2018	LEGAL DEADLINE: Statutory
** COMPLETED: 11/29/2018	COMPLETED ACTION: Consistent with Change
AGENCY: USDA-FNS	RIN: 0584-AE53	Status: Concluded
TITLE: Child Nutrition Programs: Flexibilities for Milk, Whole Grains, and Sodium Requirements
STAGE: Final Rule	ECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 07/05/2018	LEGAL DEADLINE: None
REVIEW EXTENDED
** COMPLETED: 11/29/2018	COMPLETED ACTION: Consistent with Change

FTC

FTC Returns more than $750,000 to Consumers Who Bought Two Deceptively Marketed Supplements from Health Research Laboratories, LLC

@FDArecalls, @SGottliebFDA, @FDAfood

• Ø Gemini Food Corporation Conducts Voluntary Recall of Imperial Taste Fried Red Onions and Fried Garlic Due to Undeclared Wheat http://dlvr.it/QsRQMR
• Ø ELM Pet Foods Recall of Dry Dog Food Due to Elevated Levels of Vitamin D http://dlvr.it/QsQn54
• Ø THREAD: Today, #FDA warned a company for selling nicotine-containing e-liquids that resemble kid-friendly foods, such as cereal, candy & peanut butter and jelly. The action is part of the agency’s ongoing efforts to protect kids from tobacco products: https://go.usa.gov/xPFvf
• Ø We’re seeing too many cases of e-liquid packaging that resembles children’s food items. There’s no excuse for this sort of egregious marketing that can lead to accidental ingestion of nicotine by young kids. We’ll continue to target these products and companies that market them.
• Ø This new warning letter is part of series of actions over the past several months to address an epidemic growth in the use of e-cigarettes by children. Those include actions to target those who design products in ways that are clearly marketed to appeal to children.
• Ø #FDA will continue to implement new steps to ensure children aren’t started down a path to nicotine addiction. No child should be using any tobacco product. We’ll continue to hold industry accountable to ensure these products aren’t being marketed to, sold to or used by kids.
• Ø It's time for a biennial registration renewal for @FDAfood regulated food manufacturers. What does that mean? Do you need to register? How should your firm go about renewing? Any time saving tips? All those answers & more here: http://ow.ly/x0Bf30mN1WA .

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