May 22, 2018

Federal Register

Food and Nutrition Service

Notices

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

School Breakfast Program

Filed on: 05/22/2018 at 08:45 am Scheduled Pub. Date: 05/23/2018

FR Document: 2018-11073 PDF 4 Pages (149 KB) Permalink

Agricultural Marketing Service

Proposed Rules

National Bio engineered Food Disclosures Standard

Filed on: 05/22/2018 at 08:45 am Scheduled Pub. Date: 05/23/2018

FR Document: 2018-11025 PDF 2 Pages (8.49 KB) Permalink

Environmental Protection Agency

Rules

Pesticide Tolerances:

Clopyralid

Filed on: 05/22/2018 at 08:45 am Scheduled Pub. Date: 05/23/2018

FR Document: 2018-10693 PDF 24 Pages (458 KB) Permalink

FDA

Recalls

Date	Brand Name	Product Description	Reason/Problem	Company
05/21/2018	Melanie	Mini Cookies with Caramel Flavor	Undeclared peanuts	Melanie Wholesale Inc.
05/18/2018	Ziyad	Tahini	Salmonella	Ziyad Brothers Importing
05/18/2018	Melanie	Liubitelskie Cookies	Undeclared peanuts	Melanie Wholesale Inc.

FSIS

J Bar B Foods Recalls Chicken Sausage Products due to Misbranding and an Undeclared Allergen

AskFSIS

Breaking of Shell Eggs Associated with Highly Pathogenic Avian Influenza (HPAI) Part II

What is the serving size for bologna packaged in one-ounce slices?

Does the serving size weight include the weight of bone for bone-in meat and poultry cuts?

The Reason to Develop a Food Defense Plan

AMS

USDA Restricts PACA Violators in Florida and Illinois from Operating in the Produce Industry

OEHHA

Acrylamide – Information about the Proposition 65 carcinogen acrylamide

@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA, @FDAMedia, @FDAanimalhealth, @FDArecalls

• · Ziyad Brothers Importing Recalls Tahini Because of Possible Health Risk http://dlvr.it/QTbXlN
• · Even though Food Allergy Action Month is coming to an end, always stay alert for symptoms & know actions to take if a food allergy occurs. https://go.usa.gov/xQPQf
• · Get outside & gather yummy fruit #PickStrawberriesDay. We have guidelines for selecting & safely serving strawberries plus other fruit & vegetables. for http://go.usa.gov/xXXvB
• · Melanie Wholesale Issues Allergy Alert on Undeclared Peanuts in Cookies http://dlvr.it/QTcYzg

Melanie Wholesale Inc. Issues Allergy Alert on Undeclared Peanuts in Melanie Mini Cookies with Caramel Flavor http://dlvr.it/QTcjp7

May 23, 2018

Federal Register

Food and Drug Administration

Notices

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

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

Filed on: 05/23/2018 at 08:45 am Scheduled Pub. Date: 05/24/2018

FR Document: 2018-11114 PDF 8 Pages (44.2 KB) Permalink

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 05/23/2018 at 08:45 am Scheduled Pub. Date: 05/24/2018

FR Document: 2018-11094 PDF 3 Pages (87.9 KB) Permalink

Continued Suspension of Supervision Fee Assessment under the United States Grain Standards Act

Filed on: 05/23/2018 at 08:45 am Scheduled Pub. Date: 05/24/2018

FR Document: 2018-11086 PDF 3 Pages (79.4 KB) Permalink

Animal and Plant Health Inspection Service

Rules

National Environmental Policy Act Implementing Procedures

Filed on: 05/23/2018 at 08:45 am Scheduled Pub. Date: 05/24/2018

FR Document: 2018-11083 PDF 35 Pages (266 KB) Permalink

Agricultural Marketing Service

Proposed Rules

Irish Potatoes Grown in Colorado; Increased Assessment Rate for Area No. 2

Filed on: 05/23/2018 at 08:45 am Scheduled Pub. Date: 05/24/2018

FR Document: 2018-11084 PDF 15 Pages (258 KB) Permalink

Environmental Protection Agency

Pesticide Tolerances:

Pydiflumetofen

Filed on: 05/23/2018 at 08:45 am Scheduled Pub. Date: 05/24/2018

FR Document: 2018-11192 PDF 34 Pages (386 KB) Permalink

Notices

Registration Reviews:

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

Filed on: 05/23/2018 at 08:45 am Scheduled Pub. Date: 05/24/2018

FR Document: 2018-11196 PDF 8 Pages (238 KB) Permalink

Proposed Interim Decisions for Several Pesticides

Filed on: 05/23/2018 at 08:45 am Scheduled Pub. Date: 05/24/2018

FR Document: 2018-11193 PDF 8 Pages (304 KB) Permalink

FDA

FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses

Statement from FDA Commissioner Scott Gottlieb, M.D., on new FDA actions to keep consumers safe from the harmful effects of sun exposure, and ensure the long-term safety and benefits of sunscreens

Recalls

Date	Brand Name	Product Description	Reason/Problem	Company
05/22/2018	Golden International brand or none	Farm Raised Frozen whole tilapia fish IQF	Stolen and may be contaminated with Salmonella	Golden International Corporation

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
05/18/2018	Front Range Kratom	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
05/18/2018	Pharmacy Direct, PDU	Center for Food Safety and Applied Nutrition	New Drug/Labeling/Misbranded	Not Issued *
05/18/2018	Revibe, Inc.	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
05/18/2018	GliSODin Skin Nutrients	Center for Food Safety and Applied Nutrition	New Drug/Labeling/Misbranded	Not Issued *
05/18/2018	Sunergized LLC	Center for Food Safety and Applied Nutrition	New Drug/Labeling/Misbranded	Not Issued *
05/18/2018	Kratom Spot	Center for Drug Evaluation and Research	Unapproved New Drug/Misbranded	Not Issued *
05/18/2018	Napa Valley Bioscience	Center for Food Safety and Applied Nutrition	New Drug/Labeling/Misbranded	Not Issued *
05/16/2018	New England Confectionery Company, Inc.	Center for Food Safety and Applied Nutrition	CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated	Not Issued *

AskFSIS

How should servings per container be expressed for discrete units?

Is the product of the number of servings multiplied by the parenthetical metric equivalent of the serving size expected to equal the net quantity of the product declared on the principal display panel?

AMS

AMS Adds Export Verification Program for Beef Exports to Australia

@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA, @FDAMedia, @FDAanimalhealth, @FDArecalls

• · DYK? For high impact recalls, #FDAORA provides additional insight of its involvement and other information for consumers & industry representatives. Check out the major product recalls HERE: http://go.usa.gov/xnZaZ #FDARecalls101
• · FDA warns companies selling illegal, unapproved kratom products marketed for opioid cessation, pain treatment and other medical uses: http://go.usa.gov/xQmgG
• · FDA takes action against unapproved drugs deceptively marketed for the treatment of opioid addiction and withdrawal. Today we posted warning letters to 3 kratom companies. Unsubstantiated claims also included lowering blood pressure & treating cancer http://go.usa.gov/xQmgG
• · Planning to eat outdoors during the warm-weather months? Of course you are! Remember to handle food safely! https://go.usa.gov/xQmBm
• · Today we sent warning letters to five companies illegally marketing pills and capsules labeled as dietary supplements that made unproven drug claims about protecting consumers from sun exposure. https://go.usa.gov/xQmjW
• · Enjoy the summer – and protect yourselves and your loved ones from sun damage. #FDA is continuing to take actions to ensure that the products you use are safe and effective. https://go.usa.gov/xQmjW
• · Golden International Corporation Issues Public Safety Warning For Stolen Tilapia Because of Possible Health Risk http://dlvr.it/QTmv4L

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