September 10, 2018

Federal Register

Environmental Protection Agency

Rules

Pesticide Tolerances:

Cloquintocet-mexyl

Filed on: 09/10/2018 at 08:45 am Scheduled Pub. Date: 09/11/2018

FR Document: 2018-19757 PDF 11 Pages (314 KB) Permalink

Spiromesifen

Filed on: 09/10/2018 at 08:45 am Scheduled Pub. Date: 09/11/2018

FR Document: 2018-19760 PDF 22 Pages (309 KB) Permalink

Tolerance Exemptions:

2-Propenoic acid, 2-methyl-, 2-oxiranylmethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and 2-ethylhexyl 2-propenoate

Filed on: 09/10/2018 at 08:45 am Scheduled Pub. Date: 09/11/2018

FR Document: 2018-19758 PDF 13 Pages (318 KB) Permalink

FDA

Recalls

Date	Brand	Product Description	Reason/Problem	Company
09/08/2018	Gravel Ridge Farms	Cage Free Eggs	Salmonella	Gravel Ridge Farms
09/07/2018	Steve's Real Food, Quest	Pet food	Steve's Real Food, Quest	Steve's Real Food

USDA

USDA Extends Deadline for Expressions of Interest for New ERS & NIFA Headquarters

FSIS

Sep 07, 2018 | PDF

• September is Food Safety Education Month
• Webinar: Reporting of Whole Genome Sequencing Results in Quarterly Establishment Information Letters
• Disasters Happen: Prepare Now. Learn How.

AMS

Pre-Solicitation Announcement for Trade Mitigation Purchase of Orange (Fresh) Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Orange (Juice) Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Lemon (Fresh) Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Hazelnut Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Potatoes Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Grapefruit (Fresh) Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Lentils Dry Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Grape (Dried and Fresh) Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Beans Dark Red Kidney Can 24/300

Pre-Solicitation Announcement for Trade Mitigation Purchase of Fig Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Beans Navy Dry, Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Cranberry Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Beef Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Apple Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Pork Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Walnut Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Strawberry Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Plum (Dried and Fresh) Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Pistachio Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Pecan Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Pear (Fresh) Products

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

• · Public Comment Request: FDA issued draft guidance for industry on the labeling of live microbial ingredients (#Probiotics) in dietary supplements. This guidance represents our current thinking on the topic & is now open for public comment. https://go.usa.gov/xPxNK
• · It’s #backtoschool time & kids are starting sports practices. Companies are offering dietary supplements that falsely claim to prevent, treat, or cure concussions & traumatic brain injuries. LEARN MORE in this #FDAConsumerUpdate: https://go.usa.gov/xUfB5 #FDAhealthfraud
• · DYK The term "cosmeceutical" has no meaning under the law. Don't be confused by cosmetics labeling, find out more https://go.usa.gov/xPqaY
• · Before enjoying that delicious, nutritious juice find out what you need to know about avoiding #foodborne illnesses. http://go.usa.gov/xU5eU
• · Did you know that children under 5, pregnant women, adults 65 and older, and people with weakened immune systems are more likely to get food poisoning? https://go.usa.gov/xQf96 #FoodSafetyMonth
• · Gravel Ridge Farms Recalls Cage Free Egg Due to Possible Salmonella Contamination http://dlvr.it/QjYBrG
• · States continue to raise concerns related to Kratom; as more states look to ban or limit access to the opioid
• · Steve’s Real Food Voluntarily Recalls One Lot of Turducken Recipe, One Lot of Quest Emu, and One Lot of Quest Beef Due to Possible Salmonella and L. Mono Contamination http://dlvr.it/QjYspv
• · This week #FDAORA leadership will be attending the 102nd National Association of State Departments of Agriculture (NASDA) Annual Meeting @NASDANews #ORAInfo

September 11, 2018

Federal Register

Food and Drug Administration / Food Safety and Inspection Service

Notices

Meetings:

Joint Public Meeting on Use of Cell Culture Technology to Develop Products Derived from Livestock and Poultry

Filed on: 09/10/2018 at 04:15 pm Scheduled Pub. Date: 09/13/2018

FR Document: 2018-19907 PDF 16 Pages (396 KB) Permalink

Food and Drug Administration

Rules

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

Filed on: 09/11/2018 at 08:45 am Scheduled Pub. Date: 09/12/2018

FR Document: 2018-19855 PDF 11 Pages (198 KB) Permalink

Agricultural Marketing Service

Rules

Cranberries Grown in States of Massachusetts, et al.:

Establishment of 2018-19 Seasonal Volume Regulation

Filed on: 09/11/2018 at 08:45 am Scheduled Pub. Date: 09/12/2018

FR Document: 2018-19825 PDF 42 Pages (297 KB) Permalink

Proposed Rules

Pears Grown in Oregon and Washington:

Decreased Assessment Rate for Processed Pears

Filed on: 09/11/2018 at 08:45 am Scheduled Pub. Date: 09/12/2018

FR Document: 2018-19683 PDF 14 Pages (248 KB) Permalink

Notices

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

Almonds Grown in California (Marketing Order No. 981)

Filed on: 09/11/2018 at 08:45 am Scheduled Pub. Date: 09/12/2018

FR Document: 2018-19827 PDF 6 Pages (130 KB) Permalink

Environmental Protection Agency

Rules

Pesticide Tolerances; Exemptions:

Metschnikowia fructicola strain NRRL Y-27328

Filed on: 09/11/2018 at 08:45 am Scheduled Pub. Date: 09/12/2018

FR Document: 2018-19870 PDF 10 Pages (309 KB) Permalink

Notices

Pesticide Product Registrations:

Applications for New Uses

Filed on: 09/11/2018 at 08:45 am Scheduled Pub. Date: 09/12/2018

FR Document: 2018-19869 PDF 6 Pages (171 KB) Permalink

FDA

FDA’s Center for Veterinary Medicine Announces Third eSubmitter Webinar in Ongoing Series

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

FDA Investigating Multistate Outbreak of Salmonella Enteritidis Linked to Shell Eggs from Gravel Ridge Farms

Recalls

Date	Brand	Product Description	Reason/Problem	Company
09/10/2018	Gourmet Take Away	Sesame Noodle Salad	Undeclared egg	Market of Choice

USDA

USDA and FDA Announce Joint Public Meeting on Use of Animal Cell Culture Technology to Develop Products Derived from Livestock and Poultry

FSIS

ADVISORY: FSIS Small Plant Outreach Roundtable with Congressman Ted Yoho to Discuss Siluriformes Inspection

USDA and FDA announce joint public meeting on use of animal cell culture technology to develop products derived from livestock and poultry

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

• · FDA’s Center for Veterinary Medicine Announces Third eSubmitter Webinar in Ongoing Series...Save the Date - September 19! https://go.usa.gov/xPCkd
• · FDA highlights its BPA research at FDA Sept 13 Grand Rounds https://go.usa.gov/xUFhV
• · Today @SGottliebFDA & @SecretarySonny announced a joint public meeting this Oct. to discuss the use of cell culture technology to develop products derived from livestock & poultry: https://go.usa.gov/xPCQY
• · Agriculture Secretary Sonny and FDA Commissioner Scott Gottlieb, M.D. today announced a joint public meeting to be held on Oct. 23-24, 2018, to discuss the use of cell culture technology to develop products derived from livestock and poultry. https://go.usa.gov/xPCUb
• · THREAD: 1/6 Today, @SecretarySonny and I announced a joint public meeting to be held Oct. 23-24 to discuss the use of cell culture technology to develop products derived from livestock and poultry https://go.usa.gov/xPCQY
• · 2/6 FDA knows how vital it is to ensure safety of our nation’s food supply and the critical role science and risk-based, modern regulatory frameworks are to fostering innovation.
• · 3/6 I look forward to the opportunity to hold a meeting with our @USDA colleagues as part of an open public dialogue about this technology and the products.
• · 4/6 The public meeting’s 1st day (Oct. 23) will focus on potential hazards that need to be controlled for the safe production of animal cell cultured food products & oversight considerations by regulatory agencies.
• · 5/6 The public meeting’s 2nd day (Oct. 24) will focus on labeling considerations. More info. including how to submit comments and register: https://go.usa.gov/xPCQV
• · 6/6 Comments previously submitted to #FDA from our July 12, 2018 public meeting will also be considered: https://go.usa.gov/xPCQT
• · ICYMI - update from @SGottliebFDA on upcoming meeting to discuss the use of cell culture technology to develop products derived from livestock and poultry
• · Are you prepared for #HurricaneFlorence? Learn how to protect your food & water during power outages and flooding. Follow these #hurricane #FoodSafety tips: http://go.usa.gov/36q9d
• · Federal & state health officials are investigating cases of #Salmonella associated with eggs from Gravel Ridge Farms. The company has cooperated & taken swift action to issue a recall. https://go.usa.gov/xPCpP 1of3
• · The eggs were distributed to TN, AL & GA. If any consumers have Gravel Ridge Farms eggs in their refrigerator, they should be thrown out, regardless of the date stamped on package 2of3
• · FDA has started inspecting Gravel Ridge Farm facility & the company has stopped shipments of eggs. Consumers should check eggs in their refrigerator against recall notice & throw away or return any impacted product 3of3
• · Interested in attending our joint public meeting with @USDA to discuss the use of cell culture technology to develop products derived from livestock and poultry? Pre-register here: https://go.usa.gov/xPCU6
• · Market of Choice Issues Allergy Alert for Undeclared Egg in Sesame Noodle Salad Vegan http://dlvr.it/Qjn8tg

September 12, 2018

Federal Register

Food and Drug Administration

Proposed Rules

Public Information

Filed on: 09/12/2018 at 08:45 am Scheduled Pub. Date: 09/13/2018

FR Document: 2018-19864 PDF 29 Pages (179 KB) Permalink

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: 09/12/2018 at 08:45 am Scheduled Pub. Date: 09/13/2018

FR Document: 2018-19909 PDF 5 Pages (23.1 KB) Permalink

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

Filed on: 09/12/2018 at 08:45 am Scheduled Pub. Date: 09/13/2018

FR Document: 2018-19911 PDF 4 Pages (18.4 KB) Permalink

Food Contact Substance Notification Program

Filed on: 09/12/2018 at 08:45 am Scheduled Pub. Date: 09/13/2018

FR Document: 2018-19898 PDF 10 Pages (120 KB) Permalink

Meetings:

Science Board to Food and Drug Administration Advisory Committee

Filed on: 09/12/2018 at 08:45 am Scheduled Pub. Date: 09/13/2018

FR Document: 2018-19906 PDF 4 Pages (81.9 KB) Permalink

Environmental Protection Agency

Rules

Pesticide Tolerances:

Afidopyropen

Filed on: 09/12/2018 at 08:45 am Scheduled Pub. Date: 09/13/2018

FR Document: 2018-19951 PDF 27 Pages (211 KB) Permalink

Tolerance Exemptions:

Bacteriophage Active against Xanthomonas citri subsp. citri

Filed on: 09/12/2018 at 08:45 am Scheduled Pub. Date: 09/13/2018

FR Document: 2018-19958 PDF 10 Pages (390 KB) Permalink

Pepino Mosaic Virus, Strain CH2, Isolate 1906

Filed on: 09/12/2018 at 08:45 am Scheduled Pub. Date: 09/13/2018

FR Document: 2018-19959 PDF 10 Pages (387 KB) Permalink

Tolerance Requirements; Exemptions:

Bacteriophage Active against Erwinia amylovora

Filed on: 09/12/2018 at 08:45 am Scheduled Pub. Date: 09/13/2018

FR Document: 2018-19954 PDF 9 Pages (388 KB) Permalink

FDA

On-Farm Readiness Reviews Support Farmers as They Safeguard Produce

Statement from FDA Commissioner Scott Gottlieb, M.D., on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
09/05/2018	Samuel Zimmerman	New York District Office	PHS Act/Shell Egg Regulation/Adulterated	Not Issued *
09/04/2018	Chillin Mix Kratom	Center for Drug Evaluation and Research	Finished Pharmaceuticals/Unapproved New Drug/Misbranded	Not Issued *
09/04/2018	Mitra Distributing Inc.	Center for Drug Evaluation and Research	Finished Pharmaceuticals/Unapproved New Drug/Misbranded	Not Issued *

FSIS

CTI Foods LLC Recalls Ready-To-Eat Philly Steak Products Due To Possible Listeria Contamination

AMS

Pre-Solicitation Announcement for Trade Mitigation Purchase of Dry Peas Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Rice Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Dairy Products

Pre-Solicitation Announcement for Trade Mitigation Purchase of Peanut Products

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

• · Statement from FDA Commissioner @SGottliebFDA on new warning letters FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about kratom https://go.usa.gov/xPrqS
• · In making preparations for #HurricaneFlorence, learn how to protect your food and water during power outages and flooding. Follow these #hurricane #FoodSafety tips: http://go.usa.gov/36q9d
• · Find out about #foodsafety today! https://go.usa.gov/xPrqN
• · Are you in the potential path of a hurricane? Prepare now – not just for yourselves, but also for your livestock. https://go.usa.gov/xPCv9 #Florence #Olivia #Isaac
• · In the path of Hurricane Florence? Heavy rains may cause flooding & power loss that can compromise the safety of your food. It’s not too late to make sure your food stays safe! Actions you can take NOW before the storm hits: http://go.usa.gov/xUzMu #HurricaneFlorence
• · Prepare now, it’s not too late - FDA's advice on #foodsafety in case you lose power ⇨ http://go.usa.gov/xQwku #HurricaneFlorence
• · FDA is committed to making sure that the standards designed to minimize the risk of produce contamination are workable, and that farmers have the information and tools needed to effectively implement them. https://go.usa.gov/xPrgS
• · My statement on new warning letters #FDA is issuing to companies marketing kratom with unproven medical claims; and the agency’s ongoing concerns about the risks associated with the opioid kratom http://go.usa.gov/xPrqS
• · FDA’s Special Agents/@TheJusticeDept: Kentucky cattle company and veterinarian indicted for false health certificates on livestock https://go.usa.gov/xPC8y

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