Laws and Regulations Committee Update 9/10 – 9/12, 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
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
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
FSIS
ADVISORY: FSIS Small Plant Outreach Roundtable with Congressman Ted Yoho to Discuss Siluriformes Inspection
@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
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
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