Laws and Regulations Committee Update 7/30 – 8/3, 2018

Federal Register

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 07/30/2018 at 08:45 am Scheduled Pub. Date: 07/31/2018

FR Document: 2018-16180  PDF 4 Pages (90.2 KB)  Permalink

Filed on: 07/30/2018 at 08:45 am Scheduled Pub. Date: 07/31/2018

FR Document: 2018-16261  PDF 3 Pages (16.6 KB)  Permalink

Food Safety and Inspection Service

Proposed Rules

Elimination of the Requirement That Livestock Carcasses Be Marked U.S. Inspected and Passed at the Time of Inspection within a Slaughter Establishment for Carcasses to be Further Processed within the Same Establishment

Filed on: 07/30/2018 at 08:45 am Scheduled Pub. Date: 07/31/2018

FR Document: 2018-16345  PDF 17 Pages (220 KB)  Permalink

Preparation of Uninspected Products Outside of the Hours of Inspectional Supervision

Filed on: 07/30/2018 at 08:45 am Scheduled Pub. Date: 07/31/2018

FR Document: 2018-16339  PDF 14 Pages (224 KB)  Permalink

FDA

Recalls

DateBrand NameProduct DescriptionReason/ProblemCompany
07/28/2018Premo, Fresh GrabSandwiches Listeria monocytogenesLipari Foods LLC
07/26/2018TeaSource  Loose Leaf TeaUndeclared almondsTeaSource

USDA

USDA Invites Comments on the Implementation of the e-Connectivity Pilot Program

Secretary Perdue Statement on EJC Ruling on Genome Editing

FSIS

Jul 27, 2018 | PDF

  • Availability of Guideline for Minimizing the Risk of Campylobacter and Salmonella Illnesses Associated with Chicken Liver
  • FSIS Posts Updated Quarterly Sampling Results
  • FSIS Seeks Comments on Two Deregulatory Actions
  • FSIS Extends Deadline for the Small and Very Small Plant Outreach Survey

AMS

USDA Restricts PACA Violators in California from Operating in the Produce Industry

USDA Extends Restrictions on Two Produce Businesses in Florida for Repeated PACA Violations

USDA Restricts PACA Violators in Arizona and Texas from Operating in the Produce Industry

OEHHA

Announcement of the Developmental and Reproductive Toxicant Identification Committee Meeting Scheduled For October 11, 2018 and Availability of Hazard Identification Materials for Nickel and Nickel Compounds

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

  • TeaSource Issues Allergy Alert on Undeclared Almonds in Product http://dlvr.it/Qd0GnQ 
  • Lipari Foods Issues Voluntary Recall of Premo Brand & Fresh Grab Turkey & Swiss Submarine Sandwiches Due to Potential Contamination of Listeria Monocytogenes http://dlvr.it/Qd5Pmf 
  • FOOD RECALL: Lipari Foods is recalling certain Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches due to potential Listeria contamination. No illnesses at this time. https://go.usa.gov/xUVvT 
  • #FDA is working with Lipari Foods to recall certain Premo Brand and Fresh Grab turkey and Swiss submarine sandwiches due to potential Listeria contamination. No illnesses have been reported at this time: https://go.usa.gov/xUVvT 

July 31, 2018

Federal Register

Animal and Plant Health Inspection Service

Notices

Environmental Assessments; Availability, etc.:

Texas A and M AgriLife Research; Cotton Genetically Engineered for Ultra-low Gossypol Levels in Cottonseed

Filed on: 07/31/2018 at 08:45 am Scheduled Pub. Date: 08/01/2018

FR Document: 2018-16389  PDF 7 Pages (184 KB)  Permalink

Environmental Protection Agency

Rules

Tolerance Exemptions:

Titanium dioxide

Filed on: 07/31/2018 at 08:45 am Scheduled Pub. Date: 08/01/2018

FR Document: 2018-16470  PDF 17 Pages (200 KB)  Permalink

USDA

USDA Encourages Rural Communities, Water Districts to Apply for Loans to Improve, Rebuild Infrastructure; $4 Billion Available

In Argentina, Perdue Welcomes U.S. Pork Back to Market

FSIS

Establishment Application for Export (FSIS Form 9080-3)

FSIS Issues Public Health Alert for Beef, Pork and Poultry Products due to Concerns about Contamination with Cyclospora

Minimizing the Risk of Campylobacter and Salmonella Illnesses Associated with Chicken Liver (Jul 2018)

APHIS

USDA Begins 2018 Oral Rabies Vaccine Efforts in Eastern United States

AMS

USDA Sets Referendum Dates for South Texas Onions Marketing Order Proposed Amendments

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

August 1, 2018

FDA

Warning Letters

Letter Issue DateCompany NameIssuing OfficeSubjectClouse Out Date
07/26/2018Kerry IncChicago District OfficeCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedNot Issued *
07/13/2018GC NaturalLos Angeles District Office   CGMP/Dietary Supplement/Adulterated/MisbrandedNot Issued *

FSIS

Availability of Updated Meat and Poultry Hazards and Controls Guide

APHIS

Availability of Draft Environmental Assessment and Draft Plant Pest Risk Assessment for Petition to Deregulate GE Low-Gossypol Cotton

NIH-ODS

Message from ODS Acting Director Dr. Joseph Betz

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

  • #TipoftheDay: Try to choose and prepare foods with little salt, at the same time consume potassium-rich foods, such as fruits and vegetables. *Photo by @eastofkitchen
  • Are you prepared for severe storms & other natural disasters? Did you consider #foodsafety strategies? Have your plan in place – http://go.usa.gov/xRADn 
  • We’re at the end of #NationalGrillingMonth but that doesn’t mean we should stop following BBQ #foodsafety steps! http://go.usa.gov/xNAhN 
  • We value our longstanding partnership w/@US_FDA to combat the many variables related to anti-microbial resistance and look forward to working with FDA and livestock producers to bring forward science-based, common-sense solutions in the future.
  • OUTBREAK UPDATE: #FDA recently confirmed cyclospora in Fresh Express salad mix used in recalled McDonald’s salads. No product should be available for consumers. Investigation is ongoing. https://go.usa.gov/xUvfw 
  • #FDA recently confirmed the presence of cyclospora in Fresh Express salad mix used primarily in recalled McDonald’s salads sold before 7/13. No product should currently be available for consumers as it has exceeded its shelf life. https://go.usa.gov/xUvfw 
  • This positive sample is a first for an #FDA cyclosporiasis produce investigation. We deployed a newly validated lab method earlier this year, advancing our ability to investigate cyclospora outbreaks and identify the parasite in foods.
  • Fresh Express already recalled expired lots of romaine lettuce that could have been contaminated with cyclospora. Romaine from the same lots was not packaged for direct retail sale by Fresh Express and had already expired.

August 2, 2018

Federal Register

Food and Drug Administration

Notices

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

Food Additive Petitions and Investigational Food Additive Exemptions

Filed on: 08/02/2018 at 08:45 am Scheduled Pub. Date:08/03/2018

FR Document: 2018-16616  PDF 8 Pages (111 KB)  Permalink

Survey on Occurrence of Foodborne Illness Risk Factors in Selected Institutional Foodservice and Retail Food Stores Facility Types

Filed on: 08/02/2018 at 08:45 am Scheduled Pub. Date: 08/03/2018

FR Document: 2018-16648 PDF 17 Pages (135 KB) Permalink

FDA

Commissioner Updates State Leaders on Implementation of the Produce Safety Rule

Recalls

DateBrand NameProduct DescriptionReason/ ProblemCompany
08/01/2018Sweet Earth  Aloha BBQ Quesadilla  Undeclared Egg and MilkSweet Earth Foods

AMS

USDA Chicken Products Purchase Program Announced

USDA Turkey Products Purchase Program Announced

USDA Catfish Products Purchase Program Announced

FNS

USDA Proclaims National WIC Breastfeeding Week and Launches New Campaign

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

  • FDA #FoodSafety Plan Builder is a free desktop app to help #foodmanufacturers develop a plan specific to their facility. Download at https://go.usa.gov/xRfYA  #FSMA #foodsafety
  • Cyclospora Outbreak: Do not eat various beef, pork and poultry salad and wrap products. They may be contaminated with Cyclospora, an illness caused by an intestinal parasite. If you have these products, do not consume. More Info: http://go.usa.gov/xUwrE
  • Sweet Earth Foods Issues Allergy Alert for Undeclared Egg and Milk in Aloha BBQ Quesadillas Due to Mismatched Packaging http://dlvr.it/QdWsnd
  • OUTBREAK UPDATE: @CDCgov reports 58 new cases related to the Salmonella investigation linked to Hy-Vee Spring Mix Pasta Salad. Product was recalled. #FDA is continuing to investigate this outbreak & will provide updates as we learn more https://go.usa.gov/xUwTG
  • FDA’s #CORE Network investigates not only foodborne outbreaks, but the response & post-response efforts. Learn about the CORE teams’ process at http://go.usa.gov/3HWUJ

August 3, 2018

Federal Register

Agricultural Marketing Service

Notices

United States Classes, Standards, and Grades for Poultry

Filed on: 08/03/2018 at 08:45 am Scheduled Pub. Date: 08/06/2018

FR Document: 2018-16249  PDF 3 Pages (159 KB)  Permalink

Environmental Protection Agency

Notices

Pesticide Product Registrations:

Applications for New Uses

Filed on: 08/03/2018 at 08:45 am Scheduled Pub. Date: 08/06/2018

FR Document: 2018-16768  PDF 3 Pages (281 KB)  Permalink

FDA

Letter from Commissioner Gottlieb to National Association of State Departments of Agriculture (NASDA) 2018

Recalls

DateBrand NameProduct DescriptionReason/ProblemCompany
08/02/2018Almond Breeze Vanilla almondmilkUndeclared milkHP Hood LLC

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

  • OUTBREAK UPDATE: @CDCgov reports 58 new cases related to the Salmonella investigation linked to Hy-Vee Spring Mix Pasta Salad. Product was recalled. #FDA is continuing to investigate this outbreak & will provide updates as we learn more https://go.usa.gov/xUwTG 
  • Sweet Earth Foods Issues Allergy Alert for Undeclared Egg and Milk in Aloha BBQ Quesadillas Due to Mismatched Packaging http://dlvr.it/QdWsnd 
  • Cyclospora Outbreak: Do not eat various beef, pork and poultry salad and wrap products. They may be contaminated with Cyclospora, an illness caused by an intestinal parasite. If you have these products, do not consume. More Info: http://go.usa.gov/xUwrE 
  • #TBT – On this day, August 2, 2013, FDA issued a final rule defining #glutenfree for food labels ensuring products marked gluten-free meet FDA standards. LEARN MORE: https://go.usa.gov/xU2ea 
  • HP Hood LLC Recalls Select Units of Half-Gallon Refrigerated Vanilla Almond Breeze Almond Milk due to Possible Milk Allergen http://dlvr.it/QddX1c 
  • OUTBREAK Update: As of August 2, @CDCgov reports 395 lab confirmed cases of #Cyclospora – 16 hospitalized, no deaths. @FDAFood & @CDCgov report the McDonald’s salads by Fresh Express recalled from 15 states are the source of this outbreak. https://go.usa.gov/xUvfw 

The investigation is ongoing with the FDA reviewing distribution & supplier info. Consumers with Cyclospora symptoms (diarrhea, loss of appetite, nausea) should contact their healthcare provider. https://go.usa.gov/xUvfw