Laws and Regulations Committee Update 10/2 – 10/5, 2018

Federal Register

FDA

Rules

Food Additives Permitted in Feed and Drinking Water of Animals:

25-Hydroxyvitamin D3

Filed on: 10/01/2018 at 08:45 am Scheduled Pub. Date: 10/02/2018

FR Document: 2018-21396 PDF 8 Pages (182 KB) Permalink

Proposed Rules

Filing of Food Additive Petitions: Kemin Industries, Inc.

Filed on: 10/01/2018 at 08:45 am Scheduled Pub. Date: 10/02/2018

FR Document:2018-21395  PDF 5 Pages (27 KB)  Permalink

  • Chromium propionate as a source of supplemental chromium in horse feed.

USDA

Proposed Rules

United States Standards: Canola

Filed on: 10/01/2018 at 08:45 am Scheduled Pub. Date: 10/02/2018

FR Document: 2018-21426  PDF 2 Pages (92.4 KB)  Permalink

Corn

Filed on: 10/01/2018 at 08:45 am Scheduled Pub. Date: 10/02/2018

FR Document: 2018-21427  PDF 2 Pages (92.3 KB)  Permalink

Soybeans; Reopening of Comment Period

Filed on: 10/01/2018 at 08:45 am Scheduled Pub. Date: 10/02/2018

FR Document: 2018-21425  PDF 2 Pages (91.1 KB) Permalink

FDA

FY 2016 Pesticide Analysis Demonstrates Consistent Trends Over Five Years

FDA Issues New Export Certificates for Certain Foods

@SGottliebFDA, @FDAFood

  • Every year, #FDA scientists test foods commonly eaten by consumers and animals for pesticide residues to ensure that they meet federal standards and don’t pose a risk to the public health. Today we’re releasing the latest set of results. https://go.usa.gov/xPBUr 
  • The results are from our 2016 Pesticide Monitoring Program report which show that in more than 7,000 samples, the overall levels of pesticide chemicals are below limits and don’t pose a risk to consumers or animals
  • Our report also contains the results of a special testing assignment for glyphosate and glufosinate in corn, soybeans, milk and eggs. None of the samples contained violative levels of glyphosate or glufosinate and no residues were found in the milk and egg samples.
  • #FDA may take action if any foods are found to contain pesticide residues that are found to contain pesticide residues that are above the federal standard to keep consumers safety
  • Today we issued final results for the annual FDA Pesticide Residue Monitoring Program from foods collected in FY16. We found that the vast majority of samples were below the tolerance levels set by the @EPA. Find out more about this thorough process >>> http://go.usa.gov/xnjVz 
  • Enjoy this season’s bounty of apples! Make smart decisions selecting, washing, & preparing this fall treat. http://go.usa.gov/xXXvB  #AppleMonth

FSIS

Sep 28, 2018 | PDF

  • FSIS Posts Foodborne Illness Outbreak Investigation Report
  • FSIS Posts Transcript and Recording from Whole Genome Sequencing Webinar 
  • Reminder: USDA and FDA Will Hold a Joint Public Meeting on Use of Animal Cell Culture Technology to Develop Products Derived from Livestock and Poultry

AMS

USDA Files Action Against Sunrise International LLC in Florida for Alleged PACA Violations

USDA Files Action Against Spiech Farms LLC in Michigan for Alleged PACA Violations

October 3, 2018

Federal Register

Animal and Plant Health Inspection Service

Rules

Establishing a Performance Standard for Authorizing the Importation and Interstate Movement of Fruits and Vegetables; Correction

Filed on: 10/03/2018 at 08:45 am Scheduled Pub. Date: 10/04/2018

FR Document: 2018-21627  PDF   3 Pages (80.7 KB)  Permalink

Notices

International Sanitary and Phytosanitary Standard-Setting Activities

Filed on: 10/03/2018 at 08:45 am Scheduled Pub. Date: 10/04/2018

FR Document: 2018-21577  PDF  17 Pages (163 KB) Permalink

FDA

Warning Letters

Letter Issue DateCompany NameIssuing OfficeSubjectClose Out Date
09/21/2018Vinill Inc.New York District OfficeSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsNot Issued *
08/28/2018Duy Drugs Inc.San Juan District OfficeDietary Supplement/New Drug/MisbrandedNot Issued *
08/15/2018Don Julio Tropical Food LLCSan Juan District OfficeCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedNot Issued *
06/01/2017Appel Feinkost GmbH & Co. KGCenter for Food Safety and Applied NutritionLow Acid Canned Food Regulation/AdulteratedNot Issued *

AMS

USDA Settles a Case with Hatch Auction Inc., d.b.a. Cow House Resulting in a $650 Penalty

USDA Announces Changes to Handling Regulations for Some Irish Potatoes Grown in Idaho and Oregon

@FDAFood, @SGottliebFDA, @FDA_ORA

OEHHA

Notice of Proposed Rulemaking: Title 27, California Code of Regulations – Amendment to Section 25805 Specific Regulatory Levels: Chemicals Causing Reproductive Toxicity n-Hexane

National Academies

USDA Receives Guidance on Updating Their Data Programs to More Completely Understand American Agriculture, Says New Report

October 4, 2018

Federal Register

Food and Drug Administration

Notices

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

Electronic User Fee Payment Request Forms

Filed on: 10/04/2018 at 08:45 am Scheduled Pub. Date: 10/05/2018

FR Document: 2018-21682  PDF   4 Pages (14.9 KB)  Permalink

Guidance:

Policy Regarding Quantitative Labeling of Dietary Supplements Containing Live Microbials

Filed on: 10/04/2018 at 08:45 am Scheduled Pub. Date: 10/05/2018

FR Document: 2018-21677  PDF 2 Pages (73.1 KB) Permalink

Environmental Protection Agency

Rules

Pesticide Tolerances: Flumioxazin

Filed on: 10/04/2018 at 08:45 am  Scheduled Pub. Date: 10/05/2018

FR Document: 2018-21746  PDF  21 Pages (134 KB)  Permalink

FSIS

JBS Tolleson, Inc. Recalls Raw Beef Products Due to Possible Salmonella Newport Contamination

Johnston County Hams Recalls Ready-To-Eat Ham Products Due to Possible Listeria Contamination

@FDAFood, @FDA_ORA, @SGottliebFDA

AMS

USDA Settles a Case with Jerry & Carla Hixon dba Dairyman’s & Cattleman’s Beef Auction Resulting in a $1000 Penalty

APHIS

USDA Informs the Public on International Sanitary and Phytosanitary Standard-Setting Activities

October 5, 2018

Federal Register

Food and Drug Administration

Rules

Food Additive Regulations: Synthetic Flavoring Agents and Adjuvants

Filed on: 10/05/2018 at 08:45 am Scheduled Pub. Date: 10/09/2018

FR Document: 2018-21807  PDF  52 Pages (226 KB) Permalink

  • FDA is removing food additive regulations for benzophenone, ethyl acrylate, eugenyl methyl ester, mycrene, pulegone, and pyridine as synthetic flavoring substances for use in food.

Food Additives Permitted for Direct Addition to Food for Human Consumption:

Styrene

Filed on: 10/05/2018 at 08:45 am Scheduled Pub. Date: 10/09/2018

FR Document: 2018-21808  PDF  11 Pages (114 KB)  Permalink

Food Safety and Inspection Service

Notices

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

Laboratories

Filed on: 10/05/2018 at 08:45 am Scheduled Pub. Date: 10/09/2018

FR Document: 2018-21858  PDF  8 Pages (216 KB)  Permalink

Records to be Kept by Official Establishments and Retail Stores that Grind Raw Beef Products

Filed on: 10/05/2018 at 08:45 am Scheduled Pub. Date: 10/09/2018

FR Document: 2018-21857  PDF  8 Pages (217 KB)  Permalink

Requests for Nominations:

National Advisory Committee on Meat and Poultry Inspection

Filed on: 10/05/2018 at 08:45 am Scheduled Pub. Date: 10/09/2018

FR Document: 2018-21859  

Agricultural Marketing Service

Rules

United States Standards: Grades of Pecans

Filed on: 10/05/2018 at 08:45 am Scheduled Pub. Date: 10/09/2018

FR Document: 2018-21845  PDF  10 Pages (185 KB)  Permalink

FDA

FDA Removes 7 Synthetic Flavoring Substances from Food Additives List

Recalls

DateBrandProduct DescriptionReason / ProblemCompany
10/03/2018Pet Alive, Native Remedies, Healthful NaturalsHomeopathic Drug Products (liquid)Microbial ContaminationSilver Star Brands, Inc.

@FDA_ORA, @FDASpox, @FDAFood

  • #FridayCaseFiles – 2017: The CEO of a printing & packaging company pays over $40K in fines & forfeitures, pleads guilty to making & shipping counterfeit labels for veterinary drugs, incl. Frontline, Frontline Plus & Rimadyl. https://go.usa.gov/xPrYm  #FDAOCI #FridayCaseFile
  • Read @SGottliebFDA’s recent statement on the #FDA investigations into foods associated with Cyclospora illnesses, our important food safety work and how we fulfill our critical mission of protecting consumers https://go.usa.gov/xP2TE
  • FLAGGING: Today, @CDCgov released “Notes From the Field” on Cyclospora illnesses this year detailing the 2018 outbreak season and the large number of reported cases.
  • RECALL: Don’t eat, serve, or sell recalled deli ham (including country ham) from Johnston County Hams. This ham is linked to a Listeria outbreak. More info: https://go.usa.gov/xPkBz

AMS

USDA Cites McAllen Produce LLC and Charles Jeffrey Edwards for PACA Violations

USDA Settles a Case with the Cattleman’s Brenham Livestock Auction LP Resulting in a $3,000 Penalty

NTP

PFAS in the spotlight across the globe

CLARITY-BPA releases grantee data and core study report

Regulators play key roles in replacing animals in tox testing