Laws and Regulations Committee Update 2/1 – 2/8, 2018

February 1, 2018

Federal Register

Food Safety and Inspection Service

Notices

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

Mechanically Tenderized Beef Products

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

FR Document: 2018-02092  PDF  8 Pages (213 KB) Permalink

CFSAN

FDA Takes Important New Steps to Strengthen Oversight of Food Imports

@FDA_ORA, @SGottliebFDA, @FDAFood

  • #FDAORA issues advisory letter to Gallbladder Attack for using website to market unapproved drugs making false claims to treat or prevent many diseases, including dementia, cancer, Alzheimer’s:  https://go.usa.gov/xnpzY  #healthfraud
  • Announcing the first accredited body under the #FSMA Third-Party Accreditation Program #TAP – it’s ANSI-ASQ National Accreditation Board  @ANAB_ACCREDIT  https://go.usa.gov/xn7Ug
  • FDA starts accepting applications TODAY for #VQIP (Voluntary Qualified Importer Program). Questions about the benefits? We’ve got answers for importers of FDA-regulated human and/or animal food. https://go.usa.gov/xn7n4
  • Importing food, drugs, or other FDA-regulated products? Get the info you need for commercial or personal shipments, and find  #FDAORA contacts for questions about entries:  https://go.usa.gov/xnR2t  #ORAImports
  • Today, FDA and @USDA launched a new effort to improve coordination on key food safety issues such as produce safety, biotechnology and dual-jurisdiction facilities.  https://go.usa.gov/xnGhr
  • Today, FDA and @USDA launched a new effort to improve coordination on key food safety issues such as produce safety, biotechnology and dual-jurisdiction facilities.  https://go.usa.gov/xnGhr

CVM

FDA Takes Important New Steps to Strengthen Oversight of Food Imports

AMS

USDA Fruit and Tree Nut Purchase Program Announced

USDA Vegetable Purchase Program Announced

February 2, 2018

Federal Register

Agricultural Marketing Service

Rules

Handling of Spearmint Oil Produced in the Far West: Marketing Order; Revision of Salable Quantity and Allotment Percentage for Class 3 (Native) Spearmint Oil for 2017–2018 Marketing Year

Filed on: 02/02/2018 at 08:45 am Scheduled Pub. Date: 02/05/2018

FR Document: 2018-02264  PDF26 Pages (291 KB)  Permalink

Consumer Product Safety Commission

Proposed Rules

Fireworks Regulations: Meetings; Opportunity for Oral Presentation

Filed on: 02/02/2018 at 08:45 am Scheduled Pub. Date: 02/05/2018

FR Document: 2018-02258  PDF 3 Pages (116 KB)  Permalink

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals: Playground Surfaces Survey

Filed on: 02/02/2018 at 08:45 am Scheduled Pub. Date: 02/05/2018

FR Document: 2018-02223  PDF 6 Pages (134 KB)  Permalink

Food and Drug Administration

Guidance:

Hazard Analysis and Risk-Based Preventive Controls for Food for Animals; Correction

Filed on: 02/02/2018 at 08:45 am Scheduled Pub. Date: 02/05/2018

FR Document: 2018-02181  PDF 2 Pages (77 KB)  Permalink

FDA

FDA Takes Important New Steps to Strengthen Oversight of Food Imports

What Do Farmers Need to Know About Complying with the Produce Safety Rule?

Recalls

DateBrand NameProduct DescriptionReason/ ProblemCompany
02/01/2018Daisho  Kimchi Hot Pot Soup Base  Undeclared crustacean shellfish (shrimp, crab)JFC International Inc.

@FDAFood, @FDA_ORA, @SGottliebFDA

  • larger #farms must now comply with the #FSMA Produce Safety Rule. What do these science-based standards for safe growing, harvesting, packing & holding of fruits & vegetables mean For #farmershttps://go.usa.gov/xn7HU 
  • Larger #farms must now comply with the #FSMA Produce Safety Rule. What do these science-based standards for safe growing, harvesting, packing & holding of fruits & vegetables mean for #farmershttps://go.usa.gov/xn7HU 

FSIS

Recalls

Product RecalledDate of RecallRetail Distribution List
007-2018 Whip City Jerky, LLC Recalls Beef Jerky Products Due to Misbranding and an Undeclared AllergenFeb 01, 2018Feb 02, 2018

AMS

USDA Determines Individual Not Responsibly Connected to Texas Violator

GAO

Improvements Needed in Internal Controls over Budget Execution Processes 

NAD

Ultra Max Health Says it Will Permanently Discontinue Claims for Max Synapse Supplements Following NAD Inquiry

February 5, 2018

Federal Register

Agricultural Marketing Service

Rules

Guidance on Growers’ Trust Protection Eligibility and Clarification of Written Notification

Filed on: 02/05/2018 at 08:45 am Scheduled Pub. Date: 02/06/2018

FR Document: 2018-02066  PDF 18 Pages (274 KB) Permalink

Proposed Rules

Marketing Orders: California Federal Milk

Filed on: 02/05/2018 at 08:45 am Scheduled Pub. Date:02/06/2018

FR Document: 2018-02386 PDF 4 Pages (226 KB) Permalink

Animal and Plant Health Inspection Service

Rules

Imports: Fresh Citrus from Colombia Into the United States

Filed on:  02/05/2018 at 08:45 am Scheduled Pub. Date: 02/06/2018

FR Document: 2018-02382 PDF 11 Pages (122 KB) Permalink

CFSAN

CFSAN’s New Senior Science Advisor Will Work to Advance Produce Safety

FSIS

Feb 02, 2018 | PDF

FSIS Updates PHIS Export Country Rollout Strategy

AskFSIS

Removal of Specified Risk Materials (SRM) from Beef Carcasses

Extent of Records to be Reviewed During Preshipment

USDAPerdue Names New Leaders in USDA’s Departmental Administration

February 6, 2018

Federal Register

Food and Drug Administration

State Enforcement Notifications

Filed on: 02/06/2018 at 08:45 am Scheduled Pub. Date: 02/07/2018

FR Document: 2018-02417  PDF 6 Pages (106 KB) Permalink

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

Filed on: 02/06/2018 at 08:45 am Scheduled Pub. Date:02/07/2018

FR Document: 2018-02413  PDF  16 Pages (134 KB)  Permalink

Survey on the Occurrence of Foodborne Illness Risk Factors in Selected Retail and Foodservice Facility Types

Filed on: 02/06/2018 at 08:45 am Scheduled Pub. Date: 02/07/2018

FR Document: 2018-02414  PDF  15 Pages (129 KB)  Permalink

Agriculture Department

Notices

Requests for Information: Improving Customer Service

Filed on: 02/06/2018 at 08:45 am Scheduled Pub. Date: 02/07/2018

FR Document: 2018-02388  PDF  4 Pages (175 KB)  Permalink

Environmental Protection Agency

Pesticide Tolerances: Fomesafen

Filed on: 02/06/2018 at 08:45 am Scheduled Pub. Date: 02/07/2018

FR Document: 2018-02344  PDF  22 Pages (220 KB) Permalink

Isoxaben

Filed on: 02/06/2018 at 08:45 am Scheduled Pub. Date: 02/07/2018

FR Document: 2018-02346  PDF  22 Pages (222 KB) Permalink

FDA

Recalls

DateBrand NameProduct DescriptionReason/ ProblemCompany
02/02/2018Southern Grove  Unsalted Almonds  Undeclared Wheat and SoyKanan Enterprises, Inc.

@SGottliebFDA, @FDAFood, @FDArecalls, @FDA_ORA

APHIS

APHIS Accepts Comments on Updated Import Requirements for Fresh Citrus Fruit from Colombia

NTP

A Strategic Roadmap for Establishing New Approaches to Evaluate the Safety of Chemicals and Medical Products in the US

February 7, 2018

Federal Register

Environmental Protection Agency

Proposed Rules

Modification of Significant New Use of a Certain Chemical Substance

Filed on: 02/07/2018 at 08:45 am Scheduled Pub. Date: 02/08/2018

FR Document: 2018-02461  PDF 22 Pages (275 KB)  Permalink

Notices

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

Application for Reference and Equivalent Method Determination

Filed on: 02/07/2018 at 08:45 am Scheduled Pub. Date: 02/08/2018

FR Document: 2018-02542  PDF 3 Pages (195 KB)  Permalink

Submission of Unreasonable Adverse Effects Information

Filed on: 02/07/2018 at 08:45 am Scheduled Pub. Date: 02/08/2018

FR Document: 2018-02547  PDF 5 Pages (184 KB)  Permalink

Assignment and Application of the Unique Identifier under the Toxic Substances Control Act

Filed on: 02/07/2018 at 08:45 am Scheduled Pub. Date: 02/08/2018

FR Document: 2018-02548  PDF 7 Pages (311 KB)  Permalink

Federal Emergency Management Agency

Proposed Rules

General Administrative Regulations:

Subpart L – Reinsurance Agreement – Standards for Approval; Regulations for the 2019 and Subsequent Reinsurance Years

Filed on: 02/07/2018 at 08:45 am Scheduled Pub. Date: 02/08/2018

FR Document: 2018-02489  PDF 13 Pages (189 KB)  Permalink

FDA

Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s scientific evidence on the presence of opioid compounds in kratom, underscoring its potential for abuse

Correction; Draft Guidance for Industry; Hazard Analysis and Risk-Based Prevention Controls for Food for Animals 

Notice of Agency Information Collection Activities; Animal Drug Adverse Event Reporting and Recordkeeping 

Warning Letters

Letter Issue DateCompany NameIssuing OfficeSubjectClose Out Date
01/31/2018Long Life UnlimitedCincinnati District OfficeNew Drug/MisbrandedNot Issued *
11/16/2017U.L. Manufacturing Company Ltd.Center for Food Safety and Applied NutritionAcidified Foods/Emergency Permit Control/AdulteratedNot Issued *
08/10/2017MS Fruit & Vegetable Co., LLCCincinnati District OfficeCGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/AdulteratedNot Issued *

FSIS

Product RecalledDate of Recall
009-2018 Guymon Extracts, Inc. Recalls Fully Cooked Pork Products Due to Possible Processing DeviationFeb 06, 2018
008-2018 Olymel S.E.C./ L.P. Recalls Pork Products Produced Without Benefit of Import InspectionFeb 06, 2018

AMS

USDA Seeks National Mango Board Nominees

APHIS

Perdue Announces Emergency Funding for Spotted Lanternfly in Pennsylvania

FTC

Advertising Firm Barred from Assisting in the Marketing and Sale of Weight-Loss Supplements Deceptively Pitched to Consumers

FTC Approves Final Order Requiring Canadian Fertilizer and Chemical Companies PotashCorp and Agrium to Divest 2 Production Facilities as Condition of Merger

NIH

Now Available: ODS 2017 Annual Report

ODS Practicum Applications Being Accepted Now Through March 12

@FDA_ORA, @SGottliebFDA, @FDAFood, @US_FDA

February 8, 2018

Federal Register

Environmental Protection Agency

Rules

Pesticide Tolerances:

Cyflufenamid

Filed on: 02/08/2018 at 08:45 am Scheduled Pub. Date: 02/09/2018

FR Document: 2018-02670  PDF 26 Pages (230 KB)  Permalink

Zoxamide

Filed on: 02/08/2018 at 08:45 am Scheduled Pub. Date: 02/09/2018

FR Document: 2018-02668  PDF 13 Pages (195 KB)  Permalink

AMS

USDA Clarifies Grower’s Trust Protection Eligibility and Notification Requirements in Final Rule Amending PACA Regulations

02/22 to 02/23 Agricultural Outlook Forum

FSIS

Notices

NumberTitleDate IssuedExpiration Date
09-18Requirements for the Disposition of Non-Ambulatory Disabled Veal CalvesFeb 07, 2018Feb 01, 2019
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