Association of Food and Drug Officials

Laws and Regulations Committee Update 12/29/17 - 1/4/17

January 05, 2018 2:20 PM | Amy Bonsell (Administrator)

December 29, 2017

Federal Register

Food and Drug Administration

Rules

Food Additives Permitted in Feed and Drinking Water of Animals: Formic Acid as a Feed Acidifying Agent in Complete Poultry Feeds

Filed on: 12/29/2017 at 08:45 am Scheduled Pub. Date: 01/02/2018

FR Document: 2017-28251 PDF 6 Pages (181 KB) Permalink

 

Notices

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

Food and Cosmetic Export Certificate Application Process

Filed on: 12/29/2017 at 08:45 am Scheduled Pub. Date:01/02/2018

FR Document: 2017-28258   PDF 8 Pages (110 KB)  Permalink

 

Agricultural Marketing Service

Rules

Increased Assessment Rates: Hazelnuts Grown in Oregon and Washington

Filed on: 12/28/2017 at 08:45 am Scheduled Pub. Date: 12/29/2017

FR Document:2017-28171  PDF 17 Pages (256 KB) Permalink

 

Proposed Rules

Exemption Requirements: Tart Cherries Grown in the States of Michigan, et al.

Filed on:12/29/2017 at 08:45 am  Scheduled Pub. Date:01/02/2018

FR Document: 2017-28167 PDF 21 Pages (307 KB) Permalink

 

Free and Restricted Percentages for 2017-18 Crop Year:

Cranberries Grown in States of Massachusetts, et al.

Filed on:12/29/2017 at 08:45 am Scheduled Pub. Date: 01/02/2018

FR Document:2017-28169 PDF 32 Pages (286 KB) Permalink

 

FDA

Recalls

Date

Brand Name

Product Description

Reason/ Problem

Company

12/28/2017

Daisy’s Bakery Inc.  

Gourmet Concha  

Undeclared Milk

Daisy’s Bakery Inc.

 

@FDAFood, @FDA_ORA, @SGottliebFDA

  • ·        #FDAORA issues #warningletter to a Nebraska #dairy operation after investigation w/@USDAFoodSafety revealed violations of regulations for proper use of animal drugs in animals used for human consumption: https://go.usa.gov/xnQ6d
  • ·        #FDAORA issues #warningletter to an Ohio airline catering facility for insanitary conditions in violation of federal #foodsafety regulations & for failing to register facility w/FDA: https://go.usa.gov/xnQFt
  • ·        FDA is working with @CDCgov and Canadian officials on an outbreak of E. coli O157:H7 illnesses. 17 cases reported in U.S. Source of U.S. infections is not yet identified. More information will be released as it becomes available
  • ·        Looking for data on #recalls#imports#FDAORA inspections or compliance actions? Visit FDA’s NEW visual data dashboard: https://go.usa.gov/xnEdv
  • ·        FDA is committed to food safety. OIG report examined ‘12-‘15 practices but much has changed. We’ve made many improvements on speed and scope of our recalls. We'll release new policies in 2018, and updated data to document progress (data from 2017 not 2012) https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm590423.htm …

 

AskFSIS

FSIS Directive 12,600.2 - Cutting a Carcass to Facilitate Loading

NR timeframe to complete and issue

Verification When Establishment Takes Corrective Action

Does FSIS restrict where shipments of meat, poultry, egg products, or Siluriformes fish present for import reinspection?

 

AMS

USDA Announces National Mango Board Appointments

 

FTC

Blurred Lines: An Exploration of Consumers’ Advertising Recognition in the Contexts of Search Engines and Native Advertising: A Federal Trade Commission Staff Report

The Bureau of Consumer Protection Office of Claims and Refunds Annual Report 2017: Consumer Refunds Effected From July 2016 Through June 2017


January 2, 2018

FDA

Warning Letters

Letter Issue Date

Company Name

Issuing Office

Subject

Close Out Date

11/30/2017

TruVision Health LLC

Denver District Office

CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug

Not Issued *

11/22/2017

First Choice E Trading Corp.

New York District Office

Seafood HACCP/CGMP for Foods/Adulterated

Not Issued *

08/16/2017

KBF INC

New York District Office

Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

Not Issued *

07/21/2017

Derby Paradise, Inc.

New York District Office

Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions

Not Issued *

Recalls

Date

Brand Name

Product Description

Reason/ Problem

Company

12/29/2017

New Seasons Market Grab and Go  

Macaroni and Cheese  

Undeclared egg

New Seasons Market

 

@FDAFood, @FDA_ORA, @SGottliebFDA

  • Ø  FDA is committed to food safety. OIG report examined ‘12-‘15 practices but much has changed. We’ve made many improvements on speed and scope of our recalls. We'll release new policies in 2018, and updated data to document progress (data from 2017 not 2012) https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm590423.htm …
  • Ø  In an FDA survey, only 37% of people in 2010 ever heard of #Listeriaas a problem. That grew to 58% awareness in 2016 http://go.usa.gov/x8Rq4  #foodborneillness
  • Ø  Federal investigators say the F.D.A. must get tainted foods off the shelves faster to protect consumers from illness https://t.co/s0fP1NHuuL
  • o   Scott Gottlieb response: This report, first released in 2016, was re-released over Christmas. It’s based on a selective review of 30 complex food recalls from 2012-2015 out of 1,000s performed. In many of the 30 FDA was slow to act. Even a few flawed recalls are too many. We must and are doing better. We made MANY process improvements to speed food recalls; increase our rigor. We’ll release updated analysis - from 2017 NOT 2012 - on how we’re doing. More reforms in store for 2018; including changes to make sure we release much more info to consumers when food is recalled. Americans MUST have confidence FDA acts quickly in setting of food recalls to protect them. This is core of our consumer protection role. We’ve improved much; will prove it with updated data; and will make the process even better in 2018. Wish everyone a happy, safe, New Year.

 

FSIS

Product Recalled

Date of Recall

Retail Distribution List

131-2017 Swift Beef Company Recalls Beef Stew Products Due to Possible Foreign Matter Contamination | En Español

Dec 26, 2017

 Dec 27, 2017

 

askFSIS

Designing a Sanitation SOP Daily Record

Amenability of Domestically Raised Game Birds and Waterfowl

FSIS Directive 5000.2 - Aeorbic Plate Count (APC) and Coliform Records

FSIS Directive 5000.2 - Documenting a Weekly MOI

Listeria

Definition of Food Contact Surface

 

FTC

FTC Requires Canadian Fertilizer and Chemical Companies PotashCorp and Agrium to Divest 2 Production Facilities as Condition of Merger

 

OEHHS

Notice of Proposed Rulemaking Title 27, California Code of Regulations Amendment to Section 25705 Specific Regulatory Levels Posing No Significant Risk: Bromodichloroacetic Acid

  • Ø  Notice of proposed rulemaking regarding specific regulatory levels posing no significant risk: bromodichloroacetic acid.

Notice of Proposed Rulemaking Title 27, California Code of Regulations Amendment to Section 25705 Specific Regulatory Levels Posing No Significant Risk: Bromochloroacetic Acid

  • Ø  Notice of proposed rulemaking regarding specific regulatory levels posing no significant risk: bromochloroacetic acid.

Chemical Listed Effective December 29, 2017 as Known to the State of California to Cause Cancer: Vinylidene Chloride (1,1-dichloroethylene)

  • Ø  Vinylidene Chloride (1,1-dichloroethylene) Listed Effective December 29, 2017 as Known to the State of California to Cause Cancer via the Labor Code (LC) mechanism.

 

NIH-ODS

Executive Summary of Analytical Methods and Reference Materials External Program Review

 

NTP

Peer Review of the Draft Report on Carcinogens Monograph on Antimony Trioxide – January 4, 2018

January 3, 2018

Federal Register

Agriculture Department

Proposed Rules

Withdrawal of Certain Proposed Rules and Other Proposed Actions

Filed on: 01/03/2018 at 08:45 am Scheduled Pub. Date: 01/04/2018

FR Document: 2017-28433  PDF 4 Pages (180 KB)  Permalink

 

OIRA

AGENCY: HHS-FDA

RIN: 0910-AH83

Status: Pending Review

TITLE: Food Labeling: Calorie Labeling of Articles of Food Sold From Certain Vending Machines; Front of Package Type Size

STAGE: Proposed Rule

ECONOMICALLY SIGNIFICANT: No

** RECEIVED DATE: 01/02/2018

LEGAL DEADLINE: None  

 

FDA

Explaining How the Voluntary Qualified Importer Program Will Work

Recalls

Date

Brand Name

Product Description

Reason/ Problem

Company

12/29/2017

Southern Home, Shur Fine, Valu Time, more  

biscuits  

Listeria monocytogenes

T. Marzetti Company

 

@FDAFood, @FDA_ORA, @SGottliebFDA

 

askFSIS

Can Older Editions of FSIS Form 9060-5 Be Used?

Sanitation Standard Operating Procedures Records

PHIS- Entering US Retain or US Condemn Tag Numbers

 

AMS

USDA Proposes Seasonal Volume Control for Cranberries during the 2017–18 Crop Year

 

January 4, 2018

Federal Register

Agricultural Marketing Service

Rules

Assessment Rates: Onions Grown in South Texas

Filed on: 01/04/2018 at 08:45 am Scheduled Pub. Date: 01/05/2018

FR Document: 2017-28504  PDF 15 Pages (153 KB)  Permalink

 

Assessment Rates: Pears Grown in Oregon and Washington

Filed on: 01/04/2018 at 08:45 am Scheduled Pub. Date: 01/05/2018

FR Document: 2017-28505  PDF 18 Pages (183 KB)  Permalink

 

Environmental Protection Agency

Notices

Pesticide Product Registrations: New Active Ingredients

Filed on: 01/04/2018 at 08:45 am Scheduled Pub. Date: 01/05/2018

FR Document: 2018-00021  PDF 4 Pages (86 KB)  Permalink

 

Food and Drug Administration

Rules

Guidance: Policy Regarding Certain Entities Subject to the Current Good Manufacturing Practice and Preventive Controls, Produce Safety, and/or Foreign Supplier Verification Programs

Filed on: 01/04/2018 at 08:45 am Scheduled Pub. Date: 01/05/2018

FR Document: 2018-00050  PDF 7 Pages (135 KB)  Permalink

 

FDA

FDA Announces Enforcement Discretion Policy for Certain FSMA Regulations

Recalls

Date

Brand Name

Product Description

Reason/ Problem

Company

01/03/2018

Polly Ann  

Ice Bars  

Undeclared milk

California Popsicle, Inc.

 

@FDAFood, @FDA_ORA, @SGottliebFDA

 

AMS

USDA Lifts PACA Reparation Sanctions on Arizona Produce Business

USDA Proposes Seasonal Volume Control for Cranberries during the 2017–18 Crop Year


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