News Article

Laws and Regulations Committee Update 5/14 - 5/16, 2018

Posted on May 18, 2018

Blog: Association of Food & Drug Officials (AFDO)

May 14, 2018

Federal Register

Environmental Protection Agency

Proposed Rules

Pesticide Petitions:

Residues of Pesticide Chemicals in or on Various Commodities; Correction

Filed on: 05/14/2018 at 08:45 am Scheduled Pub. Date: 05/15/2018

FR Document: 2018-10344 PDF 3 Pages (277 KB) Permalink

Filed on: 05/14/2018 at 08:45 am Scheduled Pub. Date: 05/15/2018

FR Document: 2018-10347 PDF 3 Pages (277 KB) Permalink

FDA

Notice of Availability of Small Entity Compliance Guide: FSMA; Extension and Clarification of Compliance Dates for Certain Provisions of Four Implementing Rules

Recalls

Date

Brand Name

Product Description

Reason/Problem

Company

05/11/2018

Sugarfina

Sugar Cookies Products

Sugar Cookies Products

Sugarfina, Inc.

FSIS

Secretary Perdue Announces FSIS Key Leadership

USDA Announces Proposed Rule to Eliminate a Redundant Hog Carcass Cleaning Regulation

May 11, 2018 | PDF

  • Secretary Perdue Announces FSIS Key Leadership;
  • Secretary Perdue Announces FSIS Key Leadership;
  • FSIS Proposes to Eliminate Redundant Hog Carcass Cleaning Regulation;
  • FSIS Launches Outreach Initiative for Small and Very Small Plants;
  • FSIS Posts Next Set of Establishment Specific Datasets;
  • FSIS Posts Updated Dataset on Import Refusals;
  • Listeria monocytogenes Testing Update;
  • Reminder: FSIS Comment Period on Petition on Beef and Meat Labeling Requirements Ends May 17, 2018.

AskFSIS

Sanitation Standard Operating Procedures Preventive Measures

If an establishment relies on its own product cook tests for its validated cooking instructions, must the cook tests be approved by a process authority?

Does "neutral" background refer to the background color of the package and could you use a red background with black type?

Because microwave instructions on labels seem to be of much concern, what type of information and data needs to be reviewed if microwave cooking instructions are included on the label of products that contain raw or partially cooked poultry

AMS

USDA Proposes Volume Regulation for 2017–18 Tart Cherries

USDA Finds Lack of Consensus Among Farmers for a New Organic Marketing Board

May 15, 2018

Federal Register

Food Safety and Inspection Service

Proposed Rules

Eliminating Unnecessary Requirements for Hog Carcass Cleaning

Filed on: 05/15/2018 at 08:45 am Scheduled Pub. Date: 05/16/2018

FR Document: 2018-10488 PDF 17 Pages (239 KB) Permalink

Notices

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

Requirements to Notify FSIS of Adulterated or Misbranded Product, Prepare and Maintain Written Recall Procedures, and Document Certain HACCP Plan Reassessments

Filed on: 05/15/2018 at 08:45 am Scheduled Pub. Date: 05/16/2018

FR Document: 2018-10489 PDF 9 Pages (208 KB) Permalink

Voluntary Recalls of Meat, Poultry, and Egg Products

Filed on: 05/15/2018 at 08:45 am Scheduled Pub. Date: 05/16/2018

FR Document: 2018-10484 PDF 8 Pages (208 KB) Permalink

Environmental Protection Agency

Rules

Pesticide Tolerances:

Tebuconazole

Filed on: 05/15/2018 at 08:45 am Scheduled Pub. Date: 05/16/2018

FR Document: 2018-10345 PDF 23 Pages (357 KB) Permalink

FDA

FDA Approves Mirataz, a New Animal Drug to Manage Undesired Weight Loss in Cats

Notice of Agency Information Collection Activities; Electronic User Fee Payment Request Forms

Notice of OMB Approvals of Agency Information Collection Activities

USDA

Secretary Perdue Appoints New Members to National Advisory Committee on Microbiological Criteria for Foods

FSIS

Secretary Perdue Appoints New Members to National Advisory Committee on Microbiological Criteria for Foods

J.T.M. Provisions Company Recalls Beef Products Due to Possible Foreign Matter Contamination

Fresh Foods Manufacturing Co. Recalls Ready-To-Eat Salad Products Due to Possible E. coli O157:H7 Contamination

AskFSIS

FSIS Directive 5000.4 - Direct Observation of Sanitation SOP Monitoring

Can the print be condensed?

Must cooking instructions advise consumers whether product should be cooked from a frozen state or from a thawed state?

Must cooking instructions advise consumers where to place the thermometer in the product (i.e., coldest/thickest part), or how many temperature readings to take?

Designing a Sanitation SOP Daily Record

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

May 16, 2018

Federal Register

Food and Drug Administration

Notices

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

Food and Cosmetic Export Certificate Application Process

Filed on: 05/16/2018 at 08:45 am Scheduled Pub. Date: 05/17/2018

FR Document: 2018-10551 PDF 5 Pages (87.9 KB) Permalink

Agricultural Marketing Service

Rules

General Regulations for Federal Fruit, Vegetable, and Specialty Crop Marketing Agreements and Orders; Authority to Meet Via Electronic Communications

Filed on: 05/16/2018 at 08:45 am Scheduled Pub. Date: 05/17/2018

FR Document: 2018-10487 PDF 7 Pages (233 KB) Permalink

Animal and Plant Health Inspection Service

Rules

Virus-Serum-Toxin Act Records and Reports Specific to International Standards for Pharmacovigilance

Filed on: 05/16/2018 at 08:45 am Scheduled Pub. Date: 05/17/2018

FR Document: 2018-10540 PDF 17 Pages (304 KB) Permalink

Notices

Environmental Impact Statements; Availability, etc.:

Permit for Release of Genetically Engineered Citrus tristeza virus; Preliminary Pest Risk Assessment

Filed on: 05/16/2018 at 08:45 am Scheduled Pub. Date: 05/17/2018

FR Document: 2018-10490 PDF 5 Pages (102 KB) Permalink

Environmental Protection Agency

Rules

Pesticide Tolerances:

Pyroxasulfone

Filed on: 05/16/2018 at 08:45 am Scheduled Pub. Date: 05/17/2018

FR Document: 2018-10582 PDF 22 Pages (426 KB) Permalink

Notices

Pesticide Product Registrations; Applications:

New Active Ingredients

Filed on: 05/16/2018 at 08:45 am Scheduled Pub. Date: 05/17/2018

FR Document: 2018-10578 PDF 10 Pages (181 KB) Permalink

FDA

GRAS Notices

GRN No.

Substance

Date of Closure

FDA’s Letter

780

Rebaudioside M

Pending

779

Isomalto-oligosaccharides

Pending

778

Hemp seed oil

Pending

777

Algal oil (55% docosahexaenoic acid) from Schizochytrium sp. FCC-3204

Pending

776

Algal oil (35% docosahexaenoic acid) from Schizochytrium sp. FCC-1324

Pending

757

Colicin

Pending

749

2’-O-fucosyllactose

Apr 23, 2018

FDA has no questions (in PDF) (95 kB)

748

Tomato powder

Apr 19, 2018

At the notifier's request, FDA ceased to evaluate this notice (in PDF) (44 kB)

745

Steviol glycosides consisting primarily of rebaudioside M

Apr 20, 2018

FDA has no questions (in PDF) (103 kB)

744

Steviol glycosides consisting primarily of rebaudioside M

Mar 23, 2018

FDA has no questions (in PDF) (131 kB)

738

Thaumatin

Apr 18, 2018

FDA has no questions (in PDF) (77 kB)

735

2’-Fucosyllactose

Apr 6, 2018

FDA has no questions (in PDF) (103 kB)

Warning Letters

Letter Issue Date

Company Name

Issuing Office

Subject

Close Out Date

04/25/2018

Baker's Best Health Products, Inc.

Chicago District Office

Unapproved New Drugs/Misbranded

Not Issued *

AskFSIS

PHIS Tasks Performed During Overtime

Noncompliance records (NR) Association – PHIS task code

HACCP Recordkeeping

If a company has done its own cooking validation, is it the agency’s expectation that each individual product must be tested, or can like items be grouped together?

OEHHA

Acrylamide – Information about the Proposition 65 carcinogen acrylamide

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


Go to Original Post