Laws and Regulations Committee Update 4/18 – 4/20, 2018

April 18, 2018

FDA

Statement by Dr. Susan Mayne on FDA efforts to reduce consumer exposure to arsenic in rice

Remarks from FDA Commissioner Scott Gottlieb, M.D. on Fiscal Year 2019 budget request for FDA

Recalls

DateBrand NameProduct DescriptionReason/ProblemCompany
04/17/2018Formagerie de la Brie brandl’Explorateur soft ripened cheesepotential to be contaminated with Listeria monocytogenesWorld’s Best Cheeses
04/16/2018Vital Essentials®Dog/pet food Freeze-Dried Beef Toppers and Frozen Beef Chubpotential to be contaminated with SalmonellaCarnivore Meat Company
04/16/2018Publix, Sunups, moreShell eggsSalmonellaCal-Maine Foods, Inc.

FSIS

Completion of the Export Certificate Questionnaire

AskFSIS

Can protein be expressed as percent Daily Value (percent DV) on foods for adults and children over 4 and how should it be calculated

Will the values for the Recommended Daily Intakes (RDI) for adults and children over four years of age, which are the same as the U.S. Recommended Daily Allowances (RDA) established in 1973, be changed in the near future?

Export requirements for products from Asia

Salmonella Testing of Shell Eggs Diverted to Official Egg Products Plants

Sanitation SOP Procedure – Definition

HACCP CCP Location Requirement

AMS

USDA Seeks Nominees for the National Honey Board

ORA FOIA

Record DateFEI NumberFirm NameRecord TypeStateEstablishment TypeDate Posted
04/17/20182000023438Rose Acre Farms-Hyde County Egg483NCShell Egg Producer04/17/2018

CSPI

Consumer and Health Groups, Researchers Urge Trump Not to Misuse Trade Talks to Undermine Nutrition Labeling

OEHHA

Current Proposition 65 No Significant Risk Levels (NSRLs) Maximum Allowable Dose Levels (MADLs)

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

  • Remarks from FDA Commissioner @SGottliebFDA on Fiscal Year 2019 budget request for FDA https://go.usa.gov/xQD4n 
  • What happens when perishable foods are left in the #DangerZone (40-140°F)? Bacteria can double in number in as little as every 20 minutes! #FoodSafety
  • My testimony today before House Appropriations Subcommittee re: #FDA’s FY19 budget request. We’re fortunate for bipartisan support received in recent years, reflecting shared obligation to agency’s vital role protecting & promoting public health https://go.usa.gov/xQDgv 
  • #FDA’s FY19 budget request includes new resources to make significant investments and capitalize on remarkable opportunities we have to advance critical areas of science, domestic technology and public health https://go.usa.gov/xQDgv 
  • Investments in better regulatory tools, better management of our process and better science will help #FDA fulfill our critical consumer protection role and advance opportunities for Americans to improve their health https://go.usa.gov/xQDgv 
  • #EggRecall FDA continues investigating #salmonella braenderup outbreak linked to shell eggs from #RoseAcreFarms. LOT CODES 011 through 102 from Plant Number P-1065 printed on carton. https://go.usa.gov/xQjqt 
  • Eggs recalled were sold under multiple brand including Coburn Farms, Country Daybreak, Food Lion, Glenview, Great Value, Nelms, Sunshine Farms. Consumers with these eggs shouldn’t eat them. Throw away or return to place of purchase for credit or refund https://go.usa.gov/xQjPu 
  • #RECALL of certain eggs distributed to CO, FL, NJ, NY, NC, PA, SC, VA, WV. See the list of specific products that were recalled: https://go.usa.gov/xQjPC 
  • New @USGAO report highlights FDA work to protect infants from inorganic arsenic in rice. Pregnant women & infants should eat a variety of grains. We’ll update risk assessment as science evolves and finalize industry guidance this year. https://go.usa.gov/xQDCc 
  • Triangle Pharmataturals Recalls Kratom Products Due to Potential Salmonella Contamination http://dlvr.it/QPtdzN 
  • Carnivore Meat Company Issues Voluntary Recall of limited batches of “Vital Essentials® Freeze-Dried Beef Toppers” and “Vital Essentials® Frozen Beef Chub Entrée for Dogs” Pet Food http://dlvr.it/QPv4bv 

This #WellnessWednesday#FDAORA helps keep consumers in the know on the latest recalls of foods & dietary supplements. Find out what’s on the list & keep your family protected. MORE: https://go.usa.gov/xnJBF 

April 19, 2018

Federal Register

Agriculture Department

Proposed Rules

Federal Policy for the Protection of Human Subjects:

Proposed Six Month Delay of the General Compliance Date While Allowing the Use of Three Burden-Reducing Provisions During the Delay Period

Filed on: 04/19/2018 at 08:45 am Scheduled Pub. Date: 04/20/2018

FR Document: 2018-08231  PDF 97 Pages (432 KB)  Permalink

Animal and Plant Health Inspection Service

Proposed Rules

Imports:

Fresh Cape Gooseberry Fruit From Ecuador to the Continental United States

Filed on: 04/19/2018 at 08:45 am Scheduled Pub. Date: 04/20/2018

FR Document: 2018-08251  PDF 15 Pages (131 KB)  Permalink

Peppers From the Republic of Korea; Mesh Screening Size

Filed on: 04/19/2018 at 08:45 am Scheduled Pub. Date: 04/20/2018

FR Document: 2018-08250  PDF 9 Pages (100 KB)  Permalink

Notices

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

Importation of Clementines from Spain

Filed on: 04/19/2018 at 08:45 am Scheduled Pub. Date: 04/20/2018

FR Document: 2018-08303  PDF 4 Pages (163 KB)  Permalink

Importation of Fresh Pitaya Fruit from Central America Into the Continental United States

Filed on: 04/19/2018 at 08:45 am Scheduled Pub. Date: 04/20/2018

FR Document: 2018-08301  PDF 4 Pages (98.5 KB)  Permalink

Importation of Longan from Taiwan

Filed on:

04/19/2018 at 08:45 am

Scheduled Pub. Date: 04/20/2018

FR Document: 2018-08304  PDF 4 Pages (104 KB)  Permalink

Agricultural Marketing Service

Proposed Rules

Marketing Orders:

Almonds Grown in California; Adjusted Kernel Weight Computation

Filed on: 04/19/2018 at 08:45 am Scheduled Pub. Date: 04/20/2018

FR Document: 2018-08249  PDF 16 Pages (337 KB)  Permalink

Environmental Protection Agency

Rules

Tolerance Exemptions:

Bacillus licheniformis strain FMCH001

Filed on: 04/19/2018 at 08:45 am Scheduled Pub. Date: 04/20/2018

FR Document: 2018-08309  PDF 9 Pages (447 KB)  Permalink

Bacillus subtilis strain FMCH002

Filed on: 04/19/2018 at 08:45 am Scheduled Pub. Date: 04/20/2018

FR Document: 2018-08317  PDF 9 Pages (447 KB)  Permalink

FDA

Recalls

DateBrand NameProduct DescriptionReason/ProblemCompany
04/18/2018Various: Pain Out, Nirvanio, Calivarious kratom dietary supplementspotential for contamination with SalmonellaNutriZone, LLC
04/17/2018Various: Raw Form Organics, Molecule, Chameleon, Naturally, Lifted, Live Well, Third Eye  Powdered kratom productsMANDATORY RECALL ordered for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLCTriangle Pharmanaturals LLC
04/17/2018Herbal-SalvationKratom containing powder productspotential to be contaminated with SalmonellaViable Solutions
04/17/2018TRUDOGPet food-freezed dried raw beef topperpotential to be contaminated with SalmonellaTruPet, LLC

FSIS

Notification of Export Certificates to The People’s Republic of China

AskFSIS

Computer Generated Export Stamps

What is a Specified Risk Material (SRM) Statement?

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

Does total carbohydrate include dietary fiber?

Can an added solution statement like those on marinated product labeling be used in place of a retained water statement?

Does total fat, which is defined as total lipid fatty acids expressed as triglycerides, include cholesterol?

Are absorbent pads used to absorb moisture in packages of product part of the net weight of the product?

Should the sum of saturated, monounsaturated, and polyunsaturated fatty acids equal the total fat content?

When grams of saturated, monounsaturated, and polyunsaturated fat are calculated for listing on the nutrition panel, how is the glycerol component of fat dealt with in determining amounts of specific fatty acids?

Identifying the producing (processing) establishment on the official foreign inspection certificate

Grant of Federal Inspection

Meat and Poultry Hazards and Controls Guide

Carcass Wash Cabinets

AMS

USDA Lifts PACA Reparation Sanctions on Arizona Produce Business

NIH

Now Available: Health Professional Fact Sheet on Pantothenic Acid (aka Vitamin B5)

Now Available: Fact Sheet on Dietary Supplements for Primary Mitochondrial Disorders

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

April 20, 2018

Federal Register

Agricultural Marketing Service

Rules

Oranges, Grapefruit, Tangerines and Pummelos Grown in Florida and Imported Grapefruit:

Change of Size Requirements for Grapefruit

Filed on: 04/20/2018 at 08:45 am Scheduled Pub. Date: 04/23/2018

FR Document: 2018-08424  PDF 11 Pages (246 KB)  Permalink

FDA

Recalls

DateBrand NameProduct DescriptionReason/ProblemCompany
04/18/2018NXTGEN Kratom dietary supplementpotential to be contaminated with SalmonellaNGB Corp
04/18/2018Simply Superior, Morey’sSmoked Salmon SpreadsListeria monocytogenesSuperior Foods Company

FSIS

Sensenig Turkey Farm LLC Recalls Turkey Sausage Products Due to Misbranding and Undeclared Allergens

AskFSIS

What information needs to be included by a small company faxing labels to FSIS for evaluation and approval?

APHIS

APHIS Proposes to Allow the Importation of Fresh Cape Gooseberry Fruit from Ecuador

APHIS Proposes to Amend Import Regulations for Peppers from the Republic of Korea

AMS

Amended, USDA Poultry Purchase Program Announced

CSPI

Baltimore Mayor Signs Healthy Kids Meal Bill

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

  • Did you know the FDA actively monitors levels of metals in food? See what our Toxic Elements Working Group of experts is doing to keep our food supply safe. https://go.usa.gov/xQjmM 
  • #RECALL continues for #ChoppedRomaine
  • Dietary supplements labeled “natural” may not always be safe. Health scammers put the word “natural” on the package, knowing it may inspire trust in certain ethnic groups. Get the facts:  https://go.usa.gov/xnh6x  #NMHM18
  • NGB Corp. Recalls NxtGen Botanicals Maeng Da Kratom Because of Possible Salmonella Contamination  http://dlvr.it/QQ5jNJ 
  • Superior Foods Company Voluntarily Recalls 487 lbs. of Smoked Salmon Spreads http://dlvr.it/QQ5t0G 
  • RECALL: More eggs recalled. Don’t eat eggs from cartons printed with plant number P-1359D and Julian date 048A or 049A, with Best By dates of APR 02 and APR 03. http://go.usa.gov/xQjd4 
  • Lima beans are an excellent source of protein, iron, & magnesium plus rich in dietary fiber. No wonder there’s a  #LimaBeanRespectDay
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