Laws and Regulations Committee Update 8/13 – 8/16, 2018

Federal Register

Food and Drug Administration

Notices

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

Food Safety, Health, and Diet Survey

Filed on: 08/13/2018 at 08:45 am Scheduled Pub. Date: 08/14/2018

FR Document: 2018-17363  PDF 6 Pages (96.1 KB)  Permalink

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Title: Consumer Complaint Monitoring System

Filed on: 08/13/2018 at 08:45 am Scheduled Pub. Date: 08/14/2018

FR Document: 2018-17397  PDF 5 Pages (116 KB)  Permalink

Food Safety and Inspection Service

Notices

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

Certificates of Medical Examination

Filed on: 08/13/2018 at 08:45 am Scheduled Pub. Date: 08/14/2018

FR Document: 2018-17424  PDF 9 Pages (211 KB)  Permalink

Foodborne Illness Outbreak Investigation Survey for FSIS Public Health Partners

Filed on: 08/13/2018 at 08:45 am Scheduled Pub. Date: 08/14/2018

FR Document: 2018-17427  PDF 8 Pages (218 KB)  Permalink

Environmental Protection Agency

Notices

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

Experimental Use Permits for Pesticides

Filed on: 08/13/2018 at 08:45 am Scheduled Pub. Date: 08/14/2018

FR Document: 2018-17443  PDF 4 Pages (182 KB)  Permalink

Pesticide Petitions:

Residues of Pesticide Chemicals in or on Various Commodities

Filed on: 08/13/2018 at 08:45 am Scheduled Pub. Date: 08/14/2018

FR Document: 2018-17450  PDF 8 Pages (95.2 KB)  Permalink

FSIS

Aug 10, 2018 | PDF

  • FSIS Posts Updated Dataset on Imports
  • FSIS Posts Next Set of Establishment-Specific Datasets

AMS

USDA Announces Grain Inspection Advisory Committee Meeting

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

  • Have you heard about the @HHSPrevention Healthy People Initiative? The #healthypeople initiative is a collaborative health promotion & disease prevention effort w/a vision towards a healthier nation. MORE about this effort here: https://go.usa.gov/xUKXa 
  • Q&A: FDA’s Investigation into Possible Connection Between Diet and Canine Heart Disease https://go.usa.gov/xUH3v 
  • Does your #FamilyFunMonth include picnics & barbecuing? Avoid #foodpoisoning and follow our #foodsafety rules. http://go.usa.gov/xNAhN  & enjoy #NationalSmoresDay !
  • One of the ways #FDA achieves its mission of protecting and promoting public health is by providing accurate, science-based information about medical products and foods. This week’s #SUNDAYTWEETORIAL highlights some of FDA’s many patient and consumer resources-It’s #NEWSYOUCANUSE
  • FDA’s Center for Veterinary Medicine protects both human and animal health. To learn more about animal health topics from pet food to heartworm visit https://bit.ly/2KzwMDx . Info on recalls and withdrawals of animal & veterinary products is found here https://bit.ly/2EKHGXZ 
  • FDA provides information regarding the measures we take when a food product is mislabeled, presents a health risk because of contamination, or has caused an outbreak of illness. For a list of food and dietary supplement recalls, visit https://bit.ly/2rMOwF1 
  • Stay informed about foodborne illness outbreaks linked to FDA-regulated food products. FDA’s Coordinated Outbreak Response and Evaluation (CORE) Network manages response, surveillance, and post-response activities https://bit.ly/2MnfRpk 
  • Want to learn more about food safety and nutrition? Visit our Education Resource Library, a catalog of printable educational materials and videos intended for consumers, educators, dietitians and health professionals https://bit.ly/2Mbc6qf 

August 14, 2018

Federal Register

Food Safety and Inspection Service

Notices

Retail Exemptions Adjusted Dollar Limitations

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

FR Document: 2018-17546  PDF  6 Pages (205 KB)  Permalink

Animal and Plant Health Inspection Service

Rules

Conditions for Payment of Highly Pathogenic Avian Influenza Indemnity Claims

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

FR Document: 2018-17554  PDF   23 Pages (134 KB) Permalink

FDA

What’s Next For PC Animal Food Implementation? 

Recalls

DateBrandProduct DescriptionReason / ProblemCompany
08/13/2018Blissful RemediesProducts Containing KratomHigh microbial loadWorld Organix, LLC

AMS

USDA Determines Individual Not Responsibly Connected to Arizona Violator

USDA Adds New Service for Fruit & Vegetable Growers, USDA GAP Audit Now Recognized by the Global Food Safety Initiative and FDA

USDA Proposes Revising Terminology in Several Specialty Crops Standards

August 15, 2018

FDA

Warning Letters

Letter Issue DateCompany NameIssuing OfficeSubjectClose Out Date
07/31/2018Signature Formulations, LLCSan Francisco District OfficeCGMP/Finished Pharmaceuticals/AdulteratedNot Issued *
07/12/2018www.poppyseedwash.comCenter for Food Safety and Applied NutritionNew Drug/Labeling/MisbrandedNot Issued *

GRAS

GRN No.SubstanceDate of ClosureFDA’s Letter
802Endolysin Pending
801Chymosin enzyme from Camelius dromedarius produced in Aspergillus niger Pending
800gamma-oryzanol Pending
799Rebaudioside M Pending
798Saccharomyces cerevisiae strain yBBS002 Pending
797Fructooligosaccharides Pending
796Orange extract (85% hesperidin) Pending
795Purified steviol glycosides           Pending
794Shiitake, pea, and rice protein fermented with Lentinula edodes Pending
780Rebaudioside MJul 31, 2018FDA has no questions (in PDF) (115 kB)
764Rebaudioside DJul 10, 2018FDA has no questions (in PDF ) (111 kB)
754Algal oil (87% oleic acid) derived from Prototheca moriformis strain S6697Jul 23, 2018FDA has no questions (in PDF) (111 kB)

USDA

USDA Adds New Tools, Resources to Farmers.gov to Aid Producers

FSIS

USDA Provides Food Safety Tips to Keep Foodborne Illness Out of the Classroom

APHIS

APHIS Finalizes Conditions for Paying Highly Pathogenic Avian Influenza Indemnity

AMS

USDA Vegetable Purchase Program Announced

USDA Fresh Fluid Milk Purchase Program Announced

USDA Chicken Products Purchase Program Announced

USDA Beef Products Purchase Program Announced

National Academies

Understanding and Overcoming the Challenge of Obesity and Overweight in the Armed Forces: Proceedings of a Workshop–in Brief

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

  • The food supply in the US is among the safest in the world, yet foodborne illness can still occur. Everyone can be affected by this & some people are at greater risk. LEARN MORE about these at-risk groups: https://go.usa.gov/xUByH 
  • What should animal food producers expect during the next compliance dates for the FSMA Preventative Controls for Animal Foods Rule? Read here to find out more https://go.usa.gov/xU6ev 

August 16, 2018

Federal Register

Food and Nutrition Service

Notices

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

Supplemental Nutrition Assistance Program, Store Applications

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

FR Document: 2018-17722  PDF 7 Pages (304 KB)  Permalink

Agricultural Marketing Service

Rules

Cotton Board Rules and Regulations:

Adjusting Supplemental Assessment on Imports (2018 Amendments)

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

FR Document: 2018-17723  PDF 69 Pages (593 KB) m Permalink

Notices

Standards for Grades of Pork Carcasses

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

FR Document: 2018-17725  PDF 4 Pages (162 KB)  Permalink

FDA

Recalls

DateBrandProduct DescriptionReason/ProblemCompany
08/15/2018Marsee BakingCookiesUndeclared PeanutsMarsee Foods Inc. dba Marsee Baking
08/14/2018Zakah LifeKratom Containing ProductsSalmonellaZakah Life, LLC
08/14/2018Salt & StrawChocolate Gooey Brownie Ice CreamUndeclared peanutsSalt & Straw Ice Cream

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

  • Beware of companies or people selling bogus cancer “cures.” Advertised as “natural” treatments or dietary supplements online or on social media, they may appear harmless but can delay or interfere w/proven, beneficial treatments: http://go.usa.gov/xndE7  #ORAConsumerUpdate
  • Salt & Straw Voluntarily Recalls Certain Lots of Chocolate Gooey Brownie Ice Cream Pints Due to Possible Undeclared Peanuts http://dlvr.it/QfzDs0 
  • Wash kitchen towels frequently & on the HOT washing machine cycle to remove any bacteria contaminating your kitchen towels. Check out the Kitchen Towel Playbook for more #foodsafety info. https://go.usa.gov/xQM6m  #WednesdayWisdom
  • Thanks to @NCAgriculture@NASDANews & @NCFarmBureau for hosting #FDA for an On-Farm Readiness Review in North Carolina today!
  • The On-Farm Readiness Reviews are a productive way for farmers to assess their level of compliance with the #FSMA Produce Safety Rule.
  • #FDA is committed to helping farmers meet the new #FSMA requirements to ensure safe produce for Americans.
  • #FDA is continuing its commitment to support farmers in implementing the new produce safety standards under #FSMA. FDA staff are in North Carolina this week for an on-farm readiness review demonstration – a way for farmers to assess their level of compliance w/ the produce rule.
  • The #FSMA Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing & holding of fruits & vegetables grown for human consumption. For more info see: https://go.usa.gov/xUFuv .
  • Marsee Baking Issues Allergy Alert On Undeclared Peanuts In Cookies Sold At Café Yumm! Restaurants http://dlvr.it/Qg1cm5 

Zakah Life Recalls Kratom Because Of Possible Health Risk http://dlvr.it/Qg2Gdb 

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