News Article

Laws and Regulations Committee Update 9/17 - 9/19, 2018

Posted on September 21, 2018

Blog: Association of Food & Drug Officials (AFDO)

August 17, 2018

Federal Register

Food and Drug Administration

Proposed Rules

Food Additive Petitions:

Oakshire Naturals LP

Filed on: 09/17/2018 at 08:45 am Scheduled Pub. Date: 09/18/2018

FR Document: 2018-20217  PDF 2 Pages (78.5 KB)  Permalink

 

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 09/17/2018 at 08:45 am Scheduled Pub. Date: 09/18/2018

FR Document: 2018-20281  PDF 4 Pages (113 KB)  Permalink

 

Food Safety and Inspection Service

Proposed Rules

Eligibility of Thailand to Export Siluriformes Fish and Fish Products to the United States

Filed on: 09/14/2018 at 04:15 pm Scheduled Pub. Date: 09/19/2018

FR Document: 2018-20380  PDF 22 Pages (172 KB)  Permalink

 

Eligibility of the People’s Republic of China to Export Siluriformes Fish and Fish Products to the United States

Filed on: 09/14/2018 at 04:15 pm Scheduled Pub. Date: 09/19/2018

FR Document: 2018-20379  PDF 23 Pages (188 KB)  Permalink

 

Eligibility of the Socialist Republic of Vietnam to Export Siluriformes Fish and Fish Products to the United States

Filed on: 09/14/2018 at 04:15 pm Scheduled Pub. Date: 09/19/2018

FR Document: 2018-20376  PDF 22 Pages (173 KB)  Permalink

 

Environmental Protection Agency

Rules

Tolerance Exemptions:

Special Federal Aviation Regulation No. 79

Filed on: 09/17/2018 at 08:45 am Scheduled Pub. Date: 09/18/2018

FR Document: 2018-20285  PDF 9 Pages (386 KB)  Permalink

 

FDA

FDA Releases Information for Qualified Facilities under Preventive Controls Rules

Resources for Food Producers in Flooded Areas

FDA Releases Information for Qualified Facilities under Preventive Controls Rules

FDA Releases Five-Year Plan for Supporting Antimicrobial Stewardship in Veterinary Settings

Notice of Availability of Guidance for Industry; Determination of Status as a Qualified Facility Under the CGMP, Hazard Analysis, and Risk-Based Preventive Controls for Human and Animal Food Rules 

Guidance for Industry: Determination of Status as a Qualified Facility Under Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food AND Part 507: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals

 

FSIS

Sep 14, 2018 | PDF

  • FSIS to Publish Proposed Rules to List Vietnam, China, and Thailand as Eligible to Export Siluriformes Fish and Fish Products to the U.S.
  • USDA and FDA Announce Joint Public Meeting on Use of Animal Cell Culture Technology to Develop Products Derived from Livestock and Poultry
  • FSIS Names New Chief Scientist
  • FSIS Posts Updated Dataset on Imports
  • FSIS Posts Individual Salmonella Category Status for Poultry Carcass Establishments and Aggregate Results for Chicken Parts, Comminuted Poultry and Poultry Carcasses Tested for Salmonella

 

AMS

USDA Restricts PACA Violators in Illinois, New York, Texas and Virginia from Operating in the Produce Industry

Pre-Solicitation Announcement for Trade Mitigation Purchase of Corn Frozen Products

 

Presidential Actions

Presidential Proclamation on National Farm Safety and Health Week, 2018

 

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

  • ·        For those of you in the Southest affected by #flooding & power outages, follow these tips to prevent foodborne illness: http://go.usa.gov/sFPw 
  • ·        Staying clean is the first step to #foodsafety. Do you know what to wash and when? https://go.usa.gov/xPrVE 
  • ·        Guidance released by #FDA to help certain facilities determine if they are Qualified Facilities under PC Human Food or PC Animal Food Rules, & if so, what modified reqs might apply to them #FSMA https://go.usa.gov/xPgDU 
  • ·        FDA has resources for food producers #Farmers in flooded areas! FDA has information that can be used for assessing potential damage to your food crops plus contact info. #HurricaneFlorence #Flood #Farms https://go.usa.gov/xPgTh 
  • ·        Going out to eat for dinner? Some foods are safer than others. Here’s what to watch out for: https://go.usa.gov/xPrjQ  . #NFSEM #foodsafety
  • ·        #Foodsafety tip: Never allow raw seafood to touch produce that won’t be cooked. Put this tip into practice when you make this delicious and nutritious Grilled Tuna with Chickpea and Spinach Salad. https://go.usa.gov/xPrBK  #recipe #foodsafe #NFSEM #FVMMMonth
  • ·        We’re also closely monitoring #HurricaneFlorence’s impact on the food and agriculture industry. #FDA recently updated resources on crops harvested from flooded fields for farmers who have food crops  https://go.usa.gov/xPgTh  and animal food producers: https://go.usa.gov/xPgWQ 
  • ·        Similarly, inappropriate antibiotic use in animals – both companion and food-producing animals – can contribute to the emergence of antibiotic-resistant bacteria; and these resistant bacteria may then be transmitted to people and cause infections that are difficult to treat.
  • ·        Antibiotic stewardship in veterinary medicine promotes the judicious use of antibiotics in food animals, which includes the concept that medically-important antimicrobial drugs should only be used in animals when necessary for treatment, control or prevention of specific diseases
  • ·        This approach has eliminated production use of medically-important antimicrobials and brought the therapeutic use of such drugs in animal feed and water under veterinary oversight https://bit.ly/2N6zyX3 .
  • ·        FDA’s Center for Veterinary Medicine’s new 5-year plan builds on existing progress. It would bring the remaining 5% of medically-important antimicrobials approved for use in animals, such as certain injectable antimicrobials, under the oversight of vets. https://bit.ly/2CRvaqb 
  • ·        CVM will also devise a strategy to ensure that all medically-important antimicrobials used in animal feed and water are labeled with appropriate durations of use. Look for an FDA public meeting on the 5-year plan sometime this fall.
  • ·        Having good data is essential to understanding the drivers of resistance in human and vet settings and formulating appropriate responses. But acquiring that data is complicated. It requires collaboration with USDA, CDC, NIH and others.
  • ·        Improvements in the National Antimicrobial Resistance Monitoring System, with our @USDA and @CDCgov partners is one way to get better data. It tracks and provides information on AMR in food borne bacteria in humans, retail meats and food-producing animals. https://bit.ly/2MmRabE 
  • ·        Also, we’re refining industry reporting of animal antimicrobial sales data to better understand how these products are used on farms. To track hospital resistance, we’re planning to leverage IVD data standards to enhance real-time infectious disease/AMR surveillance with labs.
  • ·        I’m confident these and future efforts will help us achieve our goal of facilitating antimicrobial stewardship and advancing innovation across human and animal health, within our borders and across them.

September 18, 2018

Federal Register

Animal and Plant Health Inspection Service

Proposed Rules

Removal of Emerald Ash Borer Domestic Quarantine Regulations

Filed on: 09/18/2018 at 08:45 am Scheduled Pub. Date: 09/19/2018

FR Document: 2018-20296  PDF 12 Pages (197 KB)  Permalink

 

HHS

First Comprehensive HHS Data Sharing Report Released

 

USDA

USDA Provides Additional Food Options to SNAP Participants Impacted by Hurricane Florence

 

APHIS

Availability of the Proposal to Remove the Domestic Quarantine for Emerald Ash Borer

 

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

 

September 19, 2018

Federal Register

Food and Drug Administration

Rules

Food Additives Permitted for Direct Addition to Food for Human Consumption:

Vitamin D3

Filed on: 09/19/2018 at 08:45 am Scheduled Pub. Date: 09/20/2018

FR Document: 2018-20375  PDF 12 Pages (124 KB)  Permalink

 

Agriculture Department

Notices

Meetings:

National Agricultural Research, Extension, Education, and Economics Advisory Board

Filed on: 09/19/2018 at 08:45 am Scheduled Pub. Date: 09/20/2018

FR Document: 2018-20452  PDF 3 Pages (80 KB)  Permalink

 

Animal and Plant Health Inspection Service

Notices

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

Importation of Fresh Peppers from Peru into Continental United States and Territories

Filed on: 09/19/2018 at 08:45 am Scheduled Pub. Date: 09/20/2018

FR Document: 2018-20449  PDF 4 Pages (98.1 KB)  Permalink

 

FDA

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s ongoing efforts to prevent foodborne outbreaks of Cyclospora

Recalls

Date

Brand

Product Description

Reason/Problem

Company

09/13/2018

Bellona

Milk Chocolate Flavored Coated Wafer with Hazelnut Crème Filling and White Chocolate Flavor

Undeclared Wheat

Lidl US

Warning Letters

Letter Issue Date

Company Name

Issuing Office

Subject

Close Out Date

09/07/2018

Best Nutrition Products, Inc.

San Francisco District Office

CGMP/Dietary Supplement/Adulterated/Misbranded

Not Issued *

09/06/2018

Rose Acre Farms-Hyde County

Atlanta District Office

PHS Act/Shell Egg Regulation/Adulterated

Not Issued *

09/04/2018

Natural Sea Product Co., Ltd.

Center for Food Safety and Applied Nutrition

Seafood HACCP/CGMP for Foods/Adulterated

Not Issued *

08/29/2018

Dolezal Dairy

Kansas City District Office

Illegal Drug Residue Animal Tissue/Adulterated/False Guaranty

Not Issued *

08/28/2018

Celletech, Ltd

Minneapolis District Office

New Drugs/Dietary Supplements/Food Labeling/Misbranded

Not Issued *

 

AMS

USDA Announces $102.7 Million Investment to Expand Markets for Specialty Crop and Other Farmers

 

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

  • ·        Have a problem or adverse reaction to a food, cosmetic or dietary supplement? Contact an FDA Consumer Complaint Coordinator or submit a voluntary MedWatch form. https://go.usa.gov/xUtRD 
  • ·        Here's what you should throw out after a power outage: Meat, poultry, seafood products Soft/shredded cheeses Milk, cream, yogurt & other dairy products Opened baby formula Eggs and egg products Dough, cooked pasta Cooked or cut product
  • ·        Do you bring your groceries straight home from the store? Do you keep your refrigerator at the right temperature? Learn how to be #foodsafe at: https://go.usa.gov/xPrBr  .
  • ·        Lidl Voluntarily Recalls Bellona Brand Hazelnut Wafers Due to Improperly Declared Wheat Allergen http://dlvr.it/QkbjjC 
  • ·        How can you tell when poultry is safe to serve and eat? Use a food thermometer, as instructed in this delicious #recipe for 20-minute Chicken and Mushroom Fricassee. #foodsafety https://go.usa.gov/xPrBa 
  • ·        LEARN the 7 tips to clean your fruits & vegetables safely this Fruits & Veggies – More Matters Month. Federal health officials estimate that <48 million people are sickened by food contaminated w/harmful germs yearly. Some of the causes may surprise you. http://go.usa.gov/xU9US 


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