Laws and Regulations Committee Update 9/17 – 9/19, 2018
Federal Register
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
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
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
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
- FDA has resources for food producers #Farmers in flooded areas! There is information that can be used for assessing potential damage to your food crops plus contact info. #HurricaneFlorence #flooding #Farms https://go.usa.gov/xPgTh
- Raw, undercooked, or unwashed foods can put your health at risk! Find out how to tell if it’s #foodsafe. https://go.usa.gov/xPrVP
- If power is out, a full freezer will hold its temp for 48 hrs (24 if half-full) & a fridge for 4 hrs w/ door closed. This & other prep tips: https://go.usa.gov/xPrxa
- Planning a #foodsafety education program? This toolbox and guide can help you develop and evaluate your program and activities. https://go.usa.gov/xPrqY #NFSEM
- FDA’s advice on #FoodSafety in case you lost power during #HurricaneFlorence ⇨ http://go.usa.gov/WJjh
- Don’t trust “exotic fruit juice” products that promise to cure a wide range of unrelated conditions. If it sounds too good to be true, it’s probably a #healthfraud scam. LEARN MORE: http://bit.ly/2LFLyOi
September 19, 2018
Federal Register
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
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
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