Laws and Regulations Committee Update 3/22 – 3/27, 2018
March 22nd, 2018
Federal Register
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018
FR Document: 2018-06154 PDF 4 Pages (91.1 KB) Permalink
National Agriculture and Food Defense Strategy Survey
Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018
FR Document: 2018-06135 PDF 8 Pages (36.9 KB) Permalink
Premarket Notification for a New Dietary Ingredient
Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018
FR Document: 2018-06155 PDF 6 Pages (92.3 KB) Permalink
Animal and Plant Health Inspection Service
Notices
Determinations:
Fever Tick Status of the State of Chihuahua, Excluding the Municipalities of Guadalupe y Calvo and Morelos
Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018
FR Document: 2018-06131 PDF 4 Pages (11.3 KB) Permalink
FDA
Recalls
| Date | Brand Name | Product Description | Reason/Problem | Company |
| 03/26/2018 | Blue Ridge Beef | Complete raw pet food | May contain Salmonella and Listeria monocytogenes | Blue Ridge Beef |
| 03/26/2018 | Natural Selections and ZooLogics | Fresh raw meals for dogs | May contain Salmonella and E. coli O128 | Darwin’s Natural Pet Products |
| 03/25/2018 | Mrs. Gerry’s, Open Acres, Festival, Knowlan’s and Market Fresh | Egg Salads and Potato Salads | Undeclared Seafood in Salad | Mrs. Gerry’s Kitchen Inc. |
| 03/25/2018 | Whole Foods Market | Decorated (iced) cookies | Undeclared Egg Allergen | Whole Foods Market |
| 03/23/2018 | Kitchen’s Cravings | Egg Salad Sandwich | May contain traces of Imitation Crab Meat | Kwik Trip, Inc. |
Warning Letters
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
| 03/13/2018 | Biotek, Inc. | Denver District Office | Unapproved New Drugs/Misbranded | Not Issued * |
| 03/16/2018 | Bhavani Fruits & Vegetables LLC | New York District Office | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | Not Issued * |
| 03/19/2018 | Remnant Inc. DBA The Donut Stop | Kansas City District Office | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Not Issued * |
| 03/21/2018 | Starlight Desserts Inc | Seattle District Office | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Not Issued * |
FSIS
Training Requirement for International Travel
AMS
USDA Vegetable Purchase Program Announced
@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls
- Help keep fruits and vegetables safe when buying and storing them. Learn the simple steps you can take to help prevent foodborne illness. #NationalNutritionMonth http://go.usa.gov/xnzKu
- Kwik Trip, Inc. Issues Allergen Alert for Undeclared Fish or Shellfish on Premium Egg Salad Sandwich on Oat Multigrain Bread http://dlvr.it/QMRBDf
- Stay informed on the latest guidance regarding food & nutrition labeling. Use these #FDAORA resources to LEARN MORE: https://go.usa.gov/xn6yp
- Mrs. Gerry’s Kitchen Issues Allergen Alert on Undeclared Seafood in Salad http://dlvr.it/QMSdn3
- Blue Ridge Beef Voluntarily Recalls BRB Complete Raw Pet Food Lot#GA0131 Because of Possible Contamination http://dlvr.it/QMSdnf
- Store perishable fresh fruits and vegetables at 40° F or below. Use a refrigerator thermometer to check! http://go.usa.gov/xXx8n #NNM
- Allergy Alert Issued in Select Northern California Whole Foods Market Stores for Undeclared Egg in Some Cookies http://dlvr.it/QMT70M
- Darwin’s Natural Pet Products Issues Voluntary Recalls for Darwin’s Brand Dog Foods Due To Contamination Salmonella And Shiga Toxin-Producing Escherichia Coli O128 http://dlvr.it/QMTKKg
March 26, 2018
Federal Register
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Guidance on Consultation Procedures: Foods Derived From New Plant Varieties
Filed on: 03/26/2018 at 08:45 am Scheduled Pub. Date: 03/27/2018
FR Document: 2018-06069 PDF 6 Pages (91 KB) Permalink
Guidance:
Elemental Impurities in Animal Drug Products – Questions and Answers
Filed on: 03/26/2018 at 08:45 am Scheduled Pub. Date: 03/27/2018
FR Document: 2018-06061 PDF 5 Pages (27.3 KB) Permalink
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals
Filed on: 03/26/2018 at 08:45 am Scheduled Pub. Date: 03/27/2018
FR Document: 2018-05796 PDF 3 Pages (86.8 KB) Permalink
FDA
Recalls
| Date | Brand Name | Product Description | Reason/Problem | Company |
| 03/23/2018 | Delizza | Mini Eclairs | Listeria monocytogenes | Poppies International, Inc. |
| 03/23/2018 | King Arthur | Organic Coconut Flour | May contain Salmonella | King Arthur Flour Company |
| 03/23/2018 | Eclipse | Eclipse Kratom-containing powder products | May contain Salmonella | Tamarack Inc. |
| 03/22/2018 | Milo’s Kitchen | Dog treats | Products potentially contain elevated levels of beef thyroid hormone. | J.M. Smucker Company |
FSIS
Delayed Implementation of Verification of Revised Appendix A and B
- askFSIS Questions about Lethality and FSIS Appendix A
- askFSIS Questions about Stabilization and FSIS Appendix B
- askFSIS Questions about fully-cooked meat patties and compliance with 9 CFR 318.23
- askFSIS Questions about HACCP monitoring of Lethality and Stabilization CCPs
Follow-Up Sampling in Raw Poultry Establishments Not Meeting Salmonella Performance Standards
Mar 23, 2018 | PDF
- AskFSIS to Handle Questions on Siluriformes
- PHIS Quick Reference Guide Available on FSIS Website
- FSIS to Include Additional Establishment Categorization Information in PHIS
- FSIS Shares Updated Application for Export Certificate
AskFSIS
Inedible container
Containers used for inedible product
APHIS
USDA Provides Almost $70 Million in Fiscal Year 2018 to Protect Agriculture and Plants from Pests and Diseases through the 2014 Farm Bill Section 10007
- The APHIS News and Announcements page includes articles on the individual funding amounts received for 12 states. Please let me know if you would like a breakdown of this information.
AMS
USDA Restricts PACA Violators in Florida, Tennessee and Texas from Operating in the Produce Industry
USDA Seeks Nominees for the National Sheep Industry Improvement Center
USDA Seeks Nominees for the American Lamb Board
04/25 to 04/27 April 2018 NOSB Oral Comment In-Person Registration
04/25 to 04/27 National Organic Standards Board (NOSB) Meeting – Tucson, AZ
@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls
- #FridayFunFact #FDAORA investigators use the PREDICT risk assessment tool to identify #imports that could pose a risk to #publichealth. MORE: https://go.usa.gov/xnnyH
- Limited Production of Two Varieties of Milo’s Kitchen® Dog Treats Voluntarily Recalled Due to Potentially Elevated Levels of Thyroid Hormone http://dlvr.it/QM7Pdd
- King Arthur Flour Company, Inc. Voluntarily Recalls Organic Coconut Flour (16 Oz.) Because of Possible Health Risk http://dlvr.it/QM7zLg
- Chocolate bunnies are an Easter staple but be sure they aren’t on your furry friend’s menu. #NationalPuppyDay https://go.usa.gov/xQabx
- Keep chocolate away from your furry friends!
- Poppies International, Inc. Recalls Delizza Belgian Custard Cream Mini Eclairs 30 Count, Due to Potential Health Risks http://dlvr.it/QM8p6n
- Did you know pet food can carry germs like #Salmonella? Handwashing and proper storage can prevent illness for you, your pet, and your family. Check out our tips for pet #foodsafety #OneHealth #NationalPuppyDay http://go.usa.gov/xQaTB
- How Many Calories Are in That Cocktail? Soon You’ll Know
- Tamarack Inc. Recalls Eclipse Kratom Because of Possible Salmonella Contamination http://dlvr.it/QMGqbr
March 27, 2018
Federal Register
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Food Labeling; Calorie Labeling of Articles of Food in Vending Machines and Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments
Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018
FR Document: 2018-06154 PDF 4 Pages (91.1 KB) Permalink
National Agriculture and Food Defense Strategy Survey
Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018
FR Document: 2018-06135 PDF 8 Pages (36.9 KB) Permalink
Premarket Notification for a New Dietary Ingredient
Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018
FR Document: 2018-06155 PDF 6 Pages (92.3 KB) Permalink
Animal and Plant Health Inspection Service
Notices
Determinations:
Fever Tick Status of the State of Chihuahua, Excluding the Municipalities of Guadalupe y Calvo and Morelos
Filed on: 03/27/2018 at 08:45 am Scheduled Pub. Date: 03/28/2018
FR Document: 2018-06131 PDF 4 Pages (11.3 KB) Permalink
FDA
Recalls
| Date | Brand Name | Product Description | Reason/Problem | Company |
| 03/26/2018 | Blue Ridge Beef | Complete raw pet food | May contain Salmonella and Listeria monocytogenes | Blue Ridge Beef |
| 03/26/2018 | Natural Selections and ZooLogics | Fresh raw meals for dogs | May contain Salmonella and E. coli O128 | Darwin’s Natural Pet Products |
| 03/25/2018 | Mrs. Gerry’s, Open Acres, Festival, Knowlan’s and Market Fresh | Egg Salads and Potato Salads | Undeclared Seafood in Salad | Mrs. Gerry’s Kitchen Inc. |
| 03/25/2018 | Whole Foods Market | Decorated (iced) cookies | Undeclared Egg Allergen | Whole Foods Market |
| 03/23/2018 | Kitchen’s Cravings | Egg Salad Sandwich | May contain traces of Imitation Crab Meat | Kwik Trip, Inc. |
Warning Letters
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
| 03/13/2018 | Biotek, Inc. | Denver District Office | Unapproved New Drugs/Misbranded | Not Issued * |
| 03/16/2018 | Bhavani Fruits & Vegetables LLC | New York District Office | CGMP/Manufacturing, Packing or Holding Human Food/Adulterated/Insanitary Conditions | Not Issued * |
| 03/19/2018 | Remnant Inc. DBA The Donut Stop | Kansas City District Office | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Not Issued * |
| 03/21/2018 | Starlight Desserts Inc | Seattle District Office | CGMP/Food/Prepared, Packed or Held Under Insanitary Conditions/Adulterated | Not Issued * |
FSIS
Training Requirement for International Travel
AMS
USDA Vegetable Purchase Program Announced
@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA. @FDAMedia, @FDAanimalhealth, @FDArecalls
- Help keep fruits and vegetables safe when buying and storing them. Learn the simple steps you can take to help prevent foodborne illness. #NationalNutritionMonth http://go.usa.gov/xnzKu
- Kwik Trip, Inc. Issues Allergen Alert for Undeclared Fish or Shellfish on Premium Egg Salad Sandwich on Oat Multigrain Bread http://dlvr.it/QMRBDf
- Stay informed on the latest guidance regarding food & nutrition labeling. Use these #FDAORA resources to LEARN MORE: https://go.usa.gov/xn6yp
- Mrs. Gerry’s Kitchen Issues Allergen Alert on Undeclared Seafood in Salad http://dlvr.it/QMSdn3
- Blue Ridge Beef Voluntarily Recalls BRB Complete Raw Pet Food Lot#GA0131 Because of Possible Contamination http://dlvr.it/QMSdnf
- Store perishable fresh fruits and vegetables at 40° F or below. Use a refrigerator thermometer to check! http://go.usa.gov/xXx8n #NNM
- Allergy Alert Issued in Select Northern California Whole Foods Market Stores for Undeclared Egg in Some Cookies http://dlvr.it/QMT70M
- Darwin’s Natural Pet Products Issues Voluntary Recalls for Darwin’s Brand Dog Foods Due To Contamination Salmonella And Shiga Toxin-Producing Escherichia Coli O128 http://dlvr.it/QMTKKg