News Article

Laws and Regulations Committee Update 6/19 - 6/21, 2018

Posted on June 21, 2018

Blog: Association of Food & Drug Officials (AFDO)

June 19, 2018

Federal Register

Food and Drug Administration

Notices

Guidance:

Mitigation Strategies to Protect Food against Intentional Adulteration

Filed on: 06/19/2018 at 08:45 am Scheduled Pub. Date: 06/20/2018

FR Document: 2018-13222 PDF 6 Pages (104 KB) Permalink

Agriculture Department

Proposed Rules

Identifying Regulatory Reform Initiatives

Filed on: 06/19/2018 at 08:45 am Scheduled Pub. Date: 06/20/2018

FR Document: 2018-13153 PDF 2 Pages (230 KB) Permalink

Agricultural Marketing Service

Rules

Almonds Grown in California; Kernel Weight Computation

Filed on: 06/19/2018 at 08:45 am Scheduled Pub. Date: 06/20/2018

FR Document: 2018-13272 PDF 17 Pages (262 KB) Permalink

Assessment Rates:

Olives Grown in California

Filed on: 06/19/2018 at 08:45 am Scheduled Pub. Date: 06/20/2018

FR Document: 2018-13271 PDF 15 Pages (275 KB) Permalink

Proposed Rules

National Bioengineered Food Disclosure Standard; Correction

Filed on: 06/19/2018 at 08:45 am Scheduled Pub. Date: 06/20/2018

FR Document: 2018-13155 PDF 3 Pages (78.7 KB) Permalink

FDA

FDA Investigates Multistate Outbreak of Cyclospora illnesses linked to Del Monte Vegetable Trays

GRAS Notices

GRN No.	Substance	Date of Closure	FDA’s Letter
787	Quinoa sprout powder		Pending
786	Calcium propionate		Pending
785	Calcium chloride		Pending
784	Siraitia grosvenorii Swingle (Luo Han Guo) fruit extract		Pending
783	Triacylglycerol lipase from Rhizopus oryzae produced in Aspergillus niger		Pending
782	L-arabinose		Pending
782	Alpha-tocopherol (fruit and vegetable derived)		Pending
761	Esterified propoxylated glycerol	May 25, 2018	FDA has no questions (in PDF) (105 kB)
759	Steviol glycosides consisting primarily of rebaudioside M produced in Yarrowia lipolytica	May 25, 2018	FDA has no questions (in PDF) (106 kB)
755	D-psicose	May 10, 2018	At the notifier's request, FDA ceased to evaluate this notice (in PDF) (56 kB)
740	Glycolipids from Dacryopinax spathularia	May 17, 2018	FDA has no questions (in PDF) (93 kB)

AMS

USDA Alerts Vendors to Change in System for Award Management Registration

USDA Settles a Case with Crystal River Meats LLC, dba Crystal River Meats and Tai Jacober Resulting in a $750 Penalty

USDA Settles a Case with Tecumseh Livestock Auction Resulting in a $3,000 Penalty

OMB

Statement from the President Regarding Trade with China

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

· Check your cabinets for #honeysmacks!
· RECALL: Do you have Del Monte 6, 12, 28oz #vegetable trays in your fridge or freezer? These are being withdrawn from the market in IA, IL, IN, MN, WI due to associated #Cyclospora illnesses. Consumers in these areas - do not eat & throw away these products https://go.usa.gov/xQzKr
· Don’t forget the fruits and vegetables! Heart disease in the number one killer of men. You can help protect your heart with a more balanced diet. #MensHealthMonth http://bit.ly/2rRkyOz
· Planning on celebrating International #PicnicDay? Follow #foodsafety advice like “keep the cold foods cold” to make it enjoyable. http://go.usa.gov/xNGb7
· OUTBREAK #RECALL UPDATE: @US_FDA along with @CDCgov are advising consumers to not eat ANY Kellogg’s #HoneySmacks cereal because of possible #Salmonella Mbandaka illnesses. This is regardless of size or “best if used by” dates. https://go.usa.gov/xQtHc
· The recalled products were distributed across the United States including Guam & Saipan; internationally in: Aruba/Curaçao/Saint Maarten (Netherlands Antilles), the Bahamas, Barbados, Tortola (BVI), Costa Rica, Guatemala, Haiti, Mexico, Panama, & Tahiti (French Polynesia)
· Say #ByeTransFat! As of today, June 18, most food products cannot have Partially Hydrogenated Oils #PHOs added. With extensive research & public comment, FDA determined removal PHOs could prevent 1000s of heart attacks & deaths each year. https://go.usa.gov/xQusq
· #FDA and @CDCgov are continuing to partner as our teams work hard to find the source of Salmonella contamination linked to pre-cut melon. We will share updates as soon as we know more: https://go.usa.gov/xQHPC
· Pre-cut melon has a very short shelf life, but a lot of consumers freeze fruit and use it in many different ways later on. Make sure you didn’t freeze any of the pre-cut melon from Caito foods that has been recalled: https://go.usa.gov/xQHPC
· Do you like fruit salad? Many people start their day with a nutritious fruit salad. Consumers should be aware that #FDA recently linked pre-cut melon from a list (at link) of major retailers to an outbreak of Salmonella: https://go.usa.gov/xQMev

June 20, 2018

FDA

Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration

FDA Considering Revised Approach to Declaration of Added Sugars on Pure Maple Syrup and Pure Honey

Statement from FDA Commissioner Scott Gottlieb, M.D., on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply

Recalls

Date	Brand Name	Product Description	Reason/Problem	Company
06/19/2018	ALREEF	Dried Apricots Sour	Undeclared Sulfites	Golden Star Wholesale

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
06/11/2018	LNZRO Pizza Empire, Inc.	New York District Office	Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions	Not Issued *
06/08/2018	Kaltec Food Packaging Inc.	New York District Office	Acidified Foods/Emergency Permit Control/Adulterated/Misbranded	Not Issued *
06/07/2018	Up Inya Gear	Center for Food Safety and Applied Nutrition	New Drug/Misbranded	Not Issued *
06/06/2018	The Health Management Group Inc.	Cincinnati District Office	CGMP/Dietary Supplement/Adulterated/Misbranded	Not Issued *

USDA

USDA Appoints Members to National Fluid Milk Processor Promotion Board

Secretary Perdue Announces New Budget Director at USDA

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

· PRODUCT RECALL REMINDER: Kellogg’s recalled Honey Smacks cereal due to the presence of Salmonella. Consumers should discard the cereal or return unopened product for a refund https://go.usa.gov/xQJXx
· Statement from FDA Commissioner @SGottliebFDA on new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply https://go.usa.gov/xQJEZ
· Golden Star Wholesale Issues Allergy Alert on Undeclared Sulfites in Dried Apricots Sour http://dlvr.it/QXqM9y
· Fact or fiction? Putting hands under running water is enough to get the germs off. Find out about this and other myths & facts about #foodsafety in this #FDAConsumerUpdate: https://go.usa.gov/xQRGC #NationalSafetyMonth
· THREAD 1/4 - Congress entrusted the FDA with new authorities & resources, as part of the FDA Food Safety Modernization Act, to strengthen FDA’s ability to oversee efforts to protect against the possibility of someone using our food supply to harm American consumers.
· 2/4 The Intentional Adulteration rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration & to ensure those strategies are working.
· 3/4 Today #FDA issued a new guidance to help manufacturers implement protections against potential attacks on the U.S. food supply and to come into compliance with the rule: http://go.usa.gov/xQJEN .
· 4/4 The #FDA is committed to ensuring that the agency is implementing the rule in a way that will best protect our food supply and allow companies to efficiently meet the new requirements. We’ll advance the 2nd and 3rd installments of this guidance later this year.
· The FDA has new draft guidance to help #foodmanufacturers implement protections #FoodDefense against potential, intentional attacks on the U.S. food supply. #foodsafety https://go.usa.gov/xQJm6
· #FDA is continuing to work with Kellogg’s to ensure that Honey Smacks cereal linked to a multi-state outbreak of Salmonella is recalled from the market place. Do not eat ANY Honey Smacks cereal https://go.usa.gov/xQJXx
· FDA is considering a revised approach to declaring #AddedSugars in maple syrup & pure honey on the Nutrition Facts label. We continue to review the public comments & look forward to working with stakeholders to devise a sensible solution. https://go.usa.gov/xQJ7q
· It’s easy to get distracted when you’re cooking. Remember that clean hands & surfaces are key to food safety. Wash hands w/ warm water & soap for at least 20 seconds before and after handling food. https://go.usa.gov/xQuEV
· The #FDA is considering a revised approach to declaring added sugars on labels of pure maple syrup and honey. We’re carefully reviewing industry input and public feedback before making a final determination. http://go.usa.gov/xQJws
· #FDA recognizes complexity of this issue; we’re grateful for the feedback we’ve received, including more than 3,000 comments. http://go.usa.gov/xQJws We know that firms are anxious to update their Nutrition Facts labels, so we aim to finalize an approach as quickly as possible
· Federal health officials updated case information today in the Salmonella outbreak investigation linked to pre-cut melon. Caito Foods recalled pre-cut melon products on June 9 so none of the potentially contaminated product should be for sale https://go.usa.gov/xQMev
· The most recent illness being reported was on June 3. #FDA and @CDCgov will provide updates as they become available and we provided a list of retailers and addresses for consumers to check against the recall if they froze any of the pre-cut melon here: https://go.usa.gov/xQHPC
· OUTBREAK UPDATE: Multi-state #Salmonella Adelaide illness investigation that may be linked to cut melons. Today, @CDCgov reports 70 cases in 7 states w/ 34 hospitalized. Illnesses occurred 4/30-6/3/2018 in people less than 1 to 97 y.o. No deaths reported. http://go.usa.gov/xQFqA
· I want to thank the leadership of @NASDAnews for visiting with me and my team at #FDA today. Our partnership with NASDA and the states is key to our shared efforts to successfully implement FSMA and our joint commitment to give every American high confidence in food safety
· Congress entrusted the #FDA with new authorities and resources, as part of the FDA Food Safety Modernization Act, to strengthen FDA’s ability to oversee efforts to protect against the possibility of someone using our food supply to harm American consumers
· Working with @NASDAnews leadership today to further our Integrated Food Safety System through collaboration and information sharing, including this training video:

June 21, 2018

Federal Register

Environmental Protection Agency

Rules

Pesticide Tolerances:

Acetochlor