Laws and Regulations Committee Update 10/29 – 10/31, 2018

Federal Register

Food and Drug Administration

Proposed Rules

Food Additive Petitions:

Adisseo France S.A.S.

Filed on: 10/29/2018 at 8:45 am Scheduled Pub. Date: 10/30/2018

FR Document: 2018-23671 PDF 2 Pages (83.9 KB) Permalink

• The petition proposes to amend 21 CFR Part 573 to provide for the safe use of silicon dioxide as a carrier for selenomethionine hydroxyl analogue at a level not to exceed 95% of the selenomethionine hydroxyl analogue in its packaged form.

Zinpro Corp.

Filed on: 10/29/2018 at 8:45 am Scheduled Pub. Date: 10/30/2018

FR Document: 2018-23672 PDF 2 Pages (83.6 KB) Permalink

• The petition proposes to amend 21 CFR 573 to provide for the safe use of silicon dioxide as an anticaking agent for the use with zinc-L-selenomethionine as a feed component.

Orders:

Sesame as an Allergen in Foods

Filed on: 10/29/2018 at 8:45 am Scheduled Pub. Date: 10/30/2018

FR Document: 2018-23635 PDF 10 Pages (118 KB) Permalink

• FDA is requesting comments, data, and other information on the prevalence and severity of sesame allergies in the U.S. and the prevalence of sesame-containing foods sold in the U.S. that are not required to disclose sesame as an ingredient to inform possible regulatory action on sesame to protect and promote public health.

FDA

Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s new consideration of labeling for sesame allergies

CFSAN

FDA Asks for Input on Sesame Allergies and Food Labeling

USDA

Assistance Available through NRCS for Ag Land Damaged by Hurricane Michael

AMS

USDA Announces Amendments to California Raisin Marketing Order

FSIS

Oct 26, 2018 | PDF

• FSIS to Post Individual Salmonella Category Status for Establishments Producing Chicken Parts and NRTE Comminuted Poultry Products Using New Categorization Procedures
• FSIS To Post Updated Quarterly Sampling Results
• USDA and FDA Joint Public Meeting on Cell Culture Technology

Notices

Recalls

Microbiological Testing Program for E. coli 0157:H7 and non-0157 Shiga Toxin-Producing E.coli

Table 1: Raw Ground Beef (RGB) Analyzed for E. coli O157:H7, Current Calendar Year

Table 2: Raw Ground Beef Components (RGBC) Analyzed for Target STECs, Current Calendar Year

White House

Remarks by President Trump at the 91st Annual Future Farmers of America Convention and Expo

@FDAMedia, @FDACosmetics, @FDAanimalhealth, @FDAfood, @FDA_ORA, @SGottliebFDA

• Statement from FDA Commissioner @SGottliebFDA on the FDA’s new consideration of labeling for sesame allergies https://go.usa.gov/xPEJB
• #Recall: GoodFibers LLC recalls the Royal Family branded Calming Lavender, Refreshing Cucumber, and All Skin Types versions of makeup remover wipes due to contamination with Pseudomonas aeruginosa. https://go.usa.gov/xPE4p
• FDA Issues Warning Letter to No More Fleas Please, Inc. for selling a variety of unapproved products intended for use in cats and dogs. For more information, go to: https://go.usa.gov/xPExH
• Product was sold in Michigan, Minnesota, Illinois, Indiana, Ohio, Missouri & Colorado. Retailers please remove from shelves, Baraka Brand with UPC CODES 822514265566 & 822514265535 then place aside for pick up from a UBC company representative.
• #RECALL – UBC Food Distributors Inc, is voluntarily recalling Baraka HOT #CURRY POWER & CURRY POWDER, due to a high level of #lead found in testing done by @MichDeptofAg . @FDAFood is in contact with the importer. Do not eat. Return to place of purchase. https://go.usa.gov/xPPhK
• #FridayCaseFile – 2015: A Canadian corporation that manufactures & sells cattle feed was fined $80K for importing contaminated product into the US that contained more than 2x the amount of an antibiotic that is regularly used for animal feed. http://bit.ly/2x7wrD9
• #FDA will host four public meetings in Portland, Anaheim, Albany, and Atlanta to discuss FDA’s draft guidance on how to implement the Produce Safety Rule. Registration kicks off October 31.
• The meetings will provide an opportunity for #FDA to receive public input on the draft Produce Safety Rule guidance released on Oct. 19, to help farmers better understand how to comply with the Produce Safety Rule. Come join us! https://go.usa.gov/xPPKd

October 30, 2018

Federal Register

Food and Drug Administration

Rules

Termination of Listing of Color Additive Exempt From Certification; Lead Acetate

Filed on: 10/30/2018 at 8:45 am Scheduled Pub. Date: 10/31/2018

FR Document: 2018-23725 PDF 34 Pages (235 KB) Permalink

Notices

Meetings:

Science Advisory Board to the National Center for Toxicological Research (NCTR) Advisory Committee

Filed on: 10/30/2018 at 8:45 am Scheduled Pub. Date: 10/31/2018

FR Document: 2018-23742 PDF 4 Pages (13.6 KB) Permalink

• CFSAN and other FDA Centers will each briefly discuss their center-specific research strategic needs and potential areas of collaboration.

FDA

Recalls

Warning Letters

USDA

USDA Announces Early Release of Select Commodity Tables for USDA’s Agricultural Projections to 2028

@SGottliebFDA, @DrMayneFDAFood, @FDAfood

• #FDA is taking new steps to consider that food labels be updated to require disclosure of the allergen sesame to address growing prevalence of these risks
• Maribel’s Sweets Inc. Allergy Alert on Undeclared Milk Allergens in Chocolate Bars http://dlvr.it/QptykL 
• FDA is aware of & concerned about emerging evidence regarding #sesame allergies. In response to this serious concern we are issuing an #RFI to gather information regarding the prevalence & severity of sesame allergies in the U.S. https://go.usa.gov/xPm4j
• Thanks to all who participated in the @USDAFSIS & @FDAFood Oct 23 & 24 public meeting on Cell-Cultured meats. The docket is open for public comment until Nov 26, 2018 https://www.regulations.gov/docket?D=FSIS-2018-0036 …
• ]The undeclared presence of allergens in packaged foods continues to be public health issue and we’re taking first step today to address growing concern of sesame allergies in U.S. https://go.usa.gov/xPEuS
• ]My statement today on the #FDA’s new consideration of food labeling for sesame allergies http://go.usa.gov/xPEJB 

October 30, 2018

Federal Register

Food and Drug Administration

Rules

Listing of Color Additives Exempt from Certification:

Synthetic Iron Oxide

Filed on: 10/31/2018 at 8:45 am Scheduled Pub. Date: 11/01/2018

FR Document: 2018-23863 PDF 13 Pages (126 KB) Permalink

Proposed Rules

Food Additive Petitions:

Bonamar Corp.

Filed on: 10/31/2018 at 8:45 am Scheduled Pub. Date: 11/01/2018

FR Document: 2018-23946 PDF 2 Pages (78.8 KB)  Permalink

• Ø  The petition proposes amendments to the food additive regulations to provide for the safe use of ionizing radiation to control food-borne pathogens in chilled or frozen raw finfish and flatfish and frozen, raw vacuum-packed finfish and flatfish.

Guidance:

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption

Filed on: 10/31/2018 at 8:45 am Scheduled Pub. Date: 11/01/2018

FR Document: 2018-23868 PDF 11 Pages (52.8 KB) Permalink

Animal and Plant Health Inspection Service

Notices

Secretary’s Advisory Committee on Animal Health; Intent to Reestablish

Filed on: 10/31/2018 at 8:45 am Scheduled Pub. Date: 11/01/2018

FR Document: 2018-23836 PDF 2 Pages (151 KB) Permalink

FDA

FDA to Hold Four Public Meetings to Discuss Draft Produce Safety Rule Guidance

Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Anna Abram on the FDA’s new plan to advance plant, animal biotechnology innovation

CVM

FDA Announces Plant and Animal Biotechnology Innovation Action Plan

@SGottliebFDA, @FDAanimalhealth, @FDArecalls

• FDA intends to publish guidance in 2019 to clarify its regulatory approach to the regulation of intentional genomic alterations in animals, including through genome editing https://www.fda.gov/downloads/Safety/Biotechnology/UCM624517.pdf …
• CVM is excited to launch the Veterinary Innovation Program (VIP). Our new pilot program will offer technical and programmatic assistance to developers of certain innovative veterinary products, including animal biotech products. https://go.usa.gov/xPmyf
• Food Recall of Fit & Active Southwest Veggie Stuffed Sandwiches Due to Possible Listeria monocytogenes and Salmonella Contamination in Vegetables http://dlvr.it/QpzQZG