News Article

Laws and Regulations Committee Update 11/19 - 11/20, 2018

Posted on November 21, 2018

Blog: Association of Food & Drug Officials (AFDO)

November 19, 2018

Federal Register

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 11/19/2018 at 8:45 am Scheduled Pub. Date: 11/20/2018

FR Document: 2018-25295 PDF 4 Pages (115 KB) Permalink

Ø Relating to dairy grading program

Food Safety and Inspection Service

Notices

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

Stakeholder Input on Federal Outreach to Control Listeria Monocytogenes at Retail

Filed on: 11/19/2018 at 8:45 am Scheduled Pub. Date: 11/20/2018

FR Document: 2018-25265 PDF 10 Pages (229 KB) Permalink

Ø Requesting stakeholder input regarding improvements to FSIS’s “Guidance for Controlling Lm in Retail Delicatessens”

FDA

Statement from USDA Secretary Perdue and FDA Commissioner Gottlieb on the regulation of cell-cultured food products from cell lines of livestock and poultry

Recalls

Date	Brand	Product Description	Reason/Problem	Company
11/16/2018	Cap’n Crunch’s	Peanut Butter Crunch Cereal	Salmonella potential contamination	The Quaker Oats Company
11/16/2018	Chukar Cherries	Amaretto Rainier Chocolate Cherries	Undeclared Milk	Chukar Cherries
11/16/2018	Green Cedar	Ackawi Cheese	Listeria monocytogenes potential contamination	Green Cedar Dairy

GRAS Notices

GRAS No.	Substance
819	Fatty acid ethyl esters from Alaskan pollack
818	Isomalto-oligosaccharides
817	Serine endopeptidase from Malbranchea cinnamomea produced in Trichoderma reesei
816	Xylooligosaccharides from sugarcane

FSIS

Nov 16, 2018 | PDF

FSIS Extends Comment Period on Revised Salmonella and Campylobacter Categorization Procedures
FSIS Posts Updated Dataset on Imports
FSIS Posts Next Set of Establishment Specific Datasets

Recalls

Product Recalled	Date of Recall
114-2018 Swift Beef Company Recalls Ground Beef Products due to Possible E. Coli O157:H7 Contamination	Nov 17, 2018
113-2018 Majestic Meat Company Recalls Ground Beef Products due to Possible E. Coli O157:H7 Contamination	Nov 16, 2018

APHIS

APHIS Issues Final Environmental Impact Statement for the National Fruit Fly Cooperative Control Program

USDA Launches New Biosecurity Campaign Asking All Poultry Owners, Workers and Hobbyists to Protect the Health of Live Poultry

GAO

Memory Supplements: Results of Testing for Selected Supplements, GAO-19-23R Published: Oct 18, 2018. Publicly Released: Nov 14, 2018.

Illegal Marijuana: Opportunities Exist to Improve Oversight of State and Local Eradication Efforts, GAO-19-9:Published: Nov 14, 2018. Publicly Released: Nov 14, 2018.

FTC

FTC Issues Agency Financial Report for Fiscal Year 2018

OEHHA

Proposed Amendments to Article 6 Clear and Reasonable Warnings Section 25600.2 Responsibility to Provide Consumer Products Exposure Warnings

Ø this rulemaking proposes additional clarifying changes to Section 25600.2, subsections (b) and (c) concerning the responsibility for providing warnings under Proposition 65, and further clarify the term “actual knowledge” in subsection (f)

@SGottliebFDA, @FDArecalls, @SecretarySonny, @USDAFoodSafety

Ø In this week’s #FDA #Sundaytweetorial, I’m going to reflect on the intersection and connectedness of veterinary and human health, and FDA’s commitment to the #OneHealth philosophy – that the health of people, animals and the environment are intertwined.
Ø This month, we approved the first drug to reduce ammonia gas emissions from an animal or its waste. Novel animal drugs with an indication like this embody One Health https://go.usa.gov/xP7kc .
Ø Aquaculture is becoming an increasingly important source of food available for human consumption. As the number of aquaculture facilities grows, so does the need to develop safe and effective drugs for treating fish diseases https://go.usa.gov/xP78n .
Ø Until lately antibiotics were used in animals both to protect against disease and bring animals to market faster but this can contribute to antimicrobial resistance in bacteria that may be transferred to humans, potentially making these drugs less effective to treat human disease
Ø As a result, combating antimicrobial resistance (AMR), a subject of an earlier #FDA #SundayTweetorial, is a key priority for FDA, especially CVM, which recently released a 5-year action plan for antimicrobial stewardship in veterinary settings https://go.usa.gov/xP7WM .
Ø A main tenet of CVM’s approach is supporting the judicious use of antimicrobials in food animals. Medically important antimicrobials should only be used in animals when necessary to treat, control, or prevent specific diseases.
Ø Part of the battle against AMR involves surveillance. The National Antimicrobial Resistance Monitoring System (NARMS) with #CDC and #USDA tracks resistance trends in foodborne bacteria, which helps w/pre-approval evaluation of new animal antibiotics https://go.usa.gov/xP7kX .
Ø #FDA & @USDA announce joint regulatory framework for cell-cultured food derived from livestock & poultry: https://go.usa.gov/xP7Kk It leverages FDA experience regulating cell-culture tech and living biosystems; USDA expertise in livestock, poultry products for human consumption.
Ø Just announced: @USDA & @US_FDA to share oversight of cell-cultured food products. Employs USDA’s expertise regulating livestock & poultry products and FDA’s experience regulating cell-culture technology and living biosystems. Statement w/@SGottliebFDA: https://bit.ly/2OQ96g6
Ø #FDA reminds parents don’t feed honey to children younger than 1 year after honey pacifiers suspected in 4 Texas infant botulism cases. Botulism is a rare but serious illness caused by toxin that triggers difficulty breathing, muscle paralysis, even death https://go.usa.gov/xP7jz
Ø FDA is working to identify online retailers that sell honey-filled pacifiers & ask that they discontinue sales.
Ø The Quaker Oats Company Issues Voluntary Recall of a Small Quantity of Cap’n Crunch’s Peanut Butter Crunch Cereal Distributed to Five Target Stores Due to Possible Health Risk http://dlvr.it/QrS794
Ø RECALL ALERT: Check your fridge & freezer for Jennie-O ground turkey labeled “P-190,” usually found inside USDA mark of inspection, with use-by dates of 10/1 or 10/2/2018. Do not eat it. Return to store or throw it away. https://go.usa.gov/xP7K3

November 20, 2018

Federal Register

Food and Drug Administration

Notices

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

Use of the Names of Dairy Foods in the Labeling of Plant-Based Products; Extension of Comment Period

Filed on: 11/20/2018 at 8:45 am Scheduled Pub. Date: 11/21/2018

FR Document: 2018-25347 PDF 5 Pages (32.7 KB) Permalink

Ø The new comment due date is January 28, 2019

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 11/20/2018 at 8:45 am Scheduled Pub. Date: 11/21/2018

FR Document: 2018-25395 PDF 4 Pages (114 KB) Permalink

Ø Related to consumer behavior research to inform revisions to current Safe Handling Instructions label

FDA

FDA Completes Review of Qualified Health Claim Petition for Oleic Acid and the Risk of Coronary Heart Disease

Ø FDA determined there is credible evidence to support a qualified health claim that consuming oleic acid in edible oils, such as olive oil, sunflower oil, or canola oil, may reduce the risk of coronary artery disease

Statement from FDA Commissioner Scott Gottlieb, M.D., on a new qualified health claim for consuming oils with high levels of oleic acid to reduce coronary heart disease risk

FSIS

Product Recalled	Date of Recall	Retail Distribution List
115-2018 Deleite Foods Enterprises, Inc. Recalls Poultry Products Due to Misbranding and Undeclared Allergens	Nov 19, 2018	N/A (Class II Recall)