August 17, 2018

Federal Register

Food and Drug Administration

Rules

Guidance:

Questions and Answers Regarding Food Facility Registration (Seventh Edition)

Filed on: 08/17/2018 at 08:45 am Scheduled Pub. Date: 08/20/2018

FR Document: 2018-17853 PDF 5 Pages (100 KB) Permalink

Proposed Rules

Guidance:

Supplemental Questions and Answers Regarding Food Facility Registration

Filed on: 08/17/2018 at 08:45 am Scheduled Pub. Date: 08/20/2018

FR Document: 2018-17852 PDF 5 Pages (191 KB) Permalink

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Title: Voluntary Recalls of Meat and Poultry Products

Filed on: 08/17/2018 at 08:45 am Scheduled Pub. Date: 08/20/2018

FR Document: 2018-17881 PDF 5 Pages (117 KB) Permalink

Food and Nutrition Service

Notices

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

Special Milk Program for Children

Filed on: 08/17/2018 at 08:45 am Scheduled Pub. Date: 08/20/2018

FR Document: 2018-17841 PDF 6 Pages (80.9 KB) Permalink

Study of School Food Authority Procurement Practices

Filed on: 08/17/2018 at 08:45 am Scheduled Pub. Date: 08/20/2018

FR Document: 2018-17840 PDF 9 Pages (163 KB) Permalink

FDA

FDA Extends the Public Comment Period for the Comprehensive, Multi-Year Nutrition Innovation Strategy

FDA Issues Guidance Documents on Food Facility Registration

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

• · The comment period for FDA’s #NutritionInnovation Strategy will be extended 45 days in response to interested persons requesting additional time to offer statements. Be sure to submit your comment(s) to the docket by October 11! http://go.usa.gov/xUPhT
• · OUTBREAK UPDATE: As of 8/16/18, a total of 476 laboratory-confirmed cases of #Cyclospora infection were reported in people who consumed salads from #McDonalds restaurants; the cases were reported by 15 states. https://go.usa.gov/xUvfw
• · The investigation is ongoing and the #FDA is currently reviewing distribution & supplier info for romaine & carrots. Consumers with Cyclospora symptoms (diarrhea, loss of appetite, nausea) should contact their healthcare provider. https://go.usa.gov/xUvfw

August 20, 2018

FDA

Draft Guidance for Industry: Supplemental Questions and Answers Regarding Food Facility Registration

Questions and Answers Regarding Food Facility Registration (Seventh Edition)

GRAS

GRN No.	Substance	Date of Closure	FDA’s Letter
803	Pea protein		Pending

FSIS

Aug 17, 2018 | PDF

• FSIS Extends Comment Period for Petition on “Product of U.S.A.” Labeling Claim
• FSIS Retail Exemptions Adjusted Dollar Limitations
• USDA Provides Food Safety Tips to Keep Foodborne Illness Out of the Classroom
• FSIS To Update Individual Salmonella Category Status for Poultry Carcass Establishments and Aggregate Results for Chicken Parts, Comminuted Poultry and Poultry Carcasses Tested for Salmonella and Campylobacter

AMS

USDA Maintains Pork Grade Standards

OEHHA

Announcement of the Carcinogen Identification Committee Meeting Scheduled for November 1, 2018 and Availability of Hazard Identification Materials for N-Nitrosohexamethyleneimine and Gentian Violet

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

• · Recall Alert: World Organix is voluntarily recalling their kratom products as they were found to contain high counts of various bacteria, including Salmonella, Clostridium difficile, Klebsiella pneumoniae and Pseudomonas aeruginosa. https://go.usa.gov/xUe3b
• · Recall Alert: Zakah Life is voluntarily recalling four kratom products after their products tested positive for salmonella. https://go.usa.gov/xUe3W
• · OUTBREAK UPDATE: @cdcgov reported 40 new cyclospora illnesses from Fresh Express lettuce mostly used by McDonalds. No product should be available for consumers. https://go.usa.gov/xUvfw
• · In July, #FDA warned that a high proportion of kratom and kratom-containing products may be contaminated with salmonella. This week, 2 more companies recalled their kratom products which were found to have salmonella and other bacteria, like c. diff. https://go.usa.gov/xUe34
• · There are no proven medical uses for kratom and #FDA strongly discourages the public from consuming it. Kratom is an opioid and it's an inherently addictive product that can cause harm, which is reason enough not to consume it, but also may make users sick https://go.usa.gov/xUe3T
• · If you or a loved one are addicted to the opioid kratom, treatment options are available. #FDA approved medications combined w/counseling & behavioral therapies can help regain control of your life, transition to one of sobriety. Please consult your doctor https://go.usa.gov/xUe3N
• · Thawing frozen food? Never thaw food at room temp, like on the counter top. There are 3 safe places to defrost food: refrigerator, cold water, & microwave. Food thawed in cold water or in the microwave should be cooked immediately. https://go.usa.gov/xUFFZ
• · Deaths and adverse events from the opioid Kratom are on the rise - Aug 16, The Philadelphia Inquirer. Consumers should take measure of these risks. Safe, effective treatments are available for those suffering from addiction
• · Consumers want and expect safe, wholesome and affordable food. They deserve nothing less. In today’s #FDA #SUNDAYTWEETORIAL I’m talking about what steps the FDA, the states and produce farmers are taking - in collaboration - to ensure the safety of fresh fruits and vegetables.
• · We hear too often about food safety concerns involving fresh fruit and vegetables -most recently the outbreak of E. coli O157:H7 infections associated with romaine lettuce from the Yuma growing region, the largest such outbreak in the U.S. in more than 10 years.
• · From 1998-2008 there were 455 produce-associated food outbreaks, with more than 16,000 people becoming ill, more than twice the number of produce-associated illnesses from 1973-1997. This is a significant public health burden that should be largely preventable.
• · These trends prompted Congress to pass the Food Safety Modernization Act of 2010 (FSMA) which transformed our food safety system, including our approach to produce safety, from one that responds to contamination to one that prevents it in the first place https://bit.ly/2KTiQEC
• · During my previous tenures at #FDA, preventing and handling outbreaks was frustrating and challenging because we lacked the necessary tools. It taught me the importance of preventive steps and a modern safety framework like FSMA.
• · FSMA requires #FDA to establish science-based, minimum standards for the safe growing, harvesting, packing and holding of produce on farms to minimize the presence of potentially dangerous contamination that could cause serious adverse health consequences or death.
• · After extensive public outreach in meetings, webinars, listening session and farm visits, we issued the Nov. 2015 Produce Safety Final Rule https://bit.ly/2MFizXl to implement these standards. Congress told us to make the rule practical, flexible and effective, and we did that.
• · The new standards address agricultural water quality; employee health and hygiene; soil amendments of animal origin (compost and manure); equipment, tools and buildings; and domesticated and wild animals. These areas were identified as sources of contamination in the past.
• · Essential for success is creating an integrated food safety system that emphasizes education and culture change and requires industry, academia, and government to work together to promote best practices and support compliance strategies.
• · But getting the rule ready for prime-time is hard. We’ve learned that some provisions, including agricultural water, require further consideration. We've taken a flexible approach. We’ve pushed back inspections. We’ve created structures for continued collaboration and education.
• · The 1st major compliance date for large farms was in January. But routine inspections will not begin until spring of 2019 to give time for more guidance, training, technical assistance and planning. Small farm compliance dates are forthcoming https://bit.ly/2BboORu .
• · Since states are often the most familiar with their farmers’ growing and harvesting practices, we will rely on them to conduct most routine inspections. #FDA has provided 46 states with $32.5 million for State Produce Safety Programs to implement standards in their communities.
• · Training farmers is critical and a number of training opportunities are available. The Produce Safety Alliance https://bit.ly/2w6pJNs has trained 25,000 farmers both here and abroad at 1,000+ courses. To leverage resources, it has also conducted 66 train-the trainer courses.
• · The National Association of State Departments of Agriculture (NASDA), in collaboration with FDA, has developed an On-Farm Readiness Review (OFRR) program. Food safety experts conduct free, voluntary, non-regulatory visits to farms to observe practices & provide constructive input
• · After successful pilot runs, OFRR is being rolled out this summer. NASDA is also training those who will conduct these audits with 14 training sessions already completed and is working with states to set up mechanisms for farms to request OFRRs. @NASDAnews
• · I had the opportunity to join an informal OFRR visit to the Willis family farm in OR, engaging in a frank discussion about the issues local farmers face in meeting the Produce Safety Rule requirements. My appreciation for the hardworking American farming community only deepened.
• · To support stakeholder implementation of the rule, #FDA stood up the Produce Safety Network - produce safety experts from our food center (CFSAN) and specialized investigators from the Office of Regulatory Affairs who are located across the country.
• · We are also partnering with USDA to make sure that USDA’s harmonized good agricultural practices (HGAP) audit program is fully aligned with FSMA to help growers around the country comply with the Produce Rule requirements.
• · The Produce International Partnership for Education and Outreach is coordinating an international outreach strategy and adapting the standardized curriculum for overseas growers who export 53% of fresh fruit and 29% of vegetables consumed in the U.S. https://bit.ly/2MhugaM .
• · #FDA is committed to imported produce being as safe as produce grown in the U.S. By relying on states for most domestic inspections, we can focus our resources on foreign inspections, using new tools such as FSMA’s Foreign Supplier Verification Programs https://bit.ly/2nKoAYd .
• · Guidance and training is essential. We issued a small entity guidance. Additional guidance is coming soon to help farmers better understand the many ways they can meet FSMA requirements. Some components of the produce safety rule needs more dialogue with the farming community.
• · Many feel our microbial quality water standards are too complicated and in some cases too costly to be effectively implemented. We've collected info about on-farm conditions and water systems at an Ag water summit and from additional farm tours and are considering next steps.
• · We’re also working on rulemaking that will clarify the definition of a farm and address questions we have received on what requirements such entities as packing houses and terminal markets should follow.
• · And we're continuing work on the safe use of untreated biological soil amendments of animal origin, such as raw manure. @USDA has been a great partner, conducting research that will inform future policy https://bit.ly/2MJQMoN .
• · Food safety is one of my highest priorities. The measures outlined by the Produce Safety Rule, when fully implemented, will reduce the chance of an outbreak like the recent one involving romaine lettuce. That’s our goal. And it's our solemn commitment to the American public.
• · Healthy meal tips for #firstdayofschool ⇨ Don’t take, “Mom, I don’t have time for breakfast” as an excuse: https://youtu.be/nmdoBVWOhbU
• · Recently, the US has had several large outbreaks of foodborne illness caused by contaminated fruits/veggies, including: spinach, cantaloupe, tomatoes, & lettuce. LEARN 7 tips for cleaning fruits, veggies to avoid getting sick in this #FDAConsumerUpdate: https://go.usa.gov/xU9US

August 21, 2018

Federal Register

Food and Drug Administration

Notices

Comprehensive, Multi-Year Nutrition Innovation Strategy; Extension of Comment Period

Filed on: 08/21/2018 at 08:45 am Scheduled Pub. Date: 08/22/2018

FR Document: 2018-18072 PDF 5 Pages (99.6 KB) Permalink

Animal and Plant Health Inspection Service

Notices

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

Qualitative Feedback on Agency Service Delivery

Filed on: 08/21/2018 at 08:45 am Scheduled Pub. Date: 08/22/2018

FR Document: 2018-18137 PDF 5 Pages (98.8 KB) Permalink

Agricultural Marketing Service

Rules

Establishment of Handler Diversions, Reporting Requirements, and New Information Collections:

Cranberries Grown in States of Massachusetts, et al.; Correction

Filed on: 08/21/2018 at 08:45 am Scheduled Pub. Date: 08/22/2018

FR Document: 2018-18039 PDF 3 Pages (146 KB) Permalink

AMS

New Vendor Training from USDA Web-Based Supply Chain Management

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

• · Are you aware that illnesses from Salmonella spike in the summer? And that the majority of hospitalizations occur in children under 5 years of age? Check out these poultry handling tips to help everyone have a summer without Salmonella! http://bit.ly/2LO7dmX

August 22, 2018

Recalls

Date	Brand	Product Description	Reason/Problem	Company
08/21/2018	Rad Cat	Rad Cat Raw Diet	Potential for Listeria monocytogenes	Radagast Pet Food, Inc.
08/21/2018	Premo Brand	Turkey and Cheese Wedge Sandwiches	Listeria monocytogenes	Lipari Foods, LLC

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
08/15/2018	Healthy Healing dba Crystal Star	Minneapolis District Office	New Drug/Labeling/Misbranded	Not Issued *

FSIS

End Of The Year Performance Management Instructions

Taylor Farms Northwest, LLC Recalls Ready-To-Eat Meatloaf Products Due To Misbranding and Undeclared Allergens

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

• · Practice #foodsafety at the grocery store - separate raw meat, poultry, seafood, & eggs from other foods in your grocery shopping cart, grocery bags, & refrigerator. https://go.usa.gov/xUF6w
• · FDA’s Special Agents/@TheJusticeDept: Florida man pleads guilty to marketing “all natural” dietary supplements containing the active ingredient found in Viagra https://go.usa.gov/xUtN6
• · Keep poultry in the same plastic bag from the grocery store to your refrigerator at home! Watch video: http://bit.ly/2vIVVGv
• · Lipari Foods Issues Voluntary Recall of Premo Brand Turkey & Cheese Wedge Sandwiches Because of Possible Health Risk http://dlvr.it/Qgdvm0
• · FDA extends the public comment period Nutrition Innovation Strategy. It will remain open until Oct. 11, 2018. https://go.usa.gov/xUtBC
• · FOOD RECALL: #FDA is working with Lipari Foods to recall Premo Brand turkey & cheese wedge sandwiches due to potential contamination of Listeria. The products have an enjoy by date of 8/31/18 & were distributed to the 11 states listed here: https://go.usa.gov/xUzkU
• · Radagast Pet Food Voluntarily Expands Recall to Include Rad Cat Raw Diet Products With Best By Dates of 10/19/18 Through 12/3/19 Due to Potential Health Risk http://dlvr.it/Qgh694

Go to Original Post