Laws and Regulations Committee Update 6/11 – 6/13, 2018

June 11, 2018 in Federal Register Updates

Federal Register

Food and Drug Administration

Notices

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

Irradiation in Production, Processing, and Handling of Food

Filed on: 06/11/2018 at 08:45 am Scheduled Pub. Date: 06/12/2018

FR Document: 2018-12614 PDF 4 Pages (86.1 KB) Permalink

Qualified Facility Attestation

Filed on: 06/11/2018 at 08:45 am Scheduled Pub. Date: 06/12/2018

FR Document: 2018-12615 PDF 6 Pages (94.5 KB) Permalink

Guidance:

General Principles for Evaluating Human Food Safety of New Animal Drugs Used in Food-Producing Animals

Filed on: 06/11/2018 at 08:45 am Scheduled Pub. Date: 06/12/2018

FR Document: 2018-12607 PDF 6 Pages (101 KB) Permalink

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 06/11/2018 at 08:45 am Scheduled Pub. Date: 06/12/2018

FR Document: 2018-12585 PDF 7 Pages (99 KB) Permalink

Animal and Plant Health Inspection Service

Notices

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

Goat 2019 Study

Filed on: 06/11/2018 at 08:45 am Scheduled Pub. Date: 06/12/2018

FR Document: 2018-12589 PDF 5 Pages (26.8 KB) Permalink

Agricultural Marketing Service

Rules

Inspection Application Requirements

Filed on: 06/11/2018 at 08:45 am Scheduled Pub. Date: 06/12/2018

FR Document: 2018-12538 PDF 7 Pages (201 KB) Permalink

FDA

FDA Investigating Multistate Outbreak of Salmonella Adelaide Infections Linked to Pre-Cut Melons

Notice of Agency Information Collection Activities; Veterinary Feed Directive

Recalls

Date	Brand Name	Product Description	Reason/Problem	Company
06/09/2018	Caito Food, Reaniassance Food Group, Open Acres, more	Fresh cut cantaloupe, honeydew melon, watermelon, more	potential to be contaminated with Salmonella	Caito Foods

FSIS

Venda Ravioli, Inc. Recalls Meat Ravioli Products Produced Without Benefit of Inspection

Tyson Foods Inc. Recalls Breaded Chicken Products Due to Possible Foreign Matter Contamination

Jun 08, 2018 | PDF

Comment Period for the Proposed Rule to Amend Egg Products Inspection Regulations Ends on June 13
Reminder: FSIS Webinar on Individual Salmonella Category Status for Poultry Parts and Comminuted Poultry

APHIS

APHIS Wildlife Services Conducts First Field Trial of Feral Swine Toxic Bait; Plans Modifications to Mitigate Hazards to Non-Target Species

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

#FDAORA issues #warningletter to South Carolina pecan processing facility for violations of regulations for ready-to-eat foods. Among other things, ORA inspection revealed insect and rodent activity in the facility: https://go.usa.gov/xQGsc #youvebeenwarned
Fish for dinner? Here are some easy to follow safety steps for when you buy, prepare, & store #fish http://go.usa.gov/3z7px #foodsafety
#FDA, CDC and partners are investigating a Salmonella Adelaide outbreak in five Midwestern states linked to pre-cut cantaloupe, watermelon or fruit salad mix with melon. https://go.usa.gov/xQHPC
#FDA has identified Caito Foods, LLC, a company specializing in fresh produce distribution and fresh food processing nationwide, as a source. Investigation is ongoing; we will release more info. as it becomes available. https://go.usa.gov/xQHPC
Caito Foods, LLC has agreed to recall fruit salad mixes that contain pre-cut watermelon, honeydew melon, cantaloupe and fresh-cut fruit medley products containing one of these melons. https://go.usa.gov/xQHPC
Consumers should not eat the recalled, cut mixed fruit from Caito Foods LLC. People who think they might have symptoms of a Salmonella infection should contact a healthcare professional. https://go.usa.gov/xQHPC
Caito Foods, LLC Voluntarily Recalls Fresh Cut Melon Products Because of Possible Health Risk http://dlvr.it/QWlDb5
New Salmonella outbreak: 60 people sick in 5 states linked to pre-cut melon sold at several stores. Read CDC’s outbreak notice: http://bit.ly/2sJ9WmV
1/2 In the Sunday @nytimes reporter Coral Davenport cites FDA’s earlier decision to disband a single food advisory committee (one of the 50+ #FDA adcoms the agency maintains) which hadn’t met since 2015 and was replaced by the FDA Science Board as evidence of ‘anti science bias.’
2/2 The decision to disband that single adcom of dozens and dozens of advisory committees we maintain was made by FDA career leadership for sound scientific and programmatic reasons; and FDA will always promote science based decision making and seek the counsel of expert advisors
#FDA has identified Caito Foods, a company specializing in fresh produce distribution and fresh food processing nationwide, as source of a salmonella outbreak related to pre-cut cantaloupe, watermelon or fruit salad mix with melon. http://go.usa.gov/xQHPC
Building on our new guidance asserting dietary supplements made of pure or highly concentrated caffeine in powder or liquid forms are generally unlawful when sold directly to consumers in bulk packaging; we sent warning letters to makers of these products
Important advice for people in GA, IL, IN, KY, MI, MO, NC, OH: Check fridge and freezer for recalled pre-cut melon linked to Salmonella outbreak: http://bit.ly/2Meh7vh @CDCgov

June 12, 2018

Federal Register

Food and Nutrition Service

Notices

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

Child Nutrition Program Operations Study-II

Filed on: 06/12/2018 at 08:45 am Scheduled Pub. Date: 06/13/2018

FR Document: 2018-12650 PDF 7 Pages (48.3 KB) Permalink

FDA

Notice of Agency Information Collection Activities; Qualified Facility Attestation

Notice of Availability of Guidance for Industry; General Principles for Evaluating the Human Food Safety of New Animal Drugs Used in Food-Producing Animals

AMS

USDA Restricts PACA Violators in California, Florida, Georgia and Illinois from Operating in the Produce Industry

National Academies

Harmonization of Approaches to Nutrient Reference Values: Applications to Young Children and Women of Reproductive Age

Global Harmonization of Methodological Approaches to Nutrient Intake Recommendations: Proceedings of a Workshop

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

#FDAORA issues #warningletter to South Carolina manufacturing facility for selling unapproved new drugs, adulterated & misbranded dietary supplements, & foods containing unapproved food additives: https://go.usa.gov/xQGsx #youvebeenwarned
The discussion – pre-market safety assessments performed for foods from #genetically engineered plants & scientific factors important when considering whether metabolic profiling data would have utility/ added value in food safety assessments from #genetically engineered plants
FDA, CDC and partners are continuing to investigate a multi-state outbreak of Salmonella linked to products that contain watermelon, honeydew melon, cantaloupe & fresh-cut fruit medley containing melon: https://go.usa.gov/xQHPC
#FDA worked to trace products potentially linked to this outbreak back to one distribution facility based on the patient information received by CDC and our state partners. FDA initiated an inspection of facility that cut the melon and Caito Foods recalled implicated products.
#FDA and CDC are continuing to investigate this Salmonella outbreak and will share more information as it becomes available.
Who is at the highest risk for foodborne illness? Children under 1 year, older adults, the immune-compromised, and pregnant women. Learn about food safety for high-risk populations in this #FDAConsumerUpdate: https://go.usa.gov/xQURw

June 13, 2018

Federal Register

Agricultural Marketing Service

Rules

Change in Assessment Rate Computation:

Peanut Promotion, Research, and Information Order