Laws and Regulations Committee Update 1/12 – 1/18, 2018
January 12, 2018
Federal Register
Proposed Rules
Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease
Filed on: 01/12/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018
FR Document: 2018-00683 PDF 5 Pages (32.1 KB) Permalink
Animal and Plant Health Inspection Service
Notices
Affirmation of Addition of Treatments for Aircraft: Certain Hitchhiking Pests
Filed on: 01/12/2018 at 08:45 am Scheduled Pub. Date: 01/16/2018
FR Document: 2018-00569 PDF 4 Pages (25 KB) Permalink
Determinations: Classical Swine Fever Status of Mexico
Filed on: 01/12/2018 at 08:45 am Scheduled Pub. Date: 01/16/2018
FR Document: 2018-00576 PDF 5 Pages (167 KB) Permalink
FDA
Healthy Innovation, Safer Families: FDA’s 2018 Strategic Policy Roadmap
Recalls
| Date | Brand Name | Product Description | Reason/ Problem | Company |
| 01/11/2018 | Sundae Shoppe | Raspberry Cream Bars | Listeria monocytogenes | Fieldbrook Foods Corporation |
| 01/11/2018 | Mary B’s® | Biscuits | Listeria monocytogenes | Hom/Ade Foods, Inc |
@FDAFood, @FDA_ORA, @SGottliebFDA
- #RECALL Fieldbrook Foods ice cream bars & orange cream bars produced in 2017 w/plant code: 362677 possible #Listeria under a variety of brand names (Lucerne, Kroger, etc.) https://go.usa.gov/xndbb
- Gilster – Mary Lee Corp. Issues a Recall For Undeclared Milk Allergen in Essential Everyday® Chicken Coating http://dlvr.it/Q9rLN8
- Folic acid, long used to fortify some enriched grains, helps moms-to-be by adding a B vitamin to their diet. This may help prevent neural tube defects. Last year FDA approved this addition to corn masa flour. Learn more for #FolicAcidAwarenessWeek https://go.usa.gov/xnpvF
FNS
FNS-640 SY 2016-17 Reporting Guidance
January 16, 2018
Federal Register
Agricultural Marketing Service
Proposed Rules
Meeting of the National Organic Standards Board
Filed on: 01/16/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018
FR Document: 2017-28170 PDF 4 Pages (14.5 KB) Permalink
National Organic Program: National List of Allowed and Prohibited Substances (Crops, Livestock and Handling)
Filed on: 01/16/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018
FR Document: 2017-28172 PDF 99 Pages (535 KB) Permalink
Notices
United States Standards for Grades of Pork Carcasses
Filed on: 01/16/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018
FR Document: 2018-00627 PDF 3 Pages (158 KB) Permalink
Animal and Plant Health Inspection Service
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Specimen Submission
Filed on: 01/16/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018
FR Document: 2018-00694 PDF 4 Pages (98.4 KB) Permalink
List of Regions Affected by Highly Pathogenic Avian Influenza:
Addition of the Philippines
Filed on: 01/16/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018
FR Document: 2018-00696 PDF 3 Pages (8.55 KB) Permalink
Proposed Rules
Food Labeling: Health Claims; Soy Protein and Coronary Heart Disease
Filed on: 01/12/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018
FR Document: 2018-00683 PDF 5 Pages (32.1 KB) Permalink
Notices
Veterinary Feed Directive
Filed on: 01/16/2018 at 08:45 am Scheduled Pub. Date: 01/17/2018
FR Document: 2018-00676 PDF 10 Pages (123 KB) Permalink
FDA
FDA Extends Comment Period for Proposed Rule to Revoke Authorized Health Claim Regarding Soy Protein and Coronary Heart Disease
Recalls
| Date | Brand Name | Product Description | Reason/ Problem | Company |
| 01/13/2018 | Hiland Dairy, Tampico | Orange Juice, Citrus Punch | products may contain milk protein | Hiland Dairy |
@FDAFood, @FDA_ORA, @SGottliebFDA
- Fieldbrook Foods Corporation Clarifies Scope of its Voluntary Recall. Products Include Orange Cream http://dlvr.it/Q9txpR
- Federal Register Notice: comment period extended in re: revoke FDA regulation authorizing the use of health claims on the relationship between #soyprotein & reduced risk of #coronary heart disease https://go.usa.gov/xndyc
- #RECALL Check your freezer! Mary B’s® brand biscuits voluntary recall due to potential contamination with #Listeria see link for all products involved https://go.usa.gov/xndph
- Hiland Dairy Announces Voluntary Recall Of Hiland Dairy Orange Juice And Tampico Citrus Punch http://dlvr.it/QB6385
- #FDAORA offers FREE virtual training for state, local, & tribal regulatory partners. Courses include food/drug law, #foodborneillness investigations, & more. REGISTER: https://go.usa.gov/xnNaT
FSIS
Jan 12, 2018 | PDF
- USDA Announces Proposed Rule to Amend Egg Products Inspection Regulations
- FSIS Announces Webinar for Posting Individual Salmonella Category Status for Poultry Carcass Establishments
- FSIS Announces Webinar for Trading Partners, Foreign Establishments and Importers
- 2018 Rate Changes for the Basetime, Overtime, Holiday and Laboratory Services Rates
- Establishment Specific Datasets Now Available
- FSIS Posts Updated Dataset on Import Refusals
AMS
USDA Announces National Peanut Board Appointments
APHIS
APHIS Recognizes Mexico as Free of Classical Swine Fever
January 17, 2018
OIRA
| AGENCY: USDA-FNS | RIN: 0584-AE57 | Status: Pending Review |
| TITLE: Supplemental Nutrition Assistance Program: Requirements and Services for Able-Bodied Adults Without Dependents | ||
| STAGE: Prerule | ECONOMICALLY SIGNIFICANT: No | |
| ** RECEIVED DATE: 01/16/2018 | LEGAL DEADLINE: None | |
FDA
Warning Letters
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
| 12/29/2017 | Transbuana International Express | Center for Food Safety and Applied Nutrition | Seafood HACCP/CGMP for Foods/Adulterated/Insanitary Conditions | Not Issued * |
@FDAFood, @FDA_ORA, @SGottliebFDA
- FDA Commissioner discusses transparency and the availability of FDA data, including: #FDAORA data dashboard and weekly enforcement reports https://go.usa.gov/xnvgz
- #RECALL Check your freezer! FDA advises consumers not to eat recalled Coconut Tree Brand Frozen Shredded Coconut because the product has the potential to cause #salmonellosis. https://go.usa.gov/xnvBA
- Salmonella Outbreak: 25 people in 9 states sick. Check your home for recalled Coconut Tree Brand frozen Shredded Coconut. http://bit.ly/2DbcD3y
- Bellisio Foods, Inc. Issues Allergy Alert Regarding Certain Michelina’s Fettuccine Alfredo Packages Due to Potential Presence of Undeclared Soy http://dlvr.it/QBVjkQ
- #FDA’S 2018 STRATEGIC POLICY ROADMAP: Priorities include helping consumers make better and more informed decisions when it comes to diets and health. All part of the FDA’s Healthy Innovation, Safer Families http://go.usa.gov/xndZa
askFSIS
Electronic Records Maintained on Computers
KIS™ testing
DOAs in a Poultry Slaughter Establishment
AMS
USDA Announces Popcorn Board Appointments
USDA Lifts PACA Reparation Sanctions on Washington Produce Business
The National Academies
Academy Honors 19 for Major Contributions to Science
January 18, 2018
Federal Register
Agriculture Department (see also Consumer Product Safety Commission, Environmental Protection Agency, Health and Human Services Department)
Rules
Federal Policy for the Protection of Human Subjects: Delay of the Revisions to the Federal Policy for the Protection of Human Subjects
Filed on: 01/17/2018 at 04:15 pm Scheduled Pub. Date: 01/22/2018
FR Document: 2018-00997 PDF 72 Pages (344 KB) Permalink
Proposed Rules
Withdrawal of Certain Proposed Rules and Other Proposed Actions; Correction
Filed on: 01/18/2018 at 08:45 am Scheduled Pub. Date: 01/19/2018
FR Document: 2018-00893 PDF 2 Pages (84.9 KB) Permalink
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals
Filed on: 01/18/2018 at 08:45 am Scheduled Pub. Date: 01/19/2018
FR Document: 2018-00879 PDF 4 Pages (90 KB) Permalink
Environmental Protection Agency
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Cross-Media Electronic Reporting Rule
Filed on: 01/18/2018 at 08:45 am Scheduled Pub. Date: 01/19/2018
FR Document: 2018-00939 PDF 4 Pages (197 KB) Permalink
Recordkeeping and Reporting of the Production, Import, Export, Destruction, Transhipment, and Exempted Uses of Ozone-Depleting Substances
Filed on: 01/18/2018 at 08:45 am Scheduled Pub. Date: 01/19/2018
FR Document: 2018-00938 PDF 8 Pages (215 KB) Permalink
Environmental Impact Statements; Availability, etc.: Weekly Receipts
Filed on: 01/18/2018 at 08:45 am Scheduled Pub. Date: 01/19/2018
FR Document: 2018-00929 PDF 2 Pages (5.98 KB) Permalink
Proposed Rules
Guidance: Public Warning and Notification of Recalls
Filed on: 01/18/2018 at 08:45 am Scheduled Pub. Date: 01/19/2018
FR Document: 2018-00918 PDF5 Pages (29.2 KB) Permalink
- The draft guidance, when finalized, will establish official guidance for industry and FDA staff regarding the use, content, and timing of public warnings and public notification of recalls under part 7 (21 CFR Part 7). The draft guidance is part of a larger effort FDA is undertaking to give additional guidance to industry and FDA staff regarding the execution and oversight of voluntary recalls under part 7.
FDA
FDA to Expedite Release of Recall Information
- FDA has decided that the public would benefit by having recall information about FDA-regulated products as soon as possible, even though further evaluation remains to be done. Moving forward, FDA will include “not-yet-classified” recalls of human drugs, foods, and veterinary products in the weekly Enforcement Report, even while classification work is still ongoing.
Recalls
| Date | Brand Name | Product Description | Reason/ Problem | Company |
| 01/17/2018 | Palmer Bakery Delights | Sea Salt Caramel Hearts | Undeclared Peanuts | Palmer Candy Company |
@FDAFood, @FDA_ORA, @SGottliebFDA
- Watch a recording of yesterday’s forum with a keynote speech by @US_FDA Commissioner @SGottliebFDA: https://www.c-span.org/video/?439824-1/dr-scott-gottlieb-discusses-fda-oversight …
- #FDA, CDC & others continue to investigate Salmonella illnesses linked to imported frozen shredded coconut. Our state partner @MassDPH made significant progress & matched recalled product identified in outbreak w/strain of Salmonella. Read our update: http://go.usa.gov/xnvBP
- #TBT: #FDAORA investigators are responsible for ensuring #seafood is safe to eat. After atomic bomb testing from 1954 to the 1960s, inspectors used Geiger counters to measure seafood for radioactivity. LEARN MORE: http://bit.ly/2BFiYHw
- #FSMA keeps our food supply safe by giving FDA more tools to prevent food contamination. MORE: http://go.usa.gov/xWZ69
askFSIS
Maintaining a Physical Inspection Presence
AMS
USDA Reopens the Comment Period for Proposed Revisions to the Pork Grade Standards
FTC
FTC Posts Blog on Voices for Liberty Video Project