Laws and Regulations Committee Update 5/14 – 5/16, 2018
May 14, 2018
Federal Register
Environmental Protection Agency
Proposed Rules
Pesticide Petitions:
Residues of Pesticide Chemicals in or on Various Commodities; Correction
Filed on: 05/14/2018 at 08:45 am Scheduled Pub. Date: 05/15/2018
FR Document: 2018-10344 PDF 3 Pages (277 KB) Permalink
Filed on: 05/14/2018 at 08:45 am Scheduled Pub. Date: 05/15/2018
FR Document: 2018-10347 PDF 3 Pages (277 KB) Permalink
FDA
Recalls
| Date | Brand Name | Product Description | Reason/Problem | Company |
| 05/11/2018 | Sugarfina | Sugar Cookies Products | Sugar Cookies Products | Sugarfina, Inc. |
FSIS
Secretary Perdue Announces FSIS Key Leadership
USDA Announces Proposed Rule to Eliminate a Redundant Hog Carcass Cleaning Regulation
May 11, 2018 | PDF
- Secretary Perdue Announces FSIS Key Leadership;
- Secretary Perdue Announces FSIS Key Leadership;
- FSIS Proposes to Eliminate Redundant Hog Carcass Cleaning Regulation;
- FSIS Launches Outreach Initiative for Small and Very Small Plants;
- FSIS Posts Next Set of Establishment Specific Datasets;
- FSIS Posts Updated Dataset on Import Refusals;
- Listeria monocytogenes Testing Update;
- Reminder: FSIS Comment Period on Petition on Beef and Meat Labeling Requirements Ends May 17, 2018.
AskFSIS
Sanitation Standard Operating Procedures Preventive Measures
If an establishment relies on its own product cook tests for its validated cooking instructions, must the cook tests be approved by a process authority?
Does “neutral” background refer to the background color of the package and could you use a red background with black type?
Because microwave instructions on labels seem to be of much concern, what type of information and data needs to be reviewed if microwave cooking instructions are included on the label of products that contain raw or partially cooked poultry
AMS
USDA Proposes Volume Regulation for 2017–18 Tart Cherries
USDA Finds Lack of Consensus Among Farmers for a New Organic Marketing Board
May 15, 2018
Federal Register
Food Safety and Inspection Service
Proposed Rules
Eliminating Unnecessary Requirements for Hog Carcass Cleaning
Filed on: 05/15/2018 at 08:45 am Scheduled Pub. Date: 05/16/2018
FR Document: 2018-10488 PDF 17 Pages (239 KB) Permalink
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Requirements to Notify FSIS of Adulterated or Misbranded Product, Prepare and Maintain Written Recall Procedures, and Document Certain HACCP Plan Reassessments
Filed on: 05/15/2018 at 08:45 am Scheduled Pub. Date: 05/16/2018
FR Document: 2018-10489 PDF 9 Pages (208 KB) Permalink
Voluntary Recalls of Meat, Poultry, and Egg Products
Filed on: 05/15/2018 at 08:45 am Scheduled Pub. Date: 05/16/2018
FR Document: 2018-10484 PDF 8 Pages (208 KB) Permalink
Environmental Protection Agency
Rules
Pesticide Tolerances:
Tebuconazole
Filed on: 05/15/2018 at 08:45 am Scheduled Pub. Date: 05/16/2018
FR Document: 2018-10345 PDF 23 Pages (357 KB) Permalink
FDA
FDA Approves Mirataz, a New Animal Drug to Manage Undesired Weight Loss in Cats
Notice of Agency Information Collection Activities; Electronic User Fee Payment Request Forms
Notice of OMB Approvals of Agency Information Collection Activities
USDA
FSIS
J.T.M. Provisions Company Recalls Beef Products Due to Possible Foreign Matter Contamination
Fresh Foods Manufacturing Co. Recalls Ready-To-Eat Salad Products Due to Possible E. coli O157:H7 Contamination
AskFSIS
FSIS Directive 5000.4 – Direct Observation of Sanitation SOP Monitoring
Can the print be condensed?
Must cooking instructions advise consumers whether product should be cooked from a frozen state or from a thawed state?
Must cooking instructions advise consumers where to place the thermometer in the product (i.e., coldest/thickest part), or how many temperature readings to take?
Designing a Sanitation SOP Daily Record
@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA, @FDAMedia, @FDAanimalhealth, @FDArecalls
- Companies that label their foods as free of gluten are responsible for using #glutenfree claims in an accurate & not misleading manner. They must comply with the gluten-free food labeling regulation enforced by FDA https://go.usa.gov/xQnW4
- Experts from FDA will be presenting @IFSH Food Safety & High Throughput Sequencing (#HTS) Symposium – What Does the Future Hold? May 30-31 https://go.usa.gov/xnwja #foodindustry
- The only way to manage celiac disease is to avoid eating foods containing gluten. Learn how FDA’s definition of ‘gluten free’ on food labels makes that possible. #celiacawarenessmonth https://go.usa.gov/xQQTy
May 16, 2018
Federal Register
Notices
Agency Information Collection Activities; Proposals, Submissions, and Approvals:
Food and Cosmetic Export Certificate Application Process
Filed on: 05/16/2018 at 08:45 am Scheduled Pub. Date: 05/17/2018
FR Document: 2018-10551 PDF 5 Pages (87.9 KB) Permalink
Agricultural Marketing Service
Rules
General Regulations for Federal Fruit, Vegetable, and Specialty Crop Marketing Agreements and Orders; Authority to Meet Via Electronic Communications
Filed on: 05/16/2018 at 08:45 am Scheduled Pub. Date: 05/17/2018
FR Document: 2018-10487 PDF 7 Pages (233 KB) Permalink
Animal and Plant Health Inspection Service
Rules
Virus-Serum-Toxin Act Records and Reports Specific to International Standards for Pharmacovigilance
Filed on: 05/16/2018 at 08:45 am Scheduled Pub. Date: 05/17/2018
FR Document: 2018-10540 PDF 17 Pages (304 KB) Permalink
Notices
Environmental Impact Statements; Availability, etc.:
Permit for Release of Genetically Engineered Citrus tristeza virus; Preliminary Pest Risk Assessment
Filed on: 05/16/2018 at 08:45 am Scheduled Pub. Date: 05/17/2018
FR Document: 2018-10490 PDF 5 Pages (102 KB) Permalink
Environmental Protection Agency
Rules
Pesticide Tolerances:
Pyroxasulfone
Filed on: 05/16/2018 at 08:45 am Scheduled Pub. Date: 05/17/2018
FR Document: 2018-10582 PDF 22 Pages (426 KB) Permalink
Notices
Pesticide Product Registrations; Applications:
New Active Ingredients
Filed on: 05/16/2018 at 08:45 am Scheduled Pub. Date: 05/17/2018
FR Document: 2018-10578 PDF 10 Pages (181 KB) Permalink
FDA
GRAS Notices
| GRN No. | Substance | Date of Closure | FDA’s Letter |
| 780 | Rebaudioside M | Pending | |
| 779 | Isomalto-oligosaccharides | Pending | |
| 778 | Hemp seed oil | Pending | |
| 777 | Algal oil (55% docosahexaenoic acid) from Schizochytrium sp. FCC-3204 | Pending | |
| 776 | Algal oil (35% docosahexaenoic acid) from Schizochytrium sp. FCC-1324 | Pending | |
| 757 | Colicin | Pending | |
| 749 | 2’-O-fucosyllactose | Apr 23, 2018 | FDA has no questions (in PDF) (95 kB) |
| 748 | Tomato powder | Apr 19, 2018 | At the notifier’s request, FDA ceased to evaluate this notice (in PDF) (44 kB) |
| 745 | Steviol glycosides consisting primarily of rebaudioside M | Apr 20, 2018 | FDA has no questions (in PDF) (103 kB) |
| 744 | Steviol glycosides consisting primarily of rebaudioside M | Mar 23, 2018 | FDA has no questions (in PDF) (131 kB) |
| 738 | Thaumatin | Apr 18, 2018 | FDA has no questions (in PDF) (77 kB) |
| 735 | 2’-Fucosyllactose | Apr 6, 2018 | FDA has no questions (in PDF) (103 kB) |
Warning Letters
| Letter Issue Date | Company Name | Issuing Office | Subject | Close Out Date |
| 04/25/2018 | Baker’s Best Health Products, Inc. | Chicago District Office | Unapproved New Drugs/Misbranded | Not Issued * |
AskFSIS
PHIS Tasks Performed During Overtime
Noncompliance records (NR) Association – PHIS task code
HACCP Recordkeeping
If a company has done its own cooking validation, is it the agency’s expectation that each individual product must be tested, or can like items be grouped together?
OEHHA
Acrylamide – Information about the Proposition 65 carcinogen acrylamide
@FDAfood, @US_FDA, @SGottliebFDA, @FDA_ORA, @FDAMedia, @FDAanimalhealth, @FDArecalls
- Celebrate #NationalChocolateChipDay today, but avoid eating raw cookie dough. Baking removes bacteria that could cause infections. http://go.usa.gov/xnqCa
- Keep track of the supplements & medicines you take; download this form by the @US_FDA: https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM095018.pdf …
- It’s Food Allergy Awareness Week! DYK 15 million Americans have a #foodallergy? Sometimes products are recalled due to accidental mislabeling of foods containing allergens. Sign up to receive food allergy alerts from FDA: https://go.usa.gov/xQb2d