Laws and Regulations Committee Update 4/30 – 5/2, 2018

April 30, 2018

Federal Register

Food and Nutrition Service


Requirements for Processing of Donated Foods:

Revisions and Clarifications

Filed on: 04/30/2018 at 08:45 am Scheduled Pub. Date: 05/01/2018

FR Document: 2018-09168  PDF 92 Pages (447 KB)  Permalink


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

Special Supplemental Nutrition Program for Women, Infants, and Children Infant and Toddler Feeding Practices Study-2 Age 6 Extension Study

Filed on: 04/30/2018 at 08:45 am Scheduled Pub. Date: 05/01/2018

FR Document: 2018-09216  PDF 6 Pages (278 KB)  Permalink

Environmental Protection Agency


Interim Registration Review Decisions and Case Closures:

Several Pesticides

Filed on: 04/30/2018 at 08:45 am Scheduled Pub. Date: 05/01/2018

FR Document: 2018-09203  PDF 5 Pages (168 KB)  Permalink


Notice of Availability of Guidance for Industry; The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species 


DateBrand NameProduct DescriptionReason/ProblemCompany
04/27/2018Van’sWafflesProduct may contain gluten and undeclared milkVan’s Foods
04/26/2018Bombay KitchenBhavnagri MixUndeclared peanutsEthnic Foods Inc.


Pinnacle Foods Inc. Recalls Beef Products Due to Possible Processing Deviation

Fiscal Year 2018 Dioxin Survey

Apr 27, 2018 | PDF

  • FSIS Announces the Fiscal Year 2018 Dioxin Survey
  • Reminder: FSIS Comment Period on Petition on Beef and Meat Labeling Requirements Ends May 17
  • FSIS Posts Updated Quarterly Sampling Results


What is the primary difference between the FSIS simplified format and FDA’s simplified format and why didn’t FSIS elect to use the FDA simplified format?

If a product qualifies to use the simplified format but the manufacturer elects to list the insignificant level nutrient(s) as zero in the vertical column, can the footnote still be shortened?

Is mechanically separated meat or poultry subject to the retained water rule?

Do insert labels have to bear a retained water statement?

What is the difference between FDA’s shortened format and the FSIS simplified format?

Can nutrients be listed as zero at the bottom of the panel instead of using the wording “not a significant source of” in order to save space?

Does FSIS have the same provision as FDA’s in order to use or not use the statement “Not a significant source of ________.”?

What types of terms or statements should be included when revising labels for uncooked breaded, boneless poultry product labels to convey to consumers that these products are not ready to eat?

Can a tabular display be used when the label has space for the long format but it will wrap around the product and might be inconvenient to read?

When can tabular and linear (string) displays be used?

Is a break in the vertical alignment allowed with the standard format?

When will an example of a linear display be available?

Where does the statement that will convey that the product is uncooked or partially cooked need to appear on the label?

Sanitation SOP Evaluation

Egg Product Production Codes

FSIS Generic HACCP models

Addressing APC Swab Testing Programs In a Food Safety System


APHIS Invites Public Comment on Draft Environmental Impact Statement for the National Fruit Fly Cooperative Control Program


USDA Files Action Against Goodness Greeness Inc. in Illinois for Alleged PACA Violations

USDA Proposes Seasonal Volume Regulation for Cranberries during the 2018–19 Crop Year


AGENCY: EPA-OLEMRIN: 2050-ZA14Status: Concluded
TITLE: Q&As for CERCLA and EPCRA Reporting Requirements for Air Releases of Hazardous Substances from Animal Waste at Farms
** COMPLETED: 04/27/2018COMPLETED ACTION: Consistent with Change

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

  • Ethnic Foods Inc. Issues Allergy Alert on Undeclared Peanuts in “Bhavnagri Mix” 
  • #FDA provided investigation update for E.coli outbreak linked to romaine lettuce ID’ing farm that provided whole-head romaine that sickened people in Alaska. Investigation still ongoing for source of chopped romaine linked to other cases in outbreak 
  • #FDA and CDC continue to advise consumers to not eat romaine lettuce if they know it is from the Yuma growing region: 
  • #OUTBREAK UPDATE: At least 98 people in 22 states are now sick with E. coli infections linked to romaine #lettuce. Don’t eat or buy romaine lettuce unless you can confirm it’s not from Yuma, AZ. If you can’t confirm it, don’t eat or buy romaine. 
  • Thanks to our CFSAN laboratory scientists for making every week #LabWeek#FoodSafety for you!
  • Yummy ways to #StopFoodWaste 
  • #FDA has identified a farm that provided whole-head romaine lettuce that sickened people in Alaska. The overall investigation is still ongoing for the source of chopped romaine linked to other cases that are part of the outbreak 
  • Van’s Foods Voluntarily Recalls Gluten Free Waffles in Eleven States 

May 1, 2018


FDA Advises Consumers & Retailers to Avoid Potentially Contaminated Raw Oysters from Canada


DateBrand NameProduct DescriptionReason/ProblemCompany
04/30/2018Stonewall KitchenBasil PestoUndeclared EggStonewall Kitchen


Criteria for Recommending an Onsite Verification Audit as Part of a Reinstatement of Equivalence Determination


FSIS Directive 6410.1- Visible Contamination

Are abbreviations for other than Daily Value allowed?

Can the product name be placed within the nutrition panel?

When using a dual declaration, such as for a condensed soup and its prepared form, can the actual quantitative amounts be listed for the prepared form?

Food Bank Registration

HACCP thawing product

9 CFR 417.4(a)(2)(ii)- Direct Observation


AGENCY: USDA-AMSRIN: 0581-AD54Status: Concluded
TITLE: National Bioengineered Food Disclosure Standard
** COMPLETED: 04/30/2018COMPLETED ACTION: Consistent with Change

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

  • The new Resturaunt menu labels will inform consumers of important, basic information about food nutrition; and will also create more competition to offer options that are more healthful. Data shows menu labels can help meaningfully address obesity epidemic …
  • Studies show menu labeling reduces average number of calories ordered by 30-50 calories.  And other research suggests that an average reduction of just 64 fewer calories per day is needed to meet Healthy People 2020 goals for youth obesity @GoHealthyPeople
  • FDA cautions you to avoid skin creams, beauty/antiseptic soaps & lotions containing mercury which are illegally marketed as “anti-aging” or “skin lightening” products. LEARN MORE in this #FDAORA #consumerupdate 
  • The #FDA has worked hard to make sure new menu labeling rule can be implemented in way that’s maximally beneficial to consumers and minimally burdensome to restaurants. The National Restaurant Association says thousands of restaurants are already labeling 
  • When a #disaster hits, be sure you are prepared. Have enough food, water, and supplies for three days AFTER an event. Remember: the first 72 is on you! 
  • Stonewall Kitchen Voluntarily Recalls a Limited Amount of Basil Pesto Aioli due to Mislabeling and Undeclared Presence of the Dairy Allergen, Egg 
  • It’s #SmallBusinessWeek! Do you have a food business or plan to start a new one? Check w/FDA about government requirements: 
  • Restaurant menu labeling is coming. Studies show it reduces average number of calories ordered by 30-50 calories.  And other research shows an average reduction of just 64 fewer calories per day is needed to meet Healthy People 2020 goals for youth obesity
  • FDA and partners are investigating a norovirus outbreak linked to oysters from Baynes Sound, British Columbia, Canada. Consumers and retailers should throw out any product from the identified lots 
  • #FDA has confirmed oysters that sickened people in Canada were sent to retailers in several states including CA, IL, MA and WA have received the product. As we continue investigating FDA will provide more info 

May 2, 2018

Federal Register

Food and Drug Administration


Crabmeat; Amendment of Common or Usual Name Regulation

Filed on: 05/02/2018 at 08:45 am Scheduled Pub. Date: 05/03/2018

FR Document: 2018-09371  PDF 8 Pages (97.5 KB)  Permalink


FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies


DateBrand NameProduct DescriptionReason/ProblemCompany
05/01/2018Gerard DominiqueWild Coho Smoked SalmonPotential Clostridium botulinum contaminationSeabear Company

Warning Letters

Letter Issue DateCompany NameIssuing OfficeSubjectClose Out Date
04/18/2018MC Fish CoCincinnati District OfficeSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsNot Issued *

GRAS Notices

GRN No. (sorted Z-A)SubstanceDate of ClosureFDA’s Letter
774Glutaminase from Bacillus licheniformis produced in Bacillus licheniformis Pending
773Dried biomass of Chlamydomonas reinhardtii Pending
772Green tea extract Pending
771Hemp seed protein Pending
770Potassium polyaspartate Pending
769Vitamin C (fruit and vegetable derived) Pending
768Stevia leaf extract Pending
767Polyvinyl alcohol Pending
7663′-sialyllactose sodium salt Pending
765Hulled hemp seed Pending


Child Nutrition (CN) Products – Contact Information

When percent Daily Values (DV) for protein and potassium are included on the nutrition panel on foods for adults and children over 4 years, where is the Daily Reference Value (DRV) information placed?

Will consumers be confused to see a gram weight of zero in conjunction with 1 percent Daily Value (DV) for the same nutrient and should the percent DV be expressed as zero in these cases?


USDA Seeks Nominees for the National Potato Promotion Board

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

  • Retailers should not serve raw #oysters harvested from the following harvest locations (or landfiles) within Baynes Sound: #1402060, #1411206, #1400483, and #278757.
  • FDA, FTC take action against companies misleading kids with e-liquids that resemble children’s juice boxes, candies and cookies: 
  • DYK? In 2017, FDA issued over 15K warning letters to manufacturers, distributors & importers of FDA-regulated products: LEARN MORE:  #FDAFacts
  • May is #HamburgerMonth! Millions of ways to top it. Only 1 way to keep it safe. Remember to use your food thermometer & cook to 160°F for safety!
  • It’s #SmallBusinessWeek! Do you dream of having food business? Are you in the midst of your plan to start a new one? Check w/FDA about government requirements: 
  • Seabear Company Issues a Voluntary Recall of Cold Smoked Wild Coho Salmon Lox Because of Possible Health Risk 

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