Laws and Regulations Committee Update June 4 – 6, 2018

Federal Register

Environmental Protection Agency

Rules

Pesticide Tolerances:

Alpha-cypermethrin

Filed on: 06/04/2018 at 08:45 am Scheduled Pub. Date: 06/05/2018

FR Document: 2018-12066  PDF 13 Pages (317 KB)  Permalink

Tolerance Exemptions:

Ethoxylated Fatty Acid Methyl Esters

Filed on: 06/04/2018 at 08:45 am Scheduled Pub. Date: 06/05/2018

FR Document: 2018-12060  PDF 18 Pages (416 KB)  Permalink

FDA

FDA Investigating Multistate Outbreak of E. coli O157:H7 Infections Linked to Romaine Lettuce from Yuma Growing Region

Recalls

DateBrand NameProduct DescriptionReason/ProblemCompany
06/01/2018Sanders Candy Fudge BitesUndeclared almondsSanders Candy
06/01/2018SDQ Trading  Cheese biscuitsUndeclared milkSDQ Trading Inc.

FSIS

Supermercado Selectos Recalls Raw, Frozen Meat and Poultry Products Produced Without Benefit of Inspection

Jun 01, 2018 | PDF

  • FSIS Publishes Final Rule to Eliminate Trichinae Control Regulations
  • FSIS Information Sheet on Antibiotic Residues in FSIS-Regulated Products 
  • Reminder: PHIS Export Component to Launch June 29 
  • FSIS Webinar on Individual Salmonella Category Status for Poultry Parts and Comminuted Poultry

APHIS

APHIS Updates its Animal Welfare Regulations to Provide Certain Small Scale Dealers and Exhibitors with Additional Exemptions from Licensing Requirements

AMS

Recorded Webinar on Proposed National Bioengineered Food Disclosure Standard

Transcript of Webinar (pdf)

OEHHA

Announcement of Second Public Comment Period for the Draft Technical Support Document on the Proposed Updates of the Public Health Goals for Cis-/Trans-1,2-Dichloroethylene in Drinking Water

CSPI

WHO Panel Nixes Support for Sugary Drink Taxes

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

  • The FDA continues to investigate the outbreak of E. coli O157:H7 infections associated with romaine lettuce from the Yuma growing region. Any contaminated product from the Yuma growing region is no longer available for consumption. https://go.usa.gov/xQf4f 
  • We are committed to investigating the source of the outbreak and working with industry to help prevent similar events in the future.
  • #FridayCaseFiles – 2015: Raw Deal Inc: Owner of dietary supplement company told employees to add “fillers” like cocoa replacer and rice flours to supplements, diluting and adulterating the products: http://bit.ly/2I6jt17  #FDAOCI
  • Barbequing this weekend? Use a food thermometer to reach safe cooking temperatures for what’s on your grill. Is your chicken done to 165°F? The burgers at 160°F? We’ve got these & other #foodsafety tips http://go.usa.gov/xNGb7 
  • The E. coli outbreak linked to romaine is serious and tragic. Federal officials updated the case counts today and we’re devoting considerable effort to identifying the primary source of contamination. http://go.usa.gov/xQwXc 
  • Our thoughts are with the families of those who passed away. Our goal is to find a possible explanation so that steps can be taken to prevent this tragedy from recurring. http://go.usa.gov/xQwXc 
  • Remembering when the jelly on your peanut butter sandwich wasn’t really jelly–and how the FDA protects you from such deception. https://www.flickr.com/photos/fdaphotos/40692239540/in/album-72157624615595535/ … #FlashbackFriday
  • SDQ Trading Inc Issues Alert on Undeclared Milk Allergen in Cheese Biscuits http://dlvr.it/QVtn4t 
  • Sanders Issues Allergy Alert on Undeclared Almonds in Fudge Mini Bites http://dlvr.it/QVvyPj 
  • Because it’s June! Local fresh fruits & vegetables made it to the farmer’s markets. Have you? https://go.usa.gov/xQw99  #FreshFruit
  • Enjoy #NationalCheeseDay. Check the label to make sure it pasteurized! http://go.usa.gov/xXqsH 
  • TOMORROW: #FDAORA Office of Human and Animal Food Operations West Director Joann Givens will discuss FSMA progress, updates, and what comes next at @EP_NAFS North American Food Safety & Quality 2018. #NAFS18 #ORAInfo

June 5, 2018 

FDA

Recalls

DateBrand NameProduct DescriptionReason/ProblemCompany
06/04/2018MeijerDill Pickle Flavored Potato Chips undeclared milkShearer’s Foods, LLC

FSIS

Goodman Food Products Recalls Fully Cooked Ground Beef Products Due to Possible Foreign Matter Contamination

AMS

USDA Files Action Against Tumi Produce International Corp. in New York for Alleged PACA Violations

OIRA

AGENCY: USDA-APHISRIN: 0579-AE14Status: Pending Review
TITLE: Conditions for Payment of Highly Pathogenic Avian Influenza Indemnity Claims
STAGE: Final RuleECONOMICALLY SIGNIFICANT: No
** RECEIVED DATE: 06/04/2018LEGAL DEADLINE: None  

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

  • Hurricane season is here. Prepare now for unpredictable weather emergencies, as floods & power outages from storms can cut off water supplies & quickly contaminate food. Use these FDA resources to protect yourself, your family & pets: https://go.usa.gov/xQUmq 
  • Whether aiming to gain muscle or lose weight, meal prep may be a large part of your healthy lifestyle. Don’t let food poisoning delay reaching your goals! Cooked meals are only safe for up to 4 days in the fridge. #MensHealthMonth
  • Do your part to decrease #foodwaste for #WorldEnvironmentDay & every day. http://go.usa.gov/xNz9d 
  • Shearer’s Foods, LLC Issues an Allergy Alert for Undeclared Milk in Meijer Brand Dill Pickle Flavored Potato Chips http://dlvr.it/QWC5y1 
  • I look forward to hosting @SecretarySonny at #FDA’s campus for a town hall meeting later today to discuss our collaborative efforts to enhance food safety and continuing efforts under a formal agreement we signed in January: https://go.usa.gov/xQ7NW 


June 6, 2018

Federal Register

Food and Drug Administration

Notices

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

Record Retention Requirements for Soy Protein and Risk of Coronary Heart Disease Health Claim

Filed on: 06/06/2018 at 08:45 am Scheduled Pub. Date: 06/07/2018

FR Document: 2018-12216  PDF 3 Pages (82.4 KB)  Permalink

Animal and Plant Health Inspection Service

Notices

Determinations:

Classical Swine Fever and Swine Vesicular Disease Status of Japan

Filed on: 06/06/2018 at 08:45 am Scheduled Pub. Date: 06/07/2018

FR Document: 2018-12186  PDF 4 Pages (83.8 KB)  Permalink

Environmental Assessments; Availability, etc.:

Bayer CropScience LP; Cotton Genetically Engineered For Resistance to HPPD-Inhibitor Herbicides (e.g., Isoxaflutole) and Glyphosate

Filed on: 06/06/2018 at 08:45 am Scheduled Pub. Date: 06/07/2018

FR Document: 2018-12187  PDF 8 Pages (186 KB)  Permalink

Environmental Protection Agency

Rules

Pesticide Tolerances:

Acequinocyl

Filed on: 06/06/2018 at 08:45 am Scheduled Pub. Date: 06/07/2018

FR Document: 2018-12297  PDF 20 Pages (339 KB)  Permalink

FDA

FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products

FDA and USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers

Warning Letters

Letter Issue DateCompany NameIssuing OfficeSubjectClose Out Date
05/31/2018Fair Fish Co., Inc.New York District OfficeSeafood HACCP/CGMP for Foods/Adulterated/Insanitary ConditionsNot Issued *
05/29/2018LiquidCaffeine.comCenter for Food Safety and Applied NutritionDietary Supplement/AdulteratedNot Issued *
05/29/2018Dual Health Body and MindCenter for Food Safety and Applied NutritionDietary Supplement/AdulteratedNot Issued *
05/17/2018Silver Armor, Inc.Atlanta District OfficeUnapproved New Drugs/MisbrandedNot Issued *

USDA

USDA and FDA Announce Key Step to Advance Collaborative Efforts to Streamline Produce Safety Requirements for Farmers

FSIS

Update on Partially Hydrogenated Oils in Meat, Poultry and Egg Products

FNS

FY 2018 NSLP Equipment Assistance Grants for School Food Authorities

AMS

USDA Aligns Good Agricultural Practices Audits with FDA Food Safety Rule, Alignment Advances Food Safety Practices, Streamlines Regulatory Requirements

USDA Restricts PACA Violators in California, Illinois, Texas and Virginia from Operating in the Produce Industry

USDA Restricts PACA Violators in California and Texas from Operating in the Produce Industry

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

OIRA

AGENCY: USDA-APHISRIN: 0579-AD44Status: Concluded
TITLE: Lacey Act Implementation Plan: De Minimis Exception
STAGE: Proposed RuleECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 02/27/2018LEGAL DEADLINE: None  
REVIEW EXTENDED
** COMPLETED: 06/05/2018COMPLETED ACTION: Consistent with Change
AGENCY: USDA-APHISRIN: 0579-AE36Status: Concluded
TITLE: Lacey Act Implementation Plan: Composite Plant Materials
STAGE: PreruleECONOMICALLY SIGNIFICANT: No
RECEIVED DATE: 02/27/2018LEGAL DEADLINE: None  
** COMPLETED: 06/05/2018COMPLETED ACTION: Consistent with Change

GAO

FARM PROGRAMS: Information on Payments [Reissued with Revisions Jun. 05, 2018] 

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

  • FDA warns companies to stop selling dangerous and illegal pure and highly concentrated caffeine products https://go.usa.gov/xQ7Vy 
  • FDA will continue to take action against those responsible for illegally selling certain highly concentrated #caffeine products considered a threat to public health. FDA issued warning letters to http://liquidcaffeine.com  & Dual Health Body and Mind. https://go.usa.gov/xQ7vB 
  • “Despite being informed of the dangers of highly concentrated and pure caffeine; we’re still finding companies that are disregarding consumer safety by illegally selling products with potentially dangerous and lethal amounts of caffeine… …”
  • The FDA recently released a guidance for industry to help companies determine if their pure and highly concentrated caffeine products are adulterated and pose an unacceptable risk to consumers. https://go.usa.gov/xQ7wr 
  • We’ve already seen at least two deaths linked to pure or concentrated caffeine, and we’ll be enforcing the law to protect consumers from these products” – @SGottliebFDA
  • FDA and @USDA announce key step to advance collaborative efforts to streamline produce safety requirements for farmers https://go.usa.gov/xQ7As 
  • Who regulates it – @USDA or #FDA?? @secretarysonny and I put my staff to food regulation pop quiz. Well done, FDA! You make me proud.
  • We couldn’t let @secretarysonny leave without a small token to remind him of #FDA. From our colleagues at CFSAN, a shirt with a caption that reads “The ‘F’ in FDA”
  • Interagency confab with @SGottliebFDA and @SecretarySonny at FDA. Very rare to see a Secretary of Agriculture at @US_FDA.
  • Caffeine can be made available in safe ways. This warning from FDA about highly concentrated caffeine products is important to prevent serious adverse events and death. @DukeForge
  • Thanks @SecretarySonny for coming to today’s Town Hall at FDA; especially the discussion of the collaborative efforts of @USDA and @FDAfood #foodsafety #FSMA
  • Today @SecretarySonny and I announced a key step to advance collaborative efforts between the #FDA and @USDA to streamline produce safety requirements for farmers: https://go.usa.gov/xQ77j 
  • FDA has issued warning letters to the parties responsible for illegally selling certain highly concentrated caffeine products. We consider these to be a threat to public health. https://go.usa.gov/xQ7vB 
  • Dr. Susan Mayne’s stellar leadership and the @US_FDA‘s Nutrition Innovation Strategy are poised to improve our nation’s health.
  • While enjoying #FreshFruitandVegetablesMonth be sure to start with these safe handling tips to protect yourself from #Foodborneillness http://go.usa.gov/xXXvB 
  • Men, beware! Products falsely marketed as “dietary supplements” or “foods” that promise to enhance your sexual performance or increase sexual stimulation may contain hidden drugs or other ingredients and can endanger your health! MORE: https://go.usa.gov/xQQDK  #MensHealthMonth