November, 26, 2018

Federal Register

Agriculture Department

Notices

Agency Information Collection Activities; Proposals, Submissions, and Approvals

Filed on: 11/23/2018 at 8:45 am Scheduled Pub. Date: 11/26/2018

FR Document: 2018-25625 PDF 4 Pages (89.9 KB) Permalink

• Ø Related to importation of fresh peppers from Peru under Plant Protection Act § 319.56-73

Agricultural Marketing Service

Proposed Rules

Meetings:

National Organic Standards Board

Filed on: 11/23/2018 at 8:45 am Scheduled Pub. Date: 11/26/2018

FR Document: 2018-25572 PDF 4 Pages (15.2 KB) Permalink

Environmental Protection Agency

Rules

Pesticide Tolerances:

Pyrifluquinazon

Filed on: 11/23/2018 at 8:45 am Scheduled Pub. Date: 11/26/2018

FR Document: 2018-25690 PDF 23 Pages (357 KB) Permalink

Proposed Rules

Notification of Submission to the Secretaries of Agriculture and Health and Human Services; Pesticides; Technical Amendment to Data Requirements for Antimicrobial Pesticides

Filed on: 11/23/2018 at 8:45 am Scheduled Pub. Date: 11/26/2018

FR Document: 2018-25554 PDF 4 Pages (11.5 KB) Permalink

Notices

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

Certification of Pesticide Applicators

Filed on: 11/26/2018 at 8:45 am Scheduled Pub. Date: 11/27/2018

FR Document: 2018-25713 PDF 4 Pages (137 KB) Permalink

• Ø Relating to the certification of pesticide applicators for certain restricted use pesticides (RUPs)

FDA

E. coli O157:H7 Infections Likely Linked to Romaine Lettuce

Recalls

Date	Brand	Product Description	Reason/Problem	Company
11/23/2018	Ottogi	Jin Ramen	Undeclared egg	Ottogi America, Inc.

Warning Letters

Letter Issue Date	Company Name	Issuing Office	Subject	Close Out Date
11/08/2018	Avalon Packaging	Denver District Office	New Drugs/Dietary Supplements/Food Labeling/Misbranded	Not Issued *

FSIS

Nov 23, 2018 | PDF

• FSIS Posts Individual Category Status and Aggregate Results for Poultry Carcasses, Chicken Parts, and Comminuted Poultry Tested for Salmonella
• U.S.-Canada RCC Stakeholder Forum to be Held in Early December
• Establishment Specific Dataset Now Available

Recalls

Product Recalled	Date of Recall	Retail Distribution List
117-2018 Chunwei, Inc. Recalls Meat and Poultry Products Due to Misbranding and Undeclared Allergens and Monosodium Glutamate	Nov 23, 2018
114-2018 Swift Beef Company Recalls Ground Beef Products due to Possible E. coli O157:H7 Contamination | En Español	Nov 17, 2018	Nov 21, 2018

AMS

USDA Lifts PACA Reparation Sanctions on California Produce Business

OEHHA

Chemicals Listed Effective November 23, 2018 as Known to the State of California to Cause Cancer: Gentian Violet and N-Nitrosohexamethyleneimine

Notice of Modification of Chemical Listing by the Labor Code Mechanism Effective November 23, 2018: Alcoholic Beverages

Notice of Intent to List: p-Chloro-α,α,α-trifluorotoluene (Para-Chlorobenzotrifluoride, PCBTF)

• Ø Requesting comments as to whether p‑chloro‑α,α,α-trifluorotoluene meets the criteria set forth in the Proposition 65 regulations for authoritative bodies listings – comments due by December 24, 2018.

@SGottliebFDA

• Ø UPDATE ON OUTBREAK: The romaine implicated in the current outbreak is likely from California based on growing and harvesting patterns. The goal now is to withdraw the product that’s at risk of being contaminated from the market, and then re-stock the market.....
• Ø ....New romaine from different growing regions, including Florida and Arizona, will soon be harvested. We’re working with growers and distributors on labeling produce for location and harvest date and possibly other ways of informing consumers that the product is “post-purge”....
• Ø ....We want to help unaffected growers get back into production and enable stores and consumers to re-stock. One goal we’re seeking is to make this type of labeling the new standard rather than a short-term fix; as a way to improve idenfitifaction and traceability in the system.
• Ø THREAD - UPDATE ON ROMAINE: #FDA is working closely with our federal partners to narrow the scope of this outbreak and traceback specific locations where the implicated romaine is coming from, and we will aim to provide updates by Monday as we learn more http://go.usa.gov/xPAFh
• Ø Some lettuce packing is labeled in a way that doesn’t make it clear where the product was grown. If you look at a package of lettuce, it’s most likely going to have the address of the company on the back; not the location of the growing fields.
• Ø That’s a large part of why we issued such a broad warning. Our ultimate goal is the protection of consumers. And entering into a holiday weekend that's very food-centric, we felt the need to make this statement. It's likely that the implicated produce is from California.
• Ø Most of the romaine lettuce that's on the market now is from the California region. The key is to get the current stock off the market to limit the present risk, and then re-stock with new produce. New romaine lettuce will be harvested soon from Florida, Yuma, and other regions.
• Ø As a key response to the outbreaks FDA will begin a special effort to sample, test romaine for contamination throughout the market; investigate why we see some continued risks with romaine; and if there are features related to its growing, harvesting, packaging that create risks

November 27, 2018

FDA

Statement from FDA Commissioner Scott Gottlieb, M.D., on the current romaine lettuce E. coli O157:H7 outbreak investigation

FSIS

Notices

Number	Title	Date Issued	Expiration Date
64-18	Eligibility of Argentina to Export Raw Beef to the United States	Nov 26, 2018	Dec 01, 2019

CVM

FDA Welcomes Grant Applications for Animal Drugs for Minor Uses and Minor Species

@FDAfood, @SGottliebFDA

• Ø #OUTBREAK UPDATE – Preliminary traceback info indicates E. Coli illnesses are likely linked to #romaine lettuce grown in California this fall. Total illnesses – 43, hospitalizations – 16, deaths – 0 in 12 states. For up-to-date, detailed info >> https://go.usa.gov/xP6ac
• Ø THREAD: Federal health officials at #FDA and @CDCgov updated our investigation and advice related to the current E. coli outbreak linked to romaine lettuce. As of Nov. 26, this outbreak has resulted in 43 people becoming ill in 12 states https://go.usa.gov/xP6C8
• Ø We are pleased that many of our industry stakeholders voluntarily withdrew potentially contaminated romaine and agreed to voluntarily label future romaine shipments with harvest locations to help consumers know where their lettuce came from.
• Ø In addition, the leafy greens industry has agreed to establish a task force to find solutions for long term labeling of romaine lettuce and other leafy greens for helping to identify products and to put in place standards for traceability of product.
• Ø We remain committed to identifying ways to decrease the incidence and impact of foodborne illness outbreaks, and #FDA will continue to provide updates on our investigation and changes to our advice on romaine lettuce as more information becomes available.

November 28, 2018

Federal Register

Agriculture Department

Rules

Revision of Delegations of Authority

Filed on: 11/28/2018 at 8:45 am Scheduled Pub. Date: 11/29/2018

FR Document: 2018-25443 PDF 42 Pages (320 KB) Permalink

FDA

FDA Signs MOU with China to Outline Certification Process for Certain Exports

FDA Investigating a Multistate Outbreak of Salmonella Concord Linked to Tahini Produced by Achdut Ltd.

Statement by FDA Commissioner Scott Gottlieb, M.D., on risk of heavy metals, including nickel and lead, found in some kratom products

Recalls

Date	Brand	Product Description	Reason/Problem	Company
11/27/2018	Kitchen Cravings	Strawberry and Mixed Berry Parfaits	May contain undeclared traces of cashews or almonds	Kwik Trip, Inc
11/27/2018	Achdut, Baron's, S&F, Pepperwood and others	Tahini	Salmonella	Achdut LTD
11/27/2018	Evolve, Sportsman's Pride, and Triumph	Dry Dog Food	Potentially elevated levels of Vitamin D	Sunshine Mills Inc.

USDA

Secretary Perdue Statement on Confirmation of Stephen Vaden for Key USDA Post

FSIS

Recalls

Product Recalled	Date of Recall	Retail Distribution List
117-2018 Chunwei, Inc. Recalls Meat and Poultry Products Due to Misbranding and Undeclared Allergens and Monosodium Glutamate	Nov 23, 2018	Nov 27, 2018
096-2018 GHSE, LLC Recalls Salads Containing Meat Products due to Possible Salmonella and Listeria monocytogenes Contamination In Corn | En Español	Oct 17, 2018	Nov 27, 2018

APHIS

Strategic Plan: tangible and specific goals that will guide APHIS through 2023

FTC

FTC Testifies before Senate Commerce Subcommittee about the Agency's Work to Protect Consumers, Promote Competition, and Maximize Resources

@SGottliebFDA, @FDArecalls

• Ø FDA warns high levels of heavy metals found in kratom products http://www2.philly.com/philly/health/kratom-fda-opioids-lead-nickel-addiction-pain-20181127.html?__vfz=medium%3Dsharebar … via @phillydotcom
• Ø FDA & @CDCgov are investigating a multi-state #outbreak of #Salmonella linked to #tahini produced by Achdut Ltd. FDA is advising to not eat the recalled tahini w/exp dates from April 7, 2020 - May 21, 2020. For complete list of affected products >> https://go.usa.gov/xP6va
• Ø Achdut Recalls Multiple Brands of "Tahini" Because It May Be Contaminated with Salmonella http://dlvr.it/QsG92C
• Ø Sunshine Mills, Inc. Issues Voluntary Recall of Dry Dog Food Due to Potentially Elevated Levels of Vitamin D http://dlvr.it/QsFWnn

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