Association of Food and Drug Officials

Laws and Regulations Committee Update 3/4 - 3/5, 2019

March 08, 2019 9:58 AM | Amy Bonsell (Administrator)

March 4, 2019

Federal Register

Agricultural Marketing Service



2018 Farm Bill Implementation Listening Session on Hemp

Filed on: 03/04/2019 at 8:45 am Scheduled Pub. Date: 03/05/2019

FR Document:  2019-03912 PDF 3 Pages (161 KB) Permalink


Animal and Plant Health Inspection Service


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

Importation of Fresh Andean Blackberry and Raspberry Fruit from Ecuador Into the Continental United States

Filed on: 03/04/2019 at 8:45 am Scheduled Pub. Date: 03/05/2019

FR Document: 2019-03859 PDF 4 Pages (174 KB) Permalink


International Trade Administration


Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Fresh Tomatoes from Mexico

Filed on: 03/04/2019 at 8:45 am Scheduled Pub. Date: 03/05/2019

FR Document: 2019-03928 PDF 11 Pages (164 KB) Permalink






Product Description




Sunstone Organics

White Vein Kratom and Maeng Da Kratom

Potential for Salmonella

Sunstone Organics


Golean Detox

Dietary Supplement for Weight Loss

Undeclared Sibutramine

Golean Detox USA


Nova Salted Biscuit

Nova Salted Biscuit

Undeclared Milk

Asia Foods Distributor Inc.



Mar 01, 2019 | PDF

  • FSIS Announces Resources to Help Prevent Illness from Undercooked Chicken Liver
  • FSIS Posts List of Approved Import Inspection Establishments as APHIS Rapid Defrost Facilities


Product Recalled

Date of Recall

Retail Distribution List

024-2019 Washington Beef, LLC Recalls Ground Beef Products due to Possible Foreign Matter Contamination

Mar 02, 2019


018-2019 TV Food LLC. Recalls Siluriformes Products Produced Without Benefit of Inspection

Feb 22, 2019

Mar 01, 2019




Date Issued

Expiration Date


Instructions for Kidney Dispositions in Poultry Carcasses

Mar 01, 2019

Mar 01, 2020



USDA Announces Appointments to the U.S. Highbush Blueberry Council

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

USDA Continues Suspension of Supervision Fee Assessment under the United States Grain Standards Act



APHIS Proposes To Allow Public Comment on Protocols for Deregulating Fields Previously Infested with Pale Cyst Nematode



National Consumer Protection Week 2019 Kicks off Sunday, March 3




  • ·        As Americans we count on having a diverse selection of fresh and affordable food in all seasons. That means we must rely in part on imported food. In today’s #FDA #SundayTweetorial I’ll talk about what FDA is doing to ensure the safety of food from abroad .
  • ·        You might be surprised by how much of what you eat comes from beyond our borders. About 15% of the nation’s overall food supply is imported from more than 200 countries or territories representing about 125,000 food facilities plus farms.
  • ·        And the volume of imported food just keeps rising. In 2012, other countries supplied 21% of our fresh vegetables; 49% of our fresh fruit; and at least 85 % of our seafood. By 2017, imports accounted for 32% of our fresh vegetables; 55% of our fresh fruit; and 94% of our seafood.
  • ·        There are other facets of globalization. We see complex supply chains and increased specialization, where a single manufacturer may be responsible for a single ingredient which could find its way into many different finished products .
  • ·        Despite these trends, food safety hasn’t waned thanks to important roles played by FDA, the food industry, the states and our global regulatory counterparts. Implementation of the FDA Food Safety Modernization Act (FSMA)  has been a big factor.
  • ·        FSMA marked a fundamental shift in our approach from responding to contamination to preventing it. FSMA gave us additional authority over importers and food producers and provided assurance that food would meet the same safety standard, whether from a foreign or domestic supplier
  • ·        To optimize FSMA’s new tools and better integrate them with our other longstanding tools and authorities, we’ve developed a new comprehensive strategy for ensuring imported food safety. . It lays out 4 food safety goals.
  • ·        1. Preventing food safety problems in the foreign supply chain prior to entry; 2. Detecting and refusing entry of unsafe foods at the border; 3. Quickly responding when unsafe imported food is detected; and 4. Developing and publishing metrics to monitor our progress.
  • ·        First, onsite foreign inspections are an obvious way to prevent food safety problems in the supply chain. But given the number of facilities, we must prioritize based on risk, which we achieve with the help of data and info from other oversight activities and partners.
  • ·        One source of data flows from our Foreign Supplier Verification Programs (FSVP) rule . It requires that importer conduct hazard analyses, evaluate food and supplier risk and verify that their suppliers meet U.S. food safety standards.
  • ·        FDA’s Accredited 3rd-Party Certification program  provides a framework for recognized groups to conduct audits verifying that foreign food facilities comply w/ U.S. food safety standards. It supplements FDA oversight and provides us with vital data.
  • ·        Importers can use accredited 3rd-party audits to help establish their eligibility under our fee-based Voluntary Qualified Importer Program (VQIP). Participants get expedited review and entry of their food shipments at our borders .
  • ·        Finally, we rely on information from reliable regulatory counterparts to inform our work planning and to allocate resources based on risk . We currently recognize Canada, New Zealand and Australia.
  • ·        So, what are we doing at the border to detect and refuse unsafe products? Importers are required to provide FDA with prior notification before food is offered for import into the United States. It helps us prepare .
  • ·        We ID riskier shipments using PREDICT, an automated import screening tool that uses data mining, pattern discovery, and automated queries of FDA database. . We intend to optimize this tool by using new data from - VQIP, FSVP and accredited 3rd-party audits.
  • ·        Sampling and testing food at the border is an effective way to detect contamination, but it's labor-intensive and costly. We’re using data from multiple sources to target riskier products for these tasks. And we’re also expanding our analytical test methods.
  • ·        FDA scientists use 100s of established, validated tests and screening methods to detect pathogens or contaminants in different types of food. When a test doesn’t exist, we work to develop and validate new ones, as we did for cyclospora .
  • ·        If unsafe food products do enter domestic channels, our 3rd goal is responding quickly to unsafe imported food. That means marshalling our sampling and testing strategies; our recall authority and import alerts; and info sharing with the states and other partners.
  • ·        FDA’s Coordinated Outbreak Response and Evaluation network  is essential in outbreaks. It analyzes internal and external information to identify foodborne illness and injury trends and evaluate potential illness clusters, then coordinates our response.
  • ·        Finally, to ensure that our import program is effective and efficient we’ll be developing an improved global inventory of food facilities and farms to help optimize our oversight activities as well as new performance metrics to help us measure how well we’re doing.


  • ·        Under an Act of March 1, 1899, FDA (then the @USDA Div of Chemistry) investigated imported food for adulteration. Violative products were refused entry. Several import labs were set up around the country, and the function was folded into 1906 Food and Drugs Act. #FDAHistory


“CVM is an organization that nurtures creativity and innovation.” – Virginia, PhD  #IAmHHS #FDA #CVMCareers #CVMCarreras @FDAJobs

March 5, 2019

Federal Register

Food and Drug Administration


Food Additives Permitted in Feed and Drinking Water of Animals; Selenomethionine Hydroxy Analogue

Filed on: 03/05/2019 at 8:45 am Scheduled Pub. Date: 03/06/2019

FR Document: 2019-03909 PDF 9 Pages (112 KB) Permalink




Mitigation Strategies to Protect Food Against Intentional Adulteration

Filed on: 03/05/2019 at 8:45 am Scheduled Pub. Date: 03/06/2019

FR Document: 2019-04060 PDF 6 Pages (105 KB) Permalink


International Trade Administration


Antidumping or Countervailing Duty Investigations, Orders, or Reviews:

Certain Frozen Warmwater Shrimp from the Socialist Republic of Vietnam

Filed on: 03/05/2019 at 8:45 am Scheduled Pub. Date: 03/06/2019

FR Document: 2019-04045 PDF 9 Pages (164 KB) Permalink



USDA Names Importer Member to the Cotton Board




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