Tag Archives: food contact

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FDA Announces Proposed Framework for Post-Market Review of Chemicals Added to Food

By Food Safety Tech Staff
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The FDA is seeking to enhance its approach to post-market review of chemicals added to—as well as those that come in contact with—food products. Robert M. Califf, M.D., Commissioner of Food and Drugs, and Susan Mayne, Ph.D., Director of the Center for Food Safety and Applied Nutrition, at the FDA, released a statement on May 26, outlining the agency’s intent to enhance surveillance and scrutiny and improve processes to identify potentially dangerous chemicals as new information comes to light.

As part of its “more modernized, systematic reassessment of chemicals with a focus on post-market review,” the FDA is focusing on new approaches to mine data and prioritize substances for in-depth review based on risk.

The enhanced approach to post-market regulation of food chemical safety shared by Drs. Califf and Mayne offers a proposed framework to systematically reassess chemicals post-market, which includes:

·      Expanding tools and methods used when conducting safety reviews and assessments of chemicals in food and substances that come into contact with food to keep pace with scientific advances and technological innovations

·      Updating processes to identify, evaluate, prioritize and communicate new and evolving information to determine if reassessment of a chemical by the FDA is warranted

·      Continuing to monitor the food supply to ensure that chemicals in food are present at levels that are not a risk to public health

They are seeking greater funding as well as additional staff to establish the proposed ongoing post-market monitoring framework. “This, combined with additional authorities to require industry to share new data and information, would allow the FDA to prioritize based on risk and better target our resources toward chemicals that we think warrant in-depth post-market review,” the statement reads.

The agency plans to engage stakeholders and provide opportunities for public comment and other stakeholder feedback about the framework through public meetings, webinars, and other engagements, and will share more information in the coming months.

 

 

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As States Look to Reopen, FDA Releases Best Practices for Retail Food Establishments

By Food Safety Tech Staff
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Across the country, many restaurants have been closed for at least two months, while others have been partially closed and offering take-out or delivery to customers during the COVID-19 pandemic. As states begin their strategy to reopen the economy, many restaurants have already opened, and others are preparing for when this day comes. To better help food retail establishments during this uncertain time, the FDA has issued the checklist, “Best Practices for Re-Opening Retail Food Establishments During the COVID-19 Pandemic”, along with a two-page infographic.

The checklist offers guidance in several key areas related to food safety practices, including:

  • Facility Operations
  • Water, Plumbing and Ice
  • Food Contact and Non-food Contact Surfaces (clean, disinfect, sanitize)
  • Food Temperature Control
  • Product Inspection, Rotation
  • Dishwashing Equipment
  • Handwashing Stations
  • Employee Health/Screening
  • Social Distancing

While the food safety checklist covers a lot of ground, the FDA has stated that the list is not comprehensive. “We encourage retail food establishments to partner with local regulatory/health authorities to discuss the specific requirements for their retail food establishment prior to re-opening,” the agency states.

Steve Ardagh, Eagle Protect
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Glove Polymers: The Unregulated Food Safety Threat

By Steve Ardagh
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Steve Ardagh, Eagle Protect

Various polymers are used in food contact applications that include food packaging and disposable gloves. More than 30 different types are used in packaging and up to six in disposables gloves. In terms of safeguards for the U.S. food supply as well as user safety, it is worth noting that 87% of the production of packaging polymers is based in the United States and subject to FDA regulation and monitoring. On the other hand, all (100%) of the 100 or more glove factories supplying the United States are based in Southeast Asia, according to a report by the British Medical Association and are not subjected to the same FDA monitoring or scrutiny.1

Packaging production is carefully overseen by the FDA, is included in FSMA, and covered in the HACCP process. Toxicology of food packaging is carefully prescribed and subject to strict enforcement action from production to storage.

Glove factories, however, are generally self-regulated, with FDA compliance required for a rough outline of the ingredients of the gloves rather than the final product. Few controls are required for glove manufacturing relating to the reliability of raw materials, manufacturing processes and factory compliance. A clear opportunity exists for accidental contamination within the glove-making process. More significantly, because of the geographic and economic implications in workforce and workplace conditions, intentional contamination potential is greatly increased. Polymer gloves utilized in food processing and service have been implicated in 15–18% of foodborne illness outbreaks in the United States.2

There is a striking difference in the requirements for these two different types of food contact polymers. Food packaging is extensively regulated, gets tested within the context of completed food product and has production primarily in the United States under close supervision. Disposable gloves, on the other hand, rely on self certification, often with testing results only on glove constituents, and little or no oversight of factory process and conditions. It seems as though this is a glaringly obvious but little accounted for risk to the U.S. food sector.

As a result, based on the root cause analysis of food cross contamination, a selection of tests and certifications, some of which are unique to the glove industry, are being implemented by one particular glove supplier. These tests ensure that their gloves coming into the United States are made in clean, well-run factories, free of any type of contamination and are consistent in material makeup to original food safe specifications. This glove fingerprint testing program consists of a number of proprietary risk reduction steps and targeted third-party testing methods, includes gas chromatography combined with mass spectroscopy (GC/MS, surface free energy determination, in vitro cytotoxicity analysis, and microbial viability-linked metagenomic analysis.

With a great deal of faith placed on a glove supplier’s ability to deliver disposable gloves sight unseen, I believe these tests are essential to further reduce the food safety risks associated with them. Objective…Zero surprises!

References

  1. Bhutta, M. and Santhakumar, A. (March 2016). In Good Hands. Tackling labor rights concerns in the manufacture of medical gloves. British Medical Association. Retrieved from https://www.bma.org.uk/collective-voice/influence/international/global-justice/fair-medical-trade/medical-gloves-report.
  2. Michaels, B. (2018). Determination of the % of Foodborne Illness Outbreaks Attributed to Glove-Related Cross-Contamination. Unpublished report

The author would like to acknowledge Barry Michaels, an international scientific consultant on food safety, infectious disease transmission and glove use, who has assisted in the fingerprint testing program discussed in this column.