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House Appropriations Bill Highlights Support for Restructuring of FDA

By Food Safety Tech Staff
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The U.S. House of Representatives’ Committee on Appropriations has directed the FDA to unify its food program under a Deputy Commissioner for Foods and highlighted additional priorities for the agency related to cell-cultured meat products, allergen labeling and quantitative pathogen testing.

In its recent bill appropriating funds for the USDA, FDA and related agencies for fiscal year 2024, the committee laid out its priorities for these agencies, including:

Human Foods Program Restructuring. The Committee directed FDA to unify the foods program under an expert, empowered Deputy Commissioner for Foods with full line authority over CFSAN, the food and feed-related activities of the Center for Veterinary Medicine (CVM), and all food-related components of the Office of Regulatory Affairs, including inspection and compliance, food-related laboratories, import oversight, State partnerships, training, and information technology.

Allergen Labeling. The Committee stated that it is concerned about the increase in the diagnosis of food allergies to new and emerging food allergens not currently required to be labeled. The Committee urged the Center for Food Safety and Applied Nutrition (CFSAN) to identify potential future food allergens that would require labeling on food packaging and to implement the required process toward labeling on packaged foods.

Cell Cultured Meat Labeling. In light of the FDA’s first pre-market consultation for a human food made from cultured animal cells, the Committee stated that it is interested in the internal FDA protocols related to pre-market consultations for cell-cultured protein products, specifically whether or not there are special or unique considerations made for these products in pre-market consultation processes. The Committee requested a report outlining the pre-market consultation process for cell-cultured protein products, noting any special accommodations made to comply with the Formal Agreement between the FDA and the USDA and any agency plans to coordinate with its counterparts at USDA on further action regarding the same products.

FASTER Act. The Committee shared its concerns of reports that companies are circumventing the intent of the FASTER Act by intentionally adding sesame to food products to avoid the cost of preventing cross-contamination. FDA is directed to report on implementation of the FASTER Act, including plans to address this issue and an analysis of whether actions by companies in response to the Act’s passage violated federal food safety rules.

Listeria. The Committee directed FDA to apply a risk-based approach and direct its regulatory efforts toward high risk ready-to eat foods that support the growth of Listeria monocytogenes (Lm). Additionally, the Committee encouraged a regulatory approach that encourages industry to adopt quantitative Lm testing schemes and facilitate robust environmental monitoring programs. The Committee directed FDA to work with industry stakeholders to gather supporting information and data to assist with implementation of this Lm approach to align with other international regulatory standards and restore a level playing field for U.S. food processors in the global marketplace.

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IFT Rebrands Quality Management Division to Highlight Food Safety Focus

By Food Safety Tech Staff
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The Institute of Food Technologists (IFT), a nonprofit scientific organization committed to advancing the science of food and its application across the global food system, has rebranded its Quality Management Division. The newly named Food Safety & Quality Management Division (FSQM)—announced on World Food Safety Day 2023—brings together more than 1,500 members from more than 60 countries to collaborate, network, and share ideas around food safety. IFT chose to rebrand the division to better reflect the overall responsibilities of its members who focus on assurance, quality control, food safety, and food wholesomeness.

IFT’s topical, interest-based groups, known as Divisions, support learning, collaboration, and innovation through the sharing of knowledge via webcasts and podcasts, online forums, and in-person events. In total, the organization hosts 25 Divisions spanning the science of food.

“Rebranding to Food Safety & Quality Management Division communicates to the food community that this Division is a home for those interested in food safety,” added Eric Ewert, Chair of IFT’s Food Safety & Quality Management Division.

 

 

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USDA FSIS Releases New Salmonella Control Guideline for Swine Slaughter and Pork Processing

By Food Safety Tech Staff
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The USDA Food Safety and Inspection Services (FSIS) has updated its voluntary guideline for federally regulated swine slaughter and pork processing establishments to control Salmonella in market hogs from pre-harvest through slaughter. The agency announced that it updated the document in response to comments on the previous guideline and to incorporate current, peer-reviewed scientific references related to pre-harvest controls, swine slaughter, processing of pork cuts, and comminuted pork products.

The guideline covers:

  • Pre-harvest controls, including farm rearing, multi-hurdle interventions, transport, and lairage
  • Slaughter controls
  • Best practice recommendations for pork fabrication controls, including processing, packaging, and distribution controls for pork cuts and comminuted pork products.

Download the new guideline here.

 

Conor Kearney

FoodChain ID Announces New CEO

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Conor Kearney

Conor Kearney has been appointed CEO of FoodChain ID. He succeeds Brad Riemenapp, who led FoodChain ID as CEO for more than five years before his death due to cancer in May. Kearney joined FoodChain ID in 2021 and most recently served as Interim CEO during Riemenapp’s medical leave of absence.

Kearney previously served as the company’s Senior Vice President of Strategy and Operations. Before joining FoodChain ID, he worked for 11 years at Staples, holding multiple leadership roles, and five years at McKinsey & Company. Kearney earned his MBA from Harvard Business School and a bachelor’s degree in Biochemistry and Molecular Biology from Dartmouth College.

“Conor has already had a significant impact on FoodChain ID. His collaborative leadership style and ability to rally the organization to achieve its goals make him the absolute right person to lead FoodChain ID in the next stage of its growth journey,” said Ted Rainaud, Managing Director at Berkshire Partners.

“Brad was a great mentor to me, and I’m committed to continue building on his vision and delivering on FoodChain ID’s mission to make the food supply chain safer and more transparent,” said Kearney.

 

World Food Safety Day 2023

Celebrating World Food Safety Day

By Food Safety Tech Staff
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World Food Safety Day 2023

Wednesday, June 7 is World Food Safety Day. The annual event was established in 2018 by the United Nations General Assembly to raise awareness and inspire action to help prevent, detect, and manage foodborne risks.

This year’s theme is “Food Standards Save Lives,” which highlights the role of established food safety practices and standards to ensure food safety and quality.

The Food and Agriculture Organization of the UN (FAO) in collaboration with the World Health Organization (WHO) is calling on countries, companies, and educational institutions to further adoption of safe food practices. Following are this year’s calls to action:

Policy makers

Make safe food an easy choice by shaping public support for programs, such as food aid, school feeding and other publicly owned food outlets.

Focus on establishing a robust national food safety system and ensure it complies with food safety standards.

Encourage and engage in multisectoral collaboration at the local, national, regional, and global levels.

Food businesses

Engage employees, suppliers and other stakeholders to grow and develop a food safety culture.

Comply with national and international food standards.

Educational institutions and workplaces

Promote safe food handling.

Engage with families and involve them in food safety activities.

Support food safety education.

 

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FDA Launches Webpage on Equivalence and Food Safety

By Food Safety Tech Staff
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On June 5, the FDA published a new webpage dedicated to equivalence—the process of determining whether a foreign regulatory counterpart’s food safety controls achieve at least the same level of public health protection as measures required by U.S. law—for food safety.

As the FDA explains, equivalence is a right and an obligation for all members of the World Trade Organization (WTO). All members must accept the sanitary or phytosanitary measures of the other members as equivalent, even if these measures differ from their own or from those used by other members trading in the same product, if the exporting member objectively demonstrates to the importing member that its measures achieve the importing member’s appropriate level of sanitary or phytosanitary protection.

This means that a foreign regulatory authority is not required to develop and implement the same exact procedures and food safety controls that FDA requires, but rather that it must objectively demonstrate how its food safety controls meet at least the same level of public health protection achieved by U.S. measures. Likewise, for food exported from the United States, foods produced in compliance with U.S. regulations may be permitted entry into foreign markets based on a positive equivalence determination.

The webpage explains how equivalence is determined, the current equivalence determinations, and how regulatory authorities can submit a formal request for equivalence for FDA-regulated food products.

 

 

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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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FDA Releases Small Entity Compliance Guide for the Food Traceability Rule

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The FDA has released a Small Entity Compliance Guide for the FSMA Food Traceability Rule. This guidance document is intended to help small entities, including farms and small businesses, comply with the requirements of the Food Traceability Rule. It offers recommendations—unless specific regulatory or statutory requirements are cited—on how small entities can comply with the new regulations, which were issued in November 2022. The compliance date for recordkeeping requirements is Jan. 20, 2026.

The guidance document covers:

  • Who is subject to the traceability rule
  • Who is exempt
  • What records must be kept, and for how long
  • How to apply for a modification or exemption
  • How to petition the FDA for waivers
  • Consequences of failure to comply

Download the compliance guide here.

 

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FDA Releases Draft Compliance Policy Guide for Food Allergen Labeling and Cross-Contact

By Food Safety Tech Staff
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On May 16, the FDA released a draft Compliance Policy Guide (CPG) to provide guidance for FDA staff on the enforcement policy regarding major food allergen labeling and cross-contact. The guide reflects FDA’s thinking on major food allergen enforcement policy based on the current regulatory framework and latest science. When finalized, it will replace the existing CPG 555.250 for FDA staff.

Among the updates, the draft CPG describes the labeling requirements for major food allergens and proper use of the ingredient list and the “Contains” statement for major food allergen declarations. It also describes requirements for firms to implement controls to prevent or significantly minimize allergen cross-contact. In addition, the draft CPG describes additional allergen labeling violations and directs FDA staff to examine potential product adulteration due to allergen cross-contact as well as potential labeling violations.

The agency stated that it is aware that some manufacturers are intentionally adding sesame to products that previously did not contain sesame and are labeling the products to indicate its presence. While the draft CPG does not specifically address this issue, the FDA said that it recognizes that this practice may make it more difficult for sesame-allergic consumers to find foods that are safe for them to consume—an outcome that the FDA does not support, and that the agency is engaging with stakeholders on this issue. The draft CPG does address the FDA’s enforcement policy for labeling and cross-contact controls for major food allergens, including sesame.

Stakeholders can submit electronic or written comments within 60 days of publication in the Federal Register.

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FDA Warns Industry on Food Safety Risks of Transferring Genes for Proteins that are Food Allergens

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The FDA has issued a letter to developers and manufacturers of new plant varieties who intend to transfer genes for proteins that are food allergens (including allergens from foods identified as major food allergens) into new plant varieties used for food. The purpose of the letter is to remind them of the relevant legal requirements for these products, which may include adding a gene for an allergenic animal protein to a new plant variety to provide a non-animal source of the protein for use as an ingredient in another food.

While the agency noted that it is not aware of any foods currently in the U.S. market derived from these types of new plant varieties, it is aware of research and development in this area.

The FDA is asking developers to consider the food safety risks posed by such allergens and plan early in development to manage those risks, including the potential for recalls due to undeclared allergens.

“We are specifically reminding those developers who are now exploring development of these types of plant varieties of their responsibility for food safety. In particular, we are reminding them to consider the allergenicity issues related to their products, and how they would be stewarded from production to manufacturing to consumption so that they do not inadvertently or unexpectedly enter the food supply,” the FDA stated. “We are also reminding them that they need to be properly labeled when intentionally part of the food supply.”

To reduce risk to consumers as well as the risk of recalls, the FDA is encouraging developers of new plant varieties to consult with the agency through its voluntary premarket consultation program for foods from new plant varieties prior to marketing.