FDA, USDA and EPA announce joint platform to streamline information about agricultural biotechnology products

Hi,Welcome to FWQRC Regulatory Focus News Letter…

Today, in recognition of January 2020 as National Biotechnology Month, the U.S. Food and Drug Administration, the Department of Agriculture and the Environmental Protection Agency launched a Unified Website for Biotechnology Regulation. The website streamlines information about the three regulatory agencies charged with overseeing agriculture biotechnology products and is part of President Donald J. Trump’s Executive Order on Modernizing the Regulatory Framework for Agricultural Biotechnology Products.

“This is a time of unprecedented scientific innovation. Agricultural biotechnology promises to bring dynamic new products to the marketplace,” said FDA Commissioner Stephen Hahn, M.D. “At the FDA, we are committed to fostering flexible, risk-based approaches in this field while upholding our mission of protecting and promoting both human and animal health and animal well-being, for example by reducing their susceptibility to diseases like novel influenzas and resistance to zoonotic or foreign animal diseases. Our approach balances our internationally respected, science-based review standards with our ongoing risk-based regulatory approaches to ensure the safety of our food supply.”

The Unified Website for Biotechnology Regulation describes the federal review process for certain biotechnology products and allows users to submit questions to the three agencies. The goals of this website are to provide enhanced customer service to innovators and developers, while ensuring Americans continue to enjoy the safest and most affordable food supply in the world and can learn more about the safe use of biotechnology innovations.

In October 2018, the FDA announced its Plant and Animal Biotechnology Innovation Action Plan, which focuses on the agency’s risk-based regulatory approach. This approach will help secure confidence in the reliability and performance of plant and animal-based innovative products for consumers and America’s global trading partners. Making sure these products are safe is critical to maintaining consumer and commercial confidence in them and will help them to realize their full potential benefits for human and animal health.

The FDA uses a flexible, risk-based approach to the oversight of plant- and animal- derived products of biotechnology, focusing on safety and, where applicable, effectiveness. The agency’s approach includes, when appropriate, updating and clarifying science-based policies to support innovation and ensure that our regulatory processes are efficient, predictable, and proportionate to risk.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Investigation of Listeria monocytogenes

Welcome to FWQRC Regulatory focus news LetterHere we are going to review on the Outbreak Investigation of Listeria monocytogenes Linked to Hard-Boiled Eggs, December 2019FDA, CDC, and state and local partners are currently investigating a multistate outbreak of Listeria monocytogenes infections linked to foods that contain hard-boiled eggs. On December 20, 2019, Almark Foods recalled and suspended production of hard-boiled and peeled eggs in pails due to the potential for contamination with Listeria monocytogenes. These hard-boiledand peeled eggs were sold in pails under the following names: Rainbow Select Hard-cooked Eggs, Rainbow Select Hard-cooked Eggs in Vinegar, Nic’s Salad Hard-boiled Eggs, Almark Hard-cooked Eggs, and Sutherland Select Hard-cooked Eggs. A full list of recalled products is included below.RecommendationFood processors, restaurants, and retailers should not sell or serve any of the recalled hard-boiled and peeled eggs in pails from Almark Foods. These products were not sold directly to consumers.Additionally, FDA recommends that food processors, restaurants and retailers who have received Almark Foods bulk, fresh hard-boiled eggs, use extra vigilance in cleaning and sanitizing any surfaces that may have come in contact with these products, to reduce the risk of cross-contamination.Background:As of December 17, 2019, a total of seven people infected with the outbreak strain of Listeria monocytogenes have been reported from five states. In interviews, ill people answered questions about the foods they ate and other exposures in the month before they became ill. Of the five people for whom information was available, four reported eating products containing eggs. Three of these people reported eating hard-boiled eggs in deli salads purchased from grocery stores and in salads eaten at restaurants. Illnesses started on dates ranging from April 10, 2017 to November 12, 2019.Additionally, based on whole-genome sequencing, the Listeria monocytogenes found in environmental samples collected at the firm’s processing facility during an FDA inspection conducted in February 2019 is a genetic match to the outbreak strain. FDA is conducting additional inspections and sampling. Almark Foods has been cooperating with the ongoing investigation and announced a voluntary recall of hard-boiled and peeled eggs in pails on December 20, 2019.This outbreak strain was found during environmental sampling in 2017 of one other food facility. That facility is not currently handling food and ceased operation in 2018.Thank you for viewing FWQRC blogs….

5 Tips to Consider When Preparing Recommendations for Changes to Retail Food Policy

Hi, Welcome to FWQRC Regulatory Focus News letter

Developing recommended changes for the most effective, efficient, and feasible policy is challenging. Through our work in retail food policy analysis, we have identified five things individuals can consider to prepare retail food policy recommendations.

1. Define the problem that needs to be addressed

• Describe and provide evidence for the existence, size, and severity of the problem.
• Public policy making is about problem solving. If no problem exists, there is no need to offer a policy solution. Establishing policy to fix a nonexistent problem may unduly burden stakeholders.

2. Describe the cause of the problem

• Provide the reasoning and evidence to support a link between the problem and cause.
• Problem solving requires identifying, understanding, and explaining the underlying cause(s) of the problem. Providing information about the source of the problem will help to choose the best solution. Anticipate that your reasoning and evidence may be challenged.

3. Explain why the current policy is not addressing the problem

• Explain what barriers or challenges exist that make the current policy insufficient.
• The existing policy may not be sufficient to solve the problem. There may be formal challenges such as existing laws, and informal challenges such as differing perceptions or lack of awareness or training that you should consider and explain.

4. Present your policy recommendation and explain how it compares to possible alternatives

• Provide information on alternative solutions considered and explain how and why your policy recommendation is preferable.
• Policy recommendations should offer a solution to the problem that was identified.
• Sometimes policy isn’t the best solution to a problem. Gaps in knowledge, resources, and enforcement of current policy can impact effectiveness. Before proposing a new policy or changes to policy, alternatives should be considered. This should include a description of the criteria you used for the comparison.

5. Characterize the impact of your proposed policy recommendation

• Describe the intended and/or unintended consequences, positive and negative, that may result from implementing the proposed policy recommendation
• Do the positive consequences outweigh the negative consequences? Describe why the proposal is a more effective, efficient, and feasible solution.
• Anticipate stakeholder questions and concerns
• Be prepared to address questions and concerns regarding areas of potential disagreement.

Questions may come in the form of:

A fact – what is and what isn’t or what happened or didn’t happen

A value – what is appropriate and inappropriate

Or a policy – what we should do or what the policy should be