Safe + Sound Week

According to the Occupational Safety and Health Administration (OSHA), thousands of workers become sick from occupational heat exposure each year—and some of these cases turn fatal. Hazardous heat exposure can occur indoors or outdoors, during any season, and to anyone. This is why it is important that all employers take steps to reduce heat exposure and protect employee health and safety.

Heat-Related Illnesses and Injuries

Exposure to extreme heat (i.e., heat stress) can result in occupational illnesses and injuries, including heat stroke, heat exhaustion, heat cramps, or heat rashes. Heat can also increase the risk of ancillary injuries due to sweaty palms, fogged-up safety glasses, dizziness, and even deterioration of fine motor performance. Burns may also occur from accidental contact with hot surfaces or steam.

Heat stroke is the most serious heat-related disorder and should be considered a medical emergency. It occurs when the body becomes unable to control its own temperature. Workers suffering from heat stroke may experience dizziness or unconsciousness, disorientation, slurred speech, chills, and headache. If you or another employee are suffering from heat stroke, exhaustion, or fainting, alert a supervisor immediately and call 911.

Risk Factors

Workers who are exposed to extreme heat or work in hot environments may be at greater risk of heat stress. This includes both outdoor workers and workers in hot environments (e.g., firefighters, cooks/chefs, bakery workers, farmers, construction workers, miners, boiler room workers, factory workers, and others). Occupational risk factors for heat illness include heavy physical activity, lack of acclimatization, and wearing clothing that holds in body heat. In addition, individuals who may be particularly susceptible to heat-related illness include those who are 65 years of age or older, are overweight, have heart disease or high blood pressure, or take medications that may be affected by extreme heat.

Planning and Prevention

Heat-related illness is often preventable, especially with management commitment to providing the most effective controls. An effective heat-related illness prevention program should be developed and incorporated into every company’s broader safety and health program. Important elements to consider when creating the heat plan include the following:

• Who will provide oversight and heat monitoring throughout the workday as conditions change?
• How will new and/or temporary workers gradually develop heat tolerance (i.e., acclimatization)?
• How will the employer ensure first aid is adequate?
• What is the protocol for summoning medical assistance?
• What engineering controls and administrative work practices will be used to reduce heat stress?
• How will heat stress be measured?
• How will the company respond when the National Weather Service issues a heat advisory or heat warning?
• What training will be provided to workers and supervisors?

Controls

Workplace heat stress can be reduced using several methods. Engineering controls involve changing the design of the workplace in ways that reduce exposure to heat. This might include increasing air velocity; using reflective or heat-absorbing barriers; or reducing steam leaks, wet floors, and humidity. Administrative (workplace) practices involve changes to tasks, schedules, and behaviors to reduce heat stress. These may include:

• Limiting time in the heat and/or increasing recovery time spent in a cool area.
• Increasing the number of workers per task.
• Requiring workers to conduct self-monitoring.
• Creating work groups (i.e., workers, a qualified healthcare provider, and a safety manager) to make decisions on self-monitoring options and standard operating procedures.
• Providing adequate amounts of cool, potable water near the work area and encouraging workers to drink often.
• Using a heat alert program whenever the weather service forecasts a heat wave.

Acclimatization— the process of building heat tolerance—is a particularly important control. 50% to 70% of outdoor fatalities occur in the first few days of working in warm or hot environments because the body needs to build a tolerance to the heat gradually over time. Employers should ensure that new workers, temporary workers, and workers who have been on vacation are acclimatized before they work in a hot environment by gradually increasing workers’ time in hot conditions over 7 to 14 days.

Finally, employers should provide training to workers so they understand what heat stress is, how it affects their health and safety, and how it can be prevented. Training should include:

• Signs and symptoms of heat-related illnesses and administra­tion of first aid.
• Causes of heat-related illnesses and steps to reduce the risk.
• Proper care and use of heat-protective clothing and equipment and the added heat load caused by exertion, clothing, and per­sonal protective equipment.
• Effects of other factors (drugs, alcohol, obesity, etc.) on tolerance to occupational heat stress.
• Acclimatization process.
• Reporting symptoms or signs of heat-related illness.
• Procedures for responding to symptoms of possible heat-related illness and for contacting emergency medical ser­vices.

Personal Accountability

To avoid becoming a victim of heat stress of any type, wear light-colored, breathable clothing, such as cotton. Gradually build up to more strenuous work. Schedule more breaks on days with extreme heat and humidity. Drink water! Lots of water! Avoid soda, energy drinks, alcohol, or any other drinks that have high amounts of caffeine and sugar in them. And ALWAYS monitor yourself and others who are at risk for heat stress in hot and /or humid conditions.

More resources:

• https://www.cdc.gov/niosh/topics/heatstress/default.html
• https://www.osha.gov/heat-exposure

Safe + Sound Week

In the post-COVID world, working remotely and alone has become much more common. In many industries, particular attention needs to be paid to these lone workers to ensure appropriate practices and procedures are in place to keep them safe.

What Is a Lone Worker?

Lone workers are people who perform their jobs alone—without someone else present and without any supervision. Lone workers cannot be heard or seen by another individual while working. They may work in more remote locations with limited emergency response or perform jobs during nonstandard work hours. Lone workers may also work in the same building or area as others but out of viewing or hearing distance.

Workplace Safety Hazards

A workplace safety hazard is anything that could potentially cause harm or damage to people, property, or equipment. The most common safety hazard for all workers, including lone workers, is slips, trips and falls. Another common safety hazard that lone workers face is from machinery and equipment, which can injure or trap the worker. 

To avoid workplace safety hazards, there are certain conditions where lone work is not recommended and/or prohibited, including the following conditions:

• From height
• With electricity or in confined spaces
• During severe weather conditions
• Around avalanche risks
• Near chemical exposure that could incapacitate a worker
• When respirators or air monitoring is required
• Using hazardous equipment (e.g., chainsaws, firearms)
• Where the potential for violence is present

Planning and Preparation

The Occupational Safety and Health Administration (OSHA) does not have a standard for employees working alone; however, there are several standards that apply to specific lone-work situations (e.g., emergency response, interior structural firefighting). OSHA further recommends that employers develop emergency procedures and provide “a wireless electronic notification device and/or cellphone to those employees.”

As best practice, any company with lone workers should develop and implement a lone worker safety program with specific practices and procedures to minimize the risk of injury. This includes the following:

1. Identify, assess, and mitigate work hazards. It is important to identify safety hazards in any work environment but particularly for lone workers who must navigate hazardous situations alone. Each hazard’s level of risk must be assessed. Once this assessment is complete, strategies can then be implemented to remove existing dangers to the extent possible, prioritizing the highest risk hazards. Hazard mitigation should consider physical modifications, safety education and training, and communication to help ensure workplace injuries and incidents occur less frequently.
2. Create a lone worker policy. This policy should establish the organization’s rules and practices for working alone. Generally, a lone worker safety policy should include:
   • Contact information and location of all lone workers
   • General safety guidance
   • Roles and responsibilities
   • Safety procedures and processes, including predetermined safety check-ins and stop-work guidance
   • Methods of communication and available backups (e.g., cell phone, GPS devices, and mobile apps)
   • Emergency procedures and contacts
   • Lone worker training and continuous education
3. Monitor lone workers. Lone workers must be monitored, whether through regular manual check-ins or automated monitoring systems. Both allow the employer to confirm the worker’s safety and well-being. If a worker misses a check-in, an automated system can immediately request help and employ tools such as GPS location tracking to provide necessary assistance. 

Don’t forget about your lone workers. They play an important role and special provisions need to be taken to ensure they are monitored and protected.

Safe + Sound Week

When it comes to the characteristics of an excellent safety culture, communication is at the top. It is vital that all levels of management (senior, middle, supervisory) communicate their commitment to safety clearly to workers. It is equally important that workers feel empowered to discuss their safety concerns.

Having a safety culture where workers do not feel like they can speak up at work when it comes to their safety can present significant threats to workers and the overall well-being of the company. A high percentage of workplace injuries occur when a worker witnesses unsafe behaviors or conditions but chooses not to say anything. Those injuries are 100% preventable. However, it requires creating a culture of transparency and openness that encourages staff to look out for each other and speak up when concerns arise—and a culture where team members are not afraid of voicing their safety concerns, no matter how big or how small they may be.

How to Effectively Speak Safety

Workers may be reluctant to accept safety advice for many reasons:

• They don’t like being told what to do.
• They don’t believe they are in danger.
• They perceive safety conversations/assistance as punishment or aggression.

The challenge is to have productive conversations about safety despite these barriers, considering not only what you say but how you say it. For many, this does not necessarily come naturally, which is why effective safety conversations should be taught and practiced.

These tips can help make speaking about safety easier:

• Take a persuasive approach versus a punitive one. Safety conversations shouldn’t be about catching someone doing something wrong. The goal should be safety, not punishment.
• Demonstrate care and concern. It is much more meaningful to show concern for the personal safety of individuals than to reinforce compliance with rules.
• Speak the worker’s language. Think about who you are speaking to and what is important to them. Delivering a safety message to senior management will differ than communicating with field staff.
• Focus on specifics. Avoid expressing judgment or disapproval. When addressing a specific safety behavior or situation, limit comments to that rather than making general statements.
• Listen. Good communication goes both ways. A respectful conversation will involve both expressing yourself and listening to the other person.
• Don’t be intimidated. The fear of a negative reaction is common, particularly when a less experienced person must deliver advice to someone more senior. Remember, no one is immune to safety concerns.
• Lead by example and encourage others to do the same. It is one thing to say that safety is a priority; it is another thing to show that it is.

Sometimes, relying on those around us to help notice and communicate when something isn’t right can provide the best form of safety protection—because no one is immune to safety concerns, safety errors, distraction, or complacency. Improving an organization’s overall safety culture and the atmosphere around safety conversations can make it easier to both give and receive advice in a constructive way and, best-case scenario, save lives.

Functionality: What does it do?

Depending on the breadth and location(s) of a company’s operations, managing permits and their associated requirements and due dates without a centralized system in place can present significant challenges: How many permits does your operating system have–and what are the associated requirements? Who is responsible? Are there key/critical dates? How do you manage all that information and verify compliance? KTL’s permit tracking tool provides a central repository to track, manage, and communicate permit activity tracking. 

Benefits: Why do you need it?

A web-based permit tracking system can help:

• Catalog and track permits and associated requirements and timeframes in one database.
• Manage change information.
• Store critical documents for easy access and effective record control.
• Send and receive notifications of permits about to expire.
• Coordinate and communicate with project contractors.
• Establish accountability and a standardized approach for reporting, monitoring, and performance measurement.
• Improve permit compliance assurance reliability, efficiency, and consistency.

Technology Used

• Microsoft Power Automate: send/receive notifications
• Canvas PowerApp: catalog permits, trigger notifications, create user interface
• SharePoint Lists: tracking changes, store data
• SharePoint Document Library: store attachments, permits, contracts, etc.

The threat of terrorism against our food supply is as real today as it ever has been. Whether it’s an attack on the products themselves, such as product tampering or sabotage, or a cyberattack against a company’s internet infrastructure, it can be harmful and costly if not recognized in advance. Plans should be in place to not only respond to such an attack but also to prevent it. ~ Rod Wheeler, NSF.org

National Security Memorandum

On November 10, 2022, President Joe Biden signed National Security Memorandum-16 (NSM-16) to strengthen the security and resilience of U.S. food and agriculture. This critical sector has continued to face increasing deliberate and naturally occurring threats to security and resilience, including intentional adulteration (IA), catastrophic events (e.g., pandemics that impact critical infrastructure), consequences of climate change, and cyber- and technology-related vulnerabilities.

NSM-16 replaces Homeland Security Presidential Directive 9 (Defense of United States Agriculture and Food – HSPD-9) and outlines the Administration’s guidance to:

1. Identify and assess the threats of greatest consequence. This includes redefining how chemical, biological, radiological, and nuclear threats are defined; focusing on increased cyber threats and climate change impacts; and enhancing threat and risk assessments by mandating a continuous process to assess and mitigate risks and vulnerabilities.
2. Strengthen partnerships to enhance the resilience of the workforce, who are typically the first line of response, and coordinate our government to act more efficiently and effectively. Essential critical infrastructure workers need guidance to work safely, while supporting operations during high-consequence incidents.
3. Enhance preparedness and response by training partners on how to prepare for and respond to threats, increasing testing and diagnostic surge capacity, and standardizing diagnostic and reporting tools to facilitate timely information sharing.

Ongoing Security Actions

NSM-16 builds upon ongoing actions by the Administration to strengthen the resilience of the U.S. food and agriculture supply chains.

• U.S. Department of Agriculture (USDA) considers defense of the food and agriculture sector critical. USDA’s Food Safety and Inspection Service (FSIS), Animal and Plant Health Inspection Service (APHIS), and National Institute of Food and Agriculture (NIFA) have launched numerous programs to protect these sectors, including FSIS working to help industry partners develop effective food defense plans.
• U.S. Department of Homeland Security (DHS) Office of Health Security Health, Food, and Agriculture Resilience (OHS/HFAR) directorate is also working to help safeguard the American food supply against catastrophic incidents by bringing a national security perspective to the food and agriculture sector.  In recent years, OHS/HFAR has engaged directly with partners to perform risk assessments, develop strategic guidance, and design and deliver tailored exercises to better prepare for, respond to, and recover from catastrophic events.
• U.S. Food and Drug Administration (FDA) is engaging with federal; state, local, tribal, and territorial (SLTT) governments; the private sector; and academia on the following activities:
  • Conduct of vulnerability assessments
  • Risk mitigation analysis
  • Federal risk mitigation strategy
  • Strengthening existing efforts for information sharing procedures
  • Research and development

Roles of Food Safety and Food Defense

According to USDA-FSIS, to prevent, protect against, mitigate, respond to, and recover from threats and hazards of greatest risk to the food supply, preparedness efforts must encompass food safety and food defense.

Food safety provides for the protection of food products from unintentional contamination. Food defense involves the protection of food products from intentional contamination or adulteration (e.g., biological, chemical, physical, or radiological) that causes harm to public health or disrupts the economy in other ways.

The anticipated outcome of combined food safety and food defense efforts is food security. Food security exists when all people, at all times, have physical, social and economic access to sufficient, safe and nutritious food which meets their dietary needs and food preferences for an active and healthy life (United Nations Food and Agriculture Organization (FAO)).

Your Role: Food Defense Plan

Food defense involves putting security measures in place to reduce the chances of someone intentionally contaminating the food supply. FDA’s Food Safety Modernization Act (FSMA) rule on Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) establishes requirements for industry to play an active role in improving the nation’s food security and resilience. This rule requires covered facilities to prepare and implement food defense plans.

The food defense plan incorporates four major elements:

• The vulnerability assessment identifies those areas in the process that pose the greatest IA risks. Each step in the facility’s process should be evaluated for the following:
  • Potential severity and scale of the impact on the public.
  • Physical access to the product.
  • Ability to successfully alter/contaminate the product.
• Facilities must develop and implement mitigation/preventive strategies at each step in the process to address vulnerabilities and minimize the risks of IA.
• A system must be put in place to ensure implementation of mitigation strategies and to effectively manage the following:
  • Monitoring mitigation strategies, including frequency.
  • Corrective action response.
  • Verification activities.
• Appropriate recordkeeping must be maintained for food defense monitoring, corrective actions, and verification, and key personnel must receive appropriate training.

The safety and security of our country’s food products requires developing, implementing, and enforcing policies and programs to support strong food defense. And it requires continually involving all employees in these food defense and security efforts to create a robust food safety culture. The threats to our nation’s food supply—and to those companies who work in the food supply chain—will continue. Taking an active role in controlling what you can and proactively managing your organization’s food defense efforts can play a significant role in securing the food supply chain.

According to the Occupational Safety and Health Administration (OSHA), successful safety and health programs can proactively identify and manage workplace hazards before they cause injury or illness, improving sustainability and the bottom line. An organization’s safety culture is ultimately reflected in the way that safety is managed in the workplace, and having a strong safety and health program can help create:

• Fewer accidents, losses, and disruptions by preventing workplace injuries and illnesses.
• Engaged employees and improved morale.
• Increased productivity and enhanced overall business operations.
• Lower workers’ compensation and insurance claims.
• Improved compliance with OSHA regulations.
• Improved reputation to attract new customers and employees and retain existing ones.
• Better brand and shareholder value that tie to social responsibility.

H&S Observations

The National Safety Council (NSC) cites that more than 4,400 preventable workplace deaths and 4.26 million injuries occurred in 2021. Raising public awareness about workplace safety can significantly decrease the number of preventable injuries and deaths. Every June, NSC observes National Safety Month to do just this by encouraging employers and individuals alike to be safety role models.

Much like NSC, OSHA created Safe + Sound Week (August 7-13, 2023) as a year-round campaign to encourage America’s workplaces to commit to workplace safety and health by starting a health and safety program, energizing an existing one, or recognizing health and safety successes.

Taking the Pledge

This year, both NSC and OSHA are encouraging companies to reaffirm their commitments to safety and health by taking a pledge:

Safe + Sound pledge: I pledge to make safety a core workplace value. Everyone has the right to a safe and healthy workplace, and I will work to ensure everyone goes home safe and sound every day. My workplace will be taking action to improve our safety and health program during Safe + Sound Week 2023.

NSC SafeAtWork pledge: I commit to:

• Actively help my employer improve our safety programs.  
• Report hazards promptly and suggest solutions.  
• Be a good safety role model for my friends and family, even off the job.  

Core Elements of Workplace Health and Safety

OSHA reiterates that the core elements of a workplace health and safety program include the following elements:

• Management leadership. Management must provide the leadership, vision, and resources needed to implement an effective safety and health program.
• Worker participation. Engaging workers at all levels in establishing, implementing, evaluating, and improving safety and health in the workplace creates buy-in.
• Systematic approach to finding and fixing hazards. Finding and fixing hazards in the workplace is an ongoing process to better identify and control sources of potential injuries or illnesses.

KTL’s Series on Investing in Safety

Throughout OSHA’s Safe + Sound Week (August 7-13, 2023), KTL will be featuring a series of articles and posts on our blog and social media (i.e., Facebook, LinkedIn, Twitter) reinforcing these concepts from OSHA and NSC and discussing why businesses should invest in safety. Topics will include the following:

• Speaking safety
• Lone worker safety
• Heat stress
• Safety Management Systems (SMS)
• Root cause analysis

Watch for these articles! For more information on what your organization can do to participate and promote a strong safety culture, visit the websites for OSHA Safe + Sound Week and NSC National Safety Month.

According to the World Health Organization (WHO), foodborne diseases affect 1 in 10 people worldwide each year. Safe food is a key contributor to reducing these foodborne illnesses and other poor health conditions, including impaired development, micronutrient deficiencies, noncommunicable and communicable diseases, and mental illnesses. Only when food is safe can we fully benefit from its nutritional value.

FAO Strategic Priorities for Food Safety

In March 2023, the Food and Agriculture Organization of the United Nations (FAO) published its Strategic Priorities for Food Safety 2022-2031 to “support members in continuing to improve food safety at all levels by providing scientific advice and strengthening their food safety capacities for efficient, inclusive, resilient and sustainable agrifood systems.”  

The Strategic Priorities document is structured around four strategic outcomes:

• Governance (intergovernmental and intersectoral) is coordinated and reinforced at all levels.
• Scientific advice and evidence provide the foundation for decisions made about food safety.
• National food control systems are continually strengthened and improved by supporting members in:
  • Evaluating food control systems, identifying needs, and designing programs.
  • Developing and transitioning economy countries to participate in Codex Alimentarius work.
  • Developing and updating food safety standards, legal frameworks, government policies, and operational procedures and guidelines.
  • Generating relevant food safety data to reflect the national situation.
  • Implementing technology developments in food control and food safety management.
• Public-private partnerships along the food chain are being fostered to ensure food safety management and controls.

World Food Safety Day

On June 7, countries around the globe celebrated World Food Safety Day, focusing this year on “Food Standards Save Lives” as the theme. Established by the United Nations General Assembly in 2018, World Food Safety Day is an annual observation intended to mobilize action to prevent, detect, and manage foodborne risks and improve human health. The WHO and the FAO jointly facilitate the observance of World Food Safety Day.

This year’s theme coincides with the 60th anniversary of Codex Alimentarius, a collection of food standards, guidelines, and codes of practice that encourage governments and food safety advocates around the world to focus on the importance of applying safety standards.

Along with WHO and FAO, the U.S. Food and Drug Administration (FDA) is calling on everyone to join in the efforts to ensure safe food for all. Check out FDA’s information on ways to reduce foodborne illnesses and the Guide to World Food Safety Day 2023 for ideas on how you can participate in World Food Safety Day every day.

KTL is pleased to introduce our newest team members:

Estefania Lopez, Consultant, is an FSQA professional with nearly 10 years of experience working in the food industry. She is an SQF Practitioner and PCQI with specialized expertise in managing supplier and manufacturer compliance with state and federal food safety regulations, certification standards, supplier requirements, and internal programs. In addition, Estefania has significant laboratory experience conducting nutrient, chemical, environmental, and sensory testing. She is based in California.

Victoria Gutierrez, Consultant, is an FSQA professional with experience working across many areas of the food and beverage industry, including supply chain, distribution, and retail. She has working knowledge of FDA and USDA food safety regulations and GFSI certification standards. Victoria has experience developing and implementing digital platforms and IT systems to help manage food safety programs. She excels at finding IT solutions to improve data management and create operational efficiencies. She is based in Iowa.

Kyle Weiher, Consultant, is a Power Platform Developer with experience developing and implementing digital platforms and IT solutions to help clients manage business processes and improve performance, reliability, and compliance. Kyle is expert in various IT systems (e.g., Microsoft® SharePoint, Power Apps, Power Automate, Dataverse) and has been involved in the design, development, and implementation process of building out Power Platform solutions. He is based in Wisconsin.

Functionality: What does it do?

Certification standards are designed to ensure an organization’s customers, suppliers, and stakeholders that its products/services meet best practices. Each of these standards (e.g., ISO, GFSI, industry-specific) has a set of requirements that must be met to achieve certification. An electronic standards register organizes all of an organization’s standards requirements into an online tool, allowing for better management, tracking, and overall compliance.

Benefits: Why do you need it?

An electronic standards register:

• Assists with compliance demonstration and document control by allowing mapping of documents to specific certification standard requirements.
• Facilitates activities during remote or onsite audits.
• Ensures standard version support during future updates.
• Identifies common requirements and allows documentation to be linked between standards, as needed.
• Allows the internal audit team to complete and keep notes for the internal audit.

Technology Used

SharePoint

The National Bioengineered Food Disclosure Standard defines bioengineered foods (a/k/a genetically modified organisms (GMOs)) as “foods that contain detectable genetic material that has been modified through certain laboratory techniques and for which the modification could not be obtained through conventional breeding or found in nature.”

Genetic engineering allows scientists to take a beneficial gene (e.g., insect resistance or drought tolerance) and transfer it to a plant. Genetic modifications can create many desirable results, including higher crop yields, less crop loss, longer storage life, better appearance, enhanced nutritional value, or some combination thereof.

Genetic engineering can also be used to create a plant-based protein. The Food and Drug Administration (FDA) is aware that some developers are now exploring transferring genes for proteins that are known food allergens (including the “Big 9”) into new plant varieties for foods. Managing this introduction of food allergens into bioengineered food is a significant concern.

Regulatory Framework

The FDA, Environmental Protection Agency (EPA), and U.S. Department of Agriculture (USDA) work together to ensure bioengineered foods are as safe and healthful for humans, plants, and animals—or even more so—as their non-GMO counterparts.

• FDA ensures those who produce, process, store, ship, or sell bioengineered foods or foods with bioengineered ingredients meet the same food safety standards as all other foods. FDA’s voluntary Plant Biotechnology Consultation Program allows developers to work with FDA on a product-by-product basis to evaluate the safety of bioengineered foods before they enter the market. 
• EPA regulates the safety of the substances that protect bioengineered plants to make them resistant to insects and disease and monitors all types of pesticides used on crops.
• USDA Animal and Plant Health Inspection Service (APHIS) establishes regulations to ensure bioengineered plants do not harm other plants.

Warning Letter

In April 2023, FDA issued a letter to developers and manufacturers who intend to transfer genes for proteins that are known food allergens into new plant varieties for foods. The letter serves as an important reminder that developers of these new plant varieties are obligated to make sure the products they market are safe for consumers and implement all measures needed to comply with the Food, Drug, and Cosmetic (FD&C) Act.

If not appropriately managed, the development of these plants could result in the presence of an unexpected allergen in the bioengineered food product. And if an unexpected allergen enters the food supply, there is real risk of a severe or even life-threatening allergic reaction and, subsequently, needing to recall affected products.

Early Actions

The FDA implores, “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 is asking developers to consider the food safety risks posed by such allergens and to plan early in development to manage those risks. Developers who intend to create these plant varieties using proteins that are food allergens need to:

• Take advantage of the Plant Biotechnology Consultation Program early in the development process to ensure new varieties meet FD&C Act requirements and consumers are protected.
• Develop a robust risk management plan that includes significantly stronger mitigation strategies and practices (e.g., crop segregation) to provide assurance that foods containing the transferred allergen are not mixed with other foods.
• Consider whether the entire supply chain can maintain appropriate conditions to prevent allergens from inadvertently entering the food supply.
• Properly label bioengineered foods by declaring the presence of an allergen on the food label.