Category Archives: Regulations

Industry Experience on Regulation

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I sent a questionnaire to a dozen or so leading entomophagy companies in North America (the questions are listed in this post).

The responses received were overall positive. Not all parties responded and some responses were limited due to the confidential nature of the topic.

Key take a ways:

  • Regulators, including state and local agencies, are aware that the companies are producing insect containing food products.
  • Producers are demonstrating that the insects used are wholesome and that the food is being produced using Good Manufacturing Practices (GMPs).
  • Food safety information in the form of a GRAS dossier has not been required by regulators.
  • Allergen risk is being communicated.
  • Consumers are informed that their products contain insects.
  • No one is aware of efforts to limit used of insects as food.

What Is Really Happening With Edible Insect Regulation?

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Regulations have been a gray area for insect businesses and investors so it’s an issue that needs to be understood.

I’ve broken it down to two possible scenarios.

One is that companies have not being pressed by regulators about edible insects. Entomophagy is not a risk and is not considered a regulatory concern that is different than any other agricultural product or prepared food.

Second is that companies are managing regulation internally. If they are questioned by regulators, they are addressing them directly. Regulation may be an issue that companies are actively addressing but are not openly sharing.

I have not seen much activity on websites or in the press about regulation except that it is a potential issue. The IFT Annual Meeting has a technical session on edible insects and one of the speakers segment is called ‘Regulatory Issues, Concerns, and Status of Insect Based Foods and Ingredients’. (I’ll be there!)

Regulation is an issue but what’s really happening? My thoughts here.

I put together a questionnaire to help find out the current state of regulatory affairs with edible insects.

Please send me comments on the following questions or leave comments on the blog. It would be very helpful to the industry.

I have also sent the questionnaire to a few of the leading groups for entomophagy in North America. Once I get some feedback Ill post a regulatory snap shot.

  • Do you own, rent, or outsource (contract manufacture) the facility where you make your product?
  • If you use outside manufacturing or a commercial kitchen how did you convince them to allow you to process insect foods or were they open to it?
  • Do you deal directly with any local, state or federal regulatory agencies? Which ones?
  • How do regulatory agencies feel about you using insects as food? Do they know about it?
  • Are you aware of any directed efforts to limit or disallow the use of insects in foods? Could be from regulatory bodies, lobbyist or other activists.
  • How do you demonstrate that the insects you are using are safe for human consumption? Have you been asked by any regulators?
  • Have you ever been audited by a third party organization?
  • Do you take any special precautions on the packaging to inform consumers that the products contain insects?
  • How much extra resources are required because you are producing insect containing foods compared to other foods in the same category.
  • Is there a threshold for flavor/taste that determines how much you can add? Insect type, preparation and application.
  • It’s important to understand how entomophagy could affect the population at large (this how the FDA looks at potential issues). What are your sales volumes and estimated growth?

Regulatory Update

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Federal, state and local regulations

State and local regulations vary by state. As you are using insects as food, follow all of the regulations that govern food production. An overview can be found on the FDA website.

USDA or FDA

On a Federal level, insects used as food fall under FDA oversight. The USDA’s Food and Safety Inspection Service (FSIS) regulates meat, poultry and eggs. Everything else defaults to FDA regulation. FDA regulates sea food (which is most similar to insects …think shrimp and soft shell crab) and even covers game such as venison.

The USDA may be involved in insect farming through their Animal and Plant Health Inspection Service (APHIS) agency. For example, if you want to import a new species that is not currently in the US, you would need to contact APHIS.legeal scales from Avery

No regulations address insects consumed as food in USA

Insects aren’t mention in regulations except in the Food Defect Action Levels. Insects are an unavoidable defect is some agricultural products such as tomatoes. Limits are set as to how much is allowed. However, this context does not apply when insects are purposefully added as a food ingredient.

My recommendation is to use the FDA-Seafood guidance documents for insects to ensure that wholesome food is being produced. The FDA has specific regulations for seafood because they are relatively high risk food products. Lobster, crab and shrimp are regulated by FDA-Seafood.

Grasshoppers are the shrimp of the land.

FDA Seafood Guidance documents link – FDA Seafood

Food safety hazards for insects

As for any food ingredient or product, potential hazards must be evaluated and monitored. The standard process is to use HACCP (Hazard Analysis & Critical Control Points)

Some potential hazards for edible insects:

  • Choking Hazard: Arthropods can have long legs that can potentially be a choking hazard. A lot of common foods are choking hazards like hot dogs and popcorn so don’t blow this out of proportion. Bay leaves are a hazard because then can cause splintering and cuts when consumed whole/crushed. Ensure that the particle size is sufficiently small in cricket flour. For whole crickets and grasshoppers, evaluate your supply to on the rigidity and hardness of the exoskeleton. Young cricket exoskeleton is still soft. Most dried crickets fracture and crumble easily and don’t pose a risk. image_1 (2)
  • Pathogens: Microbiological food safety will be something your company will need to address as you go from start up to and sustainable food business. Its common practice for established food companies to monitor and control yeast, bacteria and fungi. Startups can accept a lot more risk in this area. Companies that purchase cricket flour can leverage their supplier for microbiological information. A baseline measurement is Arobic Plate Count (APC) which indicates the total amount of bacteria present. The logic is that if there are a lot of total bacteria, it is more likely that there will be bad bacteria. For raw crickets, a producer can measure for the presence of pathogens as part of their quality control program. As pathogen testing requires resources, an alternative is to recommend safe handling procedures for raw insects. This is the practice for raw red meat and poultry. More info at Micro Standards Link.
  • Environmental Hazards: These are best controlled for via farming. Good feed in will result in good food out. Post-harvest analysis for wild caught can be performed by outside labs such as Certified Laboratories who specialized in doing safety analyses.
  • Keep in mind there may be some unforeseen issues such as anti-nutrients, side-effects from high chitin consumption and inherent toxic chemicals.

How can you legally use insects in food?

From the FDA website:

“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive.

The approach to legally sell insects as food is by making a GRAS determination. The legal requirements for making a GRAS determination are quite strict and can be found here http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/

Three approaches businesses can take to make a GRAS determination:

The “common sense” approach: People have been eating insects for the past 10,000 years. 2 billion people around the world currently consume insects as part of their diet. They are already in our food coming from unavoidable defects. Here is a summary of people eating insects without ill effects. Of course they are safe.

The “I have done my homework” approach: We have assessed the safety of using insects as food. The insects are farmed for human consumption and produced using the attached HACCP plan. The product is free from hazards. Here is the most current research on the safety of using insects as food.

The “GRAS determination” approach: This approach is best executed using help from a firm that specializes in GRAS determinations. They use scientific evidence to show that they are safe. The end result is a GRAS dossier the meets the legal requirements for a GRAS determination.

The first two approaches would not pass the scrutiny of FDA review. However, because the edible insect industry is very small and that evidence is lacking showing that insects are harmful, it is unlikely that the FDA will prevent companies from producing entomophagy products.

Are insects a food allergen?

Insects are a potential allergen. Insects are very similar to other arthropods and therefore have similar protein. Research to date has not proved that insects are indeed allergens or that they are cross reactive with shellfish allergens. A costly clinical study is required to prove this. It would be interesting to test cricket flour using a shellfish ELISA (enzyme-linked immunosorbent assay) test. While the test would not be definitive it would provide information to help assess the risk from a business standpoint. That being said… insects probably are an allergen even if we can’t prove it. The recommended industry practice is to include an advisory statement such as:

ALLERGY WARNING: Contains Insects (people who are allergic to shellfish may also be allergic to insects)Insect allergen warning

What do you need to do to protect your company?

Manufacturers that use insects need to have a safety dossier available upon regulatory inspection. Even if it’s not that thorough, something is better than nothing and it shows that you have given it some thought. Follow regulations and best practices that apply to all food products. Include arguments in the dossier that support a GRAS determination. Have documentation and records showing that good, wholesome foods are being produced.

Insects are “new” to our food supply and carry some unknowns about regulation, safety and market growth. It is ultimately a business decision to determine how best to mitigate those risks and grow a new industry.

Insect food allergens are a bigger issue than previously thought

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Potential insect allergens may cause the FDA to disagree with a GRAS determination. This premise means that an ingredient being added to food that is an allergen, like whey protein concentrate, would not be allowed. How is whey powder allowed as a food ingredient? I feel like I am missing part of the puzzle. But let’s not get into this for now.

There are a lot of food products that contain potentially fatal allergens. Regulators feel the danger is well managed by requiring allergen containing products to state that they contain allergens. The allergens that cause reactions are also well known to consumers. A person with a milk allergen knows that they can’t consume dairy products and they know to look at the ingredients and/or allergen statement to find out if the food is OK. We don’t have this luxury for insects. People don’t know that insects can cause a reaction and they don’t know if they will be affected if they eat insects.

Im making the assumption that some people are allergic to insects. Not all insects may be allergenic. Very few people may be allergic but we just don’t know. Protein sequencing can determine if proteins present in crickets, for example, are known allergens. The Food Allergy Research and Resource Program has an online database and other resources. While the technical information may be helpful, for now, a practical approach to addressing the issue is needed.

Proposal for Insect Allergen Communication.

Whether insects are being added to processed foods, sold as an agricultural product or used in restaurant dishes; a common platform for communicating the allergen risk can benefit entomophagy.

A visual to communicate risk:

  • Can be used on product packaging, posters and more.

Insect Allergen Warning Entomophagy

A source for more information:

Link to website about allergens

What allergens are in insects?

Who may be affected by insect allergens?

How do I find out if I am allergic?

What do I do if I have a reaction?

(I cant answers these at this time. Go to http://www.foodallergy.org/ for general Food allergies information)

 Not yet!

I don’t think we need to take these step yet. A strong warning may scare people from trying insects for the first time. However, this approach is an option to prevent regulator objection. This option could also be presented if and when any regulatory bodies object. Take a look at how the FDA addressed Added Caffeine in Gum. A potentially dangerous food ingredient (caffeine) was added to a food where it is not normally present (gum). A regulatory objection will probably start as a negotiation and not a new law.

I recommend a label explicitly stating that insects are an allergen, then providing more information about who is likely susceptible:

ALLERGY WARNING: Contains Insects (people who are allergic to shellfish may also be allergic to insects)

Food Recalls – Can this happen to entomophagy products?

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As we all know, a food recall is bad PR. What reasons do recalls take place and who initiates recalls?

Most recalls are initiated by the manufacturer. The top two reasons foods are recalled are for undeclared allergens (ex. milk) and pathogens (ex. salmonella). Any product that violates the Code of Federal Regulations (CFR) or the Federal Food, Drug, and Cosmetic Act (FD&C Act) should be recalled.

The FDA states that they hear about a problem a variety of ways:

  • A company discovers a problem and contacts FDA.
  • FDA inspects a manufacturing facility and determines the potential for a recall.
  • FDA receives reports of health problems through various reporting systems.
  • The Centers for Disease Control and Prevention (CDC) contacts FDA.

Up until fairly recently, the FDA did not have the authority to mandate a recall. They now have the authority to mandate a recall with the passing of the Food Safety Modernization Act (FSMA).  From Food Safety News: FDA Reports Only One Use of Mandatory Recall Authority To Date . The FDA would first request a recall, and if matters are not sufficiently handled, the FDA would then mandate a recall. It seems unlikely that edible insect products would get to this stage. My understanding is that the FDA can also proactively send a desist letter for products before they get to market.

A recall request is a more likely scenario. Here is what the Regulatory Procedures Manual says about requesting a recall:

“An FDA request that a firm recall a product is ordinarily reserved for urgent situations. The request is directed to the firm that has primary responsibility for the manufacture or marketing of the product when the responsible firm does not undertake a product recall on its own initiative. FDA requested recalls are most often classified as Class I. Generally, before FDA formally requests recall action, the agency will have evidence capable of supporting legal action, i.e.seizure. Exceptions include situations where there exists a real or potential danger to health, or in emergency circumstances such as outbreak of disease involving epidemiological findings. The completion of either a firm initiated or FDA requested recall does not preclude FDA from taking further regulatory action against a responsible firm.”

Recall classes from FDA website:

Class I: Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.

Class II: Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.

Class III: Products that are unlikely to cause any adverse health reaction, but that violate FDA labeling or manufacturing laws. Examples include: a minor container defect and lack of English labeling in a retail food.

If insect products were to be recalled just for having insects, my understanding is that it would be a class III. There is not evidence to supports that farmed insects pose a “slight threat of a serious nature”. Insect products could have a Class I designation if they are contaminated with pathogens etc.

One situation where edible insect products could be subject to recall is by not meeting GRAS criteria. If a GRAS determination is deemed not valid, then the products would be in violation of manufacturing laws. This scenario can happen when the FDA (in partnership with state regulatory agencies) inspects a manufacturing facility. I recommend that firms have at least some documentation that supports a GRAS determination be internally filed. So if inspectors question the safety of using insects as food, the firm will have information detailing its safety, and hopefully prevent an escalation of a safety issue/ recall/ facility shutdown.

Where are we at now?

  • The FDA is marginally aware that insects are being introduced into the food supply
  • The volume at which insects are being consumed is very low
  • Manufacturers that use insects have a GRAS dossier available upon regulatory inspection?
  • The FDA’s risk assessment of insect containing foods (without other hazards) would result in low risk and therefore not a priority to the FDA when considering a proactive recall

What else do we need to consider?

  • There may be ways for regulatory agencies to prevent manufacturing/marketing of products before they get to a recall stage.
  • State and local rules vary state to state and may also cause, unaccounted  for, road blocks.

Allergies and Insects

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Bee AllergenInsects can cause an allergic reaction in people. Generally speaking, one mechanism is through a food consumption, secondly is through environmental exposure.

What does the FDA think about food allergens?

The FDA’s primary concern with regard to food allergens are the ‘Big 8’. They are Milk, Eggs, Fish, Crustacean shellfish, Tree nuts, Peanuts, Wheat and, Soybeans. These foods account for over 90% of food allergic reactions. There are over 160 foods that can cause allergies but these 8 are the only ones that require labeling by law. People allergic the shells may see cross reactivity to insects. The prevalence of shellfish allergy in the United States is around 2%. The majority of the population can consume insects without significant risk of an allergic reaction. I do recommend voluntary allergen labeling for packaged insect products. Consumer education will help general acceptance of insects as food.

Environmental insect matter can cause allergy symptoms. Skin contact and dust inhalation can have adverse effects on people farming and post-harvest processing of insects. Fecal matter and dried insect parts can become airborne and subsequently be inhaled. Sensitization can occur from repeat exposure. Issues with worker related environmental allergens would involve the Occupational Safety and Health Administration (OSHA). I am curious to know if insect farmers that currently produce high volumes have come across this issue.

What should we do about insect allergens?

  • Regularly clean farming facilities including the farming equipment and other building surfaces to remove dust and particulate matter.
  • Monitor the health of insect farmers for development of allergic sensitization. Use personal protective equipment such as mask and googles when appropriate.
  • Limit dispersal of fine particulates when making insect flour through engineering controls.
  • Label insect containing food products with an allergen statement such as ‘People allergic to shell fish may also be allergic to insects’.

Are Insects Safe to Eat

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Generally Recognized As Safe (GRAS) is a food substance designation put forth by the FDA. GRAS substances can be used in food under specified conditions as long as the safety of the substance can be validated.

There are two paths to achieve GRAS status. One is through scientific procedures with data being generally available. The second path, for a substance used in food before 1958, is through experience based on common use in food. This is kind of vague but check out this link:

FDA GRAS Page

Do insects meet GRAS requirements? Insects have been consumed for food throughout human history. There are also experts in the science community that promote the wholesomeness of insects as food. There are no known hazards associated with consuming insects except for allergies. Domestically farming insects using good manufacturing practices will reduce or eliminate the risk of common hazards such as pesticide residue.

I do not agree with Edible insects: future prospects for food and feed security’s interpretation that insects are additives. Insects used in food are GRAS and therefore do not default to a food additive status. Additives require premarket approval.

Commonly consumed edible insect in the US such as meal worms, crickets and wax worms should be considered GRAS.

FDA approval of GRAS substances is not required before using them in food. There is a GRAS notification program to notify the FDA of a substance but it is not necessary. The program either confirms your determination or disagrees.

Article: Is the GRAS Process Broken?