Category Archives: Business

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?

Feed For Edible Insects

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Livestock feed is especially important for insects. One of the reasons is that we consume the whole insect, including what is in their gut. Their gut can be purged by not feeding them for a few days before harvest. How effective this is varies species to species and I would say is probably not worth doing. I feel a better approach is use high quality feed. You can also gut load insects. It involves feeding insects particular nutrients right before harvest so when they are consumed, the contents of the gut are also ingested, providing additional nutrients. This practice is used when feeding crickets to lizards so they get all of the nutrients they need. I think this is not necessary for people because there will be getting other nutrients from other parts of their diet. An idea to explore is to add seasoning to the feed and see if the flavor is apparent. Cinnamon might pair well with the nutty flavor is some insects.

Another reason why feed is important is for sustainability. Sustainability is a core reason why we should be incorporating insects into our diets. Insect have a high feed conversion rate and low waste. In Thailand, high protein animal feed is used to raise insects according to a recent FAO document (http://www.fao.org/docrep/017/i3246e/i3246e.pdf). Feeding insects chicken defeats the purpose.

So what should we feed insects? I feel the best answer is an organic vegan diet. Let take a look at wax worm feed. The main components of wax worm feed that I have seen are honey, oats and glycerin. The glycerin is added to control water availability and texture. It would be better if there were formulations that don’t have glycerin. Honey can be replaced by high fructose corn syrup to lower costs. Maybe cane sugar syrup will be a suitable compromise. There is considerable flexibility in insect feed. As a consumer, you will ultimately decide what is in the insect feed. But please, no chicken.

I feel that producers need to be transparent about the feed they use to raise their insects. By doing this they can gain customer trust and customers will feel more comfortable consuming insects. Western culture feels eating insects is taboo. Educating consumers about what insects eat will help alleviate this issue. Open and honest communication with consumers and potential customers is the best way to gain acceptance and engagement with entomophagy.