Category Archives: Regulations

Edible Insect Farming and Processing Questionnaire

It is important that insect processors and consumer goods companies have information about where there insects come from. I put together a questionnaire to help facilitate a dialog between the insect supplier and customer. It will also serve as a record.

Here is a link to the Word doc: Edible Insect Farming and Processing Questionnaire

 

survey

Edible Insect Farming and Processing Questionnaire

Company

Facility locations

Name

Title

Date

General/Facility

  1. Describe the current Good Manufacturing Process (cGMP) used at the facility
  1. Describe the sanitation procedures
    1. Insect contact surfaces and equipment cleaning
    2. Environmental monitoring
  1. Are the insects clean and wholesome? Explain.
    1. Do they contain any external waste
  1. Are the insects raised specifically for human consumption
  1. What are the technical specifications of the product? Please attach a specification for each requested product.
    1. Protein content
    2. Size
    3. Microbiological
  1. Please attach a pictures of the finished good including packaging and labels
  1. Describe the facility security

Farming

  1. Describe the rearing process
    1. Do you rear insects yourself
  1. Describe the feed.
    1. Feed ingredients
  1. Describe the housing
    1. Size(volume) per housing unit
    2. Surface area per housing unit
    3. Number of crickets per housing unit
  1. Are the insect treated humanely. Explain.
    1. Access to food
    2. Access to water/moisture
    3. Freedom to exercise instinctual behaviors
    4. Cannibalism
    5. Monitoring frequency
  1. Describe how the insects are harvested
    1. How are live insects separated from the remains
    2. Slaughter process
  1. Describe the storage conditions
    1. Packaging
    2. Temperature

Processing

  1. Describe the further processing

 

Let me know if I missed any questions.

FDA response to inquiry

UPDATE: added a third and fourth reference.

Fourth: Food Navigator article that includes the standard response and additional follow up questions.

Edible insects: Beyond the novelty factor

By Elaine Watson+, 28-Sep-2016

If the edible insects market is heating up, and big name retailers from Publix to Sprouts are now stocking cricket bars, snacks and protein powders, why is Whole Foods – which has reportedly temporarily dropped all bug-based products – apparently cooling down?

Third: A power point from by the director of the National Institute of Food and Agriculture (NIFA) Dr. Sonny Ramaswamy.

Here is the LINK. (the file is from Ben Guarino’s Inverse article.)

FD&C edible insects 1

GRAS edible insects

The first is courtesy of Andrew Brentano of Tiny Farms. Tiny Farms has an excellent forum, Open Bug Farm, that covers a wide range is topics on edible insects.

FDA edible insect response regulationI attempted to secure my own copy by messaging the FDA’s Food and Cosmetic Information Center (FCIC). The first response did not have much content so I sent a follow up note.

My interest in getting a copy came from the IFT (2015) panel discussion on edible insects. One of the speakers, who is from the FDA, mentioned that there was a standard response for edible insects. The key points he mentioned were on point with the letter Andrew received.

The response I received was slightly different and didn’t have some of the same key points.

FCIC FDA responseSome follow up questions I have from the letters:

  • Why don’t they match more consistently in content and language?
  • Why must insects be raised specifically for human consumption? Corn is diverted all over the place.
  • What is the basis for disallowing wild crafted insects? I feel its no different than trolling for shrimp.
  • There is no mention of needing a GRAS determination.
  • Whats the definition of ‘Exotic Food’ and why does it matter? This is the first mention of ‘Exotic Food’ I have seen. Its not in any regulations.

Please share any letter or response you have received.

Be in touch on Twitter at Bob the Cricketpic122

Edible Insects and Consumer Litigation

I have been blogging about government regulations in the US on edible insects. Current thinking is the the FDA/regulators will not press edible insects companies to stop making products. US Regulation

Today’s post will discuss the risk of consumer litigation for edible insect businesses.

Edible insect producers could experience class action law suits or individual lawsuits. The plaintiffs would need to prove damages and prove causation of injury. The legal structure of your business will affect your liability.

Is the FDA involved in consumer litigation? What can occur is that the FDA can send a warning letter… FDA Warning Letter to KIND via Food Navigator

Top 4 concerns for consumer litigation related to edible insects.

  1. Physical hazards – For example, dry roasted whole cicadas can be a choking hazard. Legs/exoskeleton can get caught in ones throat. It would probably not cause full obstruction of the airway. Objects that are round and the same size of the airway are more likely to cause blockage. A stuck leg could cause other foods to get stuck also. See The American Academy of Pediatric Policy Statement on choking prevention. I feel a choking hazard warning is not needed. If a piece of insect gets trapped in ones throat and doesn’t go away then, I recommend that the consumer seeks medical attention to have it removed. Very annoying but not likely to cause long term harm.
  2. Asphyxia– Insect are a potential food allergen. More info on insect allergens.
  3. Antinutrients – Not well studied and would be difficult to prove harm.
  4. Claimscricket front label frozen warning
    1. Nutrient claims – The nutrition facts panel of a processed food need to be accurate. One of the benefits of edible insects is the protein and mineral content. Nutrient contents of insects can vary greatly by species and how they are grown, harvested and processed. Accountability falls to the consumer goods company and not the suppliers or manufacturers. Front of package claims must be in line with regulations. FDA’s Food Labeling Guide
    2. Animal welfare – We know that cricket can be cannibals if they don’t have enough space or food. How can we qualify that the crickets are being raised and harvested humanely?
    3. Sustainability – Companies often promote environmental benefits on their website as a key feature of their product. Do insects meet third party standards for sustainability? Report Debunks Walmart’s Claims of Sustainability and Fairness in Its Food Supply Chain

The best way companies can manage risk from consumer litigation is to use an allergen warning. Secondly, any claims must be supported with data and documentation.

Did I miss anything? Should industry be using a choking hazard for whole orthoptera products?

Let us know in the comments.

Industry Experience on Regulation

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?

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

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.