Category Archives: Regulations

Insects as a Potential Food Allergen – PDF Link

Allergenicity is a topic that comes up often when discussing regulation of edible insect. Phil Johnson of UNL presented ‘Insects as a Potential Food Allergen’ at the IFT Annual Meeting symposium Challenges in Edible Insect-Based Food Industry: Farm to Fork

Phil Johnson is a Biologist by training and a food scientist by preference. After completing Undergraduate and Post Graduate degrees in molecular biology and biochemistry at Durham University and John Innes Centre, he went on to work on lipid synthesis and starch synthesis before setting on his current field of food allergy. Phil currently works within the Food Allergen research and Research Program at the University of Nebraska. Lee Palmer, a student in Phil’s lab is currently working on novel protein-rich foods, especially insects.

Here are the slides:

IFT17 Insects as a Potential Food Allergens PDF

 

Review of U.S. State-Level Entomophagy Regulation 2015

From the International Food Protection Training Institute (Link)

PDF of Review

Review of U.S. State-Level Entomophagy Regulation 2015

Adam Lewis
Agricultural Consultant
Minnesota Department of Agriculture
International Food Protection Training Institute (IFPTI)
2015 Fellow in Applied Science, Law, and Policy: Fellowship in Food Protection

Abstract

This study examined state-level food safety regulatory response to the use of insects for human consumption, or “entomophagy.” Interviews were conducted with state regulatory officials from the 50 states; multiple interviews were conducted in states where regulation of retail and manufacturing of food are carried out by different agencies or delegated to a local agency. The study identified states where insects are sold at retail and the number of insect manufacturers; current regulations; types of insect food products; regulatory challenges regarding manufacturing facilities; and perceived food safety risks. Twenty states either reported receiving inquiries related to beginning an entomophagy-based business within their state; had previously regulated entomophagy facilities; or currently regulate entomophagy at the manufacturing or retail level. However, while the Food and Drug Administration (FDA) has jurisdiction over food being made using insects that is wholesaled and crosses state lines, there is no clearly-defined guidance at present for state regulators from the FDA. The study concludes that present state-level food safety regulation is fragmented, inconsistent, and does not address the current widespread use of insects as food. Recommendations include increased FDA-industry collaboration in order to create an entomophagy guidance document for the successful implementation of a preventive control system in order to provide consistent regulation of entomophagy processing and manufacturing facilities.

Keywords: 50 states, approved source, crickets, food safety, Food Safety Modernization Act (FSMA), guidance document, hazards, insects as food, insects for human consumption, Preventive Controls for Human Food (PCHF)

Background

People throughout the world have been eating insects as a regular part of their diets for millennia (van Huis et al., 2013, p.1). More than 1900 species are regarded as edible, including beetles, caterpillars, bees, wasps, ants, grasshoppers, locusts, crickets, cicadas, leaf- and planthoppers, scale insects, termites, dragonflies, and flies (van Huis et al., 2013, p.1). The benefits of entomophagy include utilizing a nutrition source that is high in calcium, zinc, and iron; environmental friendliness (e.g., requiring 12 times less feed than cattle to convert feed into the same amount of protein); and economic benefit, as the cost of start-up is significantly less than traditional farm-raised animals (van Huis et al., 2013, p.2).

Insect food producers are currently regulated by the FDA using Good Manufacturing Practices (GMPs) (Halloran & Munke, 2014); however, these GMPs are subject to a variety of interpretations. The FDA has published guidance documents and provided regulations for seafood and juice processors incorporating hazard analysis and critical control point (HACCP) principles which provide industry and regulators with consistent, sound scientific evidence to ensure the product and process is safe. However, the FDA has not provided guidance for insect food processors.

The Food Safety Modernization Act (FSMA) Preventive Controls for Human Food (PCHF) rule is now final (U. S. Food and Drug Administration [FDA], 2016) and uses HACCP-based principles that food facilities must follow unless the facilities are covered by an exemption. If not, the firm has the responsibility for: conducting a hazard analysis, preventive controls, monitoring, verification, corrective actions, and making corrections. Farms are exempt from the preventive controls rule unless raw agricultural commodities (RACs) are changed into a processed food. The FDA identifies multiple activities that change an RAC to a processed food, including slaughtering of animals and freezing. Insect farms would be exempt from the new FSMA PCHF rule unless facilities are slaughtering insects, freezing them, or conducting activities that would change the product into a processed food. FDA is developing guidance documents addressing the following: hazard analysis and preventive controls, environmental monitoring, food allergen controls, and validation of process controls. However, no guidance document currently exists for insect processors despite the fact that insects are rich in nutrients and moisture, and provide a favorable environment for microbial survival and growth (van Huis et al., 2013, p.117).

Problem Statement

At present, there is no comprehensive description of the state regulation of the processing and sale of insects for human consumption.

Research Questions

  1. What types of insects are most commonly being processed and consumed for human consumption?
  2. What types of foods are produced using insects?
  3. What are the challenges associated with the regulation of insect-processing facilities?
  4. What are the food safety risks related to insect processing and consumption based on the current understanding of state food safety regulators?

Methodology

A telephone survey of state agriculture and local health officials was carried out using the Directory of State and Local Officials (Association of Food and Drug Officials [AFDO], 2015). An introductory e-mail provided the subjects with thirteen questions to be asked in the telephone survey. Eight questions focused on the subject’s regulatory framework and five questions related to the regulatory process. Responses to the survey questions were analyzed to address the four research questions above.

Results

All 50 states responded to the survey. Twenty states indicated that they had either received inquiries related to beginning an entomophagy-based business within their state; had previously regulated entomophagy facilities; or currently regulate entomophagy at the manufacturing or retail level. Six of the 20 states were currently regulating crickets or cricket products using Good Manufacturing Practices (GMPs) (see Table 1). Two of the 20 states had previously regulated cricket entomophagy products using the GMPs (Louisiana and Utah); nine of the 20 states had received inquiries related to cricket entomophagy (Alaska, Idaho, Maine, Michigan, Minnesota, South Carolina, Texas, Vermont, and Washington); and two states (Arizona and New York) reported currently regulating entomophagy at the retail level.

Several responses to the survey questions illustrate the diversity of regulatory experiences related to entomophagy. A Montana regulatory official stated, “There has been talk and phone calls about insects for human food, and we have seen insects used for human food that fall under our temporary food exemption.” An Arizona regulatory official said, “The State Fair is primarily where insects for human consumption are offered for sale, and the insects used at the State Fair are primarily from California. There are also numerous retail stores selling packaged entomophagy products including novelty items such as lollipops with an edible insect such as scorpions inside of the lollipop.” From Kansas, a regulatory official commented that “There was a startup for mealworm flour, and at this point the start-up operation falls under the cottage food retail exemption.”

The widespread nature of entomophagy is illustrated by two manufacturers: Chapul and Exo. Chapul produces cricket bars using cricket protein powder that is dairy- and soy-free. Exo produces protein bars using cricket flour and claims that the bars are all natural, dairy-free, gluten-free, paleo-friendly, soy-free, and contain 10g of protein. These two companies distribute products to 42 of the 50 states, primarily to retail establishments (Exo, n.d.; Chapul Bars, n.d.).

All of the states using the GMPs (or a modified form of the GMPs) to regulate entomophagy facilities identified crickets as an ingredient, or sold as a whole insect as shown in Table 1.

alewis-figure-1The potential size and evolution of large producers is illustrated by two other manufacturers: Big Cricket Farms in Ohio and Aspire, located in Texas. According to its website, Aspire has the capacity to process up to 7 million crickets on a weekly basis (Aspire Food Group, 2016). Big Cricket Farms, whose mission statement starts with “To drive the edible insect industry forward” also raises crickets specifically for human consumption; the company bills itself on its website as “the first American insect farm to obtain food-grade certification from their state Department of Agriculture and the FDA.” The firm raises Gryllodes sigillatus, a.k.a. the Tropical Banded Cricket (Big Cricket Farms, 2014). An Ohio regulatory official who has been to the facility identified jurisdiction as one of the biggest challenges in regulating insect facilities, as the Ohio Department of Agriculture does not have jurisdiction until the crickets are dead—in effect, after an important part of the manufacturing process has already taken place.

California was the lone state in the survey to regulate products other than crickets or cricket products using the GMPs. A California regulatory official identified insects in hard candies such as ants and scorpions (which are regulated under the GMPs) and chocolate-covered grasshoppers during the interview. Products found on the website of California’s Hotlix Candy Store include ant wafers and whole crickets flavored with bacon and cheddar, sour cream and onion, and salt and vinegar. Worm snacks were also offered in BBQ, Mexican spice, and cheddar cheese flavors (Hotlix Candy Store, 2015).

During each interview, state representatives were asked to identify challenges related to regulating entomophagy facilities. Table 2 shows what challenges were identified for all states participating in the survey. Approved source, understanding the process, and understanding the hazards accounted for 66% of challenges identified. Of the six states indicating that entomophagy regulation was occurring and applying the GMPs in Table 1, ten responses to challenges were noted. The challenges identified (from the states listed in Table 1) included understanding the process (40%), determining approved source (20%), understanding the hazards (20%), the unknown (10%), and establishing jurisdiction (10%).

alewis-figure-2Of the eight states that regulated entomophagy firms or had previously regulated entomophagy firms using the GMPs, none indicated that any hazards were identified during inspection work. A New York State regulatory official pointed to a 2001 incident where approximately 15 people became ill following the annual Explorers Club dinner in New York City. The primary symptom was burning mouth/throat due to the mechanical irritation caused by the urticating hairs of tarantula. A food prep review found that some of the tarantulas may not have been adequately singed to remove the hairs. The tarantula example illustrates the hazards within entomophagy which could easily be overlooked without scientific guidance provided to industry and regulators.

A Georgia regulatory official shared information received from the FDA that there is a growing body of scientific literature that people who are allergic to shellfish (shrimp, lobster, etc.) may also be allergic to insects either as food or as adulterants in foods.

The FDA has provided e-mail guidance to a Pennsylvania regulatory official that states there is no specific FDA regulation that either prohibits or condones the use of insects as food. The Food, Drug, and Cosmetic Act requires food products to be “fit for food” (FDA, 1938). In general, “fit for food” means the product is safe and wholesome and does not present a health hazard. Firms, not the FDA, must determine if this is the case and FDA’s role should be to oversee that firms meet this charge.

Conclusions

Entomophagy regulation lacks national standardization and existing regulation is fragmentary and often ad hoc. However, entomophagy is found in most states; nationally, the volume of product is increasing. States are currently regulating entomophagy manufacturers using GMPs, which is not a food process- or product-specific regulation. Insect processors may fall under the Preventive Controls for Human Food (PCHF) rules, in which case regulators would rely on industry to provide information related to hazards in the product and process. The PCHF rules will also require manufacturers to identify hazards in their operation and validate and verify control of these hazards based on scientific data. Additionally, the FDA has not provided guidance to state regulators or to industry regarding hazards, processes, and sources. As a result, there is a current and significant need for increased guidance for consistent entomophagy regulation.

Recommendations

The FDA should work with the manufacturers of entomophagy products to provide a guidance document for entomophagy. The guide would be used as a resource for industry and regulators to provide consistent, sound, scientific evidence ensuring the product and process is safe.

An expanded study should be conducted to identify potential hazards associated with the production of insect-based foods in order to assist in the continued effort to achieve a comprehensive description of the regulation and sale of insects for human consumption.

Acknowledgments

I would like to thank Dr. Benjamin Miller, Division Director; Valerie Gamble, Outreach and Delegation Coordinator/Previous Supervisor, and Lorna Girard, Supervisor for giving me the appropriate time to complete this project and for encouraging me to apply to the program. Thank you to the International Food Protection Training Institute (IFPTI) for giving me the opportunity to complete the Fellowship Program and be a part of Cohort V. More specifically, I want to thank the following individuals from IFPTI: Dr. Craig Kaml, Senior Vice President, and Gerald Wojtala, Executive Director, for providing valuable feedback during our presentations and on my journal article and expressing his ideas and suggestions to make our projects successful; Dr. Paul Dezendorf, IFPTI Research Subject Matter Expert, for all of the guidance provided throughout the process and taking time out of his busy schedule to help assist me in the development of my project; Mr. Cameron Smoak, Mentor, for his professional guidance throughout the program; Ms. Suzanne Kidder, Curriculum Delivery Coordinator, for all of the work she has done in providing and setting up the food and lodging accommodations and working with me during the application process; and Ms. Denise Miller, Staff Writer, for making a batch of cricket flour cookies for the Fellows to sample. I would also like to thank all of the state and local officials who participated in the survey. Lastly, I would like to thank my family for all of their support during this process, including my wife Becky, my mother Suzanne, my father Darold, and my sister Gina.

References

Aspire Food Group. (2016). Frequently asked questions about cricket nutrition and farming. Retrieved from Aketta.com Website: http://www.aketta.com/aketta-crickets/faq.aspx

Association of Food and Drug Officials. (2015). Directory of State and Local Officials. Retrieved from http://dslo.afdo.org/

Big Cricket Farms. (2014). F.A.Q.: Frequently asked questions. Retrieved from http://bigcricketfarms.com/faq.html

Chapul Bars. (n.d.). Find a Store. Retrieved from http://www.chapul.com/find-a-store

Exo. (n.d.). Find a Store. Retrieved from https://www.exoprotein.com/pages/store-locator

Halloran, A. & Munke, C. (2014). Discussion paper: Regulatory frameworks influencing insects as food and feed. Retrieved from http://www.fao.org/forestry/39620-04ee142dbb758d9a521c619f31e28b004.pdf

Hotlix Candy Store. (2015). Hotlix candy. Retrieved from http://www.hotlix.com/candy/ http://www.fao.org/docrep/018/i3253e/i3253e00.htm

U. S. Food and Drug Administration. (1938). Federal Food, Drug, and Cosmetic Act FD&C Act: 21 U.S.C. 342 – adulterated food. Retrieved from https://www.gpo.gov/fdsys/granule/USCODE-2011-title21/USCODE-2011-title21-chap9-subchapIV-sec342/content-detail.html

U. S. Food and Drug Administration. (2016). FSMA final rule for preventive controls for human food. Retrieved from http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm334115.htm

van Huis, A., Van Itterbeeck, J., Klunder, H., Mertens, E., Halloran, A., Muir, G., & Vantomme, P. (2013). Edible insects: Future prospects for food and feed security. (FAO Forestry Paper 171). Retrieved from Food and Agriculture Organization of the United Nations website:

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.