The National Bioengineered Food Disclosure Standard

Bioengineered foods have been with us for decades. A new law has been created by the USDA so as to regulate these types of foods to avoid misinterpretation and fraud especially in labelling. This is called the National Bioengineered Food Disclosure Standard (BE Standard).

In this article we will cover the law’s requirements, the scope (types of foods covered), the exemptions, making disclosures and keeping records. Compliance and enforcement is also one key element.

FoodWrite has made a point of discussing this because it is going to be an important regulation going forward with modified ingredients in the USA. It may well have a bearing on products coming in from Europe and Asia for example. We insisted we got this correct interpretation and explained it as fully as possible.

Public Law 114-216

Originally there was the Agricultural Marketing Act of 1946. A new law came into being which was signed on July 29th, 2016 which amended this 1946 act.

This law directed the US Secretary of Agriculture to establish National Bioengineered Food Disclosure Standard. This was law concerns disclosure by food producers of bioengineered food or food that may have been bioengineered.

In December 2018, the final iteration of the law was signed off.

Who gets regulated?

There are three main entities or groups of people who will be regulated by this standard.

• Food manufacturers
• Importers – importers of record as used by the customer and border forces. needs correct labeling
• Retailers. These are retailers though who package and label food for retail sale and ones who sell bulk food items.

The entities not being regulated are restaurants and similar retail food establishments. Likewise, the really small food manufacturers who take less than $2.5 million in annual receipts are exempt too.

Foods considered to be bioengineered

The USDA have a decision tree on their web-site which should help producers find out if they need to comply with the standard. 

The USDA asks each ingredient as it appears on the ingredient list to be considered in turn.

The first consideration is whether the first food ingredient is subject to three elements, FMIA (Federal Meat Inspection Act), PPIA (Poultry Products Inspection Act) or EPIA (Eggs Products Inspection Act).

The type of foods covered off according to the USDA are beef and pork, goat and sheep, catfish, turkey and chicken and other domesticated birds, and finally an egg product but not a cracked egg.

If they are subject to those three acts, then they are not subject to this particular standard.

Consideration must be made too about the whether the first ingredient is water, a broth, similar solution or stock. If the answer in turn down the list has a ‘yes’ because it is one of those types of food already mentioned then it is subject to those three standards. The food cannot be subject to the BE standard. 

What is a bioengineered food?

Well, a bioengineered food is one that contains any genetic material which has been modified using in vitro rDNA technology and for which the modification couldn’t have otherwise been obtained through conventional breeding or found in nature.

It applies to modified crops which have been around for nearly 30 years, the plant-based alternative proteins etc.

The excluded foods are ones where the modified genetic material isn’t detectable – these are not bioengineered. The other case is when the food contains incidental additives. These will have no technical function in the food and would be process aids for example.

There is often a question asked about what it means to be ‘found in nature’ or ‘conventional breeding’. 

The USDA has not defined either of these terms. It intends to make its determinations about whether specific modification is one of these on a case-by-case basis.

The List Of Possible Bioengineered Foods

In the first instance, there is a list of bioengineered foods that must be considered.

•  alfalfa
• apple (Arctic™ varieties)
• canola
• corn
• cotton
• eggplant (BARI Bt Begun varieties)
• papaya (ringspot virus-resistant varieties)
• pineapple (pink flesh varieties in particular)
• potato
• salmon (AquaAdvantage™)
• soybean
• squash (summer)
• sugarbeet.

The second consideration is if you have actual knowledge a BE food being used as an ingredient. So as well as something on that list there may be some microorganisms such as yeasts which are bioengineered must be included.

Exemptions

The exemptions are critical. There is a threshold for example where you are allowed each ingredient to contain up to 5 per cent of a bioengineered material as long as it is technically unavoidable or added inadvertently.

It excludes animal fed bioengineered feed. It means if a chicken is fed with bioengineered meal, its eggs would not be bioengineered either. the same would be said for milk if the cows too were fed BE feed.

It also excludes food certified under the National Organic Program. Biotechnology is not allowed under this programme.

The Disclosure Options

Disclosure as to whether the food is bioengineered is made on the information panel next to the manufacturer and distributors information or the principal display panel. When there is insufficient space on either panel, then disclosure is made on any other panel that can be seen by the consumer under ordinary shopping conditions. It must not be hidden! There are no specific size requirements however.

The four disclosure options are:-

• on-package text
• a symbol
• electronic or digital disclosure
• text message

There is some flexibility of small manufacturers of foods and where packages are not large. In this case when the annula receipts of the small food manufacturers is between $2.5 million and $10 million dollars, the disclosure can be through a telephone contact or on a web-site.

When the packaging is really small, shortened statements are made for electronically or digitally, by text message and through a phone number. The very smallest packages can use an existing URL or a phone number.

The On-Package Text Disclosure is either:-

‘Bioengineered food’

‘Contains a bioengineered food ingredient’ or ‘Contains bioengineered food ingredients’.

Symbol – there is a coloured or black and white version

When it comes to an electronic or digital disclosure, the food package information must include the instructions to

“Scan here for more food information” or related and similar language that is reflecting any change in technology. It could say ‘Scan anywhere on package for more food information’ for example.

When the information is accessed, the electronic or digital link must go directly to the product information page. This product information page must be the first to appear on any digital or electronic device, to include the bioengineered food disclosure in its text or symbol form. There can be no marketing information. It must not collect any information about the consumer or the use of their devices.

the other feature on electronic disclosure is that it must be accompanied by a telephone number which is close to the initial disclosure information. It includes the statement “Call (tel. no.) for more food information’. 

The bioengineered food disclosure can be a recorded message.

The final option is a text message disclosure. This is a request to “Text [command word] to [number] for bioengineered food information.” It must be in text form.

This number must be genuine and include a short code that sends an immediate response to the consumer’s mobile device. 

Disclosure On Foods Sold In Bulk Containers

Finally, retailers are responsible for disclosure. The disclosure can be made using any one of the four standard options mentioned previously. 

The disclosure has to be placed on any signs or other materials on or near the bulk food items.

Voluntary Disclosure

The first voluntary disclosure is when entities that are exempt such as restaurants or the very small food manufacturers. They can disclose if they wish when using such bioengineered ingredients in their products.

The second instance is this:-

For foods that do not contain detectable modified genetic material but are derived from bioengineering. These include highly refined foods that might contain bioengineered ingredients.  It only applies to foods when the modified food is no longer detectable. This would include  any sugar that was extracted from sugar beet for example or oil extracted from soybeans.

Voluntary disclosure is not allowed for any other foods or ingredients. The USDA cites examples where voluntary disclosure is not allowed such as food produced from animals fed bioengineered feed, any soups where the first ingredient is meat or when incidental additives were used.

The text in a  voluntary disclosure must be ‘derived from bioengineering’ or ‘ingredients derived from a bioengineered source’. It can take any one of two symbols that is placed on the packaging which say above

Recordkeeping Requirements

The USDA is clear that for non-disclosure of foods on the List of Bioengineered Foods, the records need to validate that the food is not bioengineered or no longer contains detectable modified genetic material pursuant to no. 66.9 The records must be very clear.

Where there is positive disclosure of foods on the List of Bioengineered Foods, records just have to identify the food or ingredient.

Recordkeeping

The records kept are relatively flexible but there is a duty to make sure they are accurate. All of us who are subject to the mandatory bioengineered food disclosure must make sure the records are appropriate and sufficient so that they establish compliance with the standard.

No new forms or records are needed but they must be kept as in the normal course of business.

The regulated entities can determine which records are to be maintained, provided they are appropriate and sufficient to demonstrate compliance. They can be in any format and stored at any business location.

The type of records that can be kept to show compliance are:-

• invoices
• bills of laden
• country of origin records 
• inventory records
• process verifications
• organic certification
• supply chain records
• laboratory test results

The records must be maintained for two years after the food is labelled, sold or distributed for retail.

In some cases the records must be retained for longer when verifying a particular process of manufacture or when a food is being tested. The records must always be retained fr as long as the process of manufacturing is operating with two afterwards.

The USDA can expect the records to be produced within five business days unless it grants an extension. When they need on-site access, the USDA provides at least three business days in advance.

Enforcement

A failure to make a bioengineered food disclosure when required by the NBFDS is forbidden.

Complaints about possible violations of the NBFDS are made to the AMS. The AMS determines whether further investigation is needed and conducts a records audit as appropriate. 

Regulated entities will be able to appeal the results of an audit or investigation.

Following an appeals hearing,  the AMS will notify the regulated entity of its final determination. The AMS cannot fine or ban anybody or recall products – just publish results on the their web-site about their findings. States can have their own enforcement mechanism as long as they follow the same regulations as the USDA.

Compliance date

The mandatory compliance for all regulated entities is January 1st, 2022. 

You can voluntarily comply before this time and you may use existing labels.

References

Worth checking the web-site www.ams.usda.gov/be

Additional material came from the SHIFT2020 IFT Annual meeting through a presentation called ‘National Bioengineered Food Disclosure Standard’ given by the USDA’s Agricultural Marketing Service  about bioengineered food labelling.