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Questions for Dr. Waller about the bioengineered food labeling laws

 

1. Why are some foods exempt from labeling?

 

a. Congress passed an amendment to the Agricultural Marketing Act of 1946 on July 29, 2016.  That amendment established the Standard and set out the scope for what foods would require a bioengineered food disclosure, and noted which foods are exempt from labeling. 

b. The Standard describes exemptions at 7 CFR 66.5

c. At 7 CFR 66.5(a), the Standard exempts food served in a restaurant or similar retail food establishment. Further, 7 CFR 66.1 defines “similar retail food establishment” as meaning, “a cafeteria, lunch room, food stand, food truck, transportation carrier (such as a train or airplane), saloon, tavern, bar, lounge, other similar establishment operated as an enterprise engaged in the business of selling prepared food to the public, or salad bars, delicatessens, and other food enterprises located within retail establishments that provide ready-to-eat foods that are consumed either on or outside of the retailer's premises.”

d. 7 CFR 66.5(b) exempts very small food manufacturers from the Standard.  At 7 CFR 66.1, very small food manufacturers are defined as any food manufacturer with annual receipts of less than $2,500,000. This exemption does not exempt food manufacturers from the responsibility of making a disclosure in accordance with the Standard when they source ingredients from suppliers with less than $2,500,000 in annual sales.

e. The threshold exemption at 7 CFR 66.5(c) only applies when the presence of a bioengineered substance is inadvertent or technically unavoidable, and below five percent for each ingredient. This exemption is designed to recognize the realities of the supply chain and acknowledge that BE and non-BE food and ingredients are often grown, harvested, transported, and processed in close proximity to one another.  Any intentional use of a BE substance requires a disclosure, regardless of the percentage that food or ingredient represents in the finished food product.

f. At 7 CFR 66.5(d), the Standard states that food produced from an animal fed bioengineered feed is not considered a bioengineered food solely because the animal ate that bioengineered feed.  For example, the egg from a chicken that ate bioengineered soybeans is not considered a bioengineered food just because the chicken ate bioengineered soybeans.

g. The Standard, at 7 CFR 66.5(e), exempts food certified under the National Organic Program from disclosure. This exemption applies to all NOP certified label categories (“100% Organic,” “Organic,” and “Made with Organic” that applies to foods with at least 70% organic ingredients) because NOP regulations at 7 CFR 205.301(a) through (c) do not allow bioengineered food ingredients. See 7 CFR 205.301(f)(1) and 205.105(e) and the definition of “excluded methods” in 7 CFR 205.2.       

2.        Can you buy a product that has a non-deregulated bioengineered crop in the ingredients? (ie., cowpea or eggplant)

 

a. Disclosure under the Standard is required in two different scenarios.  First, if a regulated entity is using a food on the List of Bioengineered Foods (the List), found at 7 CFR 66.6, or a food produced from an item on the List, then they must make a bioengineered food disclosure unless a regulated entity has records to demonstrate that the food they are using is not bioengineered.  Second, in accordance with 7 CFR 66.109, a regulated entity must make a bioengineered food disclosure if they have actual knowledge that a food or ingredient they are using is bioengineered. If a regulated entity is using a food or ingredient such as cowpea or eggplant, and they have actual knowledge that those ingredients are bioengineered, then they would have to make a bioengineered food disclosure.

 

3.       What are the consequences of not disclosing? Is there a tip line for reporting violations?

 

a. Enforcement of the Standard will be driven by a complaint process. USDA may request records to determine compliance after a complaint has been made against a regulated entity. After AMS reviews a complaint, it may investigate and request records from the regulated entity to determine compliance.” Pursuant to 7 USC 1639b(g)(4), USDA has no authority to recall any food subject to the Standard ‘‘on the basis of whether the food bears a disclosure that the food is bioengineered.’’ Anyone who suspects a violation of the Standard may submit a complaint at https://www.ams.usda.gov/rules-regulations/be/file-complaint

4.       I’m confused about what an “incidental additive” is. Can you give me an example?

 

a. The definition of bioengineered food, at 7 CFR 66.1, excludes incidental additives that are present in food at an insignificant level and that do not have any technical or functional effect in the food, as described in 21 CFR 101.100(a)(3).  Incidental additives, when used in accordance with this definition, are not required to be included on the ingredient list. 

b. Some examples of incidental additives could be, Substances that are added to a food during the processing of such food but are removed in some manner from the food before it is packaged in its finished form; Substances that are added to a food during processing, are converted into constituents normally present in the food, and do not significantly increase the amount of the constituents naturally found in the food; or Substances that are added to a food for their technical or functional effect in the processing but are present in the finished food at insignificant levels and do not have any technical or functional effect in that food.

5.       For clarification, is the bioengineered foods symbol required on packaging if there is a digital link, such as a QR code, that opens to the bioengineered symbol and product information?

 

a. The Standard provides four different disclosure options to disclose the presence of a bioengineered food or bioengineered food ingredient.  As mentioned in subpart B of the regulations, those four options are on-package text, the BE symbol, electronic or digital link, or text message.  Regulated entities are only required to use one of the disclosure options.

 

6.       Who pays for the added time and cost of labeling bioengineered crops?

 

a. The Standard was written with the goal of providing information to consumers about the bioengineered status of their foods while minimizing cost burdens to regulated entities.   The Standard seeks to minimize implementation and compliance costs for the food industry—costs that could be passed on to consumers.  The Standard provides multiple disclosure options, a phased implementation period, and simplified recordkeeping requirements by providing the List of Bioengineered Foods.

 

7.       How do governmental regulators play a role and who are their advisors?

 

a. USDA oversees the Standard because Congress enacted the law by amending the Agricultural Marketing Act of 1946 and directed the Secretary of Agriculture to implement its provisions. 

b. The regulatory oversight by USDA and other Federal Government agencies ensures that food produced through bioengineering meets all relevant Federal health, safety, and environmental standards. The agencies responsible for oversight of the products of biotechnology include: USDA’s Animal and Plant Health Inspection Service (APHIS), the U.S. Environmental Protection Agency (EPA), and the Department of Health and Human Services’ Food and Drug Administration (FDA). The Coordinated Framework for Regulation of Biotechnology (Coordinated Framework) is a policy framework that summarizes the roles and responsibilities of these three principal regulatory agencies with respect to regulating biotechnology products.

8.      Wouldn't sugarbeets be included as bioengineered?

 

a. The List of Bioengineered Foods (the List) found at 7 CFR 66.6 and on the AMS website is updated based on two criteria, as stated at 7 CFR 66.7: (1) whether foods proposed for inclusion on the List have been authorized for commercial production somewhere in the world, and (2) whether the food is currently in legal commercial production for human food somewhere in the world. As stated at 7 CFR 66.7, AMS will update the List annually.

Currently, the List includes:

  • Alfalfa
  • Apple (ArcticTM varieties)
  • Canola
  • Corn
  • Cotton
  • Eggplant (BARI Bt Begun varieties)
  • Papaya (ringspot virus-resistant varieties)
  • Pineapple (pink flesh varieties)
  • Potato
  • Salmon (AquAdvantage®)
  • Soybean
  • Squash (summer)
  • Sugarbeet