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USDA Issues Guidance to Facilitate Compliance with Bioengineered Food Disclosure Standard

Key Takeaways:

  • What Happened: USDA published guidance describing two pathways for regulated parties to demonstrate that a product is exempt from federal bioengineered food labeling requirements.

  • Who’s Impacted: Food manufacturers, importers, and certain retailers that sell or distribute bioengineered foods or food ingredients.

  • What Should They Consider Doing in Response: Review internal processes to identify covered products and maintain records to demonstrate that such products either include bioengineered foods disclosures or are exempt from disclosure.

In December 2018, the U.S. Department of Agriculture (USDA) Agricultural Marketing Service (AMS) promulgated a new National Bioengineered Food Disclosure Standard (NBFD Standard or the Standard) to require food manufacturers, importers, and other entities that label foods for retail sale to disclose information about bioengineered food and bioengineered food ingredients. While compliance with all of the Standard’s requirements will not be mandatory until January 1, 2022, a “voluntary compliance period” began on January 1, 2020, during which time regulated entities (above $10 million in gross receipts) must identify covered products and may (but are not required to) disclose bioengineered foods and ingredients. 

On July 2, 2020, AMS published final guidance with accompanying “frequently asked questions” (FAQ) documents to facilitate regulated entities’ compliance with the Standard’s disclosure exemption for refined foods and ingredients that do not contain a “detectable amount” of modified genetic material. The first guidance document describes how a refining process may be validated such that a food or ingredient refined through that process need not be further tested for modified genetic material. The second document addresses acceptable testing methods of specific foods or ingredients.

This new guidance is not binding on regulated entities but is intended to provide clarity regarding the existing requirements established under the final NBFD Standard.

Background

Unless otherwise exempt, the presence of a bioengineered food or food ingredient must be disclosed in product labeling by the regulated entity. Three categories of entities are responsible under the Standard: food manufacturers, food importers, and food retailers that package food or sell food in bulk containers or displays.

The Standard incorporates the statutory definition of “bioengineered food,” which means a food “that contains genetic material that has been modified through in vitro recombinant deoxyribonucleic acid (rDNA) techniques and for which the modification could not otherwise be obtained through conventional breeding or found in nature.” 7 C.F.R. § 66.1. However, a food does not contain modified genetic material if the genetic material is “not detectable,” which can be demonstrated via:

  1. records to verify that the food is sourced from a non-bioengineered crop or source;

  2. records to verify that the food has been subjected to a refinement process validated to make the modified genetic material in the food undetectable; or

  3. records of testing appropriate to the specific food that confirm the absence of modified genetic material. 

7 C.F.R. § 66.9(a). A regulated entity may use any of these three methods to determine that no modified genetic material is detectable in their product. AMS’s latest guidance documents clarify the second and third of these options: validating refinement processes and testing the specific food.

Validating Refinement Processes

In its final guidance, AMS identifies and discusses eight general steps to validate a refinement process that makes the modified genetic material undetectable:

  1. Identify raw materials, ingredients, and product-contact materials.

  2. Define characteristics and intended use of end product.

  3. Define the sequence and interaction of all processing steps used to arrive at the end product.

  4. Identify the key steps or parameters (e.g., time, temperature, or content level) that may influence the end product’s characteristics and its ability to meet specified requirements.

  5. Assemble relevant validation information that demonstrates that the refinement process works as intended.

  6. Continually verify that the process is operating as validated.

  7. Revalidate the refinement process if significant changes are made to the process.

  8. Maintain records of the validation and ongoing verification.

AMS clarifies that a refining process may be validated as a whole; individual steps do not require validation. Thus, a process may be validated to show that any modified genetic material has been rendered undetectable by the time the food or ingredient has reached a certain step, but it is not necessary to identify the exact point at which that material became undetectable. If a part of a production process is common to multiple ingredients, that common part of the process may also be validated.

Validated processes do not need to be re-validated unless a regulated entity makes a “significant change,” which AMS defines as “changes to key steps that could impact or affect the process’s ability to make modified genetic material undetectable (i.e. time, temperature, content level).” Minor changes that do not hinder this ability do not require revalidation.

Testing the Specific Food

AMS’s testing methods guidance identifies five factors “critical” for ensuring that a food-specific testing method is “fit for purpose.” According to AMS, when testing for modified genetic material in a food or ingredient, a regulated entity should ensure that its testing method is:

  1. Specific to the analyte of interest;

  2. Appropriate (validated) for the product or commodity being tested;

  3. Accurate, precise, robust, reliable, and reproducible;

  4. Have appropriate sensitivity for the measurement value; and

  5. Be accessible and practical for testing needs.

To this end, AMS recommends that regulated entities use validated methods accepted by international bodies or validate their own methods to detect modified genetic material. 

AMS specifically notes that while polymerase chain reaction (PCR) is the most widely used and commercially accepted test method for determining whether modified genetic material is detectable in a food or ingredient, it may not be appropriate for all target analytes or products. For instance, highly refined foods may contain lipids that interfere with a PCR reaction. Regulated entities should therefore follow appropriate procedures to either remove PCR-inhibiting compounds or identify alternative testing methods to ensure compliance with the Standard.

AMS also clarifies that testing laboratories must meet the above standards, and recommends that regulated entities choose to work with laboratories that adhere to the ISO 17025 standard for testing and calibration laboratories.

Compliance Determined by Recordkeeping

Both of AMS’s new guidance documents reinforce that it does not intend to test individual food products to ensure compliance with the Standard’s disclosure requirements. Rather, AMS may audit a regulated entity’s records to determine whether they have complied with those requirements. Regulated entities should therefore maintain “customary or reasonable records” for at least two years beyond a product’s date of sale or distribution for sale, which may include supply chain records, supplier attestations, third party certifications, laboratory testing results, validated process verifications, or other records normally generated or maintained by the business.

© 2020 Beveridge & Diamond PC National Law Review, Volume X, Number 190

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About this Author

Alan J. Sachs Regulatory Attorney Beveridge & Diamond Washington, DC
Principal

Alan’s practice focuses on the wide range of regulatory issues faced by the global agriculture, food, biotechnology, and bioenergy industries.

Practicing environmental law provides him with daily opportunities to use his legal skills and training to help clients overcome often extremely technical business and regulatory challenges in order to ensure compliance with applicable environmental requirements.

He advises numerous Forbes Global 2000 companies on the legal and regulatory requirements associated with both domestic and foreign production, and the import, export, and...

202-789-6049
Kathryn E. Szmuszkovicz Litigation Attorney Beveridge & Diamond Washington, DC
Managing Principal

Kathryn E. Szmuszkovicz litigates and provides strategic regulatory counsel.

Kathy litigates on behalf of individual companies, groups of companies and trade associations in federal and state courts across the country. She also provides alternative dispute resolution (ADR), compliance, strategic planning, and commercial services focused on the regulatory aspects of her clients’ businesses. Kathy’s practice focuses on clients who manufacture, sell, and use products regulated by EPA, USDA, FDA, DOI, DOC, and analogous state agencies under the environmental, health, and safety laws that these agencies implement.

In particular, Kathy works with clients in the agricultural sector (including pesticides and seeds businesses), and food, chemicals, and consumer products industries. This includes traditional products and products produced through biotechnology or nanotechnology. Examples of her work include:

  • Bringing or defending litigation where necessary to protect clients’ products, projects, or practices.
  • Advising clients on strategies for obtaining federal approvals for new products or substances, defending products once they are on the market, and phasing out products for regulatory or commercial reasons.
  • Advising clients who manufacture, sell, license, or use these regulated products on government requirements and commercial transactions.
  • Defending companies against enforcement actions.
  • Proposing and commenting on regulatory and legislative initiatives.
  • Supporting acquisition or sale of particular products or businesses.
  • Advising on stewardship and sustainability practices.

Kathy has litigated in federal courts across the country, including the United States Supreme Court, and has represented clients in every EPA region and many states. She has advocated for clients in ADR proceedings, including ADR mandated by statute, mini-trials and other ADR designed by parties to resolve disputes privately without court intervention, and mediation.

Kathy is Beveridge & Diamond’s firmwide Managing Principal. Before assuming this role, she served for many years on B&D's Management Committee and as the chair or co-chair of the firm’s pesticides and biotechnology practices. Kathy served for six years on the Board of Directors of a privately held company that discovers, manufactures, and sells proprietary chemicals. Before her legal career, Kathy served in federal and Michigan state government.

202-789-6037
Jack B. Zietman Regulatory Environmental Attorney Beveridge & Diamond Washington, DC
Associate

Jack litigates and practices regulatory environmental law with a focus on groundwater issues and the agriculture, food, and chemical manufacturing industries.

His representative experience includes work on products liability and environmental tort litigation, as well as regulatory counsel for products regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA). He is also familiar with fishery management issues, particularly pertaining to the conservation of endangered species, and the evolving U.S. regulations of...

202-789-6036