On July 2, 2020, USDA’s Agricultural Marketing Service (“AMS”) published final guidance documents and FAQs to assist companies in complying with the National Bioengineered (“BE”) Food Disclosure Standard (“NBFDS”). Under the NBFDS, a responsible party need not make a BE disclosure for a BE food if the party can show (1) the food is sourced from a non-BE crop or source, (2) through laboratory testing that the food does not contain detectable BE material, or (3) that the food is subject to a refining process validated to make BE material undetectable. The two guidance documents and accompanying FAQs detail how responsible parties can demonstrate no BE disclosure is required under methods (2) and (3) (“Testing Guidance” and “Validation Guidance,” respectively). We summarize below the Testing and Validation Guidances and accompanying FAQs, highlighting changes made from the initial proposals in response to industry comments.

Guidance on Testing Methods

The NBFDS provides high-level principles that should guide BE testing, including that test results be valid, reliable, accurate, and sensitive, and that the test method be fit for purpose. 7 CFR 66.9. AMS’s Testing Guidance provides further details on the considerations that should guide testing methodology and laboratory selection, as well as compliance with recordkeeping requirements.

Under the Testing Guidance, responsible parties should select a test method that is specific to the analyte of interest; appropriate to the commodity tested; accurate, precise, robust, reliable and reproducible; appropriately sensitive; and accessible and practical for testing needs. AMS recognizes that polymerase chain reaction (“PCR”) is the most widely used and commercially acceptable test for detecting BE material. AMS cautions, however, that PCR-inhibiting compounds can limit PCR testing, and that the method selected should be validated for the specific matrix at issue. AMS is also open to the use of emerging technologies, so long as they meet the high-level requirements under 7 CFR 66.9, described above. Regulated entities must maintain “customary or reasonable” records for each ingredient to demonstrate compliance, and records must be kept for two years.

The final Guidance is largely the same as the draft instruction originally proposed, with a few differences:

• AMS removed its prior preference for quantitative over qualitative PCR testing. The FAQs now state that AMS does not prefer one method over the other.
• AMS also removed language from the Guidance cautioning that PCR testing may not be appropriate for highly processed foods that consist almost exclusively of lipids or sugars. It did, however, retain language in the FAQs urging caution with foods that have “inherently interfering compounds,” providing lipids as an example of such compounds.
• The FAQs also clarify that regulated entities should follow Codex guidance for determining sample size.

Neither the Testing Guidance, Validation Guidance, nor the accompanying FAQs establish a level at which BE material is considered “undetectable.”

Guidance on Validating a Refining Process

AMS’s Validation Guidance outlines the steps manufacturers should follow when validating a refining process that removes detectable BE material from a BE food. Under the Validation Guidance, manufacturers should identify “key steps” in the refining process that render BE material undetectable. Manufacturers should define the parameters and limits that make this a key step, and collect evidence or data to demonstrate that key steps consistently and effectively eliminate detectable BE material. This data or information can be gathered through a variety of approaches, including testing and reference to scientific or technical literature. Manufacturers can use existing data and information to validate the process, but must document this data for their own records.

Manufacturers should continually monitor the refining process to ensure it is operating as validated. Revalidation is needed if changes are made to key steps that could impact the process’s ability to meet specified requirements. Regulated entities should maintain “customary or reasonable” records for at least two years to demonstrate compliance, which can include third-party certifications, laboratory testing results, and “validated process verification.”

The Validation Guidance makes several notable changes to the proposed instruction:

• Instead of using the HACCP language of “critical control points,” the Guidance calls these critical processes “key steps.” AMS made this change to “clarify that the Standard is solely for marketing and not related to food safety.”
• The Validation Guidance also appears to narrow the list of acceptable types of information that can validate refining processes by removing mentions of “mathematical modelling” and “surveys.”
• The Validation Guidance requires continued “monitoring,” rather than continued analytical testing, toning down prior language which implied verification required continued testing.
• Language was also added explaining the “customary or reasonable records” that can be used to demonstrate compliance, listed above.
• The Validation FAQs clarified that refining processes can be validated by testing finished ingredients for detectable BE material, rather than validating individual steps.
• The Validation FAQs also clarify that a process, once validated, can be used at other facilities without requiring revalidation. Validation can be done in-house, and can validate a process common to the production of multiple ingredients.
• The Validation Guidance removed prior language suggesting that an “indirect measurement” may be more appropriate than PCR testing when the chemical and physical characteristics of the matrix may cause interference.
• As stated above, AMS declined to impose a particular limit for detectability. AMS says that this does not create a moving target as technology improves because processes can be validated based on testing once, and then continue to use that process (so long as no significant changes are made).

The Testing and Validation Guidance documents, as well as the accompanying FAQs, may be used to comply with the NBFDS by the mandatory compliance date of January 1, 2022.

If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Drug, and Device practice.