BE Frequently Asked Questions - For Manufacturers

Q. What records are sufficient to verify that a food is sourced from a non-bioengineered crop?

  • A variety of records may be sufficient to verify a food is sourced from a non-bioengineered crop. A non-exhaustive list includes: organic certification, records that show a non-BE crop variety was used, and records that show a food originated in an area where that specific BE food is not produced.

Q. What is a validated refining process?

  • A validated refining process is one that has been demonstrated to make modified genetic material undetectable when followed. Validation is confirmed through testing and through maintenance of processing records.
  • AMS has published a guidance on validation and to select a test method. Both the guidance documents and relevant FAQs can be found under detectability testing.

Q. Once I have validated that a refining process makes modified genetic material undetectable, do I need to continue to test that process?

  • No, once a process has been validated through testing and a regulated entity maintains records showing the validated process is followed, the process does not need to be tested again unless significant changes are made to that refining process.

Q. What kind of testing is required to confirm the presence or absence of modified genetic material?

  • AMS does not specify which tests must be used, but we provide standards of performance regarding detectability testing methodology.
  • In general, the testing laboratory is expected to employ quality assurance standards common to the industry to ensure the validity and reliability of test results.
  • Specific standards of performance are described in § 66.9(c) of the NBFDS, and AMS will provide additional guidance regarding those standards in the future.

Q. What is the threshold for bioengineered substance, and how is it measured?

  • The threshold 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. Because of this reality, even when a non-BE ingredient is used, there may be a trace amount of a BE substance that remains on shared equipment.
  • The threshold exempts food in which no ingredient intentionally contains a bioengineered substance and allows for the inadvertent or technically unavoidable presence of a BE substance, of up to five percent, in each ingredient.

Q. What is inadvertent or technically unavoidable?

  • The inadvertent or technically unavoidable presence of a BE substance is that which occurs unintentionally when reasonable and customary practices are implemented to separate BE and non-BE ingredients. A small amount of BE corn that remained in a combine after a reasonable effort to remove all BE corn before harvesting non-BE corn would be considered inadvertent or technically unavoidable if present in an amount less than five percent. Conversely, if a food manufacturer was producing a non-BE cracker, ran out of one non-BE ingredient, and decided to use a BE version of that ingredient, that would be considered an intentional use and would require a BE food disclosure.

Q. If I am a food manufacturer, importer, or retailer and I don’t use a food, or an ingredient produced from a food, on the List of Bioengineered Foods, am I subject to the Standard?

  • Regulated entities are those responsible for making bioengineered food disclosures on retail food packages. Regardless of a food’s inclusion on the List, the entity responsible for labeling the food for retail sale must comply with the Standard if they have actual knowledge that the food or ingredient is bioengineered.

Q. What are the recordkeeping requirements for regulated entities?

  • Regulated entities must keep records that are customary and reasonable to demonstrate compliance with the Standard. Examples of such records include, among other things, supply chain documents, bills of lading, invoices, supplier attestations, labels, contracts, brokers’ statements, third-party certifications, laboratory testing results, validated process verifications, and other records generated and maintained in the normal course of business.
  • If a regulated entity uses a food, or an ingredient produced from a food, on the List of Bioengineered Foods, the entity must maintain records regarding that food or ingredient.
  • If a regulated entity uses a food, or an ingredient produced from a food, that is not on the List of Bioengineered Foods, but the regulated entity has actual knowledge that the food or ingredient is bioengineered, the entity must maintain records for that food or ingredient.

Q. How long are regulated entities required to retain records that verify compliance with NBFDS?

  • Records can be kept in electronic or paper form and must be kept for two years beyond the date a food is sold or distributed for retail sale.

Q. When am I required to notify USDA of a new BE product being developed?

  • There is no requirement to notify USDA AMS of a new BE product being developed.
  • When conducting annual List reviews, AMS will rely on a variety of resources and public input to determine what foods should be added to the List. Updates to the List will be completed using notice and comment rulemaking.

Q. We are a co-packer of frozen entrees and processed meats containing several ingredients.  Would we have to have records on all of the ingredients for each meal we make?

  • Specific recordkeeping requirements are included at 7 CFR 66.302(b).  If you are using a food (including an ingredient produced from such food) on the List of Bioengineered Foods, which is located at 7 CFR 66.6, then you must maintain records regarding that food or ingredient.  If you have actual knowledge that a food (including an ingredient produced from such food) is bioengineered and make a disclosure in accordance with 7 CFR 66.109, then you must maintain records for that specific food or ingredient.