About this course
This course explains how genetically modified organism (GMO), or "bioengineered," testing supports labeling compliance in the United States. Learners walk through why facilities test ingredients and finished products for bioengineered content, what the results mean, and how testing connects to the paperwork a facility must keep on file.
The regulatory driver is USDA's National Bioengineered Food Disclosure Standard (7 CFR Part 66), which became mandatory on January 1, 2022. The standard requires disclosure when a food contains a detectable amount of bioengineered substance, or when any single ingredient contains more than 5% bioengineered substance as a result of inadvertent or unintentional presence. Regulated entities may disclose using on-package text, a symbol, a digital link, or a text message option, and must use the term "bioengineered" rather than alternatives like "GMO" or "genetically modified."
This course is intended for QA staff and regulatory/compliance personnel who manage supplier documentation, coordinate ingredient testing, or maintain records demonstrating disclosure compliance.
After completing this course, learners will understand the disclosure thresholds in the standard, know when analytical testing (such as PCR-based methods that detect bioengineered DNA sequences) is used to verify supplier claims or investigate an unexpected result, and be able to identify what "customary and reasonable" records look like for an audit trail — including supply chain documents, certificates of analysis, and supplier attestations.
Topics covered
- What the National Bioengineered Food Disclosure Standard requires and who it applies to
- The 5% inadvertent-presence threshold and how it's applied
- How PCR-based testing verifies bioengineered content in ingredients and finished goods
- Recordkeeping expectations: supplier attestations, bills of lading, and certificates of analysis
- What to do when a test result conflicts with a supplier's non-bioengineered claim
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