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On 17 December 2019 the U.S. Agricultural Marketing Service (AMS), an agency within the U.S. Department of Agriculture (USDA), published a request for comments and feedback on draft instructions for validation of refining processes concerning the National Bioengineered Food Disclosure Standard (NBFDS). Comments are due by 16 January 2020.
Verisk 3E Review
The new rule, which became effective on 19 February 2019 with an implementation date of 1 January 2021, (with some exceptions) provides a mandatory uniform national standard for disclosure of information to consumers about the bioengineered (BE) status of foods.
Foods that do not contain detectable modified genetic material are not considered to be bioengineered and do not require disclosure according to the NBFDS (7 CFR 66.1). The recordkeeping requirements for detectability (7 CFR 66.9) provide the requirements for validating that a refining process renders modified genetic material in a food undetectable. A refining process is validated through analytical testing that meets certain standards:
- Laboratory quality assurance must ensure the validity and reliability of test results
- Analytical method selection, validation and verification must ensure that the testing method used is appropriate (fit for purpose) and that the laboratory can successfully perform the testing
- The demonstration of testing validity must ensure consistent accurate analytical performance
- Method performance specifications must ensure analytical tests are sufficiently sensitive for the purposes of the detectability requirements of this part
In the preamble to the final rule, USDA indicated instructions would be provided for the industry to explain how they can ensure acceptable validation of refining processes in accordance with AMS standards (83 FR 65843). AMS has provided a draft of the instructions on the AMS bioengineered food disclosure website.
AMS has developed a List of Bioengineered Foods to identify the crops or foods that are available in a bioengineered form and for which food manufacturers, importers and other retail entities (regulated entities) must maintain records. The list, which is updated annually, is provided in 7 CFR § 66.6 of the standard.
Regulated entities may disclose the presence of bioengineered foods by text, various symbols derived from electronic or digital link and/or text message. Small food manufacturers and very small food packages may utilize additional options such as a phone number or web address to disclose this information.
The standard exempts from disclosure very small food manufacturers (receipts below $2,500) and food served in restaurants or similar retail food establishments such as a cafeteria, food truck, salad bar and train, airline, etc. Regulated entities may voluntarily comply with the standard until 31 December 2021.
Verisk 3E Analysis
The request for comments on the draft instructions for validation of the refining process concerning the NBFDS is extended to food manufacturers, importers and retailers involved in the packaging and labeling of food products for retail sale or the sale of bulk food items. Comments may be sent electronically and will be accepted until 16 January 2020.