March 15, 2016

S. 764 – Vehicle for the Biotech Labeling Solutions Act

S. 764 – Vehicle for the Biotech Labeling Solutions Act

Noteworthy

Background: Senator Roberts filed substitute amendment 3450 to S. 764, the vehicle for the Biotech Labeling Solutions Act, on March 14, 2016. The amendment builds on S. 2609, a bill to establish a national voluntary labeling standard for bioengineered foods, which the Agriculture, Nutrition, and Forestry Committee reported on March 1 by a bipartisan vote of 14 to 6. The House passed a related bill, H.R. 1599, on July 23, 2015, by a bipartisan vote of 275 to 150.

Floor Situation: On Wednesday, March 16, one hour after the Senate convenes, the Senate will vote on cloture on the motion to concur in the House amendment to S. 764 with Roberts substitute amendment 3450.

Executive Summary: The legislation, as amended by Roberts substitute amendment 3450, will provide for a national voluntary labeling standard for bioengineered foods. If substantial participation is not achieved, it creates an alternative national mandatory labeling standard for bioengineered foods.   

Overview of the Issue

No national standard for voluntary labeling of bioengineered food exists other than the Federal Food, Drug and Cosmetic Act’s prohibition against interstate commerce of food that is misbranded. A food is misbranded if, among other things, “it fails to reveal facts that are ‘material’ regarding representations made or suggested in the labeling or ‘material’ with respect to consequences that could result from the use of the food.”

The Food and Drug Administration generally does not consider a food’s bioengineering to be a material fact that must represented on its labeling. The agency has concluded that a food’s bioengineering does not make it less safe than food developed with traditional plant breeding. The agency only considers a food’s bioengineering to be a material fact that must be represented on its labeling when necessary to protect public health or safety.

Many food companies voluntarily label their foods to indicate that they do not include bioengineered ingredients. Such labeling is lawful as long as it is not false or misleading.

On July 1, Vermont will become the first state to enact a state standard for mandatory labeling of bioengineered food. Connecticut and Maine also have passed state standards, but they will not implement their laws until five contiguous states also pass state standards. State legislatures in New Jersey, Alaska, Hawaii, Iowa, Illinois, and Massachusetts also are considering state standards. State legislatures in Michigan and North Dakota have passed legislation urging the U.S. Congress to pass a uniform labeling standard.

Considerations on the Bill

Opponents of mandatory labeling of bioengineered food have expressed concerns about the developing patchwork of state standards. They argue that consumers might interpret mandatory labeling as “warning labels” implying that bioengineered food is less safe or nutritious than conventional food, even though the preponderance of scientific evidence indicates otherwise. They contend that mandatory labeling would require development of a costly and possibly unattainable supply chain management system to ensure that bioengineered and non-bioengineered foods remain segregated from the farm to the store, with no benefit to the consumer. They worry about having to navigate a complicated patchwork of state standards in the absence of a national standard which would only add to those compliance costs. They have asserted that the marketplace will support a voluntary labeling system if consumers desire to purchase non-bioengineered foods, similar to what exists for organic foods.

Supporters of mandatory labeling of bioengineered food have argued that consumers should have an opportunity to see all relevant information on labels so that they can make food choices based on their own views about its perceived quality or safety.

The legislation provides a compromise national solution to the developing patchwork of state laws. It combines a voluntary national labeling standard with an incentive for the marketplace to provide more information to the consumer. It balances this with a mandatory national labeling standard in the event that the incentive for the marketplace to provide more information to the consumer does not work.

The legislation has broad support among farmers, processors, lenders, retailers, and both Republicans and Democrats in Congress.

Notable Bill Provisions

Amends the Agricultural Marketing Act of 1946.

Section 291 – Definitions

Defines bioengineered food as a food that: (A) contains genetic material that has been modified through in vitro recombinant DNA technology that joins together DNA molecules from two different species that are inserted into a host organism to produce new genetic combinations; and (B) for which the modification could not otherwise be obtained through conventional breeding or found in nature.

Section 293 – National voluntary bioengineered food labeling standard

Requires the secretary of agriculture to establish a national voluntary bioengineered food labeling standard within one year with respect to any bioengineered food and any food that may be bioengineered or may have been produced or developed using bioengineering.

Permits a food to be labeled as bioengineered only in accordance with regulations promulgated by the secretary. Requires those regulations to: (A) prohibit any express or implied claim that a food is or is not safer or of higher quality solely based on whether the food is or is not bioengineered; (B) determine the amounts of a bioengineered substance that may be present in food in order for the food to be labeled as a bioengineered food; (C) establish a process for requesting and granting a determination regarding other factors and conditions under which a food may be labeled as bioengineered food; (D) require that, if a food is voluntarily labeled with scannable images or codes or other similar technologies, the label clearly indicate that more information is available about the ingredients of the food, and the scannable image, code, or similar technology provide direct access to information regarding whether the food is bioengineered.

Prohibits a state or political subdivision of a state from directly or indirectly establishing or continuing for a food in interstate commerce any requirement relating to the labeling or disclosure of whether the food is bioengineered for food that is subject to a bioengineered food labeling standard that is not identical to the legislation’s voluntary standard.  

Section 294 – Substantial participation rulemaking

Requires the secretary to promulgate regulations within one year defining the circumstances that constitute substantial participation by labeled foods with voluntary disclosures of whether the food is, is not, or may be bioengineered. Requires the secretary to consider the following in promulgating those regulations: (1) the percentage of the labeled foods consumed by consumers that disclose whether the food is, is not, or may be bioengineered; and (2) the extent to which there is clear indication in a usual and customary form that information is available for the most frequently consumed labeled foods or direct access to disclosures for the most frequently consumed labeled foods, including through means that are clear and direct other than the label or labeling, such as responses to consumer inquiries through call centers, the Internet, websites, social media, scannable images or codes, or other similar technologies.

Section 294A – National mandatory bioengineered food labeling standard

Requires the secretary to establish a mandatory bioengineered food labeling standard within two years after the date the secretary promulgates regulations for the national voluntary bioengineered food labeling standard and the substantial participation rulemaking only if the secretary determines that there is not at least 70 percent substantial participation.

Permits a food to be labeled as bioengineered only in accordance with regulations promulgated by the secretary. Requires those regulations to: (A) prohibit any express or implied claim that a food is or is not safer or of higher quality solely based on whether the food is or is not bioengineered; (B) determine the amounts of a bioengineered substance that may be present in food in order for the food to be labeled as a bioengineered food; (C) establish a process for requesting and granting a determination regarding other factors and conditions under which a food may be labeled as bioengineered food; (D) exclude food served in a restaurant or similar establishment; and (E) require an appropriate person to disclose food that is subject to the mandatory standard either through a statement made on the labeling or by means other than the labeling, including through call centers, the Internet, websites, social media, scannable images or codes, or other similar technologies.

Prohibits a state or political subdivision of a state from directly or indirectly establishing or continuing for a food in interstate commerce any requirement relating to the labeling or disclosure of whether the food is bioengineered for food that is subject to a bioengineered food labeling standard that is not identical to the legislation’s mandatory standard. 

Prohibits a person from knowingly failing to make a required disclosure. Requires recordkeeping to demonstrate compliance. Provides the secretary with examination and audit, but not recall, authority.

Section 295 – Federal preemption

Prohibits a state or political subdivision of a state from directly or indirectly establishing or continuing for a food or seed in interstate commerce any requirement relating to the labeling of whether a food (including food served in a restaurant or similar establishment) or seed is genetically engineered or was developed or produced using genetic engineering, including any requirement for claims that a food or seed is or contains an ingredient that was developed or produced using genetic engineering.

Administration Position

The administration has not issued a Statement of Administration Policy at this time.

Cost

While CBO has not issued a formal cost report at this time, CBO has determined that the substitute amendment will not affect direct spending.

Amendments

The amendment situation is unclear at this time.