bioengineered food disclosure rulemaking update

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Bioengineered Food Disclosure Rulemaking UpdateKaren E. Carr, Partner, Arent Fox LLP

8th Annual Food Policy ImpactFebruary 12, 2019

Federal Disclosure Law: BackgroundStatute passed Senate and House in July 2016Key concepts– UNIFORMITY

– Requires Secretary of Agriculture to establish a national, uniform disclosurestandard for food intended for human consumption that is or may be “bioengineered”

– 3 options for disclosure: symbol, text, electronic or digital link

– PREEMPTION– Prevents states and local governments from establishing or enforcing disclosure or

labeling requirements except those that are identical to the national standard

28th Annual Food Policy Impact, February 12, 2019

Federal Disclosure Law: Key Concepts

BIOENGINEERING: “With respect to a food, refers to a food—– (A) that contains genetic material that has been modified through in

vitro recombinant DNA techniques; AND– (B) for which the modification could not otherwise be obtained through

conventional breeding or found in nature”


Federal Disclosure Law: Preemption

Preemption #1:– “[No] State or political subdivision of a State may directly or

indirectly establish under any authority or continue in effect as to any food in interstate commerce any requirement relating to the labeling or disclosure of whether a food is bioengineered or was developed or produced using bioengineering for a food that is the subject of the national bioengineered food disclosure standard … that is not identical to the mandatory disclosure requirement under that standard.” Subtitle E, Section 293(e).


Federal Disclosure Law: Preemption

Preemption #2:– “No State or political subdivision of a State may directly or

indirectly establish under any authority or continue in effect as to any 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….” Subtitle F, Section 295(b).


Federal Disclosure Law: USDA ActivityUSDA State Preemption Letter30 “Proposed Rule Questions Under Consideration” (July 2017)Access/retailer Study (Sept. 6, 2017)Notice of Proposed Rulemaking (May 4, 2018)Final Rule (December 21, 2018)


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Final Rule: Compliance TimingImplementation date – January 1, 2020– Date for “small food manufacturers” is January 1, 2021– “Small food manufacturers” = annual receipts of at least $2.5M but

less than $10M

All may voluntarily comply until December 31, 2021 – Okay to use Vermont labels, stickers, ink stamps during that period

Mandatory compliance – January 1, 2022


Final Rule: “Bioengineered Food”Applies to:– Foods for human consumption (not pet food or animal feed)– Foods subject to FDA labeling requirements:

– Raw and processed foods, seafood– Dietary supplements

– Foods subject to USDA’s labeling requirements for meat, poultry, and egg products if:

– most predominant ingredient independently subject to FDA labeling; or– most predominant ingredient is broth, stock, water, or similar solution and 2nd most

predominant ingredient independently subject to FDA labeling


Final Rule: Mandatory DisclosureResponsible parties:– Food manufacturers – Retailers who package or who sell in bulk– Importers

Location:– Info panel adjacent to manufacture name/location– Principal display panel– Alternate (if insufficient space)


Final Rule: “Bioengineered Food”“Bioengineered foods” are subject to the BE disclosure requirement unless exemptedA BE food is:– Subject to factors, conditions, and limitations*– A food that contains detectable genetic material modified through in

vitro recombinant deoxyribonucleic acid (rDNA) techniques for which the modification could not otherwise be obtained through conventional breeding** or found in nature**

– *Incidental additive present in food at an insignificant level and that does not have any technical or functional effect in food

– Agency did not define “conventional breeding” or “found in nature”


Final Rule: “Bioengineered Food”Applies to:– BE processing aids and enzymes

– Foods produced using BE processing aids and enzymes are covered unless they meet FDA’s definition of “incidental additives” or are otherwise exempted

– Agency indicated it could not categorically exempt microorganisms in final rule, factors and conditions process could do so


Final Rule: “Bioengineered Food”Applies to:– Refined ingredients

– Refined ingredients that do not contain detectable modified genetic material are not BE foods and are not subject to disclosure

– Three ways to demonstrate non-detectability:– verification that product is sourced from a non-BE crop or food– verification that the product has been subjected to a refinement process

validated to render modified genetic material undetectable– maintaining certificates of analysis/other testing records to confirm absence of

modified genetic material re specific product


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Final Rule: ExemptionsFood served in restaurants or similar retail food establishmentsVery small food manufacturers (annual receipts < $2.5M)Food solely because derived from animals fed BE feed– Declined to extend exemption to yeast, rennet, or enzymes produced by

fermentation using a BE substrate


Final Rule: ExemptionsThreshold– “A food in which no ingredient intentionally contains a BE substance, with an

allowance for inadvertent or technically unavoidable BE presence of up to five percent (5%) for each ingredient”

– Disclosure required for foods with any intentional BE content or that unintentionally contain more than 5% of a BE substance for any single ingredient


Final Rule: ExemptionsFood certified under National Organic Program– Covers food with “100% Organic,” “Organic,” and “Made with Organic”

labels– May also be labeled “non-bioengineered,” “Non-GMO,” or similar – Food products with <70% organically-produced ingredients are not

exempt and remain subject to disclosure


Final Rule: The ListThe List:

– “Tool” for regulated entities– Intended to include BE foods currently produced

domestically and in other countries that could be offered for retail sale in the US

– Non-exhaustive– Actual knowledge– Presumption


Final Rule: The ListThe List:

– Process for annual review/revision

– Federal Register announcement seeking

recommendations for additions/deletions

– Inter-agency consultation

– Authorized and in production somewhere in the world

– 18-month compliance grace period

– Fact sheets: https://goo.gl/hU8PGp

8th Annual Food Policy Impact, February 12, 2019 17

Final Rule: The ListAlfalfaApple (ArcticTM varieties)CanolaCornCottonEggplant (BARI Bt Begun varieties)Papaya (ringspot virus-resistant varieties)

Pineapple (pink flesh)Potato Salmon (AquAdvantage®)SoybeanSquash (summer)Sugarbeet


https://goo.gl/hU8PGp

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Final Rule: Factors & Conditions“Other factors and conditions”

– Process for adding exemptions– Petition and rulemaking– Standards for consideration; inter-agency consultation

– Incidental additivesIntended impact is to limit scope of definition of BE food, potentially excluding certain products from disclosure


Final Rule: Mandatory DisclosureText– “bioengineered food” or– “contains a bioengineered

food ingredient”

Symbol

Electronic/Digital Link– “Scan here for more food

information” – “Call [1-000-000-0000] for

more food information” in close proximity to link

Text message

2018 IFT Food Policy Impact 20

Final Rule: Add’l Options for DisclosureSmall food manufacturers

– Phone number (“call 1-800… for more food information”) – URL (“visit www.xxx” for more food information”)

Small/very small packages– Definitions from FDA labeling requirements: 21 CFR 101.9– Small/very small: “Scan for info” or “Text for info”– Very small: preexisting URL or telephone number

Bulk containers– Must appear on signage other materials (stickers, bindings) on or near item– May use any disclosure option


Final Rule: Voluntary Disclosure(1) Exempt entities (comply with mandatory disclosure req’ments)

– Very small food manufacturers– Restaurants and other retail food establishments

(2) Foods derived from BE crops or foods in which rDNA material is not detectable:

– “Derived from bioengineering” or – Contains “ingredients derived from bioengineered source”

Not available for exempt foods: certified organic foods, below threshold, foods solely because derived from animals fed BE feed


Final Rule: Absence ClaimsAct does not authorize absence claims– FDA and FSIS retain authority– “Entities seeking to use absence claims should ensure that such claims

are in compliance with all applicable Federal laws and regulations and are otherwise truthful and not misleading.”

Act does not give USDA “authority to establish or align the NBFDS with a non-GMO label” Voluntary labeling initiatives, e.g., non-GMO Project, if in compliance with all applicable Federal laws and regulations


Final Rule: Administrative ProvisionsRecordkeeping – Responsible parties

– Food manufacturers, importers, retailers, any others – Self-determination– Retain for 2 years

– Records maintained for foods on The List or “actual knowledge” foods– USDA can request


http://www.xxx/

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Final Rule: Administrative ProvisionsEnforcement– Written complaints, audit/examination if warranted– Objections and hearing request– Summary made public


NBFDL: Issues to WatchPressure re voluntary disclosure/labelingPotential for challenges to final ruleState/local efforts to test preemption provisionsEnforcement under State law – “Nothing in this subtitle, subtitle E, or any regulation, rule, or requirement

promulgated in accordance with this subtitle or subtitle E shall be construed to preempt any remedy created by a State or Federal statutory or common law right.’’ Subtitle F, Section 296.


Questions? Karen E. [email protected]

Arent Fox LLPwww.arentfox.com


bioengineered food disclosure rulemaking update

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