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”
38th Annual Food Policy Impact, February 12, 2019
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).
48th Annual Food Policy Impact, February 12, 2019
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).
58th Annual Food Policy Impact, February 12, 2019
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)
68th Annual Food Policy Impact, February 12, 2019
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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
78th Annual Food Policy Impact, February 12, 2019
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
88th Annual Food Policy Impact, February 12, 2019
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)
98th Annual Food Policy Impact, February 12, 2019
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”
108th Annual Food Policy Impact, February 12, 2019
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
118th Annual Food Policy Impact, February 12, 2019
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
128th Annual Food Policy Impact, February 12, 2019
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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
138th Annual Food Policy Impact, February 12, 2019
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
148th Annual Food Policy Impact, February 12, 2019
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
158th Annual Food Policy Impact, February 12, 2019
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
168th Annual Food Policy Impact, February 12, 2019
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
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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
188th Annual Food Policy Impact, February 12, 2019
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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
198th Annual Food Policy Impact, February 12, 2019
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
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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
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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
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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
248th Annual Food Policy Impact, February 12, 2019
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Final Rule: Administrative ProvisionsEnforcement– Written complaints, audit/examination if warranted– Objections and hearing request– Summary made public
258th Annual Food Policy Impact, February 12, 2019
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.
268th Annual Food Policy Impact, February 12, 2019
Questions? Karen E. [email protected]
Arent Fox LLPwww.arentfox.com
288th Annual Food Policy Impact, February 12, 2019