National Bioengineered Food Disclosure Standard: Final Rule Presentation for SNAC International - Martin J. Hahn, Partner Veronica Colas, Senior ...

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National Bioengineered Food Disclosure Standard: Final Rule Presentation for SNAC International - Martin J. Hahn, Partner Veronica Colas, Senior ...
National Bioengineered Food Disclosure
Standard: Final Rule
Presentation for SNAC International
Martin J. Hahn, Partner
Veronica Colas, Senior Associate
January 9, 2019
National Bioengineered Food Disclosure Standard: Final Rule Presentation for SNAC International - Martin J. Hahn, Partner Veronica Colas, Senior ...
Agenda
• Quick highlights
• Deep dive
  – Background
  – Scope of the disclosure standard
  – Mechanics of disclosure
  – Recordkeeping and compliance

                                       Hogan Lovells | 2
National Bioengineered Food Disclosure Standard: Final Rule Presentation for SNAC International - Martin J. Hahn, Partner Veronica Colas, Senior ...
Quick highlights of final rule
1.       Mandatory compliance date = Jan. 1, 2022
     –    “Implementation date” of Jan. 1, 2020 for large food manufacturers; Jan. 1, 2021 for small
          manufacturers with ≥ $2.5M and < $10M in annual receipts
2.       Refined ingredients/foods not subject to mandatory disclosure, provided they
         contain no detectable levels of modified DNA
3.       Voluntary disclosure permitted for refined ingredients/foods using specific text
         (“derived from bioengineering”) or symbol, but narrow in scope
4.       Threshold = no disclosure required where the food contains no more than 5%
         per ingredient of inadvertent/technically unavoidable presence of BE
         substances (No 0.9% threshold for intentionally added BE ingredients)
5.       Incidental additives exempt; no other categorical exemptions other than those in
         statute (e.g., certified organic foods)
6.       Disclosure
     –    Text = “bioengineered” or “contains [a] bioengineered food ingredient(s)”
     –    Symbol uses the term “bioengineered” (see image of symbol to the right)
     –    Digital/electronic link – must provide on-pack telephone number and disclosure must appear on first
          screen accessed from link
     –    Text message disclosure option
                                                                                                                Hogan Lovells | 3
National Bioengineered Food Disclosure Standard: Final Rule Presentation for SNAC International - Martin J. Hahn, Partner Veronica Colas, Senior ...
Background
National Bioengineered Food Disclosure Standard: Final Rule Presentation for SNAC International - Martin J. Hahn, Partner Veronica Colas, Senior ...
Background
• States passed laws mandating food
  labels disclose GMO content
  – Vermont law became effective June 2016
  – Food industry could not label foods for one
    state

                                                  Hogan Lovells | 5
National Bioengineered Food Disclosure Standard: Final Rule Presentation for SNAC International - Martin J. Hahn, Partner Veronica Colas, Senior ...
GMO Labeling: Help Has Arrived!
• Signed into law July 30, 2016
• The law:
  – Preempts state and local GE labeling laws
  – Provides a mandatory national disclosure standard for
    bioengineered foods, to be implemented by USDA
    – USDA must establish the mandatory disclosure standard
      within 2 years of the bill’s enactment

                                                              6
National Bioengineered Food Disclosure Standard: Final Rule Presentation for SNAC International - Martin J. Hahn, Partner Veronica Colas, Senior ...
Scope of Rulemaking
• Congress left many key details to be worked out by USDA’s Agricultural
  Marketing Service (AMS) in rulemaking
  – Which foods are within the scope of the standard?
  – Which foods are BE foods requiring a disclosure?
  – What process should be established to create exemptions and what considerations apply?
  – What threshold of a bioengineered substance makes the food a BE food?
  – What are the specifics of how the disclosure will be made?
  – What is the compliance date?
• Does not require USDA to define “non-GMO”
• A food will not be considered “not bioengineered,” “non-GMO,” or any
  similar term simply because the food is not required to bear a
  bioengineering disclosure
                                                                                             7
National Bioengineered Food Disclosure Standard: Final Rule Presentation for SNAC International - Martin J. Hahn, Partner Veronica Colas, Senior ...
AMS Implementation of Law
• August 2017: AMS solicited comments from stakeholders on 30 questions
  posted on its website
  – Over 112,000 responses!

• AMS completed a study on technological challenges related to electronic
  or digital disclosure methods
• May 2018: AMS issues proposed rule; comments due July 3
  – 14,000 comments received

• August 31, 2018: AMS sends final rule to OMB for review
• Dec. 20, 2018: Final rule released

                                                                            8
National Bioengineered Food Disclosure Standard: Final Rule Presentation for SNAC International - Martin J. Hahn, Partner Veronica Colas, Senior ...
Definition of “Bioengineering” and “Bioengineered food”
• Statutory definition:
   • The term “bioengineering” is defined to refer to a food that (A) contains genetic
     material that has been modified through in vitro recombinant deoxyribonucleic acid
     (DNA) techniques; and (B) for which the modification could not otherwise be obtained
     through conventional breeding or found in nature.
• A key issue for AMS to determine: Does the definition cover refined ingredients that are
  derived from a BE crop but have been processed and may no longer contain modified DNA?
   • e.g., sugar from BE sugar beets, high fructose corn syrup from BE corn
• In July 2016, USDA stated that it interprets the statutory language as providing authority to
  require disclosure for such refined ingredients
• In comments to AMS, the food and agriculture industries were split on whether refined
  ingredients should require disclosure

                                                                                                  9
National Bioengineered Food Disclosure Standard: Final Rule Presentation for SNAC International - Martin J. Hahn, Partner Veronica Colas, Senior ...
Scope of Standard
How to Determine Whether Disclosure is Needed
1.   Who is responsible for the disclosure?
2. Is the product a “food”?
3. Does the food fall within the scope of the
   standard?
4. Is the food a “bioengineered” food requiring
   disclosure?
5. Do any exemptions apply?

                                                  Hogan Lovells | 11
1. Who is responsible for the disclosure?
• If food is pre-packaged (before receipt by
  a retailer)
  –  the manufacturer or the importer of
    record

• If a retailer packages the food
  –  the retailer

• Bulk foods
  –  retailer is responsible for signage

                                               Hogan Lovells | 12
2. Is the product a “food”?
• “Food” is defined as a “food (as defined in section 201 of the Federal
  Food, Drug, and Cosmetic Act (21 U.S.C. 321)) that is intended for human
  consumption”
  – Pet food and animal feed are not covered
  – Dietary supplements, processing aids, and enzymes, are all “food”

                                                                        Hogan Lovells | 13
3. Does the food fall within the scope of the standard?
• Law covers:
  – Products subject to labeling requirements under the FFDCA
  – Meat, poultry, and egg products subject to labeling requirements of
    the FMIA, PPIA, and EPIA only if:
        – the most predominant ingredient would be subject to FFDCA;
          OR
        – if the most predominant ingredient is broth, stock, water, or a
          similar solution, and the second most predominant
          ingredient is subject to the FFDCA
• All other meat, poultry, and egg products are excluded
• AMS defines “predominance” as the order of ingredients
  on the label by weight
  – “Predominant ingredients are those most abundant by weight in the
    product”

                                                                            Hogan Lovells | 14
3. Does the food fall within the scope of the standard?
• Examples
 – Soup with ingredients of broth, carrots, chicken,
   etc.
   – Falls within the scope of the standard because
     chicken is the third-ingredient – not the second after
     broth
   – Separate question as to whether it is a BE food
     requiring disclosure
 – Canned ham with ingredients of pork, corn syrup,
   etc.
   – Not subject to standard because pork is the most
     predominant ingredient
   – (Doesn’t matter if corn syrup is from BE corn)
 – Pork rinds with first ingredient of pork are exempt
                                                              Hogan Lovells | 15
4. Is the food a “BE food”?
• Bioengineered food means—
 – A food that contains genetic material that has been modified
   through in vitro recombinant deoxyribonucleic acid (rDNA)
   techniques and for which the modification could not otherwise be
   obtained through conventional breeding or found in nature;
   provided that
  – Such a food does not contain modified genetic material if
    the genetic material is not detectable pursuant to § 66.9.
• Note, “conventional breeding” and “found in nature” are not
  defined

                                                              Hogan Lovells | 16
Treatment of refined ingredients
• For refined foods or ingredients that are derived from BE sources (e.g., corn
  syrup derived from BE corn), no disclosure is required if the food does not
  contain detectable modified genetic material
• Final rule sets out how to demonstrate that modified DNA is undetectable
  1.   Records verifying the food is from a non-BE source
  2. Records showing the food has been subject to a refinement process “validated” to render
     modified genetic material undetectable
       – Once process is validated, additional testing not needed, provided no significant changes to
         process
  3. COAs or other testing records appropriate to the specific food tested that confirm the absence
     of modified genetic material
• Rule includes standards of performance for testing
• AMS states that if testing methodologies evolve so that the modified DNA in a
  food becomes detectable in the future, the food would be subject to disclosure
                                                                                             Hogan Lovells | 17
Bioengineered foods list
•   Alfalfa
•   Apple (Arctic™ varieties)
•   Canola
•   Corn
•   Cotton
•   Eggplant (BARI Bt Begun varieties)
•   Papaya (ringspot virus-resistant varieties)
•   Pineapple (pink flesh)
•   Potato
•   Salmon (AquAdvantage®)
•   Soybean
•   Squash (summer), and
•   Sugar beet                                    Hogan Lovells | 18
Bioengineered foods list
• Non-exhaustive!
• The list is just a starting point – a “tool” to help regulated entities
  – Even if a food is not on the list, companies with actual knowledge that a food they are
    selling is bioengineered are subject to the disclosure requirements
     – AMS example: “enzymes, yeasts, and other similar foods produced in controlled
       environments”
  – Simply because a crop or food is on the list does not necessarily mean it requires
    disclosure; if, for example, the regulated entity maintains records that they are using a
    non-bioengineered version of the food or the food does not contain
• AMS will maintain more detailed information on its website about each
  food/crop on the list to help determine whether disclosure is required

                                                                                       Hogan Lovells | 19
Future revisions to the BE foods list
• AMS will review the list of BE foods annually,
  and update it as needed via rulemaking
• The final rule provides an 18-month
  compliance period from the effective date of
  any revisions for regulated entities to revise
  labels
• “AMS maintains that the products of
  technology, rather than the technology itself,
  should determine whether a food meets the
  BE food definition”

                                                   Hogan Lovells | 21
4. Is the food a BE food?
Do “other factors or conditions” affect the foods BE status?

• The final rule establishes a process for submitting a request or petition to
  limit the scope of the definition of bioengineered food, based on other
  “factors or conditions”
• AMS also listed one “factor or condition” in the final rule:
  – Incidental additives – i.e., those that are present in food at an insignificant level and
    that do not have any technical or functional effect in the food – are not considered BE
    foods.

                                                                                      Hogan Lovells | 22
Yeasts, enzymes, microorganisms
• If they qualify as incidental additives that
  are not required to be labeled as ingredients
  on a food label, then they do not require
  disclosure as BE foods
• If they do not meet the incidental additive
  definition, may require disclosure unless
  they are otherwise exempt (e.g., if the
  modified DNA is not detectable)
• No categorical exemption for
  microorganisms or other fermentation
  products, but such an exemption could be
  considered through the factors and
  conditions petition process

                                                  Hogan Lovells | 23
5. Are there any applicable exemptions?
1. Food served in a restaurant or similar
   retail food establishment
  – Packaged foods sold by manufacturers to food service
    establishments are not exempt
  – The portions of grocery stores that prepare food for
    immediate consumption (e.g., deli or prepared food section)
    are exempt
  – AMS suggests in the preamble that unpackaged food in the
    produce section would be subject to disclosure if it is a BE
    food
  – Foods that are packaged by retailers or sold in bulk require
    disclosure, although bulk foods may use signage rather than
    the label

2. Very small food manufacturers
  – Less than $2.5M in annual receipts                             Hogan Lovells | 24
Exemptions, continued
3. A food derived from animals is not
   considered a BE food solely because the
   animal consumed feed produced from,
   containing, or consisting of a BE substance
  – Milk, meat, eggs would not be considered “bioengineered”
    solely because the cow, animal, or chicken consumed BE
    feed
  – Insects are considered animals, so honey is exempt
  – Rennet and other enzymes derived from animals are also
    exempt (but microbial rennet and enzymes are not
    categorically exempt)

                                                               Hogan Lovells | 25
Exemptions, continued – organic foods
4. Foods certified under the National Organic Program
  – Covers all NOP certified label categories (‘‘100% Organic,’’ ‘‘Organic,’’ and
    ‘‘Made with Organic ____’’)
  – Does not cover products with less than 70% organic ingredients
  – Organic products are also eligible for a “non-GMO” claim (per statute)

                                                                               Hogan Lovells | 26
Exemptions, continued – Threshold
5. Foods with less than a designated amount of BE substances due to
   inadvertent presence
  – Statute directs AMS to determine the amounts of a “BE substance” that may be present in
    order for a food to be considered a BE food
     – “BE substance” = substance that contains modified genetic material
     – e.g., BE soy in wheat flour would be a “BE substance”
  – Final rule establishes a threshold for the inadvertent or technically unavoidable presence
    of BE substances of up to 5% for each ingredient, provided that no ingredients are
    intentionally used in the food that contain a BE substance
  – No threshold for intentionally added BE ingredients unless the ingredient qualifies as an
    incidental additive

                                                                                      Hogan Lovells | 27
Threshold
• As an example, we interpret the final rule as not
  requiring disclosure for a food that contains wheat
  flour as an ingredient, when the wheat flour
  contains no more than 5% of BE soy and BE corn
  due to cross contact
• Only customary business records required:
  • “AMS will look to the records to determine
    whether a regulated entity intended to purchase
    non-BE ingredients and the documentation they
    have from their suppliers indicating as much”

                                                        Hogan Lovells | 28
Mechanics of Disclosure
Disclosure Options
•   Disclosure Must Be:
    1. A text
    2. Symbol
    3. An electronic or digital link (can’t use URL), or
    4. A text message disclosure
         – A new option established by AMS based on the agency’s determination that consumers
           would not have sufficient access to the disclosure through only digital means under ordinary
           shopping conditions
    Small businesses (at least $2.5M but less than $10M in annual receipts) get two more options:
    5.   A telephone number and language, or
    6. A website URL
    Additional flexibility for small and very small packages
                                                                                                      30
Disclosure Options
• Disclosure Must Be:
                                            What does the text say?
  1. A text disclosure                          • “Bioengineered food”
                                                     • If the food is a raw agricultural
  2. Symbol
                                                        commodity or a processed food
  3. An electronic or digital link (can’t               that contains only BE food
     use URL)                                           ingredients
                                                • “Contains a bioengineered food
  4. A text message disclosure
                                                   ingredient”
                                                     • For a multi-ingredient food that
                                                        contains one or more BE food
                                                        ingredients and does not fall
                                                        into the first category above

                                            “May contain” not permitted!
                                                                                           31
Disclosure Options
• Disclosure Must Be:
  1. A text
  2. Symbol
     – Incorporates the word “bioengineered”
     – No “contains a bioengineered food ingredient” option
     – Black and white or specified color versions may be used
     – Symbols found on AMS website
  3. An electronic or digital link (can’t use URL)
  4. A text message disclosure

                                                                 32
Disclosure Options
• Disclosure Must Be:
  1. A text
  2. Symbol
  3. An electronic or digital link (can’t use URL), or
  4. A text message disclosure

                                                         33
Electronic Disclosure Requirements
On package:
1.       Scan here statement. On-package language must appear directly
         above or below the link: “Scan here for more food information” or
         equivalent language that only reflects technological changes
     –   “Scan anywhere on package for more food information,” “Scan icon for more food information”
2.       Link. No specific requirements for how link is to appear (other than
         general prominence and placement requirements). Disclosure may not
         collect, analyze, or sell any personally identifiable information about
         consumers or the devices of consumers.
3.       On-package phone number . Must provide access to the disclosure at
         any time of day. The following must appear in close proximity to the on-
         package link: “Call 1-____________ for more food information”
Disclosure accessed by link:
• Link must provide the disclosure (text or symbol) on the first screen to
  appear on the device after the link is accessed
• Page must exclude marketing and promotional material
                                                                                                       34
Disclosure Options
• Disclosure Must Be:
  1. A text
  2. Symbol
  3. An electronic or digital link (can’t use URL), or
  4. A text message and “text [command word] to
     [number] for more food information”
     – Must include a statement on the package that
       instructs consumers to “Text [command word] to
       [number] for bioengineered food information”
     – Number would be a telephone number or short
       code that immediately responds with the disclosure
       using the disclosure text required under option 1

                                                            35
Disclosure Options
• Disclosure Must Be:
  1. A text
  2. Symbol
  3. An electronic or digital link (can’t use URL), or
  4. A text message disclosure
• Small businesses (at least $2.5M but less than $10M in annual receipts) get two more
  options:
  5. A telephone number and language, or
     – Number and “Call for more food information”
     – Telephone number must provide the disclosure at any time of day
  6. A website URL & “Visit [URL] for more food information”
• Additional flexibility for small and very small packages
                                                                                         36
Disclosure Options
•   Disclosure Must Be:
    1.   A text
    2.   Symbol
    3.   An electronic or digital link (can’t use URL), or
    4.   A text message disclosure
•   Small businesses (at least $2.5M but less than $10M in annual receipts) get two more options:
    5.   A telephone number and language, or
    6.   A website URL & “Visit [URL] for more food information”
•   Additional flexibility for small and very small packages
    – Shortened language on labels: “Call for info”, “Text for info,” “Scan for info”
    – For very small packages only may use existing website URL or telephone number to provide disclosure
    – Very small package = < 12 sq. in total surface area
    – Small package < 40 sq. in total surface area

                                                                                                        37
General Prominence and Placement Requirements
• Apply to all disclosure methods
• Prominence
  – No specific text size requirement
  – Sufficient size and clarity to appear prominently and conspicuously on the label, making
    it likely to be read and understood by the consumer under ordinary shopping conditions

• Placement – 3 options
  1. Information panel, directly adjacent to the statement identifying the name and location
     of the handler, distributor, packer, manufacturer, importer, or any statement disclosing
     similar information
  2. Anywhere on PDP
  3. If insufficient space on 1 & 2, on an alternate panel

                                                                                                38
Voluntary Disclosure
Voluntary disclosure - scope
• The rule is prescriptive with regard to the foods that qualify for the voluntary disclosure
• The following foods clearly qualify for the voluntary disclosure
   –   Foods sold by very small food manufacturers (must use same disclosure as BE foods)
   –   Foods sold by restaurants and similar institutions (must use same disclosure as BE foods)
   –   Foods that contain a refined ingredient derived from a listed BE crop but do not contain detectable DNA (must use
       voluntary disclosure options with distinct language)
• The rule does not authorize a voluntary disclosure for:
   –   Incidental additives that are bioengineered
   –   Inadvertent BE substances at no more than 5% per ingredient
   –   An animal product derived from an animal that consumed BE feed
   –   Being derived from a bioengineered food not on the bioengineered food list
   –   Certified organic foods
• AMS states that an FSIS-regulated food that does not fall within the scope of the standard
  may not bear the voluntary disclosure regardless of the other ingredients in the product

                                                                                                                           40
Voluntary disclosure
• Final rule allows voluntary disclosures that a food is
  derived from a bioengineered source, including when
  modified genetic material is not detectable in the food (e.g.,
  refined ingredients)
• Using one of same methods as for mandatory disclosure
  but using different language
  – Text: “derived from bioengineering” or “ingredient(s) derived from a
    bioengineered source” or “corn syrup derived from a bioengineered
    source”
  – Symbol: AMS has established a unique symbol that can be used on
    foods derived from BE
  – Electronic or Digital Link and phone number
  – Text Message must use above language or symbol, as appropriate         41
Voluntary disclosure - scope
•   If you can’t call them “bioengineered” or “derived
    from bioengineering,” what can you say about FSIS-
    regulated foods with BE ingredients; foods that are
    derived from an animal that consumed BE feed; or
    foods that contain BE incidental additives, trace
    amounts of BE substances due to adventitious
    presence, or refined ingredients derived from foods
    not on the BE food list?
    – “Nothing in this subpart will prohibit regulated
      entities from making other claims regarding
      bioengineered foods, provided that such claims
      are consistent with applicable Federal law.”
      – No similar provision for foods that are not BE
        foods
    – First Amendment considerations

                                                          42
Recordkeeping and Compliance
Compliance Date

    Jan. 1, 2020
                       Jan. 1, 2021
    Implementation
    date for larger                       Jan. 1, 2022
                       Implementation
    manufacturers (≥   date for larger
    $10M annual                           Mandatory
                       manufacturers (≥   compliance date
    sales)             $2.5M and <        for all regulated
                       $10M annual        entities
                       sales)

                                                              Hogan Lovells | 44
Compliance Date
• Mandatory compliance date
  – Beginning Jan. 1, 2022, “all regulated entities must comply with the requirements”
  – “Foods entering commerce after this date must be labeled in compliance with the Standard.”
• Implementation period
  – “Regulated entities should begin implementing the NBFDS… by identifying the foods
    that will need to bear a BE disclosure, the records necessary to meet the recordkeeping
    requirements, and the type of BE disclosure they will use on their products”
  – Now – Dec. 31, 2021: “voluntary compliance period”
  – May also use now-preempted Vermont GMO labeling language during this period
  – Stickering and ink-jetting permitted
  – Dates align with compliance dates for FDA’s nutrition labeling rules
• No label runout period
                                                                                         Hogan Lovells | 45
Compliance dates for NFP and BE food rules – large manufacturers

                                  Continue
            Now              implementing FDA
                              nutrition labeling
                                     rules

                             All FDA-regulated             Begin
           Jan. 1,           products labeled
                            on or after this date
                                                     implementing BE
                                                      food disclosure
           2020             must bear the new
                                    NFP
                                                    rule; may continue
                                                    using VT language

                                                      Foods entering
           Jan. 1,                --
                                                     commerce on or
                                                    after this date must
            2022                                    comply with the BE
                                                    food disclosure rule
                                                                           Hogan Lovells | 46
Compliance dates – small manufacturers ($2.5M to < $10M annually)

                                 Continue
             Now            implementing FDA
                             nutrition labeling
                                    rules

                             All FDA-regulated
            Jan. 1,          products labeled
                            on or after this date
                                                    Begin implementing
                                                     BE food disclosure

             2021           must bear the new
                                    NFP
                                                     rule; may continue
                                                     using VT language

                                                      Foods entering
            Jan. 1,               --
                                                     commerce on or
                                                    after this date must
             2022                                   comply with the BE
                                                    food disclosure rule

                                                                           Hogan Lovells | 47
Enforcement
• Law prohibits:
  – Knowingly failing to disclose that a food is bioengineered as required by the standard and
    USDA’s regulations
  – Declaring that a food is bioengineered except in compliance with the federal standard
• Companies must maintain and make available any records required under
  USDA regulations to establish compliance with the standard
• USDA authorized to conduct audits of records to demonstrate compliance
  with the standard
  – USDA must provide notice and an opportunity for a hearing on the results of the audit, after
    which USDA must make the results of the audit public
• AMS does not have recall authority based on compliance with disclosure
  standard
• “AMS does not intend to test final food products to determine compliance
  with the rule”
                                                                                                   48
Recordkeeping
• Must keep “customary or reasonable” records to demonstrate compliance
  – For example: Supply chain records, bills of lading, invoices, supplier attestations, labels,
    contracts, brokers’ statements, third party certifications, laboratory testing results, validated
    process verifications, and other records generated or maintained by the regulated entity in the
    normal course of business
• Records must contain sufficient detail as to be readily understood and audited
• If a food is on the BE foods list, must keep records regarding the food or
  ingredient
• If a food bears a disclosure based on actual knowledge and is not on the list,
  must maintain records for such food or ingredient
• If records demonstrate that a product originates from a country where BE
  food is not commercially grown, those records are sufficient to justify lack of
  disclosure and demonstrate compliance with the NBFDS
                                                                                             Hogan Lovells | 49
Recordkeeping
• May be in paper or electronic form
• May be maintained at a central location
• Must maintain records at least 2 years after
  the date the food is sold or distributed for
  retail sale
• Must provide to AMS within 5 days upon
  request, unless AMS extends the deadline
• AMS would provide at least 3 days notice if
  the agency needs to access records at the
  entity’s place of business

                                                 Hogan Lovells | 50
Audits or Examinations
• Any interested person may file a written statement or complaint with the
  agency about a possible violation of the disclosure standard
• If AMS determines that reasonable grounds exist for an investigation of
  the complaint, it may conduct an audit or examination of the records of
  the entity responsible for the disclosure
  – After completing the audit or examination, AMS would make its findings available to the
    entity audited
  – The entity could then request a hearing objecting to the AMS finding
  – After the conclusion of the hearing, or after 30 days from the entity’s receipt of the
    finding, if the entity does not request a hearing, AMS would make public a summary of
    the final results of the audit or examination

                                                                                    Hogan Lovells | 51
A note on “non-GMO”
• No specific exemption for products certified
  by third parties as “non-GMO”
• Records created through third-party
  certification programs could be used to
  support a decision not to disclose, to the
  extent the records align with the rule
• Statute and final rule do not address “non-
  GMO” claims, other than:
  – Certified organic foods may bear a non-GMO claim
  – Simply because a food does not require the mandatory
    disclosure does not mean it automatically qualifies as
    non-GMO

                                                             Hogan Lovells | 52
Issues to Consider as You Implement the Rule
• Enzymes declared as ingredients: Are the BE
  microorganisms incidental additives that are
  exempt from disclosure even if rDNA is present in
  the enzyme?
• Packaged foods sold to food service: AMS
  says the packaged food must bear the disclosure
  even though the consumer will never see it
• Truthful Statements: What voluntary
  statements are allowed for foods that don’t qualify
  for the voluntary disclosure?
• Landing Page: When using the electronic link
  option, is your QR code and website set up to
  provide the disclosure appear on the first screen?
• Many others: As we examine the rule more
  closely many others issues likely will surface
                                                        Hogan Lovells | 53
Questions?

             Hogan Lovells | 54
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