[Federal Register Volume 83, Number 245 (Friday, December 21, 2018)]
[Rules and Regulations]
[Pages 65814-65876]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-27283]
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Vol. 83
Friday,
No. 245
December 21, 2018
Part II
Department of Agriculture
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Agricultural Marketing Service
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7 CFR Part 66
National Bioengineered Food Disclosure Standard; Rules
Federal Register / Vol. 83 , No. 245 / Friday, December 21, 2018 /
Rules and Regulations
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DEPARTMENT OF AGRICULTURE
Agricultural Marketing Service
7 CFR Part 66
[Doc. No. AMS-TM-17-0050]
RIN 0581-AD54
National Bioengineered Food Disclosure Standard
AGENCY: Agricultural Marketing Service, USDA.
ACTION: Final rule.
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SUMMARY: This rule establishes the new national mandatory bioengineered
(BE) food disclosure standard (NBFDS or Standard). The new Standard
requires food manufacturers, importers, and other entities that label
foods for retail sale to disclose information about BE food and BE food
ingredients. This rule is intended to provide a mandatory uniform
national standard for disclosure of information to consumers about the
BE status of foods. Establishment and implementation of the new
Standard is required by an amendment to the Agricultural Marketing Act
of 1946.
DATES: Effective Date: This rule becomes effective February 19, 2019.
Implementation Date: January 1, 2020.
Extended Implementation Date (for small food manufacturers):
January 1, 2021.
Voluntary Compliance Date: Ends on December 31, 2021.
Mandatory Compliance Date: January 1, 2022.
FOR FURTHER INFORMATION CONTACT: Arthur L. Neal, Jr, Deputy
Administrator, Transportation and Marketing Program, AMS, USDA, 1400
Independence Ave. SW, Room 4543-S, Washington, DC 20250; email:
[email protected]; telephone: 202-690-1300; or fax: 202-690-0338.
SUPPLEMENTARY INFORMATION: On July 29, 2016, Public Law 114-216 amended
the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et seq.), as
amended (amended Act), by adding Subtitles E and F. Subtitle E of the
amended Act directs the Secretary of Agriculture (Secretary) to
establish the NBFDS for disclosing any food that is or may be
bioengineered. 7 U.S.C. 1639b(a)(1). Subtitle E also directs the
Secretary to establish requirements and procedures necessary to carry
out the new Standard. 7 U.S.C. 1639b(a)(2).
Outline of the Final Rule
I. Introduction
II. Applicability
A. Definitions
B. Food Subject to Disclosure
C. Bioengineered Food
1. Definition of ``Bioengineering'' and ``Bioengineered Food''
2. Conventional Breeding
3. Found in Nature
D. List of Bioengineered Foods
1. List Maintenance and Revision
2. Treatment of Technologies
E. Factors and Conditions
1. Incidental Additives
2. Undetectable Modified Genetic Material
F. Exemptions
1. Food Served in a Restaurant or Similar Retail Food
Establishment
2. Very Small Food Manufacturers
3. Threshold
4. Animals Fed With Bioengineered Feed and Their Products
5. Food Certified Under the National Organic Program
G. Severability
III. Disclosure
A. General
1. Responsibility for Disclosure
2. International Impact
3. Appearance of Disclosure
4. Placement of Disclosure
5. How the List of Bioengineered Foods Relates to Disclosure
a. Disclosure Options
b. Use of the ``May Be'' Option
B. Text Disclosure
C. Symbol Disclosure
D. Electronic or Digital Link Disclosure
E. Study on Electronic Disclosure and a Text Message Disclosure
Option
F. Small Food Manufacturers
1. Definition
2. Telephone Number
3. Internet website
G. Small and Very Small Packages
H. Food Sold in Bulk Containers
I. Voluntary Disclosure
IV. Administrative Provisions
A. Recordkeeping Requirements
B. Enforcement
C. Effective, Implementation, and Compliance Dates
D. Use of Existing Label Inventories
V. Comments on the NPRM
VI. Rulemaking Analyses and Notices
A. Paperwork Reduction Act
1. Comments on Information Collection and Recordkeeping
B. E-Gov
C. Civil Rights Review
D. Executive Orders 12866, 13563, and 13771
E. Final Regulatory Flexibility Analysis
1. Introduction
2. Economic Effects on Small Entities
3. Definition of Small Business
4. Coordination of Definition of Small Food Manufacturers With
FDA Definition
5. Exemptions for Very Small Food Manufacturers
6. Costs to Small Entities
7. Summary
F. Executive Order 13175
G. Executive Order 12988
H. Executive Order 13132
I. Introduction
The Secretary delegated authority for establishing and
administering the NBFDS to the Agricultural Marketing Service (AMS). To
assist with development of the new Standard, AMS posted 30 questions
for public consideration and comment on its website (https://www.ams.usda.gov/rules-regulations/public-input-bioengineered-food-disclosure-questions) on June 28, 2017. Contributors from diverse
backgrounds, including consumers, food manufacturers and retailers,
farmers and processors, State and foreign governments, and various
associations and other interested groups representing consumers and
industry submitted over 112,000 responses. AMS posted the responses on
its website.
AMS considered responses to the 30 questions in the development of
a proposed rule, which was included in a notice of proposed rulemaking
(NPRM) published in the Federal Register on May 4, 2018 (83 FR 19860).
The NPRM outlined AMS's proposed requirements and procedures for the
new Standard to be codified at 7 CFR part 66 and requested public
comment on several regulatory alternatives offered for consideration.
The public comment period closed on July 3, 2018. AMS received
approximately 14,000 comments by the end of the comment period.
Subsequent to publication of the NPRM, AMS published two documents
in the Federal Register related to this proceeding. The first,
published on May 23, 2018 (83 FR 23827), announced the availability of
a recorded webinar about the proposed NBFDS on AMS's website. The
second, published on June 20, 2018 (83 FR 28547), made a correction to
the Initial Regulatory Flexibility Analysis contained in the NPRM to
clarify that the proposed rule was not expected to have a significant
economic impact on a substantial number of small business entities.
AMS also published two supplemental documents related to the NBFDS.
One, a Regulatory Impact Analysis and its supporting documents, was
posted on Regulations.gov at https://www.regulations.gov/document?D=AMS-TM-17-0050-2833. The other, a graphic document showing
alternative proposals for BE food disclosure labels, was posted on
Regulations.gov at https://www.regulations.gov/document?D=AMS-TM-17-0050-0003, and on AMS's website at https://www.ams.usda.gov/sites/default/files/media/ProposedBioengineeredLabels.pdf.
The amended Act directs the Secretary to conduct a study to
identify potential technological challenges related to electronic or
digital disclosure
[[Page 65815]]
methods. See 7 U.S.C. 1639b(c)(1). AMS sponsored such a study, and the
results were published on AMS's website (https://www.ams.usda.gov/reports/study-electronic-or-digital-disclosure) in September 2017.
Public comments on the results of the study were solicited in
conjunction with the NPRM. The Secretary's determination regarding this
matter is discussed in Section III of this final rule.
Finally, Subtitle F of the amended Act addresses Federal preemption
of State and local genetic engineering labeling requirements. 7 U.S.C.
1639i. Subtitle F also specifies that certification of food under the
U.S. Department of Agriculture's (USDA) National Organic Program (NOP)
(7 CFR part 205) shall be considered sufficient to make claims about
the absence of bioengineering in the food. 7 U.S.C. 6524.
The purpose of the NBFDS as contained in this final rule is to
provide a mandatory disclosure standard for BE food, by which uniform
information is provided to consumers. Nothing in the disclosure
requirements set out in this final rule conveys information about the
health, safety, or environmental attributes of BE food as compared to
non-BE counterparts.
In fact, the regulatory oversight by USDA and other Federal
Government agencies ensures that food produced through bioengineering
meets all relevant Federal health, safety, and environmental standards.
The agencies responsible for oversight of the products of biotechnology
include: USDA's Animal and Plant Health Inspection Service (APHIS), the
U.S. Environmental Protection Agency (EPA), and the Department of
Health and Human Services' Food and Drug Administration (FDA). The
Coordinated Framework for Regulation of Biotechnology (Coordinated
Framework) is a policy framework that summarizes the roles and
responsibilities of these three principal regulatory agencies with
respect to regulating biotechnology products.
The final rule is intended to provide for disclosure of foods that
are or may be bioengineered to consumers, but also seeks to minimize
implementation and compliance costs for the food industry--costs that
could be passed on to all consumers. To that end, AMS has tried to
craft requirements that are clear and straightforward, incorporating
flexibility where appropriate. Public input has been invaluable to this
effort; public comments submitted in response to the proposed rule were
critical to the development of the final rule.
The following discussion of the NBFDS is divided into three parts:
(1) Applicability; (2) disclosure; and (3) administrative provisions.
II. Applicability
The amended Act directs USDA to promulgate regulations regarding
foods required to bear a disclosure indicating that the food is or may
be bioengineered. 7 U.S.C. 1639b(b). At the outset, the amended Act
establishes the scope of the NBFDS by defining ``bioengineering'' and
``food,'' and by limiting mandatory disclosure to those foods subject
to the labeling requirements of the Federal Food, Drug, and Cosmetic
Act (FDCA) (21 U.S.C. 301 et seq.) and to certain foods subject to
labeling under the Federal Meat Inspection Act (FMIA)(21 U.S.C. 601 et
seq.), the Poultry Products Inspection Act (PPIA)(21 U.S.C. 451 et
seq.), or the Egg Products Inspection Act (EPIA)(21 U.S.C. 1031 et
seq.) administered by the Food Safety and Inspection Service (FSIS). 7
U.S.C. 1639 and 1639a. Definitions pertinent to the new part 66,
descriptions of foods that are subject to disclosure, and explanations
of applicable exemptions are included in subpart A of the new
regulatory section.
Section 66.3 sets forth the general requirements for disclosure.
Section 66.3(a) requires that labels for bioengineered food must bear a
BE disclosure consistent with the requirements of part 66. Section
66.3(a)(2) prohibits labels for food that is not bioengineered from
bearing a BE disclosure unless the food may bear a voluntary disclosure
under Sec. 66.116, based on records maintained under Sec. 66.302.
A. Definitions
Section 66.1 lists the definitions that apply to new part 66. For
subpart A, the key terms are ``bioengineered food,'' ``bioengineered
substance,'' ``food,'' ``label,'' ``predominance,'' ``similar retail
food establishment,'' ``very small food manufacturer,'' and ``List of
Bioengineered Foods.'' These terms are critical in determining what
foods require a BE disclosure.
B. Food Subject to Disclosure
Whether a food is subject to the labeling requirements of the
amended Act, depends as a preliminary matter on whether the product at
issue is a food. The amended Act codified the definition of ``food'' as
``a food (as defined in section 321 of title 21) that is intended for
human consumption.''\1\ 7 U.S.C. 1639(2). The final rule adopts the
same definition of ``food'' as used in the amended Act.
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\1\ The original text of the amended Act referred to section 201
of the FDCA, but the reference was changed to section 321 of title
21 in the codification of the statute.
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The FDCA defines ``food'' as ``. . . (1) articles used for food or
drink for man or other animals, (2) chewing gum, and (3) articles used
for components of any such article.'' 21 U.S.C. 321(f). Ultimately, FDA
has jurisdiction over the FDCA and has the authority to determine what
is considered ``food'' under the FDCA. AMS has deferred to FDA in
interpreting the definition of ``food.'' However, the amended Act
limits the definition of food for purposes of the NBFDS to articles
used for human consumption and does not include articles used for
animals. Therefore, although pet food and animal feed are ``food''
under the FDCA, such foods for animals are not covered by this
regulation, pursuant to the amended Act. Chewing gum is considered to
be ``intended for human consumption,'' and is therefore considered a
``food'' for the purpose of the NBFDS.
Under the FDCA, the definition of ``food'' includes both articles
used for food or drink and articles used for components of any such
article. For instance, a raw agricultural commodity such as an apple
constitutes food under FDCA. A processed item like a soup with the
following ingredients--water, broccoli, vegetable oil, modified food
starch, and wheat flour--is also a food, as are each of those
ingredients. Other examples of ``food'' under the FDCA include dietary
supplements, processing aids, and enzymes.
Not all food within the FDCA's definition falls within the scope of
the NBFDS. The amended Act limits the disclosure to (1) food that is
subject to the labeling requirements of the FDCA; or (2) food that is
subject to the requirements of the three FSIS statutes previously
mentioned, with certain exceptions. See 7 U.S.C. 1639a. As for the
FDCA, which is under FDA jurisdiction, the NBFDS applies to all foods
subject to its labeling requirements, including but not limited to raw
produce, seafood, dietary supplements, and most prepared foods, such as
breads, cereals, non-meat canned and frozen foods, snacks, desserts,
and drinks. Distilled spirits, wines, or malt beverages as defined by
the Federal Alcohol Administration Act (FAA Act) are foods under the
FDCA but are not subject to the NBFDS because they are subject to the
labeling provisions of the FAA Act rather than the labeling
requirements of the FDCA. Alcoholic beverages not subject to the
labeling provisions of the FAA Act, such as wines with less than seven
percent alcohol by volume and beers brewed without malted barley and
hops,
[[Page 65816]]
would be subject to the NBFDS. The amended Act also specifies that the
NBFDS only applies to foods subject to the labeling requirements of the
three FSIS statutes if the most predominant ingredient of the food
would independently be subject to the labeling requirements under the
FDCA; or if the most predominant ingredient of the food is broth,
stock, water, or a similar solution and the second-most predominant
ingredient of the food would independently be subject to the labeling
requirements under the FDCA. See 7 U.S.C. 1639a(c)(2).
FDA's method of determining predominance relies on weight of the
ingredients, as does FSIS's. The NBFDS uses the same methods FDA uses
to determine predominance at 21 CFR 101.4(a)(1), which provides that
ingredients required to be declared on the label or labeling of a food,
including foods that comply with standards of identity, except those
ingredients exempted by Sec. 101.100, shall be listed by common or
usual name in descending order of predominance by weight on either the
principal display panel or the information panel in accordance with the
provisions of Sec. 101.2. Thus, a multi-ingredient food product that
contains meat, poultry, or egg product (including beef broth, if
identified as a composite ingredient), subject to the FMIA, the PPIA,
or the EPIA, respectively, as the first ingredient of the ingredient
list on the food label would not be subject to the NBFDS, per the
amended Act.
A multi-ingredient food product that contains broth, stock, water,
or similar solution as the first ingredient, and a meat, poultry, or
egg product as the second ingredient on the food label would also not
be subject to the NBFDS. For example, a canned stew where pork is the
primary ingredient followed by other ingredients such as sweet corn,
would not be subject to the NBFDS. The corn may be bioengineered, but
pork, which is subject to the labeling requirements of the FMIA, is the
predominant ingredient, so the canned stew product is not subject to
the NBFDS, per the amended Act. If, however, a meat, poultry, or egg
product is the third most predominant ingredient or lower, the food
would be subject to the NBFDS. For example, a soup with the following
ingredient list--broth, carrots, chicken, etc., would be subject to
disclosure under the NBFDS, and the analysis as to whether it would be
considered a ``bioengineered food'' subject to the NBFDS's disclosure
requirements would continue.
Seafood, except Siluriformes (catfishes), and meats such as venison
and rabbit are subject to the FDCA (but not the Federal Meat Inspection
Act). Thus, a multi-ingredient food product that contains one of these
as the first ingredient would be subject to the NBFDS. A multi-
ingredient product that contained one of these as the second most
predominant ingredient or lower, could also require disclosure, unless
the product is otherwise exempt (for example, due to the predominance
of another ingredient such as chicken or beef, as described above).
C. Bioengineered Food
The amended Act delegates authority to the Secretary to establish
the NBFDS regarding ``bioengineered food.'' 7 U.S.C. 1639b(a). This
authority includes the ability to define ``bioengineered food,''
consistent with the statutory provisions that address this term. The
amended Act also authorizes the Secretary to determine other terms that
are similar to ``bioengineering.'' 7 U.S.C. 1639(1).
1. Definition of ``Bioengineering'' and ``Bioengineered Food''
The amended Act defines ``bioengineering'' with respect to a food
as referring to a food ``(A) that 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.'' 7 U.S.C.
1639(1). In accordance with its statutory mandate and for purposes of
consistency, AMS is directly incorporating this statutory definition
into the definition of ``bioengineered food''.
The NPRM invited public comment on two different interpretations of
the statutory definition of ``bioengineering'' and on the scope of the
regulatory definition of ``bioengineered food.'' Specifically, comments
were solicited on whether refined foods and ingredients should be
subject to disclosure under the NBFDS.
The first interpretation, identified as Position 1 in the NPRM,
stated that refined products do not ``contain genetic material that has
been modified through in vitro recombinant deoxyribonucleic acid (DNA)
techniques'' because the refining process rendered genetic material
undetectable using common testing methods. The second interpretation,
identified as Position 2 in the NPRM, stated that the scope of the
definition of ``bioengineering'' applies to all foods produced from
bioengineering, such as refined products.
AMS adopts Position 1 with some modifications. The statutory
definition of ``bioengineering'' makes clear that food must ``contain[
] genetic material that has been modified through in vitro recombinant
deoxyribonucleic acid (DNA) techniques . . .'' to be labeled as a
``bioengineered food.'' AMS believes that the definition of
``bioengineering'' sets forth the scope of the mandatory disclosure
and, therefore, is incorporated into the definition of ``bioengineered
food.'' A commenter suggested that AMS adopt a definition of ``highly
refined'' if it adopts Position 1. We did not do so because the final
rule does not use that term.
AMS has chosen to adopt the definition of ``bioengineered food''
that hews closely to the plain language of the amended Act. This
definition references Sec. 66.9 to explain how a regulated entity may
demonstrate that a food, including a refined food ingredient, does not
contain detectable modified genetic material. AMS has revised the
proposed definition of ``bioengineered food'' to reflect its
interpretation of the amended Act that foods with undetectable modified
genetic material are not bioengineered foods.
Whether a food or food ingredient contains modified genetic
material may vary depending on the refining process used to produce the
food. For refined foods that are derived from bioengineered crops, no
disclosure is required if the food does not contain detectable modified
genetic material.
Commenters discussed how testing might be used to detect the
presence of modified genetic material in a food. Some commenters stated
that testing for modified genetic material would be difficult to
enforce, expensive, and present barriers to international trade. These
commenters stated that regulated entities may choose to make a BE
disclosure rather than conduct testing, thereby resulting in different
labels for similar food products.
Other commenters supported the use of testing to determine
detectability and offered ideas regarding testing methods and standards
to determine the presence or absence of detectable modified genetic
material. A few commenters asked AMS to establish minimal standards
regarding the analytical tools used for detecting, identifying, and
quantifying modified genetic material. Some commenters also urged AMS
to update the NBFDS as scientific detection methods evolve, and a few
further recommended that AMS maintain publicly available guidance
documents or lists of scientifically validated genetic testing methods
to
[[Page 65817]]
ensure testing consistency in the marketplace.
AMS acknowledges there are multiple ways to determine whether a
food or ingredient contains detectable modified genetic material.
Because the amended Act authorizes examinations, audits, and similar
activities with respect to records for enforcement of the NBFDS (7
U.S.C. 1639b(g)(2)-(3)), AMS added provisions in Sec. 66.9 that
describe how regulated entities can use records to demonstrate that
modified genetic material is not detectable. Regulated entities are in
the best position to know about the products they are sourcing and the
refinement processes they have undergone. An entity's records,
therefore, can be used to demonstrate that modified genetic material is
not detectable.
First, as provided in Sec. 66.9(a)(1), regulated entities can
demonstrate that modified genetic material is not detectable with
records verifying that the food is sourced from a non-bioengineered
crop or other food source, such as non-bioengineered salmon.
Second, as provided in Sec. 66.9(a)(2), regulated entities can
demonstrate that modified genetic material is not detectable in the
food with records verifying that the food has been subjected to a
refinement process ``validated'' to render modified genetic material
undetectable. Process validation for the purposes of the NBFDS can be
achieved through laboratory testing, as provided in Sec. 66.9(b).
Commenters stated that modified genetic material is undetectable when
bioengineered crops are refined or processed under certain conditions.
Commenters described the food refining and manufacturing process and
explained the rigorous quality controls necessary to meet modern
customer demands. Based on this information, AMS believes that once a
refiner's process has been validated by testing to render modified
genetic material undetectable, foods subjected to the same process in a
defined, controlled, documented, and repeated way will also have no
detectable modified genetic material. Regulated entities that produce
or use refined foods may rely on processing records alone to prove the
absence of detectable modified genetic material. In other words, foods
subjected to the validated refining process would not require
additional laboratory testing to prove the lack of modified genetic
material.
To comply with NBFDS requirements, regulated entities can maintain
records to verify the foods they use have been subjected to refining
processes that have been validated to render modified genetic material
undetectable. Such records may include customary processing records
maintained in the normal course of business, as well as copies of the
most recent analytical testing results used to validate the refining
process. Section 66.9(c) provides standards of performance for
analytical testing to validate that foods subjected to specific
refining processes contain no detectable modified genetic material.
Third, as provided in Sec. 66.9(a)(3), regulated entities can
demonstrate that modified genetic material is not detectable by
maintaining certificates of analysis or other testing records
appropriate to the specific food tested which confirm the absence of
modified genetic material. As mentioned above and provided in Sec.
66.9(c), AMS established performance standards related to detectability
analyses for the purposes of the NBFDS.
AMS recognizes that some regulated entities may wish to disclose
that their processed food is derived from a bioengineered source even
when modified genetic material is not detectable in the food. In
addition to the authority to establish the mandatory disclosure
Standard, the amended Act at 7 U.S.C. 1639b(a)(2) grants the Secretary
the authority to establish other requirements that are necessary to
carry out the Standard. AMS has determined, based on numerous comments,
that it is necessary for the Standard to include the ability for
regulated entities to disclose voluntarily that their processed food
was made with ingredients derived from a bioengineered source to
provide a mechanism for regulated entities to provide information to
consumers. This provision is discussed in more detail Section III.I.--
Voluntary Disclosure, below.
2. Conventional Breeding
AMS did not include a proposed definition of ``conventional
breeding,'' a component term of the definition of ``bioengineering.''
The NPRM solicited comments on whether such a definition should be
included in the NBFDS, and if so, what it should be.
Many commenters recommended that AMS define ``conventional
breeding'' within the NBFDS final rule, to better define the scope of
NBFDS for regulated entities and consumers. Several commenters
suggested various definitions, including adopting the definition used
by FDA or from the Codex Alimentarius. Several commenters stated that
the term ``conventional breeding'' is commonly understood in the
industry and, therefore, does not need to be defined. Some of those
commenters who did not support defining the term argued that any such
attempts would be inherently confusing or misleading to consumers.
AMS finds no compelling reason to adopt a definition of
``conventional breeding'' at this time and agrees with commenters who
advised not defining the term. AMS finds that ``conventional breeding''
is a commonly understood term within industry and does not need to be
defined. As techniques and technology evolve, any definition today
could become unworkable or obsolete because it does not and could not
anticipate those advancements. Foregoing defining the term allows AMS
to respond to those challenges in real time.
3. Found in Nature
AMS did not include a proposed definition of ``found in nature,''
another component term of the definition of ``bioengineering.'' The
NPRM solicited comments on whether such a definition should be included
in the NBFDS, and if so, what it should be. The NPRM specifically
requested comments on whether protections under intellectual property
law might be considered when determining whether a genetic modification
could be found in nature. Comments were also sought on other possible
methods for determining whether a genetic modification could be ``found
in nature.''
Commenters generally did not support defining or including the term
``found in nature'' within the NBFDS. Many of those in opposition
believed the term ``found in nature'' itself was nebulous, misleading,
and not adequately defined by science. Others argued that agriculture
is inherently separate from nature. Of those that did request the term
be defined, two common suggestions were ``spontaneously occurs in
nature, such as natural biological evolution, and does not overcome
natural physiological reproductive or combination barriers,'' or ``the
kinds of genetic modifications which can occur in nature within the
genome of an organism, without human intervention.''
One commenter was concerned that if definitions are deemed
necessary, the definitions avoid setting precedents in other regulatory
areas, and be kept as simple and as clear as possible. Another group of
commenters stated that ``this should be done through a supplemental
proposed rule that provides the public with an additional opportunity
to provide public comments.''
Commenters mostly rejected the idea of using intellectual property
law as a method of determination. Some of the
[[Page 65818]]
objections were that it would add more complexity to the NBFDS without
any additional clarity; could create unintended disincentives towards
development of non-BE foods; or is outside the scope of the NBFDS. One
commenter supported the consideration of intellectual property law
``when appropriate, as one non-dispositive factor among others in
making a determination.'' Another stated that the absence of a patent
should not be a factor in determining if a modification can be found in
nature, since it is not required to seek patents on BE food.
AMS finds it unnecessary to define the term ``found in nature.''
AMS received no compelling arguments to define the term and believes
that attempting to do so may cause confusion in light of the rapid pace
of innovation. In addition, there was little support for relying on
intellectual property law to inform decisions about whether specific
modifications ``could not otherwise be found in nature.'' In order to
incorporate technological changes in industry into this mandatory
labeling standard, AMS believes it needs to retain maximum flexibility.
That will not be accomplished by narrowly defining ``found in nature.''
D. List of Bioengineered Foods
AMS has developed the List of Bioengineered Foods (List) to
identify the crops or foods that are available in a bioengineered form,
and to aid regulated entities considering whether they may need to make
a BE disclosure. The List is provided in Sec. 66.6 of the Standard. As
will be discussed later in Section III--Disclosure, a regulated
entity's records will determine whether disclosure for that food is
required under the NBFDS. The List includes bioengineered foods for
human consumption that may be produced anywhere in the world. But the
List should not be considered exhaustive, as new BE products continue
to be developed. Even if a food is not on the List, regulated entities
that have actual knowledge that a food they are selling is
bioengineered, as defined in Sec. 66.1, must make appropriate
disclosure of that food. The List will be maintained and updated as
described later in this section.
The List of Bioengineered Foods replaces the two lists of
commercially available bioengineered foods in the United States that
AMS proposed in the NPRM. AMS proposed in the NPRM maintaining lists of
``highly adopted'' and ``non-highly adopted'' BE foods based on U.S.
planted crop acreage.
While some commenters agreed that the lists might simplify
compliance with the NBFDS, many recommended consolidating the two lists
into one and expanding the consolidated list to include bioengineered
foods produced in other countries to provide a more complete picture of
the variety of foods produced through bioengineering. Commenters argued
against equating U.S. planted acreage with human food production and
commercial availability in the United States, explaining that a large
percentage of highly adopted bioengineered crops are used for animal
feed, and that U.S. planted acreage does not necessarily reflect the
prevalence of bioengineered foods available on the market. Commenters
further argued that commercial availability should not be a basis for
regulation, because that attribute is not specified in the definition
of BE food, and because commercial availability can vary from country
to country, depending on how foods are approved for use.
For simplicity, AMS consolidated the two lists into one and
expanded the consolidated List to include bioengineered crops and foods
that may be produced in other countries. The List makes no presumptions
about market share represented by bioengineered versions of those crops
and foods in the United States. It merely provides information about
what bioengineered crops and foods (including ingredients made from
such foods), that meet the definition of ``bioengineered food'', could
be offered for retail sale in the United States, based on information
available to AMS. A crop or food may be included on the List, but not
require disclosure under the NBFDS. For instance, not all apple
varieties are bioengineered. Non-bioengineered apples would not require
disclosure. As noted elsewhere, the amended Act requires each person
subject to mandatory BE food disclosure under the NBFDS to maintain
records such as the Secretary determines to be customary or reasonable
in the food industry to establish compliance with the Standard. See 7
U.S.C. 1639b(g)(2). The List establishes the need for recordkeeping by
regulated entities who are using or selling the crops and foods on the
List. Further, the List will aid regulated entities in deciding whether
they may need to make a BE disclosure. Options for disclosure related
to a regulated entity's records about foods on the List are described
in Section III.A.5 and IV.A of this document.
To compile the lists that were proposed in the NPRM, AMS considered
data published by the International Service for the Acquisition of
Agri-biotech Applications (ISAAA),\2\ FDA's list of Biotechnology
Consultations on Food from GE Plant Varieties (Consultations), and
information published by USDA's Economic Research Service (ERS).\3\ AMS
also considered input from industry stakeholders and consumers about
which foods should be considered bioengineered and require disclosure
labeling. Some commenters in response to the NPRM recommended that
ISAAA be the sole source for information on international BE foods and
the modifications that have been made to them. Some commenters said
that foods should be added to the list as soon as any one of FDA's
consultation processes are completed for that food. Other commenters
suggested that additional sources of data on BE foods, such as
Statistics Canada,\4\ should be considered, given the frequent exchange
of foods between Canada and the U.S.
---------------------------------------------------------------------------
\2\ ISAAA (2016), Global Status of Commercialized Biotech/GM
Crops: 2016. ISAAA Brief No. 52. ISAAA: Ithaca, NY. http://www.isaaa.org/resources/publications/briefs/52/default.asp, accessed
February 5, 2018.
\3\ Economic Research Service (2017), Genetically engineered
varieties of corn, upland cotton, and soybeans, by state and for the
United States, 2000-17, Adoption of Genetically Engineered Crops in
the U.S., https://www.ers.usda.gov/data-products/adoption-of-genetically-engineered-crops-in-the-us.aspx, accessed February 5,
2018.
\4\ Statistics Canada, https://www.statcan.gc.ca/eng/start,
accessed July 26, 2018.
---------------------------------------------------------------------------
Each of the recommended sources assists in the development and
maintenance of the List; the List should represent a composite of
information gathered from many sources. However, to be consistent in
determining what crops or foods should be on the List, AMS has
determined that the foods included on the initial List of Bioengineered
Foods must meet the following criteria: (1) They are authorized for
commercial production somewhere in the world, and (2) they are reported
to be in legal commercial production for human food somewhere in the
world. AMS relied on resources such as USDA reports and databases, and
ISAAA reports and databases,\5\ to determine what crops and foods
currently meet those criteria. The List attempts to capture any BE
crops or foods that meet the statutory definition of
``bioengineering,'' based on existing technology, and that could
potentially be offered for sale in the United States. AMS recognizes
that there are other bioengineered foods that meet one of the criteria
for list inclusion, but not both. For example, bioengineered rice has
been authorized for production and use
[[Page 65819]]
as food in several countries, but AMS finds no evidence that it is
currently in legal commercial production anywhere. Foods such as BE
rice could be added to the List through the update process described
below when available information suggests that it would be appropriate
to do so.
---------------------------------------------------------------------------
\5\ ISAAA GM Approval Database: http://www.isaaa.org/gmapprovaldatabase/. Accessed August 10, 2018.
---------------------------------------------------------------------------
The considerations described above and the NBFDS definition for
``bioengineered food'' will be used to determine what foods would be
added to or removed from the List moving forward. (See the Treatment of
Technologies section, below.)
Section 66.1 of the NBFDS defines the List of Bioengineered Foods
as a list maintained and updated by AMS of foods for which
bioengineered versions have been developed. In the NPRM, AMS proposed
to describe the initial List in the preamble to the final rule and to
update the List by notice in the Federal Register with the opportunity
for public comment. Given the impact of including foods on the List, we
have determined that it is appropriate to incorporate the foods on the
List in the final rule text to provide greater transparency. Further,
AMS will update the List through rulemaking.
Information and data to support inclusion of each crop or food on
the List come from a variety of reliable sources, including industry
reports and academic and government sources. In some cases, the listed
crop or food itself may not typically be considered human food, but it
may be the source from which human food is made. For example, products
made from field corn, such as grits, corn chips, corn tortillas, and
corn cereal are human foods and may be subject to disclosure if they
meet the definition of bioengineered food. The following foods comprise
the List of Bioengineered Foods: alfalfa, apple (Arctic\TM\ varieties),
canola, corn, cotton, eggplant (BARI Bt Begun varieties), papaya
(ringspot virus-resistant varieties), pineapple (pink flesh), potato,
salmon (AquAdvantage[supreg]), soybean, squash (summer), and sugarbeet.
Where practical, the List includes specific information about
individual crops and foods, such as descriptions or trade names, to
help distinguish bioengineered versions of those foods from their non-
bioengineered counterparts, as requested by commenters. This
specificity is intended to identify foods for which disclosure may be
necessary, based on the regulated entities' records. For instance,
although apples are on the List, most apple varieties are not known to
be bioengineered. The List is narrowed by identifying the specific
apples that are known to be bioengineered. As other BE versions of the
listed foods are authorized and become legally available, AMS will
revise such listings to be more generic during the annual update
process.
Regulated entities may refer to the AMS website to obtain
additional information regarding the associated bioengineered events
for crops or foods they are sourcing and determine whether they need to
make a disclosure. In some cases, trade names or other information may
be provided to further simplify the identification and determination
process for regulated entities. As well, information on the website may
provide consumers additional details about traits (e.g., non-browning,
pesticide resistance, virus resistance, enhanced growth, etc.) for
which the foods have been bioengineered. Providing this detailed
information is intended to help reduce burdens for regulated entities
by narrowing the list of varieties of each food that may be
bioengineered.
1. List Maintenance and Revision
AMS proposed in the NPRM that the List be subject to review and
update on an annual basis, allowing for public input into the process.
AMS also proposed an 18-month compliance period following List updates
to allow for food label revisions in response. Such a schedule was
proposed to minimize the frequency with which regulated entities would
be required to update food labels, if, for instance, new BE foods were
added to the List. Some commenters urged AMS to revise the List more
frequently to avoid delay providing current information to consumers.
Others suggested updates should occur less frequently than proposed to
minimize the impact on small businesses that might have to change
labels accordingly. Some commenters asked that the compliance period
for revising labels be shortened, and others asked that it be extended.
The NPRM described a process to update the List on an annual basis.
The final rule adopts that process, except that AMS will also initiate
rulemaking to amend the List as appropriate. As described in Sec.
66.7(a), AMS will announce the annual review through the Federal
Register and on the AMS website. Interested parties may submit
recommendations about foods that could be added to or deleted from the
List at any time, including in response to the request for
recommendations that accompanies the review notice. Recommendations
should include data or other information to support those
recommendations. AMS will publish any recommendations, along with
supporting information, on its website and request comments on the
recommendations.
Following a review of available information, including consultation
with Federal Government agencies that comprise the Coordinated
Framework or any successor body, AMS will make a determination on
whether to initiate rulemaking to amend the List. Section 66.7(b)
provides an 18-month compliance period from the effective date of any
revision to the List to allow regulated entities time to revise
existing food labels if needed.
While the List of Bioengineered Foods identifies the foods for
which regulated entities must maintain records and that may be required
to bear a BE disclosure, the List and the records kept do not alleviate
a regulated entity's responsibility for disclosure when the entity has
actual knowledge that its food is a BE food. Under Sec. 66.109, a
regulated entity with actual knowledge that it is using BE food is
responsible for disclosing BE foods, even if the food is not listed on
the List of Bioengineered Foods. This section does not require
regulated entities to seek out that information, but they also cannot
ignore or be willfully blind to information that the food they are
sourcing is in fact bioengineered.
2. Treatment of Technologies
Technologies continue to evolve, and food produced through a
specific technology may or may not meet the definition of BE food.
Respondents to the 30 questions urged AMS to determine whether foods
developed through certain emerging technologies would be within the
scope of the definition of BE food. However, AMS proposed in the NPRM
that the products of technology, rather than solely the technology
itself, should be evaluated to determine whether a food meets the BE
food definition and might require disclosure. AMS proposed to provide
for the consideration of new technologies used to develop foods during
the process of reviewing and revising the List pursuant to Sec.
66.7(a). AMS proposed to do so through consultation with the U.S.
Government agencies responsible for oversight of the products of
biotechnology--USDA-APHIS, EPA, FDA, and appropriate members of the
Coordinated Framework for the Regulation of Biotechnology. In that way,
AMS could understand whether foods resulting from new technologies
would meet the definition of ``bioengineered food'' and should be added
to the List. Conversely, foods may be removed from the List if they are
no
[[Page 65820]]
longer produced from a technology that meets the definition of
``bioengineered food.'' In other cases, some varieties may meet the
definition, while others do not.
Comments in response to the NPRM ranged from those commenters who
urged that the scope of the NBFDS should reflect the use of all current
and emerging technologies to those who argued that some new genetic
engineering techniques would fall outside the scope of the statutory
definition. AMS continues to believe that determinations about what
constitutes BE food for the purposes of the NBFDS should focus
primarily on the characteristics of foods that have been produced using
bioengineering as defined in the amended Act, and whether such foods
meet the definition of ``bioengineered food.'' Thus, as proposed, the
products of new technologies will be considered during reviews and
updates of the List of Bioengineered Foods.
E. Factors and Conditions
As described in the proposed rule, in promulgating a regulation to
carry out the Standard, the amended Act directs the Secretary to
establish a process for requesting and granting a determination by the
Secretary regarding other factors and conditions under which a food is
considered a BE food. 7 U.S.C. 1639b(b)(2)(C). The amended Act does not
specify the process by which the Secretary will determine other factors
and conditions under which a food is considered a BE food; rather, it
provides the Secretary with discretion in setting up such a process.
Commenters were generally supportive of the proposed process for
adopting factors or conditions under which a food is considered a BE
food, and AMS is adopting the proposed process described in the NPRM.
Subpart C describes the process by which people can submit a request or
petition for a determination regarding other factors or conditions. The
acceptance of a request or petition for determination regarding a
factor or condition would then culminate in rulemaking to incorporate
the factor or condition into the ``bioengineered food'' definition.
Rulemaking allows for transparency and public participation in
determining whether or not the definition of ``bioengineered food''
should be amended. Ultimately, the impact of adopting the proposed
factors or conditions (as follows) would be to limit the scope of the
definition of ``bioengineered food,'' thus potentially excluding
certain products from disclosure.
Under Sec. 66.200, the determination process begins with the
submission of a request or petition for determination regarding other
factors and conditions under which a food is considered a BE food in
accordance with Sec. 66.204. Section 66.204 describes the process for
submitting a request or petition, including where to send the
submission. The submission needs to include a description and analysis
of the requested new factor or condition and any supporting documents
or data. Section 66.204 describes how to properly mark confidential
business information that may be included to support the request, to
ensure its confidentiality. Finally, Sec. 66.204 instructs that the
submission must explain how the standards for consideration apply to
the requested factor or condition.
Section 66.202 describes the standards for consideration by which
the Secretary's designee, the AMS Administrator, would evaluate the
request or petition. Given the existing statutory definition of
``bioengineering,'' the first standard, in paragraph (a), requires the
requested factor or condition to be within the scope of the definition
of ``bioengineering'' in 7 U.S.C. 1639(1). The second standard, in
paragraph (b), requires the Administrator to evaluate the cost of
implementation and compliance. In applying this second standard, the
Administrator will evaluate the cost related to the factor or
condition, the difficulty for affected regulated entities to implement
the factor or condition, especially small businesses, and the
difficulty AMS would have in monitoring compliance with the factor or
condition. Paragraph (c) allows the Administrator to consider other
relevant information as part of the evaluation. Relevant information
for a particular proposed factor or condition will include its
compatibility with the food labeling requirements of other Federal
agencies or foreign governments. In determining compatibility with
other requirements, AMS will consult with the U.S. Government agencies
responsible for oversight of the products of biotechnology: USDA-APHIS,
EPA, and FDA. Such information may allow AMS to align the NBFDS with
the standards of other Federal agencies or foreign governments, which
may facilitate interstate commerce and trade by allowing for
recognition of compatible standards.
The Administrator will also consult with the United States Trade
Representative (USTR) and the Department of State to ensure the request
or petition regarding other factors and conditions related to BE
disclosure requirements results in implementation in a manner
consistent with international trade obligations as mandated by 7 U.S.C.
1639c(a). If the Administrator determines that the request or petition
satisfies the standards for consideration, AMS will initiate rulemaking
that seeks to amend the definition of ``bioengineered food'' in Sec.
66.1 to include the factor or condition.
Some commenters asked AMS to clarify in the final rule the
parameters for submitting petitions to adopt factors or conditions. A
few commenters asked AMS to establish a specific time period within
which the agency would respond to requests for adoption of factors or
conditions, as well as a time period for regulated entities to attain
compliance with adopted factors or conditions.
AMS has made no changes to the submission parameters in connection
with requests or petition for factors and conditions, as we believe
they are clear and transparent. AMS has not established a time period
within which the agency will respond to requests for adoption of
factors or conditions because such responses will vary depending on
agency resources, the complexity of the submitted request for adoption
of factors or conditions, and the nature of implementing regulation.
Similarly, AMS has not provided a time period for regulated entities to
attain compliance with adopted factors and conditions in subpart C, as
adopted factors and conditions act as carve outs from the statutory
definition of bioengineering such that compliance with the adopted
factor or condition should not be burdensome. To the extent that the
adopted factors or conditions would be burdensome or require additional
time for compliance, AMS would address any compliance period in future
rulemakings considering the specific adopted factors and conditions.
In the NPRM, AMS proposed two submitted requests for factors and
conditions under which a food is considered a BE food. Those requests
involved (1) whether incidental additives present in food should be
considered ``bioengineered food'' and labeled accordingly; and (2)
whether the modified genetic material in a refined food may be
detected. The impact of adopting these factors or conditions will be to
limit the scope of the definition of ``bioengineered food,'' thus
potentially excluding certain products from disclosure.
[[Page 65821]]
1. Incidental Additives
The first factor or condition concerns a BE food that is an
incidental additive. As described in 21 CFR 101.100(a)(3), incidental
additives that are present in food at an insignificant level and do not
have any technical or functional effect in the food are exempt from
certain labeling requirements under the FDCA. Commenters in response to
AMS's 30 questions requested that incidental additives not be subject
to disclosure under the proposed NBFDS because they are exempt from
inclusion in the ingredient statement on a food label, according to 21
CFR 101.100(a)(3). AMS is aware that an ingredient that is required to
be listed in the ingredient list in one product may be used in another
product as an incidental additive that is not required to be included
in the ingredient list. Under this factor or condition, such an item
will only trigger disclosure when it is used as an ingredient that is
included on the ingredient list, not when used as an incidental
additive.
Application of this factor or condition falls within the scope of
the definition of ``bioengineering'' in 7 U.S.C. 1639(1), and thus
meets the first standard for consideration. This factor or condition
will also satisfy the second standard for consideration--cost of
implementation and compliance. Aligning the disclosure requirements of
the NBFDS with the ingredient declaration requirements under applicable
FDA regulations will simplify compliance and reduce labeling costs for
regulated entities. Finally, AMS finds it relevant that adoption of
this factor or condition would be compatible with the food labeling
requirements of other Federal agencies and some foreign governments.
The impact of adopting this proposed factor or condition as not
being within the definition of ``bioengineered food'' is to exclude
certain incidental additives from disclosure. Based on public comments
on the 30 questions and the NPRM, AMS believes adopting this factor or
condition may exempt a number of enzymes that are currently used in
food production but not currently listed in the ingredient statement on
a food label. However, based on those same comments, AMS is aware that
some enzymes may be used in a manner that requires them to be labeled
on the ingredient statement. In the NPRM, AMS sought comment on
whether, more generally, enzymes present in food should be considered
``bioengineered food.''
AMS has made no changes to this factor and condition regarding
incidental additives under which products can be excluded from
disclosure. The amended Act provides the Secretary with authority to
limit disclosure in certain circumstances. The factors and conditions
process offers a fair and rational method by which to consider various
proposals. For the reasons mentioned, AMS believes that exempting
incidental additives from BE disclosure that are not required to be
labeled per FDCA regulations is sensible, in alignment with the
labeling requirements of other trading partners and will limit the
burden on regulated entities without unduly limiting disclosure for
consumers.
Some commenters sought modifications to the text of this provision
clarifying what ``insignificant'' means or clarifying the types of
incidental additives that are not subject to disclosure. AMS does not
believe such clarification is necessary. The provision references the
FDA regulations that AMS relied upon in drafting the provision. That
FDA regulation describes the circumstances in which incidental
additives are not labeled as an ingredient. Title 21 CFR 101.100(a)(3)
provides an exemption for incidental additives that are present in a
food at insignificant levels and do not have any technical or
functional effect in that food. For the purposes of Sec.
101.100(a)(3), incidental additives are:
Substances that have no technical or functional effect
but are present in a food by reason of having been incorporated into
the food as an ingredient of another food, in which the substance
did have a functional or technical effect.
Processing aids, which are as follows:
[cir] Substances that are added to a food during the processing
of such food but are removed in some manner from the food before it
is packaged in its finished form.
[cir] Substances that are added to a food during processing, are
converted into constituents normally present in the food, and do not
significantly increase the amount of the constituents naturally
found in the food.
[cir] Substances that are added to a food for their technical or
functional effect in the processing but are present in the finished
food at insignificant levels and do not have any technical or
functional effect in that food.
Substances migrating to food from equipment or
packaging or otherwise affecting food that are not food additives as
defined in section 201(s) of the act; or if they are food additives
as so defined, they are used in conformity with regulations
established pursuant to section 409 of the act.
Section 101.100(a)(3)(i), (ii), and (iii) provide a list of
incidental additives that are not required to be labeled under FDA
regulations and by extension are not required to be disclosed as BE
foods. AMS believes that the cross-reference to the FDA regulations is
clear.
With respect to treatment of yeasts, enzymes, or any other
microorganisms, AMS agrees that 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. However, bioengineered
yeasts, enzymes, and other organisms that do not qualify as incidental
additives that are not required to be labeled as ingredients may
require disclosure as BE foods unless they meet the requirements of
another provision (for instance, by establishing that their modified
genetic material is not detectable). AMS cannot make a categorical
exemption for microorganisms in this final rule; however, such an
exemption is possible through the factors and conditions process in
future rulemakings.
2. Undetectable Modified Genetic Material
The NPRM also sought comment on another proposed factor and
condition--excluding food from the disclosure standard where the
modified genetic material in the food cannot be detected. As the NPRM
noted, if AMS ultimately proceeded with Position 2 and presumed that
refined ingredients are bioengineered foods, this factor or condition,
if adopted, would be a means to potentially exclude products where
modified genetic material cannot be detected. As discussed above, AMS
did not adopt Position 2, so this factor or condition is not
incorporated into the final rule. The definition of ``bioengineered
food'' in the final rule already excludes foods where modified genetic
material is not detectable.
F. Exemptions
The amended Act includes two express exemptions to the disclosure
requirement: For food served in a restaurant or similar retail food
establishment and for very small food manufacturers. 7 U.S.C.
1639b(b)(2)(G). The amended Act also authorizes the Secretary to
``determine the amounts of a bioengineered substance that may be
present in food, as appropriate, in order for the food to be a
bioengineered food.'' 7 U.S.C. 1639b(b)(2)(B). As well, the amended Act
prohibits food derived from an animal to be considered a BE food solely
because the animal consumed feed produced from, containing, or
consisting of a bioengineered substance. 7 U.S.C. 1639b(b)(2)(A).
Finally, Subtitle F specifies that the certification of food under
USDA's National Organic Program (7 CFR part 205) shall be
[[Page 65822]]
considered sufficient to make claims about the absence of
bioengineering in the food. 7 U.S.C. 6524. Section 66.5 incorporates
each of these as regulatory exemptions in the NBFDS.
1. Food Served in a Restaurant or Similar Retail Food Establishment
Section 66.5(a) exempts food served in a restaurant or similar
retail food establishment from disclosure under the NBFDS. In the NPRM,
Sec. 66.1 defined ``similar retail food establishment'' as a
cafeteria, lunch room, food stand, saloon, tavern, bar, lounge, other
similar establishment operated as an enterprise engaged in the business
of selling prepared food to the public, or salad bars, delicatessens,
and other food enterprises located within retail establishments that
provide ready-to-eat foods that are consumed either on or outside the
retailer's premises. This definition is consistent with the definition
of ``food service establishment'' included in other labeling programs
authorized by the amended Act. See 7 U.S.C. 1638(3) and the regulations
at 7 CFR 60.107 and 7 CFR 65.140, with minor modifications.
The NPRM solicited comments on the scope of this definition. Some
commenters stated that restaurants should not be exempt from the NBFDS
because it would undermine the transparency and consistency important
to consumers who want to know the origins of their food. Other
commenters supported the exemption generally and AMS's proposed
definition. Other commenters stated that AMS's proposed definition was
too narrow and should include a list of places as examples, rather than
an exclusive list, such as cafeteria, lunch room, food stand, food
truck, saloon, tavern, bar, lounge, salad bar, delicatessen,
entertainment venue, or other retail business establishment where meals
or refreshments constituting food may be purchased. One commenter
requested that transportation carriers be added to the list of places
exempted from the NBFDS.
Another commenter stated that all foods prepared, processed, or
packaged in the retail food establishment, including those utilizing
``central kitchen'' locations for certain prepared foods, should be
exempt from the disclosure requirement and that the term ``packaged''
should conform to 21 CFR 1.20, FDA's general food labeling
requirements.
Based on the comments received, AMS has modified the definition of
``similar retail food establishment'' to add additional examples,
including food truck and transportation carrier. AMS considered
including a list of places as examples, rather than an exhaustive list,
but believes that the reference to ``other similar establishment
operated as an enterprise engaged in the business of selling prepared
food to the public'' should capture any additional places that are not
specifically listed. To clearly address a point of confusion observed
in the comments received, AMS is clarifying that salads, soups, and
other ready-to-eat items prepared by grocery stores are exempt from the
disclosure requirements.
AMS has not modified the definition to state ``where meals or
refreshments constituting food may be purchased,'' as we believe that
with this insertion the exemption would be much broader than the plain
meaning of the amended Act. AMS believes that the exemption is intended
to cover ready-to-eat or prepared foods. To extend the exemption to all
foods prepared, processed, or packaged in a retail food establishment,
which would include bulk foods such as granola or apples in a bin,
would conflict with the requirement that foods subject to FDCA's
labeling requirements are subject to disclosure. The modified
definition provides clarity and flexibility to regulated entities and
is in accordance with the plain language of the amended Act.
2. Very Small Food Manufacturers
Section 66.5(b) exempts very small food manufacturers from the
disclosure requirement of the NBFDS. Section 66.1 defines ``very small
food manufacturer'' as a food manufacturer with annual receipts of less
than $2.5 million. To develop this definition, AMS considered FDA's
exemptions or special labeling requirements for certain food if the
food is offered for sale by certain persons who have annual gross sales
made or business done in sales to consumers that are not more than
$500,000 under certain conditions (see 21 CFR 101.9(j)(1)(i) and
101.36(h)(1)) and U.S. Census Bureau (USCB) regulations. AMS evaluated
the impact of applying various definitions of ``very small food
manufacturer'' by estimating the number of firms that would be
exempted, the number of products that would likely be exempt, and the
proportion of annual industry sales that would be exempt under each
exemption level. The NPRM included the following tables showing the
cumulative percentage of firms, products (UPCs), and sales that would
be exempt if the definition of ``very small food manufacturer'' were
set at the top of each of the annual revenue ranges (based on USCB's
2012 Statistics of U.S. Businesses).
Food Manufacturers
----------------------------------------------------------------------------------------------------------------
Cumulative Cumulative Cumulative
percent of percent of percent of
Establishment receipts threshold (in $) firms exempt products sales exempt
(%) exempt (%) (%)
----------------------------------------------------------------------------------------------------------------
<100,000........................................................ 20 0 0
100,000-499,999................................................. 45 1 0
500,000-999,999................................................. 58 2 1
1,000,000-2,499,999............................................. 74 4 1
2,500,000-4,999,999............................................. 81 6 2
5,000,000-7,499,999............................................. 84 7 3
7,500,000-9,999,999............................................. 86 8 3
----------------------------------------------------------------------------------------------------------------
[[Page 65823]]
Dietary Supplement Manufacturers
----------------------------------------------------------------------------------------------------------------
Cumulative Cumulative Cumulative
percent of percent of percent of
Establishment receipts threshold (in $) firms exempt products sales exempt
(%) exempt (%) (%)
----------------------------------------------------------------------------------------------------------------
<100,000........................................................ 7.36 0.02 0.00
100,000-499,999................................................. 16.75 0.12 0.10
500,000-999,999................................................. 26.14 0.33 0.32
1,000,000-2,499,999............................................. 45.18 1.54 1.26
2,500,000-4,999,999............................................. 59.14 3.26 2.63
5,000,000-7,499,999............................................. 62.18 3.83 3.15
7,500,000-9,999,999............................................. 63.96 4.41 3.63
----------------------------------------------------------------------------------------------------------------
Applying the FDA exemptions (annual sales of no more than $500,000)
at 21 CFR 101.9(j)(1)(i) and 101.36(h)(1) as described above would
exempt 45 percent of firms, only one percent of products, and less than
0.5 percent of sales for food manufacturers, and only 17 percent of
firms and about 0.1 percent of products and sales for dietary
supplement manufacturers. In conducting the Initial Regulatory Impact
Analysis, we estimated the impact of applying the USCB definition of
very small enterprise (fewer than 20 employees), which falls somewhere
between the $2.5 million and $5 million annual sales cutoffs. We found
that both of these revenue cutoff levels for the definition of ``very
small food manufacturer'' would offer significantly greater relief for
those manufacturers, while still having a relatively minor impact on
the amount of information available to consumers. Exempting
manufacturers with annual receipts of less than $2.5 million would
provide regulatory relief to 74 percent of food manufacturers and 45
percent of dietary supplement manufacturers, while reducing the number
of products covered by four percent (two percent for dietary
supplements), and the number of purchases covered by only one percent
for both food and dietary supplement manufacturers.
The NPRM solicited comments on alternative revenue cutoffs for the
definition of ``very small food manufacturer'' of $500,000 and $5
million. Many commenters generally supported AMS's proposal. Some
stated that there should be no exemption for very small food
manufacturers or to use a $500,000 or $1,000,000 revenue cutoff. Some
commenters stated that number of employees was a more suitable
criterion in determining the threshold for a very small food
manufacturer. One commenter recommended the agency should revise the
definition of ``very small food manufacturer'' in proposed 7 CFR 66.1
to read: ``any food manufacturer with either (1) annual receipts of
less than $2,500,000 or (2) 50 or fewer employees, measured as an
annual daily average.''
Some commenters suggested that we should use food sales, rather
than total receipts, to define small food manufacturers to avoid
inclusion of firms that have multiple sources of income that could
cause them to exceed the threshold. Some commenters stated that the
exemption for very small food manufacturers be extended to small
retailers.
AMS has made no changes to its proposal. In considering this
definition, AMS must balance providing regulatory flexibility for
regulated entities and providing information to consumers regarding the
bioengineered status of their foods. AMS considered other revenue
cutoffs, including those above and below $2,500,000, and considered
other definitions from various sources. Because food and dietary
supplement manufacturers are in the manufacturing sector, they are both
defined by number of employees for purposes of SBA size categorization.
However, the firms defined as small or very small for purposes of the
NBFDS all fall well below the SBA size categorizations, so we do not
feel we need to be bound by that methodology.
In addition, the small food manufacturer definition was defined to
be consistent with the FDA definition of small manufacturer under its
nutrition labeling standards, which use annual receipts. AMS believes
that the very small food manufacturer definition should be consistent
with these other definitions.
AMS believes that annual receipts are a reasonable measure in
determining the threshold for small businesses and specifically here,
very small food manufacturers. Using total receipts is administratively
simpler than tracking and demonstrating revenue by category for
purposes of this rule. We do not expect that there are a significant
number of firms for which this distinction would make a difference, but
it would increase recordkeeping burden for all firms that fall under
this exemption if it was based on food sales rather than annual
receipts.
The $2.5 million threshold will provide relief to small businesses,
but will not markedly decrease the number of products subject to
disclosure. By defining ``very small food manufacturers'' as those with
annual receipts below $2,500,000, about 74 percent of food
manufacturers are exempt from mandatory disclosure, but 96 percent of
products will still be subject to disclosure. An increase in revenue
cutoff would increase the number of exempt businesses, but would also
increase the number of products exempt from disclosure. The definition
of very small food manufacturer provides flexibility for small entities
while providing information to consumers regarding the bioengineered
status of their foods.
With respect to comments seeking that this exemption extend to
small retailers, AMS states that this exemption is statutorily mandated
and cannot be extended to small retailers. To the extent that a small
retailer is also a very small food manufacturer, they may be able to
take advantage of the exemption in that instance.
3. Threshold
Section 66.5(c) establishes a threshold for the inadvertent or
technically unavoidable presence of bioengineered substances of up to
five percent (5%) for each ingredient, with no such allowance for any
BE presence that is intentional. Section 66.1 defines ``bioengineered
substance'' as substance 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. This
definition differs slightly from the definition in the NPRM. We
replaced the word ``matter'' with ``substance'' to simplify
[[Page 65824]]
discussions about threshold. Thus, food in which any single ingredient
contains more than 5% of a bioengineered substance, regardless of
whether its presence is inadvertent or unintentional, is subject to
disclosure. Food containing any amount of a bioengineered substance
that is not inadvertent or unintentional is also subject to disclosure.
In proposing an appropriate threshold level, AMS considered
responses to the 30 questions posted on its website. Respondents
offered a number of concepts to consider, including different threshold
levels for determining exemptions (0.9, 5, and 10 percent) and
different ways of calculating the threshold (by ingredient or by total
weight). The NPRM solicited comments on multiple proposed issues
pertaining to threshold exemptions. These exemptions consisted of three
alternative thresholds for bioengineered substances that would trigger
disclosure.
The first proposed option (Alternative 1-A) would establish that
food in which an ingredient contains a BE substance that is inadvertent
or technically unavoidable, and accounts for no more than five percent
(5%) of the specific ingredient, would not be subject to disclosure as
a result of that one ingredient. The second proposed option
(Alternative 1-B) would establish that food, in which an ingredient
contains a BE substance that is inadvertent or technically unavoidable,
and accounts for no more than nine-tenths percent (0.9%) of the
specific ingredient by weight, would not be subject to disclosure as a
result of that one ingredient. The third proposed option (Alternative
1-C) would allow regulated entities to use intentionally a small amount
of BE ingredients up to a certain threshold, such as 5% of the total
weight of the product, before being required to label a product with a
BE disclosure.
Some commenters supported threshold alternative 1-B, which would
have exempted products where the bioengineered substance in an
ingredient was inadvertent or technically unavoidable and less than 0.9
percent of each specific ingredient by weight. They suggested that this
alternative is the most transparent, aligns with consumer expectations,
is more widely used in other countries, and is the most closely aligned
with existing industry standards.
A small number of comments supported alternative 1-C, an exemption
allowing for the intentional use of a bioengineered substance up to 5
percent of the total weight of the food, because it would allow for the
de minimis use of BE ingredients. Many commenters generally opposed
alternative 1-C.
AMS has adopted Alternative 1-A because we believe this approach
appropriately balances providing disclosure to consumers with the
realities of the food supply chain. A threshold amount of 5 percent
allows BE and non-BE production systems to coexist, whereas a lower
threshold, such as 0.9 percent, may increase the regulatory burden for
producers and food processors. Any disruption or increased burden on
the food supply chain may unnecessarily increase the cost of producing
food, and that cost may ultimately be passed on to consumers. To the
degree that some production systems and supply chains have already
adopted a threshold lower than 5 percent for purposes of voluntary
labeling, continued compliance with a lower threshold for the
inadvertent or technically unavoidable presence of a BE substance would
meet the requirements of the NBFDS.
AMS considered the threshold amounts used by other countries and
acknowledges that there is no uniform or universal threshold amount.
While some other countries have chosen lower amounts for their
threshold, such as 0.9 percent, compliance with a lower threshold for a
foreign country would still comply with the NBFDS. For example, a food
produced and labeled for sale in a country with a threshold amount of
0.9 percent, would still comply with the 5 percent threshold AMS has
chosen because 0.9 percent is lower than 5 percent. AMS believes this
approach minimizes the potential burden on trade.
AMS did not choose alternative 1-C or allow for the intentional use
of a BE substance without requiring disclosure because the agency
believes that allowing entities to avoid disclosing despite the
intentional presence of BE substances in food does not provide
consumers with the information they desire. In addition, AMS believes
that, to the degree regulated entities are currently tracking the use
of BE and non-BE foods for voluntary disclosure, most customary records
only indicate the presence or absence of a BE substance and not
necessarily the amount. Requiring regulated entities to track the
amount of a BE substance for purposes of disclosure would create an
unnecessary burden on regulated entities and likely increase their
compliance costs.
AMS reiterates that the threshold is intended to allow for
coexistence among BE and non-BE crops, and nothing about the threshold
amount is meant to convey anything related to health, safety, or
environmental attributes of BE food as compared to non-BE alternatives.
This rule is intended only to provide a mandatory uniform national
standard to equip consumers with information for their personal use.
4. Animals Fed With Bioengineered Feed and Their Products
The amended Act prohibits a food derived from an animal from being
considered a BE food solely because the animal consumed feed produced
from, containing, or consisting of a BE substance. 7 U.S.C.
1639b(b)(2)(A). Section 66.5(d) incorporates this statutory exemption.
For example, eggs used in a baked good, where the eggs come from a
chicken fed feed produced from BE corn and soy, would not be considered
bioengineered solely on the basis of the chicken's feed.
As most commenters noted, this exemption is mandated by the amended
Act, and AMS does not have the authority to change this statutory
mandate. Some commenters argued that the rationale for excluding the
products of animals fed bioengineered feed should also apply to yeasts,
rennet, and enzymes produced by fermentation using a bioengineered
substrate. The plain reading of the statutory language exempting the
products of animals fed bioengineered feed does not provide authority
for AMS to extend the exemption to yeast, rennet, or enzymes or to
extend the definition of ``animal'' to include those substances. As
discussed above, those substances may be exempted if they qualify as an
incidental additive or if they do not contain detectable modified
genetic material. Thus, the final rule adopts the proposed rule text
without revisions.
5. Food Certified Under the National Organic Program
Subtitle F states that ``[i]n the case of food certified under the
national organic program established under the Organic Foods Production
Act of 1990 (7 U.S.C. 6501 et seq.), the certification shall be
considered sufficient to make a claim regarding the absence of
bioengineering in the food, such as `not bioengineered', `non-GMO', or
another similar claim.'' 7 U.S.C. 6524. The NPRM stated that implicit
in the statutory provision is that certified organic foods are not
subject to BE disclosure. This implication, in conjunction with the
Secretary's authority to consider establishing consistency between the
NBFDS and the Organic Foods Production Act, permits a regulatory
exemption for products certified under
[[Page 65825]]
the NOP. See 7 U.S.C. 1639b(f). The NPRM proposed that Sec. 66.5(e)
would exempt certified organic foods from BE disclosure.
Commenters generally supported this exemption and some commenters
stated the need for a technical correction to accurately exempt all
food certified under the NOP and to create consistency with both the
language and the meaning in the amended Act. The prohibition on the use
of excluded methods extends to all NOP certified label categories
(``100% Organic,'' ``Organic,'' and ``Made with Organic'') and all
ingredients (organic and nonorganic) contained within each label
category. Commenters stated that the inclusion of the phrase ``. . .
certified organic . . .'' is problematic because it could imply that
the exemption does not extend to products certified in the ``made with
organic (specified ingredients or food group(s))'' labeling category
and recommended that the exemption should be applied to foods certified
under the NOP.
AMS agrees with commenters that a technical correction to this
provision is required. This exemption is intended to cover all NOP
certified label categories (``100% Organic,'' ``Organic,'' and ``Made
with Organic'') because NOP regulations at 7 CFR 205.301(a) through (c)
clearly require that no ingredient may be bioengineered. See 7 CFR
205.301(f)(1) and 205.105(e) and the definition of ``excluded methods''
in 7 CFR 205.2. Accordingly, Sec. 66.5(e) is revised to read ``Food
certified under the National Organic Program.'' This exemption,
however, does not apply to ``products with less than 70 percent
organically produced ingredients'' as described in 7 CFR 205.301(d) and
205.305 because those products may include bioengineered ingredients
along with organic ingredients.
G. Severability
AMS has added a new Sec. 66.11 on severability in subpart A. This
is a standard provision in regulations. This section provides that if
any provision of part 66 is found to be invalid, the remainder of the
part shall not be affected.
III. Disclosure
As statutorily required, the NBFDS, ``for the purposes of
regulations promulgated and food disclosures made pursuant to[], a
bioengineered food that has successfully completed the pre-market
Federal regulatory review process shall not be treated as safer than,
or not as safe as, a non-bioengineered counterpart of the food solely
because the food is bioengineered or produced or developed with the use
of bioengineering.'' 7 U.S.C. 1639b(b)(3) The amended Act provides
three disclosure options for all food subject to the mandatory BE food
disclosure standard, as well as additional options for small food
manufacturers, and requires that the Secretary provide reasonable
alternative disclosure options for food contained in small and very
small packages. 7 U.S.C. 1639b(b)(2)(D), 1639b(b)(F), and 1639b(b)(E).
In addition, the amended Act required the Secretary to conduct a study
to identify potential technological challenges that may impact whether
consumers have access to the bioengineering disclosure through
electronic or digital disclosure methods and provides specific factors
to be considered in the study. 7 U.S.C. 1639b(c)(1) and 1639(b)(c)(3).
Based on the study, if the Secretary determines that consumers would
not have sufficient access to the bioengineering disclosure through
electronic or digital disclosure methods, the Secretary, after
consultation with food retailers and manufacturers, shall provide
additional and comparable disclosure options. 7 U.S.C. 1639b(c)(4).
Subpart B specifies: (1) Who is responsible for the BE food
disclosure in Sec. 66.100; (2) the text disclosure in Sec. 66.102;
(3) the symbol disclosure in Sec. 66.104; (4) the electronic or
digital link disclosure in Sec. 66.106; (5) the text message
disclosure in Sec. 66.108; (6) the disclosure options for small food
manufacturers in Sec. 66.110; (7) the disclosure options for small or
very small packages in Sec. 66.112; (8) the disclosure for food sold
in bulk containers in Sec. 66.114; (9) the voluntary disclosure in
Sec. 66.116; and (10) other claims in Sec. 66.118. As used in subpart
B, the key terms include ``information panel'' and ``label.'' As
defined in Sec. 66.1, these definitions are consistent with those used
in the NOP regulations, 7 CFR 205.2. In addition, the terms ``regulated
entity,'' ``marketing and promotional information,'' ``principal
display panel,'' ``small package,'' ``very small package,'' and ``small
food manufacturer,'' are also discussed.
A. General
1. Responsibility for Disclosure
The amended Act requires bioengineered food and bioengineered food
ingredients to be labeled or ``disclosed'' in accordance with
regulations promulgated by the Secretary. 7 U.S.C. 1639b(b)(1). Section
66.100(a) identifies three categories of entities responsible for
disclosure: Food manufacturers, importers, and certain retailers. This
final rule adopts these three categories of responsible entities as
proposed. For purposes of clarity, a definition of ``regulated entity''
is incorporated in Sec. 66.1 as ``the food manufacturer, importer, or
retailer that is responsible for making bioengineered food disclosures
under Sec. 66.100(a).'' Accordingly, if a food is packaged prior to
receipt by a retailer, either the food manufacturer or the importer is
responsible for ensuring that the food label bears a BE food disclosure
in accordance with this part. If a retailer packages a food or sells
food in a bulk container and/or display, then the retailer is
responsible for ensuring that the food bears a BE food disclosure in
accordance with this part. Based on the input received from commenters,
this approach will align responsibility for labeling with the
requirements of other mandatory food labeling laws and regulations,
including those administered by FDA and USDA FSIS.
2. International Impact
Based on extensive input from commenters, we continue to find that
importers should be subject to the same disclosure and compliance
requirements as domestic entities. Importers of BE foods are subject to
the requirements of the NBFDS and are required to make appropriate
disclosures on the labels of BE foods imported and sold in the United
States.
Based on comments, this rule finds that establishing mutual
recognition arrangements with appropriate foreign government entities
that have established labeling standards for BE food may be appropriate
in the future. No such recognition arrangements are currently in place
or are established under this regulation. As no mutual recognition
arrangements are currently in place, imports of products are subject to
the disclosure and recordkeeping requirements of the NBFDS as described
in this final rule. U.S. exports to non-partner countries will need to
continue to meet that country's import requirements.
3. Appearance of Disclosure
Requirements on how the disclosure must appear on food labels and
packaging remain the same as proposed in the NPRM. As provided in Sec.
66.100(c), the disclosure is required to be of 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. AMS believes these requirements will align with
other mandatory food labeling requirements, including those
[[Page 65826]]
administered by FDA (21 CFR 101.15) and FSIS (9 CFR 317.2(b)). While
FDA uses the term ``customary conditions of purchase'' (21 CFR 101.15),
we have decided to utilize the term ``ordinary shopping conditions,''
as the statutory language references ``shopping'' in 7 U.S.C.
1639b(c)(4). AMS considered prescribing specific type sizes for
different disclosure options, but after considering comments,
determined that the number and type of disclosure options, combined
with the variety of food package sizes, shapes, and colors, would make
prescriptive requirements too difficult to implement. AMS believes that
the requirements in Sec. 66.100(c) will likely provide the BE food
disclosure information to consumers in an accessible and transparent
manner, while allowing regulated entities to have flexibility in
implementing the requirements.
4. Placement of Disclosure
As proposed, Sec. 66.100(d) offered that the BE food disclosure be
placed in one of the following places: The information panel adjacent
to the statement identifying the name and location of the manufacturer/
distributor or similar information; anywhere on the principal display
panel; or an alternate panel if there is insufficient space to place
the disclosure on the information panel or the principal display panel.
Section 66.100(d) would not apply to bulk foods (see Sec. 66.114).
``Information panel'' as defined in Sec. 66.1 is consistent with the
definitions found in the USDA NOP regulations at 7 CFR 205.2, which
largely reflect those found in FDA's food labeling regulations at 21
CFR 101.2. ``Principal display panel,'' as defined in Sec. 66.1,
reflects the definition found in FDA's food labeling regulations at 21
CFR 101.1. Based on input from commenters, if there is insufficient
space on either the information panel or the principal display panel,
the disclosure may be placed on an alternate panel likely to be seen by
a consumer under ordinary shopping conditions.
Based on commenter feedback, this rule requires locating the
disclosure on the information panel or the principal display panel
because that is where consumers who are interested in additional food
information typically look for information about their food. The
information panel typically includes the nutrition fact panel, the
ingredient list, the manufacturer/distributor name and address, and, if
applicable, the country of origin. The principal display panel
typically includes the statement of identity and the net quantity
statement, in addition to other marketing claims. AMS believes that
placing the BE food disclosure near this existing information will be
effective because consumers will be able to see all the disclosures,
statements, and marketing claims in one common place on the label.
The NBFDS will require placement of the disclosure adjacent to the
manufacturer/distributor name and location statement. Such placement
will avoid interference with other required statements on the
information panel. We think that the information panel will be an
appropriate location for a mandatory BE food disclosure because food
manufacturers are accustomed to making statements and disclosures
required by FDA and FSIS on the information panel. By also permitting
that the disclosure may appear on the principal display panel, AMS
acknowledges that some regulated entities may want to increase
transparency or highlight specific traits from the BE food in tandem
with the BE food disclosure. Also, as a result of input from
commenters, we are including additional flexibilities for food
manufacturers; if there is insufficient space on the information panel
or the principal display panel, the disclosure may be displayed in an
alternate panel, provided the disclosure is available to the consumer
under ordinary shopping conditions. In response to a received comment,
AMS is clarifying the BE disclosure for multi-unit packages. For multi-
unit packages where individual units are not labeled for retail sale
and are enclosed within and not intended to be separated from the
multi-unit package, AMS has determined that disclosure on the outer
packaging in a manner consistent with the options provided in Sec.
66.100(c) is sufficient to meet the requirements of the NBFDS. Any
additional requirements regarding multi-unit packaging would be
addressed in future rulemakings.
This subpart does not prevent, pursuant to Sec. 66.118, regulated
entities from making other claims regarding bioengineered foods,
provided that such claims are consistent with applicable Federal law.
5. How the List of Bioengineered Foods Relates to Disclosure
The purpose of the List of Bioengineered Foods is to provide
regulated entities with a tool to determine whether a food must bear a
BE disclosure. If a food or food ingredient is on the List of
Bioengineered Foods, and the regulated entity's records show that the
food is a bioengineered food or does not indicate whether or not the
food is bioengineered, the food must bear a BE disclosure. While we
acknowledge that this framework may result in regulated entities
placing a BE disclosure on a food that they do not know with certainty
is bioengineered, we believe that it is appropriate to err on the side
of disclosure to provide consumers with the fullest information about
food that could be bioengineered.
The List of Bioengineered Foods is alfalfa, apple (Arctic\TM\
varieties), canola, corn, cotton, eggplant (BARI Bt Begun varieties),
papaya (ringspot virus-resistant varieties), pineapple (pink flesh),
potato, salmon (AquAdvantage[supreg]), soybean, squash (summer), and
sugarbeet. These foods comprise most of the bioengineered crops or
foods grown in the world and, therefore, most of the bioengineered food
and food ingredients. As described in Sec. 66.7, AMS will conduct
annual reviews of the List. Through this process, AMS will request
public input, including data and other information, to support any
changes made. Any amendments (additions or deletions) to this List will
be made through rulemaking. We recognize that for some items on this
List, most varietals are not bioengineered. Because of this, AMS will
maintain more detailed information on its website about each
bioengineered crop or food to help regulated entities understand the
associated bioengineered events for crops or foods they are sourcing
and assist in determining whether disclosure is required. AMS will
update information on its website as necessary.
If a regulated entity is using a food, including an ingredient
produced from such food, not on the List of Bioengineered Foods, and
the regulated entity has actual knowledge that the crop or ingredient
is, in fact, bioengineered, the entity is still responsible for
labeling the food in compliance with the NBFDS. If a regulated entity
uses a food, including an ingredient produced from such food, on the
List of Bioengineered Foods and its records demonstrate that the food
is not bioengineered (e.g., modified genetic material is not detectable
in accordance with Sec. 66.9) or is exempt from disclosure under Sec.
66.5, the food is not required to bear a BE disclosure.
a. Disclosure Options
Regulated entities have several disclosure options (text, symbol,
electronic or digital link, and/or text message, with additional
options available to small food manufacturers or for small or very
small packages), with differing requirements, as described
[[Page 65827]]
below. Regardless of the type of disclosure used, regulated entities
can generally look to the List of Bioengineered Foods to determine if
the food is required to have a BE disclosure.
b. Use of the ``May Be'' Option
The NPRM specifically requested comments on whether the phrase
``may be'' could be used when making a disclosure under the NBFDS. As
proposed, the phrase ``may be'' would have been able to be inserted
prior to the word ``bioengineered'' in the various disclosure methods,
including a ``may be bioengineered'' symbol. This proposal was
primarily included in the NPRM to provide regulated entities with
flexibility when using food ingredients on the ``low adoption'' list of
bioengineered foods. Because the List of Bioengineered Foods adopted in
this rule does not distinguish between low and high adoption
bioengineered foods, the ``may be'' option is no longer appropriate.
Additionally, commenters explained how the use of ``may be'' in the
disclosure will lead to unnecessary confusion for regulated entities
and for consumers. Commenters explained that when consumers see the
words ``may be bioengineered'' on a food package, consumers may be
unsure whether the food is bioengineered or whether certain ingredients
are bioengineered. Many commenters suggested that the disclosure be an
affirmative statement. They noted that many of the countries with
mandatory disclosure requirements do not allow the use of a ``may''
statement. Comments from food companies also described confusion around
when the ``may be'' wording is appropriate. Commenters noted that
because records must be maintained to substantiate claims of disclosure
and non-disclosure, any such use of ``may'' claims would only serve to
confuse consumers. For these reasons, disclosure under the NBFDS must
be made with the term ``bioengineered,'' unless making a voluntary
disclosure as described in Sec. 66.116. The ``may be bioengineered''
disclosure cannot be used.
B. Text Disclosure
The amended Act allows for BE food to be labeled with a text
disclosure. 7 U.S.C. 1639b(b)(2)(D). Regulated entities may utilize
text to disclose the presence of bioengineered food or bioengineered
food ingredients for foods in the List of Bioengineered Foods. For a
food, including a food ingredient produced from that food, that is a
raw agricultural commodity and for which records demonstrate that the
food or food ingredient is bioengineered or does not indicate whether
the food or food ingredient is bioengineered, the text disclosure is
``bioengineered food.'' This same disclosure is applicable to multi-
ingredient food products in which all ingredients are on the List of
Bioengineered Foods and are bioengineered or records do not indicate
whether the ingredients are bioengineered. For a multi-ingredient food
that contains ingredients that are and are not on the List of
Bioengineered Foods and records demonstrate that at least one of the
ingredients is bioengineered, or do not indicate whether any of the
ingredients produced from one of the foods on the List of Bioengineered
Foods are bioengineered, the text disclosure is ``contains a
bioengineered food ingredient.'' We believe this approach provides
flexibility to regulated entities, transparency to consumers, and
recognizes that some foods are entirely a product of bioengineering and
that some foods are a mix of BE and non-BE food ingredients.
For BE food that is distributed solely in a U.S. territory, Sec.
66.102(b) requires that disclosure statements equivalent to those above
be allowed in the predominant language of that territory. AMS believes
this approach will make the BE food disclosure more accessible in
territories where the predominant language is something other than
English. AMS also believes this allows regulated entities who only
distribute food in a given territory to respond to consumer demand.
C. Symbol Disclosure
A symbol is another form of BE food disclosure regulated entities
may use as set forth in the amended Act. 7 U.S.C. 1639b(c)(4).
Regulated entities can use this symbol to designate BE food or food
that contains a BE food ingredient.
AMS proposed three alternative symbols with variations of those
symbols and invited comment on each alternative and its variation. The
three symbols were designed to communicate the bioengineered status of
a food in a way that would not disparage biotechnology or suggest BE
food is more or less safe than non-BE food. Based on comments, we have
decided to use a variation of option 2-A below. AMS requested comments
on whether the word ``bioengineered'' should be incorporated into the
design of the chosen disclosure symbol. Based on comments, we have
decided to include the word ``bioengineered'' in the symbol. This will
improve the understanding of the symbol, as many comments explained
that they did not understand what the acronym ``BE'' stood for.
Comments in response to the NPRM reported results of independent
surveys conducted during the public comment period that suggested the
greatest number of respondents believe the symbol with the word
``bioengineered'' provides the right amount of information when
compared to the symbol with the letters ``BE.'' \6 7\
---------------------------------------------------------------------------
\6\ Public comment submitted by the International Food
Information Council Foundation (IFIC) reports their May 2018 study
regarding consumer attitudes and perceptions related to the NPRM.
Comment may be accessed at https://www.regulations.gov/document?D=AMS-TM-17-0050-8861.
\7\ Public comment submitted by the Rutgers School of
Environmental and Biological Sciences reports their June-July 2018
survey regarding consumer perceptions related to the proposed
disclosure options in the NPRM. Comment may be accessed at https://www.regulations.gov/document?D=AMS-TM-17-0050-14011.
---------------------------------------------------------------------------
The adopted symbol is a circle with a green circumference, with the
word ``bioengineered'' displayed at the top and the bottom of the outer
ring. The bottom portion of the circle contains an arch, filled in
green to the bottom of the circle. The arch contains two light green
terrace lines, sloping downward from left to right. On the left side of
the arch, near the left side of the circle, is a stem arching towards
the center of the circle, ending in a four-pointed starburst. The stem
has two leaves coming from the upper side of the stem and pointing
towards the top of the circle. At the top of the circle, to the left of
center, in the background of the leaves, is a portion of a yellow
circle that resembles a sun. The remainder of the circle is filled in
light blue, resembling the sky.
Commenters recognized that a multi-colored product label can
increase printing costs and disrupt product design in other ways.
Therefore, like the USDA Organic seal under the NOP, AMS will allow
regulated entities to use a black and white version of the symbol.
Regardless of colors, the symbol is required to meet the appearance and
placement requirements in Sec. 66.100. A supplemental document to this
final rule contains the symbol in full color, as well as another
variation of the symbol incorporating the words ``derived from
bioengineering'' (for voluntary disclosure discussed below). The
document may be viewed in the docket for this rulemaking at
regulations.gov and on the AMS website.
D. Electronic or Digital Link Disclosure
The third disclosure option available for regulated entities to use
is an electronic or digital link disclosure. 7 U.S.C. 1639b(b)(2)(D)
and 1639b(d). The amended Act requires that the use of an electronic or
digital link to disclose BE food must be accompanied by the
[[Page 65828]]
statement ``Scan here for more food information'' or equivalent
language that reflects technological changes. 7 U.S.C. 1639b(d)(1).
This statutory requirement is incorporated in Sec. 66.106(a)(1). AMS
recognizes that electronic and digital links currently used on food
products in the marketplace take different forms, and the amended Act
allows for equivalent statements that reflect technological changes.
Current technology includes, among others, quick response (QR) codes
that are detectable by consumers and digital watermark technology that
is imperceptible to consumers but can be scanned anywhere on a food
package using a smart phone or other device. These technologies may or
may not include an embedded Uniform Resource Locator (URL).
Consequently, AMS will allow for other alternative statements that can
appear above or below an electronic or digital link to direct consumers
to the link to the BE food disclosure. Examples of other statements
include: ``Scan anywhere on package for more food information,'' or
``Scan icon for more food information.'' The statement will provide the
shopper with clear instructions on how to utilize an electronic device
to scan a food package to obtain information about the bioengineered
content of the food.
Section 66.106(a)(2) incorporates the amended Act's requirement
that the electronic or digital disclosure be accompanied by a telephone
number that a consumer can call to access the disclosure information. 7
U.S.C. 1639b(d)(4). If a regulated entity decides to utilize electronic
or scannable technology to convey bioengineered food information, they
must also provide options for the consumer to access the disclosure by
calling a phone number. There must be clear instructions for the
shopper to ``Call [1-000-000-0000] for more food information.'' Many
commenters explained how certain consumers do not understand how to
utilize certain scannable technology to access food disclosure
information. AMS believes that requiring regulated entities who are
disclosing bioengineered food information through scannable means to
offer the option to call a telephone number will best provide for
accessible and understandable food information.
The telephone number must be available at all times of the day and
must clearly provide bioengineered food information to the caller. Pre-
recorded information is permitted. The telephone number and instruction
must be located in close proximity to the electronic or digital link.
The amended Act requires the electronic or digital link to provide
the bioengineering disclosure on the first product information page
accessed through the link, without any marketing and promotional
information. 7 U.S.C. 1639b(d)(2). Section 66.106(b) incorporates this
requirement. ``Marketing and promotional information'' means ``any
written, printed, audiovisual, or graphic information, including
advertising, pamphlets, flyers, catalogues, posters, and signs that are
distributed, broadcast, or made available to assist in the sale or
promotion of a product.'' This definition aligns with that in the NOP
regulations at 7 CFR 205.2. If a regulated entity wants to provide
additional information about BE food to consumers, the information
should be provided outside of the landing page that includes the BE
food disclosure.
Based on commenter suggestions to ensure reliable, consistent
disclosure information to consumers, AMS is requiring that the
disclosure on the product information page conform to the requirements
of the text disclosure in Sec. 66.102 or the symbol disclosure in
Sec. 66.104. AMS believes that using a uniform, consistent approach to
the disclosure language and symbol will make it easier for consumers to
understand the disclosure, whether that language or symbol appears on a
food label or an electronic or digital device. AMS also believes that
this approach will make compliance easier for entities responsible for
disclosure, and ensure consistency in the communication of required
disclosure information.
If the regulated entity chooses to use an electronic or digital
link, the amended Act requires that the entity not collect, analyze, or
sell any personally identifiable information about consumers or their
devices. 7 U.S.C. 1639b(d)(3)(A). Under Sec. 66.106(b)(4), if such
information must be collected to fulfill the disclosure requirements,
that information must be deleted immediately and not used for any other
purpose. 7 U.S.C. 1639b(d)(3)(B).
E. Study on Electronic or Digital Disclosure and a Text Message
Disclosure Option
The amended Act requires the Secretary to conduct a study to
identify potential technological challenges that may impact whether
consumers would have access to the bioengineering disclosure through
electronic or digital disclosure methods. 7 U.S.C. 1639b(c)(1). The
Department contracted with Deloitte Consulting LLP to perform the
study, received the study results from Deloitte Consulting LLP on July
27, 2017, and made the study available to the public on September 6,
2017, at https://www.ams.usda.gov/reports/study-electronic-or-digital-disclosure.
As required by the amended Act, the study considered five factors:
The availability of wireless internet or cellular networks; the
availability of landline telephones in stores; challenges facing small
retailers and rural retailers; the efforts that retailers and other
entities have taken to address potential technology and infrastructure
challenges; and the costs and benefits of installing in retail stores
electronic or digital link scanners or other evolving technologies that
provide bioengineering disclosure information. 7 U.S.C. 1639b(c)(3).
The amended Act also requires the Secretary, after consultation with
food retailers and manufacturers, to provide additional and comparable
options to access the bioengineering disclosure, should the Secretary
determine that consumers, while shopping, would not have sufficient
access to the bioengineering disclosure through electronic or digital
disclosure methods. 7 U.S.C. 1639b(c)(4).
Several commenters agreed that the challenges described in the
study prevented consumers from accessing electronic or digital
disclosures. Other commenters noted that smartphone usage and broadband
access were increasing in the United States. After reviewing the study
and comments submitted to the NPRM related to the study, the Secretary
has determined that consumers would not have sufficient access to the
bioengineering disclosure through electronic or digital means under
ordinary shopping conditions at this time. While a large number of
Americans have a smartphone and a large number of national and regional
supermarkets provide Wi-Fi, most consumers in the study experienced
technical challenges in accessing the bioengineered food disclosure on
their phones.
The NPRM proposed text message as an additional disclosure option
if the Secretary were to determine that shoppers would not have
sufficient access to digital or electronic disclosure. Food
manufacturers and retailers that commented on this option were
generally supportive of this option. Thus, AMS is adopting the text
message option in Sec. 66.108. Regulated entities that choose this
option are required to include a statement on the package that
instructs consumers on how to receive a text message. Those
instructions can be shared or centralized among regulated entities, if
so desired. Industry is not prohibited from developing a
[[Page 65829]]
standardized instruction or response if it is in compliance with the
NBFDS regulations. A one-time automated response would immediately
provide the disclosure using text in conformance with Sec. 66.102.
Similar to the electronic or digital disclosure, the text message is
not allowed to contain marketing and promotional information. The
regulated entity must not collect, analyze, or sell any personally
identifiable information, unless necessary to complete the disclosure,
or use any information related to the text message for marketing
purposes. If the regulated entity must collect any personally
identifiable information to complete the disclosure process, it must
immediately delete the information and not use it for any other
purpose. Additionally, consumers must not be charged a fee by the
regulated entity to access the disclosure information. However,
consumers may be subject to a text messaging fee charged through their
wireless telephone carrier.
F. Small Food Manufacturers
The amended Act provides two additional disclosure options for
small food manufacturers: (1) A telephone number accompanied by
appropriate language to indicate that the phone number provides access
to additional information; and (2) an internet website address. 7
U.S.C. 1639b(b)(2)(F)(ii). In addition, in the case of small food
manufacturers, the amended Act provides that the implementation date
not be earlier than one year after the implementation date for
regulations promulgated in accordance with the NBFDS. See 7 U.S.C.
1639b(b)(2)(F)(i).
1. Definition
AMS has made very minor changes to the definition of small food
manufacturer. AMS defines ``small food manufacturer'' as ``any food
manufacturer with annual receipts of at least $2,500,000 but less than
$10,000,000.'' This definition is similar to FDA's final rule to extend
the compliance dates for manufacturers with less than $10 million in
annual food sales (see 83 FR 19619).
Section 66.110 provides two additional options that are available
to small food manufacturers in addition to the text, symbol, electronic
or digital link, or text message disclosure options. The two options
are disclosure by telephone number and by internet website.
2. Telephone Number
Under Sec. 66.110(a), if a small food manufacturer chooses to use
a telephone number to disclose the presence of a BE food or BE food
ingredients, a compliant text accompanying the telephone number is
``Call [1-000-000-0000] for more food information.'' The telephone
number should provide the BE food disclosure regardless of the time of
day. Disclosure via telephone number must include a BE food disclosure
information that is consistent with Sec. 66.102 in audio form and can
be pre-recorded. While some commenters suggested that a telephone
disclosure at any time of day would be burdensome and unreasonable, AMS
believes that the requirement to provide the BE food disclosure at any
time of day is reasonable, given the different hours that consumers
shop for groceries and the varying time zones in the United States.
Because the disclosure by telephone can be accomplished through a
recorded message, AMS does not believe that requiring the disclosure to
be available at any time of day will increase the burden on small food
manufacturers.
3. Internet Website
Under Sec. 66.110(b), if the small food manufacturer chooses to
use an internet website to disclose the presence of BE food or BE food
ingredients, text would need to accompany the website address on the
label stating, ``Visit [Uniform Resource Locator of the website] for
more food information.'' The website must meet the requirements for a
product information page in Sec. 66.106(b). Disclosure via website
must include a bioengineered food disclosure that is consistent with
Sec. 66.102 or Sec. 66.104 in written form. AMS believes that
implementing the internet website option for small food manufacturers
in conformance with the requirements for the electronic or digital
disclosure product information page will give small food manufacturers
the flexibility to disclose in a way that is cost effective for a small
business, while providing disclosure to consumers and the same level of
protection for personally identifiable information.
G. Small and Very Small Packages
The amended Act requires the Secretary to provide alternative
reasonable disclosure options for food contained in small or very small
packages. 7 U.S.C. 1639b(b)(2)(E). In order to ensure consistency with
existing labeling requirements, the definition of ``small packages''
was taken from FDA labeling requirements at 21 CFR 101.9(j)(17). The
definition of ``very small package'' was also taken from FDA labeling
requirements at 21 CFR 101.9(j)(13)(i). Section 66.112 continues to
provide certain flexibilities for food in small and very small
packages: A modified version of the electronic or digital link
disclosure in Sec. 66.106; a modified version of the text message in
Sec. 66.108; and a modified version of the phone number disclosure in
Sec. 66.110. In addition, for very small packages, regulated entities
may use a label's preexisting Uniform Resource Locator or telephone
number for disclosure.
For the modified version of the electronic or digital link, Sec.
66.112(a) allows regulated entities to utilize the electronic or
digital link in Sec. 66.106, but replace the statement ``Scan here for
more food information'' and the accompanying phone number and
instructions required in paragraph (a) of that section with the
statement ``Scan for info.'' AMS believes that shortening the statement
may make the electronic or digital link disclosure small enough to fit
on small and very small packages.
For the modified version of the text message, Sec. 66.112(b)
allows regulated entities to utilize the text message in Sec. 66.108,
but replace the statement ``Text [number] for more bioengineered food
information'' with ``Text [number] for info.'' AMS believes that
shortening the statement may make the text message disclosure small
enough to fit on small and very small packages. Similarly, AMS believes
that a phone number with a short statement is small enough to fit on
small and very small packages. Section 66.112(c) requires the
disclosure to meet the requirements of Sec. 66.110, but allows the
statement ``Call [1-000-000-0000] for more food information'' to be
replaced with ``Call [1-000-000-0000] for info.''
AMS recognizes that very small packages have limited surface area
on which to bear disclosures. Under Sec. 66.112(d), for very small
packages, if the label includes a preexisting Uniform Resource Locator
for a website or a telephone number that a person can use to obtain
other food information, that website or telephone number may also be
used for the BE food disclosure, provided that the disclosure is
consistent with Sec. 66.102 or Sec. 66.104 in written or audio form,
as applicable.
Stakeholders representing food manufacturers who use small and very
small packages indicated that using the symbol under Sec. 66.104 is a
viable disclosure option. Accordingly, the symbol and other disclosure
options available to all entities responsible for disclosure are also
available to those who package foods in small and very small packages.
AMS believes providing the additional options described above will
provide needed flexibility for
[[Page 65830]]
disclosure on small and very small food packages.
H. Food Sold in Bulk Containers
Because bulk products, such as cornmeal in a bin or unpackaged
produce, are frequently displayed without packaging and placed on
display by retailers, rather than food manufacturers or importers, AMS
requires that retailers be held responsible for complying with the BE
food disclosure of bulk food. AMS already requires bulk foods sold in
grocery stores to comply with Country of Origin Labeling requirements
and believes that retailers are already accustomed to ensuring that
bulk food appears with appropriate signage.
As requested by several commenters, Sec. 66.114(a) requires that
the BE food disclosure on bulk foods appears using any of the options
for on-package disclosure including: Text, symbol, electronic or
digital link, or text message (if applicable). The disclosure is
required to appear on signage or other materials (stickers, bindings,
etc.) on or near the bulk item. AMS believes the requirement that the
signage or materials include the disclosure will allow consumers to
identify and understand the bioengineered status of the food and allow
retailers to adapt to new technologies and consumer preference.
Retailers who use an electronic or digital link will be required to
place any sign or image to be scanned in a place readily accessible by
consumers. For all other disclosure options, signs currently used on or
near bulk items, when supplemented with the BE food disclosure, are
sufficient to comply with the requirements of the amended Act.
I. Voluntary Disclosure
AMS received significant input on the proposed NBFDS regarding the
ability for regulated entities to voluntarily label foods not subject
to mandatory BE disclosure requirements. Comments from food companies
explained that consumers expect transparency and as much information as
possible on the origin of food ingredients. Comments from consumers
agreed. AMS acknowledges that voluntary disclosure provisions enable
food manufacturers, retailers, and other entities to share more
information with consumers, provided the information is truthful and
not misleading and otherwise in compliance with all applicable Federal
laws.
In designing the NBFDS, which is focused on positive disclosure
claims, AMS has attempted to provide as much flexibility to the food
and grocery industry as possible, along with the transparency to
consumers that they expect and deserve. As such, the final rule
provides for voluntary labeling (1) by entities that are otherwise
exempt from the requirements of the NBFDS or (2) for certain foods that
do not meet the definition of ``bioengineered food'' but are derived
from bioengineered crops or food. Voluntary labeling is only permitted
in these circumstances.
Entities that are exempt from the NBFDS are very small food
manufacturers, and restaurants and similar retail food establishments.
Under Sec. 66.116(a) those entities may voluntarily include a
bioengineered disclosure on their products in the same manner as those
that are required to provide a BE disclosure.
Under Sec. 66.116(b), regulated entities may voluntarily include a
disclosure for foods or food ingredients derived from items on the List
of Bioengineered Foods. A food that meets a factor or condition under
paragraph (2) of the definition of ``bioengineered food'' in Sec. 66.1
or is exempt from disclosure under Sec. Sec. 66.5(c)-(e), is
prohibited from voluntary disclosure under the NBFDS. For example, a
soup that lists beef broth as the first ingredient on the ingredient
list may not bear a voluntary disclosure regardless of the other
ingredients in the soup. Voluntary labeling provisions are found in
Sec. 66.116.
As described earlier in this final rule, only products that contain
ingredients with detectable modified genetic material, as demonstrated
through records maintained by the regulated entity, must be disclosed.
This means that many refined products originating from bioengineered
crops do not constitute bioengineered foods. However, if a food
manufacturer, retailer, or importer that would otherwise not be
required to provide a disclosure wants to voluntarily disclose that a
refined food originates from an item on the List of Bioengineered
Foods, it is free to do so. For example, if a beverage company makes a
carbonated soda containing corn syrup originating from BE corn, and the
corn syrup does not have detectable modified genetic material, the corn
syrup alone does not trigger mandatory disclosure. Under voluntary
labeling provisions, because the corn syrup originates from BE corn,
the beverage company may provide a disclosure explaining to the
consumer that the ingredients in the soda are ``derived from
bioengineering,'' even though the ingredient is not for the purposes of
this regulation considered to be ``bioengineered.''
AMS believes that exempt entities should also be permitted to
voluntarily disclose bioengineered foods. For instance, AMS believes
that very small food manufacturers, who are entities with less than
$2.5 million in annual receipts and who are exempt from mandatory
disclosure requirements, should also be able to voluntarily disclose
the presence of bioengineered ingredients, or ingredients originating
from bioengineered crops. If a very small food manufacturer is using
items on the List of Bioengineered Foods that contain modified genetic
material and the food would be subject to mandatory disclosure
requirements but for the company size exemption, they may provide a
disclosure as provided in Sec. 66.116(a). If a very small food
manufacturer is using ingredients that do not contain modified genetic
material but are derived from items on the List of Bioengineered Foods,
they also may utilize the voluntary disclosure rules explained in Sec.
66.116(b).
It is important to note that when entities utilize the voluntary
disclosure provisions in Sec. 66.116, they are required to comply with
the disclosure requirements (size, location on package, etc.) for text,
symbol, digital or electronic link, or text message disclosure, as
applicable.
IV. Administrative Provisions
A. Recordkeeping Requirements
The amended Act requires each person subject to mandatory BE food
disclosure under the NBFDS to maintain records such as the Secretary
determines to be customary or reasonable in the food industry to
establish compliance with the Standard. See 7 U.S.C. 1639b(g)(2).
Persons required to keep such records include food manufacturers,
importers, and retailers who label bulk foods or package and label
foods for retail sale. Section 66.302(a)(1) therefore requires that
regulated entities maintain customary or reasonable records to
demonstrate compliance with the BE food disclosure requirements. So
long as the records contain sufficient detail as to be readily
understood and audited as set forth in Sec. 66.302(a)(2), each entity
subject to the disclosure requirement may decide for itself what
records and records management protocols are appropriate, given the
scope and complexity of individual businesses, as well as the food
being produced. AMS notes that regulated entities, both domestic and
foreign, will likely have customary or reasonable records in accordance
with the NBFDS if they are maintaining records in compliance with
[[Page 65831]]
other laws or regulations associated with the food sector.
In general, comments in response to the proposed recordkeeping
requirements in the NPRM supported AMS's proposals. Commenters agreed
that the recordkeeping requirements of the NBFDS should be consistent
with those under other AMS marketing programs so as not to present an
unreasonable burden to entities who must comply with the Standard.
Commenters observed that the recordkeeping requirements as proposed
would probably not impose additional costs or burdens to existing
business practices. Commenters provided examples of typical records
generated in the course of business that should satisfy the audit
requirements under Sec. 66.402 to verify compliance with disclosure
requirements under the NBFDS. Commenters suggested that the regulation
include examples of appropriate records an entity might maintain to
meet the recordkeeping requirements. Commenters supported the proposed
flexibility that would allow for record maintenance in the format
preferred by the entity. Commenters also supported the proposed two-
year record retention period, consistent with the recordkeeping
requirements under other USDA and FDA regulations.
AMS agrees that recordkeeping and compliance requirements under the
NBFDS should be consistent with those under other AMS programs, such as
NOP and PACA, and has incorporated elements from each of those programs
into the NBFDS. Accordingly, Sec. 66.302 does not specify the records
regulated entities must maintain to demonstrate compliance with the
disclosure regulations. Instead, as with other AMS programs, regulated
entities are free to determine for themselves which of their customary
business records will demonstrate compliance and should be maintained.
Section 66.302(a)(4) includes a non-exhaustive list of records that
could satisfy the recordkeeping requirements of the NBFDS. That list
includes: Supply chain records, bills of lading, invoices, supplier
attestations, labels, contracts, brokers' statements, organic
certifications, laboratory testing results, validated process
verifications, and other records generated or maintained by the
regulated entity in the normal course of business. 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. Section
66.302(a)(2) provides that records can be in paper or electronic format
at the discretion of the regulated entity. Section 66.302(a)(3)
requires that records be maintained for at least two years beyond the
date the food or food product is sold or distributed for retail sale.
As noted above, the amended Act requires that each person subject
to mandatory BE food disclosure under the NBFDS must maintain records.
In this regard, as noted in section 66.302(b), the List of
Bioengineered Foods identifies the foods for which regulated entities
must maintain records and that may be required to bear a BE disclosure,
based on what the records show. Consistent with the statutory
requirement, where the regulated entity has actual knowledge that the
food or food ingredient is bioengineered, the regulated entity must
maintain records for that food or food ingredient, even if the food is
not on the List of Bioengineered Foods.
Some comments in response to the NPRM opposed requiring entities
who do not handle BE foods to maintain records to verify compliance
with the regulation. Other comments supported AMS's proposal to do so,
explaining that all regulated entities subject to the disclosure
standard should be required to keep the same kind of records. AMS
agrees that all food manufacturers, importers, and retailers who offer
for retail sale foods on the List of Bioengineered Foods are considered
regulated entities for purposes of the NBFDS insofar as they may be
required to make BE food disclosures. Their customary business records
should be able to satisfy an audit to determine whether they are in
compliance with the disclosure requirements of the NBFDS.
The amended Act requires each person subject to the disclosure
requirements of the NBFDS to give the Secretary access to records to
establish compliance with the disclosure requirements upon request.
Accordingly, Sec. 66.304 sets forth the provisions for AMS's access to
records.
AMS proposed in the NPRM that entities would have five business
days to provide records to AMS upon request, unless AMS extends the
deadline. AMS also proposed to provide prior notice of at least three
business days if we need to access the records at the entity's place of
business. Finally, AMS proposed that it would examine the records
during normal business hours and that entities should make their
records available during those times.
Commenters generally supported the proposed five- and three-day
timeframes for the production of records and access to records at the
entity's place of business, respectively. Some commenters suggested
that because the NBFDS is a marketing standard rather than a food
safety regulation, longer timeframes for records production would be
appropriate. AMS believes that the timelines for records production and
access are appropriate for enforcing compliance with the NBFDS and
notes that flexibility is provided in the regulation to extend
deadlines if necessary. Commenters requested that regulated entities be
allowed to maintain records at locations most convenient for each
business. AMS agrees that entities can maintain records at the location
that best serves the entity's business needs.
Accordingly, Sec. 66.304(a) provides that the entity must provide
records to AMS within five business days of AMS's request, unless AMS
extends the deadline. Section 66.304(b) provides that AMS will give at
least three business days' notice if it needs access to records at the
entity's place of business. As well, AMS will examine records during
normal business hours, and records should be made available during
those times. Finally, entities must provide AMS access to facilities
necessary for records examinations. As proposed in the NPRM, Sec.
66.304(c) specifies that if an entity fails to give AMS access to
records as required, the result of the examination or audit will be
that the entity did not comply with the requirement to provide access
to records and that AMS could not confirm whether the entity is in
compliance with the disclosure standard of the NBFDS.
B. Enforcement
The amended Act specifies that failure to make a BE food disclosure
as required by the NBFDS is prohibited. See 7 U.S.C. 1639b(g)(1).
Section 66.400 of the NBFDS captures this prohibition. The amended Act
authorizes AMS to enforce compliance with the standard only through
records audits and examinations, hearings, and public disclosure of the
summary of the results of audits, examinations, and similar activities.
See 7 U.S.C. 1639b(g)(3). The amended Act further states that the
Secretary shall have no authority to recall any food subject to the
NBFDS ``on the basis of whether the food bears a disclosure that the
food is bioengineered.'' See 7 U.S.C. 1639b(g)(4).
AMS considered responses to the 30 questions when developing the
proposed enforcement provisions of the NBFDS, and many suggestions were
incorporated into the proposal. Accordingly, the NPRM outlined a
[[Page 65832]]
process for receiving complaints about possible violations of the
disclosure standard and set forth a records audit procedure. As
provided in the amended Act, AMS proposed to review the records of
regulated entities during audits and examinations to verify compliance
with the NBFDS's disclosure requirements. Provisions for making
findings and allowing for appeals hearings in response to the findings
were proposed. Finally, provision was made for publicizing the results
of audits, examinations, and hearings.
As with responses to the 30 questions, comments on the proposed
NBFDS enforcement provisions reflected a range of opinions about how
AMS should enforce compliance with the NBFDS. Many suggested that AMS
conduct regularly scheduled or unannounced records audits. Others
supported conducting audits and examinations in response to complaints.
Some commenters called for the imposition of heavy fines or other
penalties for non-compliance, while others agreed that publicizing the
results of audits and hearings would be adequate enforcement for this
marketing regulation. Several commenters requested that records related
to product formulations and formulas remain confidential.
As pointed out in the NPRM, the amended Act does not authorize
civil penalties for violations of the NBFDS, and AMS believes some of
the other enforcement suggestions to be impractical. Therefore, the
enforcement provisions of the NBFDS reflect those proposed in the NPRM,
with one exception. Comments in response to the NPRM suggested that AMS
provide greater clarity about the process for filing complaints about
potential violations of the disclosure standard. Paragraph (a) of Sec.
66.402 is revised to include greater specificity about the complaint
process. The remainder of Sec. 66.402 continues to describe the
process for initiating records audits or examinations, including
providing notice of such activities, making the audit or examination
findings available to the regulated entity, and providing for appeals
to object to the findings. Section 66.404 provides that within 30 days
of receiving the results of an audit or examination of its records, the
regulated entity that objects to the findings may request a hearing by
filing a request and submitting a response to the findings, along with
any supporting documents, to AMS. AMS may allow the entity to make an
oral presentation, after which the AMS Administrator may revise the
findings of the audit or examination. Section 66.406 provides that AMS
will make public the summary of the final results of the audit,
examination, or similar activity, and that such final results
constitute final agency action for purposes of judicial review of the
matter. AMS agrees that the confidential business records, including
product formulations and recipes, should not be disclosed.
C. Effective, Implementation, and Compliance Dates
Because this rule is a major rule, the effective date will be
February 19, 2019 to comply with the Congressional Review Act. The
proposed rule included an initial compliance date of January 1, 2020,
and a delayed compliance date of January 1, 2021, for small food
manufacturers, as mandated by the amended Act. AMS received several
comments on the compliance date, some of which supported the proposed
dates, while others sought earlier or later dates.
After considering input from commenters and other available
information, AMS recognized that regulated entities should have
sufficient time to transition their recordkeeping and labeling
processes and procedures to implement the BE disclosure requirements
and that the transition should be completed in phases. Section 66.13
sets forth the implementation and compliance dates for the NBFDS. The
final rule establishes implementation dates of January 1, 2020, for
regulated entities other than small food manufacturers and January 1,
2021, for small food manufacturers. Regulated entities should begin
implementing the NBFDS no later than those dates 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.
Following the implementation dates, the final rule establishes a
mandatory compliance date and a voluntary compliance period. Mandatory
compliance begins on January 1, 2022, and all regulated entities must
comply with the requirements of the NBFDS beginning on that date. For
regulated entities that can and would like to do so, the final rule
provides for a voluntary compliance period that ends on December 31,
2021. We believe this phased approach balances the needs of consumers
to have access to information about bioengineered foods they may
purchase with the cost and burdens to regulated entities in complying
with the NBFDS requirements.
D. Use of Existing Label Inventories
In an effort to reduce costs and burdens, AMS proposed in the NPRM
to allow regulated entities to use up food labels that are printed by
the initial compliance date, regardless of whether the existing labels
comply with the NBFDS, until the remaining label inventories are
exhausted or until January 1, 2022, whichever comes first. Comments in
response to the NPRM generally reflected two viewpoints. Consumers and
consumer groups claimed that manufacturers could theoretically continue
printing and using non-compliant labels for up to six years after the
Act was amended to require mandatory BE food disclosure. Those
commenters urged AMS to allow a shorter compliance period for label
use-up. Food manufacturer comments generally supported the proposed
label use-up provision, but they asked that the final rule provide a
two-year compliance period after the compliance date, rather than
specifying a hard date, to allow for regulatory delays. Manufacturer
commenters also urged AMS to allow the use of labels compliant with the
preempted State GMO labeling laws during the compliance period. Some
commenters recommended that AMS allow entities to apply stickers or ink
stamp disclosures to existing labels to reduce waste. Others suggested
that AMS incorrectly assumes manufacturers maintain large label
inventories, asserting that manufacturers order labels in the smallest
batches economically practical.
As discussed above, AMS is providing a period of voluntary
compliance until December 31, 2021, with mandatory compliance to begin
on January 1, 2022. With this voluntary compliance period, it is not
necessary to provide for regulated entities to be able to use its
existing label inventories. Thus AMS is not adopting this component of
the proposed rule. However, in response to comments regarding this
proposal, regulated entities may use labels that are compliant with
preempted State labeling laws during the voluntary compliance period.
They may also apply stickers or ink stamp disclosures to existing
labels. The sticker or printing cannot cover any other mandatory
labeling, such as nutrition facts.
V. Comments on the NPRM
AMS received approximately 14,000 comments in response to the NPRM.
We received comments from individuals, consumer groups, companies, and
organizations that represent different segments of the food industry.
We
[[Page 65833]]
review and respond to the comments below.
1. Definition of ``Food''
In the NPRM, AMS described how it would implement the statutory
definition of ``food'' in the amended Act and how the disclosure
requirements would intersect with the FDCA, the FMIA, the PPIA, and the
EPIA.
Comment: Many commenters supported the proposed definition of
``food.'' Some commenters disagreed with how predominance was
determined for meat, poultry, and egg products for purposes of BE food
disclosure. Some commenters stated that the final rule should adopt the
labeling approach used by FSIS and determine the ingredient
predominance based on weight of ingredients so as not to confuse
companies and consumers. Other commenters noted that FDA permits
composite and component labeling in ingredient declaration statements.
AMS Response: AMS notes that FDA and FSIS use the same method for
determining predominance of ingredients by weight. Thus, we agree that
the predominance determination for meat, poultry, and egg products
should be based on weight. As FDA permits both composite and component
labeling, AMS also will permit such ingredient declaration labeling.
Comment: Several commenters pointed out that because most seafood
products are subject to the FDCA, BE seafood would be subject to
disclosure. However, catfish and related species would not require
disclosure because they fall under the FMIA. Commenters stated that
this will cause consumer confusion and the rule should be reworded to
require all seafood products that contain BE ingredients to be labeled.
AMS Response: AMS acknowledges that there may be consumer confusion
if the industry develops a BE catfish and it may not be subject to
disclosure, depending on its predominance on the ingredient list, while
other BE seafood would be. However, the amended Act clearly sets forth
how food subject to the FMIA are to be disclosed and AMS does not have
the statutory authority to expand disclosure beyond what those
statutory provisions provide.
Comment: Several commenters opposed limiting the definition of
``food'' to food for human consumption and sought to include food for
animal consumption to be included.
AMS Response: We appreciate that several commenters would like to
extend the BE disclosure to food for animals. The amended Act, however,
clearly limits the mandatory disclosure requirements to food for human
consumption and AMS does not have the statutory authority to require BE
disclosure for food for animal consumption on a mandatory or voluntary
basis.
2. Definition of ``Bioengineered Food''
AMS requested public comments on the definition of ``bioengineered
food.'' The statutory definition of bioengineering describes food that
``contains genetic material that has been modified through in vitro
recombinant deoxyribonucleic acid (DNA) techniques.'' In the NPRM, we
proposed two interpretations of this definition; Position 1 proposed
that highly refined products do not contain genetic material that has
been modified through in vitro recombinant deoxyribonucleic acid (rDNA)
techniques and therefore are not bioengineered food, while Position 2
proposed that all foods produced from bioengineering, including refined
and highly refined products, are bioengineered food.
Comment: Several commenters supported Position 1. Those commenters
concluded that, in general, highly refined foods and ingredients do not
meet the statutory definition of ``bioengineering,'' and thus, are not
subject to the labeling requirements because they lack rDNA. Many of
those commenters cited several scientific studies they viewed as
demonstrating an absence of genetic material in such foods. Some
commenters also noted that the proposed regulation governs the food
product, not the source plant from which the food was produced.
AMS Response: Because some countries previously established BE food
labeling requirements, the industry recognized the need for
standardized methods for the detection of rDNA. Technical Committee 34
(TC 34) ``Food Products'' of the International Organization for
Standardization (ISO) developed numerous validated sampling and
detection methods to detect rDNA in food products.\8\ Subcommittee 16
(SC 16) established the ``Horizontal methods for molecular biomarker
analysis'' in 2008. ISO/TC 34/SC 16 published 19 ISO standards and has
17 additional standards under development. The established detection
methods are generally carried out in accordance with the ISO/ICE
17025:2017 standard and validated according to Codex Alimentarius
guidelines.
---------------------------------------------------------------------------
\8\ ISO (2018) https://www.iso.org/committee/560239.html.
---------------------------------------------------------------------------
These methods are crop and event specific and most rely on
quantitative Polymerase Chain Reaction (PCR). In general, the detection
methods are most effective when applied to raw agricultural commodities
because the DNA remains relatively intact; many types of food
processing (e.g. heating) serve to degrade and eliminate DNA.
Screening of raw agricultural commodities (e.g. seeds, leaves and
roots) for rDNA is routinely conducted by the global grain and food
industries in order to maintain identity preserved supply chains. After
testing at the commodity level, identity is generally preserved through
records rather than through additional testing after processing. This
is practical since methodology for detection of rDNA at the commodity
level is well established; applying these same methods to refined
ingredients and processed foods can be much more challenging.
The Pauli study attempted to extract DNA from 55 common foodstuffs
derived from soybean, corn, potato, rice, sugar beet, tomato and
wheat.\9\ They were able to extract some DNA from most of the
foodstuffs, but were not able to extract any DNA from refined sugar and
oil.\10\ Whether rDNA can be detected in processed foods will depend on
the specific processing conditions for each food ingredient. The
Greiner study analyzed 100 foods derived from BE corn and 100 foods
derived from BE soybean; they were able to detect rDNA in 13% of the
soy products and 8% of the maize products.\11\ The Orlandi study
evaluated 63 products derived from BE corn, but only detected rDNA in
four of the products, all of which were taco shells.\12\ The Arun study
found that detectability of rDNA in cookies varied with cooking time
and cooking temperature.\13\
---------------------------------------------------------------------------
\9\ Pauli et al. (2000) Extraction and amplification of DNA from
55 foodstuffs. Mitteilungen aus Lebensmitteluntersuchung und
Hygiene. 91:491-501 (Pauli study).
\10\ In this study, the scientists were simply extracting total
DNA, and any rDNA, if present, would be a minute fraction of the
total DNA extracted.
\11\ Greiner et al. (2005) Qualitative and quantitative
detection of genetically modified maize and soy in processed foods
sold commercially in Brazil by PCR-based methods. Food Control 16:
753-759 (Greiner study).
\12\ Orlandi et al. (2002) Analysis of Flour and Food Samples
for cry9C from Bioengineered Corn. J Food Protection 65:426-431
(Orlandi study).
\13\ Arun et al. (2016) The effect of heat processing on PCR
detection of genetically modified soy in bakery products. J Health
and Food Sci. 2:130-139 (Arun study).
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When refining food ingredients from agricultural inputs, the
objective is often to produce ingredients with a high degree of purity.
Therefore, it is not
[[Page 65834]]
surprising that the industrial processes developed for the refining of
sugars and oils effectively eliminate the majority of undesired
substances, including DNA and protein. Several published studies have
demonstrated that genetic material is not detectable in refined beet
sugar or refined cane sugar.\14\ One study reported detection of rDNA
in raw cane sugar, but not in refined cane sugar; \15\ however, the
Cheavegatti-Gianotto study did not detect rDNA in raw sugar. One
commenter noted that raw cane sugar is not intended for human
consumption; rather it is intended as a feedstock for refining white
cane sugar. Therefore, all five published studies referred to above
reached the same conclusion, that DNA could not be detected in refined
sugar.
---------------------------------------------------------------------------
\14\ See Cheavegatti-Gianotto et al. (2018) Lack of Detection of
Bt Sugarcane Cry1Ab and NptII DNA and Proteins in Sugarcane
Processing Products Including Raw Sugar. Front Bioeng Biotechnology.
27:24 (Cheavegatti-Gianotto study); Joyce et al. (2013) Sugar from
genetically modified sugarcane: Tracking transgenes, transgene
products and compositional analysis. International Sugar Journal.
pp. 861-863; Klein et al. (1998) Nucleic acid and protein
elimination during the sugar manufacturing process of conventional
and transgenic sugar beets. J Biotech 60, 145-153; Oguchi et al.
(2008) Investigation of Residual DNAs in Sugar from Sugar Beet (Beta
vulgaris L.). J. Food Hyg. Soc. Japan. 50:41-46.
\15\ Cullis et al. (2014) DNA and Protein Analysis throughout
the Industrial Refining Process of Sugar Cane. Science Target 3:1-
15.
---------------------------------------------------------------------------
The sugar refining process from sugar beet or sugarcane juice that
has been extracted by pressing or diffusion, then clarified and
evaporated, results in sucrose of 99.9% purity. Several of these
refining steps involve heating which serves to degrade DNA.
Additionally, prior to crystallization, lime is used to remove the
impurities remaining in the sugar juice; DNA and protein are
effectively removed at this step in the sugar refining process. Based
on the available scientific evidence, several countries (e.g.
Australia, Brazil, Japan, Israel, New Zealand and South Korea) have
exempted refined sugar from their respective BE food labeling
requirements.
Food grade vegetable oils can be derived from a variety of BE crop
sources (e.g. corn, soybean, and canola) and can be refined with a
variety of methods (e.g. chemical vs. physical refining). The
detectability of rDNA may vary by crop and by refining method.
Substances present in raw vegetable oil are removed by steps such as
degumming, neutralizing, bleaching, deodorizing, and dewaxing.
The Pauli study was unable to extract DNA from refined oil. Another
study was unable to detect rDNA in refined soybean oil; they observed
degradation of DNA during degumming and concluded that degumming was
the most important step in removing DNA when refining soybean oil.\16\
However, one study was able to detect rDNA in refined soybean oil.\17\
These variable results may be due to differences in refining processes;
some oil refining processes may effectively eliminate all DNA, while
others, such as cold pressing, are unlikely to eliminate all DNA.
Similar to refined sugar, several countries (e.g. Australia, Brazil,
Japan, Israel, New Zealand and South Korea) have exempted refined
vegetable oils from their respective BE food labeling requirements.
---------------------------------------------------------------------------
\16\ Gryson et al. (2002) Detection of DNA during the refining
of soybean oil. JAOCS, Vol. 79, 171-174.
\17\ Costa et al. (2010) Monitoring GM soybean along the
industrial soybean oil extraction and refining processes by PCR
techniques. Food Research Intl 43:301-306.
---------------------------------------------------------------------------
The studies cited above, as well as similar studies provided by
some commenters demonstrate for many refined food products and
ingredients, the refining process removes the genetic material so that
it can no longer be detected. If the genetic material is not detected,
then it is not possible to conclude that the food product or ingredient
contains modified genetic material. Thus, based on the available
scientific evidence, refined beet and cane sugar, high fructose corn
syrup, degummed refined vegetable oils and various other refined
ingredients are unlikely to require BE food disclosure because the
conditions of processing serve effectively to degrade or eliminate the
DNA that was initially present in the raw agricultural commodity.
Comment: Many commenters supported the labeling of all foods
produced through bioengineering including refined oils, sugars and
starches. They believed processed foods originating from BE raw
agricultural commodities should be considered bioengineered food,
regardless of whether modified genetic material remains detectable in
the final product. Some commenters did not believe disclosure should
rely only on the detection of genetic material in a food, or food
ingredient, or solely on specific test methods like PCR. Commenters
noted that scientific methods may advance to where today's
``undetectable'' genetic material may be detectable using future
technologies. In support of this position, commenters cited several
studies documenting the evolution of our ability to detect previously
undetectable bioengineered products.
AMS Response: AMS appreciates commenters' position on disclosing
foods produced through bioengineering. AMS has adopted the statutory
definition of ``bioengineering,'' which makes clear that food must
``contain genetic material that has been modified through in vitro rDNA
techniques . . .'' to be labeled as a ``bioengineered food.'' Highly
refined products have undergone processes that removed genetic material
such that it cannot be detected using common testing methods. As such,
the NBFDS will not require disclosure for refined products that do not
contain modified genetic material. Regulated entities who do not
disclose such products would maintain records that substantiate their
claim that the products do not contain modified genetic material. As
described in the Preamble and in Sec. 66.9, regulated entities can
demonstrate that their food products do not contain modified genetic
material in multiple ways.
AMS maintains that the products of technology, rather than the
technology itself, should determine whether a food meets the BE food
definition and requires disclosure unless exempted from disclosure
pursuant to Sec. 66.5. We also recognize that emerging technologies
could impact the list of foods requiring disclosure. As such, AMS
provides for the consideration of new technologies used to develop
foods during the process of reviewing and revising the List of
Bioengineered Foods.
We recognize that testing methodology may evolve so that a future
test may detect modified genetic material in a food ingredient that
current tests do not. The definition of ``bioengineered food'' accounts
for this possible evolution. If the modified genetic material in that
food ingredient becomes detectable under Sec. 66.9 in the future, the
food ingredient would be subject to BE disclosure.
Comment: Some commenters supported the inclusion of highly refined
ingredients and foods, such as oils and sugars derived from
bioengineered crops, in the mandatory disclosure standard (Position 2).
Some commenters who supported Position 2 viewed it as being consistent
with the FDA's guidance to manufacturers entitled, ``Voluntary Labeling
Indicating Whether Foods Have or Have Not Been Derived from Genetically
Engineered Plants.'' Commenters considered detection of genetic
material in the food immaterial to its exemption from the Standard.
Instead, they justified their position based on consumer interest and
popular understanding of how common BE agricultural crops are grown,
not whether the food or ingredient contains modified genetic material.
These
[[Page 65835]]
commenters proposed that a narrow focus on the presence of genetic
material creates a differentiation based on rDNA that some could use to
imply a safety issue with the rDNA. Commenters further suggest such
implied issues could lead consumers to believe foods and food
ingredients containing genetic material are different in a way that
necessitates informing consumers.
AMS Response: AMS appreciates commenters' interest in the new
Standard and their efforts to be transparent and build consumer trust.
As stated in the previous comment response, AMS has adopted the
statutory definition of bioengineering. That definition focuses on the
products of technology, rather than the technology itself. For this
rule, the presence or absence of detectable modified genetic material
in a final food product determines in part whether a food meets the BE
food definition and might require disclosure. AMS reiterates that
nothing in the disclosure requirements set out in this final rule
conveys information about the health, safety, or environmental
attributes of BE food as compared to non-BE counterparts. The
regulatory oversight by USDA and other Federal government agencies
ensures that food, including that produced through bioengineering,
meets all relevant Federal health, safety, and environmental standards.
AMS values transparency and consumer interests. AMS recognizes that
some regulated entities may wish to disclose that their refined foods
(that do not contain modified genetic material and thus are not
bioengineered foods) are derived from bioengineering. Accordingly, AMS
has provided for voluntary disclosure of such foods.
Comment: One commenter supported Position 2 suggesting that non-BE,
identity-preserved, or certified organic crops and products can offer a
price premium and new or additional market access--domestic and
international--to producers. These commenters maintain that disclosing
all BE foods would improve these farmers' market transparency, while
exemption will require added costs for coexistence, segregation and
detectability testing.
AMS Response: AMS agrees that it is possible that some marketing
claims may offer a price premium or new market access. AMS has adopted
Position 1 with some modifications. For further details on our
rationale for adopting this position, see Section II.C.1 of this rule.
With the adoption of Position 1, foods with undetectable modified
genetic material are not bioengineered foods. Accordingly, regulated
entities need not disclose such foods as bioengineered foods. AMS has
determined that regulated entities can establish that their foods do
not contain detectable rDNA through their records of the foods on the
List of Bioengineered Foods.
Comment: Some commenters suggested a broad interpretation of the BE
definition and scope accounting for existing technologies like CRISPR
and TALENS, as well as for future developments. The interest of these
commenters was to prevent confusion among consumers and in the
international marketplace if the NBFDS failed to harmonize the law with
existing standards--FDA, Codex Alimentarius, and USDA Certified
Organic, all of which include gene editing and gene silencing
techniques (e.g. sequence-specific nucleases, meganucleases, zinc
finger nuclease, CRISPR-Cas system, TALENs, oligonucleotide directed
mutagenesis RNAi, RNAi pesticides, and RNA-dependent DNA methylation).
Commenters cited USDA's General Counsel Jeffrey M. Prieto, who stated
that it is well within USDA's authority under Public Law 114-216 to
mandate a broad interpretation. Another commenter was concerned that a
failure to further define bioengineering could lead to state preemption
concerns. The commenter stated that preemption, as intended by the BE
Food Disclosure Act, Sec. 295, was not intended to be limited to the
smaller subset of foods now defined as ``bioengineered,'' which, as
proposed, excludes highly refined ingredients and products of gene
editing.
AMS Response: AMS appreciates commenters' concerns and acknowledges
the range of feedback provided. AMS has adopted a modified version of
Position 1 and believes that the definition of ``bioengineering'' sets
forth the scope of the mandatory disclosure. Although the Jeffrey
Prieto letter seemingly advocated an expansive interpretation of the
statutory definition of bioengineering along the lines of Position 2,
AMS maintains that with the full range of information before it,
including additional interpretation of the amended Act and responses to
both the 30 questions and the NPRM, Position 1 is more closely aligned
with the amended Act's definition of bioengineering. AMS will adopt
Position 1 and is incorporating the statutory definition of
bioengineering into the regulatory definition of ``bioengineered
food.''
AMS does not find it necessary to further define bioengineering.
AMS also disagrees with commenters' concerns that failing to further
define bioengineering would result in limiting preemption. Subtitle F
of the amended Act addresses Federal preemption of State and local
genetic engineering labeling requirements. 7 U.S.C. 1639i. The
preemption provisions extend beyond bioengineering labeling and include
genetic engineering labeling requirements.
Also, as stated earlier, this definition of bioengineered food
focuses primarily on the products of technology, not the technology
itself. AMS is not making a blanket statement regarding the scope of
technologies that are covered by the NBFDS. Finally, AMS agrees the
NBFDS should align with some elements of existing standards to the
extent possible. In Sections II through IV of this rule, AMS outlines
its efforts to align the NBFDS with existing laws.
Comment: Several commenters supporting Position 2 also recommended
adopting the Codex Alimentarius definition for Modern Biotechnology:
(i) In vitro nucleic acid techniques, including rDNA and direct
injection of nucleic acid into cells or organelles, or (ii) fusion of
cells beyond the taxonomic family, that overcomes natural,
physiological reproductive or recombination barriers, and that are not
techniques used in traditional breeding and selection. These commenters
state that the Codex Alimentarius definition of bioengineering is
internationally recognized by the World Trade Organization as the
standard for settling trade disputes, and therefore should serve as a
guidepost for the USDA. Additionally, several commenters expressed
concern that adopting Position 1 could negatively impact trade.
According to these commenters, most countries with BE disclosure
standards require that highly refined products be disclosed. They
contend that adopting Position 1 and not aligning the NBFDS with
existing international standards would create confusion among consumers
and in the international marketplace.
AMS Response: In drafting the proposed rule and in finalizing the
rule, AMS has reviewed and considered various foreign labeling regimes.
To the extent possible, AMS has tried to align the NBFDS with existing
domestic and international regimes to reduce burdens on regulated
entities, promote consistency for consumers, and limit trade impacts.
AMS is bound by the plain language of the amended Act. As described
above, based on the language of the amended Act, AMS is incorporating
the statutory definition of bioengineering into the regulatory
definition of ``bioengineered food.'' As
[[Page 65836]]
such, if a food does not contain detectable modified genetic material,
it is not a bioengineered food and does not require disclosure.
Comment: Some commenters also cited evidence that the amended Act
did not propose the adoption of any ``other factors and conditions
under which a food is considered a bioengineered food'' as part of the
final rule. These commenters state that this rulemaking may only
provide a process to allow any person to petition AMS and request the
adoption of specified ``other factors and conditions.''
AMS Response: AMS disagrees with commenters who assert that the
amended Act did not provide for factors and conditions under which a
food is considered a bioengineered food. The amended Act clearly
provides the Secretary with this authority. 7 U.S.C. 1639b(b)(2)(C).
AMS has interpreted this statutory provision as one that limits the
scope of the definition of ``bioengineered food,'' thus potentially
excluding certain products from disclosure. The factors and conditions
process, as proposed in the NPRM and adopted in this rule, offers a
fair and rational method by which interested persons can petition AMS
to consider various proposals. See Section II.E of this rule for
details of the process.
Additionally, nothing in the amended Act precludes AMS from
considering requests for a factor and condition that were submitted as
part of responses to the 30 questions as petitions contemplated by 7
U.S.C. 1639b(b)(2)(C) and applying the process in this final rule to
consider those petitions. Because the process is a rulemaking process,
we believe that it is appropriate and efficient to consider certain
petitions that meet the standards for consideration in Sec. 66.202 as
part of this rulemaking.
Comment: One commenter stated that because there is no difference
chemically between refined and highly refined products and their non-BE
counterparts, these products should not be treated differently.
Instead, commenters believe refined and highly refined products should
be exempt from BE labeling similar to their non-BE counterparts.
Several commenters expressed concern that treating these chemically
identical products differently could negatively impact the market
appeal of highly refined products. Commenters also point out that
enzymes produced from bioengineering as sourced from bioengineered
crops are not themselves BE food, because enzymes are proteins and do
not contain DNA.
AMS Response: AMS recognizes that highly refined foods produced
from BE crops are generally chemically identical to the same foods
produced from non-BE sources. Under the NBFDS, neither product would be
subject to disclosure unless another ingredient triggers the disclosure
requirement. However, regulated entities do have the option to
voluntarily disclose information about highly refined foods derived
from BE sources.
AMS notes that enzymes may be used in a manner that requires them
to be labeled on the ingredient statement. Enzymes sometimes qualify as
incidental additives that are not required to be labeled as ingredients
on a food label. In those instances, they do not require disclosure as
BE foods. However, bioengineered enzymes that do not qualify as
incidental additives may require disclosure as BE foods, unless they do
not have detectable modified genetic material.
Comment: Some commenters feel that mandating disclosure for refined
products would disparage biotechnology. They also felt that labeling BE
products would impose a burden on them that was not levied upon the
non-BE counterpart.
AMS Response: AMS appreciates commenters' concerns about mandatory
disclosure and explains the NBFDS seeks to minimize the food industry's
implementation and compliance costs while providing a mandatory,
uniform disclosure standard for BE food. As noted, AMS has adopted
Position 1, in which products that do not contain modified genetic
material are not bioengineered foods and are not subject to mandatory
disclosure. Such products could be voluntarily disclosed.
Comment: Some commenters provided an economic argument that the
number of BE foods covered would not change if refined and highly
refined foods where no rDNA is detectable are not covered by the NBFDS.
In addition these commenters cite the inconsistency of requested
exemptions for (1) incidental additives, processing aids, secondary
direct additives; (2) food derived from insects or microorganisms that
grow or feed on a bioengineered substrate, such as a bioengineered crop
or other substance; (3) enzymes; (4) ingredients derived via
fermentation regardless of whether the microorganisms used in the
fermentation are derived using rDNA technology, and (5) food products
with medicinal or supplementary applications to be excluded from the
definition of a BE Food. They stated that exemptions for refined and
highly refined products would be no different.
AMS Response: AMS acknowledges the range of comments citing
substances that may or may not be subject to disclosure. In
establishing this rule, AMS relied on the statutory language in the
amended Act in adopting Position 1. Foods with no modified genetic
material are not bioengineered food and therefore are not subject to BE
disclosure. As stated in the RIA, because AMS has adopted this
position, there would be a reduction in the number of products that are
labeled BE. Because those foods are not bioengineered food subject to
mandatory disclosure under the amended Act, AMS does not have the
authority to require BE disclosure for those foods regardless of the
number of food products that may be affected.
In addition, AMS sought to align the disclosure requirements of the
NBFDS with the ingredient declaration requirements under applicable FDA
regulations to simplify compliance and reduce labeling costs for
regulated entities. Section II.E.1 of this rule details AMS's position
on disclosure of incidental additives, including enzymes and
microorganisms used in fermentation. AMS further discusses its position
for some of these substances in Section II.E.4 of this rule.
AMS sought to limit inconsistencies to the extent possible and
where it had the authority to do so. To the extent that interested
persons think that other products should be subject to disclosure, they
may submit a petition or request seeking to adopt a factor or condition
to potentially modify the definition of ``bioengineered food'' in a
future rulemaking.
Comment: Commenters pointed out that the NBFDS is a marketing
standard, not a safety standard. Consequently, they feel AMS should aim
to determine whether its new labeling system would confuse consumers.
These commenters were concerned that consumers who expect food
containing raw BE ingredients to be labeled as such may feel misled if
AMS adopts Position 1 for the NBFDS. Other commenters suggested that
the NBFDS clarify the definition of bioengineering to state that it is
synonymous with ``genetic engineering'' or ``GMO.'' These commenters
are concerned that the public, which commonly refers to BE products as
GMOs, may be confused when using the term bioengineering and that the
terminology may be inconsistent with other labeling systems.
Several commenters cited the option in the proposed rule to later
petition AMS to include specific factors or conditions not otherwise
provided for in the definition of ``bioengineered food''
[[Page 65837]]
and provide stakeholders with the freedom to disclose voluntarily
additional ingredients/products if they are truthful and consistent
with the NBFDS.
AMS Response: AMS acknowledges commenters' concern for potential
consumer confusion regarding the new labeling system. As explained in
earlier comments, AMS has adopted Position 1 and has incorporated the
statutory definition of bioengineering into the regulatory definition
of ``bioengineered food.'' We believe this definition of
``bioengineering'' clearly sets forth the scope of the mandatory
disclosure. AMS does not believe that the definition of bioengineered
food will create consumer confusion. However, AMS does understand that
some regulated entities are interested in disclosing that certain
products such as refined products are derived from bioengineering;
accordingly, regulated entities may voluntarily disclose such products.
AMS considered similar terms to bioengineering as permitted by the
amended Act but ultimately determined that bioengineering and
bioengineered food accurately reflected the scope of disclosure and the
products and potential technology at issue. AMS believes that using
other terms such as genetic engineering or genetically modified
organisms may create inconsistencies with the preemption provisions or
muddy the scope of disclosure.
Comment: Several commenters cited the option in the proposed rule
to later petition AMS to include specific factors or conditions not
otherwise provided for in the definition of ``bioengineered food'' and
provide stakeholders with the freedom to voluntarily disclose
additional ingredients/products if it is truthful and consistent with
the NBFDS. Many commenters saw this as a basis to exempt refined and
highly refined foods from the NBFDS as proposed in Position 1.
Some commenters were concerned with the economic impacts of
labeling refined foods as bioengineered and leading consumers to
improperly believe refined products contain bioengineered ingredients.
A related concern by one commenter maintains that Position 2
contradicts FDA's requirement that labeling be accurate. As an example,
the commenter suggested that labeling a package of sugar, a refined
food product, with one of the NBFDS disclosure options would falsely
imply the product contains modified DNA, and such a claim would not
comply with FDA's labeling requirement.
AMS Response: AMS has adopted Position 1 based on the plain
language of the amended Act. In addition, we agree that entities can
opt to voluntarily disclose information about highly refined foods made
from BE sources in accordance with Sec. 66.116.
Comment: Some commenters contend consumer expectations for BE
disclosure are driven, in part, by voluntary marketing claims like Non-
GMO Project Verified and True North. These voluntary programs label
highly refined products derived from bioengineering as GMO's.
Commenters suggest using an alternative approach to labeling these
products would cause consumer confusion and disrupt the industry.
Several commenters expressed concern this potential confusion could
impact them personally, as many have experienced health-related issues
after consuming products made with GMO ingredients. Others expressed
concerns about products made using bioengineered products.
AMS Response: AMS acknowledges that entities may participate in
voluntary labeling initiatives such as the non-GMO Project so long as
they are in compliance with all applicable Federal regulations. To the
degree possible, USDA has tried to minimize the impact the NBFDS will
have on these voluntary absence claims. AMS acknowledges that some
elements of the NBFDS may differ from requirements of some existing
voluntary marketing claims. As explained in earlier comment responses,
AMS has adopted the statutory definition of ``bioengineering,'' thereby
exempting from disclosure labeling foods such as refined products that
have undergone processes to remove modified genetic material.
In establishing this rule, AMS has considered the interest of
consumers and seeks to minimize the food industry's implementation and
compliance costs--costs that could be passed on to the consumers. That
said, as we have stated previously, nothing in this disclosure standard
conveys information about the health, safety, or environmental
attributes of BE food compared to non-BE counterparts. The NBFDS
provides a mandatory, uniform disclosure standard for BE food--as
defined in this rule, by which uniform information is provided to
consumers.
3. Conventional Breeding
AMS solicited comments on whether to define ``conventional
breeding'' and suggestions for what that definition should be.
Comment: Many commenters requested that AMS define conventional
breeding within the NBFDS final rule, to better define the scope of
NBFDS for regulated entities and consumers. Several commenters stated
that conventional breeding should be narrowly defined, opining that the
purpose of the NBFDS was to require labeling of bioengineered food.
This was in contrast to another commenter who desired a broad
definition of the term, stating that the final rule ``should recognize
that because a process accelerates what could be accomplished through
other, slower processes to achieve the same result, it should not
preclude the accelerated process from being deemed ``conventional.''
A few commenters accepted one of the sample definitions included by
AMS in the proposed rule, but there were many additional proposed
definitions. Some commenters suggested conventional breeding be defined
as ``referring to a wide range of modifications obtained through
methods that use an organism's potential genetic variability within its
gene pool.'' One commenter suggested modifying one of AMS's sample
definitions for conventional breeding to state ``protoplast fusion''
rather than ``protoplast,'' ``cell selection'' rather than ``cell'' and
``embryo rescue'' rather than ``embryo fusion.'' Other commenters
suggested adopting bioengineered food definitions from the USDA
National Organic Standard (see 7 U.S.C. 1639b(f)(2)), by the Food and
Drug Administration, or from the Codex Alimentarius. One such commenter
believed that doing so would make clear that the techniques of modern
biotechnology, such as gene editing and gene silencing, were not
conventional breeding.
A few groups of commenters requested the term be defined but did
not propose a specific definition. Many of them stated that they
disapproved of the use of any definition that includes a list, as
breeding techniques are continually evolving. One commenter argued that
the definition should be fashioned in such a way that the only products
subject to labeling are the ``products that were developed by
transferring genetic material between non-sexually compatible
species.'' A few other commenters desired that clarity would be
achieved by providing a definition and identifying, through examples,
those modifications that could be obtained through conventional
breeding. Another group of commenters stated that ``this should be done
through a supplemental proposed rule that provides the public with an
additional opportunity to provide public comments.''
[[Page 65838]]
There were, however, several commenters who believed that there was
no reason to define conventional breeding. Some stated that the term
was commonly understood and therefore unnecessary to define. Others
argued that the term was difficult to precisely define and therefore
would only sow confusion amongst the regulated if there was any attempt
to do so. One commenter worried that a definition would likely not
stand the test of time due to the pace of new technology and therefore
would not cover newly established processes.
AMS Response: AMS appreciates the wide range of comments received
related to defining ``conventional breeding.'' AMS finds ``conventional
breeding'' is a commonly understood term within the industry which does
not require a definition. Additionally, any ``conventional breeding''
definition could become unworkable or obsolete as technology and
techniques evolves. Forgoing defining the term would allow AMS to
respond to those challenges in real time.
Comment: Several commenters stated that conventional breeding is a
common term which is well understood, therefore the term does not need
to be defined. Some of those that did not wish the term to be defined
argued that any such attempts would be inherently confusing or
misleading to consumers.
AMS Response: AMS agrees that ``conventional breeding'' is a
commonly understood term within the industry that does not require
definition.
4. Found in Nature
AMS requested comments on whether the term ``found in nature''
should be defined, and if so, what that definition should be. AMS
specifically sought comment on whether intellectual property law should
be considered as one method for determination.
Comment: Commenters generally did not support defining or including
the term ``found in nature'' within the NBFDS. Many of those in
opposition believed the term ``found in nature'' itself was nebulous,
misleading, and not adequately defined by science. Others argued that
agriculture is inherently separate from nature.
Of those that did request the term be defined, two common
suggestions were ``spontaneously occurs in nature, such as natural
biological evolution, and does not overcome natural physiological
reproductive or combination barriers,'' or ``the kinds of genetic
modifications which can occur in nature within the genome of an
organism, without human intervention.''
One commenter suggested that should definitions be deemed
necessary, the definitions avoid setting precedents in other regulatory
areas, and be kept as simple and as clear as possible. Another group of
commenters stated that ``this should be done through a supplemental
proposed rule that provides the public with an additional opportunity
to provide public comments.''
AMS Response: AMS finds it unnecessary to define the term ``found
in nature.'' AMS received no compelling arguments to define the term
and believes that attempting to do so may cause confusion in light of
the rapid pace of innovation. In order to incorporate technological
changes in industry into this mandatory labeling standard, AMS believes
it needs to retain maximum flexibility. That will not be accomplished
by narrowly defining found in nature.
5. List of Bioengineered Foods
AMS solicited comments on the option of utilizing a list of foods
in an attempt to make it easier for regulated entities to identify what
products require disclosure. AMS proposed two lists: One composed of
highly adopted foods commercially available in the United States and
another of non-highly adopted foods commercially available in the
United States. AMS requested comments on maintenance of and revisions
to the lists, the threshold for ``highly adopted,'' and list
composition. AMS also requested comments on using list maintenance to
evaluate whether a particular crop meets the definition of
``bioengineering'' in light of emerging technologies; on whether
enzymes, yeasts, and other foods produced in a controlled environment
should be included on the lists; and on the treatment of foods produced
in other countries.
Comment: While some commenters suggested that a list should not be
used as a tool to help identify potential BE foods, most commenters
generally supported the use of a list method to identify foods subject
to disclosure, noting a readily available list of such foods would make
compliance less costly. A few commenters acknowledged the usefulness of
the proposed lists as a reference tool but recommended that the
presence of BE ingredients in a food trigger the disclosure requirement
even if those foods do not appear on the lists.
AMS Response: AMS agrees that the List of Bioengineered Foods is an
important part of the rule that will facilitate compliance with the
NBFDS. AMS also agrees that foods should be subject to disclosure to
the extent regulated entities have actual knowledge such foods are
bioengineered. Disclosure decisions are based on entities' records.
Nevertheless, entities that have actual knowledge that a food is
bioengineered must make appropriate disclosure of that food, even if
that food does not appear on the List. AMS believes, however, that it
would be unduly burdensome to hold regulated entities responsible for
failing to make BE disclosures for foods that do not appear on the List
and for which regulated entities have no actual knowledge of
bioengineered status. Disclosure and recordkeeping for unlisted foods
is therefore required only when regulated entities have actual
knowledge of the bioengineered status of the food in question. AMS
notes that it intends its List to be as complete as possible, aiming to
capture any BE foods that meet the definition of bioengineered food and
that could potentially be offered for sale in the United States.
Comment: While some commenters supported the use of separate lists
for highly adopted and non-highly adopted BE foods, many suggested that
using two lists with different labeling requirements would be confusing
and burdensome, and recommended the final rule call for the use of a
single list. A few commenters noted that using a single list could make
enforcement and list revision less burdensome for AMS. Others
recommended using a single list because the adoption rates forming the
basis of the two-list approach do not necessarily correspond to the
rates at which the listed crops are used in foods commercially
available for human consumption in the United States. Several
commenters recommended the single list be comprised of all commercially
available crops, while a few industry commenters asked that the single
list include only crops with a high (85%) BE adoption rate.
AMS Response: In the interest of simplifying compliance with the
NBFDS, AMS has consolidated the two lists proposed in the NPRM into one
List of Bioengineered Foods and has expanded that List to include foods
that may be produced internationally.
AMS has also determined that the purposes of the NBFDS are best
served by maintaining a list that, to the extent possible, captures all
foods meeting the regulatory definition of a ``bioengineered food''
that could potentially be offered for sale in the United States,
regardless of U.S. adoption rate. AMS has therefore expanded the List
beyond foods that are commercially available domestically. The initial
List, in Sec. 66.6, is comprised
[[Page 65839]]
of foods that, to the best of AMS's knowledge, are authorized for
production somewhere in the world and are currently in commercial
production somewhere in the world. AMS has considered information and
data from several sources, including, but not limited to USDA reports
and databases, ISAAA reports and databases, and reports and databases
produced by other Federal government agencies. Foods that AMS believes
are not currently in commercial production do not appear on the initial
List, even if such foods are authorized for production in the U.S. or
elsewhere. AMS may add those foods to the List through the process
prescribed for list maintenance and revision when available information
suggests it would be appropriate to do so. In any event, even if a food
is not on the List, regulated entities knowingly using a bioengineered
product are required to make disclosures for that food.
Comment: Several commenters recommended using an ingredients-based
list rather than a crops-based list. A few commenters stated that
presuming BE material is present in food derived from crops on the list
would frequently be unwarranted, as many such foods derive from listed
crops only because they contain certain highly refined ingredients that
lack BE material; these commenters explained that using an ingredients-
based list (such as a modified version of the lists in Exhibit 2 or
Table 5 from the Regulatory Impact Analysis) instead would avoid
creating that misleading presumption. Other commenters stated that an
ingredients-based list would make compliance easier for regulated
entities, which are often unsure which crops a food's ingredients
derive from. Some commenters, however, thought a crops-based list would
be easier for regulated entities to use and noted that a crops list,
unlike an ingredients list, could be updated and verified using
adoption rates and field data. A few commenters also expressed a need
for a list containing BE microorganisms or other BE species, such as BE
salmon.
AMS Response: AMS believes that regulated entities are in the best
position to know the source, origin, and type of food products they are
procuring, sourcing, refining, and potentially labeling. AMS developed
the List of Bioengineered Foods to reduce potential recordkeeping
burden of regulated entities while also providing information about the
scope of potentially available bioengineered foods. The List has been
expanded to include bioengineered foods that may not be produced in the
United States and non-crop bioengineered foods, for example salmon. AMS
acknowledges that the List may not be complete and may require periodic
updates. The rule provides for annual review of the List and provides a
mechanism for public input into list population, including rulemaking
as necessary, as well as consultation with other government agencies.
AMS anticipates that maintaining an ingredients-based list would be
resource-intensive, difficult to maintain, and would likely become
obsolete in short order. As stated, AMS believes that regulated
entities have more knowledge than AMS regarding the ingredients they
are sourcing. Entities who knowingly use bioengineered foods are
responsible for making appropriate disclosures, even if the food is not
on the List.
Comment: A few commenters requested that AMS establish a list of
Excluded Ingredients identifying ingredients or substances AMS
ultimately deems not to trigger the disclosure requirement. These
commenters noted that such a list could reduce compliance and
recordkeeping costs for regulated entities and suggested AMS could
periodically amend the list as appropriate without going through formal
notice and comment rulemaking. These commenters requested that AMS set
forth the process for creating and updating a list of Excluded
Ingredients in the final rule.
AMS Response: As explained in the Preamble, AMS cannot at this time
establish and maintain a list of ingredients excluded from the scope of
the disclosure requirement. Regulated entities are in the best position
to know whether disclosure is not required for the ingredients in their
products, including, for example, because records verify the products
are sourced from non-bioengineered crops or other sources, the
ingredients have been subjected to refinement processes validated to
remove genetic material, or analytical testing results demonstrate the
absence of modified genetic material.
Comment: Several commenters supported the proposed rule's exclusion
of enzymes, yeasts, and other non-crop foods created in controlled
environments from the proposed lists on the grounds that such foods
contain no genetic material and thus should not trigger the BE
disclosure requirement. Some commenters, however, recommended the lists
be expanded to include those products and all other BE-derived
substances in commercially available foods. Several of these commenters
explained that such substances, if ultimately deemed to meet the NBFDS
definition of BE food, should be included in the final lists to
facilitate compliance with the disclosure rule.
AMS Response: AMS notes that if regulated entities have actual
knowledge that enzymes, yeasts, and other similar foods produced in
controlled environments are bioengineered foods, then regulated
entities are obligated to disclose accordingly. AMS has decided not to
include on the List of Bioengineered Foods enzymes, yeasts, and other
similar foods produced in controlled environments. AMS believes that
such substances often do not meet the definition of a ``bioengineered
food'' because they may be incidental additives with no technical or
functional effect in the food under Sec. 66.1 and 21 CFR 101.100(a)(3)
(see Section E.1 of the Preamble, adopting the ``incidental additive''
factor or condition). Similarly, in many instances, a regulated entity
may be able to demonstrate that such foods do not contain modified
genetic material, such that they are not bioengineered foods. AMS
believes categorical inclusion of such substances on the List of
Bioengineered Foods would create confusion and complicate regulated
entities' efforts to comply with the NBFDS's disclosure requirement.
Regulated entities must determine whether recordkeeping and,
ultimately, disclosure of those substances are required on a case-by-
case basis.
Comment: Some commenters supported the proposed approach of listing
crops or foods generally by type rather than creating a more cumbersome
list identifying specific derivatives or varieties of listed crops.
Other commenters recommended that the final lists refer to crops with
greater specificity than the lists proposed--such as by specific
cultivars for each crop, brand name, variety, or narrowly-defined
product characteristic--to avoid burdening too many producers of non-BE
crops with the NBFDS recordkeeping requirement. For example, one
comment suggested listing ``Arctic[supreg] apple'' instead of ``Apple,
Non-browning cultivars,'' since the only commercially available version
of BE apples uses the Arctic[supreg] brand name. A few commenters also
requested clarification on which types of corn constitute ``sweet
corn'' and which types constitute ``field corn.''
AMS Response: AMS recognizes that listing foods broadly by type,
rather than by bioengineered derivatives or varieties of particular
foods, may impose disclosure or recordkeeping burdens on overbroad
segments of
[[Page 65840]]
producers or sellers of non-bioengineered foods. To address that
concern while maintaining a list of bioengineered foods that is not
overly cumbersome, AMS has decided to list foods broadly by type while
providing more details regarding specific varieties and
characteristics, where possible. With respect to apples, AMS
understands that most apple varieties are not known to be
bioengineered. AMS has modified the List to identify the specific
apples that are known to be bioengineered. As other BE versions of
foods that are listed by variety are approved and become legally
available, AMS will revise such listings to be more generic during the
annual update process.
Additional information will be provided on AMS's website about
specific varieties of foods that have been bioengineered, where that
information is available to AMS. To the extent possible, the AMS
website will also provide additional information about the traits for
which the foods have been bioengineered. The information on the AMS
website should aid regulated entities in determining which foods must
bear a BE disclosure. As part of the annual review process, AMS will
solicit information from the public to ensure that the List and the
additional information maintained on the AMS website are complete,
accurate, and as detailed, as possible.
Comment: Some commenters asked AMS to expand the proposed lists of
BE products to include any BE foods that have undergone an FDA pre-
market consultation, noting that such foods would be free to enter the
market in the United States. However, other commenters pointed out that
FDA pre-market consultation is not necessarily a reliable indicator
that commercial availability is imminent, and they supported limiting
the lists to products that are commercially available. Some commenters
also requested clarification in the final rule on the definition of
commercial availability, with a few commenters suggesting a market
threshold of 10% for deeming a product commercially available.
AMS Response: As previously discussed, AMS has replaced the two
lists of commercially available bioengineered foods proposed in the
NPRM with a consolidated List of Bioengineered Foods that includes, to
the best of AMS's knowledge, all foods that may meet the regulatory
definition of a ``bioengineered food'' that could potentially be
offered for retail sale in the United States. The consolidated List,
which can be found in Sec. 66.6, is comprised of foods that meet the
following criteria: (1) They are authorized for production somewhere in
the world and (2) they are believed to be in legal commercial
production somewhere in the world. AMS believes this approach is
consistent with the regulatory definition of ``bioengineered food'' and
avoids potential confusion on the meaning of or threshold for the term
``commercial availability,'' that was proposed in the NPRM.
Comment: Many commenters supported expanding the lists to encompass
BE crops grown in and imported from other countries, as large
quantities of foods containing or derived from such crops are
commercially available in the United States. Several commenters
acknowledged that assembling international food lists and ensuring
NBFDS compliance by foreign suppliers may be complicated, but that AMS
might accomplish those ends by, for example, collaborating with
international trade partners, using data published by organizations
like the ISAAA and setting forth specific recordkeeping and/or testing
requirements for foods imported from other countries.
AMS Response: Because bioengineered foods produced abroad are
imported and offered for sale (or incorporated into products offered
for sale) in the United States, AMS has decided to expand the list to
include bioengineered foods that are in commercial production
internationally. AMS has assembled that list by gathering information
from several sources, including data published by ISAAA, FDA's list of
completed voluntary premarket biotechnology consultations, and
information published by ERS. AMS believes ongoing maintenance of the
list may appropriately involve consideration of information from these
and similar sources, as well as information supplied by the United
States' trade partners. During the annual process to review and update
the lists, AMS will consider information from interested parties,
including importers and trade partners.
Comment: Several commenters agreed that if a food contains an
ingredient appearing on the List, the entity should make a BE
disclosure unless it keeps records verifying it is not a BE food and
does not contain BE ingredients. Other comments criticized basing the
disclosure requirement on whether foods were among the listed crops,
explaining that the presumption created by a food's inclusion on the
lists would place the rule's recordkeeping burden primarily on those
who use non-BE commodity varieties in their foods--a result these
comments viewed as at odds with congressional intent. Similarly,
another commenter suggested that AMS should be tasked with keeping
track of records supporting disclosure, allowing entities to challenge
their appearance on the list directly to USDA.
AMS Response: AMS has determined that all food manufacturers,
importers, and retailers offering for retail sale foods on the List of
Bioengineered Foods are regulated entities and must maintain records
related to those foods. The records can be used to verify disclosure or
non-disclosure decisions. AMS does not believe this approach places an
undue recordkeeping burden on entities that do not handle bioengineered
foods; the NBFDS requires all regulated entities to maintain customary
business records on foods they handle that appear on the List of
Bioengineered Foods, and AMS anticipates those customary business
records will be sufficient to demonstrate whether or not a food is
bioengineered or contains bioengineered ingredients.
It would be expensive and very difficult, if not impossible, for
AMS to keep track of records that support disclosure. AMS believes that
regulated entities are in the best position to know the foods they are
sourcing, distributing, using, and labeling, and the amended Act
requires them to maintain usual and customary records. Because
regulated entities must provide AMS with access to those records, it
would be unnecessary to keep track of those records.
Comment: While some commenters favored annual review and revision
of the lists, others found annual updates too infrequent to keep
consumers effectively apprised of the BE status of their foods, and
asked AMS to update the lists on a quarterly, monthly, or continuous
basis instead. Some commenters, by contrast, suggested annual updates
would be too frequent and unduly burdensome to AMS, particularly in
light of the delay potentially associated with seeking public input
before list revision, as proposed in the NPRM.
Commenters nevertheless generally approved of employing an open,
clear, and transparent revision process. A few commenters warned
against overreliance on the views of interested stakeholders in the
proposed revision process, encouraging AMS to rely primarily on
evidence-based criteria for list updates. Some commenters also
requested that AMS disclose the potential environmental impact of the
BE products recommended for inclusion on the lists.
AMS Response: AMS recognizes the brisk rate at which bioengineering
[[Page 65841]]
technology is advancing and new bioengineered food products are
entering the marketplace. Accordingly, and because of the role of the
List of Bioengineered Foods in determining whether specific foods
require BE disclosure, AMS believes the List should be reviewed and
updated on a regular basis. At the same time, AMS is mindful of the
need to ensure the process for updating the list is transparent and
allows for careful consideration of all relevant information on the
appropriateness of proposed revisions. AMS has determined that updating
the list on an annual basis through the notice process strikes the most
appropriate balance among these considerations.
The Preamble and Sec. 66.7(a) of the NBFDS describe the process by
which AMS will seek recommendations and conduct an annual notice
process through the Federal Register to review proposals regarding
updates to the List of Bioengineered Foods. If indicated, AMS will
conduct rulemaking to address proposed changes to the List. AMS
believes this process will supply it with a wide range of pertinent
information, including but not limited to scientific evidence, to allow
the agency to make an informed decision whether certain foods should be
added to or deleted from the list. The list review and update process
will include consultation with other U.S. Federal government agencies
with oversight of the use of bioengineered foods, including on the
environmental impacts of using bioengineered foods. AMS, however, does
not plan to attempt disclosure of potential environmental impacts as
part of the list maintenance and revision process, as the NBFDS is not
intended to convey information about the environmental attributes of BE
food. AMS will instead revise the list based on whether a food meets
the definition of a ``bioengineered food.''
Comment: Many of those who commented requested that the lists
reflect the use of new and emerging technologies such as CRISPR,
Synbio, and Talens. Those commenters recommended the lists remain
consistent with the standards set forth in other Federal regulations,
as well as the Codex Alimentarius, in order to facilitate compliance
with applicable requirements and avoid conflicts with trade partners.
Other commenters maintained that some existing or future genetic
engineering techniques may not produce foods falling within the
statutory definition of BE food and that such products should not
appear on the proposed lists.
AMS Response: As previously noted, AMS believes that the
characteristics of the biotechnology product itself, rather than the
particular technological process by which the product was created,
should determine whether a product is included on the List of
Bioengineered Foods. AMS considers this approach more compatible with
the text of the amended Act and Congressional intent. As part of the
process for list maintenance and revision, AMS will, in consultation
with the U.S. Government agencies responsible for the oversight of
biotechnology products, consider new and emerging technologies and
whether foods resulting from those technologies meet the definition of
``bioengineered food.''
Comment: Comments reflected a wide range of opinion on the
appropriate timeframe for regulated entities to attain compliance after
the BE food lists are revised. Many commenters supported the proposed
18-month compliance period. Others, concerned that the proposed period
would allow new BE products to remain undisclosed to consumers for too
long, recommended a 12-month period instead. Several industry
commenters recommended a 24-month period, explaining that labeling
costs rise and packaging waste results each time relabeling and
repackaging are required, so those processes should occur as
infrequently as reasonably possible. A few commenters suggested taking
a more flexible approach, which would allow interested parties to
submit comments on an appropriate time period as part of the list
revision process. These commenters stated that a more contracted or
extended compliance period might be appropriate, depending on the foods
proposed to be added to the lists and impacts of the proposed changes
on supply chains.
AMS Response: AMS acknowledges the burden frequent relabeling and
repackaging would place on regulated entities. We believe the proposed
18-month compliance period allows regulated entities sufficient time to
exhaust existing supplies and make necessary revisions to labels, and
strikes the most appropriate balance with the countervailing need for
consumer-facing labels to reflect accurate and updated BE information.
In addition, AMS believes using a fixed 18-month compliance period for
all changes to the list will prove more workable than setting
applicable compliance periods on an ad hoc basis as part of the annual
notice process for list revision.
6. Factors and Conditions
AMS solicited comments on whether one or both of the following
should constitute factors or conditions under which a food is
considered a BE food: (1) Whether incidental additives should be
considered a BE food and labeled accordingly; and (2) whether the
modified genetic material in a highly refined food may be detected. The
proposed definition of BE food in the NPRM included the first factor or
condition (incidental additives) but did not include the second
(detection). AMS sought comment on whether the final rule should
incorporate one or both of those factors or conditions into the
definition. The proposed rule also sought comment on the process for
seeking a determination on the adoption of other factors or conditions.
Comment: Commenters were generally supportive of the proposed
process for adopting factors or conditions under which a food is
considered a BE food. Some commenters, however, requested AMS to
clarify in the final rule the parameters for submitting petitions to
adopt factors or conditions. A few commenters asked AMS to establish a
specific time period within which the agency would respond to requests
for adoption of factors or conditions, as well as a time period for
regulated entities to attain compliance with adopted factors or
conditions. Other commenters asked AMS to allow the adoption of factors
or conditions under which food produced through new technologies falls
within the definition of BE food.
AMS Response: As noted above, AMS has determined to adopt the
process proposed in the NPRM for adopting factors and conditions under
which a food is considered a BE food. AMS believes that process as
outlined in the NPRM and this final rule is clear and transparent, and
the agency has thus declined to alter the proposed submission
parameters for petitions to adopt factors and conditions. AMS has also
declined to establish a time period within which the agency must
respond to requests for adoption of factors and conditions, as the time
necessary for responding to such requests will vary depending on
available agency resources, the complexity of the requests, and the
nature of rulemaking. Similarly, AMS has not established a fixed
compliance period within which regulated entities must attain
compliance with adopted factors and conditions. To the extent
necessary, AMS will address any compliance period in particular
rulemakings considering factors or conditions to be
[[Page 65842]]
adopted. It is the view of AMS, however, that because adopted factors
and conditions operate only to carve out foods from the definition of
``bioengineered food,'' compliance with adopted factors and conditions
will not ordinarily be burdensome.
AMS also notes that the text of the amended Act authorizes the
Secretary to establish a process for making determinations regarding
``other factors and conditions under which a food is considered a
bioengineered food.'' 7 U.S.C. 1639b(b)(2)(C). Although AMS may
consider particular technologies as part of the factors and conditions
process (as well as in revising and updating the List of Bioengineered
Foods), in accordance with the language in the amended Act, AMS
believes determinations whether to adopt a proposed factor or condition
will primarily focus on the characteristics of the final food products,
rather than on the particular technologies used to create the food
products. In deciding whether to adopt proposed factors or conditions,
AMS will consult with U.S. government agencies responsible for
oversight of biotechnology products and consider relevant information
that may allow AMS to align the NBFDS with the standards of other
Federal agencies or foreign governments.
Comment: A few commenters opposed the adoption of the factors or
conditions on which AMS solicited comments on the grounds that all
foods derived in any part from BE substances, including incidental
additives or foods with no detectable modified genetic material, should
be disclosed in the interests of transparency. The commenters added
that consumers want to know not only whether the final product contains
BE genetic material, but also whether BE substances were used to make
the final product.
AMS Response: As explained in the Preamble to this final rule, a
food does not fall within the definition of a ``bioengineered food''
simply because a BE substance was used in the process of making the
food--to be a ``bioengineered food,'' the food must contain modified
genetic material. For that reason, AMS cannot decline to adopt a
proposed factor or condition--which, under this final rule, could serve
only to exclude foods from the scope of the ``bioengineered food''
definition--solely on the basis that the factor or condition would
exclude from disclosure a food derived in part from the use of a BE
substance.
Comment: Many commenters agreed that incidental additives should
not be subject to disclosure when FDA regulations exempt them from
inclusion in the ingredient statement on a food label. These commenters
stated that aligning the NBFDS with FDA ingredient labeling
requirements would simplify compliance and reduce labeling costs for
regulated entities, and would also avoid creating consumer confusion. A
few commenters added that excluding incidental additives from
disclosure would align the NBFDS with the regulations of international
trading partners. Several commenters further noted that incidental
additives are present in food at an insignificant level and do not have
any technical or functional effect in the final food product.
AMS Response: AMS agrees with the above comments. Exempting
incidental additives that are not required to be labeled under FDCA
regulations is sensible, aligns the NBFDS with practices of trading
partners, avoids consumer confusion that could otherwise result if a
substance not appearing on a food label triggered the NBFDS disclosure
requirement, and limits the burden on regulated entities without unduly
limiting disclosure for consumers. For these reasons, AMS has adopted
the proposed factor and condition regarding incidental additives.
Comment: A few commenters recommended that enzymes be excluded from
the disclosure requirement even if FDA regulations require their
inclusion in the ingredient statement on a food label. These commenters
stated this approach would be consistent with how state laws on BE
disclosure treated enzymes. Some commenters noted, however, that
certain yeasts (unlike enzymes) must be disclosed because they contain
DNA and remain active and functional in finished food. One commenter
added that if a 5% threshold is selected, it is unlikely that the
presence of yeast would trigger disclosure.
AMS Response: AMS anticipates that enzymes, yeasts, and similar
organisms will frequently be excluded from the disclosure requirement,
either because they will meet the requirements of the incidental
additive factor or condition or because they meet some other NBFDS
provision permitting nondisclosure (such as Sec. Sec. 66.1 and 66.9
regarding foods with no detectable genetic material). For organisms
present in food that do not meet the requirements of any such
provision, however, AMS cannot provide a categorical exclusion from the
disclosure requirement. To the extent that interested parties seek a
categorical exemption for microorganisms, they may submit a request for
such a factor and condition to modify the definition of bioengineered
food in a future rulemaking.
Comment: Some commenters in favor of excluding incidental additives
from disclosure requested the proposed factor or condition to be
modified to expressly include within the meaning of ``incidental
additives'' processing aids, secondary direct additives, and substances
migrating to food from equipment or packaging. A few commenters further
requested AMS to clarify that BE microorganisms (such as those used in
fermentation) constitute incidental additives where those
microorganisms do not remain active and have no technical or functional
effect in the finished food product. One commenter requested that AMS
clarify what it considers to be an ``insignificant'' level of an
incidental additive present in food, and recommended AMS adopt a
meaning of ``insignificant'' consistent with that set forth in the
FDA's regulations on labeling ingredients in food.
AMS Response: AMS does not believe the requested modifications or
clarifications are necessary. The factor and condition regarding
incidental additives is designed to align the NBFDS with the FDA's
regulations on labeling food ingredients. Section 66.1's incorporation
of the incidental additives factor and condition into the NBFDS thus
references the FDA labeling requirement at 21 CFR 101.100(a)(3), which,
among other things, outlines the circumstances in which incidental
additives need not be labeled as ingredients and describes the types of
substances constituting ``incidental additives.'' To the extent that
secondary direct additives do not constitute incidental additives not
subject to FDCA labeling requirements, then such additives would be
subject to BE disclosure. AMS notes that 21 CFR 101.100(a)(4) defines
``insignificant'' levels of additives for certain applications of 21
CFR 101.100(a)(3). As Sec. 66.1 thus incorporates the FDA labeling
regulations' conception of ``incidental additives'' into the NBFDS, AMS
believes further clarification or modification on the meaning of, or
circumstances under which a substance may qualify as, an ``incidental
additive'' would be redundant or risk creating the appearance of a
conflict between the NBFDS's incidental additives provision and the
FDA's labeling requirements.
Comment: Many commenters opposed the factor or condition excluding
highly refined foods from disclosure where no modified genetic material
can be detected. These commenters suggested that consumers deserve to
make informed purchasing decisions and
[[Page 65843]]
expect BE disclosure where food or ingredients are derived from BE
crops, regardless of whether modified genetic material can be detected
in the finished food. Some commenters objected to this factor or
condition because it would result in fewer products being subject to
disclosure, which in their view would be inconsistent with consumer
expectations. Other commenters stated that testing for trace amounts of
modified genetic material would be difficult to enforce, impose
burdensome compliance and recordkeeping costs on the industry that
would then be passed to consumers, and present barriers for
international trade as several trade partners do not require testing
before permitting nondisclosure for highly refined ingredients. Many
regulated entities, these commenters added, would choose to make a BE
disclosure rather than undergo testing, resulting in different labeling
for similar food products. Some commenters also voiced concerns about
the ability of current testing methods and technology to accurately or
consistently capture the presence or absence of modified genetic
material.
AMS Response: The NPRM sought comment on a second proposed factor
and condition, excluding food from the disclosure requirement where
modified genetic material in the food cannot be detected. Because this
proposed factor and condition would serve a purpose in the NBFDS only
if foods without detectable modified genetic material were included
within the general definition of ``bioengineered food,'' the NPRM
explained that AMS would consider this factor and condition only if AMS
decided to proceed with Position 2 on the scope of the regulatory
definition of ``bioengineered food.'' As AMS declined to adopt Position
2 for the reasons stated in Section C.1, above, this factor and
condition will not be incorporated into the NBFDS.
Comment: One commenter generally supported the exclusion of highly
refined foods from the definition of BE food but opposed the
undetectable modified genetic material factor or condition as proposed,
on the ground that requiring regulated entities to provide the BE
disclosure unless they first disprove the presence of modified genetic
material by testing is an unconstitutional impingement on those
entities' First Amendment rights.
AMS Response: AMS has adopted Position 1. The statutory definition
of bioengineering states that food must ``contain[ ] genetic material
that has been modified through in vitro recombinant deoxyribonucleic
acid (DNA) techniques. . . '', to be labeled as a ``bioengineered
food.'' AMS is not compelling regulated entities to label refined foods
as ``bioengineered food.'' If the food product at issue is not a
bioengineered food, AMS does not require that it be mandatorily
labeled.
Comment: Many commenters supported the factor or condition
excluding highly refined foods with no detectable modified genetic
material from the disclosure requirement, pointing to several
scientific studies they viewed as demonstrating an absence of genetic
material in such foods. These comments explained that disclosure under
the amended Act is triggered by the presence of modified genetic
material and that, if no modified genetic material is detectable,
Congress did not intend the food to be disclosed as BE. A few
commenters also stated that treating highly refined ingredients derived
from BE crops differently than their non-BE counterparts would create
harmful marketplace impacts with no meaningful benefit to consumers.
AMS Response: As discussed in Section II.C.1, above, AMS agrees
that highly refined foods with no detectable modified genetic material
should not trigger the disclosure requirement. AMS, however, has
decided to permit nondisclosure for such foods by adopting Position 1
on the scope of the regulatory definition of ``bioengineered food,''
and will therefore not incorporate this proposed factor or condition
into the NBFDS.
Comment: Some parties in favor of the undetectable modified genetic
material factor or condition offered comments on the testing methods
and standards to be used to determine the presence or absence of
detectable rDNA. One commenter recommended AMS accept a ``de minimis''
level of modified genetic material at or below which ingredients are
not subject to mandatory disclosure and set that de minimis level of
detection at 0.1% modified genetic material to total DNA. That
commenter added that if AMS decides a de minimis detection level is not
appropriate, detectability should be defined in accordance with ISO/ICE
standards and using a methodology validated by Codex Alimentarius
guidelines. A few commenters asked AMS to establish minimal standards
regarding the analytical tools used for detecting, identifying, and
quantifying modified genetic material. Some commenters also urged AMS
to update the NBFDS as scientific detection methods evolve, with a few
further recommending that AMS maintain publicly available guidance
documents or lists of scientifically validated genetic testing methods
to ensure testing consistency in the marketplace.
AMS Response: As mentioned, because AMS has adopted Position 1 on
the scope of the regulatory definition of ``bioengineered food,'' the
proposed factor or condition regarding undetectable rDNA will not be
incorporated into the NBFDS. The methods by which regulated entities
may demonstrate that particular foods contain no detectable modified
general material, and thus are not bioengineered foods, are discussed
in Section II.C.1, above. As stated in the Preamble, AMS will provide
instructions to the industry to explain how they can ensure acceptable
validation of refining processes in accordance with AMS standards. AMS
will also provide instructions regarding acceptable testing methodology
used to satisfy that a food does not contain detectable modified
genetic material.
Comment: Several commenters requested AMS to establish a list of
Excluded Ingredients, identifying ingredients excluded from the scope
of the disclosure requirement under the undetectable rDNA factor or
condition. Those commenters noted that AMS could periodically amend
that list as appropriate without going through formal notice and
comment rulemaking, helping to ensure the list is kept current. Those
commenters requested AMS to set forth the process for creating and
updating a list of Excluded Ingredients in the final rule.
AMS Response: AMS has not adopted the second proposed factor or
condition. As discussed in Section II.C.1, above, AMS cannot at this
time establish and maintain a list of ingredients excluded from the
scope of the disclosure requirement. Regulated entities are in the best
position to know the products they are sourcing and the refinement
processes those products have undergone. AMS has determined that
regulated entities can demonstrate that modified genetic material is
not detectable by maintaining records verifying that a food is sourced
from a non-bioengineered crop or source, showing that a food has been
subjected to a refinement process validated to remove modified genetic
material, or maintaining records of analytical testing results
demonstrating the absence of modified genetic material.
Comment: Commenters also requested AMS to adopt additional factors
or conditions excluding the following substances from triggering the
disclosure requirement: microorganisms derived through fermentation;
ingredients derived from animals fed with or treated with
pharmaceuticals
[[Page 65844]]
produced from BE substances; ingredients produced through the chemical
transformation of BE foods or ingredients into substantially new
ingredients with no present or readily traceable BE source; and dietary
supplements and/or food products with medicinal or supplementary
applications.
AMS Response: AMS solicited comments only on the two factors and
conditions proposed in the NPRM and cannot adopt additional factors and
conditions in this final rule. It is possible, however, that some or
all of the foregoing factors and conditions may appropriately be
adopted through the factors and conditions process in future
rulemakings. The process for requesting adoption of factors and
conditions is discussed in the Preamble to this final rule and outlined
in subpart C of the NBFDS.
7. Exemptions
a. Animals Fed Bioengineered Feed
The amended Act prohibits a food derived from an animal from being
considered a BE food solely because the animal consumed feed produced
from, containing, or consisting of a BE substance. 7 U.S.C.
1639b(b)(2)(A). Section 66.5(d) incorporates this statutory exemption
and exempts products produced from animals fed bioengineered feed from
displaying any form of disclosure regarding the presence of
bioengineered ingredients or substances.
Comment: Commenters generally support the idea that animals fed
with bioengineered feed and their products, including milk and eggs,
should be exempt from the NBFDS. Many commenters understood that this
provision was statutorily mandated. One commenter suggested that this
provision should be framed as an exclusion rather than an exemption.
Some commenters stressed that the NBFDS should state that products
exempt from disclosure as bioengineered, such as products from animals
fed bioengineered animal food, cannot by default qualify for an absence
claim.
AMS Response: As commenters recognized, the amended Act prohibits a
food derived from an animal from being considered a bioengineered food
solely because the animal consumed animal feed produced from,
containing, or consisting of a bioengineered substance. 7 U.S.C.
1639b(b)(2)(A). Section 66.5(d) incorporates this statutory exemption.
For example, eggs used in a baked good, where the eggs come from a
chicken fed feed produced from BE corn and soy, would not be considered
bioengineered solely on the basis of the chicken's feed.
AMS has made no changes to this statutory mandate. Although this
provision could be framed as an exclusion, AMS believes that it is
permissible to frame it as an exemption. Moreover, the regulatory text
makes clear that food derived from an animal shall not be considered a
bioengineered food solely because the animal consumed feed produced
from, containing, or consisting of a bioengineered substance.
AMS agrees that food derived from an animal that consumed feed
produced from, containing, or consisting of a bioengineered substance
does not automatically qualify for absence claims. See 7 U.S.C.
1639c(c). AMS declines to insert this in the regulatory text because
the amended Act in this respect is self-executing. In addition, the
focus of the NBFDS is on BE claims and not on absence claims. AMS notes
that FDA (and FSIS depending on the food at issue) retain authority
over absence claims. Entities seeking to use absence claims should
ensure that they are in compliance with all pertinent Federal
regulations and that such claims are truthful and not misleading.
Comment: Some commenters suggested that AMS should work to align
``Non-GMO'' text claim mandates with the NBFDS disclosure requirements,
and that the exemption should also apply to products derived from
animals or birds treated with drugs or pharmaceuticals produced through
bioengineering.
AMS Response: AMS does not believe the amended Act provides
authority to establish or align the NBFDS with a ``non-GMO'' label.
Statutory provisions clearly instructed the Secretary to establish a
national mandatory bioengineered food disclosure standard with respect
to any ``bioengineered food'' and any food that may be
``bioengineered.'' As it pertains to other food labeling programs, the
amended Act only acknowledges food certified under the NOP as
sufficient to make a claim regarding the absence of bioengineering in
the food, such as ``not bioengineered,'' ``non-GMO,'' or another
similar claim. As noted above, AMS recognizes that FDA and FSIS retain
authority over absence claims. Entities seeking to use absence claims
should ensure that such claims comply with all applicable Federal laws
and are otherwise truthful and not misleading. Regulated entities would
need to ensure that their use of any other third-party standard that
establishes and allows use of claims such as ``non-GMO,'' ``non-
Bioengineered,'' or other similar claims does not put their product at
risk of violating the NBFDS.
With respect to products derived from animals or birds treated with
drugs or pharmaceuticals produced with bioengineering, AMS believes
that such products, if they do not contain modified genetic material,
would not meet the definition of ``bioengineered food.''
Comment: Some commenters requested that AMS define the term
``animal'' to include any animal, fish, insect, or microorganism. One
commenter specifically pointed out that bees consuming pollen from
bioengineered crops should be included in the definition of animal, and
that honey should be exempted from disclosure. Some commenters argued
that food ingredients like yeast, rennet, and enzymes should be exempt
from disclosure. They explained that because yeast, rennet, and enzymes
are typically produced or fed using bioengineered substrates, but may
not be bioengineered themselves, they should be treated the same as
products derived from animals that consumed bioengineered feed and
exempted from the NBFDS. Many commenters agreed that the term ``non-
agricultural ingredients'' is an appropriate description for such
ingredients.
Another commenter went further to state that ingredients that are
produced through the chemical transformation of a bioengineered food or
ingredient and substantially transformed into a new ingredient, such as
caramel flavoring and color, polydextrose, vitamin C, and sugar
alcohols, should also be exempted. Commenters explained how for these
kinds of ingredients that undergo significant processing, modified
genetic material is rendered undetectable. Alternatively, other
commenters argued that these ingredients should be subject to
disclosure if they are listed as ingredients on a label.
AMS Response: AMS did not define animal in the regulatory text.
AMS's understanding of an animal is based on the common understanding
of an ``animal'', which refers to any organism in the biological
kingdom Animalia, and would include fish, birds, and insects.
``Products derived from an animal'' would include milk, eggs, honey,
rennet and other enzymes derived from animals, and similar products.
The common understanding of ``animal'' and ``products derived from an
animal'' would not include yeast since yeast is a single celled
organism in the Fungi kingdom, or microbial rennet. Exempting yeast,
microbial rennet, and
[[Page 65845]]
enzymes that are not derived from animals as an extension of the
exemption for animal fed with bioengineered feed is beyond AMS's
statutory authority. As discussed above, those substances may not be
subject to BE disclosure if they qualify as an incidental additive that
is not required to be labeled or if the modified genetic material in
those products is undetectable.
Similarly, ingredients produced through the chemical transformation
of a bioengineered food or ingredient and substantially transformed
into a new ingredient, such as caramel flavoring and color,
polydextrose, vitamin C, and sugar alcohols are subject to the NBFDS.
They are not automatically exempt from disclosure. Based on AMS's
understanding, these products would not qualify as products derived
from animals that consumed bioengineered feed. However, they may not be
subject to disclosure if they qualify as an incidental additive that is
not required to be labeled or if the modified genetic material in those
products is undetectable.
Comment: One commenter requested that AMS exempt foods produced
from conventionally bred plants grafted to bioengineered rootstocks--
provided that the plants producing such food have not otherwise been
bioengineered. Such an exemption should cover the food and the plant
that produced the food, including its bioengineered rootstock.
AMS Response: AMS cannot exempt foods produced from conventionally
bred plants grafted to bioengineered rootstocks in this rulemaking. To
the extent that these plants produce foods that have otherwise not been
bioengineered, the resulting foods would not be bioengineered because
they do not contain modified genetic material or for other reasons.
b. Food Served in a Restaurant or Similar Retail Food Establishment
As required by the amended Act, AMS proposed that food served in
restaurants or similar retail food establishments should be exempt from
the NBFDS. See 7 U.S.C. 1639b(b)(2)(G)(i). We received several comments
on this exemption and what food establishments should qualify for the
exemption.
Comments: Commenters generally supported exempting restaurants and
similar retail food establishments from the NBFDS. Commenters explained
how if these kinds of establishments were subject to the NBFDS, they
would be unnecessarily burdened with maintaining product lists of
bioengineered food and ingredients sold on a daily basis. Other
comments suggested that the proposed definition was too narrow and
should include a list of places as examples, rather than an exclusive
list, such as cafeteria, lunch room, food stand, food truck, saloon,
tavern, bar, lounge, salad bar, delicatessen, entertainment venue, or
other retail business establishment where meals or refreshments
constituting food may be purchased. One commenter requested that
transportation carriers be added to the list of places exempted from
the NBFDS.
Comments were also received that opposed the exemption for
restaurants and similar retail prepared food establishments. These
comments explained how consumers deserve to know when the food they are
buying is bioengineered, regardless of whether it was purchased in a
restaurant or in a grocery store.
Another commenter explained how all foods prepared, processed, or
packaged in a retail food establishment, including those utilizing
``central kitchen'' locations for certain prepared foods, should also
be exempt from the disclosure requirements of the NBFDS.
Others suggested that AMS should consider exempting foods sold by
manufacturers to restaurants and similar establishments, and foods
marked as ``for institutional use'' or ``not for resale.''
AMS Response: This final rule continues to exempt food served in a
restaurant or similar retail food establishment from disclosure under
the NBFDS. Based on the comments received, AMS has now modified the
definition of ``similar retail food establishment'' to add additional
examples, including food truck and transportation carrier: ``Similar
retail food establishment means a cafeteria, lunch room, food stand,
food truck, transportation carrier (such as a train or airplane),
saloon, tavern, bar, lounge, other similar establishment operated as an
enterprise engaged in the business of selling prepared food to the
public, or salad bars, delicatessens, and other food enterprises
located within retail establishments that provide ready-to-eat foods
that are consumed either on or outside the retailer's premises.'' AMS
considered including a list of places as examples, rather than an
exclusive list, but believes that the reference to ``other similar
establishment operated as an enterprise engaged in the business of
selling prepared food to the public'' should capture any additional
places that are not specifically listed.
AMS has not modified the definition to state ``where meals or
refreshments constituting food may be purchased'' as we believe that
with this insertion, the exemption would be much broader than the plain
meaning of the amended Act. AMS believes that the exemption is intended
to cover ready-to-eat or prepared foods. To extend the exemption to all
foods prepared, processed, or packaged in a retail food establishment,
which would include bulk foods such as granola or packaged apples in a
bin, would conflict with the requirement that foods subject to FDCA's
labeling requirements are subject to disclosure. AMS notes it does not
have statutory authority to extend this exemption to foods sold by
manufacturers to restaurants and similar retail food establishments, or
to foods marked as ``for institutional use'' or ``not for resale.''
However, AMS anticipates that some of these foods would fall under this
exemption because the entities selling or providing such food meet the
definition of a similar retail food establishment.
AMS believes that the modified definition provides clarity and
flexibility to regulated entities and is in accordance with the plain
language of the amended Act. AMS also notes that exempt entities such
as restaurants and similar retail food establishments may voluntarily
provide disclosures of ``bioengineered food'' in accordance with the
NBFDS if they so choose.
c. Very Small Food Manufacturer
As required by the amended Act, AMS proposed that very small food
manufacturers be exempt from displaying any form of disclosure
regarding the presence of bioengineered ingredients or substances in
their products. See 7 U.S.C. 1639b(b)(2)(G)(ii).
Comment: Some commenters did not support a disclosure exemption for
very small food manufacturers. These commenters stated that the NBFDS
should apply equally to all companies regardless of size or revenue.
These commenters stated that excluding small companies would undermine
the transparency and consistency necessary for building consumer trust.
AMS Response: Section 66.5(b) exempts very small food manufacturers
from the disclosure requirement of the NBFDS, as required by the
amended Act. Section 66.1 defines ``very small food manufacturer'' as
``any food manufacturer with annual receipts of less than $2,500,000.''
AMS has made no changes to its proposal. In considering this
definition, AMS must balance between providing regulatory flexibility
for regulated entities and providing information to consumers
[[Page 65846]]
regarding the bioengineered status of their foods.
Comment: A few commenters stated that number of employees was an
equally if not more suitable criterion than receipts for a small
business. For instance, Congress has exempted small employers with 50
or few employees from some other Federal statutory provisions, such as
the Affordable Care Act (42 U.S.C. 18024(b)(2)) and the Family and
Medical Leave Act (29 U.S.C. 2601). A commenter recommended the agency
should revise the definition of ``very small food manufacturer'' to
include either those that have less than $2.5 million in annual
receipts or 50 or fewer employees.
Understanding that there is a statutory obligation to exclude very
small companies from the disclosure requirement, some commenters
suggested using the lowest reasonable financial threshold of $500,000
consistent with those exempted from labeling requirements under the
FDCA (Sec. 66.3(b) or limited to only ``cottage foods.''
A few commenters suggested revising the definition of ``very small
food manufacturer'' to align with the Food Safety Modernization Act's
definition for a ``very small business,'' which is defined as ``a
business (including any subsidiaries and affiliates) averaging less
than $1,000,000.''
AMS Response: To develop this definition, AMS considered small
business definitions under FDA (21 CFR 101.9(j)(1)(i) and 21 CFR
101.36(h)(1)) and U.S. Census Bureau (USCB) regulations. AMS evaluated
the impact of applying various definitions of ``very small food
manufacturer'' by estimating the number of firms that would be
exempted, the number of products that would likely be exempt, and the
proportion of annual industry sales that would be exempt under each
exemption level. The NPRM and the final rule above included tables
showing the cumulative percentage of firms, products (UPCs), and sales
that would be exempt if the definition of ``very small food
manufacturer'' were set at the top of each of the annual revenue ranges
(based on USCB's 2012 Statistics of U.S. Businesses).
Applying the FDA exemptions (annual sales of no more than $500,000)
at 21 CFR 101.9(j)(1)(i) and 21 CFR 101.36(h)(1) as described above
would exempt 45 percent of firms, only one percent of products, and
less than 0.5 percent of sales for food manufacturers, and only 17
percent of firms and about 0.1 percent of products and sales for
dietary supplement manufacturers. In conducting the Regulatory Impact
Analysis, we estimated the impact of applying the USCB definition of
very small businesses (fewer than 20 employees), which falls somewhere
between the $2.5 million and $5 million annual sales cutoffs. We found
that both of these revenue cutoff levels for the definition of ``very
small food manufacturer'' would offer significantly greater relief for
small manufacturers, while still having a relatively minor impact on
the amount of information available to consumers. Exempting
manufacturers with annual receipts of less than $2.5 million would
provide regulatory relief to 74 percent of food manufacturers and 45
percent of dietary supplement manufacturers, while reducing the number
of products covered by four percent (two percent for dietary
supplements), and the number of purchases covered by only one percent
for both food and dietary supplement manufacturers.
AMS considered other revenue cutoffs, including those above and
below $2,500,000 and considered other definitions from various sources.
AMS considered number of employees as a criterion by which to determine
the threshold and ultimately determined that we do not need to be bound
by that methodology. Because food and dietary supplement manufacturers
are in the manufacturing sector, they are both defined by number of
employees for purposes of SBA size categorization. However, the firms
defined as small or very small for purposes of the NBFDS all fall well
below the SBA, so we do not feel we need to be bound by that
methodology.
In addition, the small food manufacturer definition was defined to
be consistent with the FDA definition of small manufacturer under its
nutrition labeling standards, which uses annual receipts. AMS believes
that the very small food manufacturer definition should be consistent
with these other definitions.
AMS believes that annual receipts is a reasonable measure in
determining the threshold for small businesses and specifically here,
very small food manufacturers. Using total receipts is administratively
simpler than tracking and demonstrating revenue by category for
purposes of this rule. We do not expect that there are a significant
number of firms for which this distinction would make a difference, but
it would increase recordkeeping burden for all firms that fall under
this exemption if it was based on food sales, rather than annual
receipts.
The $2.5 million threshold will provide relief to small businesses
but will not markedly decrease the number of products subject to
disclosure. By defining ``very small food manufacturers'' as those with
annual receipts below $2,500,000, about 74 percent of food
manufacturers are exempt from mandatory disclosure, but 96 percent of
products will still be subject to disclosure. An increase in revenue
cutoff would increase the number of exempt businesses but would also
increase the number of products exempt from disclosure. The definition
of very small food manufacturer provides flexibility for small entities
while providing information to consumers regarding the bioengineered
status of their foods.
Comment: Some commenters expressed concern that exemptions did not
extend to small retailers that display food for sale in bulk
containers, including made-to-order products. Commenters explained how
these products often have significant variation day-to-day depending on
the ingredients available, and they can be difficult to trace. Several
small entities stated that it is nearly impossible to change the labels
on a daily basis, and that they would have to consider whether to
continue to carry these items if required to label them under the rule.
The Small Business Administration (SBA) Office of Advocacy recommended
broadening the definition of ``very small food manufacturer'' to allow
more small businesses an opportunity to take advantage of the
exemption. Similarly, they advocated extending the exemption to small
retailers to allow small or very small retailers to be exempt from the
bulk container labeling requirement.
Another commenter suggested that these revenue limits should extend
to dietary supplement manufacturers, and that AMS should consider
exempting foods sold by manufacturers to restaurants and similar
establishments, and foods marked as ``for institutional use'' or ``not
for resale'' because these foods are not consumer-facing and not
required to carry consumer-directed information such as nutrition
facts. In addition, medical foods, such as enteral foods, provided
under a physician's care should also be exempted from these
disclosures.
AMS response: With respect to comments urging AMS to extend this
exemption to small retailers, AMS states that this exemption is
statutorily mandated and cannot be extended to small retailers. To the
extent that a small retailer is also a very small food manufacturer,
they may be able to take advantage of the exemption in that instance.
Additionally, foreign very small food manufacturers shipping
[[Page 65847]]
prepackaged food products intended for U.S. retail sale are exempt from
regulation. Importers are ultimately responsible for verifying whether
or not foreign food manufacturers are subject to the requirements of
the NBFDS.
AMS acknowledges commenters' concerns regarding labeling foods sold
by manufacturers to restaurants and similar establishments, foods
marked as ``for institutional use'' or ``not for resale,'' and medical
foods. AMS notes that if such foods are subject to the labeling
requirements of the FDCA, then they are subject to the NBFDS. Such
foods may be exempt if they fall under statutory exemptions, but AMS
does not have statutory authority to create exemptions for such foods
in this rulemaking.
d. Food Certified Under the National Organic Program
AMS proposed that foods certified organic under the National
Organic Program shall be exempt from disclosure.
Comment: Many commenters that weighed in on the exemption of foods
certified under the National Organic Program (NOP) supported the
exemption. Many commenters requested that AMS clarify that the NBFDS
shall not: Affect the definition of ``excluded methods'' or any other
definition or practice under the NOP, circumvent the letter or intent
of the organic standard, or require any amendment to the organic
standard, and that organic certification shall be sufficient to claim
the absence of bioengineering in the food, such as ``not
bioengineered,'' ``not genetically engineered,'' ``non- GMO,'' or
another similar claim. A commenter recommended adding language to Sec.
66.3 to state that a food or food ingredient that is not required to
bear a BE disclosure does not necessarily mean that the food or food
ingredient qualifies for an absence claim such as ``non-GMO.'' The
commenter also suggested that food certified under the NOP may bear an
absence claim.
Additionally, other commenters stated that food certified under
other international organic product regulations with which the NOP has
established either recognition or equivalency agreements would be
exempt from this rule. These types of agreement are currently in place
with nine countries or regional trading partners, including Canada,
Mexico, and the European Union.
AMS Response: AMS has ensured that the final rule does not affect
the NOP regulation or products certified as organic under the NOP.
Subtitle F states that ``In the case of food certified under the
national organic program established under the Organic Foods Production
Act of 1990 (7 U.S.C. 6501 et seq.), the certification shall be
considered sufficient to make a claim regarding the absence of
bioengineering in the food, such as `not bioengineered', `non-GMO', or
another similar claim.'' 7 U.S.C. 6524. The NPRM stated that implicit
in the statutory provision is that certified organic foods are not
subject to bioengineering disclosure. This implication, in conjunction
with the Secretary's authority to consider establishing consistency
between the NBFDS and the Organic Foods Production Act, permits a
regulatory exemption for products certified organic under the NOP. See
7 U.S.C. 1639b(f). The NPRM proposed that Sec. 66.5(e) would exempt
certified organic foods from bioengineered disclosure, so food
manufacturers, retailers, and importers of certified organic food would
not be required to maintain additional records to demonstrate that the
organic food is not bioengineered for purpose of the NBFDS regulations.
The focus of the NBFDS is on establishing a disclosure standard
with respect to any bioengineered food and any food that may be
bioengineered. Although the amended Act mentions absence claims, the
mandate of the NBFDS is not on absence claims. Therefore, AMS has
reframed this provision as a statutory exemption and will not
incorporate absence claims in the NBFDS. The amended Act's references
to absence claims for foods certified under the NOP are self-executing.
AMS agrees with commenters that a technical correction to this
provision is required. This exemption is intended to cover all NOP
certified label categories (``100% Organic,'' ``Organic,'' and ``Made
with Organic''). Accordingly, Sec. 66.5(e) is revised to read ``Food
certified under the National Organic Program.'' In addition, AMS
confirms that food certified under other international regulations with
which the NOP has established recognition or equivalency agreements
would be exempt from the NBFDS.
Comment: Other commenters requested that the NBFDS also exempt from
disclosure foods certified/verified to the AMS Processed Verified
Program (PVP); non-GMO certification programs or third-party
verification programs such as the Non-GMO Project, NSF True North
Protocol, or SGS Non-GMO Certification; and other credible schemes. In
addition, commenters suggested that AMS should help consumers
distinguish among these many claims and standards.
AMS Response: AMS only has authority to exempt food certified under
NOP. However, to the extent that these third-party verified programs
meet the standards under Sec. 66.9 and/or recordkeeping requirements
associated with non-disclosure, then regulated entities employing these
external frameworks may use associated paperwork to show that their
products are not BE to the extent the scope of such programs align with
that of this rule. As discussed previously, regulated entities seeking
to use absence claims should ensure that such claims comply with all
applicable Federal laws and are otherwise truthful and not misleading.
Comment: Another commenter stresses that the NOP has recognized
that ingredients developed with the use of mutagenesis, such as
docosahexaenoic acid (DHA) algal oil, may be used as an ingredient in
organic foods. Under the NOP, bioengineering is considered an
``excluded method'' that cannot be used. The NBFDS needs to make clear
that mutagenesis is excluded from the definition of bioengineering.
AMS Response: AMS agrees that NOP regulations require that no
ingredient may be bioengineered. See 7 CFR 205.301(f)(1) and 205.105(e)
and the definition of ``excluded methods'' in 7 CFR 205.2. In addition,
AMS agrees that mutagenesis is a conventional breeding method.
8. Threshold
The NPRM solicited comments on an array of issues pertaining to the
threshold exemption. This proposed exemption consists of three
alternative threshold options that would exempt products from
disclosure depending on the amount of a bioengineered substance that
they contain.
a. Alternative 1-A: 5 Percent of Inadvertent or Technically Unavoidable
The first proposed alternative would establish that food in which
an ingredient contains a BE substance that is inadvertent or
technically unavoidable, and accounts for no more than five percent
(5%) of the specific ingredient by weight, would not be subject to
disclosure as a result of that one ingredient.
Comment: Many commenters generally agreed with Alternative 1-A.
These commenters suggested that this threshold offered adequate
disclosure, the most flexibility, and limited impacts on the food
supply chain. They stated that many parties throughout the food supply
chain use the same manufacturing processes and equipment for both BE
and non-BE crops, so a 5 percent threshold would allow for the
[[Page 65848]]
continued coexistence of existing supply chains without significantly
increasing costs. They also noted that the standard is a marketing
standard and not one based on health and safety.
AMS Response: AMS believes that Alternative 1-A provides the right
balance between disclosing and minimizing the potential impact on the
food supply chain. BE crops and non-BE crops are often grown in close
proximity and, depending on the crop, cross-pollination may occur.
Similarly, BE and non-BE crops are often harvested and processed using
the same equipment, which means trace amounts of BE crops may
unintentionally be mixed with non-BE crops. The proximity of
bioengineered crops to non-bioengineered crops, and the use of the same
production, transportation, and processing equipment allows for the
coexistence of different production systems without unnecessarily
increasing food production costs. Because the NBFDS is a marketing
standard and not related to health or safety, any threshold amount must
balance the benefits gained from disclosure with the costs to implement
that disclosure. AMS believes Alternative 1-A appropriately identifies
that balance.
Comment: Some commenters noted that countries such as Canada,
Indonesia, and Japan, have incorporated a 5% threshold into their
mandatory and voluntary disclosure regimes. The commenters state that
it would be prudent to mirror that level to support regulatory
certainty in the international food supply chain.
AMS Response: AMS acknowledges that some U.S. trading partners have
adopted a five percent threshold, either on a mandatory or voluntary
basis, and that aligning our threshold amount with those countries will
facilitate trade.
Comment: Some commenters proposed variations of Alternative 1-A,
including hybrid schemes that would adopt Alternative 1-A for the
inadvertent and unintentional presence of a bioengineered substance,
and then an additional threshold for intentional use of bioengineered
substances. These commenters believed such a hybrid method would give
food manufacturers flexibility and allow them to intentionally use a de
minimis amount of bioengineered ingredients without requiring
disclosure.
AMS Response: AMS determined that food containing any amount of a
bioengineered substance that is not inadvertent or unintentional is
subject to disclosure. Therefore, whenever a regulated entity
intentionally uses a food or food ingredient that contains a
bioengineered substance, no matter the amount, that food would be
subject to disclosure, so long as the food is not otherwise exempt. AMS
believes that allowing for the intentional use of food and food
ingredients that contain a bioengineered substance without requiring
disclosure would undermine consumer trust and confidence in the NBFDS.
AMS also believes that any sort of hybrid or dual threshold scheme
unnecessarily complicates compliance for regulated entities and
increases the likelihood of confusion among consumers. The agency is
not aware of customary or usual business records that would allow a
regulated entity to accurately track the percentage of a bioengineered
substance that is intentionally used in a food, and any such
requirement to create new records unnecessarily increases the cost and
complexity of complying with the NBFDS. Similarly, a marketing standard
should be designed to clearly communicate information to consumers and
a hybrid or dual threshold would unnecessarily complicate the type and
amount of information being communicated to consumers.
Comment: Some commenters stated that AMS should not measure the
threshold by weight, but by other means, such as a percent of rDNA that
is present in the food or food ingredient. They suggested that this
approach is more consistent with the BE labeling regimes of other
countries and existing industry standards.
AMS Response: AMS agrees that the phrase ``by weight'' should be
removed from the threshold exemption. AMS understands that existing
industry standards and the BE labeling requirements of other countries
do not use weight to calculate the threshold, but typically calculate
such threshold amounts as the BE content of an item or ingredient
relative to the non-BE content of that same item or ingredient. AMS
believes existing industry standards are sufficient.
Comment: A number of commenters suggested that AMS should adopt
Alternative 1-A because the NOP allows for up to 5 percent of products
that are not certified organic to be used in organic products.
AMS Response: While we recognize that the NOP regulations at 7 CFR
205.301(b) suggest that products labeled as organic may contain 5
percent of ingredients that are not organic, that would be an
incomplete understanding of that regulation. That regulation also
states that this 5 percent must be organic unless the organic form is
not commercially available and must be nonagricultural substances or
non-organically produced agricultural products produced consistent with
the National List in 7 CFR part 205, subpart G. The NOP regulations
further require that this 5 percent not be bioengineered. See 7 CFR
205.301(f)(1) and the definition of ``excluded methods'' in 7 CFR
205.2. Thus, the NOP regulations are not an analogous situation that
would be a rationale for adopting a 5 percent threshold.
b. Alternative 1-B: 0.9 Percent Inadvertent or Technically Unavoidable
Comment: Many commenters, including consumers, consumer groups,
food manufacturers, and some industry trade groups were generally in
favor of Alternative 1-B. Commenters noted that this threshold most
closely aligns with consumer expectations, the threshold used by many
trading partners, and existing domestic standards currently in use for
voluntary BE and non-BE labeling programs. Additionally, a commenter
stated that farmers, testing organizations, and food manufacturers have
used 0.9% as the maximum threshold since 2003. The commenters argued
that adopting the 0.9% threshold would avoid confusion into the
marketplace and would ease the process of negotiating and executing
mutual recognition agreements which would help stimulate trade between
countries.
AMS Response: AMS recognizes that uniformity and consistency
promote efficiency and lessen confusion. We note, however, that there
is not one consistent threshold used for all foods and inputs
domestically or by all trading partners. When determining whether the
absence or presence of a bioengineered food or substance requires
disclosure, domestic voluntary standards and/or foreign governments use
thresholds greater than 0.9%, including 5%, under specified
circumstances. AMS, however, must balance the costs and benefits for
regulated entities and consumers in the United States when establishing
thresholds for the NBFDS. A threshold substantially lower than 5% per
ingredient may not be practical or achievable in production systems
across a range of commodity groups. Furthermore, the requirements to
attempt to meet a 0.9% threshold would be overly burdensome in
proportion to the goal of providing consumers with a suitable amount of
information on the presence of bioengineered substances in food
products. AMS believes a threshold of 5% per ingredient does the best
job in balancing the costs and benefits for regulated entities and
consumers in the United States.
[[Page 65849]]
Comment: Consumer transparency is another reason commenters give
for supporting Alternative 1-B. They suggest that the relatively wide
use of Alternative 1-B internationally and domestically promotes
consumer transparency, and that adopting Alternative 1-B would ensure
that the greatest number of products are subject to disclosure while
still allowing for co-existence of BE and non-BE foods. A food
manufacturer states that consumers recognize the potential for
inadvertent and technologically unavoidable commingling of BE
substances and accept standards in use today that allow for the
presence of a BE substance up to the 0.9% level, including companies
that voluntarily disclose and voluntary standards established by third-
party organizations for non-BE labels. Some commenters suggested that
any higher threshold amount would negate the purpose of labeling and
not match consumer expectations for transparency. Commenters also said
that Alternative 1-B would promote good practices by companies because
they would be able to segregate ingredient streams, while still
allowing for some inadvertent or unavoidable introduction of BE
material.
AMS Response: AMS understands that a lower threshold would likely
result in a larger number of products being subject to disclosure. AMS
also understands that if a threshold is set too low, regulated entities
may have to label almost everything and the information may become less
meaningful to consumers. Ensuring each ingredient stream remains below
the threshold of 0.9% may not always be practical or achievable for all
commodity groups, or the processes and equipment required to do so may
increase food production costs. AMS believes a threshold of 5% per
ingredient provides the best balance between reducing costs for
regulated entities and maximizing information conveyed to consumers.
Comment: Several comments propose hybrid alternatives. A few
commenters suggested combining the requirements of Alternative 1-A
allowing for the inadvertent or technically unavoidable presence of a
BE substance up to 5% in any ingredient with the requirements of
Alternative 1-C to also allow for the intentional use of a
bioengineered substance up to 0.9% in the finished product by weight.
Another commenter suggested allowing a product to contain up to 0.9%
total ingredients that had not been tested for BE substances, and
requiring each such ingredient to comprise no more than 0.5% of the
finished weight of the product, minus added water and salt. Other
commenters were opposed to a hybrid approach. They argue that this
would be more confusing and difficult to explain to consumers and would
suggest a lack of transparency.
AMS Response: AMS understands the desire for flexibility that a
hybrid approach might create. However, AMS believes the threshold is
intended to recognize the complexities of the supply chain, not
necessarily create a mechanism to avoid BE food disclosure. A simple,
straight forward threshold that allows for the unintentional or
technically unavoidable presence of a BE substance acknowledges the
complexities of the supply chain while increasing transparency. A
hybrid or dual threshold scheme would add an unnecessary degree of
complexity that would confuse to consumers and increase the
administrative burden on regulated entities. The additional sampling,
testing, and recordkeeping requirements of a multi-pronged threshold
scheme would likely go beyond the customary business records currently
kept by regulated entities and AMS does not intend to unnecessarily
increase the administrative burden of the rule on regulated entities.
Comment: A small number of commenters in response to Alternatives
1-A and 1-B suggested making two minor changes to clarify how the
threshold would be applied and how it would be calculated. The first
recommendation was to change ``an'' to ``any'' to clarify that the
threshold applied to all ingredients. The second recommendation was to
remove ``by weight'' because some methods of testing for threshold
amounts do not calculate by weight, but rather as a percent of DNA.
AMS Response: AMS has changed the language used to define the
threshold to make it clear that it applies to all ingredients. AMS also
removed the reference to ``by weight'' to clarify that existing
industry standards for determining the amount of a BE substance that is
present in a food or food ingredient would be appropriate for purposes
of applying the threshold exemption.
Comment: A number of comments supported Alternative 1-B but called
on AMS to establish very specific testing requirements to guarantee
manufacturers applied 0.9% thresholds meaningfully. They state that the
testing should be conducted using the real-time or digital polymerase
chain reaction (PCR) method conducted by an ISO 17025 accredited
laboratory, conducted on samples where laboratory controls indicate the
DNA input is sufficiently intact to allow for valid quantitative
analysis, and follow a meaningful sampling plan in accordance with
industry standards. Regulated entities would be required to adhere to
these testing standards.
A commenter who was a food manufacturer stated that many food
manufacturers do not test food products for BE substances. They rely
instead on certifications of food ingredients from suppliers. The
commenter stated that food importers in Europe are not required to test
imported products. They stated that checking certifications from
suppliers in place of testing was reasonable because suppliers are more
familiar with ingredients, they already test their products, and there
is no requirement that food manufacturers conduct further testing.
AMS Response: AMS understands the desire for uniform application of
the threshold and a regimented approach to ensure that regulated
entities are complying with all aspects of the NBFDS, including the
threshold. However, AMS is aware that strict requirements on
methodologies, processes, testing, and recordkeeping all increase the
cost of compliance with the NBFDS. Because this is a marketing standard
that provides additional food information to consumers, there is little
benefit to highly prescriptive testing and recordkeeping requirements.
AMS has the authority to enforce compliance with the NBFDS and believes
the best way to ensure compliance is through the enforcement process
described in the final rule, not through strict, burdensome
regulations.
Comment: Those opposed to Alternative 1-B suggested that this
alternative is overly restrictive, especially for a marketing standard.
A few noted that Alternative 1-B would lead to over-disclosure because
some companies would likely consider any commingled food as BE food.
They said this could discourage consumers from purchasing products with
BE labels. Others suggested that a 0.9% threshold would denigrate
biotechnology and reduce choices for both farmers and consumers.
Similarly, some commenters state that they believe Alternative 1-B
treated BE substance as a contaminant. A few commenters believe that
any threshold below 5% is not practical or achievable for many
commodities. They state that traceability requirements would be overly
burdensome in relation to the benefits derived from providing
additional information to consumers. They believe that this would
result in technology avoidance and a stifling of innovation. A few
comments suggested that recordkeeping burdens would be costly at a 0.9%
threshold because
[[Page 65850]]
regulated entities would have to account for traces of BE substance
down to a very small degree throughout the entire supply chain.
Although food manufacturers keep records now, these commenters believe
such records are usually on a finished product basis and not by
ingredient.
AMS Response: AMS understands the concerns raised by these
comments. AMS is aware that setting a threshold too low may have
practical limitations on the supply chain and could increase costs as
entities throughout the supply chain implement additional measures to
maintain a lower threshold on the food and ingredients they produce.
While AMS understands that some supply chains and some countries
currently produce food and ingredients that contain a BE substance
below 0.9 percent, AMS does not want to unnecessarily increase the
regulatory burden and costs on supply chains that may not currently be
meeting that threshold. Moreover, those who are currently meeting the
threshold for 0.9 would still be in compliance with Alternative 1-A,
because ingredients that contain an inadvertent or technically
unavoidable BE substance below 0.9 percent are still below the 5
percent threshold in Alternative 1-A.
Comment: A few comments questioned how AMS would interpret
Alternatives 1-A and 1-B with respect to what is inadvertent or
technically unavoidable, and whether such a definition would require
any intentional use of a BE substance to be disclosed.
AMS Response: AMS has clarified in the final rule that any
intentional use of a BE substance requires disclosure.
c. Alternative 1-C: 5 Percent of Intentional Use
One of the exemptions from food labeling proposed by AMS was
Alternative 1-C. Alternative 1-C would exempt food from disclosure if
the ingredient or ingredients in the food containing a BE substance
accounted for no more than five percent (5%) of the total weight of the
food in final form. AMS also sought comments on whether the specific
threshold amount of 5% should be increased or decreased.
Comment: Comments in favor of Alternative 1-C suggest that this
approach would allow for the de minimis use of BE food ingredients
without requiring disclosure. They also indicate that this approach
would align with that used in some other countries. Supporters of this
alternative also suggest that this approach is the most supportive of
bioengineering. Some commenters also believe this alternative would
have the least impact on domestic and international value chains and
international trade. Similarly, they suggest this would also be the
option most compatible with our North American trading partners, Mexico
and Canada, neither of which mandate labeling.
AMS Response: AMS understands that for some commenters, Alternative
1-C would increase the amount of flexibility under the standard and
allow for the de minimis use of a BE substance without requiring
disclosure. Although Alternative 1-C could be used in other countries,
AMS is aware that there is no universal threshold level and that any
choice of threshold will have implications on trade. While some have
suggested that Alternative 1-C could cost less to implement because
fewer products are labeled, AMS believes that current industry
practices track the presence of absence of BE substances in an
ingredient and not necessarily the specific amount. Adding the
requirement to track the amount of a BE substance in each ingredient,
and subsequently the final product, could unnecessarily increase costs
for regulated entities, even though the number of products subject to
disclosure may ultimately be less.
Comment: Some commenters suggested that Alternative 1-C would
reduce consumer confusion.
AMS Response: AMS does not agree with those suggesting that a 5%
threshold as proposed in Alternative 1-C would reduce consumer
confusion. AMS believes it will lead to the exemption of a wider array
of foods from labeling and cause consumers to have less confidence and
trust in the NBFDS. AMS believes that providing more information and
not creating an exemption for the intentional use of a BE substance is
likely to provide more BE food information to consumers.
Comment: Several commenters suggested Alternative 1-C but with an
amount lower than 5 percent--such as 0.9 percent. One commenter said
that such an approach would exempt most fermentation/probiotic, viable
enzymes, and defining/characterizing ingredients.
AMS Response: A threshold substantially lower than 5% per
ingredient may not be practical or achievable in production systems
across a range of commodity groups. Furthermore, the traceability
requirements to attempt to meet a 0.9% threshold would be overly
burdensome in proportion to the goal of providing consumers with a
suitable amount of information on the presence of bioengineered
substances in food products. AMS believes a threshold of 5% per
ingredient does the best job in balancing the costs and benefits for
regulated entities and consumers in the United States. AMS is allowing
regulated entities to voluntarily disclose (Sec. 66.116) the presence
of bioengineered substances even when not otherwise required to do so.
This will help regulated entities to meet demands on their food
products to conform to standards used in other programs. AMS will also
work to develop mutual recognition arrangements so that countries might
agree to recognize each other's standards as comparable.
AMS understands that some food products may include only a very
small amount of a BE substance, such as enzymes or other products
created in a controlled environment. Similarly, if there are other
products that people believe should be exempted from disclosure, AMS
has established a process to exclude them under factors and conditions.
For reasons stated above, AMS believes that Alternative 1-A is the
appropriate threshold and that any intentional use of a bioengineered
substance should be disclosed.
Comment: One commenter supports the 5% threshold, but believes it
should be measured using the percent based on volume of the BE
substance in the ingredient, rather than ingredient weight. They state
that other countries quantify the threshold by the volume of BE
substance present in ingredients. They assert that a BE threshold
defined by weight is not enforceable.
AMS Response: AMS has determined Alternative 1-A is the best
approach, but has removed the phrase ``by weight'' from the regulatory
text reflecting that option.
Comment: A majority of comments received regarding Alternative 1-C
are opposed to this alternative. Many believe that this alternative is
not transparent enough and that it would exempt wide amounts of food
items from labeling. They suggest this would undermine consumer
expectations, and possibly damage consumer confidence and trust in the
labeling program. Commenters expressed the opinion that consumers
wanting to avoid BE substances would not support Alternative 1-C
because they would believe it was not low enough to be meaningful. A
number of comments suggested that Alternative 1-C subverted the amended
Act by allowing the intentional use of a BE substance into food
products without requiring labeling.
Another large group of comments state that the 5% threshold amount
will result in the rejection of our exports by countries with lower
threshold amounts, damaging our ability to trade
[[Page 65851]]
food products in foreign markets. A food exporter expressed concern
with the lack of conformity between Alternative 1-C and disclosure
requirements in other countries. The exporter said that this lack of
conformity would add complexity to their efforts to export their
products because they would have to make disclosure adjustments for
each country with differing disclosure laws.
AMS Response: AMS understands the concerns raised by Alternative 1-
C, AMS has not chosen this alternative. AMS will not allow an exemption
from labeling when a regulated entity intentionally introduces a
bioengineered substance into a food product.
AMS believes that exporters are already complying with the laws of
the countries into which they import their products and to the degree
possible, AMS has tried to minimize any potential impacts on
international trade. If other countries have a BE labeling program, AMS
is also working to develop mutual recognition agreements where the
requirements of countries with similar labeling requirements may be
recognized in the United States.
Comment: A commenter stated that the EU uses ``accidental'' and
``technologically unavoidable'' instead of inadvertent and technically
unavoidable. The exporter states that the EU defines accidental to
include BE adulteration occurring during cultivation, transportation,
or processing. AMS interprets inadvertent or technologically
unavoidable as ``insignificant amounts of a BE substance in food that
resulted from the coexistence of BE and non-BE foods in the supply
chain'' [83 FR 19869]. This commenter presses AMS to interpret
inadvertent in a manner identical to EU's ``accidental,'' or in a way
that was consistent with the EU definition for ``accidental.''
AMS Response: AMS is not in a position to interpret how the EU
implements their BE labeling law, but does intend to interpret AMS
regulations in a manner that minimizes the impact on international
trade.
Comment: Several commenters questioned how AMS will treat
ingredients that are not considered bioengineered foods, such as
incidental additives, for purposes of determining whether a food is
exempt from labeling under the threshold.
AMS Response: If an ingredient is not considered a bioengineered
food under another section of the NBFDS, such as an incidental
additive, a regulated entity does not need to apply the threshold
exemption to that ingredient to determine whether a food is disclosed
as BE. If an ingredient is otherwise not a bioengineered food, it will
not trigger labeling due to the presence of a bioengineered substance.
Comment: A commenter suggested that for Alternative 1-A and 1-B,
any intentional use of a BE substance would require labeling even if
the threshold limit is not exceeded. They then pointed out that to
avoid this, food manufacturers would have to establish records to show
that any BE substance in the food came only from inadvertent and
technically unavoidable sources. This may require the manufacturer to
keep additional records than those currently generated.
AMS Response: AMS intends to require only customary business
records. For purposes of ensuring compliance with the threshold, 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.
Comment: A commenter suggested that AMS should not require the
exclusion of water and salt from the threshold calculation. This
commenter stated that the finished product should be in the same form
as it would be when presented to the consumer and excluding the weight
of the water and salt from the calculation of the amount of BE would
add complexity. The manufacturers would have to adjust their
calculations to account for only the amount of a BE substance in the
dry ingredients in the absence of water or salt.
AMS Response: AMS did not choose Alternative 1-C and this comment
is inapplicable to Alternative 1-A. Water and salt do not contain DNA
and would therefore, as individual ingredients under Alternative 1-A,
never trigger disclosure.
Comment: A few commenters stressed that testing for BE content
should not be a requirement. They emphasized the use of proper
documentation, supplier assurances, along with existing controls should
suffice. One commenter stated that in some cases statistical and
qualitative tests could be used to obtain qualitative results and
provide adequate verification of BE content. The commenters suggest
that testing, such as PCR testing, would drive up costs significantly,
decrease efficiencies in the handling and distribution systems,
introduce new market risks, and disrupt global trade.
AMS Response: AMS does not intend to prescribe specific tests or
methodologies for verifying compliance with the threshold. AMS intends
to rely on customary business records.
9. Appearance and Placement of Disclosure
The NPRM solicited comments on the size, legibility, appearance,
and location under ordinary shopping conditions for the BE food
disclosure. The NPRM also solicited comments on the placement of the BE
disclosure. AMS received several comments on those topics.
Comment: Many commenters supported the NPRM goal of ensuring that
the BE food disclosure was likely to be read and understood under
ordinary shopping conditions. Commenters suggested that the disclosure
be concise, large enough to read, easily located, and intelligible. One
commenter recommended the BE food disclosure size be consistent with
FDA regulations at 21 CFR 101.2(c) governing ``customary conditions of
purchase.''
AMS Response: AMS agrees that the BE food disclosure should appear
prominently and conspicuously on the label, such that it can be read
and understood under ordinary shopping conditions. This position aligns
with other mandatory food labeling requirements, including the FDA
regulations at 21 CFR 101.15.
Comment: Several commenters felt that the term BE was misleading
and confusing to consumers. Commenters suggested that a disclosure
using GMO would be simple, clear and suffice.
AMS Response: AMS understands and appreciates commenters request
for clear, understandable disclosure language that references a
familiar term like ``genetically modified organism.'' However, the
amended Act clearly sets forth use of the term bioengineering. AMS
acknowledges that the amended Act authorizes the Secretary to determine
other terms that are similar to ``bioengineering.'' 7 U.S.C. 1639(1).
But, for purposes of ensuring disclosure consistency and minimizing
marketplace confusion, AMS has chosen not to adopt other similar terms
and to require the use of the term ``bioengineered.'' AMS will engage
in outreach and education to provide information about the new
disclosure term.
Comment: Some commenters recommended AMS implement strong
guidelines for the type size used for the BE disclosure. One commenter
recommended that size requirements be defined with a minimum letter
height and logo size. Another commenter requested that AMS provide
uniform requirements for the disclosure location and size. Others
suggested that the disclosure be similar in size of the product/brand
name or at least 75 percent of the font size.
[[Page 65852]]
Several commenters requested flexibility in determining the
disclosure's size and placement. One stated that AMS should give
regulated entities flexibility in selecting the size and placement
options that provide the best proportions for displaying the disclosure
while also complying with the requirement for maintaining high
visibility. Commenters also proposed if AMS specifies a disclosure size
that it should range from 0.5-1 inch in diameter.
AMS Response: AMS acknowledges that font and type size contribute
significantly to the consumers' ability to access information provided
on food labels. As such, AMS considered prescribing specific type sizes
for different disclosure options. After considering comments, however,
AMS determined that the number and type of disclosure options, combined
with the variety of food package sizes, shapes, and colors, would make
prescriptive requirements too difficult to implement. Therefore, AMS is
allowing regulated entities responsible for the disclosure to have
flexibility in implementing the disclosure requirements. The NBFDS
requires that disclosure text ``. . . be of 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.''
Comment: Most commenters supported AMS's proposal for placement of
the BE disclosure. One commenter recommended that the disclosure had to
be placed on the information panel if room allowed. The commenter
recommended that the disclosure needed to be consistent, and not at the
discretion of the manufacturer.
AMS Response: AMS acknowledges commenters' support for the NPRM's
proposed placement of the BE disclosure. AMS also agrees that the
information panel is an appropriate location for the BE disclosure
because consumers who are interested in additional information on food
products will generally look for it on the information panel. Section
III.A.4 of this rule provides a more detailed rationale regarding AMS's
position on placement of the BE disclosure.
Comment: One commenter recommended that manufacturers be given
greater flexibility in determining the disclosure placement and size.
Another commenter also stated that there should be the option of
placement and size of disclosure on the package. One commenter
recommended that the disclosure be placed on any of the panels of the
food package provided the disclosure is displayed prominently on the
label and does not interfere with mandatory nutrition labeling
requirements.
AMS Response: AMS agrees that manufacturers may need some
flexibility when determining the size and placement of a BE disclosure.
Based on its review of comments, AMS will allow manufacturers to
include the disclosure on an alternate panel likely to be seen by a
consumer under ordinary shopping conditions if there is insufficient
space on either the principal display or information panels. Similarly,
the NBFDS allows flexibility in the disclosure size. For a detailed
explanation of AMS's position regarding the appearance and placement of
the BE disclosure, refer to Section III.A.3 and Section III.A.4 of this
rule, respectively.
10. Text Disclosure
AMS solicited comments on adoption of the text disclosures:
``Bioengineered Food,'' ``Contains Bioengineered Food Ingredients,''
``May Contain Bioengineered Food Ingredients,'' and ``May Be
Bioengineered.''
Comment: Several commenters believe the phrases ``may contain a
bioengineered food ingredient'' and ``may be a bioengineered food''
would lead to more confusion for consumers who want to know the exact
nature of the ingredients being consumed by their families. Some
comments noted that many of the countries with mandatory disclosure
requirements do not allow the use of a ``may'' statement. Some
commenters stated that a ``may'' claim should be permissible to
describe foods that contain ingredients where the sourcing may change
from a bioengineered to a non-bioengineered source. Other comments
suggested that regulated entities know and have records to demonstrate
the bioengineered status of their foods and should not be permitted to
use ``may'' claims when they know with certainty that their foods are
bioengineered.
Commenters suggested that a symbol, such as an asterisk, could be
used to denote an ingredient that was BE. Commenters also suggested
that the disclosure statement should provide a declarative statement
designating the BE information.
AMS Response: AMS appreciates commenters' desire for USDA to
implement clear standards for disclosing bioengineered food products
using on-package text. We recognize that consumers want additional
information about the food they eat and may see the use of the word
``may'' in the text disclosure as ambiguous. As a result, AMS has
removed the ``may'' disclosure option and will only allow regulated
entities to make affirmative BE food disclosures.
Comment: Commenters requested straightforward labeling that would
not confuse consumers by using unfamiliar terms. Many commenters
suggested allowing or mandating other phrases such as ``genetically
modified organism,'' ``GMO'' or ``genetic engineering.'' Another
commenter suggested using the phrase ``includes'' rather than
``contains.'' Some commenters also requested clarification regarding
whether regulated entities could provide additional statements
regarding bioengineered foods as part of their disclosures.
AMS Response: AMS understands and appreciates the desire for clear,
straightforward text disclosure language. The Secretary believes that
the language used by Congress in the amended Act clearly and accurately
describes the technology and provides consumers with the information
they desire. AMS will engage in outreach and education to provide
information about the new disclosure term. AMS also notes that,
pursuant to Sec. 66.118, nothing in the final rule prohibits regulated
entities from providing additional statements or other claims regarding
bioengineered foods and bioengineered food ingredients, so long as such
statements are consistent with all other applicable laws and
regulations.
Comment: Some commenters expressed concern about the disclosure
options for foods contained on the proposed non-high adoption list of
bioengineered foods. One commenter was concerned about the possibility
that manufacturers could use loopholes to avoid having to say a food is
bioengineered.
AMS Response: AMS acknowledges the concerns and notes that, as part
of the NBFDS, AMS has developed a List of Bioengineered Foods for human
consumption that may be produced anywhere in the world. This list
establishes a presumption about what foods might require disclosure
under the NBFDS, but does not absolve regulated entities from the
requirement to disclose the bioengineered status of food and food
ingredients produced with foods not on the list when the regulated
entities have actual knowledge that such foods or food ingredients are
bioengineered.
AMS also appreciates the concerns about regulated entities
complying with the disclosure requirements. As such, subpart E of this
rule outlines the enforcement regulations established to ensure
compliance with the regulations.
[[Page 65853]]
Comment: Many commenters requested the use of the phrase
``bioengineered ingredients used in this product,'' regardless of the
amount of bioengineered foods or ingredients contained in the product.
Similarly, other commenters stated where trace amounts of bioengineered
ingredients are identified, the entire food product should be labeled
``contains BE ingredients.''
AMS Response: The amended Act directs the Secretary to determine
the amount of a bioengineered substance that may be present in a food,
as appropriate, in order for the food to be a bioengineered food.
Requiring a label for food that includes a bioengineered substance that
falls below this amount would contravene Congress's intent.
11. Symbol Disclosure
AMS solicited comments on three alternatives for disclosure
symbols, each in full color and black and white. All three include some
variation of the letters BE, short for ``bioengineered.'' AMS also
sought comment on whether the symbol should include the word
``bioengineered.''
Comment: Some comments suggested that none of the three symbols
were acceptable. Many of these commenters suggested that the
alternatives AMS provided promoted bioengineering or provided the BE
food disclosure in a misleading or confusing manner. Some comments
provided alternative symbols and others suggested general ideas that
AMS should incorporate, such as more neutral colors or images.
AMS Response: AMS appreciates the comments and alternative symbol
designs. AMS has chosen a modified version of Alternative 2-A. The
modified version removed the letters ``BE'' and instead uses the word
``Bioengineered,'' which AMS believes will better inform consumers than
just the letters ``BE.'' AMS believes the modified symbol is an
appropriate, non-disparaging way to communicate the information
required by the amended Act.
Comment: Some commenters believed adding the word ``bioengineered''
to the symbol was unnecessary and that other symbols used on food (e.g.
the organic seal, irradiation symbol, and recycling symbol) do not use
additional text to convey meaning. Other commenters, including some who
conducted research on consumer response to the proposed symbols and
text options, said the proposed symbols and text options did not
provide clear information to consumers. Conversely, other commenters
who also conducted research on consumer response to the proposed
symbols and text options, believed adding the word ``bioengineered''
would provide consumers with more information than a symbol with the
acronym ``BE.''
AMS Response: AMS has chosen to add the word ``bioengineered'' to
the symbol and believes that the combination of the symbol with the
additional text will provide consumers with more information about
their food. AMS understands that because the symbol has not yet been
used in commerce, consumers and those who may have responded to surveys
conducted during the comment period that examined the proposed
disclosure options may not fully understand the meaning of the symbol
and accompanying text. As the NBFDS is implemented, AMS is committed to
helping consumers understand the meaning of the new symbol and
accompanying text.
Comment: Of those in favor of the proposed symbols, most favored
Alternative 2-A. Commenters indicated that Alternative 2-A was the
``best choice of the three provided.'' They found it to be the ``most
simple,'' ``most professional,'' and ``most neutral'' of the three
proposed.
AMS Response: AMS agrees that Alternative 2-A is the most
appropriate choice of the three proposed alternatives and has modified
Alternative 2-A in the NPRM to address some of the concerns raised by
other commenters, as described above.
Comment: Most commenters did not support the use of Alternatives 2-
B or 2-C. Commenters believed the symbols and colors were misleading,
not neutral, and that they resembled a smiley face. Conversely, several
commenters liked the symbol because they believed they were the
``friendliest'' or ``happy'' option.
AMS Response: AMS appreciates commenters' concerns regarding the
use of Alternatives 2-B or 2-C. Based on comments received for all
three alternatives and commenter sponsored studies on consumer
perceptions of labeling (see footnotes 7 and 8), AMS has chosen a
modified version of Alternative 2-A, as discussed above.
12. Electronic or Digital Link Disclosure
AMS solicited comments on the option of an electronic or digital
link disclosure including the use of current technology such as QR
codes and digital watermark technology. In addition to the use of
electronic or digital link technology, AMS solicited comments on
language that must accompany the electronic or digital link such as,
``Scan here for more food information'' or equivalent language that
reflects technological changes. The proposal would also incorporate a
requirement to include a telephone number that provides access to the
BE food disclosure and would further require that disclosure be
available, regardless of the time of day, and that the telephone number
be located in close proximity to the electronic or digital link and
state ``Call for more food information.''
Comment: The majority of commenters did not support the use of
electronic or digital link disclosure in lieu of on-package labeling.
Many commenters cited the USDA study conducted by Deloitte Consulting
LLP, Study of Electronic or Digital Link Disclosure: A Third-Party
Evaluation of Challenges Impacting Access to Bioengineered Food
Disclosure (July 2017), and listed concerns with electronic or digital
link disclosures. Such commenters stated that reliance on electronic or
digital link disclosure would discriminate against those without access
to smartphones or other technology, such as reliable high-speed
internet access, and would disproportionately have a negative impact on
rural, low-income, minority, and elderly consumers. Commenters stated
that many consumers are not aware of QR codes or how they work. Many of
these commenters also stated that electronic or digital link disclosure
should not replace on-package disclosure because even when consumers
are aware of QR codes and attempt to access the information through
their smartphones, the QR codes do not always work and are not easy for
all consumers to use. Some of these commenters also stated that
consumers associated digital link disclosures like QR codes with
marketing, and would not be inclined to take steps to access the
disclosure information. Most of these commenters stated that electronic
or digital link disclosure would serve as a barrier between consumers
and BE disclosure. Such barriers identified by commenters included
additional costs for consumers, such as through increased data plans,
and time spent scanning and obtaining information. Some commenters
noted that consumers with families or limited windows of time for
shopping would find accessing electronic or digital link disclosures
difficult and frustrating.
AMS Response: AMS acknowledges that most commenters do not support
the use of electronic or digital link disclosure. However, AMS notes
that electronic or digital link disclosure is mandated by the amended
Act. AMS
[[Page 65854]]
also notes that if a regulated entity decides to utilize electronic or
digital link technology to convey bioengineered food information, that
entity must also provide options for the consumer to access the
disclosure by calling a phone number. AMS believes that requiring the
option to call a telephone number will provide BE food information in
an accessible and understandable manner. AMS also notes that such
telephone number disclosure must be available regardless of the time of
day.
Comment: Several commenters suggested that the use of electronic or
digital disclosures would be acceptable only in conjunction with on-
package text or symbol disclosures. Such commenters stated that on-
package labeling provided shoppers a way to quickly and easily compare
one product to another for BE ingredients and, at the same time,
compare prices and nutritional content. These commenters identified
many of the same issues as commenters opposed to electronic or digital
disclosures. Some of these commenters noted that a store could install
its own scanners to allow consumers to access electronic or digital
link disclosures, but a subset of such commenters stated that such
scanners would need to be installed within easy access to all shelves
throughout the store, and not just near check-out counters, in order to
be comparable to on-package labeling.
AMS Response: AMS notes that the amended Act mandates the
electronic or digital link disclosure without requiring any separate
on-package disclosure. AMS acknowledges that in-store scanners could
allow consumers to access electronic or digital link disclosures.
However, AMS does not believe such a requirement is necessary because
any electronic or digital link disclosure must also provide options for
the consumer to access the disclosure by calling a phone number.
Comment: Many commenters stated that if digital disclosure is
allowed, the rule should account for new developments in technology
that would be subject to guidelines to improve readability and ease of
access to information. Some commenters stated that AMS should adopt
rules to make sure that such disclosures made using electronic or
digital technology consistently scan every time, work in all
conditions, are optimized for readability and accessibility, and are
easily accessible for consumers who do not have smartphones. In
addition, commenters stated the need for AMS to ensure that QR code
design, packaging material and shape is included in its performance
standards. Commenters also stated that AMS should not allow multiple QR
codes on the same package to diminish the risk that consumers will not
know where to obtain the BE disclosure. Some commenters stated that AMS
should use language that alerts the consumers that scanning the QR code
or calling the provided number would provide BE information. Other
commenters stated that if digital disclosure is allowed, the rule
should account for new developments in technology that would be subject
to guidelines to improve readability and ease of access to information.
They also stated that AMS should use URLs or shortened URLs rather than
QR codes as a disclosure method.
AMS Response: AMS recognizes that electronic and digital links
currently used on food products in the marketplace take different
forms, and are accessible on different devices, which would make
certain specific requirements impractical. The amended Act allows for
equivalent statements that reflect technological changes. Consequently,
AMS has allowed for other alternative statements to direct consumers to
the link to the BE food disclosure. Examples of other statements
include: ``Scan anywhere on package for more food information,'' or
``Scan icon for more food information.'' AMS acknowledges that some
consumers may experience difficulty accessing electronic or digital
link disclosures. However, AMS does not believe additional rules
mandating standards for QR codes are necessary because any electronic
or digital link disclosure must also provide options for the consumer
to access the disclosure by calling a phone number. Therefore,
consumers experiencing difficulty with any electronic or digital link
disclosure methods will have an alternative disclosure method
available. AMS notes that the language to accompany any electronic or
digital link disclosure is provided in the amended Act, which only
allows for changes to the terminology based on technology, not a
specific reference to bioengineering. AMS notes that while the amended
Act does not allow for the use of URLs or shortened URLs for all
manufacturers, website disclosure is allowed for small food
manufacturers.
Comment: Many commenters urged that any electronic or digital link
disclosure must remain free from any promotional or marketing
information on the first product information page, or ``landing page,''
to which consumers are directed. These commenters urged that such
disclosure must contain only BE information, as many of these
commenters were concerned that QR codes would direct consumers to
marketing information before bioengineering disclosure information.
Some commenters disagreed with AMS's proposal requiring that the
electronic or digital link disclosure provide the bioengineering
disclosure on the first product information page.
AMS Response: Based on the amended Act, AMS believes that the
electronic or digital link disclosure requires that the bioengineering
disclosure be on the first product information page. See 7 U.S.C.
1639b(d)(2). AMS does not believe that consumers should have to
navigate to other pages to locate the bioengineering disclosure.
AMS agrees that any electronic or digital link disclosure should
remain distinct from any promotional or marketing information. While
AMS acknowledges that some commenters have urged maximum flexibility in
allowing disclosures alongside other information, AMS notes that the
amended Act requires the electronic or digital link to provide the
bioengineering disclosure on the first product information page
accessed through the link, without any marketing and promotional
information. Therefore, if a regulated entity wants to provide
additional information about BE food to consumers, the information
should be provided outside of the landing page that includes the BE
food disclosure.
Comment: Some commenters were concerned about the potential
liability digital disclosure options could present if they were
accessed by unauthorized individuals, such as hackers.
AMS Response: AMS agrees that unauthorized access to personal
information is a grave concern to many consumers. AMS notes that the
amended Act specifically states that any electronic or digital link
disclosure may not collect, analyze, or sell any personally
identifiable information about consumers or the devices of consumers
and, to the extent that any such information must be collected for the
purposes of disclosure, that information must be deleted immediately
and not used for any other purpose.
Comment: Many commenters supporting the use of electronic or
digital link disclosure also cited the Deloitte study, noting that a
vast and growing majority of Americans own smart phones capable of
accessing digital disclosures and that wireless internet access is
nearly universal in retail establishments. However, several commenters
who support the use of electronic or digital link disclosure objected
to the proposed requirement
[[Page 65855]]
for an additional phone number and call to action statement (``Call for
more food information'') in conjunction with the digital disclosure
link and digital call to action statement (``Scan here for more food
information''). Some commenters stated that such a requirement will be
costly to implement and is unnecessary when the regulated entity
chooses the digital disclosure option. From their perspective, because
existing toll-free numbers already appear on many labels, the package
will also bear a link to the digital disclosure, and consumers will
have sufficient and growing access to digital disclosure methods. Some
of these commenters suggested that when regulated entities choose the
digital disclosure option, consumers could access bioengineered food
disclosure information through existing phone numbers, with the same
placement and call to action to which consumers are accustomed.
Commenters stated that by not allowing such flexibility, consumers
could face two competing phone numbers on a single package, which would
cause confusion. In addition, commenters stated the proposed
requirement that phone lines be staffed at all hours would be extremely
costly to implement. These commenters request that AMS consider less
costly alternatives, such as allowing existing consumer support phone
lines to also provide disclosure and specify in the final regulation
that phone lines must be available only during normal business hours.
AMS Response: AMS acknowledges that a large number of Americans
have smartphones and most national and regional supermarkets provide
wireless internet connections. However, as discussed in relation to the
study identifying potential technology challenges impacting consumers,
the Secretary has determined that many consumers do not have sufficient
access to electronic or digital link disclosures under ordinary
shopping conditions at this time. AMS notes that the amended Act
requires that any electronic or digital link disclosure also includes a
telephone number that provides access to the bioengineering disclosure.
While AMS acknowledges that a product may bear more than one phone
number, AMS believes that any consumer confusion would be minimized
because the bioengineering disclosure phone number must be in close
proximity to the digital link. AMS believes that access to the
disclosure regardless of the time of day is important to provide
meaningful disclosure to consumers. AMS further believes that allowing
pre-recorded information for such a disclosure lessens any burden on
regulated entities.
13. Study on Electronic Disclosure
The amended Act requires the Secretary to conduct a study to
identify potential technological challenges that may impact whether
consumers would have access to the bioengineering disclosure through
electronic or digital disclosure methods and to solicit comment on the
study. AMS contracted with Deloitte Consulting LLP (Deloitte) to
conduct the study and posted the resulting report, Study of Electronic
or Digital Link Disclosure: A Third-Party Evaluation of Challenges
Impacting Access to Bioengineered Food Disclosure, on its website in
September 2017. As part of the NPRM, AMS sought comments on the study,
as well as the proposed text message disclosure option, should the
Secretary determine, after reviewing the study and comments, that
consumers would not have sufficient access to the bioengineering
disclosure through electronic or digital disclosure methods.
Comment: Many commenters cited the study in opposition to
electronic or digital link disclosure, with several citing the study's
finding that consumers may not have smartphones or access to internet
speeds capable of downloading BE disclosure content. These commenters
stated that this lack of access would disproportionately impact groups
such as rural consumers and retailers. Commenters also cited the
study's finding that consumers either do not know what digital links
are or, if they do recognize them, they typically associate digital
links with marketing information and they may not know, or be inclined
to use, such methods to obtain a BE disclosure. Commenters further
cited the study to note that even when consumers are aware of digital
links and attempt to use them, they often run into problems scanning
and using such links.
AMS Response: AMS acknowledges that some consumers may lack access
to technology required to utilize electronic or digital link
disclosure. In fact, after reviewing the study and comments submitted
to the NPRM related to the study, the Secretary has determined that
consumers would not have sufficient access to the bioengineering
disclosure through only electronic or digital means under ordinary
shopping conditions at this time. Thus, AMS, in compliance with the
amended Act, is adopting a text message disclosure option. See 7 U.S.C.
1639b(c)(4). The amended Act does not, however, vest AMS with authority
to eliminate the electronic or digital disclosure option. See id. The
amended Act is clear that it is the food manufacturer that selects the
disclosure option that it wants to use to make the required disclosure.
See 7 U.S.C. 1639b(b)(2)(D).
Comment: Some commenters noted additional disclosure technology
cited in the study, such as in-store digital link scanners, and stated
that digital disclosure would need to be paired with other such
disclosure options to ensure access to all consumers.
AMS Response: AMS agrees that additional technology in the grocery
stores may make electronic or digital disclosure more accessible.
Grocery stores are welcome to have those technologies in place for
consumers. However, the amended Act does not provide AMS with the
authority to require grocery stores to make those technologies
available to consumers.
Comment: Some commenters cited the study in support of digital
disclosure. These commenters noted the study's findings that wireless
internet and cellular networks are already widely available, and access
to these technologies is increasing.
AMS Response: AMS acknowledges that a large number of Americans
have smartphones and many national and regional supermarkets provide
wireless internet connections. However, as noted above, the Secretary
has determined that many consumers do not have sufficient access to
electronic or digital link disclosures under ordinary shopping
conditions at this time.
Comment: Numerous commenters, including those representing food
manufacturers and retailers, supported the use of text message
disclosure. Many of these commenters urged maximum flexibility in
disclosure, including text messages. Some commenters supporting text
message disclosure noted that it would provide for disclosure without
access to a smartphone or the internet. These commenters stated that
text message disclosure could serve a broader range of consumers than
digital disclosure options, noting the availability of cellular phone
coverage throughout the country.
AMS Response: AMS notes that the Deloitte study reported that
approximately 5% of Americans do not own mobile phones based on the Pew
Research Center's Mobile Fact Sheet. Because text messaging is not
dependent on broadband or wireless internet access, it stands to reason
that 95% of Americans can receive text messages. Thus, we agree that
text message disclosure can serve a broad range of consumers.
Additionally, the amended Act requires the Secretary to consult with
food retailers and
[[Page 65856]]
manufacturers in providing the additional and comparable option. See 7
U.S.C. 1639b(c)(4). AMS, therefore, gave significant weight to comments
from this group that overwhelmingly supported the text message
disclosure option.
Comment: Many commenters opposed the use of text message
disclosure. Several argued that the additional need for a phone, even
if it is not a smartphone, is a burden on consumers. Many of these
commenters cited the study and noted that many consumers, especially
rural consumers, do not have access to reliable cellular phone service,
making text message disclosure difficult to use. Some of these
commenters also noted that text messaging could result in additional
charges to consumers who pay for individual text messages or have to
pay for an upgraded phone plan. Other commenters stated that the need
to text for a disclosure would be time consuming and ineffective,
placing unnecessary barriers between consumers and BE disclosures.
These commenters stated that text messaging was not comparable to on-
package labeling and should not be adopted.
AMS Response: AMS acknowledges that text messaging might require an
additional cost for some consumers depending on the consumer's cellular
phone data plan. However, AMS notes that consumers must not be charged
a fee by the regulated entity to access the disclosure information by
text message. We also note that a text message disclosure request sent
by a consumer must trigger an immediate response to the consumer's
mobile device. Finally, we note that the amended Act requires a
comparable option to access the BE disclosure, not that the option be
comparable to on-package labeling. Therefore, we conclude that the text
message disclosure meets the requirements of the amended Act.
Comment: Some commenters urged that if text message disclosure is
allowed, the text message disclosure should not include any marketing
information. Other commenters noted that the proposed rule would
prohibit charging fees, data collection, and privacy invasions that
could be associated with text message disclosure, but they stated that
consumers may not know of these prohibitions.
AMS Response: AMS agrees that any text message disclosure must not
contain marketing and promotional information and is adopting proposed
Sec. 66.108(c) in the final rule to prohibit that information in the
text message option. AMS is also adopting Sec. 66.108(d) to protect
the privacy of consumers who access BE information through text
message. AMS will inform consumers of the privacy protections for text
message disclosures on its website and encourages food manufacturers
and retailers and consumer advocacy groups to do the same.
14. Disclosures for Certain Circumstances
a. Small Food Manufacturers
AMS solicited comments on two disclosure options for small food
manufacturers: (1) A telephone number accompanied by appropriate
language to indicate that the phone number provides access to
additional information; and (2) an internet website address. In
addition, in the case of small food manufacturers, the amended Act
provides that the implementation date not be earlier than one year
after the implementation date for regulations promulgated in accordance
with the NBFDS. AMS proposed to define ``small food manufacturer'' as
``any food manufacturer with less than $10 million in annual receipts
but $2,500,000 or more in annual receipts.'' This definition would be
similar to FDA's proposed rule to extend the compliance dates for
manufacturers with less than $10 million in annual food sales.
Comment: Several commenters recognized a need to give small food
manufacturers the flexibility to disclose in a way that is cost
effective for a small business, while providing the same level of
protection for consumers' personally identifiable information. Several
commenters recommended that the annual receipts threshold defining a
small food manufacturer be changed to $2,500,000 or less, while other
commenters suggested the definition should be based on number of
employees, such as 500 or 100, because the measure of annual receipts
can become outdated over time. Some commenters requested that the
implementation date for small food manufacturers be delayed one
additional year. Some commenters said no manufacturers should be exempt
from disclosure based on size, with many of those commenters stating
that the same reasons for disclosing apply regardless of the size of
the manufacturer.
AMS Response: AMS believes that annual receipts are a reasonable
measure in determining the threshold for small and very small food
manufacturers, and that the definition of ``small food manufacturer''
provides flexibility for small entities while providing information to
consumers regarding the bioengineered status of their foods. AMS notes
that it considered other revenue cutoffs and other definitions. For
instance, AMS considered the number of employees as a criterion, but
found that it could be misleading and difficult to administer given the
seasonal and part-time nature of some food manufacturing. AMS also
believes that using total receipts is administratively simpler. In
addition, AMS believes that the small food manufacturer definition
should be consistent with the FDA's definition under its nutrition
labeling standards, which also uses annual receipts. AMS believes that
delaying implementation for small food manufacturers for the
statutorily-required 1-year period, but not longer, provides such
manufacturers with enough time to ensure compliance. AMS understands
the concern of commenters that any exemption will lead to some level of
non-disclosure, but notes that the implementation delay for small food
manufacturers and the very small food manufacturer exemption are
statutorily required. AMS also notes that any electronic or digital
link disclosure utilized by small food manufacturers must take the same
steps as larger manufacturers to protect personally identifiable
information about consumers.
Comment: Several commenters recommended that the text accompanying
telephone numbers and websites be clarified to include a reference to
bioengineered disclosure so consumers know what type of information the
text refers to. Some commenters recommended that companies should be
able to use the same phone numbers and websites already on packaging to
inform consumers because having a separate phone number or website link
for bioengineered disclosure would be redundant.
AMS Response: AMS appreciates that some commenters requested a
specific reference to bioengineering on small food manufacturer
disclosures. However, AMS notes that the disclosure wording for small
food manufacturers matches the statutorily-required on-package language
required for electronic or digital link disclosures and any telephone
number disclosures. AMS also acknowledges concerns commenters expressed
regarding redundant phone numbers or website links. However, AMS
believes that the rule provides small food manufacturers flexibility in
disclosing bioengineered food information to consumers while ensuring
that the manufacturer's chosen disclosure method is consistent with the
disclosure required for larger manufacturers.
[[Page 65857]]
b. Small and Very Small Packages
AMS solicited comments on three disclosure options for small and
very small packages: (1) A modified version of the electronic or
digital link disclosure (``scan for info''); (2) a modified version of
the text (``text for info''); and (3) a modified version of the phone
number (``call for info''). The definition of ``small packages'' and
``very small packages'' was taken from FDA labeling requirements.
Comment: Many commenters supported using the FDA labeling
requirement definitions of ``small packages'' and ``very small
packages,'' with many of these commenters recognizing the need for
flexibility for disclosure as small and very small packages have
limited surface area for labels. Several commenters recommended that
the disclosures be simplified to include a clear reference to
bioengineering. Some commenters recommended that even small packages
should fully disclose BE with a symbol or distinct on-package marking,
with many such commenters stating that consumers might not have access
to technology to access links or QR codes.
AMS Response: AMS appreciates that some commenters requested a
specific reference to bioengineering on small and very small packages.
However, AMS notes that the disclosure wording for small and very small
packages matches the statutorily-required on-package language required
for other electronic or digital link disclosures and any telephone
number disclosures, but in a shortened form. AMS acknowledges concerns
some commenters expressed regarding on-package labeling, even for small
packages, and concerns with access to electronic or digital disclosure.
However, AMS believes that the disclosure options available to
manufacturers utilizing small and very small packages, including
electronic or digital disclosure, provides needed flexibility to such
manufacturers while providing disclosure to consumers.
c. Food Sold in Bulk Containers
AMS solicited comments on the AMS proposal that retailers would be
responsible for complying with the BE food disclosure of bulk food, and
that BE food disclosure on bulk foods be allowed to appear using any of
the options for on-package disclosure, including text, symbol,
electronic or digital link, or text message, if applicable.
Comment: Several commenters supported the proposed disclosure
requirements for food sold in bulk containers, stating that such
disclosure is necessary to allow consumers to easily identify and
understand the bioengineered status of the food. Such commenters stated
that the proposal provided retailers flexibility in the form of
disclosure. Some commenters expressed that bulk food should not be
subject to disclosure. While some other commenters stated the proposed
requirements were reasonable if disclosure was required. In some
instances, commenters emphasized that retailers should be given maximum
disclosure flexibility. Some commenters requested that small and very
small retailers and other businesses should be exempt from the bulk
container disclosure because the availability and selection of bulk
food, and therefore the presence of BE in such food, can change daily,
making disclosure burdensome. Other commenters noted that the bulk food
disclosure requirements may result in non-BE food being sold or
commingled with, and disclosed as, BE food.
AMS Response: AMS agrees that labeling bulk containers is necessary
to provide consumers with disclosure information. The final rule is
meant to provide retailers with flexibility in choosing a disclosure
method. With respect to comments seeking an exemption for small food
retailers, such as the exemption for very small food manufacturers, AMS
states that the very small food manufacturer exemption is statutorily
mandated and cannot be extended to small retailers. To the extent that
a small retailer is also a very small food manufacturer, it may be able
to take advantage of the exemption in that instance. Although retailers
will be required to correctly disclose BE food, AMS believes that
retailers are already accustomed to ensuring that bulk food appears
with appropriate signage because AMS already requires Country of Origin
Labeling on bulk food. Additionally, commingled bulk foods should be
disclosed in the same manner as commingled food or ingredients in
packaged or processed food.
15. Voluntary Disclosure
AMS solicited comments on voluntary BE disclosure. Recognizing that
some entities may want to provide a BE disclosure to consumers even
though they are not required to do so, AMS proposed allowing voluntary
disclosure for food that meets the definition of ``bioengineering'' in
the amended Act to ensure that entities responsible for disclosure
would have the option to disclose bioengineering information regarding
foods not subject to mandatory disclosure. AMS proposed that voluntary
disclosure methods and requirements (for text, symbol, digital or
electronic link, or text message disclosure) would be the same as for
mandatory disclosure.
Comment: Most commenters agreed that the law allowed voluntary
disclosure. However, some commenters expressed concern that voluntary
disclosures could potentially be false or misleading, while others
stated that voluntary disclosures could lead to a fractured system
where individual companies make different choices regarding the exact
same ingredients and consumers would not know what such disclosure
really means.
AMS Response: AMS agrees that voluntary disclosure is permissible
under the amended Act. AMS acknowledges that regulated entities may
make different decisions regarding voluntary disclosure. However, AMS
has attempted to provide flexibility to the food industry, along with
the transparency to consumers that they expect and deserve. Voluntary
disclosure is available to exempt entities, as described in Sec.
66.116(a), and to foods in which rDNA material is not detectable but
are derived from bioengineered crops or foods, as described in Sec.
66.116(b). AMS believes that the final voluntary disclosure provisions
give food manufacturers, retailers, and other entities the ability to
provide consumers with the information to make informed choices.
Comment: Some commenters agreed with AMS's proposal to permit
voluntary disclosure for food that meets the regulatory definition of
``bioengineered food'' but is not subject to mandatory disclosure, so
long as such disclosure is consistent with the Act. Some of these
commenters agreed that voluntary text disclosure methods should be
identical to mandatory disclosure rules to minimize consumer confusion
and unfair competition, while others recommended that AMS offer
companies additional flexibility in deciding what language to use for
voluntary disclosures. These commenters also stated that voluntary
disclosure should not be permitted for a non-bioengineered food that
was ``derived from'' or ``sourced from'' a bioengineered crop, and they
opposed allowing voluntary disclosure for highly refined ingredients
because consumers would find it challenging to make accurate
comparisons between similar products where only one bears a voluntary
disclosure. A subset of these commenters also requested that AMS
prohibit voluntary disclosure terminology that suggests that food
derived from animals fed bioengineered feed is therefore considered
[[Page 65858]]
bioengineered. Other commenters stated that AMS should permit voluntary
disclosure on food from animals consuming feed derived from BE crops.
Several commenters stated that voluntary claims such as ``non-
bioengineered'' should be prohibited for foods where there is no
bioengineered alternative.
AMS Response: AMS agrees that any methods to voluntarily disclose
bioengineered food should match the disclosure methods available to
regulated entities to ensure consistent disclosure. AMS also notes that
food companies and consumers generally agreed that consumers expect as
much information as possible on the origin of food ingredients. For
this reason, the final voluntary disclosure provisions allow for a food
manufacturer, retailer, importer, or other entity to voluntarily
disclose a food that originates from a bioengineered crop that they
would otherwise not be required to disclose, using the distinct
terminology ``derived from bioengineering.'' This terminology includes
refined ingredients. As noted above, AMS acknowledges that regulated
entities may make different decisions regarding voluntary disclosure.
However, AMS believes that allowing voluntary disclosure of these
ingredients allows food manufacturers, retailers, importers and other
entities to provide the information that consumers expect in a
consistent manner. AMS agrees with commenters that stated that
voluntary BE disclosure is not permitted for foods derived from animals
fed bioengineered feed. Section 66.116 makes clear that voluntary BE
disclosure is available in limited circumstances and does not apply to
any foods that the amended Act excludes from the requirements for
disclosure. AMS notes that the final rule does not prohibit regulated
entities from making other claims regarding bioengineered foods.
Entities seeking to use absence claims should ensure that such claims
are in compliance with all applicable Federal laws and are otherwise
truthful and not misleading.
Comment: Many commenters supported voluntary disclosure for
products that do not meet the definition of ``bioengineered food,''
with some commenters noting that many manufacturers have already
invested resources into systems of voluntary disclosure. Some of these
commenters favored the ability to use terminology that is distinctly
different from the mandatory disclosure language, provided the claims
are truthful, not misleading, and otherwise consistent with applicable
Federal law. Some of these commenters favored voluntary disclosure of
foods that contain an ingredient ``derived from'' or ``sourced from'' a
bioengineered crop, such as ingredients on the Bioengineered Source
List. Some of these commenters favored voluntary disclosure of highly
refined ingredients that are not required to be disclosed but were
derived from a BE crop, especially if AMS excludes refined ingredients
from the definition of ``bioengineered food.'' Some commenters
recommended voluntary disclosures be standardized in a way that is
rigorous but flexible, with some urging inclusion of a non-exclusive
list of examples of permitted claims into the rule. A subset of these
commenters stated that voluntary disclosure should be permitted below
the threshold or amount of a bioengineered ingredient that triggers
mandatory disclosure.
Some commenters favored voluntary disclosure of the amount of
ingredients that meet the BE food definition, regardless of whether the
finished food meets the definition. Some of these commenters favored
voluntary disclosure of a food made using genetic engineering,
ingredients sourced from gene editing, or use of other technology that
may fall outside the definition of bioengineering. Some also stated
that AMS should allow voluntary disclosure with crops that do not meet
the 85-percent acreage threshold because BE technology has not been
widely adopted.
Some of these commenters requested that AMS allow entities to
identify individual ingredients that meet the definition of BE food
within the ingredient statement by using an asterisk or other symbol
next to the ingredient in the ingredient list, regardless of whether
the finished food meets the definition of BE food. Another subset of
commenters favored voluntary disclosure permitting the use of an
asterisk or other symbol to identify ingredients in the ingredient
statement that fall outside the definition of ``bioengineered food,''
such as those derived from gene editing.
AMS Response: AMS agrees that voluntary disclosure should be
allowed for foods that do not meet the ``bioengineered food''
definition because the rDNA is not detectable, and that such disclosure
should utilize distinct terminology. As noted above, the final
voluntary disclosure provisions allow a food manufacturer, retailer,
importer, or other entity to voluntarily disclose a food that is
derived from a bioengineered crop that they would otherwise not be
required to disclose, using the statement ``derived from
bioengineering.'' AMS has considered comments requesting additional
disclosure options and understands that some entities may want to
disclose bioengineered crops or ingredients with more specificity.
Therefore, when an entity chooses to voluntarily disclose foods derived
from bioengineering with the statement ``ingredient(s) derived from a
bioengineered source,'' the word ``ingredient(s)'' may be replaced with
the name of the specific crops or ingredients that are being disclosed.
AMS acknowledges that many entities have invested resources into
alternative voluntary disclosure methods or labels, but AMS believes
that voluntary disclosure should be consistent to avoid consumer
confusion. Therefore, an entity utilizing the voluntary disclosure
provisions must comply with the disclosure requirements for text,
symbol, digital or electronic link, or text message disclosure, as
applicable. Nonetheless, as noted above, the final rule does not
prohibit regulated entities from making other claims regarding
bioengineered foods, provided that such claims are consistent with
applicable Federal law.
Comment: Some commenters favoring voluntary disclosure urged AMS
not to limit voluntary claims. They stated that AMS should recognize
that entities may want to provide additional information beyond what is
required under the disclosure standard, including statements about the
safety of bioengineering.
Many commenters stated that AMS's use of the single term
``bioengineered'' for mandatory disclosure should not preclude the use
of different terms, including ``genetically engineered'' and ``GMO,''
in additional voluntary statements and symbols about foods. However,
these commenters disagreed about whether AMS should consider these
terms synonymous and interchangeable with ``bioengineered.'' In
addition, one commenter suggested that AMS add a provision about
absence claims that would clarify that claims such as ``not
bioengineered'' or ``non-GMO'' are permitted on certified organic
products by nature of their certification and that a food may not be
considered ``not bioengineered'' solely because the food is exempt from
mandatory disclosure.
AMS Response: As noted above, AMS acknowledge that entities may
want to make additional claims regarding bioengineered foods. However,
AMS believes that voluntary disclosure should generally be consistent
to avoid consumer confusion. Therefore, an entity utilizing the
voluntary disclosure provisions must comply with the disclosure
requirements for text, symbol, digital or electronic link, or text
[[Page 65859]]
message disclosure, as applicable. Nonetheless, the final rule does not
prohibit regulated entities from making other claims regarding
bioengineered foods, provided that such claims are consistent with
applicable Federal law. With respect to absence claims, NBFDS covers
mandatory and voluntary bioengineered and BE-derived claims and 7
U.S.C. 1639b does not provide authority for AMS to establish an absence
claims regime as part of the NBFDS. AMS notes that FDA (and FSIS
depending on the food at issue) retain authority over absence claims.
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. With respect to organic
certification, AMS believes that the amended Act in this respect is
self-executing.
16. Recordkeeping
AMS proposed recordkeeping requirements that aligned with the
disclosure requirements. Commenters generally supported the proposal,
and several commenters submitted suggestions for clarification.
Comment: Many commenters appreciated the flexibility provided to
regulated entities by enabling the use of multiple documentation
sources. Commenters agreed with the 12 categories of documentation
identified as appropriate to verify that foods are not BE, though some
asked that examples of appropriate records be incorporated into the
final rule. Commenters noted that records should be in any format (hard
copy or electronic), with records stored at any business location.
AMS Response: AMS agrees with these comments. Section 66.302(a)
includes a non-exhaustive list of examples of customary or reasonable
records that demonstrate compliance with the NBFDS's disclosure
requirements. That section also clearly states that the records may be
maintained in electronic or paper format.
Comment: Many commenters noted that the reasonable or customary
records already in use throughout the industry should suffice to comply
with the Act and agreed that the recordkeeping requirements would not
impose additional costs or burden to existing practices. One commenter,
however, noted that implementation could result in significant changes
to existing supply chain documentation practices, increasing complexity
and cost throughout the value chain.
AMS Response: As the commenters stated, we do believe that many, if
not most, regulated entities currently maintain the types of records
that will satisfy the NBFDS's recordkeeping requirements. Regulated
entities may make changes to their documentation practices for business
reasons, but this final rule does not specifically require them to do
so.
Comment: A commenter suggested that USDA should require companies
to maintain records similar to those required by private certification
entities such as the Non-GMO project (i.e. for a particular crop or
ingredient, companies must have the DNA testing records, certifications
by crop suppliers of GE/non-GE content, supply chain documents,
purchase orders, bills of sale).
AMS Response: AMS believes that it is efficient to allow companies
to determine the records that best fit their business needs while
demonstrating compliance with the NBFDS. If a regulated entity
maintains one type of records that does so, it serves no purpose to
require that entity to maintain additional or redundant records.
Comment: A commenter encouraged AMS to coordinate with other
Federal agencies to better understand what recordkeeping and records
access is already required and enforced.
AMS Response: AMS agrees that recordkeeping and compliance
requirements under the NBFDS should be consistent with those under
other AMS programs, such as NOP and PACA, and has incorporated elements
from each of those programs into the NBFDS. Accordingly, Sec. 66.302
does not specify the records regulated entities must maintain to
demonstrate compliance with the disclosure regulations. Instead, as
with other AMS programs, regulated entities are free to determine for
themselves which of their customary business records will demonstrate
compliance and should be maintained.
Comment: A commenter suggested that bioengineering-specific records
should be necessary only to support decisions that disclosure is not
required. Manufacturers typically do not test for or maintain
documentation on the presence of modified genetic material in food
unless they are making a ``non-GMO'' claim. A commenter recommended a
regulated entity should only be required to maintain records about
foods on the List of Bioengineered Foods for which the regulated entity
does not make a bioengineered disclosure, including records
demonstrating that the food is below the 5 percent threshold. The
commenter also suggested that acceptable records include documentation
showing the identity preserved seed was produced and handled throughout
the supply chain in a manner to mitigate the potential for cross-
contact with BE substances in the supply chain.
AMS Response: To ensure that BE disclosures are consistent with the
requirements of the NBFDS, AMS is requiring that customary or
reasonable records be maintained when bioengineered food or food
ingredients are used.
Comment: Several commenters suggested that requiring testing
documentation would be burdensome. Commenters suggested adopting a
recordkeeping approach based on traceability and segregation rather
than analytical testing. A commenter sought clarification regarding
whether regulated entities may entirely rely on traceability records
rather than testing results to establish compliance with the Act.
AMS Response: AMS believes that regulated entities should have the
flexibility to determine what customary or reasonable records they
should maintain to demonstrate compliance with the NBFDS, because each
business is different. Section 66.302(a)(4) provides a non-exhaustive
list of record types that might be used to verify that foods are or are
not bioengineered. Further, Sec. 66.9 provides that, in order to
verify that refined foods do not contain modified genetic material,
regulated entities can choose to rely on traceability or source
records, validated process verifications, or analytical testing
results.
Comment: A commenter suggested that if AMS exempts ingredients from
disclosure that do not contain modified genetic material, AMS should
maintain a list of these kind of ingredients. This list would eliminate
the need for testing and maintaining documentation.
AMS Response: The final rule does not exempt any specific
ingredient. Rather, if the regulated entity can demonstrate that no
modified genetic material may be detected in the food or food
ingredient, the regulated entity is not required to include a BE
disclosure for that food or food ingredient. Consequently, AMS will not
maintain a list of ingredients that do not include modified genetic
material.
Comment: A commenter suggested that each BE food manufacturer has
an independent duty to comply with the standard and its provisions,
including record[hyphen]keeping, regardless of whether and when USDA
puts a food product on its lists. Other commenters argued that
[[Page 65860]]
there should be no recordkeeping requirements for foods not on the
list.
AMS Response: AMS believes that foods that bear a BE disclosure
must have records to verify that disclosure. Regulated entities do not
have to maintain records for foods that are not on the List of
Bioengineered Foods provided in Sec. 66.6, unless a regulated entity
has actual knowledge that a food or food ingredient is bioengineered.
Regulated entities must make BE disclosures when their records show
that foods or ingredients are bioengineered, regardless of whether
those foods or ingredients are on the list. If regulated entities have
actual knowledge that the foods or food ingredients are bioengineered
Sec. 66.109 requires those foods and foods ingredients to bear a BE
disclosure, and Sec. 66.302(b)(2) requires regulated entities to
maintain records for those foods.
Comment: A commenter agreed with AMS's proposed 5 days to produce
records (except in the event USDA grants an extension). A commenter
also suggested that USDA specify business days in its timelines.
Several commenters disagreed with the proposed five business days'
notice to produce records. As the NBFDS is intended as a marketing
standard unrelated to food safety, commenters stated that it is more
appropriate for record production requirements to be consistent with
other marketing programs (i.e. the four to six week notice given to
produce records establishing compliance with FDA menu labeling
requirements).
AMS Response: AMS agrees that the final rule should specify that
the timelines are business days and Sec. 66.304 makes that clear. We
also believe the timeframes in the final rule provide reasonable notice
to regulated entities to produce records. If a regulated entity
requires additional time to provide records, AMS may grant an
extension. Additionally, the timelines to produce records are
consistent with other marketing labels administered by AMS. See e.g. 7
CFR 60.400 (country of origin labeling for fish and shellfish).
Comment: Several commenters supported the timeline of at least
three days' notice for an on-site visit, but requested that the final
rule permit the entity to determine the location of the audit at the
regulated entity's discretion, including the option to conduct an audit
at a company's corporate headquarters.
AMS Response: AMS agrees that entities may maintain records at the
location that best serves the entity's business needs.
17. Compliance and Enforcement
Several commenters addressed the Enforcement section of the
proposed rule, including the complaint process and audit and hearing
procedures. Most of the comments broadly back the rule text while
emphasizing that the rule should not authorize USDA to recall any food
based on whether the food has a BE disclosure or impose civil penalties
for violations.
Comment: Several commenters argued that accountability is a key
aspect of a meaningful labeling claim, that label misuse must trigger
consequences, and that USDA must prioritize and implement a more
rigorous audit regimen and make the audit results available to the
public. However, other commenters agreed with AMS that conducting
unannounced audits or imposing steep fines for non-compliance issues
are impractical, and supported the rule on the basis that AMS's
enforcement authority remain limited as set forth in the amended Act.
AMS Response: AMS acknowledges various stakeholders' advocacy for
more rigorous enforcement provisions. We note, however, that the
amended Act prescribes an enforcement program based on records audits,
and provides for publicizing the results of an audit after the
opportunity for a hearing. The amended Act does not authorize civil
penalties or other remedial or punitive measures. We believe that the
enforcement process in the final rule that includes a complaint
process, investigations, audits, hearings of limited scope, and
resulting notifications to both regulated entity and the public
sufficiently meets the amended Act's requirement for enforcement.
Comment: Some commenters requested that USDA more clearly state
when an audit may occur, so producers are not erroneously subject to
audit reviews due to baseless complaints. Several commenters asked that
the rule specify what information is required when filing a complaint.
One commenter asked that the rule incorporate deadlines for considering
complaints.
AMS Response: In response to comments, Sec. 66.402(a) was revised
to include a description of the information that must be submitted with
a complaint alleging violation of the NBFDS. To ensure that audits are
not conducted needlessly, the rule provides that AMS will consider
complaints about potential violations of the disclosure requirements
and determine whether audits or other further investigations are
merited. Complaints will be considered on a case-by-case basis, and
depending on the complexity of the complaints, some may require more
time than others to consider, so no deadlines for consideration were
added. If the complaint merits further investigation, the regulated
entity will be given notice regarding access to its records. It should
be noted that the results of all investigations will be publicized, and
if an audit or investigation finds that the regulated entity is in
compliance with the disclosure requirement, such finding will be made
public.
Comment: Comments regarding audit procedures suggested that while
USDA's proposal is reasonable, if an audit finds a firm out of
compliance, then a detailed summary of records should not be released
to the public to protect confidential business information. Some input
cites public access concerns to confidential business information of
product formulations or recipes. Related comments requested the
regulated entity set the location where the audit should occur. Some
comments stated a labeling duty should arise only if AMS, while
conducting audit procedures, determines producer testing is inadequate
and/or its products really do contain modified genetic material.
AMS Response: AMS does not release confidential business
information, consistent with other applicable Federal regulations. AMS
agrees that entities may maintain records at the location that best
serves the entity's business needs. Audits can be conducted at the
regulated entity's place of business. Regulated entities subject to the
NBFDS should make determinations about disclosures based on records.
AMS does not intend to test final food products to determine compliance
with the rule.
Comment: Several commenters favored notice of non-compliance to
regulated entities with a 30-day window to object and request a
hearing, then making results public if a hearing is not requested or
the Administrator upholds the finding of non-compliance. In addition,
when auditing a regulated entity to determine whether the entity is in
compliance with the disclosure standard--either on its own initiative
or in response to a complaint by a consumer, competitor, state
regulator, or another party--some commenters suggested AMS should begin
by contacting the regulated entity and providing a 4 to 6-week period
for the entity to produce appropriate records. If the company can
provide records demonstrating the food is not subject to disclosure,
the entity would be deemed in compliance. Another comment addressing
timeframes advocated that deadlines for providing records for
[[Page 65861]]
review during audit or investigation be ``business days.''
AMS Response: AMS deems the goals of disclosure and minimizing
economic burden whenever feasible is best obtained by NBDFS flexibility
on maintaining customary business records, while requiring compliance
with the specified timeframes for furnishing data access to AMS. Since
all regulated entities are required to maintain customary and usual
business records to demonstrate compliance, the timeframes provided
should give entities adequate time to produce appropriate records.
Nevertheless, the rule provides for extending records access deadlines
at AMS's discretion. It should also be noted that Sec. 66.304 of the
rule specifies records production deadlines in terms of business days.
Thus, the rule declines to impose the timeframes suggested by these
comments, and provides for an audit process with the more immediate
investigative and auditing elements specified.
Comment: Several comments acknowledged the statutory obligation to
provide the results of an examination or audit, and further asserted
the rule also needs to ensure any trade secrets or confidential
commercial information is redacted before providing publicly those
results, as required under the Freedom of Information Act (FOIA). One
commenter recommended that results only be posted for six months, as
afterwards this information has diminishing relevance, but can still be
accessed via FOIA requests.
AMS Response: Proprietary business information, including product
formulation and recipes, will be kept confidential by AMS, consistent
with FOIA, 5 U.S.C. 552(b)(4). Section 66.406 does not specify how long
hearing results will be posted. The duration of posting hearing results
will be in accordance with relevant departmental policy and FOIA.
Comment: Several commenters suggested that regulated entities
making ``may contain'' disclosures should be subject to periodic
compliance audits in a separate mode from other regulated entities.
AMS Response: The final NBFDS does not provide for ``may contain''
disclosures.
Comment: Several commenters argued a deadline for agency responses
to complaints should be set, and a standard for when and why further
investigation is warranted should be established. These comments
recommended USDA should audit or examine records of manufacturers and
establish fines for non-compliance violations. In addition, comments
suggested the audit and hearing process should be undertaken pursuant
to deadlines to ensure timely resolution, and all results must be made
public.
AMS Response: AMS notes the concern, but determines the optimal
balance between expeditious enforcement and associated aspects,
including complaints, audit, examination, investigation, hearing and
appeal, and the disclosure rule's broad mandate to also facilitate
commerce, is best met by the rule's mix of strict record access
deadlines with further timeframes for hearing request and appeal. Other
response deadlines are deemed impractical, as audits or investigations
are case specific, require individual time to complete, and reflect
various factors such as extensiveness of a case under review and AMS
workload.
Comment: Many commenters recommended that AMS include limitations
on recall authority in the final rule.
AMS Response: The amended Act does not authorize product recalls
based on compliance with the disclosure requirements of the NBFDS.
Thus, establishing limitations on recall authority is unnecessary.
18. Compliance Dates
AMS proposed an initial compliance date of January 1, 2020, for all
regulated entities other than small food manufacturers whose initial
compliance date would be January 1, 2021. We also proposed allowing
regulated entities until January 1, 2022, to use up labels that have
been printed by the initial compliance date. We received many comments
on this proposal.
Comment: Several commenters argued that manufacturers have had
plenty of warning about the NBFDS and that consumers have waited a long
time for mandatory bioengineered food labeling and should not have to
wait longer. Other commenters suggested extending compliance deadlines
for all manufacturers, explaining that label changes are costly and
time consuming. Still other commenters agreed with the compliance dates
as proposed, finding that they hit a balance between consumer desire
for information and industry need for time to make label changes. Other
commenters advocated that the compliance dates for the NBFDS should
align with the FDA deadlines related to the recently updated Nutrition
Facts and Supplement Facts panel.
Several commenters claimed that manufacturers could theoretically
continue printing and using non-compliant labels for up to six years
after the Act was amended to require mandatory BE food disclosure.
Those commenters urged AMS to allow a shorter compliance period for
label use-up. Food manufacturer comments generally supported the
proposed label use-up provision, but they asked that the final rule
provide a two-year compliance period after the compliance date, rather
than specifying a hard date, to allow for regulatory delays.
Commenters also urged AMS to allow the use of labels compliant with
the preempted State GMO labeling laws during the compliance period.
Some commenters recommended that AMS allow entities to apply stickers
or ink stamp disclosures to existing labels to reduce waste. Others
suggested that AMS incorrectly assumes manufacturers maintain large
label inventories, asserting that manufacturers order labels in the
smallest batches economically practical.
Several commenters requested additional time for regulated entities
to meet the requirements of the NBFDS because complying with the
regulatory requirements of the NBFDS will be complex. They explained
how regulated entities will need time to determine how their specific
business might be impacted by the labeling and recordkeeping
requirements of the NBFDS, and the challenges in meeting the proposed
January 1, 2020, deadline. Several commenters explained how labeling
costs would not be costly as many companies print labels in minimally
necessary quantity and print labels themselves using digital equipment.
Under this view, the proposed January 1, 2020, compliance date would be
more than enough time for affected entities to make necessary changes
to achieve compliance.
Other comments supported the proposed compliance dates. Conversely,
many commenters felt that the compliance dates and compliance periods
proposed in the NPRM were too lenient, and that regulated entities
should be required to immediately change their labels to denote the
presence of bioengineered food and/or food ingredients. They explained
that consumers have a right to know that the food they are buying is
bioengineered and should have access to this information as soon as
possible.
AMS Response: Because this rule is a major rule, the effective date
will be February 19, 2019 to comply with the Congressional Review Act.
After consideration of the comments, AMS has decided to adopt
implementation dates, a compliance date, and a compliance period. The
implementation dates are the same as the proposed
[[Page 65862]]
compliance dates: January 1, 2020, for regulated entities other than
small food manufacturers and January 1, 2021, for small food
manufacturers.
As evaluated in the Regulatory Impact Analysis, AMS recognizes that
this final rule will be complicated to implement, requiring regulated
entities to modify their existing business practices, and thus,
regulated entities will need adequate time to come into compliance.
Requiring compliance on the rule's effective date or by January 1,
2020, would be overly burdensome because of the time and cost involved
in determining which foods require disclosure, identifying the required
records, modifying labels, and providing the appropriate disclosure on
the labels. In establishing the compliance dates, AMS determined that
regulated entities should have greater flexibility, beyond using
existing label inventories, to transition to the mandatory BE
disclosure and recordkeeping. Thus, the final rule includes a voluntary
compliance period and the mandatory compliance date. As explained
above, regulated entities may voluntarily comply with the requirements
of part 66 until December 31, 2021. Beginning on January 1, 2022, all
regulated entities must comply with the requirements. Those periods are
comparable to the extended compliance date of January 1, 2020, for
FDA's Nutrition Facts and Supplement Facts Label and Serving Size final
rules, which is approximately 3.5 years after FDA published the final
rules. We note that many food manufacturers have complied with the
FDA's final rules well ahead of the compliance date, and we anticipate
the same for the NBFDS.
19. Use of Existing Label Inventories
AMS recognizes that the new NBFDS will require regulated entities
to make BE disclosures on their labels. The NPRM included a proposal to
allow regulated entities a period of time to use their existing label
inventories and AMS received several comments in support and in
opposition to this proposal.
Comment: Many commenters supported continuing use of existing label
inventories until the compliance deadline. They believed that ongoing
use of existing inventories reflects the best economic, environmentally
valid option to mitigate waste associated with letting existing label
stock go unused if not depleted before the deadline. Such feedback
sought an extension of the compliance deadline until existing stock had
been exhausted or materially depleted. Several commenters were
concerned that by providing a blanket exemption for unused label stock,
AMS would be encouraging noncompliance. One commenter expressed concern
that the rule has insufficient safeguards to prevent or discourage
excess labels being printed merely to escape or unduly extend the
compliance deadline.
AMS Response: As explained above, AMS is adopting a voluntary
compliance period until December 31, 2021, to allow regulated entities
more flexibility. Thus we are not adopting the proposal to allow
regulated entities to use existing label inventories because it is
unnecessary.
Comment: Commenters suggested an alternative website disclosure
option be available until new labels can be printed.
AMS Response: The amended Act does not authorize AMS to require an
independent website disclosure. Regulated entities, however, are free
to include BE disclosures on their websites.
20. Regulatory Flexibility Analysis
The Agricultural Marketing Service sought public comment on several
aspects of the proposed National Bioengineered Food Disclosure Standard
rule to guide efforts in creating a final rule for implementation.
Though the proposed rule was not predicted to have a significant
adverse economic impact on substantial number of small entities, the
Agricultural Marketing Service conducted an initial regulatory
flexibility analysis and provided suggestions and analysis of measures
to reduce the economic effect on small entities. For purposes of the
regulatory flexibility analysis, AMS solicited comments regarding
suggested standards to define ``very small food manufacturer'' based
upon a range of annual receipts. Additionally, AMS sought comments on
the defining a ``small food manufacturer'' based upon receipts or upon
number of employees to determine what firms should receive additional
time to comply with the disclosure requirements of the rule. Comment
summaries below represent public input on suggested flexibility
provisions in the proposed rule.
Comment: Commenters supported a range of definitions for a ``very
small food manufacturer.'' Some commenters suggested that there be no
exemption for food manufacturers of any size. Many commenters supported
the alternative definition analyzed by AMS to narrow ``very small food
manufacturers'' as those with less than $500,000 in annual receipts.
Several noted this number would comply with similar standards imposed
by the FDA for nutrition labeling requirements. Many of these
commenters cited a desire for increased transparency by labeling more
products. Some commenters supported the proposed definition of food
manufacturers with $2.5 million or less in annual receipts, citing the
high costs of bringing their business into compliance with the rule.
Several commenters also proposed an alternative definition of food
manufacturers with less than $1 million in annual receipts. These
commenters cited the FDA's use of this number to define ``very small
businesses'' in rules not related to food labeling.
AMS Response: AMS considered a range of definitions for a ``very
small food manufacturer'' including the small business definitions
under FDA and U.S. Census Bureau (USCB) regulations. AMS evaluated the
impact of applying various definitions by estimating the number of
firms that would be exempted, the number of products that would likely
be exempt, and the proportion of annual industry sales that would
exempt under each exemption level. Exempting manufacturers with annual
receipts of less than $2.5 million will provide regulatory relief to 74
percent of food manufacturers and 45 percent of dietary supplement
manufacturers, while reducing the number of products covered by only
one percent for both food and dietary supplement manufacturers.
Comment: To define ``small food manufacturers,'' some commenters
expressed interest in aligning the definition with Small Business
Administration standards on number of employees rather than the
proposed annual receipts definition to promote consistency. Many of
these commenters supported the AMS alternative definition of businesses
with fewer than 500 employees. Other commenters suggested defining
``small food manufacturers'' as those with less than $2.5 million in
annual receipts.
AMS Response: The Small Business Administration uses both the
number of employees and annual receipts to describe business size
categories. Because food and dietary supplement manufacturers are in
the manufacturing sector, they are both defined by number of employees
for purposes of SBA size categorization. However, the firms defined as
small or very small for purposes of the NBFDS all fall well below the
SBA definition of small, so we do not feel we need to be bound by that
methodology. The FDA nutrition labeling definition of small is based on
sales rather than number of employees, and it is important to remain
consistent with that definition. We decided to extend the use of
receipts to define very small food manufacturers because we
[[Page 65863]]
believe it to be administratively simpler, as it does not require
development of an averaging system to track employees over time
(especially in firms that may have some degree of seasonality).
Comment: Some commenters specifically suggested that we define very
small manufacturer as a manufacturer with annual receipts below
$2,500,000 or less than 50 employees.
AMS Response: While we do not have data on manufacturers with less
than 50 employees (Census has data cutoffs at 20 employees and 100
employees), we do know that defining very small manufacturers as those
with less than 20 employees would exempt the same 74 percent of firms
as receipts less than $2,500,000. So, the compound definition would
result in significantly more exemptions. When Census uses the term very
small enterprise, it refers to 20 employees. The fact that the results
of estimating exemptions at 20 employees and $2,500,000 annual receipts
are so close gives us confidence that we are not outside of the
reasonable norm in using this cutoff.
Comment: Several commenters also sought shorter compliance
deadlines and no implementation extensions for small food manufacturers
with more than $2.5 million in annual receipts. Several commenters
insisted no entities be exempted from the NBFDS, including those
defined as very small and small food manufacturers.
AMS Response: AMS appreciates that several commenters insisted no
entities be exempted from the NBFDS including those defined as very
small and small food manufacturers, however, the very small food
manufacturer exemption is a statutory requirement. Congress
contemplated some level of undisclosed use of bioengineered foods to
avoid undue burden on very small food manufacturers. Our goal is to
find a reasonable balance between the number of small firms that are
exempted and the number of products for which the consumer may not
receive full disclosure of bioengineered content. By defining ``very
small food manufacturers'' as those with annual receipts below
$2,500,000, about 74 percent of food manufacturers are exempt from
mandatory disclosure, but 96 percent of products will still be covered.
Comment: Some comments further suggested the proposed exemption for
very small food manufacturers be extended to very small food retailers
using the standard in FDA's Menu Labeling Rule applicable only to
restaurants and similar retail food establishments that are part of a
chain with 20 or more locations doing business under the same name and
offering for sale substantially the same menu items.
AMS Response: The exemption for ``very small food manufacturers''
is provided for in the amended Act. The amended Act also provides an
exemption for all restaurants and similar food establishments. The
amended Act does not contain a similar exemption for retail
establishments that are not manufacturers or restaurants. However, the
portions of grocery stores and similar retail establishments that
prepare food for immediate consumption (e.g. deli or prepared food
section) fall within the definition of restaurant and are exempt from
the disclosure requirement. So unpackaged food in the produce section
would be subject to disclosure if it meets the definition of
bioengineered food, while the same product used as an ingredient in a
sandwich in the deli would not.
21. Regulatory Impact Analysis
AMS provided a Regulatory Impact Analysis (RIA) with the proposed
rule that provided details on the expected costs and benefits of the
rule, and solicited comments.
Comment: One commenter provided a detailed analysis of the costs
and benefits of the NBFDS conducted by John Dunham and Associates (JDA)
(National Bioengineered Food Disclosure Standard: A Review of the
United States Department of Agriculture's Regulatory Impact Analysis
(Brooklyn, NY: June 2018)). The JDA assessment estimated much higher
costs than the AMS analysis, though since it also estimated much higher
benefits, the JDA analysis concluded that the Federal disclosure
standard would be the most cost-effective method to provide information
and minimize inefficiencies caused by inconsistent State-level
standards. JBA found cost savings of avoiding compliance with twenty
separate state rules to be $97.3 billion over twenty years and $129.7
billion cost savings over the same period if all 51 states implemented
different labeling provisions.
AMS Response: The JDA assessment provides valuable corroborating
evidence of the net benefits of the NBFDS. However, AMS could not adopt
JDA's methodology--and higher cost and benefit estimates--for the RIA
since this methodology incorporates a broader set of impacts and
transfers than recommended by OMB for regulatory impact assessment. OMB
Circular A-4 admonishes agencies to focus on opportunity costs, the
real expenditure of society's resources, and to avoid counting
transfers as benefits or costs. JDA uses a partial equilibrium input-
output model (IMPLAN) to estimate the costs of the NBFDS. This model
estimates the cost of labeling to specific industries/sectors and then
calculates the multiplier effects on other industries and consumers
(prices held constant) within the study region. Such an analysis tracks
transfers rather than the commitment of real resources to compliance.
OMB Circular A-94 states ``Employment or output multipliers that
purport to measure the secondary effects of government expenditures on
employment and output should not be included in measured social
benefits or costs.'' Moreover, the JDA analysis only tracks half of the
equation in that it follows the changes in upstream expenditures
resulting from decreased expenditures by food manufacturers, but does
not track the increased downstream expenditures related to additional
income to label printers. While partial equilibrium models can be very
useful for evaluating local effects of a specific policy and for other
purposes, its results for purposes of evaluating compliance costs tends
to inflate the compliance costs by the velocity of money. However,
because the velocity of money is constant within the region, the
relative attractiveness of individual policy choices would be the same
as if those alternatives were evaluated based on opportunity cost
alone.
Comment: Many comments addressed the RIA's discussion of signage in
stores selling fresh produce. These generally disagreed with the
proposal that retailers be responsible for disclosure in any
circumstances because manufacturers and suppliers are better equipped
to provide labelling information and costs will be too burdensome on
retailers. A common concern identified proposed producer requirements
regarding modifying contracts for manufacturers to notify end users
when a product is reformulated (or otherwise changed) as time consuming
and costly. However, these comments agreed with the RIA that if
retailers must be responsible for labeling, signage as posted by the
retailer may be an appropriate method to help keep costs low for
retailers and provide consistency for consumers. Some comments asked
the final rule allow retailers to post signage such as a single sign
near a produce section listing all BE foods in that section, to further
reduce retailer burden.
AMS Response: Retailers should not have to take into account costs
associated with modifying contracts to provide for end user
notification of
[[Page 65864]]
product reformulations since packaged food will be labeled by the
manufacturers. For prepared foods sold by grocers in in-store delis or
salad bars, Sec. 66.5(a) provides an exemption for food served in a
restaurant or similar retail food establishment from disclosure under
the NBFDS. Section 66.1 now defines ``similar retail food
establishment'' as a cafeteria, lunch room, food stand, food truck,
transportation carrier (such as a train or airplane), saloon, tavern,
bar, lounge, other similar establishment operated as an enterprise
engaged in the business of selling prepared food to the public, or
salad bars, delicatessens, and other food enterprises located within
retail establishments that provide ready-to-eat foods that are consumed
either on or outside of the retailer's premises.
Comment: Some comments further suggested the proposed exemption for
very small food manufacturers be extended to very small food retailers
using the standard in FDA's Menu Labeling Rule applicable only to
restaurants and similar retail food establishments that are part of a
chain with 20 or more locations doing business under the same name and
offering for sale substantially the same menu items.
AMS Response: The exemption for ``very small food manufacturers''
is provided for in the amended Act. The amended Act also provides an
exemption for all restaurants and similar food establishments. The
amended Act does not contain a similar exemption for retail
establishments that are not manufacturers or restaurants. However, the
portions of grocery stores and similar retail establishments that
prepare food for immediate consumption (e.g. deli or prepared food
section) fall within the definition of restaurant and are exempt from
the disclosure requirement. So unpackaged food in the produce section
would be subject to disclosure if it meets the definition of
bioengineered food, while the same product used as an ingredient in a
sandwich in the deli would not.
Comment: Some comments noted the RIA does not address all market
impacts under a rule that includes products containing highly refined
ingredients within the definition of a bioengineered food. The
expressed concern was this does not consider price impacts of presuming
refined ingredients not containing modified genetic material are BE
foods under Position 2, when in fact they are identical to all other
refined ingredients from conventional crops. Such input recommended AMS
exclude refined ingredients from definition of BE foods because of
these unidentified likely significant harmful effects on the
agricultural value chain. Related comments addressed economic
consequences of presuming beet sugar is a BE food when it is identical
to other refined sugar products, noting costs will be greater than the
RIA estimates. Citing Vermont's labeling law as an example, such
feedback advised there will be significant market consequences
resulting from market discrimination resulting in higher consumer
prices if refined sugar is included in a BE food definition. Farms will
bear the brunt of the economic impact as there are currently no non-
bioengineered sugar beets grown for sugar production. A commenter
expands this concern and concludes adverse market and agricultural
impacts will flow from any RIA presumption that refined food
ingredients are presumptive BE foods, and will trigger market
discrimination against such entities. Several comments express the
broad concern that the RIA and underlying rule presume refined
ingredients are BE, resulting in competitive harm and undue costs to
the American farmer. Associated comments asserts the RIA significantly
understates the costs of the rule to the sugar industry, claiming such
industry's product is identical to all other refined sugar products,
but would be selectively burdened under BE standards.
AMS Response: The commenter is referring largely to incidence of
costs rather than the estimated magnitude. The RIA did not estimate
cost increases across the board and does not believe that doing so is
consistent with recent real-world experience. What the RIA does do is
assume that manufacturers of 20 percent of products will seek to
replace BE ingredients with non-BE alternatives. The costs associated
with trying to avoid a cost differential is, therefore, accounted for
in the RIA. Nevertheless, the final rule would allow manufacturers to
demonstrate through records (potentially including test results) that a
food or ingredient does not contain modified genetic material and would
not be required to disclose the food or ingredient as BE. The concern
raised by the commenter has been addressed by the final rule.
Comment: A number of commenters suggested that there could be
distributional effects of the NBFDS that were not considered in the
RIA, including impacts on farmers through segregation costs and
consumers through higher food prices.
AMS Response: Potential impacts on farmers arise in the case where
manufacturers and retailers take the marketing decision to replace BE
ingredients with their non-BE counterparts. The RIA notes that this
decision would entail higher costs stretching back to the farm,
including the extra cost to farmers of supplying non-BE commodities and
crops include the costs of sourcing non-BE seeds; avoiding cross
contamination with BE varieties during planting, harvesting and
transporting; driving to an elevator or handler that is farther away
than the nearest bulk elevator; and foregoing the benefits of BE
production. However, as noted in the RIA, these extra costs are
reflected in price premiums paid to farmers for non-BE varieties. The
RIA provides current estimates of this price premiums in the United
States. AMS does not include estimates of impacts on consumer food
prices in the RIA for two reasons. First, in the case of BE labeled
products, it is unlikely that manufacturers will pass labeling costs on
to consumers (manufacturers will not want to jeopardize demand for
these newly labeled products). Second, in the case of non-BE labeled
products, there is no evidence that the extra costs for production and
segregation are any higher than currently paid by consumers who prefer
non-BE products. As a result, while availability of these products
could rise as a result of the NBFDS, non-BE prices could remain
constant or actually decline in the long run as production expands.
Comment: Some comments found the RIA inadequately assessed societal
costs associated with electronic and digital disclosure. Such input
asserted these disclosure methods would ultimately burden consumers who
would not have sufficient product information, given retailers will be
reluctant to purchase expensive scanning equipment. Consumers in low-
income rural areas already lacking connective capabilities equivalent
to urban areas would be especially burdened.
AMS Response: Potential impact associated with electronic and
digital disclosure is more fully addressed by comment responses
directly assessing electronic and digital link disclosures herein. AMS
strikes a reasonable balance between offering various label disclosure
alternatives, realizing stakeholder phone, internet or digital access
may vary by locale, customer expertise, income or related factors. Not
all BE food packaging and presentation will be amenable to electronic
or digital disclosure. By offering several disclosure alternatives, AMS
seeks least burdensome commercial impact consistent with the regulatory
objective to meet public demand for consistent accurate label
information.
Comment: Several comments identified specific burden to small
[[Page 65865]]
entities from labeling and associated requirements, asserting food
retailers would also be selectively burdened by labelling and other
regulatory aspects. Other negative input alleged inconsistency and
conflict with international norms, potentially promoting trade
disputes.
AMS Response: On analysis of comments and other data, including
studies, AMS concludes impacts to producers are mitigated by exemptions
for qualifying ``small'' and ``very small'' entities, by offsetting
efficiencies of a uniform standard, and by consideration to
international norms and trade. The proposed rule subjects importers to
the same disclosure and compliance regimen as domestic entities. AMS's
interest is to facilitate imports and exports under arrangements where
BE labeling is consistent with the NBFDS. Under such arrangements,
countries could agree to recognize each other's BE labeling
requirements as comparable. This would allow foreign food products with
comparable BE labeling to be sold in the US, assuming they meet all
other labeling and safety requirements. Overall, AMS's economic
analysis indicates it is likely this rule would not have a significant
impact on a substantial number of small businesses.
Comment: A number of commenters referred to an assessment conducted
by the Grocery Manufacturers Association (GMA) in 2017 that found that
the exclusion of refined ingredient would result in 78 percent (78%)
fewer products being disclosed, as opposed to USDA's assessment that
exclusion of refined ingredients would result in 25 percent (25%) fewer
products being disclosed.
AMS Response: The GMA assessment considered a categorical exemption
of all refined ingredients. In contrast, USDA's estimate for scenario 2
considered an exemption for only sugar and oil and in scenario 3, an
exemption for ingredients that test negative for rDNA (not a blanket
exemption of all refined ingredients). In both cases, since the
exemptions are smaller than assumed in the GMA study, it is reasonable
to expect that the number of exempted food products would also be
smaller. In addition, the USDA study considered ``nesting'' when
calculating the impact of exempting refined ingredients such as sugar.
Nesting recognizes that most labeled foods contain more than one
ingredient. If products are not required to label due to the presence
of sugar, for example, that does not mean that the product itself does
not need to be labeled if it contains other ingredients that are not
part of the categorical sugar exemption. For example, just looking at
the first product that shows up on a search of food products that
contain ``sugars'' as an ingredient in LabelInsight, we find a breaded
chicken product. The first few ingredients listed on the product label
include Salt, Spice, Sugars, Water, Onion Powder, Garlic Powder,
Dextrose, and Modified Food Starch. The categorical exemption would
apply to Sugars and Dextrose, but the product would still require
disclosure to the presence of Spice and Modified Food Starch. Nesting
results in fewer products being exempted from labeling than might be
assumed from a count of refined ingredients. Since the USDA and GMA
assessments are based on two different data sets, it is impossible to
directly compare results.
Also, the two estimates are based on different data sources. USDA
relied on ingredient data reported on food labels while GMA relied on a
survey of its membership. It is not surprising that the two approaches
might come up with somewhat different results.
That said, the final version of the RIA takes another look at which
ingredients are likely to be exempt under the condition that mandatory
disclosure only applies to foods or ingredients that meet the statutory
definition of bioengineering. This reevaluation has led us to remove
some ingredients that we had assumed would universally require
disclosure. This has resulted in an estimate that is closer to the GMA
estimate.
Comment: One commenter specifically took issue with the USDA's use
of shielding to explain why administrative costs could increase for
products still required to disclose in the instance of an exemption of
refined products. The commenter argued that since manufacturers look at
the BE status of all ingredients when they develop a new product the
existence of low administrative costs ingredients does not obviate the
need for manufacturers to understand the BE status of administratively
higher cost ingredients especially for products seeking non-GMO project
certification.
AMS Response: AMS disagrees with the commenter. First, the rule
requires a disclosure determination to be made for existing as well as
new products and the RIA is based exclusively on the costs associated
with making this determination for existing products. As the commenter
points out, making this determination for new products is lower because
the BE status of ingredients is something that manufacturers do today
as a matter of course. However there is no reason to believe that a
product that is already on the market looked at the issue in as much
detail as new products might. Manufacturers of existing products would
therefore need to evaluate their ingredients and would be able to stop
doing so as soon as they discovered an ingredient that caused the
product to require disclosure. The fact that manufacturers may
voluntarily subject themselves to costs beyond what the rule requires
is not relevant to the RIA. Also, the RIA assumes that products that
have obtained non-GMO project certification incur no costs as a result
of this rule.
Comment: One commenter noted that the RIA makes many references to
uncertainty in the estimates, and often provides upper and lower
estimates to account for some level of uncertainty. The commenter goes
on to note, however, that the RIA does not include a formal uncertainty
analysis.
AMS Response: As noted by the commenter, in the RIA we provided
upper and lower bound estimates where necessary to account for
uncertainty. We incorporated more formal uncertainty analysis where
distributional information was available, such as for the estimates for
printing and label design costs (the upper bound represents the 95th
percentile of the distribution of costs estimated by FDA for its
Labeling Cost Model while the lower bound represents the 5th
percentile) and for the analytical testing costs for bioengineered
ingredients (with lower bound estimate set at the 5th percentile of the
cost distribution and the upper bound at the 95th percentile, as per
FDA's Labeling Cost Model).
Comment: One commenter stated that for the most part, the RIA is
based on quality data but that the supporting documentation for the RTI
(FDA) labeling cost model was not available to the public.
AMS Response: AMS posted the description of the FDA Labeling Cost
Model in the supporting documentation for the rule.
Comment: One commenter stated that OMB requires a discount rate of
0.2 percent and that because AMS used discount rates of three percent
and seven percent, the discounting performed for the RIA was not
properly conducted.
AMS Response: AMS used the discount rates specified in OMB Circular
A-4 that are still commonly used for regulatory analysis. The 0.2
percent discount rate referenced in the comment is from OMB Circular A-
94 and represents the cost of money to the Federal Government to be
used in cost-effectiveness analysis of Federal projects, not the
average before-tax rate
[[Page 65866]]
of return to private capital in the U.S. that is appropriate for
regulatory analysis.
VI. Rulemaking Analyses and Notices
A. Paperwork Reduction Act
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C.
3501-3520), AMS published a 60-day notice on reporting and
recordkeeping requirements related to the proposed NBFDS published in
the Federal Register on May 4, 2018. AMS submitted a request to OMB on
May 7, 2018, for approval for a new information collection totaling
7,973,566 hours. OMB subsequently assigned reference number 0581-0315
to the reporting and recordkeeping requirements. As part of the
preparation of the final rule, AMS has recalculated the information
collection estimates based on the final requirements of the NBFDS.
Based on this, AMS is requesting approval of a new information
collection totaling 20,512,720 hours. Comments received on the
reporting and recordkeeping burden are referenced below.
1. Comments on Information Collection and Recordkeeping
AMS solicited comments concerning the information collection and
recordkeeping required as a result of this rule. Specifically, AMS
wanted to know if the proposed collection of information had a
practical use and if the information would be needed for the agency to
properly conduct its functions. AMS requested feedback regarding its
estimate of the burden the proposed information collection and process
would pose on businesses. The proposed rule also sought comments on
ways to enhance the quality, utility, and clarity of the information to
be collected, as well as ways to minimize the burden of the information
collection on those required to respond.
Comment: Many commenters generally support the required collection
of records to demonstrate compliance with the NFBDS, including the
requirement for entities to maintain records for two years after a
food's distribution for retail sale. Many commenters also agree that
required records should rely on existing records that are customary,
reasonable, and regularly kept and maintained in the ordinary course of
business, and urge AMS to retain these principles in the final rule.
One commenter asked for clarification on the rule's definition of
``sufficient detail.''
While many commenters support using the twelve categories of
documentation AMS identified as appropriate to verify that foods are
not bioengineered and not subject to disclosure, several have requested
AMS offer flexibility in the types of records required to document BE
status as long as the documentation can sufficiently prove that foods
are not subject to mandatory disclosure. A few commenters suggest
supplier documentation is the most important recordkeeping component
since the disclosure requirement for finished products are based on how
the component ingredients are derived. For foods subject to disclosure,
some commenters believe that maintaining a record documenting the
presence of BE ingredients should be sufficient.
Many commenters support AMS's decision to exempt foods certified
under the National Organic Program from BE disclosure so manufacturers
of these certified products would not be required to maintain
additional records to demonstrate a certified product is not
bioengineered. Similarly, a commenter suggests AMS should also exempt
from disclosure any foods verified as ``non-GMO'' through commercial
verification systems, like the Non-GMO Project, whose standards may
meet or exceed the proposed BE standard. The commenter further suggests
this type of verification suffices as records that establish a food or
ingredient is not bioengineered. For other exempt foods--such as those
derived from animals fed BE food--another commenter strongly agrees no
records should be required from the entity producing these products.
Some commenters believe BE labeling requirements on BE products on
the ``highly adopted'' or ``not highly adopted'' lists are appropriate
and what Congress intended. These commenters also believe that, as
proposed, the BE recordkeeping requirements inappropriately place the
burden of proof on conventional food producers that have chosen not to
use or produce BE products. The commenters contend the expense, time
and responsibility of additional recordkeeping should fall on the
entities that use or produce BE products, not those who have chosen not
to use BE products. As such, they suggest the rule provides for an
alternate approach to the currently proposed recordkeeping burden. The
new approach would allow AMS to challenge foods not properly labeled as
BE.
Several commenters support the rule's requirement for imported
foods to provide the same recordkeeping documentation as food produced
domestically. According to this input, without such requirements, U.S.
food manufacturers would be at a profound disadvantage to international
food manufacturers. Another commenter suggests the rule may not need to
require a mutual recognition agreement when a prior processing
agreement exists between the U.S. and a foreign country, unless a BE
ingredient is introduced to a product during processing in that foreign
country. For example, when products are shipped to a foreign country
for further processing, shipped back to the U.S. for secondary
processing, and then sold in the U.S. market, the mutual recognition
agreement would not be needed.
AMS Response: AMS appreciates the range of comments provided
regarding recordkeeping requirements resulting from this rule and notes
commenters generally support AMS's need to collect customary business
records to establish a regulated entity's compliance with the NBFDS.
AMS agrees that regulated entities may need flexibility in the types of
records required to document compliance with the NBFDS. As such, AMS
does not specify the records that must be maintained, but allows
regulated entities discretion in determining what records will
demonstrate compliance. AMS also notes that, for the purposes of this
rule, any food manufacturer, importer or retailer offering for retail
sale foods on the List of Bioengineered Foods is considered a regulated
entity. Regulated entities must maintain records on foods that trigger
a BE disclosure and to verify food without a disclosure is not
bioengineered. Section IV.A.1 further details AMS's position on
recordkeeping.
Comment: Commenters suggest, in the final rule, AMS establish an
exemption from the NBFDS for raw fruits and vegetables, consistent with
the exemption in FDA's traditional nutrition facts panel (NFP) labeling
requirements. Commenters contend labeling raw fruits and vegetables is
not practical and would be burdensome to the regulated entities. They
further explain fruits and vegetables of the same variety may be
sourced from different suppliers and are often mixed together in large
bins. As such, requiring BE disclosure for these unpackaged foods would
be difficult and may lead to consumer confusion.
In addition, commenters suggest AMS should explore other methods of
traceability similar to those used by major U.S. trading partners.
Because highly refined products may not always have detectable modified
genetic material, this input suggests AMS seek recordkeeping, reporting
and compliance methods that validate a
[[Page 65867]]
food's BE status based on the entire food production process that led
to the final product's labeling.
AMS Response: AMS appreciates comments suggesting raw fruits and
vegetables be excluded from the BE disclosure requirements. AMS
believes that such an exemption would conflict with the statutory
requirement that foods subject to FDCA's labeling requirements are
subject to disclosure under the NBFDS. We also appreciate that some
commenters would like AMS to explore other traceability methods to
detect modified genetic material in highly refined products, thereby
causing the products to be subject to BE disclosure. However, AMS
believes that determinations about what constitutes BE food for the
purposes of the NBFDS should focus on the characteristics of the
biotechnology product and not on the process by which the product is
created. As such, highly refined products remain outside the scope of
products subject to mandatory BE disclosure.
Comment: Many commenters did not specifically address accuracy of
the estimated cost of compliance. A commenter averred prescriptive
requirements such as the mandatory placement of disclosure text or
symbol would add significant costs for label redesign or revamping of
handling practices. The commenter suggests BE disclosure requirements
remain adequately flexible to facilitate practical implementation.
AMS Response: AMS agrees that regulated entities may need some
flexibility when determining the size and placement of a BE disclosure.
The NBFDS allows flexibility for both. For further details regarding
AMS's position on the appearance and placement of the BE disclosure,
refer to Section III.A.3 and Section III.A.4 of this rule,
respectively.
Comment: Most commenters believe foods on or containing ingredients
from either of the proposed lists of commercially available foods are
BE or contain BE ingredients, thereby requiring no additional
documentation. Many also believe AMS should not create recordkeeping
requirements for foods not on nor containing ingredients from either
list. Other feedback supports the proposed presumption foods on or
containing ingredients from either list are BE or contain BE
ingredients, unless the regulated entity maintains records to
demonstrate non-disclosure is appropriate.
AMS Response: AMS agrees that regulated entities may be able to
demonstrate compliance with the NBFDS for foods on or containing
ingredients from the consolidated List of Bioengineered Foods using
their customary business records. AMS contends that, for the purposes
of this rule, any food manufacturer, importer or retailer offering for
retail sale foods on the List of Bioengineered Foods is considered a
regulated entity. As stated in an earlier comment response, regulated
entities must maintain records on foods that trigger a BE disclosure
and must keep records to verify food without a disclosure is not
bioengineered. Section IV.A.1 further details AMS's position on
recordkeeping.
Comment: In the proposed rule, AMS provided flexibility to
responsible record keepers by enabling use of multiple documentation
sources. As such, several commenters asked that AMS incorporate
examples of appropriate records into final rule text. Suggested
examples include identity preserved (IP) certification, supplier
affidavits, continuing guarantees, and statements from suppliers.
Commenters also requested AMS clarify in the final regulation that
appropriate records to support non-disclosure when foods contain
ingredients from either list are not limited to testing results and
should include traceability records. For example, if a regulated entity
does not make a disclosure for a food containing a soy ingredient, it
could maintain supplier records demonstrating non-BE soybeans were used
in a product or records showing the soy ingredient accounts for less
than 0.9% of total product weight. The commenter suggested that by
recognizing traceability records are sufficient to support non-
disclosure, AMS would help ensure recordkeeping requirements are
consistent with records customary or reasonable to maintain in the food
industry. The commenter contended food manufacturers generally do not
maintain or receive from their suppliers testing records for
ingredients or finished foods that demonstrate presence or absence of
rDNA.
One commenter asserted AMS should clarify what ``supplier
attestations'' refers to when regulated entities opt not to disclose
under the rule, but choose to rely on such attestations. This input
suggests ``supplier attestations'' is intended to refer to contractual
documents, confirmations or other certifications entered into or
provided by suppliers, and does not require buyers to engage in
supplier verification programs for a marketing rather than food safety
standard which would impose significant costs and regulatory burdens.
Some commenters requested AMS clarify disclosure and recordkeeping
requirements for foods included on the commercially available, but not
highly adopted list, be more narrowly focused on cultivars directly the
result of bioengineering. More specifically, several commenters
highlighted the need for AMS to avoid consumer confusion and incorrect
labeling of certain cultivated varieties of apples by clarifying
correct application of the definition of cultivar.
A commenter urged AMS to adopt the 5% total BE food substance
option in the final rule as the threshold for exempting foods from BE
disclosure. Since records for BE status of ingredients, as well as
amounts of any ingredients present in a food already exist as common
business practice, this option would not present an excessive
recordkeeping or cost burden on regulated entities.
AMS Response: AMS appreciates the range of comments offering ways
to improve the information collection and recordkeeping processes. For
information regarding recordkeeping flexibilities, see our responses to
other comments in the Paperwork Reduction Act section. In addition,
Section IV.A.1 further details AMS's position on recordkeeping.
Comment: Commenters generally support many of the proposed rule's
recordkeeping and information collection requirements. Some, however,
identified requirements that would pose undue burden on entities;
others proposed ways AMS could minimize the burden. Several commenters
proposed AMS simplify recordkeeping requirements for food manufacturers
by establishing one consolidated list of BE foods. Some requested any
information necessary for verification of compliance be limited to
protect confidential business information like product formulations and
recipes. Since organic food processors and manufacturers regularly
secure written verification from ingredient suppliers that highly
refined sugars and oils are not derived from genetically engineered
crops or organisms, commenters from that industry contend stakeholders
across the food supply chain have already developed necessary
recordkeeping systems to provide this type of verification regarding
ingredients. Thus, including these types of ingredients under labeling
disclosure requirements would not introduce new burdens or
complications for the food industry.
Other commenters suggest it would be burdensome to require entities
provide specific attestation or testing
[[Page 65868]]
documentation from suppliers to confirm a highly adopted crop is BE
based on merely being on the list of highly adopted, commercially
available BE foods. Several other commenters believe 5 business days is
not a reasonable timeframe for companies to produce records to AMS on
the bioengineered status of a food/food ingredient; instead, they
suggest AMS should provide businesses four to six weeks to respond to
records requests. Some input explains the longer timeframe, consistent
with FDA's Menu Labeling requirements, recognizes the Disclosure
Standard is a marketing standard not requiring the priority of a health
and safety concern. Another commenter states maintaining records for
two years is burdensome for regulated entities, and suggests the final
rule should establish a one year maintenance period as is the case for
COOL.
Some commenters stated analytical testing to detect presence of
modified genetic material would present undue financial burden on the
industry and unnecessarily increase food prices without significantly
increasing reliability of proof in support of non-disclosure. Such
input encouraged AMS to allow recordkeeping to focus on traceability
and segregation, rather than analytical testing. Another commenter
states unless a ``non-GMO''-type claim is made about a food or
ingredient, manufacturers do not typically test for, nor maintain
documentation about, genetic material content. The testing is costly
when performed and it is cost-prohibitive to buy equipment and hire
skilled laboratory personnel for in-house testing. According to the
commenter, screening tests, which are less expensive, are often
unreliable or inappropriate for certain products.
If AMS decides to exempt refined ingredients from disclosure when
they do not contain modified genetic material, one commenter suggests
AMS establish and maintain a list of refined ingredients considered to
be devoid of modified genetic material. This list would significantly
reduce the burden on entities and eliminate the need for testing and
maintaining documentation to demonstrate an ingredient is refined.
Some commenters believe AMS efforts to align effective date of this
rule with compliance date for FDA's Nutrition Facts and Supplement
Facts label final rule will have limited effectiveness in reducing cost
and burden of this rule. In their view, implementation of this rule
will require completely separate cost and burden.
Some commenters request the proposed rule not require complicated
calculations to demonstrate if a food falls below the set threshold
level to be maintained. The commenters further explain dairy
manufacturers were subject to such requirements to demonstrate
compliance with Vermont's disclosure law. According to commenters,
these records were time-consuming and extremely burdensome to compile.
AMS Response: AMS appreciates the many comments submitted offering
ways to minimize the recordkeeping burden resulting from this rule, and
we have made changes to the final rule to reflect commenters input. We
consolidated the List of Bioengineered Foods to simplify recordkeeping
requirements. We agree that recordkeeping requirements under the NBFDS
should align with those under other AMS programs to minimize the
recordkeeping burden on regulated entities, and we have provided
recordkeeping flexibilities, as outlined in responses to previous
comments in this section.
B. E-Gov
USDA is committed to complying with the E-Government Act by
promoting the use of the internet and other information technologies to
provide increased opportunities for citizen access to Government
information and services, and for other purposes.
C. Civil Rights Review
AMS has considered the potential civil rights implications of this
rule on minorities, women, or persons with disabilities to ensure that
no person or group shall be discriminated against on the basis of race,
color, national origin, gender, religion, age, disability, sexual
orientation, marital or family status, political beliefs, parental
status, or protected genetic information. This review included persons
that are employees of the entities that are subject to these
regulations.
A 60-day comment period was provided to allow interested persons to
respond to the proposed rule. All written comments received in response
to the proposed rule by the date specified were considered. A number of
commenters expressed concern that the proposed labeling options were
discriminatory in some fashion. The major issue expressed was that the
lack of a smart phone would inhibit older, more rural, poorer, and/or
minority groups from being able to access bioengineering information
that is not visible and available directly on the packaging. Some
commenters argued that the USDA study, conducted by Deloitte, on access
to bioengineering disclosures using electronic and digital link
disclosures showed that the alternatives to on-package labeling (QR
codes, website URLs, text messaging numbers, and other alternatives)
will be ineffective and are discriminatory. A commenter cited a Pew
Research Center study from 2015 which purportedly shows that of the
U.S. citizens owning a smartphone at the time, 23% had to cancel or
suspend service due to financial constraints. The same study, being
cited by the same commenter, is said to show that ``African Americans
and Latinos are around twice as likely as whites to have canceled or
cut off their smartphone service.''
Other commenters argued that there are access problems even for
those who have a smartphone. Some asserted that where stores don't
provide internet access, it could be difficult for people to access
information provided by alternatives to on-package labeling. A
commenter pointed to the 2015 Pew Research data alleging that African
Americans have disproportionate functionality problems with
smartphones, some of which is related to ``running out of data during
the month.'' It was also pointed out that the Deloitte report showed
certain tribal lands had limited broadband capabilities, thus
preventing consumers in those areas from obtaining adequate access to
the BE disclosure outside of on-package labels.
This final rule does not require regulated entities to alter their
operations in ways that could adversely affect such persons or groups,
in a discriminatory fashion. Although the electronic or digital
disclosure option is mandated by the amended Act, the amended Act does
not require regulated entities to utilize that disclosure option.
Rather, the amended Act allows regulated entities to select a
disclosure method from among several options (text, symbol, electronic
or digital link, or text message). Regulated entities that select the
electronic or digital disclosure option must also provide options for
the consumer to access the BE disclosure, regardless of time of day, by
calling a phone number. Requiring the electronic or digital disclosure
to be accompanied by a telephone number that consumers may call to
access the BE disclosure provides the disclosure in an accessible
manner. Accordingly, this final rule offers several distinct avenues of
compliance for regulated entities that can be catered to the needs of
their consumers. Applying this approach does not deny any persons or
groups the benefits of the program or subject any persons or groups to
discrimination.
[[Page 65869]]
D. Executive Orders 12866, 13563, and 13771
USDA is issuing this rule in conformance with Executive Orders
12866 and 13563, which direct agencies to assess all costs and benefits
of available regulatory alternatives and, if regulation is necessary,
to select regulatory approaches that maximize net benefits, which
include potential economic, environmental, public health and safety
effects, distributive impacts, and equity. Executive Order 13563
emphasizes the importance of quantifying both costs and benefits,
reducing costs, harmonizing rules, and promoting flexibility.
USDA estimates that the costs of the NBFDS would range from $569
million to $3.9 billion for the first year, with ongoing annual costs
of between $51 million and $117 million. The annualized costs in
perpetuity would be $68 million to $234 million at a three percent
discount rate and $91 million to $391 million at a seven percent
discount rate.
These cost estimates represent the cost of the standard relative to
a baseline in which there are no requirements for the labeling of food
containing bioengineered foods or ingredients.
The NBFDS is not expected to have any benefits to human health or
the environment. Any benefits to consumers from the provision of
reliable information about BE food products are difficult to measure.
Under some, but not all, potentially informative analytic baselines
(see the accompanying regulatory impact analysis for this rule), a more
clear-cut benefit of the NBFDS is that it eliminates costly
inefficiencies of a state-level approach to BE disclosure. We estimate
the size of these benefits by focusing on Vermont's BE labeling law
because that law had been signed into law before the NBFDS was passed.
The annualized net benefit from replacing the Vermont BE labeling law
would be between $40 million and $49 million at a three percent
discount rate and between $70 million and $84 million at a seven
percent discount rate. This is our best estimate of these potential
benefits, but we note that there is uncertainty in these estimates
given the difficulty in predicting how implementation of the Vermont BE
labeling law would have occurred absent the prospect of a national
labeling law.
This rule meets the definition of an economically significant
regulatory action under Executive Order 12866, as it is likely to
result in a rule that would have an annual effect on the economy of
$100 million or more, and thereby triggers the requirements contained
in Executive Order 13771. See OMB's Memorandum titled ``Interim
Guidance Implementing Section 2 of the Executive Order of January 30,
2017, titled `Reducing Regulation and Controlling Regulatory
Costs'[thinsp]'' (February 2, 2017).
The status of the rule under Executive Order 13771 depends on its
costs relative to the regulatory requirements that would have applied
to the regulated community before enactment of the new Federal
standard. The analysis presented here finds that in comparison to a
state-level approach to mandatory BE labeling, the NBFDS would impose
less cost on the regulated community and would therefore be
deregulatory. While acknowledging the uncertainties associated with
estimating the magnitude of the actual reduction in costs, we use the
midpoint of the estimated net benefits as an approximation of the
primary estimate of annualized savings in perpetuity. This results in
an estimated annual savings of $77 million using a discount rate of
seven percent ($45 million using a discount rate of three percent).
E. Final Regulatory Flexibility Analysis
1. Introduction
We have examined the economic implications of this rule as required
by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a rule has
significant economic impact on a substantial number of small entities,
the Regulatory Flexibility Act requires agencies to analyze regulatory
options that would lessen the economic effect of the rule on small
entities consistent with statutory objectives. We have concluded that
the rule will not have a significant economic impact on a substantial
number of small entities.
2. Economic Effects on Small Entities
Guidance on rulemaking recommends SBA's definition of small
business as it applies to the relevant economic sector, which for this
rule are NAICS 311, 312, and 325, with indirect effects on sectors 115,
424, 445 and 446. SBA recently revised the definition for small
businesses. Under SBA's definition of small firms within the each 6-
digit NAICS code expected to be impacted by the rule--164,329, or 98
percent of 166,975 total firms. With the new SBA definitions of small
business, the share of potentially affected manufacturers now
classified as small is 96 percent (26,213 out of 27,176 total
manufacturing firms).
3. Definition of Small Business
The definition of small business for the Regulatory Flexibility
Analysis are those codified in 13 CFR 121.201.
4. Coordination of Definition of Small Food Manufacturers With FDA
Definition
For the purposes of the implementation of the delay for ``small
food manufacturers,'' AMS proposed that USDA adopt a definition of
small food manufacturer that would align with FDA. AMS has attempted to
be as consistent as possible with other similar existing regulations in
order to minimize the cost burden on the industry.
The definition of small food manufacturer is ``any food
manufacturer with annual receipts of at least $2,500,000, but less than
$10,000,000.'' This definition would be similar to FDA's criteria for
allowing an extended compliance period in its recent revision
requirements for food labeling (Docket numbers FDA-2012-N-1210 and FDA-
2004-N0258).
The final rule maintains this definition of small food
manufacturer.
This maintains consistency between the NBFDS and the FDA nutrition
labeling requirements. The delay provided to small food manufacturers
applies only to the initial compliance date. Where the final rule
provides additional time to use up existing label stock the deadline
for exercising this additional flexibility is the same for all
manufacturers regardless of size.
5. Exemptions for Very Small Food Manufacturers
AMS proposed to define very small food manufacturer as ``any food
manufacturer with annual receipts of less than $2,500,000.'' We also
analyzed the following scenarios for comparison:
Alternative A: A food manufacturer with less than $500,000 in
annual receipts.
Alternative B: A food manufacturer with less than $5,000,000 in
annual receipts.
Currently, there are roughly 18,530 businesses that would fall into
the very small category under the proposed definition; 11,170
businesses that would fall into the very small category under
Alternative A; and, 20,440 businesses that would fall into the very
small category under Alternative B. This is out of an estimated 27,176
total firms.
Table 3 presents data showing the number of establishments by size
classification according to the different definitions of very small,
small, and large manufacturers.
[[Page 65870]]
Table 3--Number of Manufacturers for Alternative Size Classifications
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Size classification options for manufacturers Number of firms
----------------------------------------------------------------------------------------------------------------
All manufacturing establishments................................ 27,176
----------------------------------------------------------------------------------------------------------------
Very small Small Large
----------------------------------------------------------------------------------------------------------------
Small Firm Criteria:
Firms with less than $10 million in annual food sales (FDA N/A 23,029 4,147
definition)................................................
Very Small Firm Alternatives:
Very small alternative A:
Firms with less than $500,000 in annual receipts............ 11,527 11,502 4,147
Very small alternative B:
Firms with less than $5,000,000 in annual receipts.......... 21,581 1,448 4,147
Very small proposed definition:
Firms with less than $2,500,000 in annual receipts.......... 19,455 3,574 4,147
----------------------------------------------------------------------------------------------------------------
6. Costs to Small Entities
We compared the maximum annualized cost in our analysis of the rule
to the revenue of firms in each size category (by receipts) using 2012
Census data. There was no covered size category of firms for which
costs were greater than one percent of revenues.
7. Summary
Under the Regulatory Flexibility Act (5 U.S.C. 606(b)), we conclude
that the rule will not have a significant economic impact on a
substantial number of small entities. The statutory exemption of very
small food manufacturers further reduces the impact on the entities
that are likely to face the highest costs relative to revenue.
F. Executive Order 13175
This rule has been reviewed in accordance with the requirements of
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments. Executive Order 13175 requires Federal agencies to consult
and coordinate with tribes on a government-to-government basis on: (1)
Policies that have tribal implications, including regulations,
legislative comments or proposed legislation; and (2) other policy
statements or actions that have substantial direct effects on one or
more Indian tribes, on the relationship between the Federal Government
and Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.
AMS has assessed the impact of this rule on Indian tribes and
determined that this rule would not, to our knowledge, have tribal
implications that require tribal consultation under E.O. 13175. AMS
hosts a quarterly teleconference with Tribal Leaders where matters of
mutual interest regarding the marketing of agricultural products are
discussed. Information about the congressionally mandated NBFDS was
shared during those quarterly calls, and Tribal leaders were invited to
provide input into the development of the new national Standard. As
well, in the NPRM that was published on May 4, 2018 (83 FR 19860), AMS
invited Tribal Leaders to consult on the Tribal implications of the
proposed rule. AMS received no requests for a consultation. On June 21,
2018, AMS hosted a quarterly conference call with Tribal
representatives to update them on upcoming policies, regulations,
programs, and services that could have a substantial effect on or
benefit to Tribes. During the call, AMS provided fourteen (14) Tribal
representatives with an overview of the proposed rule and extended
opportunities for questions or requests for more information. At that
time, none were expressed.
On July 3, 2018, the comment period for the proposed rule closed.
None of the approximately 14,000 responses received on the NPRM were
identified as being submitted from Tribal representatives. AMS did
receive public comments in response to the NPRM's request for input
about the use of electronic or digital disclosures to convey
information about bioengineered food content to consumers. Commenters
asserted that Native Americans, along with elderly Americans and other
U.S. minority populations, may lack adequate access to smartphone
technology that would enable them to use electronic or digital
disclosures. The Secretary acknowledged this potential lack and
determined to provide a comparable bioengineered food disclosure option
to allow greater access to food information for all consumers. Such
provision is made in Sec. 66.108 of the final rule.
Based on the above, AMS has concluded that this final rule will not
have Tribal implications that require a consultation. In implementing
the final rule, AMS will develop and deliver outreach and education for
and to all regulated entities. In addition, AMS will work with the
Office of Tribal Relations to ensure ongoing meaningful consultation is
provided, where needed or requested. If a tribe requests consultation,
AMS will work with the USDA Office of Tribal Relations to ensure
meaningful consultation is provided where changes, additions, and
modifications identified herein are not expressly mandated by Congress.
G. Executive Order 12988
This final rule has been reviewed under Executive Order 12988,
Civil Justice Reform. The final rule is not intended to have
retroactive effect. The amended Act specifies that 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 or
disclosure of whether a food is bioengineered or was developed or
produced using bioengineering for a food subject to the national
bioengineered food disclosure standard that is not identical to the
mandatory disclosure requirements under that standard. With regard to
other Federal statutes, all labeling claims made in conjunction with
this regulation must be consistent with other applicable Federal
requirements. There are no administrative procedures that must be
exhausted prior to any judicial challenge to the provisions of this
rule.
H. Executive Order 13132
This rule has been reviewed under Executive Order 13132,
Federalism. Executive Order 13132 directs agencies to construe, in
regulations and otherwise, a Federal statute to preempt State law only
where the statute contains an express preemption provision or there is
some other clear evidence to conclude that Congress
[[Page 65871]]
intended preemption of State law, or where the exercise of State
authority conflicts with the exercise of Federal authority under the
Federal statute. The amended Act includes an express preemption of
State law. Sections 293(e) and 295(b) provide that no State may
directly or indirectly establish or continue with any food or seed
requirement relating to the labeling or disclosure of whether the food
or seed is bioengineered or was developed or produced using
bioengineering, including any requirement for claims that a food or
seed is or contains an ingredient that was developed by or produced
using bioengineering.
Upon establishment of the NBFDS, States may adopt standards that
are identical to the NBFDS, and States may impose remedies for
violations of their standards, such as monetary damages and injunctive
relief.
With regard to consultation with States, as directed by Executive
Order 13132, USDA notified the governors of each U.S. State of the
amended Act's purpose and preemption provisions by letter in August
2016. Copies of the letters may be viewed at https://www.ams.usda.gov/rules-regulations/be.
List of Subjects in 7 CFR Part 66
Agricultural commodities, Bioengineering, Food labeling, Reporting
and recordkeeping requirements.
0
For the reasons set forth in the preamble, 7 CFR chapter I is amended
by adding part 66 to read as follows:
PART 66--NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARD
Subpart A--General Provisions
Sec.
66.1 Definitions.
66.3 Disclosure requirement and applicability.
66.5 Exemptions.
66.6 List of Bioengineered Foods.
66.7 Updates to the List of Bioengineered Foods.
66.9 Detectability.
66.11 Severability.
66.13 Implementation and compliance.
Subpart B--Bioengineered Food Disclosure
66.100 General.
66.102 Text disclosure.
66.104 Symbol disclosure.
66.106 Electronic or digital link disclosure.
66.108 Text message disclosure.
66.109 Required disclosure with actual knowledge.
66.110 Small food manufacturers.
66.112 Small and very small packages.
66.114 Food sold in bulk containers.
66.116 Voluntary disclosure.
66.118 Other claims.
Subpart C--Other Factors and Conditions for Bioengineered Food
66.200 Request or petition for determination.
66.202 Standards for consideration.
66.204 Submission of request or petition.
Subpart D--Recordkeeping
66.300 Scope.
66.302 Recordkeeping requirements.
66.304 Access to records.
Subpart E--Enforcement
66.400 Prohibited act.
66.402 Audit or examination of records.
66.404 Hearing.
66.406 Summary of results.
Authority: 7 U.S.C. 1621 et seq.
Subpart A--General Provisions
Sec. 66.1 Definitions.
Act means the Agricultural Marketing Act of 1946 (7 U.S.C. 1621 et
seq.), as amended to include Subtitle E--National Bioengineered Food
Disclosure Standard and Subtitle F--Labeling of Certain Food.
Administrator means the Administrator of the Agricultural Marketing
Service, United States Department of Agriculture, or the representative
to whom authority has been delegated to act in the stead of the
Administrator.
AMS means the Agricultural Marketing Service of the United States
Department of Agriculture.
Bioengineered food means--
(1) Subject to the factors, conditions, and limitations in
paragraph (2) of this definition:
(i) 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
(ii) Such a food does not contain modified genetic material if the
genetic material is not detectable pursuant to Sec. 66.9.
(2) A food that meets one of the following factors and conditions
is not a bioengineered food.
(i) An incidental additive present in food at an insignificant
level and that does not have any technical or functional effect in the
food, as described in 21 CFR 101.100(a)(3).
(ii) [Reserved]
Bioengineered substance means substance 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.
Compliance date means--
(1) Mandatory compliance date. Entities responsible for
bioengineered food disclosure must comply with the requirements of this
part by January 1, 2022.
(2) Updates to the List of Bioengineered Foods. When AMS updates
the List of Bioengineered Foods pursuant to Sec. 66.7, entities
responsible for bioengineered food disclosures must comply with the
updates no later than 18 months after the effective date of the update.
Food means 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.
Food manufacturer means an entity that manufactures, processes, or
packs human food and labels the food or food product for U.S. retail
sale.
Importer means the importer of record, as determined by U.S.
Customs and Border Protection (19 U.S.C. 1484(a)(2)(B)), who engages in
the importation of food or food products labeled for retail sale into
the United States.
Information panel means that part of the label of a packaged
product that is immediately contiguous to and to the right of the
principal display panel as observed by an individual facing the
principal display panel, unless another section of the label is
designated as the information panel because of package size or other
package attributes (e.g. irregular shape with one usable surface).
Label means a display of written, printed, or graphic matter upon
the immediate container or outside wrapper of any retail package or
article that is easily legible on or through the outside container or
wrapper.
Labeling means all labels and other written, printed, or graphic
matter:
(1) Upon any article or any of its containers or wrappers; or
(2) Accompanying such article.
List of Bioengineered Foods means a list, maintained and updated by
AMS and provided in Sec. 66.6, of foods for which bioengineered
versions have been developed.
Marketing and promotional information means any written, printed,
audiovisual, or graphic information, including advertising, pamphlets,
flyers, catalogues, posters, and signs that are distributed, broadcast,
or made available to assist in the sale or promotion of a product.
Predominance means an ingredient's position in the ingredient list
on a product's label. Predominant ingredients are those most abundant
by weight in the product, as required under 21 CFR 101.4(a)(1).
[[Page 65872]]
Principal display panel means that part of a label that is most
likely to be displayed, presented, shown, or examined under customary
conditions of display for retail sale.
Processed food means any food other than a raw agricultural
commodity, and includes any raw agricultural commodity that has been
subject to processing, such as canning, cooking, freezing, dehydration,
or milling.
Raw agricultural commodity means any agricultural commodity in its
raw or natural state, including all fruits that are washed, colored, or
otherwise treated in their unpeeled natural form prior to marketing.
Regulated entity means the food manufacturer, importer, or retailer
that is responsible for making bioengineered food disclosures under
Sec. 66.100(a).
Secretary means the United States Secretary of Agriculture or a
representative to whom authority has been delegated to act in the
Secretary's stead.
Similar retail food establishment means a cafeteria, lunch room,
food stand, food truck, transportation carrier (such as a train or
airplane), saloon, tavern, bar, lounge, other similar establishment
operated as an enterprise engaged in the business of selling prepared
food to the public, or salad bars, delicatessens, and other food
enterprises located within retail establishments that provide ready-to-
eat foods that are consumed either on or outside of the retailer's
premises.
Small food manufacturer means any food manufacturer with annual
receipts of at least $2,500,000, but less than $10,000,000.
Small package means food packages that have a total surface area of
less than 40 square inches.
Very small food manufacturer means any food manufacturer with
annual receipts of less than $2,500,000.
Very small package means food packages that have a total surface
area of less than 12 square inches.
Sec. 66.3 Disclosure requirement and applicability.
(a) General. (1) A label for a bioengineered food must bear a
disclosure indicating that the food is a bioengineered food or contains
a bioengineered food ingredient consistent with this part.
(2) Except as provided in Sec. 66.116 for voluntary disclosure, a
label shall not bear a disclosure that a food is a bioengineered food
or contains a bioengineered food ingredient if the records maintained
in accordance with Sec. 66.302 demonstrate that the food is not a
bioengineered food or does not contain a bioengineered food ingredient.
(b) Application to food. This part applies only to a food subject
to:
(1) The labeling requirements under the Federal Food, Drug, and
Cosmetic Act (``FDCA''); or
(2) The labeling requirements under the Federal Meat Inspection
Act, the Poultry Products Inspection Act, or the Egg Products
Inspection Act only if:
(i) The most predominant ingredient of the food would independently
be subject to the labeling requirements under the FDCA; or
(ii) The most predominant ingredient of the food is broth, stock,
water, or a similar solution and the second-most predominant ingredient
of the food would independently be subject to the labeling requirements
under the FDCA.
Sec. 66.5 Exemptions.
This part shall not apply to the food and entities described in
this section.
(a) Food served in a restaurant or similar retail food
establishment.
(b) Very small food manufacturers.
(c) A food in which no ingredient intentionally contains a
bioengineered (BE) substance, with an allowance for inadvertent or
technically unavoidable BE presence of up to five percent (5%) for each
ingredient.
(d) A food derived from an animal shall not be considered a
bioengineered food solely because the animal consumed feed produced
from, containing, or consisting of a bioengineered substance.
(e) Food certified under the National Organic Program.
Sec. 66.6 List of Bioengineered Foods.
The List of Bioengineered Foods consists of the following: Alfalfa,
apple (Arctic\TM\ varieties), canola, corn, cotton, eggplant (BARI Bt
Begun varieties), papaya (ringspot virus-resistant varieties),
pineapple (pink flesh varieties), potato, salmon
(AquAdvantage[supreg]), soybean, squash (summer), and sugarbeet.
Sec. 66.7 Updates to the List of Bioengineered Foods.
(a) Updates to the List. AMS will review and consider updates to
the List on an annual basis and will solicit recommendations regarding
updates to the List through notification in the Federal Register and on
the AMS website.
(1) Recommendations regarding additions to and subtractions from
the List may be submitted to AMS at any time or as part of the annual
review process.
(2) Recommendations should be accompanied by data and other
information to support the recommended action.
(3) AMS will post public recommendations on its website, along with
information about other revisions to the List that the agency may be
considering, including input based on consultation with the government
agencies responsible for oversight of the products of biotechnology:
USDA's Animal and Plant Health Inspection Service (USDA-APHIS), the
U.S. Environmental Protection Agency (EPA), and the Department of
Health and Human Services' Food and Drug Administration (FDA), and
appropriate members of the Coordinated Framework for the Regulation of
Biotechnology or a similar successor.
(4) AMS will consider whether foods proposed for inclusion on the
List have been authorized for commercial production somewhere in the
world, and whether the food is currently in legal commercial production
for human food somewhere in the world.
(5) If AMS determines that an update to the List is appropriate
following its review of all relevant information provided, AMS will
modify the List.
(b) Compliance period. Regulated entities will have 18 months
following the effective date of the updated List of Bioengineered Foods
to revise food labels to reflect changes to the List in accordance with
the disclosure requirements of this part.
Sec. 66.9 Detectability.
(a) Recordkeeping requirements. Modified genetic material is not
detectable if, pursuant to the recordkeeping requirements of Sec.
66.302, the entity responsible for making a BE food disclosure
maintains:
(1) Records to verify that the food is sourced from a non-
bioengineered crop or source; or
(2) Records to verify that the food has been subjected to a
refinement process validated to make the modified genetic material in
the food undetectable; or
(3) Certificates of analysis or other records of testing
appropriate to the specific food that confirm the absence of modified
genetic material.
(b) Validated refining process. (1) Analytical testing that meets
the standards described in paragraph (c) of this section must be used
to validate that a refining process renders modified genetic material
in a food undetectable.
(2) Once a refining process has been so validated, additional
testing is not necessary to confirm the absence of detectable modified
genetic material in food subsequently refined through that process,
provided that no significant changes are made to the validated
[[Page 65873]]
process and provided that records are maintained to demonstrate that
the refining process has been validated and that the validated refining
process is followed.
(c) Standards of performance for detectability testing. Analytical
testing for purposes of detecting the presence of modified genetic
material in refined foods pursuant to paragraph (a) of this section
shall meet the following standard:
(1) Laboratory quality assurance must ensure the validity and
reliability of test results;
(2) 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;
(3) The demonstration of testing validity must ensure consistent
accurate analytical performance; and
(4) Method performance specifications must ensure analytical tests
are sufficiently sensitive for the purposes of the detectability
requirements of this part.
Sec. 66.11 Severability.
If any provision of this part is declared invalid or the
applicability thereof to any person or circumstances is held invalid,
the validity of the remainder of this part or the applicability thereof
to other persons or circumstances shall not be affected thereby.
Sec. 66.13 Implementation and compliance.
(a) Implementation. Except for small food manufacturers, the
implementation date for this part is January 1, 2020. For small food
manufacturers, the implementation date is January 1, 2021.
(b) Voluntary compliance. (1) Regulated entities may voluntarily
comply with the requirements in this part until December 31, 2021.
(2) During this period, regulated entities may use labels that meet
requirements of preempted State labeling regulations for genetically
engineered food. Stickers or ink stamps may be applied to existing
labels to provide appropriate bioengineered food disclosures provided
that the stickers or ink stamps do not obscure other required label
information.
(c) Mandatory compliance. All regulated entities must comply with
the requirements of this part beginning on January 1, 2022.
Subpart B--Bioengineered Food Disclosure
Sec. 66.100 General.
(a) Responsibility for disclosure. (1) For a food that is packaged
prior to receipt by a retailer, the food manufacturer or importer is
responsible for ensuring that the food label bears a bioengineered food
disclosure in accordance with this part.
(2) If a retailer packages a food or sells a food in bulk, that
retailer is responsible for ensuring that the food bears a
bioengineered food disclosure in accordance with this part.
(b) Type of disclosure. If a food must bear a bioengineered food
disclosure under this part, the disclosure must be in one of the forms
described in this paragraph (b), except as provided in Sec. Sec.
66.110 and 66.112.
(1) A text disclosure in accordance with Sec. 66.102.
(2) A symbol disclosure in accordance with Sec. 66.104.
(3) An electronic or digital link disclosure in accordance with
Sec. 66.106.
(4) A text message disclosure in accordance with Sec. 66.108.
(c) Appearance of disclosure. The required disclosure must be of
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.
(d) Placement of the disclosure. Except as provided in Sec. 66.114
for bulk food, the disclosure must be placed on the label in one of the
manners described in this paragraph (d).
(1) The disclosure is placed in the 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) The disclosure is placed in the principal display panel.
(3) The disclosure is placed in an alternate panel likely to be
seen by a consumer under ordinary shopping conditions if there is
insufficient space to place the disclosure on the information panel or
the principal display panel.
(e) Uniform Resource Locator (URL). Except for disclosures made by
small manufacturers and for disclosures on very small packages, a
bioengineered food disclosure may not include an internet website URL
that is not embedded in an electronic or digital link.
Sec. 66.102 Text disclosure.
A text disclosure must bear the text as described in this section.
A text disclosure may use a plural form if applicable, e.g. if a food
product includes more than one bioengineered food, then ``bioengineered
foods'' or ``bioengineered food ingredients'' may be used.
(a) Bioengineered foods. If a food (including any ingredient
produced from such food) is on the List of Bioengineered Foods, and
records maintained by a regulated entity demonstrate that the food is
bioengineered, the text disclosure must be one of the following, as
applicable:
(1) ``Bioengineered food'' for bioengineered food that is a raw
agricultural commodity or processed food that contains only
bioengineered food ingredients; or
(2) ``Contains a bioengineered food ingredient'' for multi-
ingredient food that is not described in paragraph (a)(1) of this
section but contains one or more bioengineered food ingredients.
(b) Predominant language in U.S. Food subject to disclosure that is
distributed solely in a U.S. territory may be labeled with statements
equivalent to those required in this part, using the predominant
language used in that territory.
Sec. 66.104 Symbol disclosure.
A symbol disclosure must replicate the form and design of Figure 1
to this section.
(a) The symbol is a circle with a green circumference, and a white
outer band. The bottom portion of the circle contains an arch, filled
in green to the bottom of the circle. The arch contains two light green
terrace lines, sloping downward from left to right. On the left side of
the arch is a stem arching towards the center of the circle, ending in
a four-pointed starburst. The stem contains two leaves originating on
the upper side of the stem and pointing towards the top of the circle.
In the background of the leaves, at the top of the circle and to the
left of center, is approximately one-half of a circle filled in yellow.
The remainder of the circle is filled in light blue. The symbol must
contain the words ``BIOENGINEERED.''
(b) If a food (including any ingredient produced from such food) is
on the List of Bioengineered Foods, and records maintained by a
regulated entity demonstrate that the food is bioengineered, or do not
demonstrate whether the food is bioengineered, the symbol disclosure
must be the following:
[[Page 65874]]
[GRAPHIC] [TIFF OMITTED] TR21DE18.000
(c) The symbol may be printed in black and white.
(d) Nothing can be added to or removed from the bioengineered food
symbol design except as allowed in this part.
Sec. 66.106 Electronic or digital link disclosure.
If a required bioengineered food disclosure is made through an
electronic or digital link printed on the label, the disclosure must
comply with the requirements described in this section.
(a) Accompanying statement. (1) An electronic or digital disclosure
must be accompanied by, and be placed directly above or below, this
statement: ``Scan here for more food information'' or equivalent
language that only reflects technological changes (e.g., ``Scan
anywhere on package for more food information'' or ``Scan icon for more
food information'').
(2) The electronic or digital disclosure must also be accompanied
by a telephone number that will provide the bioengineered food
disclosure to the consumer, regardless of the time of day. The
telephone number instructions must be in close proximity to the digital
link and the accompanying statement described in paragraph (a)(1) of
this section, must indicate that calling the telephone number will
provide more food information, and must be accompanied by the statement
``Call [1-000-000-0000] for more food information.''
(b) Product information page. When the electronic or digital link
is accessed, the link must go directly to the product information page
for display on the electronic or digital device. The product
information page must comply with the requirements described in this
paragraph (b).
(1) The product information page must be the first screen to appear
on an electronic or digital device after the link is accessed as
directed.
(2) The product information page must include a bioengineered food
disclosure that is consistent with Sec. 66.102 or Sec. 66.104.
(3) The product information page must exclude marketing and
promotional information.
(4) The electronic or digital link disclosure may not collect,
analyze, or sell any personally identifiable information about
consumers or the devices of consumers; however, if this information
must be collected to carry out the purposes of this part, the
information must be deleted immediately and not used for any other
purpose.
Sec. 66.108 Text message disclosure.
The regulated entity must not charge a person any fee to access the
bioengineered food information through text message and must comply
with the requirements described in this section.
(a) The label must include this statement ``Text [command word] to
[number] for bioengineered food information.'' The number must be a
number, including a short code, that sends an immediate response to the
consumer's mobile device.
(b) The response must be a one-time response and the only
information in the response must be the appropriate bioengineered food
disclosure described in Sec. 66.102 or Sec. 66.116.
(c) The response must exclude marketing and promotional
information.
(d) A regulated entity that selects the text message option must
comply with the requirements of this paragraph (d).
(1) The regulated entity must not collect, analyze, or sell any
personally identifiable information about consumers or the devices of
consumers.
(2) The regulated entity must not use any information related to
the text message option for any marketing purposes.
(3) If any information must be collected to carry out the purposes
of this part, the information must be deleted as soon as possible and
not be used for any other purpose.
Sec. 66.109 Required disclosure with actual knowledge.
Notwithstanding any provision in this subpart, if a food
manufacturer (other than a very small food manufacturer), a retailer,
or an importer has actual knowledge that the food is a bioengineered
food or contains a bioengineered food ingredient, it must disclose that
the food is bioengineered or contains a bioengineered food ingredient,
as applicable, using appropriate text, symbol, electronic or digital
link disclosure, or text message.
Sec. 66.110 Small food manufacturers.
A small food manufacturer must make the required bioengineered food
disclosure using one of the bioengineered food disclosure options
permitted under Sec. Sec. 66.102, 66.104, 66.106, and 66.108 or as
described in this section.
(a) The label bears the statement: ``Call for more food
information,'' which accompanies a telephone number that will provide
the bioengineered food disclosure to the consumer, regardless of the
time of day. Disclosure via telephone number must include a
bioengineered food disclosure that is consistent with Sec. 66.102 in
audio form and may be pre-recorded.
(b) The label bears the statement: ``Visit [URL of the website] for
more food information,'' which accompanies a website that meets the
requirements of Sec. 66.106(b). Disclosure via website must include a
bioengineered food disclosure that is consistent with Sec. 66.102 or
Sec. 66.104 in written form.
Sec. 66.112 Small and very small packages.
In addition to the disclosures described in this subpart, for food
in small and very small packages, the required disclosure may be in the
form described in paragraph (a), (b), or (c) of this section.
(a) The label bears the electronic or digital disclosure described
in Sec. 66.106, and replaces the statement and phone number required
in Sec. 66.106(a) with the statement ``Scan for info.''
(b) The label bears a number or short code as described in Sec.
66.108(a), and replaces the statement with ``Text for info.''
(c) The label bears a phone number as described in Sec. 66.110(a),
and replaces the statement with ``Call for info.''
(d) For very small packages only, if the label includes a
preexisting Uniform Resource Locator for a website or a telephone
number that a consumer can use to obtain food information, that website
or telephone number may also be used for the required bioengineered
food disclosure, provided that the disclosure is consistent with Sec.
66.102 or Sec. 66.104 in written or audio form, as applicable.
Sec. 66.114 Food sold in bulk containers.
(a) Bioengineered food sold in bulk containers (e.g., display case,
bin, carton, and barrel), used at the retail level to present product
to consumers, including a display at a fresh seafood counter, must use
one of the disclosure options described in Sec. 66.102, Sec. 66.104,
Sec. 66.106, or Sec. 66.108.
(b) The disclosure must appear on signage or other materials (e.g.,
placard, sign, label, sticker, band, twist tie, or other similar
format) that allows consumers to easily identify and understand the
bioengineered status of the food.
Sec. 66.116 Voluntary disclosure.
(a) Disclosure of bioengineered food by exempt entities. If a food
on the List of Bioengineered Foods is subject to
[[Page 65875]]
disclosure, a very small food manufacturer, restaurant, or similar
retail food establishment may voluntarily provide that disclosure. The
disclosure must be in one or more of the forms described in this
paragraph (a).
(1) A text disclosure, in accordance with Sec. 66.102.
(2) A symbol disclosure, in accordance with Sec. 66.104.
(3) An electronic or digital link disclosure, in accordance with
Sec. 66.106.
(4) A text message disclosure, in accordance with Sec. 66.108.
(5) Appropriate small manufacturer and small and very small package
disclosure options, in accordance with Sec. Sec. 66.110 and 66.112.
(b) Disclosure of foods derived from bioengineering. For foods or
food ingredients that do not meet paragraph (1) of the definition of
bioengineered food in Sec. 66.1, that do not qualify as a factor or
condition under paragraph (2) of the definition of bioengineered food
in Sec. 66.1, that are not exempt from disclosure under Sec. 66.5,
and that are derived from a food on the List of Bioengineered Foods,
regulated entities may disclose such foods with one of the disclosures
described in this paragraph (b).
(1) A text disclosure with the following statement: ``derived from
bioengineering'' or ``ingredient(s) derived from a bioengineered
source.'' The word ``ingredient(s)'' may be replaced with the name of
the specific crop(s) or food ingredient(s).
(2) A symbol disclosure using the following symbol:
[GRAPHIC] [TIFF OMITTED] TR21DE18.001
(3) An electronic or digital link disclosure, in accordance with
Sec. 66.106, provided that the disclosure is the text described in
paragraph (b)(1) of this section or the symbol in Figure 1 to this
section.
(4) A text message disclosure, in accordance with Sec. 66.108,
provided that the response is the text described in paragraph (b)(1) of
this section or the symbol in Figure 1 to this section.
(5) Appropriate small manufacturer and small and very small package
disclosure options, in accordance with Sec. Sec. 66.110 and 66.112,
provided that the disclosure is the text described in paragraph (b)(1)
of this section or the symbol in Figure 1 to this section.
(c) Appearance of disclosure. The disclosure should be of
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.
(d) Recordkeeping. Reasonable and customary records should be
maintained to verify disclosures made under this section, in accordance
with Sec. 66.302.
Sec. 66.118 Other claims.
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.
Subpart C--Other Factors and Conditions for Bioengineered Food
Sec. 66.200 Request or petition for determination.
(a) Any person may submit a request or petition for a determination
by the Administrator regarding other factors and conditions under which
a food is considered a bioengineered food. A request or petition must
be submitted in accordance with Sec. 66.204.
(b) The request or petition may be supplemented, amended, or
withdrawn in writing at any time without prior approval of the
Administrator, and without affecting resubmission, except when the
Administrator has responded to the request or petition.
(c) If the Administrator determines that the request or petition
satisfies the standards for consideration in Sec. 66.202, AMS will
initiate a rulemaking that would amend the definition of
``bioengineered food'' in Sec. 66.1 to include the requested factor or
condition.
(d) The Administrator's determination that the request or petition
does not satisfy the standards for consideration in Sec. 66.202
constitutes final agency action for purposes of judicial review.
Sec. 66.202 Standards for consideration.
In evaluating a request or petition, the Administrator must apply
the applicable standards described in this section.
(a) The requested factor or condition is within the scope of the
definition of ``bioengineering'' in 7 U.S.C. 1639(1).
(b) The Administrator must evaluate the difficulty and cost of
implementation and compliance related to the requested factor or
condition.
(c) The Administrator may consider other relevant information,
including whether the requested factor or condition is compatible with
the food labeling requirements of other agencies or countries, as part
of the evaluation.
Sec. 66.204 Submission of request or petition.
(a) Submission procedures and format. A person must submit the
request to the Agricultural Marketing Service in the form and manner
established by AMS.
(b) Required information. The request or petition must include the
information described in this paragraph (b).
(1) Description of the requested factor or condition.
(2) Analysis of why the requested factor or condition should be
included in considering whether a food is a bioengineered food,
including any relevant information, publications, and/or data. The
analysis should include how the Administrator should apply the
standards for consideration in Sec. 66.202.
(3) If the request or petition contains Confidential Business
Information (CBI), the submission must comply with the requirements of
this paragraph (b)(3).
(i) The requester or petitioner must submit one copy that is marked
as ``CBI Copy'' on the first page and on each page containing CBI.
(ii) The requester or petitioner must submit a second copy with the
CBI deleted. This copy must be marked as ``CBI Redacted'' on the first
page and on each page where the CBI was deleted.
(iii) The submission must include an explanation as to why the
redacted information is CBI.
Subpart D--Recordkeeping
Sec. 66.300 Scope.
This subpart applies to records regarding mandatory and voluntary
disclosures under this part for foods offered for retail sale in the
United States.
Sec. 66.302 Recordkeeping requirements.
(a) General. (1) Regulated entities must maintain records that are
customary or reasonable to demonstrate compliance with the disclosure
requirements of this part.
(2) The records must be in electronic or paper formats and must
contain sufficient detail as to be readily understood and audited by
AMS.
(3) Records must be maintained for at least two years beyond the
date the food or food product is sold or distributed for retail sale.
(4) Examples of customary or reasonable records that could be used
to demonstrate compliance with the disclosure requirements of this part
include, but are not limited to: Supply chain records, bills of lading,
invoices, supplier attestations, labels, contracts,
[[Page 65876]]
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.
(b) Recordkeeping requirements. (1) If a food (including an
ingredient produced from such food) is on the List of Bioengineered
Foods, the regulated entity must maintain records regarding that food
or food ingredient.
(2) If a food (including an ingredient produced from such food)
bears a bioengineered food disclosure based on actual knowledge and is
not on the List of Bioengineered Foods, regulated entities must
maintain records for such food or food ingredient.
Sec. 66.304 Access to records.
(a) Request for records. When AMS makes a request for records, the
entity must provide the records to AMS within five (5) business days,
unless AMS extends the deadline.
(b) On-site access. If AMS needs to access the records at the
entity's place of business, AMS will provide prior notice of at least
three (3) business days. AMS will examine the records during normal
business hours, and the records will be made available during those
times. Access to any necessary facilities for an examination of the
records must be extended to AMS.
(c) Failure to provide access. If the entity fails to provide
access to the records as required under this section, the result of the
audit or examination of records will be that the entity did not comply
with the requirement to provide access to records and that AMS could
not confirm whether the entity is in compliance with the bioengineered
food disclosure standard for purposes of Sec. 66.402.
Subpart E--Enforcement
Sec. 66.400 Prohibited act.
It is a violation of 7 U.S.C. 1639b for any person to knowingly
fail to make a bioengineered food disclosure in accordance with this
part.
Sec. 66.402 Audit or examination of records.
(a) Any interested person who has knowledge of or information
regarding a possible violation of this part may file a written
statement or complaint with the Administrator.
(1) Written statements or complaints filed with the Administrator
must include the following:
(i) Complete identifying information about the product in question;
(ii) A detailed explanation of the alleged regulatory violation;
and
(iii) Name and contact information of the person filing the
statement or complaint.
(2) Written statements or complaints should be addressed to
Director, Food Disclosure and Labeling Division, AMS Fair Trade
Practices Program, 1400 Independence Avenue SW, Washington, DC 20250;
or submitted through the NBFDS Compliance Portal on the AMS website at
https://www.ams.usda.gov/be.
(3) The Administrator will determine whether reasonable grounds
exist for an investigation of such complaint.
(b) If the Administrator determines that further investigation of a
complaint is warranted, an audit, examination, or similar activity may
be conducted with respect to the records of the entity responsible for
the disclosures.
(c) Notice regarding records audits or examinations or similar
activities will be provided in accordance with Sec. 66.304(a) and (b).
(d) At the conclusion of the audit or examination of records or
similar activity, AMS will make the findings available to the entity
that was the subject of the investigation.
(e) If the entity that is the subject of the audit or examination
of records or similar activity objects to any findings, it may request
a hearing in accordance with Sec. 66.404.
Sec. 66.404 Hearing.
(a) Within 30 days of receiving the results of an audit or
examination of records or similar activity to which the entity that was
the subject of the investigation objects, the entity may request a
hearing by filing a request, along with the entity's response to the
findings and any supporting documents, with AMS.
(b) The response to the findings of the audit or examination of
records or similar activity must identify any objection to the findings
and the basis for the objection.
(c) The AMS Administrator or designee will review the findings of
the audit or examination of records or similar activity, the response,
and any supporting documents, and may allow the entity that was the
subject of the investigation to make an oral presentation.
(d) At the conclusion of the hearing, the AMS Administrator or
designee may revise the findings of the audit or examination of records
or similar activity.
Sec. 66.406 Summary of results.
(a) If the entity that was the subject of the audit or examination
of records or similar activity does not request a hearing in accordance
with Sec. 66.404, or at the conclusion of a hearing, AMS will make
public the summary of the final results of the investigation.
(b) AMS's decision to make public the summary of the final results
constitutes final agency action for purposes of judicial review.
Dated: December 12, 2018.
Erin Morris,
Associate Administrator.
[FR Doc. 2018-27283 Filed 12-20-18; 8:45 am]
BILLING CODE P