65814 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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. 

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: 

Arthur.Neal@usda.gov; 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-inputbioengineered-food-disclosurequestions) 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 65815 

1The 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. 

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 § 66.116, 

based on records maintained under 

§ 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. 

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, 


amozie on DSK3GDR082PROD with RULES2
65816 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 § 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 

§ 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 

§ 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 § 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 § 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 nonbioengineered crop or other food source, 

such as non-bioengineered salmon. 

Second, as provided in § 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 

§ 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 § 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 § 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 


amozie on DSK3GDR082PROD with RULES2
65818 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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. 3Economic 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-theus.aspx, accessed February 5, 2018. 

4Statistics Canada, https://www.statcan.gc.ca/ 

eng/start, accessed July 26, 2018. 

5 ISAAA GM Approval Database: http://

www.isaaa.org/gmapprovaldatabase/. Accessed 

August 10, 2018. 

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 § 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 § 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. 

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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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. 

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 (ArcticTM

varieties), canola, corn, cotton, eggplant 

(BARI Bt Begun varieties), papaya 

(ringspot virus-resistant varieties), 

pineapple (pink flesh), potato, salmon 

(AquAdvantage®), 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., nonbrowning, 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 § 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 § 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 § 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 


amozie on DSK3GDR082PROD with RULES2
65820 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 § 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 § 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, § 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 § 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. 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 

§ 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: 

Æ 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. 

Æ 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. 

Æ 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 


amozie on DSK3GDR082PROD with RULES2
65822 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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, § 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

Establishment 

receipts 

threshold 

(in $) 

Cumulative 

percent of 

firms 

exempt 

(%) 

Cumulative 

percent of 

products 

exempt 

(%) 

Cumulative 

percent of 

sales 

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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 65823 

DIETARY SUPPLEMENT MANUFACTURERS

Establishment receipts threshold 

(in $) 

Cumulative 

percent of 

firms 

exempt 

(%) 

Cumulative 

percent of 

products 

exempt 

(%) 

Cumulative 

percent of 

sales 

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 


amozie on DSK3GDR082PROD with RULES2
65824 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 65825 

the NOP. See 7 U.S.C. 1639b(f). The 

NPRM proposed that § 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, § 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 § 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 premarket Federal regulatory review 

process shall not be treated as safer 

than, or not as safe as, a nonbioengineered 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 

§ 66.100; (2) the text disclosure in 

§ 66.102; (3) the symbol disclosure in 

§ 66.104; (4) the electronic or digital link 

disclosure in § 66.106; (5) the text 

message disclosure in § 66.108; (6) the 

disclosure options for small food 

manufacturers in § 66.110; (7) the 

disclosure options for small or very 

small packages in § 66.112; (8) the 

disclosure for food sold in bulk 

containers in § 66.114; (9) the voluntary 

disclosure in § 66.116; and (10) other 

claims in § 66.118. As used in subpart 

B, the key terms include ‘‘information 

panel’’ and ‘‘label.’’ As defined in 

§ 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 § 66.1 as ‘‘the food 

manufacturer, importer, or retailer that 

is responsible for making bioengineered 

food disclosures under § 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 nonpartner 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 

§ 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 


amozie on DSK3GDR082PROD with RULES2
65826 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 

§ 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, § 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 § 66.114). ‘‘Information panel’’ as 

defined in § 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 

§ 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 multiunit 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 § 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 § 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 (ArcticTM varieties), 

canola, corn, cotton, eggplant (BARI Bt 

Begun varieties), papaya (ringspot virusresistant varieties), pineapple (pink 

flesh), potato, salmon (AquAdvantage®), 

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 § 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 § 66.9) or is exempt 

from disclosure under § 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 65827 

6Public 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. 

7Public 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. 

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 § 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 multiingredient 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, § 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

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 multicolored 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 § 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 


amozie on DSK3GDR082PROD with RULES2
65828 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 

§ 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 § 66.102 or the symbol disclosure in 

§ 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 § 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 § 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 § 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 § 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 

§ 66.102 in audio form and can be prerecorded. 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 § 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 § 66.106(b). 

Disclosure via website must include a 

bioengineered food disclosure that is 

consistent with § 66.102 or § 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 

§ 66.106; a modified version of the text 

message in § 66.108; and a modified 

version of the phone number disclosure 

in § 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, § 66.112(a) 

allows regulated entities to utilize the 

electronic or digital link in § 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, § 66.112(b) allows regulated 

entities to utilize the text message in 

§ 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 

§ 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 

§ 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 § 66.102 or § 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 § 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 


amozie on DSK3GDR082PROD with RULES2
65830 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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, 

§ 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 § 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 § 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 

§ 66.1 or is exempt from disclosure 

under §§ 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 § 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 

§ 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 

§ 66.116(b). 

It is important to note that when 

entities utilize the voluntary disclosure 

provisions in § 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 § 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 

§ 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, § 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, § 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, § 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, § 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 


amozie on DSK3GDR082PROD with RULES2
65832 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 noncompliance, 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 § 66.402 is revised to 

include greater specificity about the 

complaint process. The remainder of 

§ 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 65833 

8 ISO (2018) https://www.iso.org/committee/ 

560239.html. 

9Pauli 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). 

12Orlandi et al. (2002) Analysis of Flour and 

Food Samples for cry9C from Bioengineered Corn. 

J Food Protection 65:426–431 (Orlandi study). 

13Arun 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). 

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. 

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

When refining food ingredients from 

agricultural inputs, the objective is often 

to produce ingredients with a high 

degree of purity. Therefore, it is not 


amozie on DSK3GDR082PROD with RULES2
65834 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

14See 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. 

15Cullis et al. (2014) DNA and Protein Analysis 

throughout the Industrial Refining Process of Sugar 

Cane. Science Target 3:1–15. 

16 Gryson et al. (2002) Detection of DNA during 

the refining of soybean oil. JAOCS, Vol. 79, 171– 

174. 

17Costa et al. (2010) Monitoring GM soybean 

along the industrial soybean oil extraction and 

refining processes by PCR techniques. Food 

Research Intl 43:301–306. 

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. 

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. 

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 § 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 § 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 § 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 RNAdependent 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 


amozie on DSK3GDR082PROD with RULES2
65836 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 § 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 nonBE 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’’ 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 § 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.’’ 


amozie on DSK3GDR082PROD with RULES2
65838 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 § 66.6, is comprised 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 ingredientsbased 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 BEderived 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 

§ 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 narrowlydefined product characteristic—to avoid 

burdening too many producers of nonBE crops with the NBFDS recordkeeping 

requirement. For example, one comment 

suggested listing ‘‘Arctic® apple’’ 

instead of ‘‘Apple, Non-browning 

cultivars,’’ since the only commercially 

available version of BE apples uses the 

Arctic® 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 


amozie on DSK3GDR082PROD with RULES2
65840 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

producers or sellers of nonbioengineered 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 premarket 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 § 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 § 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 


amozie on DSK3GDR082PROD with RULES2
65842 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 §§ 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 

§ 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 


amozie on DSK3GDR082PROD with RULES2
65844 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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,’’ ‘‘nonBioengineered,’’ 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 


amozie on DSK3GDR082PROD with RULES2
65846 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 

(§ 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 § 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 ‘‘nonGMO.’’ 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 § 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 selfexecuting. 

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, 

§ 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 § 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 


amozie on DSK3GDR082PROD with RULES2
65848 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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, crosspollination 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 nonorganically 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. 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 coexistence 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 


amozie on DSK3GDR082PROD with RULES2
65850 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 

(§ 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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. 


amozie on DSK3GDR082PROD with RULES2
65852 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 § 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. 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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, nondisparaging 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 


amozie on DSK3GDR082PROD with RULES2
65854 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 prerecorded 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 


amozie on DSK3GDR082PROD with RULES2
65856 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 

§ 66.108(c) in the final rule to prohibit 

that information in the text message 

option. AMS is also adopting 

§ 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 onpackage 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. 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 onpackage 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 § 66.116(a), and 

to foods in which rDNA material is not 

detectable but are derived from 

bioengineered crops or foods, as 

described in § 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 


amozie on DSK3GDR082PROD with RULES2
65858 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 ‘‘nonbioengineered’’ 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 ‘‘nonGMO’’ 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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, § 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 ‘‘nonGMO’’ 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, § 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-keeping, regardless of whether 

and when USDA puts a food product on 

its lists. Other commenters argued that 


amozie on DSK3GDR082PROD with RULES2
65860 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 § 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 § 66.109 

requires those foods and foods 

ingredients to bear a BE disclosure, and 

§ 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 § 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 noncompliance 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, § 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 § 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 noncompliant 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 useup. 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 


amozie on DSK3GDR082PROD with RULES2
65862 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 costeffective 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 inputoutput 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 


amozie on DSK3GDR082PROD with RULES2
65864 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

product reformulations since packaged 

food will be labeled by the 

manufacturers. For prepared foods sold 

by grocers in in-store delis or salad bars, 

§ 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 costeffectiveness analysis of Federal 

projects, not the average before-tax rate 


amozie on DSK3GDR082PROD with RULES2
65866 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 ‘‘nonGMO’’ 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 


amozie on DSK3GDR082PROD with RULES2
65868 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 nondisclosure. 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 costprohibitive to buy equipment and hire 

skilled laboratory personnel for inhouse 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 timeconsuming 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. 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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’ ’’ (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. 


amozie on DSK3GDR082PROD with RULES2
65870 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 definition) ............................... N/A 23,029 4,147 

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 governmentto-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 § 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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. 

■ 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 

§ 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 

§ 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 § 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 § 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). 


amozie on DSK3GDR082PROD with RULES2
65872 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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 § 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. 

§ 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 § 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 

§ 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. 

§ 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. 

§ 66.6 List of Bioengineered Foods. 

The List of Bioengineered Foods 

consists of the following: Alfalfa, apple 

(ArcticTM varieties), canola, corn, 

cotton, eggplant (BARI Bt Begun 

varieties), papaya (ringspot virusresistant varieties), pineapple (pink 

flesh varieties), potato, salmon 

(AquAdvantage®), soybean, squash 

(summer), and sugarbeet. 

§ 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. 

§ 66.9 Detectability. 

(a) Recordkeeping requirements. 

Modified genetic material is not 

detectable if, pursuant to the 

recordkeeping requirements of § 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 


amozie on DSK3GDR082PROD with RULES2
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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. 

§ 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. 

§ 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 

§ 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 

§§ 66.110 and 66.112. 

(1) A text disclosure in accordance 

with § 66.102. 

(2) A symbol disclosure in accordance 

with § 66.104. 

(3) An electronic or digital link 

disclosure in accordance with § 66.106. 

(4) A text message disclosure in 

accordance with § 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 § 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. 

§ 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. 

§ 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: 


amozie on DSK3GDR082PROD with RULES2
65874 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

(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. 

§ 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 

§ 66.102 or § 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. 

§ 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 § 66.102 or § 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. 

§ 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. 

§ 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 §§ 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 § 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 

§ 66.106(b). Disclosure via website must 

include a bioengineered food disclosure 

that is consistent with § 66.102 or 

§ 66.104 in written form. 

§ 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 § 66.106, 

and replaces the statement and phone 

number required in § 66.106(a) with the 

statement ‘‘Scan for info.’’ 

(b) The label bears a number or short 

code as described in § 66.108(a), and 

replaces the statement with ‘‘Text for 

info.’’ 

(c) The label bears a phone number as 

described in § 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 § 66.102 or 

§ 66.104 in written or audio form, as 

applicable. 

§ 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 § 66.102, § 66.104, 

§ 66.106, or § 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. 

§ 66.116 Voluntary disclosure. 

(a) Disclosure of bioengineered food 

by exempt entities. If a food on the List 

of Bioengineered Foods is subject to 


amozie on DSK3GDR082PROD with RULES2ER21DE18.000</GPH>
Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 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 § 66.102. 

(2) A symbol disclosure, in 

accordance with § 66.104. 

(3) An electronic or digital link 

disclosure, in accordance with § 66.106. 

(4) A text message disclosure, in 

accordance with § 66.108. 

(5) Appropriate small manufacturer 

and small and very small package 

disclosure options, in accordance with 

§§ 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 § 66.1, that do not qualify as a 

factor or condition under paragraph (2) 

of the definition of bioengineered food 

in § 66.1, that are not exempt from 

disclosure under § 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: 

(3) An electronic or digital link 

disclosure, in accordance with § 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 § 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 

§§ 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 

§ 66.302. 

§ 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 

§ 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 § 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 § 66.202, 

AMS will initiate a rulemaking that 

would amend the definition of 

‘‘bioengineered food’’ in § 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 § 66.202 constitutes final agency 

action for purposes of judicial review. 

§ 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. 

§ 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 § 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 

§ 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. 

§ 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, 


amozie on DSK3GDR082PROD with RULES2ER21DE18.001</GPH>
65876 Federal Register / Vol. 83, No. 245 / Friday, December 21, 2018 / Rules and Regulations 

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. 

§ 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 

§ 66.402. 

Subpart E—Enforcement 

§ 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. 

§ 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 

§ 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 § 66.404. 

§ 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. 

§ 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 § 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 


amozie on DSK3GDR082PROD with RULES2