[Federal Register Volume 87, Number 140 (Friday, July 22, 2022)]
[Proposed Rules]
[Pages 43751-43755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-15728]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF AGRICULTURE

Agricultural Marketing Service

7 CFR Part 66

[Doc. No. AMS-FTPP-20-0057]
RIN 0581-AD95


2020 Annual Updates to List of Bioengineered Foods

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: The Agricultural Marketing Service (AMS) of the United States 
Department of Agriculture (USDA) is soliciting comments and feedback on 
an update to the List of Bioengineered Foods (List) as it pertains to 
the National Bioengineered Food Disclosure Standard (the Standard or 
NBFDS).

DATES: Comments must be received on or before September 20, 2022.

ADDRESSES: We invite you to submit written comments via the internet at 
https://www.regulations.gov. Comments may also be filed with the Docket 
Clerk, 1400 Independence Ave. SW, Room 2069-South, Washington, DC 
20250; Fax: (202) 260-8369. All comments submitted in response to this 
notice, including the identity of individuals or entities submitting 
comments, will be made available to the public on the internet via 
https://www.regulations.gov. All comments should reference the docket 
number and the date and page number of this issue of the Federal 
Register and will be available for public inspection at: https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Paul Lewis, Director, Food Disclosure 
and Labeling Division, Fair Trade Practices Program, Agricultural 
Marketing Service, U.S. Department of Agriculture, Telephone (202) 720-
3252, Email: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    On July 29, 2016, Public Law 114-216 amended the Agricultural 
Marketing Act of 1946 (7 U.S.C. 1621 et. seq.) (amended Act) to require 
USDA to establish a national, mandatory standard for disclosing any 
food that is or may be bioengineered (BE). USDA published a final rule 
promulgating the regulations (7 CFR part 66) to implement the Standard 
on December 21, 2018 (83 FR 65814). The regulations became effective on 
February 19, 2019, with a mandatory compliance date of January 1, 2022. 
Under 7 CFR 66.1, a bioengineered food is a food that, subject to 
certain factors, conditions, and limitations, 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.
    The regulations, at 7 CFR 66.6, contain the List, which currently 
includes: alfalfa, apple (ArcticTM varieties), canola, corn, 
cotton, eggplant (BARI Bt Begun varieties), papaya (ringspot virus-
resistant varieties), pineapple (pink flesh varieties), potato, salmon 
(AquAdvantage[supreg]), soybean, squash (summer), and sugarbeet. As 
stated in the preamble to the final rule,

[[Page 43752]]

at 83 FR 65852, the 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. As a result, if a regulated entity 
is using a food or ingredient produced from an item on the List, they 
must make a bioengineered food disclosure unless they have records 
demonstrating that the food or ingredient they are using is not 
bioengineered. Similarly, even if a food is not on the List, a 
regulated entity must make a bioengineered food disclosure if they have 
actual knowledge that a food or a food ingredient being used is a 
bioengineered food or a bioengineered food ingredient.
    As stated in 7 CFR 66.7(a), 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. The regulations further provide that:
    (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).
    (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.
    On July 24, 2020, AMS published a Notice in the Federal Register 
seeking public comment on recommendations to update the List (85 FR 
44791). In the Notice, AMS sought comments on adding sugarcane (insect-
resistant) to the List, and amending ``squash (summer)'' to ``squash 
(summer, virus-resistant).'' As required at 7 CFR 66.7(a)(3), AMS 
consulted with the government agencies responsible for oversight of the 
products of biotechnology, APHIS, EPA, and FDA, on this matter.
    AMS also sought public comment to determine whether additional 
information was publicly available regarding bioengineered versions of 
cowpea and rice. AMS understands that bioengineered versions of cowpea 
and rice are at various stages of authorization for commercial 
production but are not yet in legal commercial production for human 
food. AMS also requested comments on any other foods not mentioned in 
the Notice that it should consider for addition to the List.
    The comment period for the Notice closed on August 24, 2020. AMS 
received a total of 17 comments. After reviewing the public comments, 
AMS is proceeding with the proposed rule to add sugarcane (Bt insect-
resistant varieties) to the List and amend ``squash (summer)'' to 
``squash (summer, mosaic virus-resistant varieties).'' AMS did not 
receive any comments on cowpea or rice and is not proposing any action 
related to those two crops at this time.
    Table 1 summarizes the proposed addition and modification to the 
List.

                                    Table 1--Proposed Amendments to the List
----------------------------------------------------------------------------------------------------------------
                  Crop                     Regulation                      Proposed rule action
----------------------------------------------------------------------------------------------------------------
Sugarcane..............................      7 CFR 66.6  Add to the List as ``Sugarcane (Bt insect-resistant
                                                          varieties)''.
Squash (summer)........................      7 CFR 66.6  Add additional description to the existing entry on the
                                                          List to read ``squash (summer, mosaic virus-resistant
                                                          varieties)''.
----------------------------------------------------------------------------------------------------------------

II. Overview of Proposed Rule

A. Addition to the List

    AMS received comments that both supported and opposed adding 
sugarcane (Bt insect-resistant varieties) to the List.
    Those in favor of adding sugarcane (Bt insect-resistant varieties) 
to the List generally agreed that it met the dual criteria identified 
at 7 CFR 66.7(a)(4) to be added to the List: (1) authorized for 
commercial production somewhere in the world and (2) currently in legal 
commercial production for human food somewhere in the world. Several 
commenters also noted that adding sugarcane (insect-resistant) to the 
List would provide consumers with more information about their food.
    Commenters opposed to adding sugarcane (Bt insect-resistant 
varieties) to the List acknowledged that commercial production of that 
crop is authorized and taking place in Brazil and that such production 
is primarily for seedling bulk up, and not for human consumption. 
However, we have no evidence that seedling bulk up is the only use for 
the crop, and we believe sugarcane (Bt insect-resistant varieties) 
could be used for human food and should be included on the List. AMS 
requests comments with data or evidence that would support or refute 
the conclusion that seedling bulk up is the only current use for 
sugarcane (Bt insect-resistant varieties).
    Another commenter suggested that sugarcane (insect-resistant) 
produced in Brazil is unlikely to end up in the United States. Whether 
a product is likely to end up in the United States is not a factor that 
AMS must consider under 7 CFR 66.7. The List reflects production of 
bioengineered foods on a global level and does not consider whether 
such foods are likely to end up in the United States.
    Lastly, some commenters suggested that because sugar produced from 
sugarcane (insect-resistant) is highly refined and does not contain 
detectable modified genetic material, it is not a bioengineered food 
and should not be added to the List. As stated above, the List 
establishes a presumption about which foods are or may be 
bioengineered. Inclusion on the List does not affirmatively mean an 
item on the List, or a food produced from an item on the List, is a 
bioengineered food. Rather, being on the List establishes a presumption 
and requires a regulated entity to make a bioengineered food disclosure 
unless they maintain records, in accordance with 7 CFR 66.9, to 
demonstrate that

[[Page 43753]]

modified genetic material is not detectable.
    AMS has considered all the information provided to the agency 
related to sugarcane (insect-resistant) and believes the criteria 
identified in 7 CFR 66.7(a)(4) are met. Accordingly, this action 
proposes to update the List to include sugarcane (insect-resistant). 
AMS invites comments on the proposed addition of insect resistant 
sugarcane to the List.

B. Amendment to the List

    Commenters were generally supportive of adding an additional 
modifier (virus-resistant) to the existing entry for squash (summer). 
One commenter noted that the additional modifier increases transparency 
and provides more information to consumers.
    Another commenter asked that AMS consider additional specificity by 
further amending the entry for squash to include the specific trade 
name, Performance Series. As mentioned in the preamble to the final 
rule (83 FR 65819), AMS will, where practical, include specific trade 
names ``to help distinguish bioengineered versions of those foods from 
their non-bioengineered counterparts.'' The List currently includes two 
foods with specific trade names: Arctic\TM\ variety apples and 
AquAdvantage[supreg] brand salmon. In each instance, the BE food 
(Arctic\TM\ variety apples or AquAdvantage[supreg] brand salmon) is the 
only one of its kind that, to AMS's knowledge, meets the criteria 
identified in 7 CFR 66.7(a)(4).\1\ However, as explained in the 
preamble to the final rule, items on the List will necessarily become 
more generic as more than one variety of a BE food are available (83 FR 
65819). Similar to potato, which does not have a specific trade name 
modifier on the List, there is more than one variety of squash (summer) 
that meets the criteria identified in 7 CFR 66.7(a)(4).\2\ As a result, 
AMS is not proposing to add a specific trade name to summer squash.
---------------------------------------------------------------------------

    \1\ Okanagan Specialty Fruits, the producer of Arctic\TM\ brand 
apples, is the only entity to apply for deregulated status for 
bioengineered apples and to consult with FDA on bioengineered 
apples. Similarly, AquaBounty Technologies, Inc., the producer of 
AquAdvantage[supreg] salmon, is the only entity to gain approval for 
production of bioengineered salmon. New Plant Variety Consultations, 
https://www.cfsanappsexternal.fda.gov/scripts/fdcc/?set=NewPlantVarietyConsultations. Petition for Determination of 
Nonregulated Status, https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status. 21 CFR 528.1092; Electronic Animal Drug Product Listing 
Directory, https://www.fda.gov/industry/structured-product-labeling-resources/electronic-animal-drug-product-listing-directory.
    \2\ Petitions for Determination of Nonregulated Status, https://www.aphis.usda.gov/aphis/ourfocus/biotechnology/permits-notifications-petitions/petitions/petition-status. New Plant Variety 
Consultations, https://www.cfsanappsexternal.fda.gov/scripts/fdcc/index.cfm?set=NewPlantVarietyConsultations.
---------------------------------------------------------------------------

    Additionally, adding ``virus-resistant'' to the existing 
description would not impact the recordkeeping burden for regulated 
entities. These entities may still be subject to an examination of 
customary or reasonable records for summer squash following a BE audit 
outlined in Sec.  66.402. If regulated entities marketing summer squash 
or sugarcane are unable to obtain records from suppliers, they can make 
a disclosure.
    After reviewing the public comments, AMS is proceeding with this 
proposed rule to amend ``squash (summer)'' to ``squash (summer, mosaic 
virus-resistant varieties).'' AMS invites comments on the proposed 
revision to summer squash on the List to specify ``squash (summer, 
mosaic virus-resistant varieties).

III. Required Regulatory Analyses

A. Paperwork Reduction Act

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520), the information collection related to the NBFDS has 
previously been approved by OMB and assigned OMB No. 0581-0315--
National Bioengineered Food Disclosure Standard. AMS estimates that 
changes in recordkeeping burden due to the proposed revisions to the 
List would be minimal.
    Generally, the records necessary to substantiate the need for a 
disclosure/label are customary and reasonable, and therefore maintained 
in the usual course of business. The same records would be required to 
substantiate a decision not to label under Sec.  66.9. Limiting 
reporting to a specific variety of summer squash does not really reduce 
recordkeeping. These entities may still be subject to an examination of 
customary or reasonable records for summer squash following a BE audit 
outlined in Sec.  66.402. It could, however, reduce the burden 
associated with making disclosures, since fewer labels would be 
required where summer squash is known not to be bioengineered for virus 
resistance. Data are not available to measure the change in the number 
of entities who would be required to comply with the revised disclosure 
and recordkeeping requirements associated with this proposal, given the 
seasonal nature of summer squash production and variations in 
production from year to year. AMS requests comments with data or 
information on market share or proportion of squash of virus-resistant 
varieties and the number of entities that might be impacted by this 
change.
    AMS did not receive any substantive comments during the open 
comment period for the Information Collection renewal request published 
earlier this year.

B. Civil Rights Review

    AMS has considered the potential civil rights implications of this 
proposed 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.
    This proposed rule offers several distinct avenues of compliance 
for regulated entities that can be tailored 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. AMS's Civil Rights Impact Analysis (CRIA) will be 
published in the Federal Register and on the AMS BE Disclosure web page 
along with publication of this proposed rule. A 60-day comment period 
will be provided to allow interested persons to respond to the CRIA. 
All written comments received in response to the CRIA and the proposed 
rule by the date specified will be considered.

C. 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 
with tribes on a government-to-government basis on policies that have 
tribal implications, including regulations, legislative comments or 
proposed legislation, and 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 the 
distribution of power and responsibilities between the Federal 
Government and Indian tribes.
    This proposed rule may impact individual members of Indian tribes 
that operate as food manufacturers or retailers; however, it would not 
have a direct effect on tribes or the relationship or distribution of 
power and

[[Page 43754]]

responsibilities between the Federal Government and Indian tribes. 
Therefore, consultation under Executive Order 13175 is not required at 
this time. However, AMS hosts a quarterly teleconference with Tribal 
Leaders where matters of mutual interest regarding the marketing of 
agricultural products are discussed. During two quarterly 
teleconference calls on March 11, 2021, and July 22, 2021, AMS provided 
Tribal representatives with an overview of the upcoming proposed rule 
that would add ``sugarcane (insect-resistant)'' to the List and amend 
``squash (summer)'' to ``squash (summer, mosaic virus-resistant 
varieties),'' and extended the opportunity for questions and requests 
for additional information. At that time, AMS received no questions or 
requests from Tribal representatives. AMS will continue to extend 
outreach to ensure tribe members are aware of the requirements and 
benefits under this proposed rule once final. Where Tribes request 
consultation on relevant matters that are not required under 
legislation, AMS will collaborate with the Office of Tribal Relations.

D. Executive Orders 12866 and 13563

    USDA is issuing this proposed 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. Pursuant 
to 7 CFR 66.7(b), ``[r]egulated 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.'' As this rule has been 
designated ``Significant,'' it has been reviewed by the Office of 
Management and Budget.
    Cost changes due to this action will be limited to the addition of 
sugarcane to the List because regulated entities have already incurred 
costs associated with the inclusion of summer squash on the List. The 
addition of sugarcane to the List would not increase the cost of 
federal enforcement. To estimate the cost of the proposed action, the 
Label Insight Database was used to determine the number of products 
that use cane sugar as an ingredient and which have no other 
ingredients that would otherwise require labeling of the product as 
bioengineered as described in the regulatory impact analysis for the 
final rule on page 19.\3\ A total of 10,600 individual UPCs were 
identified using this criteria. The upper and lower bounds of the 
estimate were calculated by multiplying 10,600 UPC by the unit cost for 
testing (unit cost range: $153-$431) and for analytical costs (unit 
cost range: $376-$3,084) established in the 2018 Final Rule. AMS 
estimates that the costs associated with this action would range from 
$6 million to $37 million for the initial year, with no ongoing annual 
costs and no significant change in benefits. Most of the estimated 
costs are related to a one-time deliberation by food manufacturers to 
confirm the source of sugar used in their products and to comply with 
recordkeeping and labeling requirements. If regulated entities 
marketing summer squash or sugarcane are unable to obtain records from 
suppliers, they can make a disclosure.
---------------------------------------------------------------------------

    \3\ https://www.regulations.gov/document/AMS-TM-17-0050-14035.
---------------------------------------------------------------------------

    The annualized cost of adding sugarcane to the list of potentially 
bioengineered products would be between $500,000 and $3.5 million 
(annualized over 20 years using a seven percent discount rate). The 
rule is, therefore, not considered to be economically significant under 
Executive Order 12866. Even considering only the first year (where all 
of the costs are expected to occur), the estimated costs do not exceed 
the $100 million threshold for economically significant.

E. Initial Regulatory Flexibility Analysis

    AMS has examined the economic implications of this proposed 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. AMS has concluded 
that the proposed rule, if finalized, would not have a significant 
economic impact on a substantial number of small entities.
    The proposed addition of sugarcane (insect-resistant) and proposed 
amendment of ``squash (summer)'' to ``squash (summer, mosaic virus-
resistant varieties)'' to the List would directly affect three industry 
sectors: cane sugar manufacturers, processed food manufacturers who use 
cane sugar or summer squash as ingredients, and grocery or other 
retailers who sell raw sugarcane (insect-resistant) or summer squash.
    According to the 2017 Study of U.S. Business (SUSB) from the US 
Census, there were 37 cane sugar manufacturers in the United States. 
Approximately 32 of the total cane sugar manufacturers would meet the 
Small Business Administration definition of small. Of the 32 small 
firms, 11 would also qualify as very small manufacturers under the 
NBFDS regulations and would be exempt from disclosure requirements. 
Accordingly, those 11 firms would incur no costs associated with the 
addition of sugarcane (insect-resistant) to the List of Bioengineered 
Foods. The remaining 21 small firms would not likely face significant 
costs as they only have one product and are likely to know where the 
cane for their sugar originates. At this time sugarcane (insect-
resistant) is grown commercially only in Brazil. If sugarcane (insect-
resistant) becomes more prevalent, cane sugar producers could 
potentially be required to keep records on the origin of the cane 
processed into sugar and could incur certification costs associated 
with demonstrating that the final product has no detectable rDNA. 
Assuming that the refinement of cane sugar, like beet sugar, would 
support such a certification, cane sugar producers would face minimal 
labeling costs.
    Food manufacturers who only use cane sugar as an ingredient will 
need to determine the certification status of the sugar they use--
assuming sugar made from sugarcane (insect-resistant) makes it into the 
U.S. market. Most food manufacturers will already face costs associated 
with confirming the ingredients of their products and the marginal cost 
associated with an additional ingredient is expected to be small. As 
with beet sugar, it is unlikely that refined cane sugar would contain 
traceable levels of rDNA. As a result, regulated entities may not have 
additional labeling costs due to the addition of sugarcane (insect-
resistant) to the List as there is a means to exempt their products 
from disclosure.
    Food manufacturers whose products contain summer squash and 
retailers who sell uncooked summer squash will see no change or, 
potentially, a slight reduction in costs as the proposal would reduce 
the varieties of squash that require labeling. Food manufacturers whose 
products contain summer squash and retailers who sell uncooked summer 
squash are already maintaining records in accordance with the NBFDS.
    Food manufacturers who use summer squash are likely concentrated in 
Fruit and Vegetable Preserving and Specialty

[[Page 43755]]

Food Manufacturing (NAICS 3114). This industry sector had 1,540 firms 
listed in the 2017 SUSB. Of these, approximately 1,475 would be 
classified as small. An additional 904 firms would be classified as 
very small by the NBFDS rule and, therefore, be exempt. Food 
manufacturers already face the administrative costs associated with 
using a product on the List of Bioengineered Foods. The proposal would 
make it easier for regulated entities, who are already maintaining 
records in compliance with the NBFDS, to demonstrate that labeling is 
not required if they know they are not receiving virus-resistant 
varieties. The proposal could also result in a slight decrease in the 
cost of labeling products containing summer squash if it is possible 
and desirable to avoid virus-resistant varieties. However, we do not 
attempt to quantify this reduction in any way. Costs to small food 
producers using summer squash therefore will remain unchanged or be 
reduced by this proposal.
    Similarly, retailers will be primarily affected by the change in 
the definition of summer squash. Their costs will remain the same as 
they are now or be reduced slightly if they do not need to label as 
many products.
    For these reasons, AMS is certifying that the proposal to add 
sugarcane (Bt insect-resistant varieties) to the List of Bioengineered 
Foods and limiting the varieties of squash listed as bioengineered 
foods to virus-resistant varieties will not have a significant economic 
impact on a substantial number of small entities.

F. Executive Order 12988

    This proposed rule has been reviewed under Executive Order 12988, 
Civil Justice Reform. The proposed rule is not intended to have 
retroactive effect. There are no administrative procedures that must be 
exhausted prior to any judicial challenge to the provisions of this 
rule.

List of Subjects in 7 CFR Part 66

    Agricultural commodities, Food labeling, Reporting and 
recordkeeping requirements.

    For the reasons set forth in the preamble, the Agricultural 
Marketing Service proposes to amend 7 CFR part 66 as follows:

PART 66--NATIONAL BIOENGINEERED FOOD DISCLOSURE STANDARD

0
1. The authority citation for 7 CFR part 66 continues to read as 
follows:

    Authority: 7 U.S.C. 1621 et seq.

0
2. Revise Sec.  66.6 to read as follows:


Sec.  66.6   List of Bioengineered Foods.

    The List of Bioengineered Foods consists of the following: Alfalfa, 
apple (Arctic\TM\ varieties), canola, corn, cotton, eggplant (BARI Bt 
Begun varieties), papaya (ringspot virus-resistant varieties), 
pineapple (pink flesh varieties), potato, salmon 
(AquAdvantage[supreg]), soybean, squash (summer, mosaic virus-resistant 
varieties), sugarbeet, and sugarcane (Bt insect-resistant varieties).

Erin Morris,
Associate Administrator, Agricultural Marketing Service.
[FR Doc. 2022-15728 Filed 7-21-22; 8:45 am]
BILLING CODE 3410-02-P