[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