Ball Horticultural Company: Determination of Nonregulated Status for Red Flower Petals African Marigold (Tagetes erecta) Event pBALL123-022-BE113 3

Issuing agencies

Abstract

We are advising the public of our determination that African marigold (Tagetes erecta) event pBALL123-022-BE113, which was developed using genetic engineering to produce red flower petals, is no longer considered regulated. Our determination is based on our evaluation of information and data submitted by Ball Horticultural Company in its petition for a determination of nonregulated status, available scientific data, the plant pest risk assessment, and public comments received in response to a previous notice announcing the availability of the petition for nonregulated status and a draft plant pest risk assessment. This notice announces the availability of our written determination and supporting documents.

Full Text

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<title>Federal Register, Volume 91 Issue 197 (Wednesday, October 14, 2026)</title>
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[Federal Register Volume 91, Number 197 (Wednesday, October 14, 2026)]
[Notices]
[Pages 65159-65160]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-20961]


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DEPARTMENT OF AGRICULTURE

Animal and Plant Health Inspection Service


Ball Horticultural Company: Determination of Nonregulated Status 
for Red Flower Petals African Marigold (Tagetes erecta) Event pBALL123-
022-BE113 3

AGENCY: Animal and Plant Health Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: We are advising the public of our determination that African 
marigold (Tagetes erecta) event pBALL123-022-BE113, which was developed 
using genetic engineering to produce red flower petals, is no longer 
considered regulated. Our determination is based on our evaluation of 
information and data submitted by Ball Horticultural Company in its 
petition for a determination of nonregulated status, available 
scientific data, the plant pest risk assessment, and public comments 
received in response to a previous notice announcing the availability 
of the petition for nonregulated status and a draft plant pest risk 
assessment. This notice announces the availability of our written 
determination and supporting documents.

DATES: This change in regulatory status is recognized as of October 14, 
2026.

ADDRESSES: You may read the petition, our determination referenced in 
this notice, and supporting documents by any of the following methods:
    <bullet> Federal eRulemaking Portal: Go to <a href="http://www.regulations.gov">www.regulations.gov</a>. 
Enter APHIS-2026-0001 in the Search field.
    <bullet> Our reading room, located in 1620 of the USDA South 
Building, 14th Street

[[Page 65160]]

and Independence Avenue SW, Washington, DC. Normal reading room hours 
are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be 
sure someone is there to help you, please call (202) 799-7039 before 
coming.

FOR FURTHER INFORMATION CONTACT: Mr. Alan Pearson, Biotechnology 
Regulatory Services, APHIS, USDA, 5601 Sunnyside Avenue, AP100-3-WS-
1151, Beltsville, MD 20705; (301) 851-3944; email: 
<a href="/cdn-cgi/l/email-protection#adccc1ccc383ddc8ccdfdec2c3edd8dec9cc83cac2db"><span class="__cf_email__" data-cfemail="aecfc2cfc080decbcfdcddc1c0eedbddcacf80c9c1d8">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the authority of the plant pest 
provisions of the Plant Protection Act (7 U.S.C. 7701-7772, 7781-7786) 
and the regulations in 7 CFR part 340, ``Introduction of Organisms and 
Products Altered or Produced Through Genetic Engineering Which Are 
Plant Pests or Which There Is Reason to Believe Are Plant Pests,'' 
Animal and Plant Health Inspection Service (APHIS) regulates, among 
other things, the introduction (importation, interstate movement, or 
release into the environment) of organisms and products altered or 
produced through genetic engineering that are plant pests or that there 
is reason to believe are plant pests. Such organisms and products are 
considered ``regulated articles.'' Section 340.6(a) of the regulations 
(7 CFR 340.6(a)) provides that any person may submit a petition to 
APHIS seeking a determination that an article should not be regulated 
under 7 CFR part 340.
    APHIS received a petition (APHIS Petition Number 25-205-01p) from 
Ball Horticultural Company (BHC) seeking a determination of 
nonregulated status for African marigold (Tagetes erecta) event 
pBALL123-022-BE113, designated as pBALL123, which has been developed 
using genetic engineering to produce red flower petals. The petition 
provides information in support of petitioners' position that pBALL123 
is unlikely to pose a plant pest risk and therefore should not be 
regulated under APHIS' regulations in 7 CFR part 340.
    As part of our decision-making process regarding the organism's 
regulatory status, APHIS prepared a draft plant pest risk assessment 
(PPRA) to assess the plant pest risk of the organism.
    APHIS published the petition and draft PPRA in the Federal Register 
(91 FR 6179, APHIS-2026-0001) and accepted public comments from 
February 11, 2026, through April 13, 2026. APHIS received 3 comments by 
the close of the comment period that were posted to the docket. APHIS 
received comments from a horticultural industry organization, a non-
governmental organization, and an unaffiliated individual. Of the 3 
comments posted to the docket, two were in support of deregulation of 
pBALL123, and one was in opposition.

Determination

    Based on APHIS' evaluation in the PPRA of information and data 
submitted by BHC in its petition, available scientific data, and public 
comments received in response to the petition and draft PPRA, APHIS has 
determined that pBALL123 is unlikely to pose a greater plant pest risk 
than the nonmodified comparator and therefore is no longer subject to 
the regulations in 7 CFR part 340 governing the introduction of certain 
organisms developed using genetic engineering.
    Copies of the signed determination, PPRA, and response to comments, 
as well as the previously published petition and supporting documents, 
are available as indicated in the ADDRESSES and FOR FURTHER INFORMATION 
CONTACT sections of this notice.

(Authority: 7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 
2.22, 2.80, and 371.3.)

    Done in Washington, DC, this 8th day of October 2026.
Kelly Moore,
Administrator, Animal and Plant Health Inspection Service.
[FR Doc. 2026-20961 Filed 10-13-26; 8:45 am]
BILLING CODE 3410-34-P


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