Ball Horticultural Company: Determination of Nonregulated Status for Red Flower Petals African Marigold (Tagetes erecta) Event pBALL123-022-BE113 3
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 flo...
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:
Federal eRulemaking Portal:
Go to
www.regulations.gov.
Enter APHIS-2026-0001 in the Search field.
Our reading room, located in 1620 of the USDA South Building, 14th Street
( printed 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:
alan.pearson@usda.gov.
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.
www.regulations.gov
7 U.S.C. 7701-7772
7 CFR part 340