SUPPLEMENTARY INFORMATION:

Under the authority of the plant pest provisions of the Plant Protection Act (7 U.S.C. 7701 et seq.), 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,” regulate, 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 provides that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340. Paragraphs (b) and (c) of § 340.6 describe the form that a petition for a determination of nonregulated status must take and the information that must be included in the petition.

APHIS has received a petition (APHIS Petition Number 25-323-01p) from Bayer U.S.-Crop Science seeking a determination of nonregulated status for MON 89151 lepidopteran-protected cotton ( Gossypium hirsutum), referred to as MON 89151, which has been developed using genetic engineering to express three insecticidal proteins (Vip3Cb1.1, Cry1Da_7, and Cry1B.3) to protect against feeding damage caused by target lepidopteran pests. The petition states that the information provided indicates that MON 89151 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' draft PPRA compared the pest risk posed by MON 89151 with that of the nonmodified variety from which it was derived. The draft PPRA concluded that MON 89151 is unlikely to pose an increased plant pest risk compared to the nonmodified cotton.

Paragraph (d) of §  340.6 provides that APHIS will publish a notice in the Federal Register providing 60 days for public comment on petitions for a determination of nonregulated status. In accordance with §  340.6(d), we are publishing this notice to inform the public that APHIS will accept written comments regarding the petition and draft PPRA from interested or affected persons for a period of 60 days from the ( printed page 59759) date of this notice. The petition and draft PPRA are available for public review and comment, and copies are available as indicated under ADDRESSES and from the individual listed under the FOR FURTHER INFORMATION CONTACT section of this notice. We are particularly interested in receiving comments regarding biological or ecological issues, and we encourage the submission of scientific data, studies, or research to support your comments.

After the comment period closes, APHIS will review and evaluate any information received during the comment period and any other relevant information. Based upon available information, APHIS will respond to the petitioner either approving or denying the petition. APHIS will post its regulatory determination on its website and publish a notice of availability in the Federal Register .

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

91 FR 59758