Sec. 10006. Pilot program for the intra-organizational movement of genetically engineered microorganisms by certain authorized parties
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Subtitle A of the Plant Protection Act ( 7 U.S.C. 7711 et seq. ) is amended by adding at the end the following: In this section: The term covered microorganism — means a genetically engineered microorganism that is a plant pest or may pose a plant pest risk; and does not include listed agents or toxins (as defined in section 212(l) of the Agricultural Bioterrorism Protection Act of 2002 ( 7 U.S.C. 8401(l) )). The term covered unauthorized release means an unauthorized release of a covered microorganism, including such a release that a responsible party suspects took place.
The term pilot program means the pilot program established under subsection (b). The term plant pest risk has the meaning given such term in section 340.3 of title 7, Code of Federal Regulations (or successor regulations). The term responsible party means a partnership, corporation, association, joint venture, or other legal entity that— has a physical address in the United States; is not owned by or otherwise affiliated with the government of a country of concern (as defined in section 10638 of the CHIPS Act of 2022 ( 42 U.S.C. 19237 )); has more than 1 responsible party biocontainment facility; employs quality control personnel that are capable of overseeing the movement and control of covered microorganisms; has, in each of the 3 years preceding enrollment in the pilot program, moved plant pests pursuant to permits granted by the Secretary under this Act; has the ability and resources to ensure compliance with the requirements under subsection
(e)for the duration of the pilot program; has implemented the precautions specified in subsection
(e)to prevent the unauthorized release of covered microorganisms; and has not, during the 5-year period preceding the date on which the relevant application is submitted under subsection (c)— caused an unauthorized release of a plant pest; materially failed to comply with a permit granted by the Secretary for the interstate movement of plant pests; or violated any provision of this section (including regulations promulgated thereunder). The term responsible party biocontainment facility — means a physical structure or portion thereof, constructed and maintained in order to contain plant pests, that is under the control of, or operated by, a responsible party within the contiguous United States; and includes sites under the control of, or operated by, any parent organization, subsidiary, or affiliate of the responsible party. Not later than 100 days after the date of enactment of this section, the Secretary shall establish a pilot program under which the Secretary shall authorize not more than 75 responsible parties— to move covered microorganisms in interstate commerce between responsible party biocontainment facilities without a permit; and to maintain control over and dispose of such covered microorganisms. The Secretary shall accept applications from responsible parties for enrollment in the pilot program during a 45-day application period, beginning on the date on which the pilot program is established under subsection (b), using a web-based application process established by the Secretary. An application submitted by a responsible party for enrollment in the pilot program shall include the following: The name and contact information of the responsible party and any agent of the responsible party that will be involved in the movement of a covered microorganism. The methods by which a covered microorganism will be moved and the measures taken to ensure that there is no unauthorized release of the covered microorganism. The manner in which a shipping container, packaging material, or any other material accompanying the covered microorganism will be disposed of to prevent the unauthorized release of a covered microorganism. A list of responsible party biocontainment facilities to which the responsible party intends to move covered microorganisms. A list of the predominant covered microorganism chassis strains that, at the time of the application, the responsible party intends to move. A sworn certification that the responsible party meets each criterion specified in subsection (a)(5). A responsible party may submit a supplemental application to the Secretary to update a list under subparagraph
(D)or
(E)of paragraph
(2)at any time during such enrollment. The Secretary shall make a determination with respect to such supplemental application not later than 30 days after the date on which such supplemental application is submitted to the Secretary. The Secretary may only deny a supplemental application if the Secretary has made the determination set forth in subsection (d)(2)(B). A denial of a supplemental application shall be subject to appeal in accordance with the terms specified in subsection (d)(3). The Secretary shall— evaluate applications received under subsection (c)(1) in the order in which the applications are received; and approve or deny all applications received during the period described in that subsection not later than 45 days after the end of that period. The Secretary shall deny an application received under subsection (c)(1) if— the Secretary has already selected 75 responsible parties for enrollment in the pilot program; or the Secretary determines that the responsible party submitting the application does not meet each criterion specified in subsection (a)(5). A responsible party seeking to enroll in the pilot program whose application has been denied under paragraph
(2)may submit to the Secretary a written appeal within— the 10-day period beginning on the date on which the responsible party receives written notification of the denial; or a longer period, if the responsible party makes a request for additional time to submit such appeal and the Secretary grants such request. The Secretary shall, within a reasonably prompt period, grant or deny an appeal under subparagraph
(A)in writing, which shall include the reasons for the decision. A responsible party shall, as a condition of enrollment in the pilot program, agree to— maintain, move, and dispose of covered microorganisms in a manner that prevents unauthorized release, spread, dispersal, or persistence of those covered microorganisms in the environment; unless otherwise authorized under a permit under this Act, only move a covered microorganism between sites that are responsible party biocontainment facilities; maintain, move, and dispose of each covered microorganism separately from other organisms; ensure that each covered microorganism is maintained, moved, and disposed of in a manner commensurate with the plant pest risk posed by that covered microorganism; use, at a minimum, a package for movement— that consists of a securely sealed inner and outer container, each of which is an effective barrier to the escape or unauthorized dissemination of the covered microorganism; the inner container of which— contains all of the applicable covered microorganism; and is cushioned and sealed in such a manner as to remain sealed during any shock, impact, or change in pressure; and the outer container of which is rigid and strong enough to withstand typical shipping conditions (such as dropping, stacking, and impact from other freight) without opening; on request, grant the Secretary access— to sample materials associated with the interstate movement of covered microorganisms under the pilot program; to observe and inspect the interstate movement of those covered microorganisms; and to audit records of the activities of the responsible party under the pilot program; maintain detailed and accurate records of all activities carried out under the pilot program to demonstrate compliance with the applicable requirements; on request, grant the Secretary access to each responsible party biocontainment facility for inspection in relation to a responsible party’s enrollment in the pilot program; and comply with any additional requirement for the containment of covered microorganisms in interstate commerce that the Secretary may require if— the Secretary determines that such an additional requirement is reasonable; and the sole purpose of such additional requirement is to avoid a covered unauthorized release. In carrying out the pilot program, the Secretary shall take no action or promulgate any regulation that— treats genetically engineered covered microorganisms less favorably than nongenetically engineered covered microorganisms; or limits the quantity or type of covered microorganisms that may be moved under the pilot program between responsible party biocontainment facilities. A responsible party shall submit to the Secretary a quarterly report that describes the activities of the responsible party under the pilot program during the period covered by the report, including— a description of each covered microorganism moved in interstate commerce, including— the 1 or more countries or localities at which the covered microorganism was collected, developed, manufactured, reared, cultivated, or cultured, as applicable; the genus, species, and any relevant subspecies and common name information of the covered microorganism; and when applicable, a brief description of the genetic modifications made in the microorganism, including— the intended phenotype that the 1 or more modifications are expected to confer; any targeted deletions, insertions, or base pair substitutions; and the genetic elements used in imparting the modification, including the name, donor organism, and a brief description of the function; each method by which the covered microorganism was moved in interstate commerce; the quantity of the covered microorganism moved in interstate commerce; and the specific responsible party biocontainment facilities between which the covered microorganism was moved in interstate commerce. In the case of a covered unauthorized release, a responsible party shall— contact the applicable office within the Animal and Plant Health Inspection Service within 48 hours of discovery of the covered unauthorized release; and submit to the Secretary a statement of facts pertaining to such release, in writing, not later than 5 business days after the date of that discovery. The Secretary shall terminate the enrollment of a responsible party in the pilot program if the Secretary has a sound factual basis to determine that— the responsible party no longer meets the eligibility criteria of a responsible party described in subsection (a)(5); the responsible party has materially failed to comply with the requirements under subsection (e); or as a result of a failure by a responsible party under subparagraph (B), the responsible party caused a covered unauthorized release during the pilot program. If the Secretary terminates the enrollment of a responsible party under paragraph (1), the Secretary shall submit that decision in writing to the responsible party. The appeal process described in subsection (d)(3) shall apply in the case of a responsible party that seeks to appeal a termination of enrollment under paragraph (1). The pilot program shall terminate on the date that is 3 years after the date on which the Secretary completes the application selection process under subsection (d)(1)(B). Not later than 6 months after the date of termination of the pilot program described in subsection (j), the Secretary shall submit to Congress a report that describes— the activities carried out under the pilot program, including— the quantities and identities of covered microorganisms that were moved; and a description of any unauthorized release of covered microorganisms that were moved, including a description of the cause and consequence of any unauthorized release; and recommendations on— whether the pilot program should become a permanent program; and whether, as a permanent program, changes should be made to the criteria for a responsible party under subsection (a)(5) or to the requirements under subsection (e). .
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Sec. 10006
Pilot program for the intra-organizational movement of genetically engineered microorganisms by certain authorized parties
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