(a) Restrictions. No person shall import, move interstate, transit, or release into the environment plant pests, biological control organisms, or associated articles, unless the importation, interstate movement, transit, or release into the environment of the plant pests, biological control organisms, or associated articles is:

(1) Authorized under an import, interstate movement, or continued curation permit issued in accordance with § 330.201; or

(2) Authorized in accordance with other APHIS regulations in this chapter; or

(3) Explicitly granted an exception from permitting requirements in this subpart; or

(4) Authorized under a general permit issued by the Administrator.

(b) Plant pests regulated by this subpart. For the purposes of this subpart, and except for an organism that has undergone genetic engineering as defined in § 340.3 of this chapter, APHIS will consider an organism to be a plant pest if the organism directly or indirectly injures, causes damage to, or causes disease in a plant or plant product, or if the organism is an unknown risk to plants or plant products, but is similar to an organism known to directly or indirectly injure, cause damage to, or cause disease in a plant or plant product. Plant pests that have undergone genetic engineering, as defined in § 340.3 of this chapter, are subject to the regulations of part 340 of this chapter.

(c) Biological control organisms regulated by this subpart. For the purposes of this subpart, biological control organisms include:

(1) Invertebrate predators and parasites (parasitoids) used to control invertebrate plant pests;

(2) Invertebrate competitors used to control invertebrate plant pests;

(3) Invertebrate herbivores used to control noxious weeds;

(4) Microbial pathogens used to control invertebrate plant pests;

(5) Microbial pathogens used to control noxious weeds;

(6) Microbial parasites used to control plant pathogens; and

(7) Any other types of biological control organisms, as determined by APHIS.

(d) Biological control organisms not regulated by this subpart. Paragraph (c) of this section notwithstanding, biological control organisms that have undergone genetic engineering, as defined in § 340.3 of this chapter, as well as products that are currently under an EPA experimental use permit, a Federal Insecticide Fungicide and Rodenticide Act (FIFRA) section 18 emergency exemption, or products that are currently registered with EPA as a microbial pesticide product, are not regulated under this subpart. Additionally, biological control organisms that are pesticides that are not registered with EPA, but are being transferred, sold, or distributed in accordance with EPA's regulations in 40 CFR 152.30, are not regulated under this subpart for their interstate movement or importation. However, an importer desiring to import a shipment of biological control organisms subject to FIFRA must submit to the EPA Administrator a Notice of Arrival of Pesticides and Devices as required by CBP regulations at 19 CFR 12.112. The Administrator will provide notification to the importer indicating the disposition to be made of shipment upon its entry into the customs territory of the United States.

(a) Types of permits. APHIS issues import permits, interstate movement permits, continued curation permits, and transit permits for plant pests, biological control organisms, and associated articles. 1

(1) Import permit. Import permits are issued to persons for secure shipment from outside the United States into the territorial limits of the United States. When import permits are issued to individuals, these individuals must be 18 years of age or older and have a physical address within the United States. When import permits are issued to corporate persons, these persons must maintain an address or business office in the United States with one or more designated individuals for service of process.

(2) Interstate movement permit. Interstate movement permits are issued to persons for secure shipment from any State into or through any other State. When interstate movement permits are issued to individuals, these individuals must be 18 years of age or older and have a physical address within the United States. When interstate movement permits are issued to corporate persons, these persons must maintain an address or business office in the United States with a designated individual for service of process.

(3) Continued curation permits. Continued curation permits are issued in conjunction with and prior to the expiration date for an import permit or interstate movement permit, in order for the permittee to continue the actions listed on the import permit or interstate movement permit. When continued curation permits are issued to individuals, these individuals must be 18 years of age or older and have a physical address within the United States. When continued curation permits are issued to corporate persons, these persons must maintain an address or business office in the United States with one or more designated individuals for service of process.

(4) Transit permits. Transit permits are issued for secure shipments through the United States. Transit permits are issued in accordance with part 352 of this chapter.

(b) Applying for a permit. Permit applications must be submitted by the applicant in writing or electronically through one of the means listed at http://www.aphis.usda.gov/plant_health/permits/index.shtml in advance of the action(s) proposed on the permit application.

(c) Completing a permit application. A permit application must be complete before APHIS will evaluate it in order to determine whether to issue the permit requested. To facilitate timely processing, applications should be submitted as far in advance as possible of the date of the proposed permit activity. Guidance regarding how to complete a permit application, including guidance specific to the various information blocks on the application, is available at http://www.aphis.usda.gov/plant_health/permits/index.shtml.

(d) APHIS action on permit applications. APHIS will review the information on the application to determine whether it is complete. In order to consider an application complete, APHIS may request additional information that it determines to be necessary in order to assess the risk to plants and plant products that may be posed by the actions proposed on the application. When it is determined that an application is complete, APHIS will commence review of the information provided.

(1) State or Tribal consultation and comment; consultation with other individuals. APHIS will share a copy of the permit application, and the proposed permit conditions, with the appropriate State or Tribal regulatory officials, and may share the application and the proposed conditions with other persons or groups to provide comment.

(2) Initial assessment of sites and facilities. Prior to issuance of a permit, APHIS will assess all sites and facilities that are listed on the permit application, including private residences, biocontainment facilities, and field locations where the organism 2 or associated article will be held or released. As part of this assessment, all sites and facilities are subject to inspection. All facilities must be determined by APHIS to be constructed and maintained in a manner that prevents the dissemination or dispersal of plant pests, biological control organisms, or associated articles from the facility. The applicant must provide all information requested by APHIS regarding this assessment, and must allow all inspections requested by APHIS during normal business hours (8 a.m. to 4:30 p.m., Monday through Friday, excluding holidays). Failure to do so constitutes grounds for denial of the permit application.

(3) Issuance of a permit. APHIS may issue a permit to an applicant if APHIS concludes that the actions indicated in the permit application are not likely to introduce or disseminate a plant pest, biological control organism, or noxious weed within the United States in a manner that exposes plants and plant products to unacceptable risk. Issuance will occur as follows:

(i) Prior to issuing the permit, APHIS will notify the applicant in writing or electronically of all proposed permit conditions. The applicant must agree in writing or electronically that he or she, and all his or her employees, agents, and/or officers, will comply with all permit conditions and all provisions of this subpart. If the organism or associated article will be contained in a private residence, the applicant must state in this agreement that he or she authorizes APHIS to conduct unscheduled assessments of the residence during normal business hours if a permit is issued.

(ii) APHIS will issue the permit after it receives and reviews the applicant's agreement. The permit will be valid for no more than 3 years. During that period, the permittee must abide by all permitting conditions, and the use of the organism or associated article must conform to the intended use on the permit. Moreover, the use of organisms derived from a regulated parent organism during that period must conform to the intended use specified on the permit for the parent organism.

(iii) All activities carried out under the permit must cease on or before the expiration date for the permit, unless, prior to that expiration date, the permittee has submitted a new permit application and a new permit has been issued to authorize continuation of those actions.

(iv) At any point following issuance of a permit but prior to its expiration date, an inspector may conduct unscheduled assessments of the site or facility in which the organisms or associated articles are held, to determine whether they are constructed and are being maintained in a manner that prevents the dissemination of organisms or associated articles from the site or facility. The permittee must allow all such assessments requested by APHIS during normal business hours. Failure to allow such assessments constitutes grounds for revocation of the permit.

(4) Denial of a permit application. APHIS may deny an application for a permit if:

(i) APHIS concludes that the actions proposed in the permit application would present an unacceptable risk to plants and plant products because of the introduction or dissemination of a plant pest, biological control organism, or noxious weed within the United States; or

(ii) The actions proposed in the permit application would be adverse to the conduct of an APHIS eradication, suppression, control, or regulatory program; or

(iii) A State or Tribal executive official, or a State or Tribal plant protection official authorized to do so, objects to the movement in writing and provides specific, detailed information that there is a risk the movement will result in the dissemination of a plant pest or noxious weed into the State, APHIS evaluates the information and agrees, and APHIS determines that such plant pest or noxious weed risk cannot be adequately addressed or mitigated; or

(iv) The applicant does not agree to observe all of the proposed permit conditions that APHIS has determined are necessary to mitigate identified risks; or

(v) The applicant does not provide information requested by APHIS as part of an assessment of sites or facilities, or does not allow APHIS to inspect sites or facilities associated with the actions listed on the permit application; or

(vi) APHIS determines that the applicant has not followed prior permit conditions, or has not adequately demonstrated that they can meet the requirements for the current application. Factors that may contribute to such a determination include, but are not limited to:

(A) The applicant, or a partnership, firm, corporation, or other legal entity in which the applicant has a substantial interest, financial or otherwise, has not complied with any permit that was previously issued by APHIS.

(B) Issuing the permit would circumvent any order denying or revoking a previous permit issued by APHIS.

(C) The applicant has previously failed to comply with any APHIS regulation.

(D) The applicant has previously failed to comply with any other Federal, State, or local laws, regulations, or instructions pertaining to plant health.

(E) The applicant has previously failed to comply with the laws or regulations of a national plant protection organization or equivalent body, as these pertain to plant health.

(F) APHIS has determined that the applicant has made false or fraudulent statements or provided false or fraudulent records to APHIS.

(G) The applicant has been convicted or has pled nolo contendere to any crime involving fraud, bribery, extortion, or any other crime involving a lack of integrity.

(5) Withdrawal of a permit application. Any permit application may be withdrawn at the request of the applicant. If the applicant wishes to withdraw a permit application, he or she must provide the request in writing to APHIS. APHIS will provide written notification to the applicant as promptly as circumstances allow regarding reception of the request and withdrawal of the application.

(6) Cancellation of a permit. Any permit that has been issued may be canceled at the request of the permittee. If a permittee wishes a permit to be canceled, he or she must provide the request in writing to APHIS-PPQ. Whenever a permit is canceled, APHIS will notify the permittee in writing regarding such cancellation.

(7) Revocation of a permit. APHIS may revoke a permit for any of the following reasons:

(i) After issuing the permit, APHIS obtains information that would have otherwise provided grounds for it to deny the permit application; or

(ii) APHIS determines that the actions undertaken under the permit have resulted in or are likely to result in the introduction into or dissemination within the United States of a plant pest or noxious weed in a manner that presents an unacceptable risk to plants or plant products; or

(iii) APHIS determines that the permittee, or any employee, agent, or officer of the permittee, has failed to comply with a provision of the permit or the regulations under which the permit was issued.

(8) Amendment of permits—(i) Amendment at permittee's request. If a permittee determines that circumstances have changed since the permit was initially issued and wishes the permit to be amended accordingly, he or she must request the amendment, either through APHIS' online portal for permit applications, or by contacting APHIS directly via phone or email. The permittee may have to provide supporting information justifying the amendment. APHIS will review the amendment request, and may amend the permit if only minor changes are necessary. Requests for more substantive changes may require a new permit application. Prior to issuance of an amended permit, the permittee may be required to agree in writing that he or she, and his or her employees, agents, and/or officers will comply with the amended permit and conditions.

(ii) Amendment initiated by APHIS. APHIS may amend any permit and its conditions at any time, upon determining that the amendment is needed to address newly identified considerations concerning the risks presented by the organism or the activities being conducted under the permit. APHIS may also amend a permit at any time to ensure that the permit conditions are consistent with all of the requirements of this part. As soon as circumstances allow, APHIS will notify the permittee of the amendment to the permit and the reason(s) for it. Depending on the nature of the amendment, the permittee may have to agree in writing or electronically that he or she, and his or her employees, agents, and/or officers, will comply with the permit and conditions as amended before APHIS will issue the amended permit. If APHIS requests such an agreement, and the permittee does not agree in writing that he or she, and his or her employees, agents, and/or officers, will comply with the amended permit and conditions, the existing permit will be revoked.

(9) Suspension of permitted actions. APHIS may suspend authorization of actions authorized under a permit if it identifies new factors that cause it to reevaluate the risk associated with those actions. APHIS will notify the permittee in writing of this suspension explaining the reasons for it and stating the actions for which APHIS is suspending authorization. Depending on the results of APHIS' evaluation, APHIS will subsequently contact the permittee to remove the suspension, amend the permit, or revoke the permit.

(10) Appeals. Any person whose application has been denied, whose permit has been revoked or amended, or whose authorization for actions authorized under a permit has been suspended, may appeal the decision in writing to the Administrator within 10 business days after receiving the written notification of the denial, revocation, amendment, or suspension. The appeal shall state all of the facts and reasons upon which the person relies to show that the application was wrongfully denied, permit revoked or amended, or authorization for actions under a permit suspended. The Administrator shall grant or deny the appeal, stating the reasons for the decision as promptly as circumstances allow.

(a) General conditions for importation, interstate movement, and release of biological control organisms. Except as provided in paragraph (b) of this section, no biological control organism regulated under this subpart may be imported, moved in interstate commerce, or released into the environment unless a permit has been issued in accordance with § 330.201 authorizing such importation, interstate movement, or release, and the organism is moved or released in accordance with this permit and the regulations in this subpart. The regulations in 40 CFR parts 1500 through 1508, part 1b of this title, and part 372 of this chapter may require APHIS to request additional information from an applicant regarding the proposed release of a biological control organism as part of its evaluation of a permit application. Further information regarding the types of information that may be requested, and the manner in which this information will be evaluated, is found at http://www.aphis.usda.gov/plant_health/permits/index.shtml.

(b) Exceptions from permitting requirements for certain biological control organisms. APHIS has determined that certain biological control organisms have become established throughout their geographical or ecological range in the continental United States, such that the additional release of pure cultures derived from field populations of taxa of such organisms into the environment of the continental United States will present no additional plant pest risk (direct or indirect) to plants or plant products. Lists of biological control organisms for invertebrate plant pests and for weeds are maintained on the PPQ Permits and Certifications website at https://www.aphis.usda.gov/aphis/resources/permits.

(1) Importation and interstate movement of listed organisms. Pure cultures of organisms excepted from permit requirements, unless otherwise indicated, may be imported or moved interstate within the continental United States without further restriction under this subpart.

(2) Release of listed organisms. Pure cultures of organisms on the list may be released into the environment of the continental United States without further restriction under this subpart.

(c) Additions to the list of organisms granted exceptions from permitting requirements for their importation, interstate movement, or release. Any person may request that APHIS add a biological control organism to the list referred to in paragraph (b) of this section by submitting a petition to APHIS via email to [email protected] or through any means listed at http://www.aphis.usda.gov/plant_health/permits/index.shtml. The petition must include the following information:

(1) Evidence indicating that the organism is indigenous to the continental United States throughout its geographical or ecological range, or evidence indicating that the organism has produced self-replicating populations within the continental United States for an amount of time sufficient, based on the organism's taxon, to consider that taxon established throughout its geographical or ecological range in the continental United States; or

(2) Evidence that the organism's geographical or ecological range includes an extremely limited area of or none of the continental United States based on its inability to maintain year to year self-replicating populations despite repeated introductions over a sufficient range of time; or

(3) The petition would include evidence that the organism cannot establish anywhere in the continental United States; or

(4) Results from a field study where data were collected from representative habitats occupied by the biological control organism. Studies must include sampling for any direct or indirect impacts on target and non-target hosts of the biological control organism in these habitats. Supporting scientific literature must be cited; or

(5) Any other data, including published scientific reports, that suggest that subsequent releases of the organism into the environment of the continental United States will present no additional plant pest risk (direct or indirect) to plants or plant products.

(d) APHIS review of petitions—(1) Evaluation. APHIS will review the petition to determine whether it is complete. If APHIS determines that the petition is complete, it will conduct an evaluation of the petition to determine whether there is sufficient evidence that the organism exists throughout its geographical or ecological range in the continental United States and that subsequent releases of pure cultures of field populations of the organism into the environment of the continental United States will present no additional plant pest risk (direct or indirect) to plants or plant products.

(2) Notice of availability of the petition. If APHIS determines that there is sufficient evidence that the organism exists throughout its geographical or ecological range in the continental United States and that subsequent releases of pure cultures of the organism into the environment of the continental United States will present no additional plant pest risk to plants or plant products, APHIS will publish a notice in the Federal Register announcing the availability of the petition and requesting public comment on that document.

(3) Notice of determination. (i) If no comments are received, or if the comments received do not lead APHIS to reconsider its determination, APHIS will publish in the Federal Register a subsequent notice describing the comments received and stating that the organism has been added to the list referred to in paragraph (b) of this section.

(ii) If the comments received lead APHIS to reconsider its determination, APHIS will publish in the Federal Register a subsequent notice describing the comments received and stating its reasons for determining not to add the organism to the list referred to in paragraph (b) of this section.

(e) Removal of organisms from the list of exempt organisms. Any biological control organism may be removed from the list referred to in paragraph (b) of this section if information emerges that would have otherwise led APHIS to deny the petition to add the organism to the list. Whenever an organism is removed from the list, APHIS will publish a notice in the Federal Register announcing that action and the basis for it.

(a) Requirements. The Administrator has determined that, unless it has been sterilized, soil is an associated article, and is thus subject to the permitting requirements of § 330.201, unless its movement:

(1) Is regulated pursuant to other APHIS regulations in this chapter; or

(2) Does not require such a permit under the provisions of paragraph (b)(1) or (c)(1) of this section.

(b) Conditions governing the importation of soil—(1) Permit. Except as provided in § 319.37-10 of this chapter and except for soil imported from areas of Canada not regulated by the national plant protection organization of Canada for a soil-borne plant pest, soil may be imported into the United States if an import permit has been issued in accordance with § 330.201 and if the soil is imported under the conditions specified on the permit.

(2) Additional conditions for the importation of soil via hand-carry. In addition to the condition of paragraph (b)(1) of this section, soil may be hand-carried into the United States only if the importation meets the conditions of § 330.205.

(3) Additional conditions for the importation of soil intended for the extraction of plant pests. In addition to the condition of paragraph (b)(1) of this section, soil may be imported into the United States for the extraction of plant pests if the soil will be imported directly to an APHIS-approved biocontainment facility.

(4) Additional conditions for the importation of soil contaminated with plant pests and intended for disposal. In addition to the condition of paragraph (b)(1) of this section, soil may be imported into the United States for the disposal of plant pests if the soil will be imported directly to an APHIS-approved disposal facility.

(5) Exemptions. The articles listed in this paragraph (b) are not soil, provided that they are free of organic material. Therefore, they may be imported into the United States without an import permit issued in accordance with § 330.201, unless the Administrator has issued an order stating otherwise. All such articles are, however, subject to inspection at the port of first arrival, subsequent reinspection at other locations, other remedial measures deemed necessary by an inspector to remove any risk the items pose of disseminating plant pests or noxious weeds, and any other restrictions of this chapter:

(i) Consolidated material derived from any strata or substrata of the earth. Examples include clay (laterites, bentonite, china clay, attapulgite, tierrafino), talc, chalk, slate, iron ore, and gravel.

(ii) Sediment, mud, or rock from saltwater bodies of water.

(iii) Cosmetic mud and other commercial mud products.

(iv) Stones, rocks, and quarry products.

(c) Conditions governing the interstate movement of soil—(1) General conditions. Except for soil moved in accordance with paragraphs (c)(2) through (5) of this section, soil may be moved interstate within the United States without prior issuance of an interstate movement permit in accordance with § 330.201 or further restriction under this subpart. However, all soil moved interstate is subject to any movement restrictions and remedial measures specified for such movement referenced in part 301 of this chapter.

(2) Conditions for the interstate movement within the continental United States of soil intended for the extraction of plant pests. Soil may be moved in interstate commerce within the continental United States with the intent of extracting plant pests, only if an interstate movement permit has been issued for its movement in accordance with § 330.201, and if the soil will be moved directly to an APHIS-approved biocontainment facility in a secure manner that prevents its dissemination into the outside environment.

(3) Conditions for the interstate movement within the continental United States of soil infested with plant pests and intended for disposal. Soil may be moved in interstate commerce within the continental United States with the intent of disposing of plant pests, only if an interstate movement permit has been issued for its movement in accordance with § 330.201, and the soil will be moved directly to an APHIS-approved disposal facility in a secure manner that prevents its dissemination into the outside environment.

(4) Conditions for the interstate movement of soil samples from an area quarantined in accordance with part 301 of this chapter for chemical or compositional testing or analysis. Soil samples may be moved for chemical or compositional testing or analysis from an area that is quarantined in accordance with part 301 of this chapter without prior issuance of an interstate movement permit in accordance with § 330.201 or further restriction under this chapter, provided that the soil is moved to a laboratory that has entered into and is operating under a compliance agreement with APHIS, is abiding by all terms and conditions of the compliance agreement, and is approved by APHIS to test and/or analyze such samples.

(5) Additional conditions for interstate movement of soil to, from, or between Hawaii, the territories, and the continental United States. In addition to all general conditions for interstate movement of soil, soil may be moved in interstate commerce to, from, or between Hawaii, the territories, and the continental United States only if an interstate movement permit has been issued for its movement in accordance with § 330.201. In addition, soil moved to, from, or between Hawaii, the territories, and the continental United States with the intent of extracting plant pests is subject to the conditions of paragraph (c)(2) of this section, while soil infested with plant pests and intended for disposal is subject to the conditions of paragraph (c)(3) of this section.

(d) Conditions governing the transit of soil through the United States. Soil may transit through the United States only if a transit permit has been issued for its movement in accordance with part 352 of this chapter.

Pursuant to section 7711 of the Plant Protection Act (7 U.S.C. 7701 et seq.), the Administrator has determined that certain plant pests may be moved interstate within the continental United States without restriction. The list of all such plant pests is on the PPQ Permits and Certifications website at https://www.aphis.usda.gov/aphis/resources/permits. Plant pests listed as being excepted from permitting requirements, unless otherwise indicated, may be moved interstate within the continental United States without further restriction under this subpart.

(a) Categories. In order to be included on the list, a plant pest must:

(1) Be from field populations or lab cultures derived from field populations of a taxon that is established throughout its entire geographical or ecological range within the continental United States; or

(2) Be commercially available and raised under the regulatory purview of other Federal agencies.

(b) Petition process to add plant pests to the list—(1) Petition. Any person may petition APHIS to have an additional plant pest added to the list of plant pests that may be imported into or moved in interstate commerce within the continental United States without restriction. To submit a petition, the person must provide, in writing, information supporting the placement of a particular pest in one of the categories listed in paragraph (a) of this section.

(i) Information that the plant pest belongs to a taxon that is established throughout its entire geographical or ecological range within the United States must include scientific literature, unpublished studies, or data regarding:

(A) The biology of the plant pest, including characteristics that allow it to be identified, known hosts, and virulence;

(B) The geographical or ecological range of the plant pest within the continental United States; and

(C) The areas of the continental United States within which the plant pest is established.

(ii) Information that the plant pest is commercially available and raised under the regulatory purview of another Federal agency must include a citation to the relevant law, regulation, or order under which the agency exercises such oversight.

(2) APHIS review. APHIS will review the information contained in the petition to determine whether it is complete. In order to consider the petition complete, APHIS may require additional information to determine whether the plant pest belongs to one of the categories listed in paragraph (a) of this section. When it is determined that the information is complete, APHIS will commence review of the petition.

(3) Action on petitions to add pests. (i) If, after review of the petition, APHIS determines there is insufficient evidence that the plant pest belongs to one of the categories listed in paragraph (a) of this section, APHIS will deny the petition, and notify the petitioner in writing regarding this denial.

(ii) If, after review of the petition, APHIS determines that the plant pest belongs to one of the categories in paragraph (a) of this section, APHIS will publish a notice in the Federal Register that announces the availability of the petition and any supporting documentation to the public, that states that APHIS intends to add the plant pest to the list of plant pests that may be imported into or moved in interstate commerce within the continental United States without restriction, and that requests public comment. If no comments are received on the notice, or if, based on the comments received, APHIS determines that its conclusions regarding the petition have not been affected, APHIS will publish in the Federal Register a subsequent notice stating that the plant pest has been added to the list.

(c) Petition process to have plant pests removed from the list—(1) Petition. Any person may petition to have a plant pest removed from the list of plant pests that may be imported into or moved interstate within the continental United States without restriction by writing to APHIS. The petition must contain independently verifiable information demonstrating that APHIS' initial determination that the plant pest belongs to one of the categories in paragraph (a) of the section should be changed, or that additional information is now available that would have caused us to change the initial decision.

(2) APHIS review. APHIS will review the information contained in the petition to determine whether it is complete. In order to consider the petition complete, APHIS may require additional information supporting the petitioner's claim. When it is determined that the information is complete, APHIS will commence review of the petition.

(3) APHIS action on petitions to remove pests. (i) If, after review of the petition, APHIS determines that there is insufficient evidence to suggest that its initial determination should be changed, APHIS will deny the petition, and notify the petitioner in writing regarding this denial.

(ii) If, after review of the petition, APHIS determines that there is a sufficient basis to suggest that its initial determination should be changed, APHIS will publish a notice in the Federal Register that announces the availability of the petition, and that requests public comment regarding removing the plant pest from the list of plant pests that may be imported into or move in interstate commerce within the continental United States without restriction. If no comments are received on the notice, or if the comments received do not affect APHIS' conclusions regarding the petition, APHIS will publish a subsequent notice in the Federal Register stating that the plant pest has been removed from the list.

(d) APHIS-initiated changes to the list. (1) APHIS may propose to add a plant pest to or remove a pest from the list of plant pests that may be imported into or move in interstate commerce within the continental United States without restriction, if it determines that there is sufficient evidence that the plant pest belongs to one of the categories listed in paragraph (a) of the section, or if evidence emerges that leads APHIS to reconsider its initial determination that the plant pest was or was not in one of the categories listed in paragraph (a) of this section. APHIS will publish a notice in the Federal Register announcing this proposed addition or removal, making available any supporting documentation that it prepares, and requesting public comment.

(2) If no comments are received on the notice or if the comments received do not affect the conclusions of the notice, APHIS will publish a subsequent notice in the Federal Register stating that the plant pest has been added to or removed from the list.

Plant pests, biological control organisms, and soil may be hand-carried into the United States only in accordance with the provisions of this section.

(a) Authorization to hand-carry—(1) Application for a permit; specification of “hand-carry” as proposed method of movement. A person must apply for an import permit for the plant pest, biological control organism, or soil, in accordance with § 330.201, and specify hand-carry of the organism or article as the method of proposed movement.

(2) Specification of individual who will hand-carry. The application must also specify the individual or individuals who will hand-carry the plant pest, biological control organism, or soil into the United States. If APHIS authorizes this individual or these individuals to hand-carry, the authorization may not be transferred to nor actions under it performed by individuals other than those identified on the permit application.

(b) Notification of intent to hand-carry. After the permittee has obtained an import permit but no less than 20 days prior to movement, the permittee must provide APHIS through APHIS' online portal for permit applications or by fax with the names of the designated hand carrier, or carriers, assigned to that movement. Additional conditions for hand-carry are available on the APHIS website. 3

(c) Denial, amendment, or cancellation of authorization to hand-carry. APHIS may deny a request to hand-carry, or amend or cancel any hand-carry authorization at any time, if it deems such action necessary to prevent the introduction or dissemination of plant pests or noxious weeds within the United States.

(d) Appeal of denial, amendment, or cancellation. Any person whose request to hand-carry has been denied, or whose authorization to hand-carry has been amended or canceled, may appeal the decision in writing to APHIS.

Shipments in which plant pests, biological control organisms, and associated articles are imported into, moved in interstate commerce, or transited through the United States must meet the general packaging requirements of this section, as well as all specific packaging requirements on the permit itself.

(a) Packaging requiremspents. All shipments must consist of an outer shipping container and at least two packages within the container. Both the container and inner packages must be securely sealed to prevent the dissemination of the enclosed plant pests, biological control organisms, or associated articles.

(1) Outer shipping container. The outer shipping container must be rigid, impenetrable and durable enough to remain closed and structurally intact in the event of dropping, lateral impact with other objects, and other shocks incidental to handling.

(2) Inner packages. The innermost package or packages within the shipping container must contain all of the organisms or articles that will be moved. As a safeguard, the innermost package must be placed within another, larger package. All packages within the shipping container must be constructed or safeguarded so that they will remain sealed and structurally intact throughout transit. The packages must be able to withstand changes in pressure, temperature, and other climatic conditions incidental to shipment.

(b) Packing material. Packing materials may be placed in the inner packages or shipping container for such purposes as cushioning, stabilizing, water absorption or retention, nourishment or substrate for regulated articles, etc. Packing material for importation must be free of plant pests, noxious weeds, biological control organisms not listed on the permit or associated articles, and, as such, must be new, or must have been sterilized or disinfected prior to reuse. Packing material must be suited for the enclosed organism or article, as well as any medium in which the organism or article will be maintained.

(c) Requirements following receipt of the shipment at the point of destination. (1) Packing material, including media and substrates, must be destroyed by incineration, be decontaminated using autoclaving or another approved method, or otherwise be disposed of in a manner specified in the permit itself.

(2) Shipping containers may be reused, provided that the container has not been contaminated with plant pests, noxious weeds, biological control organisms, or associated articles. Shipping containers that have been in contact with or otherwise contaminated with any of these items must be sufficiently sterilized or disinfected prior to reuse, or otherwise disposed of.

(d) Costs. Permittees who fail to meet the requirements of this section may be held responsible for all costs incident to inspection, rerouting, repackaging, subsequent movement, and any treatments.

The inspection services of APHIS inspectors during regularly assigned hours of duty and at the usual places of duty will be furnished without cost. APHIS will not be responsible for any costs or charges incidental to inspections or compliance with the provisions of this subpart, other than for the inspection services of the inspector.