APHIS Proposes Overhaul of Plant Pest Import Regulations

The final rule marks the culmination of a process that began with a proposed rule issued in 2001. The new regulations retain some provisions of the 2001 proposal, including the conditions under which APHIS considers an organism a plant pest. Other provisions are modified from the 2001 proposal or no longer appear, including provisions that would have authorized the movement of regulated organisms through a process consisting of compliance agreements and notification of movement. New procedures that APHIS has adopted as best practices since 2001 are also codified in the final rule.

Proposal Would Create General Permits, Allow Corporations to Apply

APHIS revised regulations require that importation, transit, interstate movement or release of plant pests, biological control organisms or associated articles be allowed unless it is: authorized under an import, interstate or continued curation permit; authorized elsewhere in APHIS regulations; exempt from permit requirements; or authorized under a general permit. For the first time, APHIS will issue permits to corporations. Corporations will have to designate a responsible individual to oversee the actions authorized by the permit, including for import and continued curation permits.

Responsible individual. The new regulations require that permittees designate a responsible individual to serve as the primary contact for communication with APHIS. The “act, omission, or failure of any responsible individual will also be deemed the act, omission, or failure of a permittee,” APHIS said. In its final rule, APHIS is eliminating a proposed requirement that the responsible individual be physically present at or near the location specified on the permit during business hours.

General permits. APHIS historically issued only specific permits applicable to a single person. However, the Plant Protection Act authorizes general permits, and APHIS has in recent years “contemplated issuing a general, web-based permit for the interstate movement of certain plant pests that we regard to be low-risk unless they are moved into certain areas” of the U.S., it said in its proposed rule. For now, APHIS will keep regulatory provisions in place that authorize general permits, but will continue issuing only specific permits in which one or more responsible individuals are identified in the permit and agree to abide by its requirements. "However, for future needs we are retaining in the regulations the language we proposed for issuing general permits and reaffirming our authority under the PPA to issue such permits. We will continue to evaluate the uses and purposes of general permits, and whenever we begin issuing them, we will announce in a Federal Register notice the existence, location, and content of each such permit we issue," APHIS said.

Permit types removed. The final rule removes provisions for permits for plant pest movement associated with national defense projects, permits for means of conveyance, and courtesy permits for organisms not subject to APHIS regulation, though existing permits remain valid.

Exemptions. APHIS is creating several exemptions to permitting requirements, as follows:

• Plant pests exempted by APHIS because they are already established, no longer pose a risk or are regulated by other agencies.
• Interstate movement of pure cultures of biological control organisms already established in the U.S.
• Biological control organism products for which the Environmental Protection Agency has issued experimental use products or has registered as microbial pesticide products.

Guidance to Recommend Submission of Application 90 Days Prior

Rather than prescribe specific application procedures, the new permitting regulations refer potential applicants to the APHIS website for more detailed information. Permit applications must be complete before APHIS begins its review. The agency specifies that, in order to facilitate timely issuance of a permit, an application should be submitted at least 90 days before the actions proposed on the permit application are scheduled to take place, with additional time allotted for complex or novel applications, or applications for high-risk plant pests.

Other permit conditions. The procedures for issuing a permit will largely mirror current agency practice. APHIS will not review a permit application until it is complete. Review will begin with consultations with states, tribes and “other individuals.” APHIS may then inspect the sites and facilities where the organism or article will be held or released. Before APHIS approves the permit, the applicant must agree in writing to comply with all permit conditions. The permit would be valid for no more than three years.

Permit revocation and suspension. APHIS will be able to revoke permits if it receives info that would have led it to reject the original permit application; determines that the actions taken under the permit have resulted in or risk the introduction of plant pests that present an unacceptable risk to plant or plant products; or the permittee or any of its officers, agents or employees have failed to comply with the permit. APHIS could also suspend a permit if it identifies new factors that cause it to re-evaluate the risk associated with a permit.

Exemptions for Listed Plant Pests, Biological Control Organisms Narrowed to Interstate Movement

While the proposed rule would have exempted certain plant pests from permit requirements for importation and interstate movement, the final rule narrows this exemption to only cover interstate movement. To be exempted from importation, APHIS would have to specifically make a finding authorizing importation without a permit. To be included on the list of exempt pests, which will be published on the APHIS PPQ website, a plant must:

• 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
• Be commercially available and raised under the regulatory purview of other federal agencies.

Similarly, as proposed, APHIS exempted importation and interstate movement of some biological control organisms, but is now narrowing that exemption to only interstate movement. A new section of APHIS’s regulations codifies permit requirements for biological control organisms, defined as “any enemy, antagonist, or competitor used to control a plant pest or noxious weed.” The exemption now applies to pure cultures of biological control organisms that have become established throughout their geographical or ecological range in the continental U.S. In the final rule, APHIS defines a pure culture as "a single species of invertebrate originating only from an identified/described population and free of disease and parasites, cryptic species, soil and other biological material, except host material and substrate as APHIS deems appropriate."

APHIS recently released lists of exempt biological control organisms, and a list of exempt pests.

Soil Provisions Overhauled, Exempt Stone and Quarry Products Clarified

APHIS is removing a subsection of its regulations that dealt specifically with “soil, stone and quarry products,” and will instead regulate such articles as it does all other articles that may contain plant pests. Soil stone and quarry products that are regulated by other sections of APHIS’s regulations, as well as most soil from Canada, are exempt from permit requirements, the agency said. For soil imported from Canada, APHIS is amending its regulations so that soil from any area of Canada regulated by the Canadian Food Inspection Agency (CFIA) for a soil-borne plant pest would require a permit.

More conditions for some soils. Additional conditions apply for soil intended for the extraction of plant pests, as well as soil harboring plant pests that is imported into the U.S. for disposal.

Stone and quarry products. The new regulations also list articles that are not soil and have a negligible risk of introducing plant pests and noxious weeds. These articles may be imported without a permit, but are still subject to inspection at the port of entry and reinspection at other locations:

• 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.
• Sediment, mud, or rock from saltwater bodies of water.
• Cosmetic mud and other commercial mud products.
• Stones, rocks and quarry products.

Stone and quarry products from areas in Canada that are infested with gypsy moth are still restricted, but those restrictions are now incorporated into Section 319.77 of APHIS’s regulations.

Proposed Revisions to Packaging Requirements

Finally, APHIS is setting packaging requirements for plant pests and biological control organisms. All shipments must consist of an outer shipping container and “at least two packages within the container,” APHIS said. The innermost package would have to contain the organisms or articles that will be moved. As a safeguard, the innermost package must be placed within another, larger package (such as bagged and sealed petri samples placed within a sealed cooler). All packages within the shipping container must be constructed or safeguarded so that they will remain sealed and structurally intact throughout transit, APHIS said. The packages must also be able to withstand changes in pressure, temperature and other climatic conditions incidental to shipment. In a change from the proposal, APHIS will no longer require that shipping containers be sterilized or disinfected for reuse as long as the inner packaging sufficiently contains the organisms to prevent contamination of the outer shipping container.

(See APHIS’s proposed rule for other provisions, including criteria for designating a plant pest, amendments to reflect agency permitting practices, revised criteria for agency decisions on whether to issue a permit, and requirements for importation of plant pests, biological control organisms and soil in personal baggage.)