APHIS Proposes Overhaul of Plant Pest Import Regulations

The proposed rule withdraws and replaces a similar proposal issued in 2001. The new proposal retains “several of the 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 proposal, APHIS said.

Proposal Would Create General Permits, Allow Corporations to Apply

APHIS revised regulations would require that importation, transit, interstate movement or release of plant pests, biological control organisms or associated articles would not 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 would issue permits to corporations. Corporations would have to designate a responsible individual to oversee the actions authorized by the permit, including for import and continued curation permits.

Responsible individual. The responsible individual required for corporate permits would have to be physically present at or near the location specified on the permit during business hours, and must 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.

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. If APHIS finalizes provisions on general permits and decides to issue one, it would announce it in the Federal Register, it said.

Permit types removed. The proposal would remove 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.

Exemptions. APHIS would create 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.
• 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 proposed 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 would issue guidance to specify 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 would 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 would 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.

APHIS Would List Exempt Pests, Create Petition Process for New Exemptions

The proposed rule would allow APHIS to issue regulations exempting plant pests from import restrictions, and create a process for petitioning the agency for exemptions for new pests. 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 sufficiently attenuated so that it no longer poses a risk to plants or plant products; or
• Be commercially available and raised under the regulatory purview of other federal agencies.

APHIS will make available a draft list of exempt pests available for comment (here), it said.

Already Established Biological Control Organisms Exempt

A new section of APHIS’s regulations would codify permit requirements for biological control organisms, defined as “any enemy, antagonist, or competitor used to control a plant pest or noxious weed.” However, some biological control organisms may qualify for exemptions. Biological control organisms that "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 a taxon of these organisms into the environment of the continental United States will present no additional plant pest risk (direct or indirect) to plants or plant products,” will not be subject to permit requirements, APHIS said.

APHIS will release a draft list of exempt biological control organisms for comment (here). The proposed rule would establish a petition process for adding new exempt biological control organisms.

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, would be exempt from permit requirements, the agency said. For soil imported from Canada, APHIS would amend its regulations so that soil from any area of Canada regulated by the Canadian Food Inspection Agency (CFIA) for a soil-borne plant pests would require a permit.

More conditions for some soils. Additional conditions would 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 would also list articles that are not soil and have a negligible risk of introducing plant pests and noxious weeds. These articles would be able to be imported without a permit, but would still be 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 would still be restricted, but those restrictions would be incorporated into Section 319.77 of APHIS’s regulations.

Proposed Revisions to Packaging Requirements

Finally, APHIS is proposing to require current packaging requirements for plant pests and biological control organisms. All shipments would have to 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 would have to be placed within another, larger package (such as bagged and sealed petri samples placed within a sealed cooler). “All packages within the shipping container would have to be constructed or safeguarded so that they will remain sealed and structurally intact throughout transit,” APHIS said. The packages would also have to be able to withstand changes in pressure, temperature, and other climatic conditions incidental to shipment.”

(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.)