USDA APHIS NBCIUSDA APHIS NBCIIn October 1996, an invitational workshop was held in Riverdale, MD, and Washington, DC, to examine biological control activities within the United States Department of Agriculture (USDA). Individuals from four USDA agencies -- the Agricultural Research Service (ARS), the Animal and Plant Health Inspection Service (APHIS), the Cooperative States Research, Education, and Extension Service (CSREES), and the Forest Service (FS) -- and from the U.S. Environmental Protection Agency (EPA), State agriculture agencies, and land grant universities attended the workshop. The participants focused on biological control coordination, regulation, and accountability within USDA and concluded the workshop by offering a number of recommendations in those three areas.
Following the workshop, a group of senior representatives from ARS, APHIS, CSREES, and FS gathered to review the workshop's proceedings and prepare an action plan to implement the key recommendations offered by the participants. This group, known as the Biological Control Coordinating Council (BCCC or the council), assembled three subcommittees to focus on the areas of coordination, accountability, and regulations. The action plans prepared by the members of those subcommittees have been consolidated in this document.
The workshop participants identified a lack of programmatic continuity in USDA's biological control programs that has led to instances of competitive, duplicative, or misdirected biological control efforts due in large part to overlapping or conflicting responsibilities and plans among the four USDA agencies with responsibilities in the realm of biological control. The participants concluded that better coordination and accountability across programs and agencies was needed, and, toward that end, suggested that the USDA should:
The BCCC recognizes the frustrations that members of the biological control community have experienced in their dealings with the Department and its agencies on biological control issues. The lack of a single point of entry into the Department through which internal or external customers could work to fully understand USDA biological control programs and processes led the workshop participants to recommend a Department-level organization to deal with biological control coordination, regulation, and accountability. The participants expected that such an organization, by providing a focal point for biological control issues and policy within USDA, would alleviate the identified problems, improve responsiveness, assist agencies in developing and implementing a systematic approach to biological control programs and activities, provide an information source that presented a unified message, and become the desired single point of entry into the Department.
The BCCC has noted that the biological control activities of each agency within the Department are not always well known by their sister agencies, which has led to some duplication of effort and uncoordinated responses to pest situations. The council has also recognized that USDA biological control activities in general could be better linked to other Departmental integrated pest management (IPM) activities, and that a more transparent and easily accessible accounting of Agency-level programs needs to be provided. With those considerations in mind, the BCCC offers several recommendations for improving biological control coordination and accountability within the Department.
In lieu of the Department-level "Center" suggested by the workshop participants, the council recommends the formation of an interagency "Advisory and Action Team" that would report to the BCCC. The team would be comprised of two representatives from each USDA agency with biological control responsibilities, i.e., ARS, APHIS, CSREES, and FS. Agency representatives should be technical experts who are knowledgeable about their agencies' biological control programs and able to accurately represent their agencies' policies and priorities. Although team membership will not be a full-time position for these representatives, it may occasionally be necessary for an agency to provide release time or reassignment of responsibilities to enable its representatives to devote significant time to the team.
Ideally, each agency will be able to designate one representative from a national or headquarters-level staff, and another representative from the operational or field level. Representation at both levels from each agency will ensure a fully coordinated effort and will help gain support for the team's work as a system-wide activity. Although the designation of individuals for membership on the team will be at the discretion of each Agency, the council firmly believes that technical expertise cited in the previous paragraph and the need for both headquarters and field representation must be the driving considerations for each agency as it considers its selection of representatives to the Advisory and Action Team. In addition to the representation from the four agencies with biological control responsibilities, the council also recommends that the Advisory and Action Team include at least one representative from the Economic Research Service, the Office of Pest Management Policy, and the chair of the USDA IPM Subcommittee.
The Advisory and Action Team, with its knowledge of biological control science and programs and its understanding of the technology transfer needed to ensure biological control is an effective and utilized pest management tool, will be able to help the BCCC guide the Department's overall biological control policy and facilitate communication among USDA agencies.
The council recognizes that there are a number of details that remain to be worked out regarding the exact disposition and implementation of the Advisory and Action Team. For such a team to remain active and viable, funding will be required from the participating agencies, team leadership and member responsibility issues will have to be addressed, and dedicated administrative support will have to be provided. However, given the demonstrated need for greater coordination and accountability in the USDA's biological control programs, and given that each agency is ready to provide representatives to form the Advisory and Action Team, the council believes that the team should meet as soon as practicable to begin work on the program inventory and needs assessment. As that work commences, the BCCC will meet to identify and resolve the details of each agency's participation in and contributions to the team.
The action plan we have developed speaks to these issues explicitly, with one exception regarding the last point. The members of the council agree that there is not a conflict between the advance notice of proposed rulemaking (ANPR) that APHIS published in the Federal Register on September 27, 1996, and the 1996 "Options for Changes in Biological Control Regulation in the United States: A Strawman for Comment" (the "Strawman"). Rather, the two documents simply differ in their focus and purpose. The ANPR is a regulatory document produced in the rulemaking context of the Administrative Procedure Act, while the "Strawman" is a conceptual document prepared for the review and comment of the scientific community. Although the "Strawman" raised issues regarding the regulation of biological control, those issues are not at odds with the directed questions pertaining to APHIS' plant pest regulations that were set out in the ANPR. That being said, the council does believe that APHIS should develop user-friendly regulations that incorporate as many appropriate principles from the "Strawman" as possible.
The council recognizes that APHIS' regulation of biological control occurs in the larger context of the Agency's statutory authority and responsibilities under the Federal Plant Pest Act (FPPA) and the Plant Quarantine Act, which require APHIS to focus on preventing the introduction and dissemination of plant pests. This means that the plant pest risk presented by an organism, rather than its intended use as a biological control agent, must be APHIS' primary consideration.
Most biological control endeavors begin with the importation of nonindigenous species that may exhibit some potential as control agents. Such importations frequently consist of field-collected organisms of unknown or unconfirmed taxonomy, which precludes an adequate pre-import pest risk assessment. Further, those organisms may be accompanied by plant materials, foreign soil, or other organisms, all of which may pose a plant pest risk. Given these factors, the initial handling of organisms with potential biological control applications does not differ substantively from that given to organisms imported for other purposes. APHIS requires that a plant pest permit be obtained for all such importations and requires that they be consigned to a registered quarantine facility, where contaminants may be safely removed and the organism of interest identified and evaluated before any further movement is allowed. With input from investigators, quarantine facility personnel, and identifiers, APHIS conducts a first-tier risk assessment that asks the following questions to determine plant pest risk:
An affirmative answer to any one of these questions will give APHIS reason to believe that the organism presents a plant pest risk and is, therefore, subject to the Agency's authority and regulations. Such organisms would require further evaluation before APHIS would allow their release into the environment. Similarly, a more in-depth assessment of the organism will be required if one or more of these questions cannot be conclusively answered at this first-tier stage. In the absence of any other evidence to the contrary, negative answers to all five questions will lead APHIS to conclude that the organism is not a plant pest and thus is not subject to the Agency's authority and regulations.
At the same time the first-tier risk assessment is being conducted, the assessors also consider whether the organism may potentially have an impact upon endangered or threatened species of plants or animals, in which case the Fish and Wildlife Service (FWS) may require further assessments of the organism. Similarly, the EPA may assert jurisdiction over some microorganisms and viruses under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).
Organisms and AffiliationsWith those considerations in mind, the council recommends an action plan that would result in: (1) A revision to APHIS' plant pest regulations that addresses the needs and concerns of our constituency with regard to the introduction of those biological control organisms that can be shown to fall within the Agency's FPPA-based authority, and (2) the establishment of a regulatory facilitation program within NBCI that would aid biological control research and practice at all levels and for all organisms, with the focus being on those non-plant-pest organisms whose release into the environment would not be covered under APHIS' regulations.
APHIS has already developed a regulatory workplan and is preparing a proposed rule to revise its Federal Plant Pest Regulations in 7 CFR part 330, particularly "Subpart--Movement of Plant Pests" (§§330.200 through 330.212).
APHIS' current plant pest regulations are for the purpose of preventing the dissemination of plant pests into the United States, or interstate, by regulating the movement of plant pests into or through the United States and interstate. When these regulations were first promulgated in 1959, they adequately addressed the needs of the regulated community, which at the time consisted mostly of government and university scientists moving plant pests into or between laboratories for research purposes. In the years since 1959, however, the range of research and applications involving organisms that present plant pest risk has broadened enormously. APHIS now regularly receives requests to import or move interstate organisms such as parasites, pathogens, and predators for the biological control of arthropod pests; centipedes, walking sticks, praying mantises, butterflies, giant cockroaches, etc. for insect zoos; and microbes for soil treatment. Although the range of organisms for which plant pest permits are requested has changed dramatically since 1959, APHIS' plant pest regulations have not been substantively amended to keep pace with those changes. In order to update those regulations and be more responsive to our customers, APHIS will be proposing to update the plant pest regulations by:
APHIS' regulatory oversight of the importation and interstate movement of plant pests is a continuing program. The changes we would propose would affect that program by reducing the number of species that would be routinely subject to regulation. Similarly, establishing a notification system for the movement of certain organisms would also reduce the number of permits applied for, processed, and issued. The proposed addition of a "release" category for permitting would have less of an effect on APHIS' regulatory program because the Agency has, for several years, issued permits that allow for release on a case-by-case basis; the proposed release permit category would simply standardize the process in that area.
We anticipate that reducing the number of species for which a permit would be required would result in no additional costs to any affected entities, public or private. Rather, we expect that researchers and others who seek permits would realize a savings in time and money as a result of having to prepare and submit fewer applications. At the same time, APHIS and State agricultural agencies would see a reduction in the number of applications to be processed and reviewed.
Because APHIS has, for several years, issued permits that allow for release of organisms into the environment on a case-by-case basis, the proposal to add a "release" category of permit is not expected to result in any additional costs and would likely save applicants time and effort by providing a standard set of criteria to be addressed. We expect that similar reductions in workload and costs would be realized by applicants and the Federal/State reviewers as a result of the proposed notification system for the interstate movement of organisms between quarantine facilities.
These proposed changes will serve as a follow-up to the ANPR that APHIS published in the Federal Register on September 27, 1996, in which the Agency solicited input on the need for regulatory changes and alternative methods of addressing plant pest risk. The proposed rule will solicit comments from the public for a period of at least 60 days, during which time any interested person will have the opportunity provide input and suggest changes.
Because APHIS' plant pest regulations do not cover all aspects of biological control, and because biological control researchers and practitioners are not always conversant in the statutory and regulatory requirements that apply to the movement and release of biological control organisms, there is a need for a facilitative center whose personnel can provide the necessary guidance.
NBCI, with its mission to promote, facilitate, and provide leadership for biological control, is ideally situated to provide the kind of assistance called for by the participants in the invitational workshop. In describing its mission and functions, NBCI offers the following:
Given those mission areas and functions, NBCI is the logical choice to be the provider of the "clear road map to compliance requirements" and the point of "centralized assistance in meeting those requirements" called for during the invitational workshop. For NBCI to fulfill that assigned role, the assistance and cooperation of all USDA agencies with a stake in biological control is critical, as is the cooperation of agencies outside of USDA, such as the EPA and the FWS. If that cooperation and assistance can be secured, NBCI will be in a position to provide information regarding the roles, responsibilities, and requirements of each Federal agency; negotiate memoranda of understanding between those agencies within a target date of six months; and help USDA's biological control constituency to identify and comply with the requirements of statutes such as the National Environmental Policy Act and the Endangered Species Act.
The council recommends that a working group be assembled, with representation from APHIS, ARS, CSREES, FS, and others to be identified, to examine the possibility of developing new legislation that would explicitly address biological control and provide a statutory basis for specific and comprehensive biological control regulations. Currently, there are two bases for the regulation of biological control organisms -- either along with plant pests under APHIS' FPPA-based authority, or along with pesticides under EPA's FIFRA-based authority -- neither of which suits the actual nature and scope of biological control.
NBCI. NBCI currently has seven staff members, all from APHIS. As NBCI's roles and responsibilities expand, additional staff and resources may be required to keep pace with the needs of its customers and its increased workload. NBCI may augment its staff through various forms of collaboration and partnering. For example, NBCI may engage students and visiting scientists from universities and other government agencies to help develop and operate parts of this Facilitation Program. Further, NBCI may adopt the latest improvements in information technology to communicate information about regulations affecting biological control.
Revised regulations. Drafting of the proposed rule can begin immediately. Based on its evaluation of the regulatory workplan for the changes to APHIS' regulations, the Office of Management and Budget has designated the proposed rule as "significant" under Executive Order 12866 and will, therefore, review the proposed rule prior to its publication.
NBCI. NBCI's role in facilitating the biological control process can begin immediately. The need for any changes in NBCI's staffing and funding will be assessed as its workload increases.
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