01-15408. Procedures and Standards Governing the Consideration of Import Requests

AGENCY:

Animal and Plant Health Inspection Service, USDA.

ACTION:

Notice and request for comments.

SUMMARY:

In accordance with section 412(d) of the Plant Protection Act, we are publishing for public comment a description of the procedures and standards that govern the consideration by the Agency's Plant Protection and Quarantine programs of import requests.

DATES:

We invite you to comment on the procedures and standards described in this notice. We will consider all comments that we receive by August 20, 2001.

ADDRESSES:

Please send four copies of your comment (an original and three copies) to: Docket No. 00-082-1, Regulatory Analysis and Development, PPD, APHIS, Suite 3C03, 4700 River Road Unit 118, Riverdale, MD 20737-1238. Please state that your comment refers to Docket No. 00-082-1.

You may read any comments that we receive on this docket in our reading room. The reading room is located in room 1141 of the USDA South Building, 14th Street and Independence Avenue SW., Washington, DC. Normal reading room hours are 8 a.m. to 4:30 p.m., Monday through Friday, except holidays. To be sure someone is there to help you, please call [phone] before coming.

APHIS documents published in the Federal Register, and related information, including the names of organizations and individuals who have commented on APHIS dockets, are available on the Internet at http://www.aphis.usda.gov/​ppd/​rad/​webrepor.html.

FOR FURTHER INFORMATION CONTACT:

Mr. Michael A. Lidsky, Assistant Director, Regulatory Coordination, PPQ, APHIS, 4700 River Road Unit 141, Riverdale, MD 20737-1236; [phone].

SUPPLEMENTARY INFORMATION:

Title IV of the Agricultural Risk Protection Act of 2000 (Pub. L. 106-224), known as the Plant Protection Act (7 U.S.C. 7701 through 7772), incorporated preexisting plant quarantine and related statutes into a comprehensive law aimed at, among other things, clarifying and augmenting the Secretary's authority to detect, control, and eradicate plant pests and noxious weeds. The Plant Protection Act was signed into law on June 20, 2000.

We are publishing this notice in accordance with sec. 412(d) of the Plant Protection Act (7 U.S.C. 7712(d)), which states:

Not later than 1 year after the date of the enactment of this Act, the Secretary shall publish for public comment a notice describing the procedures and standards that govern the consideration of import requests. The notice shall—

(1) specify how public input will be sought in advance of and during the process of promulgating regulations necessitating a risk assessment in order to ensure a fully transparent and publicly accessible process; and

(2) include consideration of the following:

(A) Public announcement of import requests that will necessitate a risk assessment.

(B) A process for assigning major/nonroutine or minor/routine status to such requests based on current state of supporting scientific information.

(C) A process for assigning priority to requests.

(D) Guidelines for seeking relevant scientific and economic information in advance of initiating informal rulemaking.

(E) Guidelines for ensuring availability and transparency of assumptions and uncertainties in the risk assessment process including applicable risk mitigation measures relied upon individually or as components of a system of mitigative measures proposed consistent with the purposes of this title.

For purposes of this notice, we are using the terms risk analysis, risk assessment, risk management, and risk communication as follows:

Risk analysis. The process that includes risk assessment, risk management, and risk communication.

Risk assessment. The process of identifying hazards and estimating the likelihood of an adverse event and the magnitude of consequences.

Risk management. The process of identifying, evaluating, and recommending alternatives for mitigating risk.

Risk communication. The open exchange of information and opinion, which leads to better understanding of risk and risk-related decisions.

This notice applies to risk analyses that are commenced on or after the date of publication of this notice.

Even before the enactment of the Plant Protection Act, Plant Protection and Quarantine (PPQ) of the Animal and Plant Health Inspection Service (APHIS) recognized the need to improve the process it uses for communicating the initiation and completion of risk analyses for commodities, in terms of making the process much more understandable, visible (transparent), and accessible to the public, while at the same time seeking to reduce the large backlog of pending risk assessments that need to be completed. PPQ management decided in the spring of 1999 to make improvements to the commodity risk analysis process because of an increase in requests to import plant commodities, a growing list of pending or incomplete risk assessments, the need for a well-defined and transparent process for risk communication, and chronic staffing shortages. The scope of the improvement project was to focus on the administrative processes related to the management of commodity plant pest risk assessment activities (e.g., documentation and data sharing and tracking, priority setting, scientific review, etc.).

The improvement project was coordinated by the APHIS Business Practices Team. These improvements in the administrative processes relative to the management of the commodity pest risk analysis process came to be known as a “quality improvement process” in which teams of Agency personnel and public sector stakeholders carefully examined the existing processes, compared them to the best practices of others, and designed and tested new processes.

In addition, a review of the PPQ safeguarding system resulted in the issuance of a report entitled “Safeguarding American Plant Resources,” which made specific recommendations concerning the need to improve risk communication, transparency of the process, and public participation, among other things. In this regard, PPQ has undertaken several actions aimed at improving the commodity risk analysis process.

PPQ held two public meetings to solicit views on specific proposals relative to improving the risk analysis process within its programs. Both meetings focused primarily on risk assessments related to the importation of fruits and vegetables. The first meeting was held on November 10, 1999, in Washington, DC (see Docket No. 99-071-1, 64 FR 54859-54860; October 8, 1999), in which we requested that interested persons: Offer criteria for when a qualitative versus a quantitative risk assessment would be appropriate; comment on the feasibility of allowing exporters or exporting countries to conduct assessments under PPQ guidance; comment on mechanisms for notifying persons of the initiation of a risk assessment; and comment on the desirability of a tracking system for permits and pest risk assessments that could be accessed through the Internet (i.e., a “web-based tracking system”).

Those who spoke at the November 1999 meeting or submitted written comments generally noted that:

• In situations where it is difficult to perform a quantitative risk analysis because there is a paucity of reliable data, risk assessments should be subject to a broad and rigorous external or peer review.
• Risk assessments could be performed by outside sources, assuming PPQ's final decisions were independent and not bound by the results of an externally prepared assessment.
• The public should receive early and systematic notification of the initiation of a pest risk assessment, using the Federal Register for the most controversial assessments.
• A web-based tracking system would be useful.

On May 18 and 19, 2000, PPQ held a symposium in Riverdale, MD (see Docket No. 00-025-1, 65 FR 20942; April 19, 2000), in which recognized experts presented information on current topics in risk analysis. In addition, Agency personnel presented information on planned improvements to the pest risk analysis process within the Agency and sought feedback on specific topics such as access and transparency, types of assessments (routine versus nonroutine), and input for purposes of scientific and technical review. Many of the same comments that were raised in the November 1999 public meeting were also brought forth at the May 2000 symposium.

In general, attendees at the May 2000 symposium sought:

• More resources directed toward completing risk assessments;
• Early and more public outreach to, and direct input from, stakeholders;
• Development of a stakeholder registry for imports in which interested persons could register online to receive information concerning commodities and countries for which risk assessments must be prepared;
• The development of program material demonstrating transparency and explaining what constitutes the current risk assessment process;
• Criteria for when an assessment will be deemed routine versus nonroutine, how assessments are prioritized, and when external or peer review will be sought for a draft risk assessment; and
• A user's guide written in clear and simple terms on how commodities may be imported.

We believe that this notice addresses not only our obligations under section 412(d) of the Plant Protection Act, but also the concerns referenced above that were brought to the Agency's attention at the November 1999 and May 2000 meetings regarding the commodity pest risk analysis process. In addition, this notice is intended to address improvements related to how we communicate with our stakeholders about risk assessments for the importation of fruits and vegetables, and about risk assessments that are in process, or will be commenced for those commodities. However, the principles discussed in this notice are also generally applicable to the importation of all plants and plant products. With regard to the issue of committing resources to the risk analysis process, PPQ is currently recruiting eight additional professional staff dedicated to the completion of risk assessments, and will soon announce vacancies for two positions to work on risk mitigation and risk management.

What Is the Current Process for Addressing Importation Requests for Commodities and How Do Risk Assessments Get Initiated?

The importation of commodities, i.e., fruits and vegetables, is subject to the requirements of the regulations found in Subpart—Fruits and Vegetables (7 CFR 319.56 through 319.56-8, referred to below as the fruits and vegetables regulations). Under § 319.56-3 of the fruits and vegetables regulations, a person must apply, in advance of any proposed shipment, for a permit to import any fruits or vegetables that are already authorized entry under the regulations. An application must include such information as the country or locality of origin of the fruits or vegetables, the port of first arrival, and the name and address in the United States of the importer to whom a permit would be issued. If the commodity is, in fact, admissible, a permit for importation will be issued in most cases. As the commodity is already authorized entry under the regulations, the preparation of a pest risk assessment would not be necessary.

However, if a commodity is not admissible and a currently accurate pest risk assessment does not exist for the commodity from a particular country or region, then a pest risk assessment must be prepared prior to making a decision about the enterability of the particular commodity. The purpose of the pest risk assessment is to determine what pest risks would be associated with the importation. If the pest risk assessment reveals that importation would result in an unacceptable level of risk of introduction of a plant pest, then the Agency must determine whether the risks can be mitigated to an acceptable level. If the risks can be so mitigated, then the Agency would issue a proposed rule to amend the fruits and vegetables regulations to allow importation under specified conditions.

It should be noted that importation requests may come from sources other than permit applications. For example, importation requests may be generated as a result of bilateral discussions between the United States and a foreign government. Other importation requests may simply result from a request submitted in a letter format from a foreign government. Such requests from foreign governments are handled in the same way as requests generated by permit applications: If no permit has been previously issued, or if there is not an applicable pest risk assessment on file, for the commodity that is the subject of the request, then a pest risk assessment must be prepared and amendments proposed to the fruits and vegetables regulations.

When Will the Public Have Opportunity for Input Concerning Importation Requests?

PPQ will take the following actions in advance of and during the process of rulemaking in order to ensure a transparent and publicly accessible process.

Utilization of Web-Based Notification and Tracking Systems To Ensure Transparency and Accessibility

PPQ intends to fully utilize web-based notification and tracking systems as a means of keeping interested persons informed of matters relating to import permit requests that require risk assessments. The principal web-based tool that we will use will be a stakeholder registry. This electronic registry will enable persons to register that they have a particular interest in being kept informed about import requests that pertain to a particular commodity, regardless of which country it is proposed to be exported from (this would be deemed a “commodity-based registration”). Alternatively, a person will be able to register to be notified of any commodity importation request pertaining to exports from a particular country (this would be deemed a “country-based registration”). A person would provide the Agency with his or her e-mail address and receive an electronic notification when either an initial import request pertaining to the commodity or country is received, or, subsequently, when a risk assessment pertaining to the specified commodity or country has been prepared and posted on the PPQ web site.

To address immediate needs, PPQ has developed an interim stakeholder registry database that is accessible via the PPQ web site (http://www.aphis.usda.gov/​ppq). This database allows interested persons to register their name and mailing address (electronic and geographic) to receive information on a specified area of interest. The current system forwards the inquiry to a designated employee who is responsible for contacting the registrant to address the concern. PPQ is currently in the process of procuring the services of a qualified contractor to fully automate the stakeholder registry.

If a person chooses not to register with the PPQ commodity stakeholder registry, they could otherwise consult the tracking systems accessible through the PPQ web site (http://www.aphis.usda.gov/​ppq). The commodity pest risk assessment web site (http://www.aphis.usda.gov/​ppq/​pra/​commodity) currently provides information on how to initiate a risk assessment for a commodity. It also includes answers to frequently asked questions and guidelines for completing a risk assessment. The web site allows interested persons to check the status of all risk assessments that are pending assignment to a risk assessor (pending) or that are in the process of being completed (active). The web site includes information regarding region, country, commodity, scientific name, and status of the commodity pest risk assessment. Copies of completed risk assessments are also available to download in portable document format (i.e., PDF files) from the web site or may be retrieved through PPQ's automatic fax vault system at [phone]. PPQ is also seeking to update its list of pending risk assessments and will be checking with requesters to confirm that they still wish us to process any pending importation requests submitted more than 18 months ago.

With regard to other related web-based mechanisms that can be used for tracking purposes, the current APHIS Import Authorization System for online permitting allows a person to check the status of his or her application for importation of fruits and vegetables, as well as submit renewals, revisions, or amendments to an existing application. To access this application, select the “Import Authorization System” direct link from the PPQ home page (http://www.aphis.usda.gov/​ppq).

Submission of Information in Support of a Risk Assessment or Submission of a Pest Risk Assessment

Once a person (i.e., any individual, group, foreign government, etc.) has been advised that the preparation of a pest risk assessment is necessary prior to importation of a fruit or vegetable, the person seeking importation of the commodity will be advised that he or she may submit specific information in support of his or her import request in order to expedite the Agency's preparation of the risk assessment. Providing the following information regarding the commodity, its country of origin, and the list of pests associated with the commodity should save the Agency the time that would otherwise be needed to gather such basic information:

1. Crop. (a) Scientific name, (b) plant part to be imported, and (c) proposed use (propagation, consumption, milling, etc.).

2. Country of origin. (a) Location of production area, as well as any unique characteristics of the production area in terms of pests or diseases, (b) name of exporting companies, (c) companies that bag, mill, or manufacture (if applicable), (d) port or ports of export, (e) export season, (f) complete address of national plant protection organization, with fax and telephone numbers, and (g) address of office or private research institution/organization that ensures phytosanitary security (if applicable).

3. List of pests and diseases associated with species. (a) Scientific name, (b) common name, (c) plant part attacked, (d) period of attack, (e) control methods, (f) efficacy of control methods, (g) economic losses associated with pests of concern, (h) pest biology or disease etiology or epidemiology, (i) system of survey and monitoring and by whom, (j) control programs and by whom, (k) systems for pest risk mitigation and by whom (quarantine treatments, free areas, systems approach, etc.), and (l) bibliographic references.

4. Certification statement. The person submitting such information should include his or her name, address, telephone, and fax numbers; e-mail address; signature and date of submission; and any tracking number that may have been previously assigned by the Agency to the import request, along with the following statement: “The information submitted is true and accurate based on the best knowledge of the submitter.”

This information should be submitted to Risk Assessments Branch Chief, Permits and Risk Assessments, PPQ, APHIS, 4700 River Road Unit 133, Riverdale, MD 20737-1236.

After reviewing the submitted information, PPQ may request any other associated information that may be needed to complete the risk assessment.

Alternatively, in lieu of submitting the above information, for “routine” assessments, an interested person may submit a complete pest risk assessment that has been prepared in accordance with the most current version of the document, “PPQ Guidelines for Pathway-Initiated Pest Risk Assessments” (currently version 5.0), which appears on the PPQ web site at http://www.aphis.usda.gov/​ppq/​pra/​commodity. PPQ encourages interested persons to prepare risk assessments using these guidelines whenever possible, but cautions that the guidelines must be very closely adhered to in order for a risk assessment to be deemed complete and be accepted for review. Furthermore, PPQ's decisions will be independent and not bound by the results of an externally prepared assessment. Interested persons are strongly encouraged to contact PPQ at [phone] prior to conducting their own pest risk assessment to ensure they have a complete information package.

Process for Assigning “Routine” Status or “Nonroutine” Status To Import Requests Based on Current State of Supporting Scientific Information

We are using the terms “routine” and “nonroutine” as a means of categorizing risk assessments instead of using the terms “major,” which is synonymous with nonroutine, and “minor,” which is synonymous with routine. We believe that the terms “routine” or “nonroutine” do not necessarily connote different types of risk assessments, but that nonroutine assessments are associated with issues that may require greater resources, including greater risk communication.

Within PPQ's Plant Health Programs staff in Riverdale, MD, the Permits and Risk Assessment (P&RA) staff is charged with processing permit requests as well as preparing pest risk assessments for commodities, propagative plant material (nursery stock), and organisms. It is the P&RA staff that is responsible, in consultation with the Phytosanitary Issues Management (PIM) staff, for applying the criteria listed below to determine whether a risk assessment will be deemed routine or nonroutine. The PIM staff seeks to resolve technical phytosanitary issues related to import and export requests, as well as provide services for the issuance of phytosanitary certificates to assist U.S. exporters.

PPQ's determination as to the type of risk assessment to be conducted will appear on the PPQ web site within one calendar quarter (90 days) from the time a risk assessment is listed as being in “active status.” Those risk assessments that have been assigned and are actively being worked on will be listed on the website as “active,” and those still pending assignment to a risk assessor will be listed as “pending.”

The following factors will be taken into consideration in categorizing risk assessments as routine or nonroutine:

• Economic value of the affected crop(s). The economic value of the domestically produced crop(s) that could be potentially affected by introduced pests, i.e., the agricultural resources potentially at risk.
• Public interest. This may be linked to the economic value of the affected crop(s), but may often reflect a significant level of interest resulting from the pest(s) to be evaluated.
• Environmental and public health importance. Measurement of the human and nonagricultural resources at risk, the potential impact on public health, plants other than crops, or endangered species.
• Level of uncertainty. The base of knowledge (or lack thereof) relative to the commodity, pests, and production area of origin for a proposed importation. The available information determines the appropriate type of assessment (e.g., qualitative, probabilistic, etc.).
• Local importance. Significance of importation of a commodity on a less than national level. While certain commodities and/or potential pest introductions may be of minor economic and/or environmental importance on a national level, they may be very significant on a regional level.
• Precedence. Whether the commodity/origin combination in question, or a similar combination, has ever been addressed in previous risk assessments and/or whether the assessment will require the use of new or different methodologies.

We encourage interested parties to submit information relevant to the importation of a particular commodity (such as comments or information on pests and diseases associated with a species) early in the process so that risk assessors will have access to this information when preparing a risk assessment. Such information could be submitted as early as when PPQ posts the initial import request on the PPQ web site, or after PPQ posts its determination as to whether the risk assessment that will be prepared is deemed to be routine or nonroutine, which should be not later than 90 days from the assignment of “active status” to a risk assessment. We hope that these initiatives aimed at improving transparency will lead to improved communication between PPQ and interested persons.

Process for Assigning Priority to Requests

It is the PIM staff that is responsible, in consultation with the P&RA staff, for assigning priorities for the completion of pest risk assessments that have been previously categorized as either routine or nonroutine using the above-referenced criteria. Once the assessments have been initially categorized as to type and priority, we will post these findings on the Agency's web site on at least a quarterly basis.

The criteria that we will use in setting priorities, (which do not appear in a specified order of significance), are as follows:

• The date on which an application was received;
• The need to reduce smuggling of a particular commodity;
• The need to further United States foreign and trade policy goals;
• The other public interest factors affected by the importation of a particular commodity;
• The need to address requests from bilateral meetings as well as the recognition of countries with multiple requests (countries with multiple requests would be asked to prioritize their requests to assist in priority-setting);

Seeking Relevant Scientific and Economic Information in Advance of Initiating Informal Rulemaking

As previously discussed elsewhere in this notice, we are taking steps via web-based mechanisms to increase the transparency of our processes and availability of all risk assessments. We will post all risk assessments on the PPQ commodity risk assessment web site when final, before the initiation of rulemaking. As explained in more detail below, we will publish a notice in the Federal Register announcing the availability of a draft of each pest risk assessment determined to be “nonroutine” and provide 60 days for the submission of comments regarding the draft risk assessment.

We recognize that not all risk assessments will generate the same level of public interest, due to factors such as the economic value of the crop proposed for importation; the amount of interest based on the size of the domestic industry; local, regional, or national impacts; potential environmental impacts; level of uncertainty; and whether the importation or methodologies used in the risk assessment or risk mitigation would be unique. Generally speaking, these factors are the same as those used to determine whether a risk assessment will be deemed routine or nonroutine. We recognize that some of the factors related to nonroutine risk assessments require a greater level of consultation with interested persons. As noted in the previous paragraph, we will solicit comments on all nonroutine risk assessments for a minimum of 60 days prior to the initiation of any rulemaking. If necessary, based on the complexity or length of a risk assessment, we may provide the public with an opportunity to comment for more than 60 days, as we did in the case of the pest risk assessment for solid wood packing materials (See Docket No. 98-057-2, 65 FR 61301; October 17, 2000), for which the Agency provided a 120-day comment period.

PPQ has already, on several other occassions, made draft pest risk assessments available for public comment in advance of rulemaking. Examples include the risk assessments pertaining to the importation of honeybees from New Zealand (Docket No. 99-091-1, 64 FR 68984; December 9, 1999) and honeybees from Australia (Docket No. 00-032-1, 65 FR 25701; May 3, 2000). Making risk assessments such as those two available for comment provides us with the opportunity to make any necessary modifications to the risk assessment prior to moving forward with a proposed rule. APHIS believes that announcing the availability of a risk assessment in the Federal Register provides an equitable means of obtaining public comment from all interested persons at the same time, since it provides all interested persons with an equal opportunity to comment. Publication in the Federal Register is “constructive notice” to the world that the Agency is soliciting comments on scientific and economic information pertaining to a particular risk assessment.

We may in select circumstances, prior to publication in the Federal Register of a draft pest risk assessment for comment, consult with non-agency technical experts pertaining to certain provisions of a draft document, in order to ensure we are setting forth a technically accurate document. This would be done in order to ensure that the Agency was making available the best possible draft document for public comment, and possibly because the Agency did not have a particular expertise available within its own ranks.

We recognize that in certain circumstances, risk assessments that have been deemed to be routine may generate or cause certain information to be brought to the Agency's attention that would cause us to reevaluate our original designation of routine. If we changed the designation of a risk assessment, we would publish a notice of availability of the draft risk assessment, with any necessary revisions to reflect the new information, in the Federal Register. We will review such situations on a case-by-case basis.

Ensuring Availability and Transparency of Assumptions and Uncertainties in the Risk Assessment Process, Including Risk Mitigation Measures Relied Upon Individually or as Components of a System of Mitigative Measures

Section 412(e) of the Plant Protection Act (7 U.S.C. 7712(e)) requires that the Secretary of Agriculture conduct a study of the role for and application of systems approaches designed to guard against the introduction of plant pathogens associated with proposals to import plants or plant products into the United States. The term “systems approach” is defined in the Act as “a defined set of phytosanitary procedures, at least two of which have an independent effect in mitigating pest risk associated with the movement of commodities” (see 7 U.S.C. 7702(18)). This section of the Act also requires the participation in the study of scientists from State departments of agriculture, colleges and universities, the private sector, and the U.S. Department of Agriculture's Agricultural Research Service. The Act further requires that a report of the results of the study be submitted to the Committee on Agriculture, Nutrition, and Forestry of the Senate and the Committee on Agriculture of the House of Representatives. In the course of conducting this study, we are certain that recommendations will be made on the need for the Agency to be sure that assumptions and uncertainties in the risk assessment process, including applicable risk mitigation measures relied upon individually or as components of a system of mitigative measures, are clearly stated in any risk assessment document. As a matter of policy, APHIS will ensure that risk assessment documents clearly specify assumptions and uncertainties in the risk assessment process, including applicable risk mitigation measures relied upon individually or as components of a system of mitigative measures.

Other Mechanisms Aimed at Ensuring Transparency and Accessibility

The Agency routinely provides a minimum of 60 days for the submission of comments from the public regarding its proposed amendments to the fruits and vegetables regulations. PPQ plans to utilize its stakeholder registry as a means of also notifying interested persons when a proposed rule which required a pest risk assessment has been published. Interested persons can download a copy of any APHIS document published in the Federal Register from the APHIS web site at http://www.aphis.usda.gov/​ppd/​rad/​webrepor.html. The APHIS web site currently has a registry that allows interested persons to enter key words and their e-mail address, which enables registrants to receive electronic notification when their specified key words appears in a notice or proposed or final rule published in the Federal Register.

Lastly, we intend to publish a brochure written in clear and simple terms, explaining the options and procedures for importing fruits and vegetables, which we believe will be of great assistance to first-time importers.

Authority: 7 U.S.C. 7701-7772.

Done in Washington, DC, this 13th day of June 2001.

Craig A. Reed,

Administrator, Animal and Plant Health Inspection Service.