Previous Article 65 FR 51 pgs. 14200-14205 - Pesticide Tolerance Reassessment and Reregistration; Proposed Public Participation Process
Type: NOTICEVolume: 65Number: 51Pages: 14200 - 14205
Docket number: [OPP-00645; FRL-6496-2]
FR document: [FR Doc. 00-6398 Filed 3-14-00; 8:45 am]
Agency: Environmental Protection Agency
Official PDF Version: PDF Version
ENVIRONMENTAL PROTECTION AGENCY
[OPP-00645; FRL-6496-2]
Pesticide Tolerance Reassessment and Reregistration; Proposed Public Participation Process
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Notice.
SUMMARY:
This notices announces EPA's proposal for a public participationprocess for pesticide tolerance reassessment and reregistration. This proposal is in response to ajoint initiative between EPA and the Department of Agriculture (USDA) to increase transparencyand stakeholder involvement in the development of pesticide risk assessments and riskmanagement documents and decisions. EPA and USDA have been actively employing a pilotpublic participation process for tolerance reassessment and reregistration of organophosphatepesticides for over 1 year (since August 1998), which was developed in consultation with theTolerance Reassessment Advisory Committee (TRAC). Consideration must now be given as towhether this public participation process or some modification of it should be adopted as thefinal process, and whether it should be used for tolerance reassessment and reregistration of allpesticides.
DATES:
Comments, identified by docket control number OPP-00645, must bereceived by EPA on or before April 14, 2000.
ADDRESSES:
Comments may be submitted by mail, electronically, or in person.Please follow the detailed instructions for each method as provided in Unit III. of the"SUPPLEMENTARY INFORMATION." To ensure proper receipt by EPA, it is imperative thatyou identify docket control number OPP-00645 in the subject line on the first page of yourresponse.
FOR FURTHER INFORMATION CONTACT:
Karen Angulo, Special Reviewand Reregistration Division (7508C), Office of Pesticide Programs, Environmental ProtectionAgency, Ariel Rios Bldg., 1200 Pennsylvannia Ave., NW., Washington, DC 20460; telephonenumber: (703) 308-8004; e-mail address: angulo.karen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Does this Action Apply to Me?
This action is directed to the public in general; however, a wide range of stakeholderswill be interested in submitting comments on the public participation process that EPA isproposing for tolerance reassessment and reregistration, including environmental, human health,and agricultural advocates; the chemical industry; pesticide users; and members of the publicinterested in the use of pesticides on food. As such, the Agency has not attempted to specificallydescribe all the entities potentially affected by this action. If you have any questions regarding theapplicability of this action to a particular entity, consult the person listed under "FOR FURTHERINFORMATION CONTACT."
II. How Can I Get Additional Information, Including Copies of this Document orOther Related Documents?
A. Electronically . You may obtain electronic copies of this document and otherrelated documents from the EPA Internet Home Page at http://www.epa.gov/. To access thisdocument, on the Home Page select "Laws and Regulations" and then look up the entry for thisdocument under the " Federal Register -Environmental Documents." You can also godirectly to the Federal Register listings at http://www.epa.gov/fedrgstr/.
To access information about the pilot public participation process that is nowbeing used for the organophosphate pesticides, you can also go directly to the Office of PesticidePrograms' (OPP) organophosphate pesticide web page at http://www.epa.gov/pesticides/op/.
B. In Person. The Agency has established an official record for this action underdocket control number OPP-00645. The official record consists of the documents specificallyreferenced in this action, any public comments received during an applicable comment period, andother information related to this action, including any information claimed as CBI. This officialrecord includes the documents that are physically located in the docket, as well as the documentsthat are referenced in those documents. The public version of the official record does not includeany information claimed as CBI. The public version of the official record, which includes printed,paper versions of any electronic comments submitted during an applicable comment period, isavailable for inspection in Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA,from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB telephonenumber is (703) 305-5805.
III. How Can I Respond to this Action?
A. How and to Whom Do I Submit Comments?
You may submit comments through the mail, in person, or electronically.To ensure proper receipt by EPA, it is imperative that you identify docket control numberOPP-00645 in the subject line on the first page of your response.
1. By mail . Submit comments to: Public Information and Records IntegrityBranch, Information Resources and Services Division (7502C), Office of Pesticide Programs,Environmental Protection Agency, Ariel Rios Bldg., 1200 Pennsylvannia Ave., NW., Washington,DC 20460.
2. In person or by courier . Deliver comments to: Public Information andRecords Integrity Branch, Information Resources and Services Division, Office of PesticidePrograms, Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson DavisHwy., Arlington, VA. The PIRIB is open from 8:30 a.m. to 4 p.m., Monday through Friday,excluding legal holidays. The PIRIB telephone number is (703) 305-5805.
3. Electronically . Submit electronic comments by e-mail to:"opp-docket@epa.gov," or you can submit a computer disk as described in this unit. Do notsubmit any information electronically that you consider to be CBI. Electronic comments must besubmitted as an ASCII file, avoiding the use of special characters and any form of encryption.Comments and data will also be accepted on standard computer disks in WordPerfect 6.1/8.0 orASCII file format. All comments in electronic form must be identified by the docket controlnumber OPP-00645. Electronic comments may also be filed online at many FederalDepository Libraries.
B. How Should I Handle CBI Information that I Want to Submit to the Agency?
Do not submit any information electronically that you consider to be CBI. You mayclaim information that you submit to EPA in response to this document as CBI by marking anypart or all of that information as CBI. Information so marked will not be disclosed except inaccordance with procedures set forth in 40 CFR part 2. In addition to one complete version ofthe comment that includes any information claimed as CBI, a copy of the comment that does notcontain the information claimed as CBI must be submitted for inclusion in the public version ofthe official record. Information not marked confidential will be included in the public version ofthe official record without prior notice. If you have any questions about CBI or the proceduresfor claiming CBI, please consult the person listed under "FOR FURTHER INFORMATIONCONTACT."
C. What Should I Consider as I Prepare My Comments for EPA?
You may find the following suggestions helpful for preparing your comments:
1.Explain your views as clearly as possible.
2.Describe any assumptions that you used.
3. Provide copies of any technical information and/or data you used that supportyour views.
4. If you estimate potential burden or costs, explain how you arrived at the estimatethat you provide.
5. Provide specific examples to illustrate your concerns.
6. Offer alternative ways to improve this notice.
7. Make sure to submit your comments by the deadline in this document.
8. To ensure proper receipt by EPA, be sure to identify the docket control numberassigned to this action in the subject line on the first page of your response. You may alsoprovide the name, date, and Federal Register citation.
IV. What Action is EPA Taking in this Notice?
EPA is making available for public comment a proposal for a public participation processfor pesticide tolerance reassessment and reregistration. This proposed public participationprocess was developed with USDA.
Public comment received as a result of this notice will be considered by EPA and USDAand a final public participation process will be developed and released to the public in a noticepublished in the Federal Register . Implementation of the final public participation process willbegin according to a schedule established and published in the final notice.
This notice discusses 3 public participation processes: Pilot, modified, and final. Thepilot public participation process refers to the process that EPA and USDA are now using fororganophosphate pesticide tolerance reassessment and reregistration. The modified publicparticipation process refers to the process that EPA and USDA proposed to the Tolerance Reassessment Advisory Committee (TRAC) during their October 20-21, 1999, meeting. The final publicparticipation process refers to the process that is being proposed in this notice. In addition, forthe purposes of this notice the words "public" and "stakeholders" are used interchangeably.
V. Background
A. Food Quality Protection Act-Process Improvements for Tolerance Reassessment and Reregistration
The Food Quality Protection Act (FQPA) of 1996 amended the Federal Insecticide,Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act(FFDCA). These amendments fundamentally changed the way EPA regulates pesticides. Themany new FQPA requirements included a new safety standard (i.e., reasonable certainty of noharm) that must be applied to all pesticides used on foods. EPA recognized that FQPAimplementation would require changes to the Agency's existing risk assessment processes and itsapproach to communication with the public (stakeholders). The process improvements would beresponsive to Vice President Gore's directive to increase transparency and opportunities forstakeholder consultation.
B. Inception of TRAC
TRAC was established in April 1998, as a subcommittee under the auspices of EPA'sNational Advisory Council for Environmental Policy and Technology (NACEPT). TRACprovided a forum for a diverse group of individuals representing a broad range of interests andbackgrounds from across the country to consult with and make recommendations to theAdministrator of EPA and the Secretary of USDA on an approach for pesticide tolerancereassessment and reregistration, including those for organophosphate pesticides, as required byFQPA. The Committee held seven public meetings: May 28-29; June 22-23; July 13-14; July 28-29; September 15-16, 1998; and April 27-28 and October 20-21, 1999. TRAC membershipincluded approximately 45 members approved by the Deputy Administrator of EPA and theDeputy Secretary of USDA. Members were selected based on their relevant experience anddiversity of perspectives on organophosphate pesticide and food safety issues, including thosefrom the following sectors: Environmental and public interest groups; pesticide industry andtrade associations; user, grower and commodity organizations; pediatric and public healthorganizations; Federal agencies; Tribal, State, and local governments; academia; and consumergroups. The Deputy Administrator of EPA and the Deputy Secretary of USDA served as TRACCo-Chairs.
C. Development of the Pilot Public Participation Process
In the summer of 1998, EPA, USDA, and TRAC set out to design a process that wouldincrease transparency of regulatory processes and consultation with affected stakeholders;expand public access to risk assessment and risk management processes; and find more effectiveways for the public to participate at critical times in the Agency's development oforganophosphate pesticide risk assessments and risk management decisions. At the July 14, 1998, meeting of the TRAC, EPA, and USDA announced that one of the public participationprocess options considered by TRAC would be implemented as a pilot. By piloting a publicparticipation process, EPA, USDA, and TRAC could test whether the process achieved the goalsof increasing transparency and stakeholder consultation. A pilot effort would provide anopportunity to identify issues associated with public release of risk assessments and managementdocuments, and to evaluate how best to obtain public input into the risk assessment and riskmanagement development processes.
D. Need for a Final Public Participation Process
EPA and USDA have been actively employing the pilot public participation process fortolerance reassessment and reregistration of organophosphate pesticides for over 1 year (since August 1998). Consideration must now be given as to whether this process or some modification of it should be adopted as the final process, and whether it should be used beyond the tolerancereassessment and reregistration for organophosphate pesticides and be applied to all pesticides.
In addition, EPA and USDA will soon begin to consider the stakeholder involvement thatwill be needed for the cumulative assessment stage. FQPA requires the assessment ofcumulative effects of pesticides that share a common mechanism of toxicity. Once the individualpesticide risk assessments are complete and the Agency has a cumulative assessmentmethodology, EPA and USDA will encourage the public to participate in the cumulativeassessment process.
VI. The Pilot Public Participation Process
A. Description of the Pilot Public Participation Process
The following provides a brief overview of the pilot public participation process:
Phase 1-Registrant "Error Only" Review (30 days) . EPA sends its preliminary human health and ecological risk assessments to registrant(s) of the pesticide for a 30-day error correction review, and to USDA. They are asked to identify any computational or other errors that EPA has made in developing its preliminary assessment of the pesticide's risks.
Phase 2-EPA Considers Registrants' Error Comments (up to 30 days) . EPA summarizes and considers comments from registrants and USDA. EPA incorporates comments or makes changes in the preliminary risk assessments to correct any errors identified. By the end of this phase, EPA opens a public docket for the pesticide.
Phase 3-Public Comment on Preliminary Risk Assessments (60 days) . EPA publishesa Federal Register (FR) Notice of Availability announcing its preliminary risk assessments, andopening a 60-day public review and comment period. Registrants, grower groups, otherstakeholders, and the public are encouraged to submit data and other information to refine EPA'spreliminary risk assessments. They also may begin submitting risk management proposals toaddress any risk concerns identified in the document. EPA may meet with registrants and otherstakeholders to discuss risk related data, use information, and risk assessment/risk managementalternatives.
Phase 4-EPA Revises Risk Assessments (up to 90 days) . EPA summarizes andconsiders comments, data, and risk mitigation proposals received during the Phase 3 publiccomment period. EPA develops the revised risk assessments and sends them to USDA forreview. EPA and USDA may host public meetings to share the revised risk assessments withinterested stakeholders and discuss risk management ideas.
Phase 5-EPA Solicits Risk Management Ideas (60 days) . EPA releases the revised riskassessments to the public for viewing in the public docket. EPA publishes an FR Notice ofAvailability opening a 60-day public consultation period during which risk managementproposals are solicited. Registrants, grower groups, other stakeholders, and the public areencouraged to participate and submit their risk management proposals. EPA and USDA maymeet with registrants and other stakeholders to discuss risk management alternatives andstrategies. Meeting minutes will be included in the public docket.
Phase 6-EPA Develops Risk Management Strategies (up to 60 days) . EPA considersall risk management proposals received. With input from USDA, EPA develops riskmanagement strategies that ultimately will contribute to the Agency's risk management decisionsfor this and other organophosphate pesticides.
B. Success of the Pilot Public Participation Process
To date, the pilot public participation process has provided EPA and USDA with a greatdeal of information for use in refining the risk assessments and in developing risk managementoptions. Stakeholder participation has risen substantially. In the fall of 1999, EPA and USDAtook a qualitative look at the strengths and challenges of the pilot public participation process.The following provides a qualitative look at the comments EPA received from registrants andother stakeholders during the phases of the pilot public participation process, and how thesecomments affected the risk assessments and process schedules.
Registrants were given an opportunity in Phase 1 to identify computational errors as wellas grammatical and spelling errors in the preliminary risk assessments. In this way, if theAgency agreed with the registrant's error identification, EPA could correct the errors in Phase 2prior to the release of the preliminary risk assessments to the public docket (Phase 3). EPAwould inform the public of the registrant's error comments and the corrective actions taken bythe Agency. However, the large majority of comments received from registrants during theirerror-identification period were considered to be non-error comments. In the cases where errorswere identified, only a few resulted in a substantial change to the preliminary risk assessmentsand a delay in the release of the assessments to the public. The majority of non-error commentsreceived were general comments about the preliminary risk assessments and promises to submitnew studies. New studies were submitted in a few instances.
Comments received during the public comment period on the preliminary riskassessments (Phase 3) substantially affected approximately one-third of the organophosphatepreliminary risk assessments, typically because of the submission of information on thepesticide's use and usage, studies, or other technical information. In several cases, registrantssubmitted new studies and studies to confirm or upgrade existing, submitted studies.
The Agency and USDA used Phase 4 to revise the preliminary risk assessments based onpublic comment. EPA released the revised risk assessments and related documents to the publicin Phase 5 and initiated a public participation period for risk management. Risk managementcomments and ideas were usually received by EPA during meetings and conference calls ratherthan through written submissions. Minutes of meetings and conference calls were recorded andplaced in the public docket.
C. A Proposal for a Final Public Participation Process was Made at the October 20-21, 1999, TRAC Meeting
EPA and USDA proposed a modified public participation process to TRAC during theirOctober 20-21, 1999, meeting. EPA and USDA approached TRAC with a proposal because thepilot public participation process had been tested for over 1 year and it was time to consider afinal public participation process. The proposed modified public participation process was basedon USDA's and EPA's experiences using the pilot public participation process. The proposedmodified public participation process included several stakeholder participation enhancements.A special emphasis was placed on the public involvement activities that take place prior to Phase 1-before the start of the public participation process-to ensure that the most complete andaccurate set of information was being used in the risk assessments. In addition, stakeholderswould be much more informed of the schedule of pesticides that EPA and USDA would beworking on in the next year, and would know when EPA and USDA needed information.Conference calls and public meetings (technical briefings that describe the revised riskassessments in general, and stakeholder meetings where the description of the risk assessments isfocused on a particular pesticide user group's area of concern) would be used to initiate thepublic comment period on the risk assessments, engage the public in a discussion of the riskassessments, and begin the discussion of risk management.
The proposed modified public participation process would have eliminated a publiccomment period on the preliminary risk assessments. This modification was a result of therecognition that the risk assessments now under development contain many more refinementsthan previous preliminary risk assessments. In the past, the preliminary risk assessments thatwere released to the public did not usually have refinements, such as probabilistic dietary riskassessment tools or the data needed for the use of these tools. The Agency saw the benefit ofreleasing these unrefined, preliminary risk assessments to the public as a means of encouragingthe submission of data that could be used for refinement purposes. The risk assessments beingdeveloped now typically contain these refinements, therefore, the Agency proposed that 2comment periods on the refined risk assessments were not necessary. Even though the proposedmodified public participation process would have eliminated a public comment period on thepreliminary risk assessments, EPA and USDA would continue to encourage and organizestakeholder communications throughout the modified public participation process through aseries of meetings and conference calls.
In addition, EPA and USDA asked TRAC members if the modified public participationprocess should be applied to pesticides other than the organophosphates, which currently are theonly class of pesticides in the pilot public participation process.
D. Summary of TRAC's Feedback
During the October 20-21, 1999, TRAC meeting, TRAC members verbally responded tothe proposed modified public participation process that EPA and USDA presented. Many TRACmembers voiced strong support for increased and enhanced EPA and USDA activities in themonths prior to formal start of the public participation process (i.e., Pre-Phase 1), includingstakeholder meetings and conference calls, the release to the public at the beginning of theprocess of a general pesticide use and usage description and the schedule of pesticides enteringthe process, and discussions with pesticide registrants and stakeholders about the submission ofdata and the data submission schedule.
Several TRAC members voiced concern over their perceived reduction in publicparticipation opportunities resulting from the elimination of one risk assessment commentperiod, and also objected to the proposed plan for having public comment on the riskassessments and risk management options occur during the same phase. Certain TRAC membersvoiced concern that the risk management options issued for public comment would be perceivedas the Agency's final risk management decision, giving stakeholders no real opportunity toweigh-in before the final decisions were made. Concern was also raised about issuing riskmanagement decisions on any uses of a pesticide before the conclusion of the public participationprocess; however, the Agency has always reserved this authority if certain uses of a pesticidewarranted action because of the risk levels identified in the risk assessments.
TRAC members expressed support for EPA issuing only highly refined risk assessmentsfor public comment, and for longer public comment periods. Support was also expressed fortechnical briefings and stakeholder meetings at the time the risk assessments are released forpublic comment, and for an enhanced public role for USDA at that time, including theorganization of stakeholder conference calls and meetings. In addition, TRAC memberssupported the application of the final public participation process to all other pesticidesscheduled for tolerance reassessment and reregistration.
VII. Proposal for the Final Tolerance Reassessment and Reregistration Process
A. EPA and USDA's Consideration of a New Public Participation Process
EPA and USDA have considered the comments received from TRAC during theirOctober 20-21, 1999, meeting, and are releasing in this notice a proposal for a final publicparticipation process. EPA and USDA reconsidered the process approach presented to TRAC,and have developed a new public participation process proposal. The new proposed publicparticipation process melds together the pilot public participation process and the modifiedpublic participation process that was proposed to TRAC. The new proposed public participationprocess retains the 6 phases and much of the structure of the pilot public participation processcurrently used for the organophosphate pesticides, and it incorporates the considerableenhancements to public participation found in the modified public participation process that waspresented to TRAC. These enhancements include increasing the communication withstakeholders prior to the initiation of the public participation process, the addition of conferencecalls with stakeholders throughout the process, the lengthening of a public participation phase,and the release of risk management proposals to the public at the beginning of Phase 5. Inaddition, the proposed public participation process emphasizes increased communication amongthose Federal government agencies concerned with pesticides.
EPA is also proposing that this public participation process be applied to all pesticidesscheduled for tolerance reassessment and reregistration. Interim planning for bringing non-organophosphate pesticides under a formal public participation process is discussed at the end ofthis notice.
The Agency anticipates that modifications to the public participation process will beappropriate for pesticides with limited use and usage, low risk concerns, small numbers ofpesticide users, or other factors. EPA will inform the public of modifications to the publicparticipation process that are warranted for a pesticide. For pesticides meeting these criteria,alterations to the public participation process will most typically include a tailoring of thestakeholder communication opportunities. For example, the public participation process couldbe modified for a pesticide with a small number of users by the substitution of a stakeholdermeeting(s) for a technical briefing upon release of the risk assessments for public comment(Phase 3) (stakeholder meetings are opportunities for stakeholder groups to meet with EPA,USDA, and other appropriate Federal government agencies to discuss specific uses of thepesticide that are of significant concern to them, whereas technical briefings provide a generaloverview of the pesticide's risk assessments). In another example, a pesticide with limited useand usage, low risk concerns, and highly refined risk assessments may only need one publiccomment period on the risk assessments as long as ample public consultation opportunities areutilized. EPA will inform the public of pesticides that will have modified public participationprocesses.
EPA will continue to issue risk management decisions on certain uses of a pesticide atany time before or during the public participation process if such action is warranted by high risklevels identified in the risk assessments. While EPA may exercise this authority at anytimeduring this process, the Agency will ensure that stakeholders and other Federal governmentagencies will be informed and involved in the decisionmaking process through meetings andconference calls.
B. Proposed Public Participation Process
The proposed final public participation process contains many of the same elements ofthe Pilot Public Participation Process and enhances public participation at important stages. Itmust be noted that the proposed final public participation process does not use the word"preliminary" to describe the risk assessments that are released to the public in the early phasesof the public participation process. This is because the risk assessments now under developmentcontain many more refinements than previous preliminary risk assessments.
Pre-Phase 1-Public Engagement . A significant focus of the process is to engagestakeholders as early as possible to ensure that risk assessments reflect actual use and usage,available data, current labeling, and other information on use practices that stakeholders canprovide. In the months prior to the formal initiation of the public participation process (whichstarts with release of the risk assessments to the registrants for error correction), USDA, EPA,and other Federal government agencies (e.g., the Department of Health and Human Services(HHS), and the Food and Drug Agency (FDA)) will work cooperatively to organize meetingswith interested stakeholders to discuss pesticide use and usage, and to encourage them to sharetheir information with the agencies.
In addition, EPA will inform the public well in advance about pesticides that arescheduled for the public participation process. Registrants will be asked to identify any ongoingstudies and analyses that are relevant to the risk assessments, and EPA will announce for eachpesticide the due dates for the submission of data, information, and analyses. In this way, thepublic will be able to prepare for the initiation of the public participation process for pesticidesthat they may be interested in, including the preparation of data and information forconsideration by the agencies.
Phase 1-Risk Assessment Registrant Error-Only Review, Chemical Use and Usage Description, and Federal Government Agency Engagement (30 Days) . Phase 1 of the proposedpublic participation process is the same as the pilot public participation process, in that the riskassessments are sent to the pesticide's registrant(s) for error correction, but an increased effort atdisseminating information to the public has been added as well as enhanced Federal agencycommunication. EPA initiates the public participation process by transmitting its human healthand ecological risk assessments to registrant(s) of the pesticide for a 30-day error correctionreview. They are asked to identify and correct any computational or other errors that EPA hasmade in developing its assessment of the pesticide's risks. Registrants will be asked again aboutdue dates for the submission of data and information to EPA, and for an indication of how thestudy or analysis may change the risk assessments. EPA will not delay its work in assessing thepotential risks associated with the use of the pesticide when a study submission date is beyondthe timeframe for the public participation process.
In addition, EPA recognizes that the public would find useful for their planning purposesa description of the pesticide that has started the public participation process. The Agency willpublish a FR Notice of Availability announcing the release of the pesticide's use and usagedescription to the public docket and internet website for 30-day public comment. Thepesticide's use and usage description would characterize the use, usage, and types of data andinformation used in the risk assessments.
At the same time that the risk assessments are sent to registrants, EPA transmits the riskassessments and related documents (including the pesticide's overview that summarizes the riskassessments, the Qualitative Usage Analysis, and the pesticide's use and usage description) toUSDA and other appropriate Federal government agencies for review and comment.
Phase 2-Agency Considers Registrant Error Comments (Up to 30 Days) . In Phase 2,EPA summarizes and considers the errors that have been identified by the registrant(s) andmakes changes in the risk assessments to correct any errors, as appropriate. EPA will alsoaddress risk assessment comments received from other Federal government agencies. By the endof this phase, the risk assessments are prepared for public release. Discussions with otherFederal government agencies on comments and issues will continue throughout the publicparticipation process, as needed.
Phase 3-Public Participation Period: Public Comment on Risk Assessments and Risk Characterization (60-90 Days) . Phase 3 provides the public with an opportunity to comment on the pesticide's risk assessments. The phase begins when EPA publishes a FR Notice ofAvailability of the risk assessments and related documents (e.g., overview, summary, tablesummarizing risk assessment information, registrant's error comments, and EPA's response tocomments, etc.) for a 60 to 90-day public review and comment period. The summary documentswill clearly characterize the risks associated with each use of the pesticide and include a useimpact discussion that identifies possible pesticide alternatives for significant uses, therebyallowing the public to discern the Agency's level of concern (if any) for each use at this stage inthe development of the risk assessments. All of the documents will be made available in thepublic docket and EPA's internet website. The length of the public comment period will be setaccording to the complexity of the risk issues associated with the pesticide in order to givestakeholders adequate time for review and comment.
In addition, an effort will be initiated among Federal government agencies to engagestakeholders in a dialogue on the risk assessments and risk characterization, and will continuethrough Phase 5 of the public participation process.
Phase 4-EPA Revises Risk Assessments and Develops Risk Management Proposal (up to 90 days) . EPA considers stakeholders comments received during Phase 3's public commentperiod, and develops the revised risk assessments and a risk management proposal. An inter-Federal government agency senior management briefing will be held to discuss the revised riskassessments and risk management proposal.
USDA may organize conference calls with stakeholders to review and discuss the revisedrisk assessments and risk management proposal. Minutes from all meetings and conference callswill be included in the public docket. EPA and USDA will work to summarize and address thecomments and ideas received during the stakeholder conference calls. In addition, an effort willbe initiated among Federal government agencies to engage stakeholders in a dialogue on the riskassessments and risk characterization, and this effort will continue through Phase 5 of the publicparticipation process.
A technical briefing and/or stakeholder meeting(s) (as appropriate for pesticides withlimited use and usage, low risk concerns, small numbers of stakeholders, or other factors) will be held atthe end of Phase 4 in order to share with the public the revised risk assessments and the range ofpossible risk management options.
Phase 5-EPA Solicits Comments on Risk Management Proposal (60 days) . EPApublishes a FR Notice of Availability announcing the release to the public of the revised riskassessments and the Agency's response to public comments. This FR notice will also releaseEPA's risk management proposal, a use impact discussion that identifies possible pesticidealternatives for significant uses, and a transition strategy, and open a 60-day comment periodduring which the public is encouraged to comment on the risk management proposal.
The effort among Federal government agencies to engage stakeholders in a dialogue onthe risk management proposal will continue throughout Phase 5.
Phase 6-Develop Final Risk Management (up to 60 Days) . In Phase 6, EPAsummaries, reviews, and considers the comments, data, and risk management ideas and proposalsreceived during the Phase 5 public comment period, and during stakeholder dialogue and themeetings that have occurred during Phases 3-5. With input from USDA and other Federalgovernment agencies, EPA develops the risk management documents. EPA releases to thepublic the risk assessments, the response to public comments, and the risk management decisionsfor the pesticide.
VIII. Interim Public Participation Process
EPA and USDA are now considering how to accomplish the movement from the publicparticipation process that was tested as a pilot (i.e., the pilot public participation process nowused exclusively for organophosphate pesticides) to the public participation process that will beadopted for future pesticide tolerance reassessment and reregistration. The majority oforganophosphate pesticides have made significant progress through the pilot publicparticipation's phases, and many are nearing completion, therefore, the pilot public participationprocess will continue to be applied to those organophosphates. The public participation processthat will be finalized after the notice and comment period described in this FR notice will befully applied to pesticide tolerance reassessment and reregistration by 2001. An interim policymust be developed for the non-organophosphate pesticides scheduled for tolerance reassessmentand reregistration development work in 2000.
The interim policy must take into account that the risk assessments are substantiallycomplete for many of the non-organophosphate pesticides scheduled for 2000. An example ofthe public participation process that EPA is considering as an interim policy for pesticides thatalready have significant risk assessment work underway would involve: A registrant errorcorrection period; a period for the Agency to respond to the registrant's error comments; therelease of the refined risk assessments and risk characterizations to the public via the docket andinternet without a formal public comment period; a significant effort on stakeholderconsultations, such as meetings and conference calls; and the issuance of the risk managementdocument to the public after the consideration of issues and discussions with stakeholders.
EPA and USDA are in the process of identifying the development status of each pesticide scheduled for tolerance reassessment and reregistration. EPA will inform stakeholders of the interim plan for each pesticide once a final public participation process is selected.
List of Subjects
Environmental protection, Chemicals, Pesticides and pests.
Dated: March 9, 2000.
Marcia E. Mulkey,
Director, Office of Pesticide Programs.
[FR Doc. 00-6398 Filed 3-14-00; 8:45 am]
BILLING CODE 6560-50-F