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Pesticides; Science Policy Issues Related to the Food Quality Protection Act

Note: EPA no longer updates this information, but it may be useful as a reference or resource.


 [Federal Register: January 4, 1999 (Volume 64, Number 1)]
[Notices]               
[Page 162-166]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04ja99-72]

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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00575; FRL-6054-8]

 
Pesticides; Science Policy Issues Related to the Food Quality 
Protection Act

AGENCY: Environmental Protection Agency (EPA).
ACTION: Notice of availability.

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SUMMARY: To assure that EPA's science policies related to implementing 
the Food Quality Protection Act (FQPA) are transparent and open to 
public participation, EPA is soliciting comments on four draft science 
policy papers--``A User's Guide to Available OPP Information on 
Assessing Dietary (Food) Exposure to Pesticides,'' ``Dietary (Drinking 
Water) Exposure Estimates,'' ``Standard Operating Procedures (SOPs) for 
Residential Exposure Assessment'' and ``Framework for Assessing Non-
Occupational, Non-Dietary (Residential) Exposure to Pesticides.'' In 
addition, EPA is announcing the availability of the National Pesticide 
Residue Data Base which is being posted on the internet for access to 
the public, and the availability of Use and Usage Matrices for 
Organophosphates. This notice is the fourth in a series concerning 
science policy documents related to FQPA and developed through the 
Tolerance Reassessment Advisory Committee (TRAC).
DATES: Written comments for each science policy paper, identified by 
the separate docket control numbers provided in Unit I. of this 
document, should be submitted by March 5, 1999.
ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I. of the SUPPLEMENTARY INFORMATION section of this 
document.
FOR FURTHER INFORMATION CONTACT: For ``A User's Guide to Available OPP 
Information on Assessing Dietary (Food) Exposure to Pesticides'' and 
``National Pesticide Residue Data Base'' contact by mail: Kathleen 
Martin, Environmental Protection Agency (7509C), 401 M St., SW., 
Washington, DC 20460; telephone number: (703) 308-2857; fax: 703-305-
5147; e-mail: martin.kathleen@epa.gov.
    For ``Standard Operating Procedures (SOPs) for Residential Exposure 
Assessment'' and ``Framework for Assessing Non-Occupational, Non-
Dietary (Residential) Exposure to Pesticides'' contact by mail: William 
Wooge, Environmental Protection Agency (7509C), 401 M St., SW., 
Washington, DC 20460; telephone number: (703) 308-8794; fax: 703-305-
5147; e-mail: wooge.william@epa.gov.
    For ``Dietary (Drinking Water) Exposure Estimates'' contact by 
mail: Denise Keehner, Environmental Protection Agency (7507C), 401 M 
St., SW., Washington, DC 20460; telephone number: (703) 305-7695; fax: 
703-305-6309; e-mail: keehner.denise@epa.gov.
    For ``Use and Usage Matrices for Organophosphates'' contact by 
mail: Kathy Davis, Environmental Protection Agency (7503C), 401 M St., 
SW., Washington, DC 20460; telephone number: (703) 308-7002; fax: 703-
308-8091; e-mail: davis.kathy@epa.gov.
SUPPLEMENTARY INFORMATION:

I. General Information

A. How Can I Get Additional Information or Copies of This Document or 
Other Documents?

    1. Electronically. You may obtain electronic copies of this 
document, the four science policy papers and ``National Pesticide 
Residue Data Base'' from the EPA Home Page under the Office of 
Pesticide Programs (OPP) at http://www.epa.gov/pesticides/. On the 
Office of Pesticide Program Home Page select ``TRAC'' and then look up 
the entry for this document. You can also go directly to the listings 
at the EPA Home page at the Federal Register -- Environmental Documents 
entry for this document under ``Laws and Regulations'' (http://
www.epa.gov/fedrgstr/) to obtain this notice and the five science 
policy papers. The Use and Usage Matrices for Organophosphates will be 
available at this site in January, 1999.
    2. Fax on Demand. You may request to receive a faxed copy of this 
document, as well as supporting information, by using a faxphone to 
call (202) 401-0527 and selecting item 6027 for ``A User's Guide to 
Available OPP Information on Assessing Dietary (Food) Exposure to 
Pesticides,'' item 6028 for ``Dietary (Drinking Water) Exposure 
Estimates,'' item 6029 for ``Standard Operating Procedures (SOPs) for 
Residential Exposure Assessment,'' and item 6030 for ``Framework for 
Assessing Non-Occupational Non-Dietary (Residential) Exposure to 
Pesticides.'' You may also follow the automated menu.
    3. In person or by phone. If you have any questions or need 
additional information about this action, you may contact the 
appropriate technical person identified in the ``FOR FURTHER 
INFORMATION CONTACT'' section of this document. In addition, the 
official records for the science policy papers listed in the SUMMARY 
section of this document, including the public versions, have been 
established under the docket control numbers listed in Unit I.B. of 
this document (including comments and data submitted electronically as 
described below). Public versions of these records, including printed, 
paper versions of any electronic comments, which do not include any 
information claimed as Confidential Business Information (CBI), are 
available for inspection in Rm. 119, Crystal Mall #2, 1921 Jefferson 
Davis Highway, Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through 
Friday, excluding legal holidays. The Public Information and Records 
Integrity Branch telephone number is 703-305-5805.

B. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. Be sure to identify the appropriate docket control 
number in your correspondence. The docket control number for ``A User's 
Guide to Available OPP Information on Assessing Dietary (Food) Exposure 
to Pesticides'' is OPP-00576, for ``Dietary (Drinking Water) Exposure 
Estimates,'' is OPP-00577, for ``Standard Operating Procedures (SOPs) 
for Residential Exposure Assessment'' is OPP-00578, and for ``Framework 
for Assessing Non-Occupational, Non-Dietary (Residential) Exposure to 
Pesticides'' is OPP-00579.
    1. By mail. Submit written comments to: Public Information and 
Records Integrity Branch, Information Resources and Services Division 
(7502C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver written comments to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis 
Highway, Arlington, VA.
    3. Electronically. Submit your comments and/or data electronically 
by e-mail to: opp-docket@epa.gov. Do not submit any information 
electronically that you consider to be CBI. Submit electronic comments 
as an ASCII file,

[[Page 163]]

avoiding the use of special characters and any form of encryption. 
Comments and data will also be accepted on standard computer disks in 
WordPerfect 5.1/6.1 or ASCII file format. All comments and data in 
electronic form must be identified by the docket control number. 
Electronic comments on this notice may also be filed online at many 
Federal Depository Libraries.

C. How Should I Handle CBI Information That I Want to Submit to the 
Agency?

    You may claim information that you submit in response to this 
document as CBI by marking any part or all of that information as CBI. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2. A copy of the comment that does 
not contain CBI must be submitted for inclusion in the public record. 
Information not marked confidential will be included in the public 
docket by EPA without prior notice. If you have any questions about CBI 
or the procedures for claiming CBI, please call the Public Information 
and Records Integrity Branch telephone number is 703-305-5805.

D. What Should I Consider As I Prepare My Comments for EPA?

    EPA invites you to provide your views on the various draft science 
policy papers, new approaches we have not considered, the potential 
impacts of the various options (including possible unintended 
consequences), and any data or information that you would like the 
Agency to consider. 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 solid technical information and/or data to support your 
views.
    4. If you estimate potential burden or costs, explain how you 
arrived at the estimate.
    5. Indicate what you support, as well as what you disagree with.
    6. Provide specific examples to illustrate your concerns.
    7. Make sure to submit your comments by the deadline in this 
notice.
    8. At the beginning of your comments (e.g., as part of the 
``Subject'' heading), be sure to properly identify the document you are 
commenting on. You can do this by providing the docket control number 
assigned to the notice, along with the name, date and Federal Register 
citation.

II. Background

    On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) 
was signed into law. Effective upon signature, the FQPA significantly 
amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) 
and the Federal Food, Drug, and Cosmetic Act (FFDCA). Among other 
changes, FQPA established a stringent health-based standard (``a 
reasonable certainty of no harm'') for pesticide residues in foods to 
assure protection from unacceptable pesticide exposure; provided 
heightened health protections for infants and children from pesticide 
risks; required expedited review of new, safer pesticides; created 
incentives for the development and maintenance of effective crop 
protection tools for farmers; required reassessment of existing 
tolerances over a 10-year period; and required periodic re-evaluation 
of pesticide registrations and tolerances to ensure that scientific 
data supporting pesticide registrations will remain up-to-date in the 
future.
    Subsequently, the Agency established the Food Safety Advisory 
Committee (FSAC) as a subcommittee of the National Advisory Council for 
Environmental Policy and Technology (NACEPT) to assist in soliciting 
input from stakeholders and to provide input to EPA on some of the 
broad policy choices facing the Agency and on strategic direction for 
the Office of Pesticide Programs. The Agency has used the interim 
approaches developed through discussions with FSAC to make regulatory 
decisions that met FQPA's standard but that could be revisited if 
additional information became available or as the science evolved. As 
EPA's approach to implementing the scientific provisions of FQPA has 
evolved, the Agency has sought independent review and public 
participation, often through presentation of many of the science policy 
issues to the FIFRA Scientific Advisory Panel (SAP), a group of 
independent, outside experts who provide peer review and scientific 
advice to OPP.
    In addition, as directed by Vice President Albert Gore, EPA has 
been working with the U.S. Department of Agriculture (USDA) and another 
subcommittee of NACEPT, the Tolerance Reassessment Advisory Committee 
(TRAC), chaired by the EPA Deputy Administrator and the USDA Deputy 
Secretary, to address FQPA issues and implementation. TRAC comprises 
more than 50 representatives of affected user, producer, consumer, 
public health, environmental, states and other interested groups. The 
TRAC has met five times as a full committee from May 27 through 
September 16, 1998.
    The Agency has been working with the TRAC to ensure that its 
science policies, risk assessments of individual pesticides, and 
process for decision making are transparent and open to public 
participation. An important product of these consultations with TRAC is 
the development of a framework for addressing key science policy 
issues. The Agency decided that the FQPA implementation process would 
benefit from initiating notice and comment on the major science policy 
issues.
    The TRAC identified nine science policy issue areas they believe 
were key to implementation of FQPA and tolerance reassessment. The 
framework calls for EPA to provide one or more documents for comment on 
each of the nine issues by announcing their availability in the Federal 
Register. In addition to comments received in response to these Federal 
Register notices, EPA will consider comments received during the TRAC 
meetings. Each of these issues is evolving and in a different stage of 
refinement. Accordingly, as the issues are further refined by EPA in 
consultation with USDA and others, they may also be presented to the 
SAP.
    In accordance with the framework described in a separate notice 
published in the Federal Register of October 29, 1998 (63 FR 58038) 
(FRL-6041-5), EPA is issuing a series of draft documents concerning 
nine science policy issues identified by the TRAC related to the 
implementation of FQPA. This notice announces the availability of four 
draft documents as identified in Unit I.B. of this document, as 
described in the framework notice published in the Federal Register of 
October 29, 1998 (63 FR 58038). EPA also stated in its October 29, 1998 
Federal Register notice that it would issue a draft document titled 
``Monte-Carlo Techniques and the 99.9th Percentile'' for comment in 
December 1998. Due to the complexity of this issue and the need to 
coordinate with the USDA, EPA will issue this document separately.

III. Summary of Draft Papers and Information

A. ``A User's Guide to Available OPP Information on Assessing Dietary 
(Food) Exposure to Pesticides''

    Assessing the amount of pesticide residues in and on the foods 
Americans consume is a complex process. Over the years the Agency has 
written a number of guidelines and policy statements related to the 
conduct and review of

[[Page 164]]

residue studies. ``A User's Guide to Available OPP Information on 
Assessing Dietary (Food) Exposure'' describes in ``plain English'' how 
EPA conducts acute and chronic pesticide dietary (food) exposure 
assessments and, more importantly, where in EPA guidance and policy 
documents one can find methods for doing such assessments.

B. ``Dietary (Drinking Water) Exposure Estimates''

    The EPA Office of Pesticide Programs is proposing to build on its 
existing policy for estimating pesticide concentrations in drinking 
water as part of its assessment of dietary exposures to pesticides. The 
most significant changes being proposed are those that refine existing 
screening methods for identifying pesticides which may be present in 
drinking water at levels of concern. These refinements will enable OPP 
to more accurately estimate the potential risks of pesticides from 
drinking water exposure to the public and sensitive populations such as 
infants and children.
    For some time the Agency has been using screening models to 
estimate pesticide concentrations in groundwater and surface water to 
rule out those food-use pesticides that are not expected to contribute 
enough exposure via drinking water to result in unacceptable levels of 
risk. The Agency uses monitoring data, where available and reliable, to 
refine its assessments in those cases where the use of the screening 
models does not result in ``clearing'' (i.e., indicate a low risk) the 
pesticide from a drinking water perspective. Specifically, OPP proposes 
to:
     1. Replace the ``farm field pond'' scenario in its surface water 
screening models with a ``drinking water reservoir'' scenario.
     2. Incorporate into the model a factor to account for the area 
surrounding the reservoir that is cropped.
     3. Develop a second-level (tier 2) screening model for 
groundwater.
     4. Evaluate how OPP uses water monitoring data in its drinking 
water assessment.
     5. Continue efforts to obtain additional monitoring of pesticides 
in drinking water.
    The proposed changes are intended to improve EPA's initial 
screening models by making them capable of producing more accurate 
estimates of pesticide concentrations in drinking water. In addition, 
EPA is seeking comment on current approaches to the use of monitoring 
data in its assessment of drinking water exposure. The Agency 
particularly seeks comments on the quantity and quality of data that 
would be appropriate for conducting drinking water assessments for 
purposes of tolerance decision-making. Finally, the Agency is 
soliciting comment on the current approach of back-calculating Drinking 
Water Levels of Comparison (DWLOC) only after all other exposures from 
food and residential use are considered.

C. ``Standard Operating Procedures (SOPs) for Residential Exposure 
Assessment''

    As required by the FQPA, EPA must now include residential and other 
non-occupational exposures in the aggregate exposure assessments for 
pesticides. Generally speaking, residential exposure monitoring data 
have not been routinely required. Thus, EPA has been relying on 
existing monitoring, survey and modeling data, including information on 
activity patterns, particularly for children, to estimate residential 
exposure to pesticides. Because highly specific, residential exposure 
data are generally lacking and there is not wide understanding and 
acceptance of existing models and assumptions, several workgroups and 
task forces are working to generate data and improve methods for 
conducting residential exposure assessments. One of these such efforts 
is the work group for developing Residential Standard Operating 
Procedures (SOPs) for Residential Exposure Assessments.
    The Residential Exposure Assessment Standard Operating Procedures 
are being developed by the Office of Pesticide Programs as standard 
methods for conducting residential exposure assessments for both 
handler and post-application exposures when pesticide-specific and/or 
site-specific field data are limited or not available. Handler and 
post-application SOPs were drafted for assessments of dermal, 
inhalation and/or potential ingestion exposures for the following major 
residential exposure scenarios: residential lawns, garden plants, trees 
(e.g., fruit, ornamental), swimming pools, painting and wood 
preservative treatments, fogging, crack and crevice, and broadcast 
treatments, pet treatments, detergent/hand soap, impregnated materials, 
termiticides, inhalation of residues from indoor treatments, and 
rodenticides.
    Each SOP includes: A description of the exposure scenario, the 
recommended methods (i.e., algorithms and default parameters) for 
quantifying potential pesticide doses, example calculations, 
limitations and uncertainties associated with the use of the SOPs and 
applicable references. The estimated doses resulting from using these 
SOPs are appropriate for use in developing estimates of human risks 
associated with residential exposures to pesticides. Potential dermal 
and inhalation doses determined by these SOPs do not, in general, 
include an adjustment for the amount of chemical likely to pass through 
the skin or lungs and be absorbed into the human system. Assessors will 
need to apply chemical-specific dermal and inhalation absorption rates, 
if available, to determine absorbed doses.
    The SOPs were jointly developed (and are now being revised) with 
the Pest Management Regulatory Agency (PMRA) of Health Canada and the 
California State EPA--Department of Pesticide Regulations. Other USEPA 
offices providing support include the National Exposure Research 
Laboratory (NERL)/ORD; the National Center for Environmental Assessment 
(NCEA)/ORD; and the Economics, Exposure, and Technology Division 
(EETD)/OPPT.
    The first draft of the SOPs was presented to the FIFRA Scientific 
Advisory Panel (SAP) on September 9, 1997, for their consideration and 
comment. In the summer of 1998, as the Agency was preparing the 
Framework for Addressing Key Science Issues, EPA believed that for the 
SOPs it would be reasonable to incorporate all the SAP's comments by 
December 1998 and in fact, this is the timeframe that was provided in 
the Framework Federal Register notice (63 FR 58038). Early this Fall, 
the Residential SOP Workgroup met to discuss the best approach for 
implementing the SAP's comments and in a separate endeavor, the Agency 
decided that the SOPs should go back to the SAP in July 1999. So, EPA's 
original schedule for producing the final SOPs has been slightly 
altered. Instead of issuing final SOPs in May 1999, as originally 
planned, a significantly revised and updated version will be released 
in June 1999 in preparation for the July 1999 SAP meeting.
     Today, the Agency is releasing a revised version (December 19, 
1997) of the SOPs for comment along with a short paper describing how 
the Agency is incorporating the SAP's September 1997 comments (``The 
Agency's Response to Comment on the Draft Residential Standard 
Operating Procedures''). More importantly, EPA is taking this 
opportunity to seek additional data and information on residential 
exposure for the next revision. Because chemical-specific residential 
exposure data are generally lacking, there are several workgroups and 
task forces working to generate data and improved methods, which could 
significantly impact refinements to the

[[Page 165]]

SOPs. It is the Agency's belief that new information will be 
forthcoming in the next few months from registrant groups and industry 
task forces, such as the Indoor Residential Exposure Joint Venture 
(IREJV) and the Outdoor Residential Exposure Task Force (ORETF), as 
well as from university and EPA researchers to more properly address 
the SAP comments and refine the SOPs for the June 1999 release.

D. ``Framework for Assessing Non-Occupational, Non-Dietary 
(Residential) Exposure to Pesticides''

     Non-occupational, non-dietary exposure assessment is an important 
component in establishing an individual's overall risk from pesticides. 
This type of assessment focuses primarily on those exposures that occur 
in and around the home (otherwise known as residential exposure 
assessment). It is important to note that exposures that occur as a 
result of pesticide applications in schools, parks and day care centers 
are included under the term ``residential'' Residential exposures are 
``non-dietary'' in nature (i.e., through the skin or inhaled).
     The importance of non-dietary residential exposure assessment has 
only increased with the passage of the Food Quality Protection Act of 
1996 and the statute's increased emphasis on the protection of 
children. EPA is currently refining its assessments in order to improve 
overall quality and achieve more realistic exposure estimates. This 
paper discusses:
     1. Exposure basics.
     2. How EPA currently conducts non-dietary residential exposure 
assessment.
     3. The generally conservative nature of the Agency's non-dietary 
residential exposure assessment.
     4. How EPA is refining non-dietary residential exposure 
assessments.

E. ``National Pesticide Residue Data Base''

    EPA stated in its October 29, 1998 Federal Register notice that it 
would complete the National Pesticide Residue Database (NPRD), a 
comprehensive database that will contain information about actual 
pesticide residues in raw and processed foods. A complete version of 
the NPRD is expected to be available on EPA's web page in January 1999. 
Provided on EPA's web site is a description on the history, development 
and use of NPRD (http://www.epa.gov/pesticides/nprd/).

F. ``Use and Usage Matrices for Organophosphates''

    To assist in the calculation of cumulative and aggregate risks from 
organophosphate (OP) pesticides and to evaluate the relative importance 
of the uses of each OP pesticide, EPA decision-makers need complete 
information about ``real-world'' pesticide usage. With the support of 
the USDA and the grower community, EPA is gathering available 
information about usage patterns and putting it into crop-by-crop 
matrices. These matrices present real-world information on pesticide 
usage and the pests which drive the usage, and are developed with 
support from the USDA and the States and the grower community is 
invited to comment.
    Matrices are being developed for approximately 75 crops, including 
details such as percent of crop treated, typical application 
information, timing of pesticide use, target pests and registered 
alternatives. All of the matrices will be made available on the 
Internet. The first 10 draft matrices will be posted on the Internet in 
January 1999.

IV. Questions/Issues for Comment

    While comments are invited on any aspect of the first four papers 
above, EPA is particularly interested in comments on the following 
questions and issues.

 A. ``A User's Guide to Available OPP Information on Assessing Dietary 
(Food) Exposure to Pesticides''

    1. Is EPA's paper clear and complete?

B. ``Dietary (Drinking Water) Exposure Estimates''

    1. Surface Water Screening Model Refinements:
    i. What factors should EPA consider in determining whether to 
replace the field pond scenario with an index reservoir in surface 
water screening models?
    ii. What factors should EPA consider in determining whether to use 
an index reservoir similar to Shipman City Lake for its surface water 
screening models?
    iii. How should the crop area factor be applied to surface water 
screening models when the pesticide may potentially be used on several 
crops present in the same watershed?
    iv. How should OPP address changes to the crop area from year to 
year, crop rotations, fallow land, and the spatial distribution of the 
crop within the watershed?
    v. How should OPP apply the crop area factor to minor-use crops for 
which data may not be available or may be limited?
    vi. What watershed-scale models are available to provide effective 
screening tools for drinking water exposure assessments for pesticides?
    2. Incorporating Water Monitoring Data in the Drinking Water 
Exposure Assessment:
    i. Under what circumstances should valid monitoring data replace 
model predictions in a drinking water assessment when the data may not 
include potentially vulnerable areas?
    ii. How should non-detects be handled in a drinking water 
assessment?
    iii. What is a workable definition of ``reliable'' monitoring data 
for the purpose of conducting a national drinking water assessment? 
Describe the quantity and quality of data that would be acceptable for 
the purpose of conducting regional or national drinking water 
assessments.
    iv. At what scale (i.e., national, regional or local) should OPP be 
conducting pesticide assessments in drinking water? What factors are 
important in determining the scale for assessements?
    v. OPP currently calculates DWLOCs only after contributions from 
food and residential exposures have been considered. Should OPP 
continue with this approach or, if not, what approach should OPP 
consider?
    vi. How should the impact of water treatment processes be 
incorporated into the drinking water assessment? What information is 
available on treatment effects on pesticides in water? Should a 
``default'' treatment (i.e., some minimum standard which is employed by 
most drinking water facilities in the country) be used? If so, what?

C. ``Standard Operating Procedures (SOPs) for Residential Exposure 
Assessment''

    1. Do EPA's responses to the SAP's comments appear reasonable?
    2. Are the SOPs technically correct, complete and based on sound 
science?

D. ``Framework for Assessing Non-Occupational (Residential) Exposure to 
Pesticides.''

    1. Is EPA's approach to non-dietary exposure assessment clear and 
complete?

V. Policies Not Rules

    The draft science policy documents discussed in this notice are 
intended to provide guidance to EPA personnel and decision-makers, and 
to the public. As guidance documents and not rules, these policies are 
not binding on either EPA or any outside parties. Although these 
guidance documents provide a starting point for EPA risk assessments, 
EPA will depart from these policies where the facts or circumstances

[[Page 166]]

warrant. In such cases, EPA will explain why a different course was 
taken. Similarly, outside parties remain free to assert that a given 
policy is not appropriate for a specific pesticide or that the 
circumstances surrounding a specific risk assessment demonstrate that a 
given policy should be abandoned.
    EPA has stated in this notice that it will make available revised 
guidance after consideration of public comment. Public comment is not 
being solicited for the purpose of converting these policy documents 
into binding rules. EPA will not be codifying these policies in the 
Code of Federal Regulations. EPA is soliciting public comment so that 
it can make fully informed decisions regarding the content of these 
guidance.
     The ``revised'' guidance will not be unalterable documents. Once a 
``revised'' guidance document is issued, EPA will continue to treat it 
as guidance, not a rule. Accordingly, on a case-by-case basis EPA will 
decide whether it is appropriate to depart from the guidance or to 
modify the overall approach in the guidance. In the course of 
commenting on the individual guidance documents, EPA would welcome 
comments that specifically address how the guidance documents can be 
structured so that they provide meaningful guidance without imposing 
binding requirements.

VI. Contents of Docket

    Documents that are referenced in this notice will be inserted in 
the docket under the docket control numbers ``OPP-00576,'' ``OPP-00577 
,'' ``OPP-00578 '' or ``OPP-00579.'' In addition, the documents 
referenced in the framework notice, which published in the Federal 
Register on October 29, 1998 (63 FR 58038) have also been inserted in 
the docket under docket control number OPP-00557.

List of Subjects

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, pesticides and pests.

    Dated: December 23, 1998.

Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 98-34736 Filed 12-31-98; 8:45 am]
BILLING CODE 6560-50-F 

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