[Federal Register Volume 63, Number 209 (Thursday, October 29, 1998)]
[Notices]
[Pages 58038-58045]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-29013]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00557; FRL-6041-5]


Framework for Addressing Key Science Issues Presented by the Food 
Quality Protection Act (FQPA) as Developed Through the Tolerance 
Reassessment Advisory Committee (TRAC)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The notice announces a schedule and framework for EPA issuance 
of a series of science policies to implement provisions in the Food 
Quality Protection Act of 1996 (FQPA). The notice and comment approach 
described in this notice was created following discussion with the 
Tolerance Reassessment Advisory Committee (TRAC), a subcommittee of the 
National Advisory Council on Environmental Policy and Technology 
(NACEPT), a committee established pursuant to the Federal Advisory 
Committee Act. Comments on individual interim science policy documents 
will be invited through separate notices in the Federal Register as 
outlined in the framework. While refining its approach to FQPA science 
policies, EPA will use the policies described in the interim documents 
when making decisions on pesticide actions.

ADDRESSES: 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. In person, deliver comments to: 
Rm. 119, CM #2, 1921 Jefferson Davis Highway, Arlington, VA.
    Comments and data may also be submitted electronically to: opp-
[email protected]. Follow the instructions under Unit VII. of this 
document. No Confidential Business Information (CBI) should be 
submitted through e-mail.
    Information submitted as a comment concerning this document may be 
claimed confidential 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. The public docket is 
available for public inspection in Rm. 119 at the Virginia address 
given above, from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 
legal holidays.

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Registration Division 
(7505C), Office of Pesticide Programs, Environmental Protection Agency, 
401 M St., SW., Washington, DC 20460. Office location, telephone 
number, and e-mail address: Rm. 713D, CM #2, 1921 Jefferson Davis 
Highway, Arlington, VA; (703) 305-5448; [email protected].
SUPPLEMENTARY INFORMATION: The following documents are available from 
the EPA Home page at the Federal Register - Environmental Documents 
entry for this document under ``Laws and Regulations'' (http://
www.epa.gov/fedrgstr/):
    1. This document.
    2. A table entitled ``Framework for Refining FQPA Science Policy.''
    3. A timeline entitled ``Schedule for Release of Guidance on 
Science Policy Issues.''
    Copies of the above-mentioned table and timeline may also be 
obtained from the OPP docket at the location listed under ADDRESSES or 
by contacting Jeff Kempter at the telephone number listed above.

I. Background

A. Food Quality Protection Act (FQPA)

    On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) 
was signed into law. Effective upon signature, 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 data 
supporting pesticide registrations will remain up-to-date in the 
future.

B. Food Safety Advisory Committee (FSAC)

    When FQPA took effect, EPA was immediately faced with having to 
implement new standards and requirements. The Agency established the 
FSAC as a subcommittee of the 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 (OPP). With the guidance and input of the FSAC, the 
Agency issued several key documents concerning how it would implement 
FQPA: (1) On January 31, 1997, Pesticide Registration Notice 97-1 
entitled ``Agency Actions Under the Requirements of the Food Quality 
Protection Act'' provided an interim decision logic for making 
regulatory decisions; (2) the ``1996 Implementation Plan,'' made 
available in March 1997, described EPA's overall plan for implementing 
the requirements of FQPA; and (3) on August 4, 1997, a Federal Register 
notice entitled ``Raw and Processed Food Schedule for Pesticide 
Tolerance Reassessment'' announced a specific plan for conducting 
reassessments of tolerances in effect as of the passage of FQPA.
    The Agency has used the interim approaches developed through 
discussions with FSAC to make regulatory decisions that met FQPA's 
standard and 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.

C. Tolerance Reassessment Advisory Committee (TRAC)

    Although the Agency has sought independent review and public 
participation on a wide variety of issues, the Agency has decided that 
the implementation process would benefit from a more thorough process 
of notice and comment on major science policy issues. As directed by 
Vice President Albert Gore, EPA has been working with the U.S. 
Department of Agriculture (USDA) and a new subcommittee of

[[Page 58039]]

NACEPT, the 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 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 document for addressing key science policy issues. This 
Federal Register notice is based on, but not identical to, the EPA 
staff paper #26 which is the draft framework document presented to the 
TRAC that identified the issues relating to these science policy 
issues.
    The TRAC identified nine science policy issues it believed were key 
to the implementation of FQPA and tolerance reassessment. The framework 
calls for EPA to provide one or more documents for public comment on 
each of the nine issues over the course of the next several months. EPA 
will issue Federal Register notices announcing the availability of each 
of these science policy documents for comment. Other opportunities for 
public involvement in the refinement of these policies may also be 
available, depending on the current status of the individual science 
policy. 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. This notice describing the framework briefly summarizes each of 
the nine science policy issues, the efforts underway to refine them, 
plans for notice and comment, and the timelines for completing 
refinements.

II. The Nine Science Policies

A. Science Policy 1: Applying the FQPA 10-Fold Factor

    FQPA requires EPA to use an additional 10-fold factor when 
assessing a pesticide's dietary risk to take into account potential 
pre- and post-natal developmental toxicity and completeness of the data 
with respect to exposure and toxicity to infants and children. The 
additional FQPA factor may be reduced or removed only if, on the basis 
of reliable data, the factor used will be safe for children. (It should 
be noted that, under certain circumstances, the Agency may use a higher 
factor than the traditional 100-fold uncertainty factor, for example, 
because of a limited toxicity data base.) In assessing risk, the Office 
of Pesticide Programs (OPP) applies the 10-fold factor unless it 
determines, based on a weight-of-the-evidence evaluation of all 
reliable, available information on toxicity and exposure, that it 
should be modified.
    The major science policy issue related to the 10-fold FQPA factor 
is the establishment of appropriate, clear, and transparent criteria 
for retaining or modifying the 10-fold factor. Another closely related 
issue is determining what constitutes a complete and reliable data base 
for toxicology and exposure data to assess risks to children.
    In part, to address these issues, an intra-agency workgroup is 
looking at general considerations regarding the FQPA factor decisions 
such as: establishing procedures for consistency and documentation; 
ensuring the adequacy of the data set for decision-making; and 
establishing criteria for retaining or modifying the FQPA factor. This 
workgroup includes representatives of the Office of Research and 
Development, the Office of Children's Health Protection, the Office of 
Water, the Office of Solid Waste and Emergency Response, as well as the 
Office of Prevention, Pesticides and Toxic Substances. In addition, OPP 
has completed a draft Standard Operating Procedure (SOP) that provides 
procedural guidance at the working level for making recommendations for 
retaining or modifying the 10-fold factor.
    In addition, EPA has solicited advice from the SAP. In October 
1996, EPA first brought to the SAP a paper that described a ``weight-
of-evidence'' approach for the 10x FQPA factor, that was developed 
prior to the passage of FQPA. In March 1998, the Agency brought OPP 
Health and Effects Division (HED) draft guidance on the application of 
the FQPA factor to the Panel. In July 1998, EPA updated the SAP on its 
progress in responding to their comments.
    The Intra-Agency workgroup draft guidance document will be 
completed and available for comment in January 1999. At that time, EPA 
will publish a notice of availability and a 60-day opportunity to 
comment on the guidance document. A revised document will be ready no 
later than June 1999. The draft working level document (the SOP) is 
complete; it will be issued with the Intra-Agency document in February 
1999, for comment and will be revised in light of public comment by 
July 1999.

B. Science Policy 2: Dietary Exposure Assessment - Whether and How to 
Use ``Monte Carlo'' Analyses

    EPA assesses dietary exposure to pesticides in raw and processed 
foods using two distinct pieces of information: the amount of pesticide 
residue that is present in and on food (i.e., the residue level) and 
the types and amounts of food that we eat (i.e., food consumption). The 
residue information comes from the numerous crop field trials and other 
sources (such as monitoring data) where the amount of pesticide residue 
on a given commodity is measured. Routinely, consumption information 
comes from USDA surveys of what people eat. In the past, EPA has used 
the Dietary Risk Evaluation System (DRES) which is a deterministic 
model to combine the residue and food consumption information with data 
on a pesticide's toxicity to calculate acute and chronic dietary risk. 
This deterministic model calculates a single value (sometimes referred 
to as a point estimate) for all the residues for a given commodity.
    Over the last few years, a different technique has been applied to 
estimating acute dietary exposure--a probabilistic evaluation called 
Monte Carlo analysis. A probabilistic analysis uses the entire range of 
data from the numerous crop field trial studies, or other sources to 
estimate the distribution of exposure to the residues for the 
population of concern. This technique allows for a more realistic 
estimate of exposure.
    There are three issues associated with the use of probabilistic 
techniques:
    1. Probabilistic analyses often exhibit a level of uncertainty at 
the extremes of the distribution. This uncertainty makes it difficult 
to judge if the results reflect an accurate estimate of risk, or an 
overestimate or underestimate risk.
    2. EPA needs to make decisions that are appropriately protective of 
larger numbers of people, especially children, necessitating estimates 
of ``high end'' exposures (e.g., 99.9th percentile).
    3. There is a concern over statistical treatment of data that are 
inputted into the Monte Carlo model. For example, how USDA's high end 
consumption estimates combine with the use of a 99.9th percentile 
output needs to be resolved.
    The following steps have been taken or are being taken to address 
these issues:
    1. In March 1998, the Agency presented to the SAP for comment draft

[[Page 58040]]

guidance for submission of probabilistic exposure assessments.
    2. USDA and EPA are jointly assessing how best to treat data 
representing the extremes of exposure.
    3. The issue of the appropriateness of using the 99.9th percentile 
was presented to the SAP. SAP comments are being considered.
    4. EPA is drafting a policy paper on use of the 99.9th percentile 
in decision-making.
    5. The Agency is working on statistical methods for effectively 
using composite data to estimate exposure from single-serving-sized 
food items.
    These products will result:
    1. SAP comments will be considered when preparing the next 
iteration of the draft document entitled ``Guidance for Submission of 
Probabilistic Exposure Assessments to the Office of Pesticide Programs' 
Health Effects Division.'' The document will be issued in October 1998 
for a 60-day comment period. Revised guidance will be issued no later 
than March 1999.
    2. In addition, USDA is reviewing its existing (1989-1991) food 
consumption data to ensure accuracy. This process will be completed in 
October 1998.
    3. The policy paper exploring probabilistic techniques and the 
99.9th percentile (draft working title ``Monte Carlo Techniques and the 
99.9th Percentile'') will be issued for a 60-day comment period in 
December 1998. A revised document will be available no later than May 
1999.
    4. Finally, the draft paper on statistical methods on using 
composite data to estimate exposure from single serving food items 
(draft working title ``Use of the Pesticide Data Program in Acute 
Dietary Assessment'') will be issued for a 60-day public comment period 
in April 1999. The Agency will issue a revised document no later than 
September 1999.

C. Science Policy 3: Exposure Assessment - Interpreting ``No Residues 
Detected''

    Pesticide manufacturers (i.e., registrants) seeking to have a 
tolerance established are required to submit data on the level of 
pesticide residues that remain in or on food. Often, instrumentation in 
the laboratory is not able to detect any residue below a specified 
level, which is called the ``limit of detection'' or LOD. However, even 
though the laboratory instrumentation cannot detect a residue, a 
residue may be present, at some level below the LOD, which may still 
present a potential concern to human health. Current EPA policy is to 
assume that non-detectable residues remain on treated commodities at 
\1/2\ LOD.
    How the Agency should interpret non-detects and how they should be 
incorporated into risk assessments presents these issues:
    1. The Agency's method for incorporating non-detectable residues 
into its risk assessment (\1/2\ LOD) may either overestimate or 
underestimate risk depending on the actual distribution of data below 
the LOD.
    2. There are potential trade and public health impacts if the 
Agency cancels a use, and subsequently revokes the corresponding 
tolerance in the U.S., based upon apparent unacceptable risks 
attributable in significant part to non-detectable residues, while 
other countries allow that use. If risks were accurately assessed or 
were underestimated, crops posing unacceptable risks may be imported 
into the U.S. because residues cannot be detected. If risks were 
overestimated, U.S. pesticide users may unnecessarily lose tools 
available to foreign growers.
    EPA, FDA, and USDA are working together to develop and validate 
improved analytic chemistry methods for detecting residues of 
organophosphate pesticides. These improved methods are expected to be 
adapted to routine surveillance monitoring programs and to provide 
greater sensitivity than currently used methods. The use of more 
sensitive analytical methods should lessen the chance that imported 
food commodities may be treated with pesticides whose use is not 
allowed in the United States. In short, new, more sensitive methods 
should help to establish a ``level playing field'' for domestic growers 
and better protect U.S. consumers.
    FQPA requirements to combine exposures from all sources (e.g., 
food, drinking water, and residential exposure) and from all chemicals 
with a common mechanism of toxicity magnify this problem. The resulting 
risk estimates may be significant even when a substantial portion of 
residues are below the level of detection.
    The Agency has two initiatives underway to address the above 
issues:
    1. An EPA workgroup is examining approaches that could allow EPA to 
determine that there is ``no reasonable expectation of finite 
residues.'' With sufficient data and clearer guidelines, uses for which 
food residues are truly insignificant could be demonstrated to have 
practically no dietary risk associated with them. This change would 
allow the Agency to focus its resources on evaluating exposures to 
pesticides at levels below the LOD, for which there is potential risk 
of concern. This change would also improve international harmonization. 
A paper entitled ``Threshold of Regulation'' will be issued in November 
1998 for a 60-day comment period and will be revised in light of public 
comment no later than April 1999.
    2. An OPP group is examining the availability of better statistical 
methods for assessing data sets that contain both detectable and 
nondetectable residues. Two papers will be issued as a result of this 
effort and will describe EPA's approaches to lessen the likelihood that 
the Agency's assessments either overestimate or underestimate food-
borne exposure. The first paper (draft working title ``Use of Censored 
Data in Risk Assessments'') describes how to use statistical methods 
for situations where some of the residues are undetectable. The second 
paper (draft working title ``ChemSAC decision regarding use of LOD vs. 
LOQ (Limit of Quantitation) in dietary exposure assessments'') 
describes the use of limit of detection versus limit of quantitation in 
dietary exposure assessment. Both of these papers will be released for 
a 60-day public comment period in November 1998, with revised guidance 
to be issued no later than April 1999.

D. Science Policy 4: Dietary (Food) Exposure Estimates

    In assessing dietary exposure from pesticide residues in food, EPA 
starts out with the ``worst-case'' residue level, which is the 
tolerance. Tolerances are regulatory levels and are set to accommodate 
the highest residue level that may be found in crops at the farm gate. 
Crop field trials are used to determine the highest residue level that 
can result from maximum legal use of a pesticide. As discussed below, 
actual residues on food are much lower, and may be virtually non-
existent. Assuming that residues are present at tolerance level and 
that 100% of the crop is treated allows rapid cost-effective decision-
making in many cases where risks are low. In these cases, there may be 
no need for registrants to collect additional data or for the Agency to 
use resources to review additional data.
    Food exposure assessments can be improved with information on 
actual pesticide use, agricultural practices, processing practices, and 
actual or anticipated residues. This type of information includes data 
on pre-harvest intervals, actual application rates, application 
frequency, percent of the crop that is treated, pesticide degradation 
between harvest and the time the crop reaches the consumer (degradation 
over time), cooking and commercial processing studies, and

[[Page 58041]]

other related information, such as more comprehensive monitoring data 
for food and water. To estimate anticipated residue levels, the Agency 
may also need certain supporting residue data, such as residue decline 
studies, or procedures to translate or model residue data for typical 
use practices.
    USDA provides the Agency with extensive information on pesticide 
use, food consumption data, and pesticide residues. The USDA 
information and information from other sources are key to the 
preparation of more realistic exposure assessments which then lead to 
more realistic acute and chronic dietary risk assessments. USDA and EPA 
work to ensure that the needed information is identified, collected, 
and used appropriately in the risk assessment. USDA and EPA have and 
will continue to obtain use information from growers which is then 
reviewed by the Agency and the registrants. EPA then identifies data 
gaps or the need for supplemental information.
    The Agency has been working to 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 in November 1998, and will 
be available on EPA's web page. EPA will provide a description on the 
history, development, and use of NPRD; this will be available in 
December 1998.
    There are several issues associated with the need for data to 
estimate food exposure more realistically:
    1. Dietary risk estimates may be unrealistically high when typical 
use practices have not been factored in.
    2. Information on actual pesticide use may be available, but 
residue levels resulting from such use cannot be calculated without 
certain residue testing, modeling efforts, or bridging data to meld the 
guideline studies with actual usage information.
    3. Monitoring data are not available for all commodities, resulting 
in use of significantly different data in risk assessments for 
different chemicals and/or foods, and high risk estimates for those 
pesticides and crops that lack monitoring data.
    To address the issues discussed above, the following products are 
forthcoming:
    1. EPA will issue for comment in December 1998 a draft overview 
document (draft working title ``Framework for Dietary (Food) Exposure 
Assessment'') that describes how OPP does acute and chronic food 
exposure assessments and, more importantly, where in the existing 
guidance one can find methods for doing such exposure assessments; it 
will also provide guidance for growers, states, and others when 
collecting use information to explain the need for certain residue 
information (a revised document will be issued no later than April 
1999).
    2. EPA will complete matrices describing organophosphate use and 
usage on individual crops by December 1998. These matrices present 
real-world information on pesticide usage and the pests which drive the 
usage, and are developed with support from USDA and the grower 
community.
    High quality consumption data are also critical to developing more 
accurate risk assessments. EPA recently acquired the capability to 
perform acute dietary risk assessments using state-of-the-art software 
and the most recently available USDA food consumption data (1989-91). 
In addition, USDA, in cooperation with EPA, is translating the most 
recently conducted food consumption survey information (1994-96) into a 
data format that can be used in EPA's risk assessments (i.e., from 
foods as eaten to the raw agricultural commodities which make up those 
foods). A peer review of the assumptions or ``recipes'' used in the 
translation of this consumption data will be held in April 1999. The 
final translation should be completed and available to EPA no later 
than June 1999. In addition, USDA is currently completing collection of 
supplementary food consumption data for children under the age of nine 
years to improve the precision of the dietary risk estimates. These 
data are being collected in such a manner that they will be combinable 
with the 1994-96 data. The translated form of the supplemental 
children's survey should be available to EPA no later than December 
1999.

E. Science Policy 5: Dietary (Drinking Water) Exposure Estimates

    For tolerance decisions under FQPA, EPA must now aggregate 
exposures to a pesticide from both dietary sources (food and drinking 
water) and all non-occupational sources for which there is reliable 
information. There are two complementary methods for estimating 
concentrations of pesticides in drinking water. The first is to measure 
pesticide residues in drinking water by taking samples of drinking 
water in use areas at appropriate times, especially during the use 
season for surface water supplies. The second is to develop and use 
mathematical models to predict pesticide levels in drinking water.
    The Pesticide Program's currently available model-based approaches 
for predicting potential drinking water exposure are based on screening 
models that predict pesticide levels in vulnerable groundwater and 
surface water. These predictions are generally believed to overestimate 
the concentration of pesticides in most drinking water sources, and 
hence, in some cases drinking water exposure may appear to present an 
unacceptable dietary risk even though actual risks to most people may 
in fact be lower.
    Several efforts are underway to address the problem that current 
screening models, particularly surface water screening models, do not 
well represent drinking water systems and may significantly 
overestimate residue levels in most drinking water sources. First, OPP 
developed and presented to the FIFRA SAP in July 1998 a proposed 
``reservoir scenario'' model as a replacement for the ``small field 
pond'' model that is currently used to produce screening level 
estimates of pesticide concentrations in drinking water derived from 
surface water. By replacing the ``small field pond'' model with an 
actual reservoir, EPA expects that its screening level drinking water 
estimates for surface water will be more accurate. Subsequent to the 
SAP presentation, OPP developed a list of about 20 possible reservoirs 
that it may further evaluate for use as an index reservoir in its 
screening level assessments. This list is currently available in the 
public docket for this notice.
    Second, OPP is working to develop the necessary data bases and 
Geographical Information System-based tools to enable it to consider 
the percentage of the area around a reservoir that is cropped and, 
thus, potentially treated with a pesticide when it uses its model to 
predict pesticide levels in a drinking water reservoir. Currently, OPP 
assumes that the entire area surrounding a body of water is planted 
with the crop and treated; this generally results in an overestimate of 
the amount of pesticide leaving the field and running off into surface 
water, and, therefore, an overestimate of pesticide concentrations in 
surface water used as drinking water.
    Third, OPP completed and presented to the FIFRA SAP in July 1998, 
its preliminary evaluation of watershed-scale surface water models. 
Further efforts are ongoing to conduct preliminary model validation of 
the basin-scale models for the White River watershed in Indiana. This 
model validation effort is expected to provide some preliminary 
understanding of the relative accuracy of each of these models. OPP 
expects that these basin-scale models will ultimately be used to 
produce more refined estimates of

[[Page 58042]]

pesticide concentrations in drinking water for those cases where an 
unreasonable risk is estimated by the use of a screening level 
estimate.
    In addition to the efforts described above, EPA has entered into a 
cooperative agreement with the International Life Sciences Institute 
(ILSI) to advance probabilistic drinking water exposure assessment 
methodology. ILSI is working to independently develop long-term 
recommendations for model development and data collection so that 
estimates of pesticide concentrations in drinking water can be used in 
probabilistic aggregate exposure analyses in the future. In September 
1998, ILSI convened a panel of over a dozen scientists to consider such 
issues as: (1) What drinking water related data are necessary to use in 
probabilistic aggregate risk analyses and how can these data be 
collected; and (2) what role modeling can play in generating 
information/estimates on pesticide concentration distributions in 
drinking water sources. Recommendations from the September 1998 meeting 
will then be used in a follow-up meeting in December 1998, to develop 
detailed recommendations on how to collect information that can be used 
in probabilistic aggregate exposure analysis. ILSI expects to finalize 
its recommendations in early 1999.
    Finally, OPP continues efforts to gather and interpret available 
drinking water monitoring data and to obtain additional monitoring of 
pesticides in drinking water as individual registration and 
reregistration decisions are made. Further, OPP is working with Federal 
government-sponsored water monitoring programs such as the United 
States Geological Survey's National Ambient Water Quality Assessment 
Program to ensure that key pesticides and drinking water source waters 
are covered; OPP is coordinating pesticide monitoring needs with EPA's 
Office of Water and the states as well.
    EPA is currently using interim policy and interim operating 
procedures to factor drinking water exposure into tolerance decision-
making. EPA will continue to update its interim policy and interim 
operating procedures as important new information becomes available.
    Over the next 12 months, OPP expects to see three products 
completed. First, the Agency will address the July 1998 SAP comments on 
replacing the ``small field pond'' scenario with the reservoir scenario 
and revise its operating policy to include the reservoir scenario in 
screening level assessments. In its revision to its operating policy, 
OPP expects also to propose a change in the Drinking Water Level of 
Concern (DWLOC) terminology. This revised policy will be made available 
for a 60-day comment period in December 1998, and will be revised in 
light of public comment no later than May 1999. EPA expects to solicit 
comment on the concept of replacing the ``small field pond'' scenario 
with a specific type and size of reservoir, as well as on the timing 
for implementation.
    Second, the Agency will complete development of an approach to 
factoring the percentage of land surrounding a reservoir that is 
``cropped'' into its screening level assessments and revise its 
operating policy to include this approach. The Agency plans to present 
to the SAP in February 1999, a specific methodology for developing 
cropped area factors, proposed cropped area factors for 5-10 major 
crops and 5-10 minor crops, and examples of how cropped area factors 
would be applied in screening level drinking water assessments. EPA 
expects to resolve any issues raised by the SAP and expects to make 
this revised policy available for a 60-day public comment period by May 
1999. After consideration of public comments, a revised policy issue 
paper will be issued no later than October 1999.
    Third, the current HED SOP for factoring drinking water exposure 
into dietary risk assessments will be updated in June 1999, to include 
the reservoir scenario and will be published for a 60-day comment 
period. EPA expects that the new SOP which incorporates the reservoir 
scenario will be completed no later than November 1999. A revised SOP 
that includes the percent cropped area treated will be made available 
in December 1999, for comment and will be revised in light of public 
comment no later than May 2000. The SOP will be periodically updated 
thereafter as needed.

F. Science Policy 6: Assessing Residential Exposure

    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. Proposed Agency SOPs, which provide standard 
methods for developing residential exposure assessments when data are 
limited, were drafted and taken to the SAP for comment in November 
1997. They are being revised based on the SAP comments and new 
information from the published literature and other sources.
    Additionally, the Indoor Residential Exposure Joint Venture, an 
industry/Agency task force, is developing information on indoor 
pesticide treatments and pet uses. In Phase I, the Joint Venture will 
provide information to better characterize pesticide use patterns and 
practices. In Phase II, it will apply these data to exposure 
assessments, including, for example, looking at transferable residue 
data from treated surfaces. The Task Force is generating these data to 
support a consortium of registrant products; that is, these chemical-
specific data will be used in conjunction with or in lieu of the SOPs 
(where deemed appropriate). Also, the Outdoor Residential Exposure Task 
Force, another industry/Agency taskforce, is in the midst of generating 
lawn and turf data to assess pesticide exposure from mixing, loading, 
and applying pesticides, as well as exposure to people who enter a 
recently treated turf area.
    The Agency plans to incorporate the 1997 SAP comments on the SOPs 
by December 1998. The revised SOPs will then be published with a 60-day 
comment period. Revised documents will be completed no later than May 
1999. On the same schedule, EPA plans to draft an overview document 
(draft working title ``Framework for Residential/Public Area Exposure 
Assessment'') on how it proposes to develop and use exposure estimates 
for pesticides applied around residences and public areas. In addition, 
the Indoor Residential Joint Venture Task Force is expected to have a 
Phase 1 draft document available in March 1999; Phase 2 will be 
completed by October 2000. Preliminary results from the Outdoor 
Residential Exposure Task Force are expected in August 1999. The Agency 
will review these chemical-specific data and information developed by 
the Task Forces and use this information in conjunction with or in 
place of the current SOPs, as appropriate.

[[Page 58043]]

G. Science Policy 7: Aggregating Exposures from all Non-Occupational 
Sources

    As noted in sections E. and F. of this unit, under the requirements 
of FQPA, in setting tolerances EPA must now aggregate exposures from 
all sources where there is available information. Methods for 
aggregating exposures are being developed.
    The current method for aggregating exposures using simple addition 
provides only point estimates. Methods that more clearly demonstrate 
the range of risks across the general population and population 
subgroups would better characterize risk for risk management decisions 
regarding pesticide use. These methods generally use probabilistic 
analyses.
    In addition to Agency efforts to address these issues, the 
scientific community is examining comprehensive aggregate exposure 
assessment approaches. In February 1998, ILSI conducted a public 
workshop where three groups of experts presented their proposed 
approaches. Workshop participants evaluated and commented on the 
approaches.
    ILSI will issue an independent scientific assessment of the 
technical issues surrounding aggregation of distributions. This report 
is scheduled to be completed in November 1998. After evaluation of this 
report, along with other comments by the scientific community, the 
Agency will develop a draft guidance document in April 1999 for a 60-
day comment period. A revised version in light of public comment should 
be available no later than September 1999. In addition, EPA is 
developing a Standard Operating Procedure paper which will follow the 
same time line.

H. Science Policy 8: How to Conduct a Cumulative Risk Assessment for 
Organophosphate Insecticides or Other Pesticides With a Common 
Mechanism of Toxicity

    Under FQPA, EPA is required to consider available information on 
the effects of cumulative exposure to the pesticide and other 
substances with common mechanisms of toxicity. EPA believes that the 
organophosphate insecticides, the first group examined for tolerance 
reassessment, should be considered to operate via at least one common 
mechanism of toxicity-cholinesterase inhibition, unless and until the 
Agency receives data demonstrating otherwise.
    In the Federal Register of August 6, 1998 (63 FR 42031) (FRL-5797-
9), EPA issued a notice announcing the availability of the proposed EPA 
pesticide policy guidance document entitled ``Guidance for Identifying 
Pesticide Chemicals That Have a Common Mechanism of Toxicity for Use in 
Assessing the Cumulative Toxic Effects of Pesticides.'' The guidance 
document describes the approach that EPA proposes to use for 
identifying and categorizing pesticide chemicals that have common 
mechanisms of toxicity for purposes of assessing the cumulative toxic 
effects of such pesticides. There is a 60-day comment period for this 
document that ends in October 1998. Revised guidance will be issued no 
later than January 1999. In developing this document, the Agency 
solicited advice from the SAP in February 1997; a year later (March 
1998), OPP reported its progress to the SAP.
    Since there are currently no standard methods for doing cumulative 
risk assessment, EPA is pursuing an open, peer-reviewed process to 
develop approaches to cumulative risk assessment. The Agency is also 
nearing completion of the revision of the Chemical Mixtures Risk 
Assessment Guidelines, which present methods for combining risks from 
multiple chemicals. In addition, ILSI is independently exploring 
appropriate methods and developing a framework for performing a 
cumulative risk assessment. ILSI held a workgroup on this subject in 
September 1998, and a report is expected in early 1999. The Agency will 
continue its ongoing efforts in this area along with examining the ILSI 
work and other sources of information in preparation for release of an 
Agency draft guidance document by June 1999 with a 60-day comment 
period. The guidance will be revised no later than November 1999.

I. Science Policy 9: Selection of Appropriate Toxicity Endpoints for 
Risk Assessments of Organophosphates

    Most organophosphate (OP) and certain carbamate insecticides exert 
their principal toxic effects on insects, mammals, and other animals by 
the mechanism of cholinesterase inhibition, which may lead to 
neurotoxicity. Measurement of cholinesterase levels in the blood or 
nervous system after exposure to OPs has become the most common 
endpoint used in risk assessments of this chemical class.
    Over the last several years, the Agency has engaged outside 
scientists and the regulatory community about how measures of 
cholinesterase inhibition should be used in risk assessments. EPA has 
also discussed more generally how these data should be viewed along 
with other types of data in risk assessments. Two issues focused on 
were: (1) The role of blood measures in risk assessment since plasma 
and red cell cholinesterases are not part of the nervous system but 
they may be an indirect measure of what is occurring in the central and 
peripheral nervous systems; and (2) whether plasma cholinesterase 
should be treated differently from red blood cell cholinesterase.
    In June 1997, OPP made a comprehensive presentation to the SAP on 
cholinesterase inhibition. The presentation included a literature 
review, a series of case studies, a summary of activities related to 
methods of cholinesterase measurement, and a proposed policy to use a 
weight-of-evidence approach considering all of the data that might 
result in the use of cholinesterase measures in plasma, red blood 
cells, or brain for defining critical effects and no-effects levels. In 
addition, EPA also asked the SAP about the feasibility of using 
measures of peripheral nervous system tissue to replace blood measures, 
which largely serve as indirect estimators of cholinesterase inhibition 
in the peripheral nervous system in animals. The positions contained in 
the paper presented to the SAP, entitled ``Office of Pesticide Programs 
Science Policy on the Use of Cholinesterase Inhibition for Risk 
Assessments of Organophosphate and Carbamate Pesticides,'' draft April 
30, 1997, will be issued for a 60-day comment period in October 1998. 
The SAP comments on that document will be provided in the docket with 
that Federal Register notice. Revised guidance will be issued no later 
than March 1999.

III. How EPA Will Address Comments

A. Comments Already Received

    Before and during the TRAC meetings, the Agency received comments 
on how to approach and improve its interim policies. Specifically, EPA 
received several petitions, including those from the National Food 
Processors Association, the Natural Resources Defense Council (NRDC) 
and others, a report from the Implementation Working Group (IWG), 
letters from the Environmental Working Group, and various 
correspondence from Congress and others. These documents will be 
considered as the Agency refines its science policies, and will also be 
made available through the public docket. Additionally, the U.S. House 
Agriculture Committee has held a hearing on FQPA implementation and 
there have been legislative or public hearings in California, Idaho, 
and

[[Page 58044]]

Michigan as well at which comments were solicited and offered.

B. NRDC Petition

    On April 23, 1998, the NRDC and various individuals and other 
public interest organizations filed a petition requesting that EPA 
issue an interpretive rule/policy statement regarding EPA's 
implementation of the FQPA provision concerning the additional 10-fold 
factor to protect infants and children. The petition seeks three 
specific actions:
    1. Issuance of a policy statement/interpretive rule providing that 
EPA ``maintain the ten-fold safety factor unless the Administrator has 
determined that there are reliable data on [evolving] pre- and post-
natal toxicity and exposure for fetuses, infants, and children.'' The 
petition sets forth a minimum set of data that petitioners believe 
constitutes ``reliable data'' and requests that the statement/rule 
direct EPA to apply the additional 10-fold factor if any of these data 
are absent.
    2. Convene a ``blue ribbon panel'' to assist EPA ``in determining 
when there are `reliable' data for pre- and post-natal toxicity to 
fetuses, infants, and children.'' NRDC recommends that this panel be 
convened under the auspices of the Children's Health Protection 
Advisory Committee.
    3. Issuance of a policy statement/interpretive rule providing that, 
pending completion of the panel's report, EPA will apply the 10-fold 
FQPA factor.

C. Grower Group and Trade Association Petition

    On May 26, 1998, EPA received a Petition on Rulemaking Under the 
Food Quality Protection Act submitted on behalf of several grower 
groups and trade associations. The petition requested EPA to use notice 
and comment rulemaking to establish policies and procedures for 
implementing FQPA. The petitioners claim that rules are needed to 
establish policies and procedures for assessing aggregate exposures, 
common mechanism of toxicity, and cumulative effects, and for 
determining when the FQPA 10-fold factor may be reduced or removed. The 
petitioners state that EPA is using its current science policies as 
though they were binding requirements. The petitioners maintain that 
neither the advisory panel process nor the notice and comment 
rulemaking on individual tolerances appropriately substitute for notice 
and comment rulemaking on major procedural or policy issues.

D. IWG Report

    The IWG, a coalition of farm, food, manufacturing, and pest 
management organizations, issued a ``road map'' report on June 18, 
1998, which ``presents the IWG's views on how EPA can ensure a more 
balanced and workable implementation of FQPA.'' The sections of the 
report include the IWG's general recommendations, their interpretation 
of Congress's intent, EPA actions to date, ``an approach to aggregate 
risk assessment and the assessment of cumulative effects of chemicals 
with a common mechanism of toxicity,'' other recommendations, and issue 
papers.

IV. EPA's Interim Approach While Assessing the Nine Science 
Policies

A. Interim Approach

    While refining its approach to the nine issues, EPA will use the 
policies described in its interim science policy documents when making 
decisions on actions such as establishing tolerances for registrations 
under section 3 of FIFRA, emergency exemptions under section 18 of 
FIFRA, and tolerance reassessments.

B. EPA's Approach to Notice and Comment

    The Agency intends to refine each of the nine science policy issues 
by seeking public input through the notice and comment process 
explained in this notice. In announcing the availability of the nine 
science policy documents for comment, the Agency will:
    1. Identify any significant comments EPA has already received on 
the various policy documents.
    2. Where appropriate, ask specific questions based on pivotal 
issues in those comments.
    3. Provide a comment period through the Federal Register notice on 
each science policy issue, as described in this notice, after which the 
Agency will respond to significant comments received in response to the 
Agency's notices, and revise each policy as appropriate.

C. Documents Available in the Docket

    The following documents prepared for the TRAC are available in the 
docket: A table entitled ``Framework for Refining FQPA Science Policy'' 
and a timeline entitled ``Schedule for Release of Guidance on Science 
Policy Issues.'' In addition, a compendium of the Agency's current 
operating guidelines is available in the docket; however, comment is 
not being requested at this time on these documents since they are 
being revised. Opportunity for comment will be offered as noted earlier 
in this notice.

V. Policies Not Rules

    The numerous 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 
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.
    Throughout this notice, EPA has stated that it will make available 
revised guidances 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 guidances.
    The ``revised'' guidances 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. Closing

    This is EPA's approach to providing for notice and comment 
regarding the nine science policy issues discussed above and on the 
timing of the process set out in the framework. Under this approach, 
for each science policy issue described above, a document which 
describes the Agency's approach for each issue will be published 
separately, as available, for public comment through the Federal 
Register.

[[Page 58045]]

VII. Public Record and Electronic Submissions

    The official record for this action, as well as the public version, 
has been established for this action under docket control number ``OPP-
00557'' (including comments and data submitted electronically as 
described below). A public version of this record, including printed, 
paper versions of electronic comments, which does not include any 
information claimed as CBI, is available for inspection from 8:30 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The 
official record is located at the Virginia address in ``ADDRESSES'' at 
the beginning of this document.
    Electronic comments can be sent directly to EPA at:
    [email protected]


    Electronic comments must be submitted as an ASCII file avoiding the 
use of special characters and any form of encryption. Comment and data 
will also be accepted on 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 ``OPP-00557.'' Electronic comments on this 
action may be filed online at many Federal Depository Libraries.

List of Subjects

    Environmental protection, FQPA, Pesticides.

    Dated: October 23, 1998.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 98-29013 Filed 10-28-98; 8:45 am]
BILLING CODE 6560-50-F