[Federal Register Volume 64, Number 1 (Monday, January 4, 1999)]
[Notices]
[Pages 162-166]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-34736]
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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,
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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
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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
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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
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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
