[Federal Register Volume 63, Number 233 (Friday, December 4, 1998)]
[Notices]
[Pages 67063-67066]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-32344]
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ENVIRONMENTAL PROTECTION AGENCY
[OPP-00568; FRL-6048-2]
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 three draft science
policy papers--``Proposed Threshold of Regulation Policy When a Food
Use Does Not Require a Tolerance,'' ``Assigning Values to Nondetected/
Nonquantified Pesticide Residues in Human Health Dietary Exposure
Assessments'' and ``A Statistical Method for Incorporating Nondetected
Pesticide Residues into Human Health Dietary Exposure Assessments.''
DATES: Written comments for each science policy paper, identified by
separate docket control numbers provided in the ADDRESSES section,
should be submitted by February 4, 1999.
ADDRESSES: The docket number for ``Proposed Threshold of Regulation
Policy When a Food Use Does Not Require a Tolerance'' is OPP-00569, for
``Assigning Values to Nondetected/Nonquantified Pesticide Residues in
Human Health Dietary Exposure Assessments'' is OPP-00570, and for ``A
Statistical Method for Incorporating Nondetected Pesticide Residues
into Human Health Dietary Exposure Assessments'' is OPP-00571. By mail,
submit written comments identified by the docket control number listed
for each 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: docket@epa.gov. Follow the instructions under Unit V. 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 from 8:30 a.m. to 4 p.m., Monday
through Friday, excluding legal holidays.
FOR FURTHER INFORMATION CONTACT: For ``Proposed Threshold of Regulation
Policy When a Food Use Does Not Require a Tolerance'' contact Vivian
Prunier, Environmental Protection Agency (7506C), 401 M St., SW.,
Washington, DC 20460. Office location and telephone number: 1921
Jefferson Davis Highway, 7509C, Arlington, VA, 22207, 703-308-9341,
fax: 703-305-5884, e-mail: prunier.vivian@epa.gov.
For ``Assigning Values to Nondetectable Pesticide Residues in Human
Health Dietary Exposure Assessments'' and ``A Statistical Method for
Incorporating Nondetectable Pesticide Residues into Human Health
Dietary Exposure Assessments'' contact by mail: Kathleen Martin,
Environmental Protection Agency (7509C), 401 M St., SW., Washington, DC
20460. Office location, telephone number, fax and e-mail: 1921
Jefferson Davis Highway, 7509C, Arlington, VA, 22207, 703-308-2857,
fax: 703-305-5147, e-mail: martin.kathleen@epa.gov.
SUPPLEMENTARY INFORMATION:
I. Electronic Availability
A. Internet
Electronic copies of this document, a table entitled ``TRAC Science
Policy Area #3: Exposure Assessment--`No Residues Detected,''' and the
three science policy papers 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/).
B. Fax-on-Demand
For Fax-on-Demand, use a faxphone to call 202-401-0527 and select
item 6024 for ``Proposed Threshold of Regulation Policy When a Food Use
Does Not Require a Tolerance,'' item 6025 for ``Assigning Values to
Nondetected Pesticide Residues in Human Health Dietary Exposure
Assessments'' and item 6026 for ``A Statistical Method for
Incorporating Nondetected Pesticide Residues into Human Health Dietary
Exposure Assessments.''
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
[[Page 67064]]
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 (OPP). 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
three draft documents identified above, all of which relate to science
policy area #3 (Exposure Assessment--Interpreting ``No Residues
Detected'') as described in the framework notice published in the
Federal Register of October 29, 1998 (63 FR 58038). A table entitled
``TRAC Science Policy Area #3: Exposure Assessment--`No Residues
Detected''' that accompanies this notice summarizes these papers and
shows how they interrelate.
III. Summary of Draft Papers
A. ``Proposed Threshold of Regulation Policy When a Food Use Does Not
Require a Tolerance''
EPA is considering a new policy regarding the use of the pesticide
on or in or near food does not result in residues that are detected in
food. Currently, EPA considers that a specific use of a pesticide
chemical will result in a pesticide residue in or on a food if the
pesticide is used in a manner which has a reasonable likelihood to
produce residues in food. Before registering a pesticide for such use
under FIFRA, EPA ordinarily requires the establishment under FFDCA of a
tolerance or an exemption from the requirement to establish a tolerance
(tolerance exemption). In practice, EPA has applied this science policy
in such a manner that an agricultural pesticide use is deemed to result
in residues in or on food unless the use is shown to result in
essentially zero residues.
EPA is deliberating whether to adopt a policy that would set forth
conditions under which the Agency would determine that there is no
requirement to establish a tolerance for an agricultural pesticide or a
pesticide otherwise used in the vicinity of food in certain
circumstances where use of the pesticide does not result in detection
of residues of a pesticide in a food. If EPA adopts such a policy, the
Agency would regulate qualifying pesticide uses solely under FIFRA. The
Agency would not perform the analyses required under section 408 of
FFDCA as to such use. However, if use of a pesticide registered in
accordance with such a policy were to result in detected residues, then
food that bears or contains such residues would be adulterated under
FFDCA and may not be sold.
Under the policy being considered, the determination could be based
on either of the following criteria:
1. Threshold of Regulation based on ``essentially zero'' risk.
There would be no requirement for a tolerance or tolerance exemption
under FFDCA if: (i) Using a reliable and appropriately sensitive
analytical method to measure residues in the commodity, there are no
detected residues in the commodity under expected conditions of use
when the commodity enters interstate commerce; and (ii) using
reasonably protective criteria, the estimated potential dietary risk of
any theoretically possible residues is so small as to not be of
concern.
2. Threshold of Regulation based on ``essentially zero'' exposure.
EPA will evaluate data concerning the amount of residue resulting from
the use of a pesticide in foods (other than milk, meat, poultry or eggs
derived from animals fed pesticide-treated feed) to determine whether
there is ``no reasonable expectation of finite residues'' in these
foods, and therefore, there would be ``essentially zero'' exposure. If
EPA makes such a determination, no tolerance would be established under
FFDCA section 408.
EPA is considering adopting the Threshold of Regulation policy
because it would allow the Agency to grant new food uses or to permit
the continuation of existing food uses that pose ``essentially zero''
dietary risk. The policy would make Agency resources available for pre-
market review of safer pesticides to replace pesticides that do not
meet the new safety standard of the Food Quality Protection Act on 1996
(FQPA). It also would support a reasonable transition for agriculture
by
[[Page 67065]]
retaining some pesticide uses that might otherwise be discontinued and
by expanding the number of potential replacements for high risk food
use pesticides.
B. ``Assigning Values to Nondetected/Nonquantified Pesticide Residues
in Human Health Dietary Exposure Assessments''
When residue data are submitted in support of establishing or
reassessing a tolerance for a particular food use, in some cases a
portion of the measurements of the levels of pesticide residue present
on food shows no detection of residues. These ``nondetects'' (NDs) do
not necessarily mean that the pesticide is not present at any level,
but simply that any amount of pesticide present was below the level
that could be detected or reliably quantified using a particular
analytical method.
The primary science policy issue concerning NDs is what value EPA
should assign to them in calculating dietary exposure and risk from a
pesticide. This science policy paper describes the value that EPA
generally will assign to NDs under different circumstances when EPA
conducts a dietary exposure and risk estimate for a pesticide food use.
First, EPA will assign a value of zero to the proportion of the data
set corresponding to the percentage of the commodities which were not
treated with the pesticide. For the remainder of the data points for
pesticide-treated commodities, EPA will use the following assumptions:
(1) If a valid Limit of Detection (LOD) exists, EPA will use \1/2\
LOD as the assigned value for NDs when conducting dietary exposure and
risk assessments.
(2) If an LOD is not available, but a valid Limit of Quantitation
(LOQ) exists, EPA will use \1/2\ LOQ for the NDs.
(3) If neither an LOD nor an LOQ is available, EPA will use the
full Lower Limit of Method Validation (LLMV) for the NDs.
(4) If unquantified residues are found between the LOQ and LOD, EPA
will use \1/2\ LOQ for those NDs.
In adopting this science policy, EPA's goal is to avoid
underestimating exposure to potentially sensitive or highly exposed
groups such as infants and children while attempting to approximate
actual residue levels as closely as possible. Both biological
information and empirical residue measurements support EPA's belief
that this science policy is consistent with these goals. Recognizing,
however, that these assumptions may, in some cases, either overestimate
or underestimate exposure, EPA's policy will be to perform a
``sensitivity analysis'' to determine the impact of different
assumptions, e.g., assuming NDs = LOQ or NDs = zero, on the Agency's
assessment of risk. If the Agency risk assessment changes as a result
of these alternate substitutions, the sensitivity analysis will have
demonstrated that the Agency risk assessment is sensitive to assumed
concentrations for the NDs and may request that additional data and/or
an improved analytical method be developed and submitted.
C. ``A Statistical Method for Incorporating Nondetected Pesticide
Residues into Human Health Dietary Exposure Assessments''
As mentioned for the previous document, the primary science policy
issue concerning NDs is what value EPA should assign to them in
calculating dietary exposure and risk from a pesticide. In adopting
this science policy, EPA has the same goal as for its policy for
assigning values to NDs. In addition, just as for that policy,
available biological information and empirical residue measurements
indicate that this science policy will be protective of public health,
including potentially sensitive or highly exposed groups such as
infants and children.
This science policy document describes a statistical method which
may be used for determining the distribution of non-detectable residues
below the LOD where some of the residues of the data set are
undetectable. This method is fully described in EPA's Guidance for Data
Quality Assessment: Practical Methods for Data Analysis issued in July
1996 (EPA/600/R-96/084, which has been peer reviewed by EPA program
offices, regional offices and laboratories. The method, referred to as
``Cohen's method,'' would be available in situations where the treated
NDs comprise less than half the data set and the rest of the data are
normally or lognormally distributed. Generally, these values would be
expected to be less than \1/2\ the LOD but greater than zero. When
properly employed, such methods can provide a scientifically sound
basis for more accurately estimating dietary exposure and risk than
assuming that ND values represent \1/2\ LOD. This document is intended
to be used chiefly by persons conducting probabilistic human health
exposure assessments for purposes of registration or reregistration of
pesticides. This guidance will help assure that dietary exposure
assessments accurately portray exposures and risks to the U.S.
population and subpopulations of special concern such as infants and
children. Such assessments will play an increasingly important role in
the evaluation of risks posed by pesticides and will improve the
Agency's ability to make regulatory decisions that fully protect public
health and sensitive subpopulations, including infants and children.
D. Public Comments on the Science Policy Issue: ``Exposure Assessment -
-Interpreting No Residues Detected''
The Agency received several comments as part of the discussions
with the Tolerance Reassessment Advisory Committee on issues relating
to some aspects of the science policies in the three papers being made
available today. In particular, a coalition of farm, food,
manufacturing and pest management organizations, called the
Implementation Working Group (IWG), argued that EPA's risk assessment
methodology tended to overstate possible exposure to pesticide residues
in food by assigning inappropriate values to samples on which no
residue had been detected. The IWG recommended that: (1) One half the
LOQ should be used as a ``general reasonable default'' for residue
levels in samples which are known or believed to have been treated but
which fall below the LOQ; (2) for certain use patterns (e.g., seed
treatments and applications to dormant fruit and nut trees), EPA should
assign a value of zero to residues falling below the LOQ; and (3) EPA
should avoid taking regulatory action against a pesticide use, due to
its dietary risk, when the risk is attributable in any extent to the
amount of residues estimated to be present for ND values. These
recommendations are addressed both in the texts of the papers and in
the identification of issues for public comment in this notice.
IV. Questions/Issues for Comment
While comments are invited on any aspect of the above three papers,
EPA is particularly interested in comments on the following questions
and issues.
A. ``Proposed Threshold of Regulation Policy When a Food Use Does Not
Require a Tolerance''
1. Is the proposed Threshold of Regulation policy a reasonable
approach for dealing with food uses which result in no detected
pesticide residues?
2. Are the data and criteria that the Agency would use for
determining that a use results in ``essentially zero'' exposure
appropriate?
3. Are the data and criteria that the Agency would use for
determining that a use results in ``essentially zero'' risk
appropriate?
[[Page 67066]]
4. Would this policy have any implications for international trade?
5. Should existing tolerances be revoked if the Threshold of
Regulation policy is adopted and certain tolerance are determined not
to be needed?
B. ``Assigning Values to Nondetectable Pesticide Residues in Human
Health Dietary Exposure Assessments''
1. Under what circumstances would either \1/2\ LOD or LOQ for NDs
significantly underestimate or overestimate dietary exposure? Does any
available information demonstrate that this method either
underestimates or overestimates dietary exposure?
2. Should EPA consider a different approach for incorporating
nondetectable samples into risk assessments depending on the type of
risk assessment being performed (i.e., chronic risks, acute risks,
short-term risks (Section 18's))?
3. Are the methods for determining LOD and LOQ adequately defined?
4. Would this policy have any implications for international trade?
C. ``A Statistical Method for Incorporating Nondetectable Pesticide
Residues into Human Health Dietary Exposure Assessments''
1. Are other methods available which may be preferable to the
methods described in this paper for statistically estimating the
distribution or mean values of nondetectable residue samples?
2. Under what circumstances, if any, would use of Cohen's method
not be considered reliable or appropriate?
V. Public Record and Electronic Submissions
A record has been established for these policy guidances under
docket control numbers ``OPP-00569,'' ``OPP-00570,'' and ``OPP-00571''
(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 public 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:
opp-docket@epa.gov
Electronic comments must be submitted as an ASCII file avoiding the
use of special characters and any form of encryption. Comments and data
will also be accepted on disks in WordPerfect in 5.1/6.1 file format or
ASCII file format. All comments and data in electronic form must be
identified by the docket control numbers ``OPP-00569,'' ``OPP-00570,''
or ``OPP-00571.'' Electronic comments on this document may be filed
online at many Federal Depository Libraries.
VI. Contents of Docket
Documents that are referenced in this notice document will be
inserted in the docket under the docket control numbers ``OPP-00569,''
``OPP-00570,'' or ``OPP-00571.'' 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: November 30, 1998.
Lynn R. Goldman,
Assistant Administrator for Prevention, Pesticides and Toxic
Substances.
[FR Doc. 98-32344 Filed 12-3-98; 8:45 am]
BILLING CODE 6560-50-F
