[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: opp-
[email protected]. 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: [email protected].
    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: [email protected].
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:
    [email protected]
    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