[Federal Register Volume 64, Number 217 (Wednesday, November 10, 1999)]
[Notices]
[Pages 61343-61346]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-29296]


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ENVIRONMENTAL PROTECTION AGENCY

[OPP-00625; FRL-6388-8]


Pesticides; 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 policies related to implementing the Food 
Quality Protection Act are transparent and open to public 
participation, EPA is soliciting comments on the pesticide draft 
science policy paper entitled ``Guidance for Performing Aggregate 
Exposure and Risk Assessments.'' This notice is the thirteenth in a 
series concerning science policy papers related to Food Quality 
Protection Act and the Tolerance Reassessment Advisory Committee.
DATES: Comments for the draft science policy paper, identified by 
docket control number OPP-00625, must be received on or before January 
10, 2000.
ADDRESSES: Comments may be submitted by mail, electronically, or in 
person. Please follow the detailed instructions for each method as 
provided in Unit I.C. of the ``SUPPLEMENTARY INFORMATION.'' To ensure 
proper receipt by EPA, it is imperative that you identify docket 
control number OPP-00625 in the subject line on the first page of your 
response.
FOR FURTHER INFORMATION CONTACT: Carol Christensen, Environmental 
Protection Agency (7505C), 401 M St., SW., Washington, DC 20460; 
telephone number: (703) 305-6230; fax: (703) 305-7147; e-mail: 
[email protected].
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

    You may be potentially affected by this action if you manufacture 
or formulate pesticides. Potentially affected categories and entities 
may include, but are not limited to:

 
------------------------------------------------------------------------
                                                         Examples of
           Categories                   NAICS            potentially
                                                      affected entities
------------------------------------------------------------------------
Pesticide producers                      32532       Pesticide
                                                      manufacturers
                                                     Pesticide
                                                      formulators
------------------------------------------------------------------------

    This listing is not intended to be exhaustive, but rather provides 
a guide for readers regarding entities likely to be affected by this 
action. Other types of entities not listed could also be affected. The 
North American Industrial Classification System (NAICS) codes have been 
provided to assist you and others in determining whether or not this 
action affects certain entities. If you have any questions regarding 
the applicability of this action to a particular entity, consult the 
person listed under ``FOR FURTHER INFORMATION CONTACT.''

B. How Can I Get Additional Information, Including Copies of this 
Document or Other Related Documents?

    1. Electronically. You may obtain electronic copies of this 
document, the draft science policy paper, and certain other related 
documents that might be available from the Office of Pesticide 
Programs' Home Page at http://www.epa.gov/pesticides/. On the Office of 
Pesticide Programs' Home Page select ``FQPA'' and then look up the 
entry for this document under ``Science Policies.'' You can also go 
directly to the listings at the EPA Home Page at http://www.epa.gov/. 
On the Home Page select ``Laws and Regulations'' and then look up the 
entry for this document under ``Federal Register-- Environmental 
Documents.'' You can go directly to the Federal Register listings 
http://www.epa.gov/fedrgstr/.
    2. Fax on demand. You may request a faxed copy of the draft science 
policy paper, as well as supporting information, by using a faxphone to 
call (202) 401-0527. Select item 6043 for the paper entitled ``Guidance 
for Performing Aggregate Exposure and Risk Assessments.'' You may also 
follow the automated menu.
    3. In person. The Agency has established an official record for 
this action under docket control number OPP-00625. In addition, the 
documents referenced in the framework notice, which published in the 
Federal Register on October 29, 1998 (63 FR 58038) (FRL-6041-5) have 
also been inserted in the docket under docket control number OPP-00557. 
The official record consists of the documents specifically referenced 
in this action, and other information related to this action, including 
any information claimed as Confidential Business Information (CBI). 
This official record includes the documents that are physically located 
in the docket, as well as the documents that are referenced in those 
documents. The public version of the official record does not include 
any information claimed as CBI. The public version of the official 
record, which includes printed, paper versions of any electronic 
comments submitted during an applicable comment period is available for 
inspection in the Public Information and Records Integrity Branch 
(PIRIB), Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., 
Arlington, VA, from 8:30 a.m. to 4 p.m., Monday through Friday, 
excluding legal holidays. The PIRIB telephone number is (703) 305-5805.

C. How and to Whom Do I Submit Comments?

    You may submit comments through the mail, in person, or 
electronically. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-00625 in the subject line on the 
first page of your response.
    1. By mail. Submit your comments to: Public Information and Records 
Integrity Branch (PIRIB), Information Resources and Services Division 
(7502C), Office of Pesticide Programs (OPP), Environmental Protection 
Agency, 401 M St., SW., Washington, DC 20460.
    2. In person or by courier. Deliver your comments to: Public 
Information

[[Page 61344]]

and Records Integrity Branch (PIRIB), Information Resources and 
Services Division (7502C), Office of Pesticide Programs (OPP), 
Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 
Jefferson Davis Highway, Arlington, VA. The PIRIB is open from 8 a.m. 
to 4 p.m., Monday through Friday, excluding legal holidays. The PIRIB 
telephone number is (703) 305-5805.
    3. Electronically. You may submit your comments electronically by 
e-mail to: [email protected], or you can submit a computer disk as 
described above. Do not submit any information electronically that you 
consider to be CBI. Avoid the use of special characters and any form of 
encryption. Electronic submissions will be accepted in WordPerfect 6.1/
8.0 or ASCII file format. All comments in electronic form must be 
identified by docket control number OPP-00625. Electronic comments may 
also be filed online at many Federal Depository Libraries.

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

    Do not submit any information electronically that you consider to 
be CBI. You may claim information that you submit to EPA 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. In addition to one complete 
version of the comment that includes any information claimed as CBI, a 
copy of the comment that does not contain the information claimed as 
CBI must be submitted for inclusion in the public version of the 
official record. Information not marked confidential will be included 
in the public version of the official record without prior notice. If 
you have any questions about CBI or the procedures for claiming CBI, 
please consult the person identified under ``FOR FURTHER INFORMATION 
CONTACT.''

E. 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. To ensure proper receipt by EPA, it is imperative that 
you identify docket control number OPP-00625 in the subject line on the 
first page of your response. You may also provide the name, date, and 
Federal Register citation.

II. Background for the Tolerance Reassessment Advisory Committee

     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 six times as a full committee from May 27, 1998 through 
April 29, 1999.
     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 and 
related policies 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 accordance with the framework described in a separate 
notice published in the Federal Register of October 29, 1998 (63 FR 
58038), EPA has been issuing a series of draft papers concerning nine 
science policy issues identified by the TRAC related to the 
implementation of FQPA. This notice announces the availability of the 
draft science policy paper as identified in the ``SUMMARY.''

III. Summary of ``Guidance for Performing Aggregate Exposure and 
Risk Assessments''

     Pesticides are regulated under both FIFRA and FFDCA. In 1996, 
Congress passed FQPA which amended both FIFRA and FFDCA. Through these 
laws,

[[Page 61345]]

EPA evaluates risks posed by the use of each pesticide to make a 
determination of safety. FQPA amended FFDCA to require the Agency to 
consider aggregate exposure. Section 408(b)(2)(ii) requires EPA to find 
for each tolerance ``a reasonable certainty that no harm will result 
from aggregate exposure to the pesticide chemical residue, including 
all anticipated dietary exposures and all other exposures for which 
there is reliable information.'' Section 408(b)(2)(C)(ii)(I) requires 
the Agency to find ``a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residues . . . .'' Finally, Section 408(b)(2)(D)(vi) directs EPA, when 
deciding on tolerances, to consider ``aggregate exposure levels...to 
the pesticide chemical residue . . . including dietary exposure and 
exposure from other non-occupational sources.''
     Implementation of FQPA has led to refinement of many decision 
tools, including methods for assessment of aggregate exposure and risk. 
The methods described in this paper increase the completeness and 
realism of EPA's estimates of potential exposures to pesticides in the 
environment. The Agency believes that these new assessment methods will 
substantially improve protection of public health.
     This draft science policy paper builds on the Interim Approach 
Paper for the March 1997 Scientific Advisory Panel (USEPA, 1997c.) It 
is one in a series of science policy papers developed to address new 
requirements imposed by FQPA. It also relies heavily on the following 
documents:
    1. Exposure Factors Handbook.
    2. Residential SOPs.
    3. Interim Guidance for Conducting Aggregate Exposure and Risk 
Assessments.
    4. Guidance for Submission of Probabilistic Human Health Exposure 
Assessments to the Office of Pesticide Programs.
     An earlier draft of this science policy paper was reviewed by the 
FIFRA SAP in February 1999. The Panel's comments and recommendations 
were considered in this revision.
     This draft science policy paper describes the general principles 
and specific procedure for assessing aggregate non-occupational human 
exposure and risk from a single chemical by all relevant pathways. The 
routes and pathways considered at this time are oral (from food, 
drinking water, and residential scenarios), inhalation (residential 
pathway), and dermal (residential pathway). EPA recognizes the gaps in 
understanding the interdependencies and linkages between and among 
exposure pathways when assessing exposure to an individual, and that 
further data collection is warranted in this area.
     Currently, EPA combines single point estimates from the relevant 
pathways to assess aggregate exposure. Under EPA's current interim 
guidelines, for example, point estimates for drinking water and 
residential exposure pathways are typically added to a point (such as 
the 99.9th percentile) selected from the distribution of dietary 
exposures. This draft science policy paper proposes a different 
approach. Under these new guidelines an analyst first assesses exposure 
by all pathways for one individual at a time; then the analyst combines 
individual assessments into an overall assessment of exposures of a 
sample population of interest. This method keeps each individual's 
characteristics consistent; all exposures agree in time and place; and 
all individual demographic characteristics are consistent and 
reasonable. Using this approach an assessor can create a distribution 
of total exposures to many individuals in a population of interest, 
while retaining inter- and intra-individual variability. And, analysis 
of distributional data can improve understanding, and even allow 
quantification of the uncertainty and variability in the data sets. EPA 
believes that these proposed changes to the performance of aggregate 
exposure and risk assessment will lead to better and more realisitic 
assessments of actual exposure and risk.

IV. Questions/Issues for Comment

     While comments are invited on any aspect of the draft science 
policy paper, OPP is particularly interested in comments on the 
following questions and issues:
     1. The draft science policy paper describes methodologies for 
assessing pesticide risks from single exposure pathways (food, 
residential and drinking water). Are these methodologies complete and 
satisfactorily described, or are changes/additions recommended?
     2. The draft science policy paper describes a process for 
combining pesticide exposures and risk from multiple routes for a given 
pathway of exposure. Is the process, as described, logical, 
scientifically defensible, and complete?
     3. A basic concept underlying the draft aggregate exposure and 
risk assessment methodology is that of the individual being exposed 
through calendar time with all model parameters referring back to that 
specific individual. Is use of this fundamental principle as the basis 
for the aggregate exposure and risk methodology appropriate and, if 
not, how should it be modified?
     4. The draft science policy paper acknowledges the need to 
understand how exposures co-occur. OPP is developing standards to 
identify co-dependencies and inter-relationships between events, and 
recognizes that product marketing data may be available to aid in this 
task. Are there any suggestions on how OPP can best evaluate and 
incorporate into its assessments co-occurrences of exposure events?
     5. During an aggregate exposure and risk assessment, some specific 
exposure scenarios may be identified as having a minimal contribution 
to the total aggregate risk. Is it appropriate to exclude specific 
exposure scenarios that contribute minimally to the total aggregate 
risk, and if so, at what risk level should an exposure scenario be 
dropped from further consideration?
     6. In certain cases and with certain pathways, it may not be 
necessary, advisable, or even possible to develop probabilistic 
exposure estimates and OPP may simply rely on deterministic (or point) 
estimates of a pathway-specific exposure instead. When aggregating, it 
will be necessary to combine the pathway-specific exposure estimates to 
develop an estimate of aggregate exposure. Is OPP's general approach to 
combining deterministic and probabilistic exposure estimates 
appropriate? If not, how should it be modified?
     7. The draft science policy paper describes three methods for 
combining risks from the three routes (oral, dermal, and inhalation). 
The Total MOE (MOET) and the Aggregate Risk Index (ARI) are currently 
being used by OPP. Should OPP continue to use these approaches or 
should OPP consider using the other described approach?

V. Policies Not Rules

    The draft science policy paper discussed in this notice is intended 
to provide guidance to EPA personnel and decision-makers, and to the 
public. As a guidance document and not a rule, the policy in this 
guidance is not binding on either EPA or any outside parties. Although 
this guidance provides a starting point for EPA risk assessments, EPA 
will depart from its policy 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 policy is not 
appropriate for a specific pesticide or that the circumstances

[[Page 61346]]

surrounding a specific risk assessment demonstrate that a 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 any policy document into 
a binding rule. EPA will not be codifying this policy in the Code of 
Federal Regulations. EPA is soliciting public comment so that it can 
make fully informed decisions regarding the content of each guidance 
document.
     The ``revised'' guidance will not be unalterable. 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 inviting 
comment on each guidance document, EPA would welcome comments that 
specifically address how a guidance document can be structured so that 
it provides meaningful guidance without imposing binding requirements.

List of Subjects

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

    Dated: October 29, 1999.
Susan H. Wayland,
Deputy Assistant Administrator for Prevention, Pesticides and Toxic 
Substances.

[FR Doc. 99-29296 Filed 11-9-99; 8:45 am]
BILLING CODE 6560-50-F