[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)]
[Proposed Rules]
[Pages 81049-81052]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27552]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2015-0653; FRL-9954-65]
Chlorpyrifos; Tolerance Revocations; Notice of Data Availability
and Request for Comment
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
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SUMMARY: EPA is announcing and inviting comment on additional
information obtained and developed by EPA in conjunction with the
proposed tolerance revocation for chlorpyrifos. This information
includes the revised human health risk assessment and the drinking
water assessment. It also includes EPA's issue paper and supporting
analyses presented to the Federal Insecticide, Fungicide and
Rodenticide Act (FIFRA) Scientific Advisory Panel's (SAP) meeting in
April 2016 that addressed chlorpyrifos biomonitoring data and adverse
neurodevelopmental outcomes, public comments received during the
meeting, the FIFRA SAP's meeting minutes and the FIFRA SAP report. EPA
is specifically soliciting comments on the validity and propriety of
the use of all the new information, data, and analyses. EPA is
accepting comment on the information and analysis, as well as reopening
comment on any other aspect of the proposal or the underlying support
documents that were previously available for comment. The EPA continues
to seek comment on possible mitigation strategies, namely, use
deletions, which might allow the EPA to retain a small subset of
existing chlorpyrifos food uses. Commenters need not resubmit comments
previously submitted. EPA will consider those comments, as well as
comments in response to this notice, in taking a final action.
DATES: Submit comments on or before January 17, 2017.
ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2015-0653, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Dana Friedman, Pesticide Re-Evaluation
Division (7508P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 347-8827; email address:
[email protected].
SUPPLEMENTARY INFORMATION:
I. How should I submit Confidential Business Information (CBI) to the
Agency?
Do not submit this information to EPA electronically. Clearly mark
the part or all of the information that you claim to be CBI. For CBI
information in a disk or CD-ROM that you mail to EPA, mark the outside
of the disk or CD-ROM as CBI and then identify electronically within
the disk or CD-ROM the specific information that is claimed as CBI. In
addition to one complete version of the comment that includes
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 docket. Information so marked will not be disclosed except in
accordance with procedures set forth in 40 CFR part 2.
II. Purpose of This Document
EPA is reopening the comment period on the proposed rule: Entitled
``Chlorpyrifos; Tolerance Revocations'' (80 FR 69080, November 6, 2015)
(FRL-
[[Page 81050]]
9935-92), herein referred to as the ``proposed rule,'' for the purpose
of obtaining public comment on the additional information and analyses
announced in this document and which may be relevant to the development
of a final action. EPA is also accepting comment on any other aspect of
the proposal or the underlying support documents that were previously
available for comment. As explained in the proposed rule, the timing of
EPA's issuance of the proposal was dictated by an August 10, 2015 order
by the U.S. Court of Appeals for the Ninth Circuit in Pesticide Action
Network North America (PANNA) v. EPA, No. 14-72794. The PANNA decision
directed EPA to respond by October 31, 2015 to PANNA and the Natural
Resource Defense Council's (NRDC) petition to revoke all chlorpyrifos
tolerances and cancel all chlorpyrifos registrations. As a result of
that timing, EPA had not yet completed portions of its scientific
assessment when it issued the proposed rule. Specifically, EPA noted
that it issued the proposed rule in advance of completing a refined
drinking water assessment and without conducting additional analysis of
the hazard from chlorpyrifos in response to comments received on EPA's
December 2014 Revised Human Health Risk Assessment. Accordingly, EPA
noted in the proposed rule that it would update the proposal with any
new or modified analyses, as EPA completed additional work after the
proposal and, to the extent practicable, EPA would provide the public
an opportunity to comment on that work prior to issuing a final rule.
Consistent with that commitment, EPA is today seeking comment on the
following documents that were not available for public comment during
the prior comment period on the proposed rule: Chlorpyrifos: Revised
Human Health Risk Assessment for Registration Review (2016); the
materials and final report from the 2016 Chlorpyrifos SAP; and
Chlorpyrifos Registration Review Drinking Water Assessment.
EPA's revised analyses do not result in a change to the EPA's
proposal to revoke all tolerances but it does modify the methods and
risk assessment used to support that finding in accordance with the
advice of the SAP. The revised analysis indicates that expected
residues of chlorpyrifos on most individual food crops exceed the
``reasonable certainty of no harm'' safety standard under the Federal
Food, Drug, and Cosmetic Act (FFDCA). In addition, the majority of
estimated drinking water exposures from currently registered uses,
including water exposures from non-food uses, continue to exceed safe
levels even taking into account more refined drinking water exposures.
Accordingly, based on current labeled uses, the agency's analysis
provided in this notice continues to indicate that the risk from the
potential aggregate exposure does not meet the FFDCA safety standard.
EPA can only retain chlorpyrifos tolerances if it is able to conclude
that such tolerances are safe. EPA has not identified a set of
currently registered uses that meets the FFDCA safety standard because
it is likely only a limited number of food uses alone, and in
combination with predicted drinking water exposures, would meet the
standard. Further, EPA has not received any proposals for mitigation
that registrants may be willing to undertake that would allow the EPA
to retain any of the tolerances subject to this rulemaking. EPA
continues to seek comment on possible mitigation strategies, namely,
use deletions, which might allow the EPA to retain a small subset of
existing chlorpyrifos food uses.
EPA consulted the FIFRA SAP for scientific advice on its analysis
of biomonitoring data at a meeting on April 19-21, 2016, at which time,
the public also had an opportunity to provide comment. The FIFRA SAP
was asked to address the use of the epidemiological study The Mothers
and Newborn Study of North Manhattan and South Bronx performed by the
Columbia Children's Center for Environmental Health (CCCEH) at Columbia
University to establish a new toxicological endpoint and associated
point of departure for chlorpyrifos based on observed adverse
neurodevelopmental outcomes in children resulting from prenatal
exposure to chlorpyrifos. While the residential uses that resulted in
chlorpyrifos exposures in the CCCEH study were cancelled in 2000, EPA
believes this study remains relevant in evaluating risks from exposure
to currently registered uses. In its presentation to the SAP, EPA
proposed to use biomonitoring data (cord blood concentrations)
identified in the CCCEH study (Rauh et al., 2006 and Rauh et al., 2011)
as the basis for its point of departure. The FIFRA SAP provided
feedback indicating that it did not believe using the cord blood data
from that study was appropriate to establish a new point of departure.
The SAP's primary criticism was that there was not enough data on the
relationship between cord blood concentrations at birth to exposures at
and around the time of chlorpyrifos application to support its use in
quantitative risk assessment. Further, the FIFRA SAP noted that EPA's
assessment did not identify a particular window of exposure within the
prenatal period linked to the effects reported. Generally, however, the
FIFRA SAP agreed with the overall conclusion of the CCCEH study, i.e.
the association between prenatal chlorpyrifos exposure and
neurodevelopmental outcomes in children.
The final FIFRA SAP report provides a detailed account of the
uncertainties associated with the agency's April 2016 proposed approach
to selecting the point of departure and its use in quantitative risk
assessment. It also outlines the SAP's concern that ``epidemiology and
toxicology studies suggest there is evidence for adverse health
outcomes associated with chlorpyrifos exposures below levels that
result in 10% red blood cell (RBC) acetylcholinesterase (AChE)
inhibition'' (FIFRA SAP, 2016, p. 18). The FIFRA SAP recommended that
EPA should derive the point of departure for neurodevelopmental effects
using the ``estimated peak blood concentration or time weighted average
blood concentration within the prenatal period'' (FIFRA SAP, 2016, p.
42).
After careful consideration of public comments and the SAP's
recommendations, EPA has concluded the most appropriate path for
reconciling the SAP's concerns is to follow through on the SAP's
recommendation to use a time weighted average approach. The agency
agrees with the 2016 FIFRA SAP (and previous SAPs) that there is a
potential for neurodevelopmental effects associated with chlorpyrifos
exposure to occur at levels below 10% RBC AChE inhibition, and that
EPA's existing point of departure (which is based on 10% AChE
inhibition), is therefore not sufficiently health protective.
As detailed in Chlorpyrifos: Revised Human Health Risk Assessment
for Registration Review (2016), in order to follow up on the SAP's
recommendation that the point of departure should be based on blood
concentrations at the time of exposure to chlorpyrifos (rather than
based on cord blood at the time of delivery), EPA evaluated the most
likely chlorpyrifos application method to determine peak exposures to
the CCCEH study cohort experiencing neurodevelopmental effects in
children. EPA contacted the technical pest advisor responsible for
overseeing New York City's housing authority in order to confirm the
application method used at the time the CCCEH study was conducted.
Based on those conversations and a review of the
[[Page 81051]]
registered uses available during that period, EPA concluded that crack
and crevice treatments were the most likely exposure pattern among
those use patterns registered at the time of the study and therefore
has used these exposures as the basis for a new point of departure.
EPA generally selects the dose at which no toxicological effects
are demonstrated to ensure our regulatory endpoint reflects a level of
exposure that does not present a risk concern. However, the CCCEH study
only supported the determination of a lowest observed adverse effects
level (LOAEL). In situations where the agency selects a POD from a
study where a no observed adverse effects level (NOAEL) has not been
identified, EPA generally will retain the Food Quality Protection Act
(FQPA) safety factor of 10X to account for the uncertainty in using a
LOAEL. The 2016 revised risk assessment retains this uncertainty factor
for chlorpyrifos and also applies a 10X uncertainty factor for
intraspecies variability because of the lack of sufficient information
to reduce or remove this factor.
The external exposure was calculated based on the assumptions and
methods outlined in the EPA's 2012 Standard Operating Procedures (SOPs)
for Residential Pesticide Exposure Assessment and chemical-specific
exposure data, where available. Specifically, the 2012 Residential
SOPs, which were peer reviewed by the FIFRA SAP in October 2009, were
used to predict the potential exposures which could have occurred to
individuals in the cohort for the indoor crack and crevice pesticide
use pattern.
EPA then used the chlorpyrifos physiologically based
pharmacokinetic (PBPK) model to estimate the study cohort mothers'
systemic dose related to the LOAEL by (1) determining time-weighted
average (TWA) blood levels from women exposed to chlorpyrifos from
indoor exposures to the cancelled crack and crevice use and (2) using
the crack and crevice TWA blood level as the internal dose for
determining points of departure for infants, children, and adults
exposed to chlorpyrifos using current exposure potential. The use of
the PBPK model to assess internal dosimetry from various exposure
scenarios continues to be supported by the SAP. This applies to the
crack and crevice scenario identified as the most likely exposure
pattern in the CCCEH study, where women were potential exposed via the
dermal, oral, and inhalation routes. The detailed rationale is
presented in Chlorpyrifos: Revised Human Health Risk Assessment for
Registration Review (2016).
EPA has also completed, and is making available for public comment,
Chlorpyrifos Registration Review Drinking Water Assessment. EPA
conducted a national screening level drinking water assessment in 2014.
Because of the court decision ordering EPA to respond to the PANNA-NRDC
Petition by October 31, 2015, EPA was not able to complete a more
refined drinking water assessment for chlorpyrifos in advance of the
proposed rule. Since that time EPA conducted the refined drinking water
assessment with the intention of providing a basis for supporting a
more tailored approach to risk mitigation. In the proposal, EPA
proposed revoking all tolerances largely because the agency could not
make a safety finding based on drinking water exposure in highly-
vulnerable watersheds. EPA reasoned if it could better identify where
such vulnerable areas might be, it could be possible for registrants to
amend product labeling in ways that might make unnecessary some number
of the proposed tolerance revocations.
Chlorpyrifos Registration Review Drinking Water Assessment serves
to combine, update and complete the work presented in the 2011 and 2014
drinking water assessments for chlorpyrifos as part of the registration
review process. This document specifically focuses on the exposure
estimates for surface water. The 2014 assessment presented an approach
for deriving more regionally-specific estimated drinking water exposure
concentrations for chlorpyrifos and chlorpyrifos-oxon for two water
resource regions, hydrologic unit code (HUC)-02. This assessment
updates those exposure assessments and provides estimates for the
remaining (i.e., 19) HUC-02 regions. Urban uses, which had not
previously been assessed, are included in this update. This assessment
also includes statistical analysis of all available monitoring data for
chlorpyrifos and chlorpyrifos-oxon. While this drinking water
assessment is more refined than the previous assessments, as a general
matter, the results did not allow for identification of many areas
where potential exposures of concern to drinking water can be ruled
out. As a result, this assessment does not significantly alter the
conclusions in the proposed rule regarding drinking water exposure and
continues to indicate potential exposure to chlorpyrifos or
chlorpyrifos-oxon in finished drinking water across the country based
on currently labeled uses. This is supported by both model estimated
concentrations as well as measured chlorpyrifos concentrations in
surface water across the United States.
Section IV of this Notice of Data Availability (NODA) describes all
additional data and analyses and how they impact the EPA's proposal.
Note, however, that this NODA does not provide an exhaustive
presentation of the additional data and analysis that EPA is placing in
the associated docket and seeking comment on. All the information
subject to this notice can be accessed as described in section III of
this notice.
EPA is providing notice on these additional analyses to provide an
opportunity for the public to submit additional data or information for
the agency's consideration as it develops the final rule. Since EPA is
still in the process of deliberating the provisions of a final rule,
EPA cannot definitively state whether this information will provide
support for any provision of the final rule, or that the agency has
determined that it is appropriate to rely on this information in
developing the final rule.
On December 10, 2015, the Ninth Circuit issued a further order
requiring EPA to complete any final rule and fully respond to the PANNA
and NRDC petition by December 30, 2016. On June 30, 2016, EPA sought a
6-month extension to that deadline in light of the SAP's recommendation
at the meeting and in order to allow EPA to fully consider the SAP's
written report. The FIFRA SAP report was finalized and made available
for EPA consideration on July 20, 2016. The court rejected EPA's
request for a 6-month extension and ordered EPA to complete its final
action by March 31, 2017 (an extension of 3 months). The court also
announced that no further extensions to that date would be granted.
III. Where can the information identified in this document be found?
The information that EPA is be made available for public review and
comment can be found in the following dockets: EPA-HQ-OPP-2015-0653,
the docket for the proposed tolerance revocations, and EPA-HQ-OPP-2016-
0062, the FIFRA SAP docket, which contains the Chlorpyrifos Issue Paper
and supporting materials. Both dockets can be accessed through http://www.regulations.gov. As noted, EPA is also reopening the comment period
to allow for comment on any aspect of the proposed revocation published
on November 6, 2015 (80 FR 69080) (FRL-9935-92).
[[Page 81052]]
IV. What analysis and data are being noticed?
1. EPA is seeking comment on the following updates to the
chlorpyrifos human health risk assessment: (1) Use of the crack and
crevice scenario to derive an exposure level for women in the Columbia
study; (2) using the LOAEL from the Columbia study and PBPK modeling to
derive an endpoint for use in quantitative risk assessment; (3) use of
the 10X uncertainty factor for intraspecies variability; (4) use of the
10X FQPA safety factor for LOAEL to NOAEL extrapolation (please include
your rationale for any alternative values suggested for this factor).
Its analysis is included in the Chlorpyrifos: Revised Human Health Risk
Assessment for Registration Review (2016), which is available in the
chlorpyrifos tolerance revocation docket (EPA-HQ-OPP-2015-0653).
2. EPA is also making available for comment the issue paper and
associated materials presented to the April 2016 FIFRA SAP and the
final report of the SAP. The FIFRA SAP materials and final report are
available in the FIFRA SAP docket (EPA-HQ-OPP-2016-0062).
3. EPA is also seeking comment on Chlorpyrifos Registration Review
Drinking Water Assessment, a highly refined drinking water assessment
that updates and completes the agency's examination of exposure through
drinking water for all registered uses of chlorpyrifos. This assessment
integrates regionally specific (i.e., spatially relevant) estimated
drinking water concentrations and an extensive evaluation of available
surface water monitoring data for chlorpyrifos and chlorpyrifos-oxon.
The assessment considers both agricultural and non-agricultural uses of
chlorpyrifos, a sensitivity analysis for model estimated
concentrations, and statistical evaluation of surface water monitoring
data.
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: November 10, 2016.
Richard P. Keigwin, Jr.,
Acting Director, Office of Pesticide Programs.
[FR Doc. 2016-27552 Filed 11-16-16; 8:45 am]
BILLING CODE 6560-50-P