[Federal Register Volume 84, Number 142 (Wednesday, July 24, 2019)]
[Rules and Regulations]
[Pages 35555-35568]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15649]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2007-1005; FRL-9997-06]


Chlorpyrifos; Final Order Denying Objections to March 2017 
Petition Denial Order

AGENCY: Environmental Protection Agency (EPA).

ACTION: Order.

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SUMMARY: In this Order, EPA denies the objections to EPA's March 29, 
2017 order denying a 2007 petition from the Pesticide Action Network 
North America (PANNA) and the Natural Resources Defense Council (NRDC) 
to revoke all tolerances and cancel all registrations for the 
insecticide chlorpyrifos. This order is issued under section 
408(g)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FFDCA) and 
constitutes final agency action on the 2007 petition. The objections 
were filed by Earthjustice on behalf of 12 public interest groups, the 
North Coast Rivers Alliance, and the States of New York, Washington, 
California, Massachusetts, Maine, Maryland, and Vermont.

DATES: This Order is effective July 24, 2019.

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2007-1005, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 
1301 Constitution Ave. NW, Washington, DC 20460-0001. The Public 
Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through 
Friday, excluding legal holidays. The telephone number for the Public 
Reading Room is (202) 566-1744, and the telephone number for the OPP 
Docket is (703) 305-5805. Please review the visitor instructions and 
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Pesticide Re-Evaluation Division 
(7508P), Office of Pesticide Programs, Environmental Protection Agency, 
1200 Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number: 
(703) 347-0206; email address: [email protected].

SUPPLEMENTARY INFORMATION: 

I. General Information

A. Does this action apply to me?

    In this document, EPA denies all objections in response to a March 
29, 2017 order denying the 2007 PANNA and NRDC petition requesting that 
EPA revoke all tolerances and cancel all pesticide product 
registrations for chlorpyrifos. In addition to the Petitioners, this 
action may be of interest to agricultural producers, food manufacturers 
or pesticide manufacturers, and others interested in food safety issues 
generally. The following list of North American Industrial 
Classification System (NAICS) codes is not intended to be exhaustive, 
but rather provides a guide to help readers determine whether this 
document applies to them. Potentially affected entities may include:
     Crop production (NAICS code 111), e.g., agricultural 
workers; greenhouse, nursery, and floriculture workers; farmers.
     Animal production (NAICS code 112), e.g., cattle ranchers 
and farmers, dairy cattle farmers, livestock farmers.
     Food manufacturing (NAICS code 311), e.g., agricultural 
workers; farmers;

[[Page 35556]]

greenhouse, nursery, and floriculture workers; ranchers; pesticide 
applicators.
     Pesticide manufacturing (NAICS code 32532), e.g., 
agricultural workers; commercial applicators; farmers, greenhouse, 
nursery, and floriculture workers; residential users.

B. What action is the agency taking?

    In this order, EPA denies objections to EPA's order of March 29, 
2017 (the Denial Order), in which EPA denied a 2007 petition (the 
Petition) from PANNA and NRDC (the Petitioners) that requested that EPA 
revoke all tolerances for the pesticide chlorpyrifos established under 
FFDCA section 408. (Ref. 1) The Petition also sought the cancellation 
of all chlorpyrifos pesticide product registrations under section 6 the 
Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C. 
136d.
    The Petition raised the following claims regarding both EPA's 2006 
FIFRA reregistration decision and active registrations of chlorpyrifos 
in support of the request for tolerance revocations and product 
cancellations:
    1. EPA has ignored genetic evidence of vulnerable populations.
    2. EPA has needlessly delayed a decision regarding endocrine 
disrupting effects.
    3. EPA has ignored data regarding cancer risks.
    4. EPA's 2006 cumulative risk assessment (CRA) for the 
organophosphates misrepresented risks and failed to apply FQPA 10X 
safety factor. (Note: For convenience's sake, the legal requirements 
regarding the additional safety margin for infants and children in 
FFDCA section 408(b)(2)(C) are referred to throughout this response as 
the ``FQPA 10X safety factor'' or simply the ``FQPA safety factor.'' 
Due to Congress' focus on both pre- and post-natal toxicity, EPA has 
interpreted this additional safety factor as pertaining to risks to 
infants and children that arise due to pre-natal exposure as well as to 
exposure during childhood years.)
    5. EPA has over-relied on registrant data.
    6. EPA has failed to properly address the exporting hazard in 
foreign countries from chlorpyrifos.
    7. EPA has failed to quantitatively incorporate data demonstrating 
long-lasting effects from early life exposure to chlorpyrifos in 
children.
    8. EPA has disregarded data demonstrating that there is no evidence 
of a safe level of exposure during pre-birth and early life stages.
    9. EPA has failed to cite or quantitatively incorporate studies and 
clinical reports suggesting potential adverse effects below 10% 
cholinesterase inhibition.
    10. EPA has failed to incorporate inhalation routes of exposure.
    EPA's Denial Order denied the Petition in full (82 FR 16581). Prior 
to issuing that order, EPA provided the Petitioners with two interim 
responses on July 16, 2012 and July 15, 2014. The July 16, 2012 
response denied claim 6 (export hazard) completely, and that portion of 
the response was a final agency action. The remainder of the July 16, 
2012 response and the July 15, 2014 response expressed EPA's intention 
to deny six other petition claims (1-5 and 10). (Note: In the 2012 
response, EPA did, however, inform Petitioners of its approval of label 
mitigation (in the form of rate reductions and spray drift buffers) to 
reduce bystander risks, including risks from inhalation exposure, which 
in effect partially granted Petition claim 10.) EPA made clear in both 
the 2012 and 2014 responses that, absent a request from Petitioners, 
EPA's denial of those six claims would not be made final until EPA 
finalized its response to the entire Petition. Petitioners made no such 
request, and EPA therefore finalized its response to those claims in 
the Denial Order.
    The remaining Petition claims (7-9) all related to same issue: 
Whether the potential exists for chlorpyrifos to cause 
neurodevelopmental effects in children at exposure levels below EPA's 
existing regulatory standard (10% cholinesterase inhibition). Because 
these claims raised novel, highly complex scientific issues, EPA 
originally decided it would be appropriate to address these issues in 
connection with the registration review of chlorpyrifos under FIFRA 
section 3(g) and decided to expedite that review, intending to finalize 
it several years in advance of the October 1, 2022 registration review 
deadline. EPA decided as a policy matter that it would address the 
Petition claims raising these matters on a similar timeframe. Although 
EPA had expedited its registration review to address these issues, the 
Petitioners were not satisfied with EPA's progress in responding to the 
Petition, and they brought legal action in the Ninth Circuit Court of 
Appeals to compel EPA to either issue an order denying the Petition or 
to grant the Petition by initiating the tolerance revocation process. 
Following several rounds of litigation (see discussion of the 
litigation in Unit III. of this Order), EPA was ordered by the Ninth 
Circuit to issue either a tolerance revocation rule or an order denying 
the Petition by March 31, 2017. In re Pesticide Action Network of North 
America v. EPA, 840 F.3d (9th Cir. 2016). Accordingly, in compliance 
with the court's order, the Denial Order also finalized EPA's response 
on claims 7-9. As to those claims, EPA concluded that, despite several 
years of study, the science addressing neurodevelopmental effects 
remains unresolved and that further evaluation of the science during 
the remaining time for completion of registration review was warranted 
regarding whether the potential exists for adverse neurodevelopmental 
effects to occur from current human exposures to chlorpyrifos. EPA 
therefore denied the remaining Petition claims, concluding that it was 
not required to complete--and would not complete--the human health 
portion of the registration review or any associated tolerance 
revocation of chlorpyrifos without resolution of those issues during 
the ongoing FIFRA registration review of chlorpyrifos.
    In June 2017, several public interest groups and states filed 
objections to the Denial Order pursuant to the procedures in FFDCA 
section 408(g)(2). Specifically, Earthjustice submitted objections on 
behalf of the following 12 public interest groups: Petitioners PANNA 
and NRDC, United Farm Workers, California Rural Legal Assistance 
Foundation, Farmworker Association of Florida, Farmworker Justice, 
GreenLatinos, Labor Council for Latin American Advancement, League of 
United Latin American Citizens, Learning Disabilities Association of 
America, National Hispanic Medical Association and Pineros y Campesinos 
Unidos del Noroeste. Another public interest group, the North Coast 
River Alliance, submitted separate objections. With respect to the 
states, New York, Washington, California, Massachusetts, Maine, 
Maryland, and Vermont submitted a joint set of objections (Ref. 2).
    The objections focus on three main topics: (1) The Objectors assert 
that the FFDCA requires EPA apply to the FFDCA safety standard in 
reviewing any petition to revoke tolerances and that EPA's decision to 
deny the Petition failed to apply that standard; (2) The Objectors 
contend that the record before EPA demonstrates that chlorpyrifos 
results in unsafe drinking water exposures and adverse 
neurodevelopmental effects and that EPA must therefore issue a final 
rule revoking all chlorpyrifos tolerances; and (3) The Objectors claim 
that EPA committed procedural error in failing to respond to comments, 
and they specifically point to comments related to neurodevelopmental 
effects, inhalation risk, and Dow AgroSciences'

[[Page 35557]]

physiologically based pharmacokinetic model (PBPK model) used in EPA's 
risk assessment. Dow AgroSciences, which is now Corteva AgriScience, 
will be referred to as Corteva throughout the remainder of this Order.
    On June 5, 2017, the same the day the Objectors were required to 
submit their objections to EPA, the League of United Latin American 
Citizens (LULAC) and the other 11 public interest Objectors represented 
by Earthjustice filed suit in the U.S. Court of Appeals for the 9th 
Circuit directly challenging the Denial Order, asserting that the court 
could review the order directly, even in the absence of EPA's final 
order under FFDCA section 408(g)(2)(C) responding to the objections 
they had just submitted. LULAC, et al. v. Wheeler, et al., No. 17-
71636. In their pleadings, Petitioners alternatively asked the court to 
issue a mandamus order compelling EPA to respond to the June 2017 
objections within 60 days. On August 9, 2018, a three-judge panel of 
the 9th Circuit vacated the Denial Order and ordered EPA to revoke all 
chlorpyrifos tolerances and cancel all chlorpyrifos registrations 
within 60 days. Id., 899 F.3d 814. EPA sought rehearing of that 
decision before an en banc panel of the 9th Circuit, a request that was 
granted on February 6, 2019, effectively vacating the August 9, 2018 
panel decision. On April 19, 2019, the en banc panel granted the 
request for mandamus and directed EPA to respond to the objections not 
later than 90 days from that date. The court did not otherwise address 
the claims in the case.
    After reviewing the objections, EPA has determined that the 
objections related to Petition claims regarding neurodevelopmental 
toxicity must be denied because the objections and the underlying 
Petition are not supported by valid, complete, and reliable evidence 
sufficient to meet the Petitioners' burden under the FFDCA, as set 
forth in EPA's implementing regulations. Further, for reasons stated in 
the Denial Order, EPA has concluded that it is also appropriate to deny 
the objections related to new issues raised after EPA's 2006 tolerance 
reassessment and reregistration of chlorpyrifos. These issues are being 
addressed according to the schedule for EPA's ongoing registration 
review of chlorpyrifos. EPA is also denying all claims related to 
drinking water risk and the use of the Corteva PBPK model in EPA's 2014 
risk assessment and 2015 proposed rule because these claims were not 
made in the Petition and the objections process cannot be used to raise 
new issues and restart the petition process. Finally, EPA is denying 
the objections claiming procedural error, as EPA is not required to 
respond to comments made during the rulemaking process in this 
adjudication denying petition objections. Any response to comments will 
be completed in connection with EPA's final action in registration 
review.

C. What is the Agency's authority for taking this action?

    The procedure for filing objections to EPA's final rule or order 
issued under FFDCA section 408(d) and EPA's authority for acting on 
such objections is contained in FFDCA section 408(g) (21 U.S.C. 
346a(g)) and EPA's regulations at 40 CFR part 178.

II. Statutory and Regulatory Background

    In this unit, EPA provides background on the relevant statutes and 
regulations governing the objections as well as on pertinent Agency 
policies and practices.

A. FFDCA and FIFRA Standards

    EPA establishes maximum residue limits, or ``tolerances,'' for 
pesticide residues in food and feed commodities under FFDCA section 
408. Without a tolerance or an exemption from the requirement of a 
tolerance, food containing a pesticide residue is ``adulterated'' under 
FFDCA section 402 and may not be legally moved in interstate commerce. 
FFDCA section 408 was substantially rewritten by the Food Quality 
Protection Act of 1996 (FQPA) (Pub. L. 104- 170, 110 Stat. 1489 
(1996)), which established a detailed safety standard for pesticides 
and integrated EPA's regulation of pesticide food residues under the 
FFDCA with EPA's registration and re-evaluation of pesticides under 
FIFRA. The standard to establish, leave in effect, modify, or revoke a 
tolerance is stated in FFDCA section 408(b)(2)(A)(i). ``The 
Administrator may establish or leave in effect a tolerance for a 
pesticide chemical residue in or on a food only if the Administrator 
determines that the tolerance is safe.'' Id. ``The Administrator shall 
modify or revoke a tolerance if the Administrator determines it is not 
safe.'' Id. ``Safe'' is defined by FFDCA section 408(b)(2)(A)(ii) to 
mean that ``there is 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.'' Among the factors that must be 
addressed in making a safety determination, FFDCA section 408(b)(2)(D) 
directs EPA to consider ``validity, completeness, and reliability of 
the available data from studies of the pesticide chemical and pesticide 
chemical residue.''
    Risks to infants and children are given special consideration. 
Specifically, FFDCA section 408(b)(2)(C)(i)(II) requires that EPA 
assess the risk of pesticides based on ``available information 
concerning the special susceptibility of infants and children to the 
pesticide chemical residues, including neurological differences between 
infants and children and adults, and effects of in utero exposure to 
pesticide chemicals . . . .'' (21 U.S.C. 346a(b)(2)(C)(i)(II)). This 
provision also creates a presumption that EPA will use an additional 
safety factor for the protection of infants and children. Specifically, 
it directs that ``[i]n the case of threshold effects, . . . an 
additional tenfold margin of safety for the pesticide chemical residue 
and other sources of exposure shall be applied for infants and children 
to take into account potential pre- and post-natal toxicity and 
completeness of the data with respect to exposure and toxicity to 
infants and children.'' (21 U.S.C. 346a(b)(2)(C)). EPA is permitted to 
``use a different margin of safety for the pesticide chemical residue 
only if, on the basis of reliable data, such margin will be safe for 
infants and children.'' Id.
    While the FFDCA authorizes the establishment of legal limits for 
pesticide residues in food, FIFRA section 3(a) requires the approval of 
pesticides prior to their sale and distribution and establishes a 
registration regime for regulating the use of pesticides. FIFRA 
regulates pesticide use in conjunction with its registration scheme by 
requiring EPA review and approval of pesticide labels and specifying 
that use of a pesticide inconsistent with its label is a violation of 
federal law. In the FQPA, Congress integrated action under the two 
statutes by requiring that the safety standard under the FFDCA be used 
as a criterion in FIFRA registration actions for pesticide uses that 
result in residues in or on food, (see FIFRA section 2(bb)), and 
directing that EPA coordinate, to the extent practicable, revocations 
of tolerances with pesticide cancellations under FIFRA. (see FFDCA 
section 408(l)(1)). FIFRA section 4 directed EPA to determine whether 
pesticides first registered prior to 1984 should be reregistered, 
including whether any associated FFDCA tolerances are safe and should 
be left in effect (see FIFRA section 4(g)(2)(E)). FFDCA section 408(q) 
directed EPA to complete that tolerance reassessment (which included 
the reassessment of all chlorpyrifos tolerances) by 2006. Following the

[[Page 35558]]

completion of FIFRA reregistration and tolerance reassessment, FIFRA 
section 3(g) requires EPA to re-evaluate pesticides under the FIFRA 
standard--which includes a determination whether to leave in effect 
existing FFDCA tolerances--every 15 years under a program known as 
``registration review.'' The deadline for completing the current 
registration review for chlorpyrifos is October 1, 2022.

B. Procedures for Establishing, Modifying, or Revoking Tolerances

    Tolerances are established, modified, or revoked by rulemaking 
under the unique procedural framework set forth in the FFDCA. 
Generally, a tolerance rulemaking is initiated by the party seeking to 
establish, modify, or revoke a tolerance by means of filing a petition 
with EPA. (See FFDCA section 408(d)(1)). EPA publishes in the Federal 
Register a notice of the petition filing and requests public comment. 
After reviewing the petition and submitted comments, FFDCA section 
408(d)(4) provides that EPA may issue a final rule establishing, 
modifying, or revoking the tolerance; issue a proposed rule to do the 
same; or issue an order denying the petition.
    Once EPA takes action granting or denying the petition, FFDCA 
section 408(g)(2) allows any party to file objections with EPA and seek 
an evidentiary hearing on those objections. Objections and hearing 
requests must be filed within 60 days after the date on which EPA 
issues its rule or order under FFDCA section 408(d). A party may not 
raise issues in objections unless they were part of the petition and an 
objecting party must state objections to the EPA decision and not just 
repeat the allegations in its petition. Corn Growers v. EPA, 613 F.3d 
266 (D.C. Cir. 2010), cert. denied, 131 S. Ct. 2931 (2011). EPA's final 
order on the objections, issued under FFDCA section 408(g)(2)(C), is 
subject to judicial review. (21 U.S.C. 346a(h)(1)).

III. Chlorpyrifos Regulatory Background

    Chlorpyrifos (0,0-diethyl-0-3,5,6-trichloro-2-pyridyl 
phosphorothioate) is a broad-spectrum, chlorinated organophosphate (OP) 
insecticide that has been registered for use in the United States since 
1965. By pounds of active ingredient, it is the most widely used 
conventional insecticide in the country. Currently registered use sites 
include a large variety of food crops (e.g., tree fruits and nuts; many 
types of small fruits and vegetables, including vegetable seed 
treatments; grain/oilseed crops; cotton), and non-food use settings 
(e.g., ornamental and agricultural seed production; non-residential 
turf; industrial sites/rights of way; greenhouse and nursery 
production; sod farms; pulpwood production; public health; and wood 
protection). For some of these crops, chlorpyrifos is currently the 
only cost-effective choice for control of certain insect pests. In 
2000, the chlorpyrifos registrants reached an agreement with EPA to 
voluntarily cancel all residential use products except those registered 
for ant and roach baits in child-resistant packaging and fire ant mound 
treatments (e.g., 65 FR 76233 (Dec. 6, 2000); 66 FR 47481 (Sept. 12, 
2001).
    The OPs are a group of closely related pesticides that affect 
functioning of the nervous system. The OPs were included in the 
Agency's first priority group of pesticides to be reviewed under FQPA. 
In 2006, EPA completed FIFRA section 4 reregistration and FFDCA 
tolerance reassessment for chlorpyrifos and the OP class of pesticides 
and determined those tolerances were safe and should be left in effect 
(Ref. 3). Having completed reregistration and tolerance reassessment, 
EPA is required to complete the next re-evaluation of chlorpyrifos 
under the FIFRA section 3(g) registration review program by October 1, 
2022. Given ongoing scientific developments in the study of the OPs 
generally, in March 2009 EPA announced its decision to prioritize the 
FIFRA section 3(g) registration review of chlorpyrifos by opening a 
public docket and releasing a preliminary work plan to complete the 
chlorpyrifos registration review by 2015--7 years in advance of the 
date required by law.
    The registration review of chlorpyrifos has proven to be far more 
complex than originally anticipated. The OPs presented EPA with 
numerous novel scientific issues that the agency has taken to multiple 
FIFRA Scientific Advisory Panel (SAP) meetings since the completion of 
reregistration in 2006. (Note: The SAP is a federal advisory committee 
created by FIFRA section 25(d) and serves as EPA's primary source of 
peer review for significant regulatory and policy matters involving 
pesticides.) Many of these complex scientific issues formed the basis 
of the 2007 petition filed by PANNA and NRDC, specifically issues 
related to potential human health risks associated with volatilization 
and neurodevelopmental effects. During the registration review process, 
EPA reviews the currently available body of scientific data, including 
animal and epidemiology data, and the assessment of potential risks 
from various routes of exposure. Therefore, when EPA began the 
registration review for chlorpyrifos in March 2009, the Agency 
indicated that the Agency had decided to address the Petition on a 
similar timeframe to EPA's expedited registration review schedule.
    Although EPA has expedited the chlorpyrifos registration review to 
address the novel scientific issues raised by the Petition in advance 
of the statutory deadline, the complexity of the issues has precluded 
EPA from finishing this review according to the Agency's original 
timeframe. The Petitioners were dissatisfied with the pace of EPA's 
response efforts and sued EPA in federal court on three separate 
occasions to compel a faster response to the Petition. As explained in 
Unit I. of this Order, EPA addressed 7 of the 10 claims asserted in the 
Petition by either denying the claim, issuing a preliminary denial or 
approving label mitigation to address the claims, but notwithstanding 
these efforts, on August 10, 2015, the court issued a mandamus order 
directing EPA to ``issue either a proposed or final revocation rule or 
a full and final response to the administrative Petition by October 31, 
2015.'' In re Pesticide Action Network of North America v. EPA, 798 
F.3d (9th Cir. 2015).
    In response to that order, EPA issued a proposed rule to revoke all 
chlorpyrifos tolerances on October 30, 2015 (published in the Federal 
Register on November 6, 2015 (80 FR 69080)), based on its unfinished 
registration review risk assessment. EPA acknowledged it had 
insufficient time to complete its drinking water assessment and its 
review of data addressing the potential for neurodevelopmental effects.
    On December 10, 2015, the Ninth Circuit issued a further order 
requiring EPA to complete any final rule (or petition denial) and fully 
respond to the Petition by December 30, 2016. On June 30, 2016, EPA 
sought a six-month extension to that deadline in order to allow EPA to 
fully consider the most recent views of the FIFRA SAP with respect to 
chlorpyrifos toxicology. The FIFRA SAP report was finalized and made 
available for EPA consideration on July 20, 2016 (Ref. 4). On August 
12, 2016, the court rejected EPA's request for an extension and ordered 
EPA to complete its final action by March 31, 2017 (effectively 
granting EPA a three-month extension). On November 17, 2016, EPA 
published a notice of data availability (NODA) seeking public comment 
on both EPA's revised risk and water assessments and reopening the 
comment period on the proposal to revoke all chlorpyrifos tolerances 
(81 FR

[[Page 35559]]

81049). The comment period for the NODA closed on January 17, 2017.
    Following the close of the comment period on the NODA, EPA issued 
the Denial Order on March 29, 2017, as described in Unit I. of this 
Order. As noted, in June 2017, EPA received objections to the Denial 
Order from both public interest groups and states, and some of those 
same organizations simultaneously filed suit in the Ninth Circuit 
seeking to challenge the Denial Order in advance of EPA's response to 
the submitted objections. That litigation is summarized in Unit I. of 
this Order.

IV. The Petition and EPA's Petition Response

    As explained in Unit I. of this Order, PANNA and NRDC submitted the 
Petition in 2007, raising 10 claims in support of their request that 
EPA revoke all chlorpyrifos tolerances under the FFDCA and cancel all 
chlorpyrifos registrations under FIFRA. EPA's Denial Order denied the 
Petition in full. The following is a summary of EPA's response in the 
Denial Order to the 10 Petition claims.

A. Claim 1: Genetic Evidence of Vulnerable Populations

    The Petitioners claimed that as part of EPA's 2006 reregistration 
and tolerance reassessment decision the Agency failed to calculate an 
appropriate intra-species uncertainty factor (i.e., within human 
variability) for chlorpyrifos in both its aggregate and cumulative risk 
assessments (CRA). They asserted that certain data (the ``Furlong 
study'') addressing intra-species variability in the behavior of the 
detoxifying enzyme paraoxonase (PON1), indicates that the Agency should 
have applied an intra-species safety factor ``of at least 150X in the 
aggregate and cumulative assessments'' rather than the 10X factor EPA 
applied.
    In the Denial Order, EPA explained that it carefully considered the 
issue of PON1 variability and determined that data addressing PON1 in 
isolation are not appropriate for use alone in deriving an intra-
species uncertainty factor and that the issue is more appropriately 
handled using a PBPK model. Further, the derivation of an intra-species 
factor of over 150X advocated by the Petitioners is based on combining 
values from humanized mice with human measured values with a range from 
highest to lowest; the Furlong study derivation is inappropriate and 
inconsistent with international risk assessment practice. In addition, 
the 2008 FIFRA SAP did not support the PON1 data used in isolation. 
Finally, Petitioners' statement that the Furlong study supports an 
intra-species uncertainty factor of at least 150X likely overstates 
potential variability. EPA therefore denied this aspect of the 
Petition.

B. Claim 2: Endocrine Disrupting Effects

    Petitioners summarized a number of studies evaluating the effects 
of chlorpyrifos on the endocrine system, asserting that, taken 
together, the studies ``suggest that chlorpyrifos may be an endocrine 
disrupting chemical, capable of interfering with multiple hormones 
controlling reproduction and neurodevelopment.''
    EPA denied this claim because the Petition did not explain whether 
and how endocrine effects should form the basis of a decision to revoke 
tolerances. The basis for seeking revocation of a tolerance is a 
showing that the pesticide is not ``safe.'' Petitioners neither 
asserted that EPA should revoke tolerances because effects on the 
endocrine system render the tolerances unsafe, nor did Petitioners 
submit a factual analysis demonstrating that aggregate exposure to 
chlorpyrifos presents an unsafe risk to humans based on effects on the 
endocrine system.
    EPA noted that while the cited studies provide qualitative 
information that exposure to chlorpyrifos may be associated with 
effects on the androgen and thyroid hormonal pathways, these data alone 
do not demonstrate that current human exposures from existing 
tolerances are unsafe. Further, EPA explained that in June 2015, it 
completed an Endocrine Disruption Screening Program weight-of-evidence 
conclusion for chlorpyrifos. That analysis evaluated all observed 
effects induced, the magnitude and pattern of responses observed across 
studies, taxa, and sexes, and the Agency also considered the conditions 
under which effects occurred, in particular whether or not endocrine-
related responses occurred at dose(s) that also resulted in general 
systemic or overt toxicity. The Agency concluded that, based on weight-
of-evidence considerations, further testing was not recommended for 
chlorpyrifos since there was no evidence of potential interaction with 
the estrogen, androgen, and thyroid pathways.

C. Claim 3: Cancer Risks

    Petitioners claim that the Agency ``ignored'' a December 2004 
National Institutes of Health Agricultural Health Study showing that 
the incidence of lung cancer has a statistically significant 
association with chlorpyrifos exposure. Petitioners did not otherwise 
explain whether and how these data support the revocation of tolerances 
or the cancellation of pesticide registrations. Specifically, 
Petitioners did not present any fact-based argument demonstrating that 
aggregate exposure to chlorpyrifos poses an unsafe carcinogenic risk. 
Accordingly, EPA denied the Petition to revoke chlorpyrifos tolerances 
or cancel chlorpyrifos registrations to the extent the Petition relies 
on claims pertaining to carcinogenicity. EPA went on to note, however, 
that while there is initial suggestive epidemiological evidence of an 
association between chlorpyrifos and lung cancer, it is reasonable to 
conclude chlorpyrifos is not a carcinogen in view of the lack of 
carcinogenicity in the rodent bioassays and the lack of a genotoxic or 
mutagenic potential.

D. Claim 4: CRA Misrepresents Risks, Failed To Apply FQPA 10X Safety 
Factor

    Petitioners asserted that EPA relied on limited data and inaccurate 
interpretations of a specific study (the ``Zheng study'') to support 
its decision to remove the FQPA safety factor in the 2006 OP cumulative 
risk assessment (CRA). Petitioners claimed the Zheng study showed an 
obvious difference between juvenile and adult responses to chlorpyrifos 
that supported retention of the 10X safety factor for chlorpyrifos in 
the CRA. EPA concluded that Petitioners' assertions did not provide a 
sufficient basis for revoking chlorpyrifos tolerances. The Petitioners' 
claim that the data EPA relied upon support a different FQPA safety 
factor for chlorpyrifos in the CRA did not amount to a showing that 
chlorpyrifos tolerances are unsafe as Petitioners did not present a 
factual analysis demonstrating that the lack of a 10X safety factor in 
the CRA for chlorpyrifos poses unsafe cumulative exposures to the OPs. 
For this reason, EPA denied the Petitioners' request to revoke 
chlorpyrifos tolerances or cancel chlorpyrifos registrations on the 
basis of the FQPA safety factor in the CRA.
    Despite the inadequacy of Petitioners' FQPA CRA safety factor 
claims, EPA nonetheless examined the evidence Petitioners cited 
regarding the Zheng study. EPA acknowledged that in that study, pups 
appeared to be more sensitive than adults at the tested high dose. 
However, at the low-dose end of the response curve, relevant for human 
exposures, little to no difference was observed. This result is 
consistent with a comparative cholinesterase study submitted by Corteva 
that specifically compared the dose-response relationship in juvenile 
and adult rats and found no basis for concluding that juveniles are 
more sensitive, further

[[Page 35560]]

supporting EPA's use of an FQPA safety factor of 1X for the AChE 
inhibition endpoint used in the 2006 OP CRA.

E. Claim 5: Over-Reliance on Registrant Data

    Petitioners asserted that in reregistering chlorpyrifos EPA 
``cherry picked'' data, ``ignoring robust, peer-reviewed data in favor 
of weak, industry-sponsored data to determine that chlorpyrifos could 
be re-registered and food tolerances be retained.'' As such, 
Petitioners argued that the Agency's reassessment decision is not 
scientifically defensible. EPA concluded that this Petition claim was 
not purported to be an independent basis for revoking chlorpyrifos 
tolerances or cancelling chlorpyrifos registrations but simply support 
for Petitioners' arguments in other parts of the Petition. While 
Petitioners claim that EPA ignored robust, peer-reviewed data in favor 
of weak, industry-sponsored data for the reregistration of 
chlorpyrifos, Petitioners did not cite to any studies other than those 
used to support their other claims. In general, Petitioners did not 
provide any studies in the Petition that EPA failed to evaluate. Since 
the specific studies cited by Petitioners were not associated with this 
claim, but rather their other claims, EPA's response to the specific 
studies were, therefore, addressed in its responses to Petitioners' 
other claims. EPA went on to explain, however, that the Agency does not 
ignore robust, peer-reviewed data in favor of industry-sponsored data 
and that EPA has a public and well-documented set of procedures that it 
applies to the use and significance of all data utilized to inform risk 
management decisions. EPA does rely on registrant-generated data 
submitted in response to FIFRA and FFDCA requirements, as these data 
are conducted and evaluated in accordance with a series of 
internationally harmonized and scientifically peer-reviewed study 
protocols designed to maintain a high standard of scientific quality 
and reproducibility. But EPA does not end its review there. To further 
inform the Agency's risk assessment, EPA is committed to the 
consideration of other sources of information such as data identified 
in the open, peer-reviewed literature and information submitted by the 
public as part of the regulatory evaluation of a pesticide.

F. Claim 6: EPA Failed to Properly Address the Exporting Hazard in 
Foreign Countries From Chlorpyrifos

    In the July 16, 2012 interim Petition response, EPA issued a final 
denial of this claim, as it was not a claim subject to the FFDCA, which 
provides for an administrative objections process following the denial 
of a petition. EPA explained in the interim response that it lacked 
authority to address the risks chlorpyrifos may pose to workers in 
foreign countries who may not utilize worker protection equipment that 
the United States requires. Further, EPA noted that it has no authority 
to ban the export of pesticides to foreign countries regardless of 
whether those pesticides may be lawfully used in the United States. 
Accordingly, EPA denied this claim, and that denial constituted final 
agency action.

G. Claims 7-9: EPA Failed to Quantitatively Incorporate Data 
Demonstrating Long-Lasting Effects From Early Life Exposure to 
Chlorpyrifos in Children; EPA Disregarded Data Demonstrating That There 
Is no Evidence of a Safe Level of Exposure During Pre-Birth and Early 
Life Stages; and EPA Failed To Cite or Quantitatively Incorporate 
Studies and Clinical Reports Suggesting Potential Adverse Effects Below 
10% Cholinesterase Inhibition.

    The Petitioners asserted that human epidemiology and rodent 
developmental neurotoxicity data suggest that pre-natal and early life 
exposure to chlorpyrifos can result in long-lasting, possibly permanent 
damage to the nervous system and that these effects are likely 
occurring at exposure levels below 10% cholinesterase inhibition, EPA's 
existing regulatory standard for chlorpyrifos and other OPs. They 
assert that EPA has therefore used the wrong endpoint as a basis for 
regulation and that, taking into account the full spectrum of toxicity, 
chlorpyrifos does not meet the FFDCA safety standard or the FIFRA 
standard for registration.
    EPA grouped these claims together because they fundamentally all 
raised the same issue: Whether the potential exists for chlorpyrifos to 
cause neurodevelopmental effects in infants and children from exposures 
(either to mothers during pregnancy or directly to infants and 
children) that are lower than those resulting in 10% cholinesterase 
inhibition--the basis for EPA's long-standing point of departure (POD) 
in regulating chlorpyrifos and other OPs. EPA noted that these claims 
were not challenges to EPA's 2006 reregistration decision for 
chlorpyrifos, but rather, new challenges to EPA's ongoing approval of 
chlorpyrifos under FIFRA and the FFDCA because they rely in large 
measure on data published after EPA completed both its 2001 
chlorpyrifos Interim Reregistration Decision and the 2006 OP CRA that 
concluded the reregistration process for chlorpyrifos and all other 
OPs. As matters that largely came to light after the completion of 
reregistration, EPA made clear that these Petition issues are being 
addressed as part of the registration review of chlorpyrifos--the next 
round of re-evaluation under FIFRA section 3(g). The Denial Order noted 
that the question of OP neurodevelopmental toxicity was, and remains, 
an issue at the cutting edge of science, involving significant 
uncertainties.
    During registration review, EPA conducted an in-depth analysis of 
the available OP and chlorpyrifos biomonitoring data and of the 
available epidemiologic studies from three major children's health 
cohort studies in the U.S., specifically from the Columbia Center for 
Children's Environmental Health (CCCEH), Center for the Health 
Assessment of Mothers and Children of Salinas (CHAMACOS), and Mt. 
Sinai. EPA three times, in 2008, 2012, and 2016 has presented 
approaches and proposals to the FIFRA SAP for evaluating this 
epidemiologic data exploring the possible connection between in utero 
and early childhood exposure to chlorpyrifos and adverse 
neurodevelopmental effects. The SAP's reports have rendered numerous 
recommendations for additional study and sometimes conflicting advice 
for how EPA should consider (or not consider) the epidemiology data in 
conducting EPA's registration review human health risk assessment for 
chlorpyrifos and served to underscore that the science on this question 
is not resolved and would benefit from additional inquiry. Indeed, EPA 
explained in the Denial Order that the comments received by EPA 
indicate that there are considerable areas of uncertainty with regard 
to what the epidemiology data show and deep disagreement over how those 
data should be considered in EPA's risk assessment. In August 2016, the 
Ninth Circuit made clear, however, that EPA was to provide a final 
response to the Petition by March 31, 2017, and that no more extensions 
would be granted--regardless of whether the science remains unsettled 
and irrespective of whatever options may exist for resolution of these 
issues during the registration review process.
    While EPA acknowledged its obligation to respond to the Petition as 
required by the court, EPA noted that the court's order did not and 
could not compel EPA to complete the registration review of 
chlorpyrifos and the issues required for that determination in advance 
of the October 1, 2022 deadline

[[Page 35561]]

provided in FIFRA section 3(g), 7 U.S.C. 136a(g). Although past EPA 
Administrators had proposed to attempt to complete that review several 
years in advance of the statutory deadline (and respond to the Petition 
on the same time frame), it was not possible to fully address these 
registration issues earlier than the registration review period. As a 
result, EPA concluded that it needed to adjust the schedule for 
chlorpyrifos so that it could complete its review of the science 
addressing neurodevelopmental effects prior to making a final 
registration review decision whether to retain, limit, or remove 
chlorpyrifos from the market. Accordingly, EPA denied the Petition 
claims and stated its intention to complete a full and appropriate 
review of the neurodevelopmental data before either finalizing the 
proposed rule of October 30, 2015, or taking an alternative regulatory 
path.
    EPA explained that that denial of the Petition on these grounds 
provided was consistent with governing law because the petition 
provision in FFDCA section 408(d) does not address the timing for 
responding to a petition, nor does it limit the extent to which EPA may 
coordinate or stage its petition responses with the registration review 
provisions of FIFRA section 3(g). Provided EPA completes registration 
review by October 1, 2022, Congress otherwise gave the EPA 
Administrator the discretion under FIFRA to determine the schedule and 
timing for completing the review of the over 1000 pesticide active 
ingredients currently subject to evaluation under FIFRA section 3(g). 
EPA may lawfully re-prioritize the registration review schedule 
developed by earlier administrations provided that decision is 
consistent with law and an appropriate exercise of discretion. See 
Federal Communications Commission v. Fox Television Stations, 129 S.Ct. 
1800 (2009) (Administrative Procedure Act does not require that a 
policy change be justified by reasons more substantial than those 
required to adopt a policy in the first instance). Nothing in FIFRA 
section 3(g) precludes EPA from altering a previously established 
registration review schedule. Given the absence of a clear statutory 
directive, FIFRA and the FFDCA provide EPA with discretion to take into 
account EPA's registration review of a pesticide in determining how and 
when the Agency responds to FFDCA petitions to revoke tolerances. As 
outlined previously, given the importance of this matter and the fact 
that critical questions remained regarding the significance of the data 
addressing neurodevelopmental effects, EPA asserted that there is good 
reason to extend the registration review of chlorpyrifos and therefore 
to deny the Petition. To find otherwise would effectively give 
petitioners under the FFDCA the authority to re-order scheduling 
decisions regarding the FIFRA registration review process that Congress 
has vested in the Administrator.

H. Claim 10: Inhalation Exposure From Volatilization

    Petitioners assert that when EPA completed its 2006 OP CRA, EPA 
failed to consider and incorporate significant exposures to 
chlorpyrifos-contaminated air that exist for some populations in 
communities where chlorpyrifos is applied. Petitioners assert that 
these exposures exceeded safe levels when considering cholinesterase 
inhibition as a POD and that developmental neurotoxicity may occur at 
even lower exposure levels than those resulting in cholinesterase 
inhibition.
    To the extent Petitioners are asserting that human exposure to 
chlorpyrifos spray drift and volatilized chlorpyrifos present 
neurodevelopmental risks for infants and children, EPA denied this 
claim for the reasons stated in EPA's response to claims 7-9.
    With respect to Petitioners' claim that exposures to spray drift 
and volatilized chlorpyrifos present a risk from cholinesterase 
inhibition, EPA denied the Petition for the reasons identified in EPA's 
Spray Drift Mitigation Decision of July 16, 2012, and EPA's interim 
response of July 15, 2014, addressing chlorpyrifos volatilization. 
Specifically, in the Spray Drift Mitigation Decision, EPA determined 
that the chlorpyrifos registrants' adoption of label mitigation (in the 
form of label use rate reductions and no-spray buffer zones) eliminated 
risk from cholinesterase inhibition as a result of spray drift. As for 
risks presented by volatilized chlorpyrifos that may occur following 
application, EPA's July 15, 2014 interim response to the Petition 
explained that vapor-phase inhalation studies for both chlorpyrifos and 
chlorpyrifos-oxon made clear that neither vapor-phase chlorpyrifos nor 
chlorpyrifos oxon presents a risk of cholinesterase inhibition.

V. Objections

    The three separate sets of objections to the Denial Order filed 
with EPA in June 2017 raise similar concerns and can be reduced to the 
following three primary arguments:
     The Objectors argue that EPA's Denial Order applied the 
wrong legal standard. (Note: All persons filing objections will be 
referred to as ``Objectors.'') They assert that neither ``scientific 
uncertainty'' nor the October 2022 deadline for registration review 
under FIFRA section 3(g), nor the widespread agricultural use of 
chlorpyrifos, provide a basis for denying petitions to revoke. They 
claim that EPA has unlawfully left chlorpyrifos tolerances in place 
without making the safety finding required by the FFDCA.
     The Objectors assert that EPA has previously found that 
chlorpyrifos tolerances are unsafe and has not disavowed those 
findings. Specifically, they claim that EPA has found that chlorpyrifos 
results in unsafe drinking water exposures and results in adverse 
neurodevelopmental effects to children and that EPA must therefore 
revoke the tolerances.
     The Objectors argue that EPA's Denial Order committed a 
procedural error by failing to address significant concerns raised in 
the comments on EPA's 2014 risk assessment and 2015 proposed revocation 
that EPA's assessment fails to protect children. In particular, the 
Objectors focus on concerns raised in comments asserting that (1) EPA's 
use of 10% cholinesterase as a regulatory standard is not protective 
for effects to children's developing brains; (2) EPA has not properly 
accounted for effects from inhalation of chlorpyrifos from spray drift 
and volatilization; and (3) EPA inappropriately used the Corteva PBPK 
model to reduce inter- and intra-species safety factors because the 
model is ethically and scientifically deficient.

VI. Corteva's Comments on the Objections

    Corteva, the primary registrant of chlorpyrifos products registered 
for use in agriculture, submitted a response to the objections on 
August 27, 2018, raising specific detailed scientific concerns with the 
objections (Ref. 4). In addition, Corteva states that there is nothing 
in the FFDCA suggesting that statute requires EPA to make a safety 
finding in order to deny a response to a petition and that the FFDCA's 
implementing regulations place the burden on a petitioner to prove that 
a pesticide is unsafe. Corteva argues that to find otherwise would lead 
to the result that EPA is required to renew its safety finding every 
time a petition is filed, irrespective of the strength and quality of 
the evidence cited and regardless of whether EPA is engaged in an 
ongoing scientific review of issues addressed in the petition through 
FIFRA registration review.

[[Page 35562]]

VII. EPA's Response to Objections

    EPA's responses to the specific objections summarized in Unit V. 
are provided in this unit.

A. Claims Regarding the Legal Standard for Reviewing Petitions To 
Revoke

    Before addressing the specific legal objections, EPA notes that the 
Objectors' concerns focus primarily on EPA's denial of Petition claims 
7-10 as they relate to the potential for adverse neurodevelopmental 
effects to children from exposure to chlorpyrifos in food, drinking 
water, and from spray drift. These concerns fundamentally relate to 
issues EPA is evaluating in its current registration review of 
chlorpyrifos. EPA is in the process of completing revised risk 
assessments to address new data and advancements in risk assessment 
methodology since EPA's 2006 safety finding for chlorpyrifos as part of 
FIFRA section 4 reregistration and FFDCA section 408(q) tolerance 
reassessment to review tolerances for pesticide residues in effect 
(Ref. 3). The Objectors have not materially challenged EPA's denial of 
Petition claims that related to matters before EPA at the time of EPA's 
2006 safety finding. Specifically, they have not raised objections to 
the denial of claims relating to the genetic evidence for human 
vulnerability with respect to the detoxifying enzyme paraoxonase, 
endocrine-related effects, or carcinogenicity (claims 1-3). Nor have 
Objectors challenged most aspects of EPA's conclusions in the Denial 
Order respecting the potential for current chlorpyrifos exposures to 
result in acetyl cholinesterase inhibition--the regulatory POD used in 
EPA's 2006 reregistration and tolerance reassessment decisions.
    In sum, the objections are focused on EPA's ongoing work in FIFRA 
registration review to evaluate more recent information addressing the 
risk of adverse neurodevelopmental effects. With respect to these 
claims, EPA has concluded, after many years of attempting to obtain 
information necessary to validate this information, that the objections 
and the underlying petition fail to provide evidence of 
neurodevelopmental effects that is sufficiently valid, complete, and 
reliable at this time to meet the burden petitioners for revocation 
bear in presenting a case that tolerances are unsafe, pursuant to the 
standard under FFDCA section 408(b)(2). In addition, as provided in the 
Denial Order, EPA has concluded that it is also appropriate to deny the 
petition to allow EPA to complete its assessment of the potential for 
adverse neurodevelopmental outcomes in connection with the ongoing 
chlorpyrifos FIFRA registration review.
    1. Burden of coming forward with valid, complete, and reliable 
evidence. In response to the Objectors' claims that EPA applied an 
incorrect legal standard in denying the Petition, EPA disagrees that 
the FFDCA requires EPA to make a new safety determination in response 
to every petition to revoke under FFDCA section 408(d) or that it must 
revoke tolerances in the absence of making a renewed safety 
determination in response to a petition. Petitioners cite the FFDCA 
safety definition and the findings EPA must make to establish a 
tolerance or leave a tolerance in effect when reassessing the safety of 
tolerance under FFDCA section 408(q) and FIFRA section 3(g). None of 
their arguments, however, specifically focus on the FFDCA section 
408(d) petition process to modify or revoke a tolerance and EPA's 
implementing procedural regulations that require persons seeking 
tolerance revocation to come forward with evidence sufficient to 
support a finding that the applicable safety standard has not been met. 
In other words, even if one were to assume, arguendo, that the same 
safety standard applies to EPA action on a petition to revoke a 
tolerance as applies to the Agency's initial establishment of a 
tolerance, that is a separate issue from the evidentiary burden a 
petitioner must meet to support its position. As explained in this 
unit, in this case, EPA reasonably construes the FFDCA and the Agency's 
implementing regulations to require petitioners seeking withdrawal of a 
tolerance to support this request with valid, complete and reliable 
data that set forth why the tolerances are unsafe, a burden Petitioners 
here have failed to meet.
    By way of background, it is important to note that while Congress 
addressed the requirements for petitions to establish a tolerance with 
considerable specificity, see FFDCA section 408(d)(2)(A), it by 
contrast expressly left the specific requirements for petitions to 
modify or revoke a tolerance to EPA's rulemaking discretion. Id., FFDCA 
section 408(d)(2)(B). In turn, EPA's long-standing regulations require 
petitions seeking modification or revocation of a tolerance based on 
``new data'' to furnish that data in the same form required for 
petitions seeking to establish tolerances, to the extent applicable. 40 
CFR 180.32(b) (``New data should be furnished in the form specified in 
180.7(b) [pertaining to ``[p]etitions proposing tolerances''] for 
submitting petitions, as applicable.''). Thus, Congress expressly 
conferred discretion on EPA to specify the requirements for withdrawal 
of an existing tolerance, and EPA's long-standing regulations require a 
petitioner seeking revocation to meet the same standard of data 
reliability as a petitioner seeking to establish a tolerance.
    FFDCA section 408(b)(2)(D)(i) requires that all actions of the 
Administrator to establish, modify, leave in effect, or revoke 
tolerances must consider, among other factors, ``the validity, 
completeness, and reliability of the available data from studies of the 
pesticide chemical and pesticide chemical residue.'' Consistent with 
this obligation, EPA regulations provide that a petitioner has a burden 
to provide ``reasonable grounds'' for revocation, including an 
assertion of facts to justify the modification or revocation of the 
tolerance (40 CFR 180.32(b)). Further, the regulations also make clear 
that persons seeking revocation have an initial evidentiary burden that 
must be met before the question of whether the applicable safety 
standard under FFDCA section 408(b)(2) is met is properly placed before 
EPA. See 40 CFR 179.91 (Party requesting revocation hearing has initial 
burden of going forward with evidence). This longstanding 
interpretation of the statute and the procedures Congress established 
is permissible and entitled to substantial deference. Sebelius v. 
Auburn Reg'l Med. Ctr., 133 S. Ct. 817, 826-827 (2013) (citing National 
Cable & Telecomm. Ass'n v. Brand X internet Servs., 545 U.S. 967, 980 
(2005)). Notably, this regulation mirrors EPA's implementing FIFRA 
hearing regulations at 40 CFR 164.80(a), which likewise make clear that 
a person seeking cancellation or suspension must present the case that 
the standards for those actions have been met.
    Recently, in Ellis v. Housenger, 252 F. Supp. 3d 800, 809 (N.D. 
Cal. 2017), the U.S. District for the Northern District of California 
interpreted those regulations, explaining that the FIFRA hearing 
regulations place the burden on the proponent of a regulatory action to 
present an affirmative case for action, and that initial burden is 
properly applied to petitions seeking immediate action. Similarly, 
before the question whether the applicable safety standard under FFDCA 
section 408(b)(2) is met is properly placed before the EPA, petitioners 
must first meet their burden of coming forward with sufficient evidence 
to show that pesticide tolerances to be modified or revoked are not 
safe.
    EPA concludes that Petitioners have not met that burden. 
Petitioners have

[[Page 35563]]

not presented evidence to establish that chlorpyrifos tolerances must 
be revoked because of the risk of neurodevelopmental effects at levels 
lower than EPA's currently regulatory standard. After several years and 
numerous, significant efforts to evaluate the petition claims related 
to neurodevelopmental toxicity, including communications with study 
authors and researchers in an effort to obtain underlying data and 
validate and replicate reported results, EPA concludes that the 
information yet presented by Petitioners is not sufficiently valid, 
complete, and reliable to support abandoning the use of AChE inhibition 
as the critical effect for regulatory purposes under the FFDCA section 
408.
    Cholinesterase inhibition and the cholinergic effects (i.e., the 
physiological or behavioral changes) caused by organophosphorous 
pesticides, including chlorpyrifos, have long been the endpoints that 
EPA and nearly every other pesticide regulatory body in the world have 
used in assessing potential human health hazards. EPA has regarded data 
showing cholinesterase inhibition in brain, red blood cell (RBC), or 
plasma, and data on physiological or behavioral changes as critical 
effects for regulatory purposes. Guideline animal toxicity studies have 
historically been used in support of the 10% RBC acetylcholinesterase 
(AChE) inhibition point of departure (POD) for chlorpyrifos in EPA risk 
assessments.
    EPA's 2006 Registration Eligibility Decision (RED) for chlorpyrifos 
relied on AChE inhibition results from laboratory animals for deriving 
the POD. Although not acknowledged by the Petitioners and Objectors, in 
conducting risk assessments in support of the chlorpyrifos RED, EPA 
also considered the emerging new information from laboratory studies 
that identified potential concern for increased sensitivity and 
susceptibility for the young from neurodevelopmental effects unrelated 
to AChE inhibition. At that time, EPA did not believe those studies 
support a neurodevelopmental POD for quantitative risk assessment, but 
it did provide the support for EPA's retention of the FQPA 10X factor 
in the 2001 chlorpyrifos IRED (Ref. 5).
    While Petitioners and Objectors are correct that EPA did not retain 
the FQPA 10X for chlorpyrifos in the OPs 2006 cumulative risk 
assessment, that assessment dealt only with the established common 
mechanism of toxicity for the OPs--AChE inhibition--not with potential 
hazards that relate to the OPs individually. Accordingly, EPA did not 
reduce the 10X safety factor as it relates to chlorpyrifos specifically 
in its 2006 tolerance reassessment and reregistration determination 
that chlorpyrifos tolerances are safe. To the extent the Objectors are 
therefore arguing that EPA must, at a minimum, retain the FQPA 10X 
factor for chlorpyrifos because of the potential for neurodevelopmental 
effects, those objections are denied as moot. EPA's most recent 
assessment of the chlorpyrifos tolerances that was challenged in the 
Petition did retain the FQPA 10X, in part because of neurodevelopmental 
studies.
    The Petition and the objections also argue, however, that EPA 
should not simply retain the FQPA 10X safety factor but should revoke 
chlorpyrifos tolerances because of evidence showing the potential for 
neurodevelopmental effects to occur well below EPA's existing 
regulatory standard. In sum, they believe EPA should be using the 
results of existing epidemiologic data to set a regulatory POD for 
chlorpyrifos at levels that would require EPA to revoke all 
chlorpyrifos tolerances.
    EPA has, since the issuance of the 2006 RED, consistently concluded 
that the available data support a conclusion of increased sensitivity 
of the young to the neurotoxic effects of chlorpyrifos and for the 
susceptibility of the developing brain to chlorpyrifos. This conclusion 
comes from an evaluation across multiples lines of evidence including 
mechanistic studies and newer in vivo laboratory animal studies, but 
particularly with the available epidemiology reports along with 
feedback from the 2012 and 2016 FIFRA SAP meetings. As noted, EPA has 
retained the FQPA 10X safety factor on these grounds. However, EPA and 
the FIFRA SAP have also consistently cited the lack of robustness of 
these data for deriving a POD for neurodevelopmental effects given (1) 
the absence of a clear mechanism of action for chlorpyrifos in the 
developing brain; (2) the dosing regimen in in vivo studies that 
differs from internationally accepted protocols; and (3) the lack of 
any meaningful raw data from the epidemiologic data that are the 
centerpiece of this area of inquiry.
    The lack of a mechanistic understanding for effects on the 
developing brain precludes EPA from validly or reliably assessing 
potential differences (and similarities) between laboratory animals and 
humans with respect to dose-response and temporal windows of 
susceptibility. In the absence of this information, EPA has no valid or 
reliable ways to bridge the scientific interpretation of the laboratory 
studies and epidemiology studies with chlorpyrifos. In addition, the 
dosing regimen used in the in vivo studies means the data are not 
sufficiently valid, complete and reliable for regulatory purposes given 
the problems they present for the quantitative interpretation and 
extrapolation of the results. Specifically, the in vivo laboratory 
animal studies generally use fewer days of dosing that are aimed at 
specific periods of rodent fetal or early post-natal development 
compared to internationally adopted guideline studies which are 
intended to cover both pre- and post-gestational periods. The degree to 
which these shorter dosing periods coincide with comparable windows of 
susceptibility in human brain development is unclear. In addition, 
except for some studies conducted recently, most of the in vivo 
laboratory studies use doses that are higher than doses that cause 10% 
RBC AChE inhibition. These studies are therefore are not useful 
quantitatively to evaluate whether EPA's current regulatory standard is 
or is not sufficient to preclude the potential for neurodevelopmental 
effects.
    Finally, and most significantly, despite numerous requests over the 
last decade, the authors of the epidemiologic studies that provide 
potentially the most relevant information regarding effects to humans 
have never provided the underlying data from their studies to EPA to 
allow EPA and others to independently verify the validity and 
reliability of the results reported in their published articles. EPA 
believes it is necessary to first replicate the statistical analyses 
used in the studies to ensure their accuracy. In addition, EPA wants to 
examine the raw data used in the analysis to ensure appropriate 
handling of data points and in potentially conducting alternative 
statistical analyses. For example, EPA would want to evaluate the 
elimination of certain study participants from the CCCEH study that 
were deemed to be outliers in order to determine whether their 
exclusion was proper and how it may have affected the results. The lack 
of publicly available raw data does not necessarily preclude EPA from 
reliance on such information for the purpose of risk assessment. Given 
the long history and internationally harmonized use of 
acetylcholinesterase inhibition as the point of departure for 
chlorpyrifos, however, EPA reasonably requires more complete 
information regarding the studies in the published articles to 
establish a POD and that threshold has not been met in this instance. 
Due to these limitations, EPA does not believe the Petition, or the 
objections make the

[[Page 35564]]

case for EPA to establish a POD based on neurodevelopmental effects, 
which remains central to the Petitioners' claims 7-9.
    EPA understands that this conclusion is at odds with its revised 
risk assessment that it published for comment with the NODA in November 
2016. By way of explanation, EPA notes that it has undertaken 
considerable efforts to assess the available chlorpyrifos data, 
including the references cited by the Petitioners in support for their 
claims related to neurodevelopmental effects. Specifically, in Chapter 
4 and Appendices 2-4 of the 2014 human health risk assessment, EPA 
provides a detailed discussion of the strengths and uncertainties 
associated with the epidemiology studies. For example, although the 
studies used US-based exposure profiles in real world situations, EPA 
noted that the lack of data on the timing of chlorpyrifos applications 
was a key concern in the exposure assessment. EPA conducted a 
preliminary review of available literature and research on epidemiology 
in mothers and children following exposures chlorpyrifos and other OPs, 
laboratory studies on animal behavior and cognition, AChE inhibition, 
and mechanisms of action, and took it to the SAP in 2008.
    The CCCEH study used concentrations of pesticides (including 
chlorpyrifos) in umbilical cord blood as a measure of exposure, while 
two other birth cohorts used urinary biomarkers in the mothers to 
estimate pesticide exposure. In 2012, the EPA convened another meeting 
of the FIFRA SAP to review the latest experimental data related to AChE 
inhibition, cholinergic and non-cholinergic adverse outcomes, including 
neurodevelopmental studies on behavior and cognition effects. The EPA 
also performed an in-depth analysis of the available chlorpyrifos 
biomonitoring data and of the available epidemiologic studies from 
three major children's health cohort studies in the U.S., including 
those from the CCCEH, Mt. Sinai, and CHAMACOS. The EPA explored 
plausible hypotheses on mode of actions/adverse outcome pathways (MOAs/
AOPs) leading to neurodevelopmental outcomes seen in the biomonitoring 
and epidemiology studies.
    EPA convened another meeting of the FIFRA SAP in April 2016, which 
was unique in focus compared to the previous meetings in that EPA 
explicitly proposed using information directly from the CCCEH published 
articles for deriving the POD. The 2016 SAP did not support the 
``direct use'' of the cord blood and working memory data for deriving 
the regulatory endpoint for several reasons, among them, the lack of 
raw data from the epidemiology study (Ref. 4).
    This feedback is consistent with concerns raised in public comments 
EPA received on the use of the epidemiology data throughout the course 
of registration review from the grower community, pesticide 
registrants, and the U.S. Department of Agriculture. The final FIFRA 
SAP report provides a detailed account of the concerns associated with 
the Agency's April 2016 proposed approach to selecting the point of 
departure (POD) and its use in quantitative risk assessment. 
Specifically, the SAP report noted that ``[t] he majority of the panel 
stated that using cord concentrations for derivation of the POD could 
not be justified by any sound scientific evaluation. The Panel was 
conflicted with respect to the importance of a 2% change in working 
memory.'' Id. at 19. The Panel went on to note that ``the Agency's 
inability to confidently estimate previous exposure patterns and/or 
intensity hinders the use of cord blood at delivery as an anchor from 
which to extrapolate back to a more toxicologically meaningful internal 
exposure metric.'' Id. at 42. The SAP also noted the insufficient 
information about timing of chlorpyrifos applications in relation to 
cord blood concentrations at the time of birth, as well as 
uncertainties about the prenatal window(s) of exposure linked to 
reported effects.
    EPA acknowledges that the 2012 and 2016 SAPs note effects in the 
epidemiology and experimental studies below 10% AChE inhibition. In 
addition, both the 2008 and 2012 SAP commented on the strengths of the 
CCCEH epidemiologic studies and the value of the information they 
provide. However, despite these strengths, both the 2008 and 2012 
Panels recommended that AChE inhibition remain as the source of data 
for the PODs. The 2016 SAP expressed significant reservations about the 
proposed approach to use the cord blood as the source of data for the 
POD. It noted the incompleteness of the information, including the lack 
of raw data, reproducibility of analytical blood data, and knowledge 
about chlorpyrifos application timing relative to pregnancy. EPA has 
evaluated the SAP's concerns, as well as public comments received on 
the 2016 updated human health risk assessment echoed a number of the 
SAP's concern regarding use of the CCCEH study. Based on the 
uncertainties identified by the 2016 SAP, the published articles from 
CCCEH are not complete for deriving a POD. EPA acknowledges this 
conclusion differs from the position supported in the 2016 revised 
human health risk assessment, but EPA believes the shortcomings of the 
data identified raise issues of validity, completeness and reliability 
under the FFDCA that direct against using the data for risk assessment 
at this time. As stated in the Denial Order, EPA intends to continue 
its exploration of the uncertainty around using neurodevelopmental 
effects to establish a POD as it works to complete registration review, 
including renewed efforts to obtain the raw data from the epidemiologic 
studies that are the central to consideration of potential 
neurodevelopmental effects.
    Notably, EPA has made requests to CCCEH, CHAMACOS, and Mt. Sinai to 
obtain the raw data, and visited Columbia University in an attempt to 
better understand their study results and what raw data exist. EPA also 
requested the original CCCEH study protocol to determine whether its 
specific questions regarding exposure timing could be addressed with 
the raw data. EPA was informed the CCCEH protocol was not available, 
and EPA did not receive the raw data from any of those research 
institutions. Columbia made a public commitment to ``share all data 
gathered,'' however, to date, CCCEH has not provided EPA with the data, 
citing subject privacy concerns. In 2018, EPA explored options for 
blinding the data to eliminate this concern. However, through these 
conversations, CCCEH indicated there is no effective way to remedy this 
issue, citing that since the cohort is from a very small geographic 
area, subject identification would still be possible, and therefore, 
was still of concern.
    In addition, EPA actively sought clarification on the kinds of 
residential application methods of chlorpyrifos used in New York City 
(NYC) during the time the CCCEH study was conducted (1998-2000) in 
order to provide additional context to the results of the CCCEH study 
conclusions. Through a series of email and telephone conversations with 
NYC pest control officials in 2016, EPA consistently heard that 
chlorpyrifos was typically applied as a crack and crevice application 
between 1998 and 2000. Unfortunately, EPA has no way to verify that 
this use pattern aligns with the exposures of participants in the CCCEH 
study and would not be able to corroborate the correlation between 
crack and crevice application and the observed neurodevelopmental 
effects.
    As indicated, EPA has undertaken considerable efforts to assess the 
CCCEH

[[Page 35565]]

study, including submitting EPA's evaluation of the CCCEH study to 
multiple SAPs. Given that CCCEH has not shared the raw data or the 
results of their exploratory analyses, EPA cannot validate or confirm 
the data analysis performed, the degree to which the statistical 
methods employed were appropriate, or the extent to which (reasonable 
or minor) changes in assumptions may have changed any final results or 
conclusions. EPA has been unable to conduct its own evaluation of the 
study conclusions utilizing the raw data nor has EPA has been able to 
address the issues identified by the 2016 SAP. While EPA has retained 
the FQPA 10x safety factor in order to address this potential 
uncertainty, given the shortcomings to date of the published 
epidemiology data, EPA does not have sufficiently complete information 
to currently support using the epidemiology studies as the POD in place 
of AChE inhibition as the POD.
    In conclusion, the epidemiologic studies are central to the 
Petitioner's claims regarding neurodevelopmental effects, yet the 
Petitioners and Objectors rely only on summaries in publications to 
present their case. Petitioners have not presented the raw data from 
the epidemiology studies for consideration of their claims. EPA has 
likewise been unable to obtain this critical information, though the 
FIFRA SAP and commenters have raised many questions about it. So, EPA 
has not been able to verify the conclusions of the epidemiology studies 
due to this lack of raw data. Further, the lack of a clear mechanism of 
action and the lack of an internationally accepted dosing regimen in 
the in vivo data also preclude EPA from determining the relevance of 
the limited animal data addressing the potential for neurodevelopmental 
effects. The Petitioners have therefore failed to meet their initial 
burden of providing sufficiently valid, complete, and reliable evidence 
that neurodevelopmental effects may be occuring at levels below EPA's 
current regulatory standard and no information submitted with the 
objections addresses this shortcoming of the Petition.
    2. Reconciling FFDCA petitions to revoke and FIFRA Registration 
Review. EPA also continues to conclude that denial is appropriate for 
claims related to matters that are the subject of registration review, 
specifically for chlorpyrifos, claims related to neurodevelopmental 
toxicity. In this case, the data deficiencies in the Petition related 
to neurodevelopmental toxicity that EPA is currently studying in a more 
up-to-date, thorough and methodical fashion in conjunction with the 
statutorily prescribed FIFRA re-registration process. In this context, 
it is particularly appropriate for EPA to take into account the 
substantive work that it is conducting under FIFRA in reaching its 
decision on the Petition.
    As EPA explained in the Denial Order, to reconcile the FFDCA 
petition procedures with the FIFRA registration review provisions that 
require EPA to conduct periodic reviews of all pesticides, EPA must be 
able to take account of the FIFRA registration review schedule for a 
pesticide in determining how and when to respond to an FFDCA petition 
that raises issues that are also the subject of a current registration 
review. As noted, the Denial Order fully responded to Petitioners' 
claims that address the substance of EPA's 2006 safety finding, and 
Petitioners and the other Objectors could have chosen to challenge and 
litigate that determination through the petition and judicial review 
provisions of the FFDCA, had they wished. The objections, however, do 
not for the most part go to the substance of EPA's 2006 safety finding. 
Those claims have largely been abandoned and instead the objections now 
focus only on compelling EPA to resolve on a petitioner-dictated 
schedule new issues regarding the potential for neurodevelopmental 
toxicity that are part of an ongoing evaluation in registration review 
in advance of the statutory deadline (October 1, 2022) provided by 
Congress in FIFRA section 3(g) for completing that assessment. To that 
end, Objectors argue that the fact Congress established a 2022 deadline 
for registration review is no license for EPA to delay its response to 
an FFDCA petition and that EPA is in fact prohibited from relying on 
registration review as a basis for determining how to complete other 
reviews of a pesticide. Specifically, they cite to language in FIFRA 
section 3(g)(1)(C) that states that ``[n]othing in this subsection 
shall prohibit the Administrator from undertaking any other review of a 
pesticide under this chapter.'' Objectors have overlooked the critical 
language at the end of this passage (``under this chapter'') that by 
its terms only speaks to how EPA should reconcile registration review 
with other reviews under FIFRA. The language does not address reviews 
under the FFDCA, much less prohibit EPA from reconciling its responses 
to FFDCA petitions with the timeframe for registration review under 
FIFRA. The Objectors also do not point to any language in the FFDCA 
prohibiting the reconciliation of a response to a petition to revoke 
tolerances with the registration review schedule for reviewing the 
pesticide--which includes a determination whether to leave existing 
tolerances in effect. The 15-year registration review interval reflects 
Congress's effort to balance the need for EPA to assure that pesticides 
meet the FFDCA and FIFRA standards, while at the same time recognizing 
that completing scientific evaluations for over 1000 active ingredients 
is both time-consuming and resource-intensive. During a registration 
review, EPA is required to ``assess changes since a pesticide's last 
[registration] review,'' including new risk assessment methods, new 
studies and new data on pesticides. 40 CFR 155.53(a). This is precisely 
the assessment EPA is in the process of undertaking in the chlorpyrifos 
registration review with respect to the Petition claims addressing new 
information on the potential for adverse neurodevelopmental effects. 
If, as Petitioners and Objectors argue, EPA were required to truncate 
its ongoing registration review process to make a new FFDCA safety 
finding every time it received a petition to modify or revoke 
tolerances, petitioners would effectively have the authority to re-
order the Administrator's scheduling of registration review decisions 
under FIFRA and dictate the extent of inquiry EPA may put to a matter 
before reaching a resolution. EPA continues to believe that with the 
passage of FIFRA section 3(g) and the 15-year review cycle created by 
that provision, Congress directed the Administrator, not FFDCA 
petitioners, to determine the appropriate timing and process for 
completing the review of dietary risk within that 15-year review 
period. EPA therefore concludes that it is also appropriate to deny the 
objections and the underlying petition to the extent they seek to 
compel EPA's consideration of neurodevelopmental toxicity issues raised 
during the course of the current registration review in advance of the 
schedule provided by Congress under FIFRA section 3(g).
    As described previously, EPA has compelling reasons to follow its 
regulatory process through registration review. Specifically, EPA is 
working to update a number of assessments that will result in a more 
complete, accurate assessment of the risks of chlorpyrifos than if EPA 
were compelled to truncate that review now. The key components of EPA's 
updates to its analysis are (1) Review of five new laboratory animal 
studies for consideration in the updated human health risk assessment, 
and (2) Incorporating refined use information

[[Page 35566]]

into the 2016 updated drinking water assessment.
    With respect to the animal data, in 2018, the California Department 
of Pesticide Regulation (CDPR) proposed to adopt a regulation 
designating chlorpyrifos as a toxic air contaminant (TAC) in 
California. As part of this determination, CDPR developed its ``Final 
Toxic Air Contaminant Evaluation of Chlorpyrifos Risk Characterization 
of Spray Drift, Dietary, and Aggregate Exposures to Residential 
Bystanders.'' The CDPR risk characterization document cites five new 
laboratory animal studies not previously reviewed by EPA (Gomez-Gimenez 
et al., 2017, 2018; Silva et al., 2017; Lee et al., 2015; Carr et al., 
2017). It is appropriate for EPA to review these five new studies in 
order to complete EPA's evaluation of potential neurodevelopmental 
effects. CDPR is using these studies as the main source of information 
for their new POD for acute oral exposure, so it is prudent for EPA to 
evaluate the data's quality and whether it provides the strong support 
for the conclusion that effects on the developing brain may occur below 
a dose eliciting 10% AChE inhibition that would be used to establish a 
new POD for the EPA's risk assessment. EPA is conducting its review in 
accordance with OPP's Guidance for Considering and Using Open 
Literature Toxicity Studies to Support Human Health Risk Assessment. It 
has contacted the primary investigators associated with the new animal 
studies in July-August 2018, and received the raw data associated with 
one of these studies.
    As for EPA's drinking water assessment, the Agency identified 
certain uses, application rates, and practices described in the current 
chlorpyrifos labels that are not actually being used in the field and 
are contributing to an over-estimate of potential drinking water 
concentrations. EPA has requested additional information from the 
registrants to confirm the accuracy of these assumptions and 
anticipates including these updates in the Proposed Interim Decision.
    To be clear, EPA remains committed to expediting its registration 
review determination so that it is completed well in advance of the 
October 2022 deadline. To that end, EPA anticipates making available 
any updates to the human health and drinking water assessments for 
public availability and comment by summer of 2020. Updates will also 
include EPA's response to public comments from the previous comment 
periods. In addition, EPA has been engaged in discussions with the 
chlorpyrifos registrants that could result in further use limitations 
affecting the outcome of EPA's assessment. The Proposed Interim 
Decision incorporating these updated assessments is anticipated for 
public availability and comment by October 2020. If EPA were compelled 
to act in advance of these registration review activities, none of 
these assessments would be available to inform that review. For 
example, OPP is pursuing the use of surface water monitoring data to 
confidently estimate pesticide concentrations in surface water that may 
be sourced by community water systems. A meeting of the FIFRA 
Scientific Advisory Panel is planned for obtaining expert feedback on 
tools and methodologies currently in development for using surface 
water monitoring data quantitatively in drinking water assessments. 
While the focus of the SAP is not specific to chlorpyrifos, the EPA 
will consider any recommendations from the SAP that are appropriate for 
inclusion in the chlorpyrifos drinking water assessment.

B. Objections Asserting That EPA Has Found Chlorpyrifos To Be Unsafe

    The Objectors argue that EPA not only failed to make a safety 
finding in denying the Petition, but that it has never disavowed 
previous EPA findings that it could not conclude chlorpyrifos is safe 
with respect to both the potential for adverse neurodevelopmental 
effects and harmful drinking water exposures. In particular, the 
objections point to various statements in EPA risk assessments and in 
EPA's 2015 proposed tolerance revocation action asserting that EPA is 
unable to conclude that chlorpyrifos tolerances are safe.
    Contrary to these assertions, as noted by Corteva in its response 
to the objections, EPA has not made any findings that chlorpyrifos 
tolerances are not safe. In fact, EPA's last final action with respect 
to the safety of chlorpyrifos tolerances was its determination in 2006 
that chlorpyrifos and the other pesticides in the organophosphate class 
meet the FFDCA safety standard in connection with FIFRA section 4 
reregistration and FFDCA section 408(q) tolerance reassessment. This is 
the only regulatory finding currently in effect for chlorpyrifos as EPA 
has taken no final action on the proposed rule it published in 2015 to 
comply with the Ninth Circuit mandamus order in the PANNA v. EPA 
decision. Proposed rules are just that--proposals; they do not bind 
federal agencies. Indeed, EPA made clear it was issuing the proposal 
because of the court order, without having resolved many of the issues 
critical to EPA's FFDCA determination and without having fully 
considered comments previously submitted to the Agency (69 FR 69079, 
69081-83). Similarly, risk assessments that underly proposed rules are 
not final agency actions and likewise are not binding.
    At this stage, EPA may choose to finalize, modify or withdraw the 
proposal based on the comments received and EPA's evaluation following 
its review of the comments. Until such time, EPA's statements in the 
proposed rule are not binding pronouncements with respect to EPA's 
decision whether to grant or deny the Petition. See, e.g., Northwest 
Coalition for Alternatives to Pesticides v. EPA, 544 F.3d 1043, 1051 
(9th Cir. 2008) (``as long as agencies follow the proper administrative 
procedures, they have the authority to change their minds before 
issuing a final order''); Public Citizen Health Research Grp. v. FDA, 
740 F.2d 21 (D.C. Cir. 1984) (``Neither the substance of the decision 
to require further study nor the circumstances leading to the decision 
. . . suffice, however, to permit us to leapfrog back over the 
Secretary's decision . . . hold the agency to its preliminary decision 
to promulgate a labeling requirement. In connection with the 
registration review of chlorpyrifos, which EPA expects to complete in 
advance of the October 1, 2022 statutory deadline, EPA will make a 
determination regarding the safety of chlorpyrifos and will either 
finalize, modify or withdraw the proposal at that time.
    With respect to objections related to drinking water, as explained 
in Unit II., a party may not raise issues in objections unless they 
were part of the petition. Corn Growers v. EPA, 613 F.3d 266 (D.C. Cir. 
2010), cert. denied, 131 S. Ct. 2931 (2011). The Petition did not 
identify drinking water exposure as a basis for seeking tolerance 
revocation, and the Objectors cannot therefore raise that concern as a 
basis for challenging EPA's denial of the Petition. The mere fact that 
EPA is considering the potential impact of chlorpyrifos exposures in 
drinking water in the Agency's FIFRA section 3(g) registration review 
does not somehow provide Petitioners and Objectors with a vehicle for 
introducing that topic in the objections process on the Petition 
denial. And the objections phase of the petition process does not 
provide Petitioners a means to effectively start the petition process 
over again by raising issues that were not originally raised in the 
2007 petition to revoke. Accordingly, EPA denies all objections 
regarding drinking water exposures. To be clear, however, EPA is 
continuing its

[[Page 35567]]

FIFRA section 3(g) registration review and to complete its evaluation 
of drinking water exposures to chlorpyrifos. EPA will address these 
issues in its upcoming registration review decision.

C. Objections Asserting That the Denial Order Failed To Respond to 
Significant Concerns Raised in Comments

    The Objectors claim that EPA has committed procedural error in 
failing to respond to certain comments raised in comments to EPA's 2014 
Revised Human Health Risk Assessment and the 2015 proposed revocation. 
The Objectors appear to assert that in the absence of any comment 
response document in the record, EPA has violated the requirements of 
section 553(c) of the Administrative Procedure Act (APA) which requires 
agencies to give consideration to relevant matter submitted during the 
comment period on proposed rules. While these objections correctly 
recite the requirements of the APA rulemaking provisions, the 
requirement to respond to comments on proposed rules applies to the 
``rules adopted'' by agencies--i.e., final rules--and EPA has neither 
finalized nor withdrawn the 2015 proposed revocation rule. Further, the 
FFDCA does not require EPA to respond to rulemaking comments in issuing 
petition denial orders under FFDCA section 408(d)(4). In connection 
with EPA's completion of the FIFRA section 3(g) registration review of 
chlorpyrifos, EPA will either finalize or withdraw the proposed rule 
and address significant comments on the proposal at that time. But EPA 
has no obligation to respond to rulemaking comments in denying the 
Petition or responding to objections, both of which are adjudicatory 
actions that are not part of the rulemaking process.
    In addition to raising procedural error, Objectors appear to adopt 
as their own substantive objections some of the comments on the 
proposed rule and risk assessment. Specifically, they focus on comments 
asserting that (1) EPA's use of 10% cholinesterase as a regulatory 
standard is not protective for effects to children's developing brains; 
(2) EPA inappropriately used Corteva's PBPK model, which is ethically 
and scientifically deficient, to reduce inter and intra-species safety 
factors; and (3) EPA has not properly accounted for effects from 
inhalation of chlorpyrifos from spray drift and volatilization.
    The comments adopted by the Objectors regarding effects on the 
developing brain mirror the claims raised in the Petition regarding the 
potential for adverse neurodevelopmental effects. Accordingly, EPA 
restates its response provided in Unit VII.A.1. that the Petition and 
the objections fail to meet burden of presenting evidence sufficiently 
valid, complete and reliable to demonstrate that chlorpyrifos results 
in neurodevelopmental effects that render its tolerances not safe.
    With respect to EPA's use of the Corteva PBPK model, these claims, 
as with claims respecting drinking water, were not raised in the 
Petition and cannot be raised for the first time in the objections 
phase of the petition process. Further, the Objections appear to oppose 
EPA's use of the PBPK model in conducting the assessment underlying 
EPA's 2014 and 2016 risk assessments and 2015 proposed tolerance 
revocation and do not appear to address EPA's Petition denial. This 
objection therefore does not appear to be relevant to the Denial Order. 
For these reasons, this objection is also denied.
    Regarding the objections related to inhalation risk, Objectors 
raise three distinct issues from the public comments that relate to 
EPA's completed inhalation exposure assessment addressing the potential 
for bystanders to experience cholinesterase inhibition from exposure to 
spray drift at the time of application and volatilized chlorpyrifos 
following application. First, the Objectors dispute EPA' s legal 
authority not to consider in its risk assessment exposures to 
chlorpyrifos from illegal spraying prohibited by product labeling. 
Second, the Objectors assert that the Denial Order inappropriately 
relied on two recent Corteva studies on the effects of chlorpyrifos in 
its vapor phase to conclude that volatilized chlorpyrifos presents no 
risk of cholinesterase inhibition. Third, the Objectors assert that 
documented poisoning incidents demonstrate that the no-spray buffer-
zones that EPA approved on product labeling in 2012 are inadequate to 
address harm from spray drift. Objectors point specifically to a May 
2017 poisoning incident in Kern County, California, involving a total 
of 50 people who were either harmed or put at risk, as evidence for 
their concern.
    In response, EPA believes it is lawful and appropriate for it to 
consider federally enforceable chlorpyrifos product labeling 
restrictions in assessing the extent of bystander risk from spray drift 
under both the FFDCA and FIFRA. Under FIFRA, pesticide labeling use 
instructions are enforceable limits on the use of the product that 
serve as the basis for EPA's evaluation of potential risks. Indeed, in 
registering pesticides, FIFRA section 3(c)(5) directs EPA to register 
pesticides when, among other things, a pesticide ``will perform its 
intended function without unreasonable effects on the environment'' and 
``when used in accordance with widespread and commonly recognized 
practice it will not generally cause unreasonable adverse effects on 
the environment.'' These directives functionally instruct EPA to 
consider the intended, widespread and commonly recognized use of a 
pesticide as set forth on proposed product labeling in determining 
whether the pesticide will cause unreasonable adverse on the 
environment. While these provisions do not serve as a bar to EPA 
considering the impacts from unlawful misuse, unless such misuse is a 
widespread or commonly recognized practice, it does not provide a basis 
for regulatory action under FIFRA or a basis for determining that 
current tolerance levels are unsafe. Rather, misuse is first and 
foremost a matter for enforcement under FIFRA. It should also be noted 
that because chlorpyrifos is a restricted use pesticide, applicators 
must have specific training meant, in part, to assure proper pesticide 
application. When these restrictions are followed, exposures are 
significantly limited. To be clear, while drift is minimized when 
applicators follow label directions, EPA does assume that some residues 
may settle off-target, and that there may be dermal and incidental oral 
exposure from contacting residential turf adjacent to treated fields. 
To address the potential for cholinesterase inhibition from these 
exposures, EPA assessed the risk from these exposures and establishes 
appropriate distances between such locations and the site of 
application. Accordingly, following EPA's assessment of spray drift in 
2012, the chlorpyrifos registrants agreed to place additional 
limitations on use to include use rate reductions and spray drift 
buffers that are sufficient to eliminate a risk of cholinesterase 
inhibition from lawful use.
    With respect to the objections concerning volatility and the 
potential for cholinesterase inhibition, EPA has not changed its 
position set forth in the Denial Order and does not believe it is 
disregarding the potential for volatilization exposures. Exposure to 
low levels of vapor-phase chlorpyrifos following application near 
treated fields is possible. After the Agency's 2011 preliminary risk 
assessment, Corteva submitted toxicity data that measured 
cholinesterase inhibition resulting from acute exposure to vapors of 
chlorpyrifos and its oxon rather than exposure to

[[Page 35568]]

aerosols of these compounds as was done for previous assessments. Since 
inhalation exposure to bystanders will be only to vapor phase 
chlorpyrifos rather than aerosols due to spray drift restrictions, use 
of these data to assess inhalation risk of cholinesterase inhibition to 
bystanders is appropriate. In these vapor-phase toxicity studies, test 
animals were exposed in atmospheres containing saturation 
concentrations of chlorpyrifos and its oxon, the maximum potential 
level of the compounds in air. No cholinesterase inhibition was 
observed, and the studies were determined to have been conducted 
properly using saturation concentrations of the compounds and controls 
appropriate for these types of studies, i.e., animals receiving no 
pesticide exposure, as further explained in ``Chlorpyrifos: 
Reevaluation of the Potential Risks from Volatilization in 
Consideration of Chlorpyrifos Parent and Oxon Vapor Inhalation Toxicity 
Studies, W. Britton, W. Irwin, 6/25/14.''
    EPA has also done a comprehensive review of chlorpyrifos incidents 
and found that most were due to accidents and misuse as specified in 
EPA's most recent final incident review ``Chlorpyrifos: Tier II 
Incident Report, S. Recore and K. Oo, 7/27/11.'' The agency is aware of 
the referenced Kern County chlorpyrifos incident that occurred in 2017 
in which the pesticide appears to have been applied in a manner in 
which direct drift onto bystanders occurred, a case of misuse. Spray 
drift buffers address exposure to bystanders when chlorpyrifos is 
applied as required by the pesticide label. In addition, it should be 
noted that EPA's 2000 cancellation of homeowner products and many 
indoor and outdoor non-residential uses (e.g., schools and parks where 
children may be exposed) has led, according to data from 2002-2010, to 
a 95% decrease in the number of incidents reported in residential 
areas. In sum, EPA does not believe available incident data suggests 
that there exists a widespread and commonly recognized practice of 
misusing chlorpyrifos and EPA therefore believes it is appropriate to 
use the enforceable label instructions as the basis for evaluating the 
potential for inhalation exposure from spray drift and volatilization.

VIII. Regulatory Assessment Requirements

    As indicated previously, this action announces the Agency's order 
denying objections filed under FFDCA section 408. As such, this action 
is an adjudication and not a rule. The regulatory assessment 
requirements imposed on rulemaking do not, therefore, apply to this 
action.

IX. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., does not apply 
because this action is not a rule for purposes of 5 U.S.C. 804(3).

X. References

    The following is a listing of the documents that are specifically 
referenced in this document. The docket includes these documents and 
other information considered by EPA, including documents that are 
referenced within the documents that are included in the docket, even 
if the referenced document is not physically located in the docket. For 
assistance in locating these other documents, please consult the person 
listed under FOR FURTHER INFORMATION CONTACT.

1. The Petition from NRDC and PANNA and EPA's various responses to 
it are available in docket number EPA-HQ-OPP-2007-1005 available at 
http://www.regulations.gov.
2. The objections submitted on the Petition Denial are available in 
docket number EPA-HQ-OPP-2007-1005 available at http://www.regulations.gov.
3. For additional information on the organophosphate cumulative risk 
assessment, see http://www.epa.gov/pesticides/cumulative/2006-op/op_cra_main.pdf.
4. FIFRA Scientific Advisory Panel (2016). ``Chlorpyrifos: Analysis 
of Biomonitoring Data''. Available at: https://www.epa.gov/sap/meeting-materials-april-19-21-2016-scientific-advisory-panel.
5. For additional information on the 2000 chlorpyrifos IRED and 2006 
chlorpyrifos RED, see https://www3.epa.gov/pesticides/chem_search/reg_actions/reregistration/red_PC-059101_1-Jul-06.pdf.
6. FIFRA Scientific Advisory Panel (2008). ``Scientific Issues 
Associated with Chlorpyrifos and PON1''. Available in docket number 
EPA-HQ-OPP-2008-0274 available at http://www.regulations.gov.
7. EPA, 2012. ``Guidance for Considering and Using Open Literature 
Toxicity Studies to Support Human Health Risk Assessment'' as well 
as it's ``Framework for Incorporating Human Epidemiologic & Incident 
Data in Health Risk Assessment.'' Available at https://www.epa.gov/sites/production/files/2015-07/documents/lit-studies.pdf.
8. EPA, 2016. Record of Correspondence. Available in docket number 
EPA-HQ-OPP-2015-0653.

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: July 18, 2019.
Alexandra Dapolito Dunn,
Assistant Administrator, Office of Chemical Safety and Pollution 
Prevention.
[FR Doc. 2019-15649 Filed 7-23-19; 8:45 am]
 BILLING CODE 6560-50-P