81_FR_81271 81 FR 81049 - Chlorpyrifos; Tolerance Revocations; Notice of Data Availability and Request for Comment

81 FR 81049 - Chlorpyrifos; Tolerance Revocations; Notice of Data Availability and Request for Comment

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 81, Issue 222 (November 17, 2016)

Page Range81049-81052
FR Document2016-27552

EPA is announcing and inviting comment on additional information obtained and developed by EPA in conjunction with the proposed tolerance revocation for chlorpyrifos. This information includes the revised human health risk assessment and the drinking water assessment. It also includes EPA's issue paper and supporting analyses presented to the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) Scientific Advisory Panel's (SAP) meeting in April 2016 that addressed chlorpyrifos biomonitoring data and adverse neurodevelopmental outcomes, public comments received during the meeting, the FIFRA SAP's meeting minutes and the FIFRA SAP report. EPA is specifically soliciting comments on the validity and propriety of the use of all the new information, data, and analyses. EPA is accepting comment on the information and analysis, as well as reopening comment on any other aspect of the proposal or the underlying support documents that were previously available for comment. The EPA continues to seek comment on possible mitigation strategies, namely, use deletions, which might allow the EPA to retain a small subset of existing chlorpyrifos food uses. Commenters need not resubmit comments previously submitted. EPA will consider those comments, as well as comments in response to this notice, in taking a final action.

Federal Register, Volume 81 Issue 222 (Thursday, November 17, 2016)
[Federal Register Volume 81, Number 222 (Thursday, November 17, 2016)]
[Proposed Rules]
[Pages 81049-81052]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-27552]


=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2015-0653; FRL-9954-65]


Chlorpyrifos; Tolerance Revocations; Notice of Data Availability 
and Request for Comment

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: EPA is announcing and inviting comment on additional 
information obtained and developed by EPA in conjunction with the 
proposed tolerance revocation for chlorpyrifos. This information 
includes the revised human health risk assessment and the drinking 
water assessment. It also includes EPA's issue paper and supporting 
analyses presented to the Federal Insecticide, Fungicide and 
Rodenticide Act (FIFRA) Scientific Advisory Panel's (SAP) meeting in 
April 2016 that addressed chlorpyrifos biomonitoring data and adverse 
neurodevelopmental outcomes, public comments received during the 
meeting, the FIFRA SAP's meeting minutes and the FIFRA SAP report. EPA 
is specifically soliciting comments on the validity and propriety of 
the use of all the new information, data, and analyses. EPA is 
accepting comment on the information and analysis, as well as reopening 
comment on any other aspect of the proposal or the underlying support 
documents that were previously available for comment. The EPA continues 
to seek comment on possible mitigation strategies, namely, use 
deletions, which might allow the EPA to retain a small subset of 
existing chlorpyrifos food uses. Commenters need not resubmit comments 
previously submitted. EPA will consider those comments, as well as 
comments in response to this notice, in taking a final action.

DATES: Submit comments on or before January 17, 2017.

ADDRESSES: Submit your comments, identified by docket identification 
(ID) number EPA-HQ-OPP-2015-0653, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be Confidential Business 
Information (CBI) or other information whose disclosure is restricted 
by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Dana Friedman, Pesticide Re-Evaluation 
Division (7508P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 347-8827; email address: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. How should I submit Confidential Business Information (CBI) to the 
Agency?

    Do not submit this information to EPA electronically. Clearly mark 
the part or all of the information that you claim to be CBI. For CBI 
information in a disk or CD-ROM that you mail to EPA, mark the outside 
of the disk or CD-ROM as CBI and then identify electronically within 
the disk or CD-ROM the specific information that is claimed as CBI. In 
addition to one complete version of the comment that includes 
information claimed as CBI, a copy of the comment that does not contain 
the information claimed as CBI must be submitted for inclusion in the 
public docket. Information so marked will not be disclosed except in 
accordance with procedures set forth in 40 CFR part 2.

II. Purpose of This Document

    EPA is reopening the comment period on the proposed rule: Entitled 
``Chlorpyrifos; Tolerance Revocations'' (80 FR 69080, November 6, 2015) 
(FRL-

[[Page 81050]]

9935-92), herein referred to as the ``proposed rule,'' for the purpose 
of obtaining public comment on the additional information and analyses 
announced in this document and which may be relevant to the development 
of a final action. EPA is also accepting comment on any other aspect of 
the proposal or the underlying support documents that were previously 
available for comment. As explained in the proposed rule, the timing of 
EPA's issuance of the proposal was dictated by an August 10, 2015 order 
by the U.S. Court of Appeals for the Ninth Circuit in Pesticide Action 
Network North America (PANNA) v. EPA, No. 14-72794. The PANNA decision 
directed EPA to respond by October 31, 2015 to PANNA and the Natural 
Resource Defense Council's (NRDC) petition to revoke all chlorpyrifos 
tolerances and cancel all chlorpyrifos registrations. As a result of 
that timing, EPA had not yet completed portions of its scientific 
assessment when it issued the proposed rule. Specifically, EPA noted 
that it issued the proposed rule in advance of completing a refined 
drinking water assessment and without conducting additional analysis of 
the hazard from chlorpyrifos in response to comments received on EPA's 
December 2014 Revised Human Health Risk Assessment. Accordingly, EPA 
noted in the proposed rule that it would update the proposal with any 
new or modified analyses, as EPA completed additional work after the 
proposal and, to the extent practicable, EPA would provide the public 
an opportunity to comment on that work prior to issuing a final rule. 
Consistent with that commitment, EPA is today seeking comment on the 
following documents that were not available for public comment during 
the prior comment period on the proposed rule: Chlorpyrifos: Revised 
Human Health Risk Assessment for Registration Review (2016); the 
materials and final report from the 2016 Chlorpyrifos SAP; and 
Chlorpyrifos Registration Review Drinking Water Assessment.
    EPA's revised analyses do not result in a change to the EPA's 
proposal to revoke all tolerances but it does modify the methods and 
risk assessment used to support that finding in accordance with the 
advice of the SAP. The revised analysis indicates that expected 
residues of chlorpyrifos on most individual food crops exceed the 
``reasonable certainty of no harm'' safety standard under the Federal 
Food, Drug, and Cosmetic Act (FFDCA). In addition, the majority of 
estimated drinking water exposures from currently registered uses, 
including water exposures from non-food uses, continue to exceed safe 
levels even taking into account more refined drinking water exposures. 
Accordingly, based on current labeled uses, the agency's analysis 
provided in this notice continues to indicate that the risk from the 
potential aggregate exposure does not meet the FFDCA safety standard. 
EPA can only retain chlorpyrifos tolerances if it is able to conclude 
that such tolerances are safe. EPA has not identified a set of 
currently registered uses that meets the FFDCA safety standard because 
it is likely only a limited number of food uses alone, and in 
combination with predicted drinking water exposures, would meet the 
standard. Further, EPA has not received any proposals for mitigation 
that registrants may be willing to undertake that would allow the EPA 
to retain any of the tolerances subject to this rulemaking. EPA 
continues to seek comment on possible mitigation strategies, namely, 
use deletions, which might allow the EPA to retain a small subset of 
existing chlorpyrifos food uses.
    EPA consulted the FIFRA SAP for scientific advice on its analysis 
of biomonitoring data at a meeting on April 19-21, 2016, at which time, 
the public also had an opportunity to provide comment. The FIFRA SAP 
was asked to address the use of the epidemiological study The Mothers 
and Newborn Study of North Manhattan and South Bronx performed by the 
Columbia Children's Center for Environmental Health (CCCEH) at Columbia 
University to establish a new toxicological endpoint and associated 
point of departure for chlorpyrifos based on observed adverse 
neurodevelopmental outcomes in children resulting from prenatal 
exposure to chlorpyrifos. While the residential uses that resulted in 
chlorpyrifos exposures in the CCCEH study were cancelled in 2000, EPA 
believes this study remains relevant in evaluating risks from exposure 
to currently registered uses. In its presentation to the SAP, EPA 
proposed to use biomonitoring data (cord blood concentrations) 
identified in the CCCEH study (Rauh et al., 2006 and Rauh et al., 2011) 
as the basis for its point of departure. The FIFRA SAP provided 
feedback indicating that it did not believe using the cord blood data 
from that study was appropriate to establish a new point of departure. 
The SAP's primary criticism was that there was not enough data on the 
relationship between cord blood concentrations at birth to exposures at 
and around the time of chlorpyrifos application to support its use in 
quantitative risk assessment. Further, the FIFRA SAP noted that EPA's 
assessment did not identify a particular window of exposure within the 
prenatal period linked to the effects reported. Generally, however, the 
FIFRA SAP agreed with the overall conclusion of the CCCEH study, i.e. 
the association between prenatal chlorpyrifos exposure and 
neurodevelopmental outcomes in children.
    The final FIFRA SAP report provides a detailed account of the 
uncertainties associated with the agency's April 2016 proposed approach 
to selecting the point of departure and its use in quantitative risk 
assessment. It also outlines the SAP's concern that ``epidemiology and 
toxicology studies suggest there is evidence for adverse health 
outcomes associated with chlorpyrifos exposures below levels that 
result in 10% red blood cell (RBC) acetylcholinesterase (AChE) 
inhibition'' (FIFRA SAP, 2016, p. 18). The FIFRA SAP recommended that 
EPA should derive the point of departure for neurodevelopmental effects 
using the ``estimated peak blood concentration or time weighted average 
blood concentration within the prenatal period'' (FIFRA SAP, 2016, p. 
42).
    After careful consideration of public comments and the SAP's 
recommendations, EPA has concluded the most appropriate path for 
reconciling the SAP's concerns is to follow through on the SAP's 
recommendation to use a time weighted average approach. The agency 
agrees with the 2016 FIFRA SAP (and previous SAPs) that there is a 
potential for neurodevelopmental effects associated with chlorpyrifos 
exposure to occur at levels below 10% RBC AChE inhibition, and that 
EPA's existing point of departure (which is based on 10% AChE 
inhibition), is therefore not sufficiently health protective.
    As detailed in Chlorpyrifos: Revised Human Health Risk Assessment 
for Registration Review (2016), in order to follow up on the SAP's 
recommendation that the point of departure should be based on blood 
concentrations at the time of exposure to chlorpyrifos (rather than 
based on cord blood at the time of delivery), EPA evaluated the most 
likely chlorpyrifos application method to determine peak exposures to 
the CCCEH study cohort experiencing neurodevelopmental effects in 
children. EPA contacted the technical pest advisor responsible for 
overseeing New York City's housing authority in order to confirm the 
application method used at the time the CCCEH study was conducted. 
Based on those conversations and a review of the

[[Page 81051]]

registered uses available during that period, EPA concluded that crack 
and crevice treatments were the most likely exposure pattern among 
those use patterns registered at the time of the study and therefore 
has used these exposures as the basis for a new point of departure.
    EPA generally selects the dose at which no toxicological effects 
are demonstrated to ensure our regulatory endpoint reflects a level of 
exposure that does not present a risk concern. However, the CCCEH study 
only supported the determination of a lowest observed adverse effects 
level (LOAEL). In situations where the agency selects a POD from a 
study where a no observed adverse effects level (NOAEL) has not been 
identified, EPA generally will retain the Food Quality Protection Act 
(FQPA) safety factor of 10X to account for the uncertainty in using a 
LOAEL. The 2016 revised risk assessment retains this uncertainty factor 
for chlorpyrifos and also applies a 10X uncertainty factor for 
intraspecies variability because of the lack of sufficient information 
to reduce or remove this factor.
    The external exposure was calculated based on the assumptions and 
methods outlined in the EPA's 2012 Standard Operating Procedures (SOPs) 
for Residential Pesticide Exposure Assessment and chemical-specific 
exposure data, where available. Specifically, the 2012 Residential 
SOPs, which were peer reviewed by the FIFRA SAP in October 2009, were 
used to predict the potential exposures which could have occurred to 
individuals in the cohort for the indoor crack and crevice pesticide 
use pattern.
    EPA then used the chlorpyrifos physiologically based 
pharmacokinetic (PBPK) model to estimate the study cohort mothers' 
systemic dose related to the LOAEL by (1) determining time-weighted 
average (TWA) blood levels from women exposed to chlorpyrifos from 
indoor exposures to the cancelled crack and crevice use and (2) using 
the crack and crevice TWA blood level as the internal dose for 
determining points of departure for infants, children, and adults 
exposed to chlorpyrifos using current exposure potential. The use of 
the PBPK model to assess internal dosimetry from various exposure 
scenarios continues to be supported by the SAP. This applies to the 
crack and crevice scenario identified as the most likely exposure 
pattern in the CCCEH study, where women were potential exposed via the 
dermal, oral, and inhalation routes. The detailed rationale is 
presented in Chlorpyrifos: Revised Human Health Risk Assessment for 
Registration Review (2016).
    EPA has also completed, and is making available for public comment, 
Chlorpyrifos Registration Review Drinking Water Assessment. EPA 
conducted a national screening level drinking water assessment in 2014. 
Because of the court decision ordering EPA to respond to the PANNA-NRDC 
Petition by October 31, 2015, EPA was not able to complete a more 
refined drinking water assessment for chlorpyrifos in advance of the 
proposed rule. Since that time EPA conducted the refined drinking water 
assessment with the intention of providing a basis for supporting a 
more tailored approach to risk mitigation. In the proposal, EPA 
proposed revoking all tolerances largely because the agency could not 
make a safety finding based on drinking water exposure in highly-
vulnerable watersheds. EPA reasoned if it could better identify where 
such vulnerable areas might be, it could be possible for registrants to 
amend product labeling in ways that might make unnecessary some number 
of the proposed tolerance revocations.
    Chlorpyrifos Registration Review Drinking Water Assessment serves 
to combine, update and complete the work presented in the 2011 and 2014 
drinking water assessments for chlorpyrifos as part of the registration 
review process. This document specifically focuses on the exposure 
estimates for surface water. The 2014 assessment presented an approach 
for deriving more regionally-specific estimated drinking water exposure 
concentrations for chlorpyrifos and chlorpyrifos-oxon for two water 
resource regions, hydrologic unit code (HUC)-02. This assessment 
updates those exposure assessments and provides estimates for the 
remaining (i.e., 19) HUC-02 regions. Urban uses, which had not 
previously been assessed, are included in this update. This assessment 
also includes statistical analysis of all available monitoring data for 
chlorpyrifos and chlorpyrifos-oxon. While this drinking water 
assessment is more refined than the previous assessments, as a general 
matter, the results did not allow for identification of many areas 
where potential exposures of concern to drinking water can be ruled 
out. As a result, this assessment does not significantly alter the 
conclusions in the proposed rule regarding drinking water exposure and 
continues to indicate potential exposure to chlorpyrifos or 
chlorpyrifos-oxon in finished drinking water across the country based 
on currently labeled uses. This is supported by both model estimated 
concentrations as well as measured chlorpyrifos concentrations in 
surface water across the United States.
    Section IV of this Notice of Data Availability (NODA) describes all 
additional data and analyses and how they impact the EPA's proposal. 
Note, however, that this NODA does not provide an exhaustive 
presentation of the additional data and analysis that EPA is placing in 
the associated docket and seeking comment on. All the information 
subject to this notice can be accessed as described in section III of 
this notice.
    EPA is providing notice on these additional analyses to provide an 
opportunity for the public to submit additional data or information for 
the agency's consideration as it develops the final rule. Since EPA is 
still in the process of deliberating the provisions of a final rule, 
EPA cannot definitively state whether this information will provide 
support for any provision of the final rule, or that the agency has 
determined that it is appropriate to rely on this information in 
developing the final rule.
    On December 10, 2015, the Ninth Circuit issued a further order 
requiring EPA to complete any final rule and fully respond to the PANNA 
and NRDC petition by December 30, 2016. On June 30, 2016, EPA sought a 
6-month extension to that deadline in light of the SAP's recommendation 
at the meeting and in order to allow EPA to fully consider the SAP's 
written report. The FIFRA SAP report was finalized and made available 
for EPA consideration on July 20, 2016. The court rejected EPA's 
request for a 6-month extension and ordered EPA to complete its final 
action by March 31, 2017 (an extension of 3 months). The court also 
announced that no further extensions to that date would be granted.

III. Where can the information identified in this document be found?

    The information that EPA is be made available for public review and 
comment can be found in the following dockets: EPA-HQ-OPP-2015-0653, 
the docket for the proposed tolerance revocations, and EPA-HQ-OPP-2016-
0062, the FIFRA SAP docket, which contains the Chlorpyrifos Issue Paper 
and supporting materials. Both dockets can be accessed through http://www.regulations.gov. As noted, EPA is also reopening the comment period 
to allow for comment on any aspect of the proposed revocation published 
on November 6, 2015 (80 FR 69080) (FRL-9935-92).

[[Page 81052]]

IV. What analysis and data are being noticed?

    1. EPA is seeking comment on the following updates to the 
chlorpyrifos human health risk assessment: (1) Use of the crack and 
crevice scenario to derive an exposure level for women in the Columbia 
study; (2) using the LOAEL from the Columbia study and PBPK modeling to 
derive an endpoint for use in quantitative risk assessment; (3) use of 
the 10X uncertainty factor for intraspecies variability; (4) use of the 
10X FQPA safety factor for LOAEL to NOAEL extrapolation (please include 
your rationale for any alternative values suggested for this factor). 
Its analysis is included in the Chlorpyrifos: Revised Human Health Risk 
Assessment for Registration Review (2016), which is available in the 
chlorpyrifos tolerance revocation docket (EPA-HQ-OPP-2015-0653).
    2. EPA is also making available for comment the issue paper and 
associated materials presented to the April 2016 FIFRA SAP and the 
final report of the SAP. The FIFRA SAP materials and final report are 
available in the FIFRA SAP docket (EPA-HQ-OPP-2016-0062).
    3. EPA is also seeking comment on Chlorpyrifos Registration Review 
Drinking Water Assessment, a highly refined drinking water assessment 
that updates and completes the agency's examination of exposure through 
drinking water for all registered uses of chlorpyrifos. This assessment 
integrates regionally specific (i.e., spatially relevant) estimated 
drinking water concentrations and an extensive evaluation of available 
surface water monitoring data for chlorpyrifos and chlorpyrifos-oxon. 
The assessment considers both agricultural and non-agricultural uses of 
chlorpyrifos, a sensitivity analysis for model estimated 
concentrations, and statistical evaluation of surface water monitoring 
data.

List of Subjects in 40 CFR Part 180

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

    Dated: November 10, 2016.
Richard P. Keigwin, Jr.,
Acting Director, Office of Pesticide Programs.
[FR Doc. 2016-27552 Filed 11-16-16; 8:45 am]
BILLING CODE 6560-50-P



                                                                            Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Proposed Rules                                                      81049

                                                  service fees listed in § 250.125 of this                                 approved ROW grant must be                          pipeline ROW grant application is
                                                  part for a pipeline ROW grant to install                                 accompanied by the additional rental                divided into two levels based on water
                                                  a new pipeline, or to convert an existing                                required under § 250.1012, if applicable.           depth, as shown in the following table:
                                                  lease term pipeline into an ROW                                          You must file a separate application for
                                                  pipeline. An application to modify an                                    each ROW. The service fee for a

                                                                         Application type                                                                                Description

                                                  (1) Shallow water applications ............................               Applications for a pipeline ROW grant for pipelines that will be located in their entirety within
                                                                                                                              water depths of 1,000 feet or less.
                                                  (2) Deepwater applications .................................              Applications for a pipeline ROW grant for pipelines, any portion of which will be located in
                                                                                                                              water depths greater than 1,000 feet.



                                                  *     *     *    *      *                                                  (d) You must pay the service fee listed           Additionally, you must pay the service
                                                  ■ 7. In § 250.1303, revise paragraph (d)                                 in § 250.125 of this part with your                 fee listed in § 250.125 with your request
                                                  to read as follows:                                                      request for a voluntary unitization                 for unitization revision. The service fee
                                                  § 250.1303 How do I apply for voluntary                                  proposal or the expansion of a                      for a request for unitization revision is
                                                  unitization?                                                             previously approved voluntary unit to               divided into two levels, as shown in the
                                                  *        *        *        *        *                                    include additional acreage.                         following table:

                                                                         Application type                                                                                Description

                                                  (1) Exhibits A and B ............................................         Applications for revisions to Exhibit A and/or Exhibit B or designation of Successor Unit Oper-
                                                                                                                              ators and/or Successor Unit Sub-operators.
                                                  (2) Exhibit C ........................................................    Applications for revisions to Exhibit C.



                                                  [FR Doc. 2016–27500 Filed 11–16–16; 8:45 am]                             information and analysis, as well as                along with more information about
                                                  BILLING CODE 4310–VH–P                                                   reopening comment on any other aspect               dockets generally, is available at http://
                                                                                                                           of the proposal or the underlying                   www.epa.gov/dockets.
                                                                                                                           support documents that were previously              FOR FURTHER INFORMATION CONTACT:
                                                  ENVIRONMENTAL PROTECTION                                                 available for comment. The EPA                      Dana Friedman, Pesticide Re-Evaluation
                                                  AGENCY                                                                   continues to seek comment on possible               Division (7508P), Office of Pesticide
                                                                                                                           mitigation strategies, namely, use                  Programs, Environmental Protection
                                                  40 CFR Part 180                                                          deletions, which might allow the EPA to             Agency, 1200 Pennsylvania Ave. NW.,
                                                  [EPA–HQ–OPP–2015–0653; FRL–9954–65]                                      retain a small subset of existing                   Washington, DC 20460–0001; telephone
                                                                                                                           chlorpyrifos food uses. Commenters                  number: (703) 347–8827; email address:
                                                  Chlorpyrifos; Tolerance Revocations;                                     need not resubmit comments previously               friedman.dana@epa.gov.
                                                  Notice of Data Availability and Request                                  submitted. EPA will consider those                  SUPPLEMENTARY INFORMATION:
                                                  for Comment                                                              comments, as well as comments in
                                                                                                                           response to this notice, in taking a final          I. How should I submit Confidential
                                                  AGENCY:  Environmental Protection                                        action.                                             Business Information (CBI) to the
                                                  Agency (EPA).                                                                                                                Agency?
                                                                                                                           DATES: Submit comments on or before
                                                  ACTION: Proposed rule.
                                                                                                                           January 17, 2017.                                      Do not submit this information to EPA
                                                  SUMMARY:   EPA is announcing and                                         ADDRESSES: Submit your comments,                    electronically. Clearly mark the part or
                                                  inviting comment on additional                                           identified by docket identification (ID)            all of the information that you claim to
                                                  information obtained and developed by                                    number EPA–HQ–OPP–2015–0653, by                     be CBI. For CBI information in a disk or
                                                  EPA in conjunction with the proposed                                     one of the following methods:                       CD–ROM that you mail to EPA, mark
                                                  tolerance revocation for chlorpyrifos.                                     • Federal eRulemaking Portal: http://             the outside of the disk or CD–ROM as
                                                  This information includes the revised                                    www.regulations.gov. Follow the online              CBI and then identify electronically
                                                  human health risk assessment and the                                     instructions for submitting comments.               within the disk or CD–ROM the specific
                                                  drinking water assessment. It also                                       Do not submit electronically any                    information that is claimed as CBI. In
                                                  includes EPA’s issue paper and                                           information you consider to be                      addition to one complete version of the
                                                  supporting analyses presented to the                                     Confidential Business Information (CBI)             comment that includes information
                                                  Federal Insecticide, Fungicide and                                       or other information whose disclosure is            claimed as CBI, a copy of the comment
                                                  Rodenticide Act (FIFRA) Scientific                                       restricted by statute.                              that does not contain the information
                                                  Advisory Panel’s (SAP) meeting in April                                    • Mail: OPP Docket, Environmental                 claimed as CBI must be submitted for
                                                  2016 that addressed chlorpyrifos                                         Protection Agency Docket Center (EPA/               inclusion in the public docket.
                                                  biomonitoring data and adverse                                           DC), (28221T), 1200 Pennsylvania Ave.               Information so marked will not be
sradovich on DSK3GMQ082PROD with PROPOSALS




                                                  neurodevelopmental outcomes, public                                      NW., Washington, DC 20460–0001.                     disclosed except in accordance with
                                                  comments received during the meeting,                                      • Hand Delivery: To make special                  procedures set forth in 40 CFR part 2.
                                                  the FIFRA SAP’s meeting minutes and                                      arrangements for hand delivery or
                                                  the FIFRA SAP report. EPA is                                             delivery of boxed information, please               II. Purpose of This Document
                                                  specifically soliciting comments on the                                  follow the instructions at http://                     EPA is reopening the comment period
                                                  validity and propriety of the use of all                                 www.epa.gov/dockets/contacts.html.                  on the proposed rule: Entitled
                                                  the new information, data, and analyses.                                   Additional instructions on                        ‘‘Chlorpyrifos; Tolerance Revocations’’
                                                  EPA is accepting comment on the                                          commenting or visiting the docket,                  (80 FR 69080, November 6, 2015) (FRL–


                                             VerDate Sep<11>2014        17:46 Nov 16, 2016       Jkt 241001      PO 00000      Frm 00035   Fmt 4702   Sfmt 4702   E:\FR\FM\17NOP1.SGM   17NOP1


                                                  81050               Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Proposed Rules

                                                  9935–92), herein referred to as the                     non-food uses, continue to exceed safe                assessment. Further, the FIFRA SAP
                                                  ‘‘proposed rule,’’ for the purpose of                   levels even taking into account more                  noted that EPA’s assessment did not
                                                  obtaining public comment on the                         refined drinking water exposures.                     identify a particular window of
                                                  additional information and analyses                     Accordingly, based on current labeled                 exposure within the prenatal period
                                                  announced in this document and which                    uses, the agency’s analysis provided in               linked to the effects reported. Generally,
                                                  may be relevant to the development of                   this notice continues to indicate that the            however, the FIFRA SAP agreed with
                                                  a final action. EPA is also accepting                   risk from the potential aggregate                     the overall conclusion of the CCCEH
                                                  comment on any other aspect of the                      exposure does not meet the FFDCA                      study, i.e. the association between
                                                  proposal or the underlying support                      safety standard. EPA can only retain                  prenatal chlorpyrifos exposure and
                                                  documents that were previously                          chlorpyrifos tolerances if it is able to              neurodevelopmental outcomes in
                                                  available for comment. As explained in                  conclude that such tolerances are safe.               children.
                                                  the proposed rule, the timing of EPA’s                  EPA has not identified a set of currently                The final FIFRA SAP report provides
                                                  issuance of the proposal was dictated by                registered uses that meets the FFDCA                  a detailed account of the uncertainties
                                                  an August 10, 2015 order by the U.S.                    safety standard because it is likely only             associated with the agency’s April 2016
                                                  Court of Appeals for the Ninth Circuit                  a limited number of food uses alone,                  proposed approach to selecting the
                                                  in Pesticide Action Network North                       and in combination with predicted                     point of departure and its use in
                                                  America (PANNA) v. EPA, No. 14–                         drinking water exposures, would meet                  quantitative risk assessment. It also
                                                  72794. The PANNA decision directed                      the standard. Further, EPA has not                    outlines the SAP’s concern that
                                                  EPA to respond by October 31, 2015 to                   received any proposals for mitigation                 ‘‘epidemiology and toxicology studies
                                                  PANNA and the Natural Resource                          that registrants may be willing to                    suggest there is evidence for adverse
                                                  Defense Council’s (NRDC) petition to                    undertake that would allow the EPA to                 health outcomes associated with
                                                  revoke all chlorpyrifos tolerances and                  retain any of the tolerances subject to               chlorpyrifos exposures below levels that
                                                  cancel all chlorpyrifos registrations. As               this rulemaking. EPA continues to seek                result in 10% red blood cell (RBC)
                                                  a result of that timing, EPA had not yet                comment on possible mitigation                        acetylcholinesterase (AChE) inhibition’’
                                                  completed portions of its scientific                    strategies, namely, use deletions, which              (FIFRA SAP, 2016, p. 18). The FIFRA
                                                  assessment when it issued the proposed                  might allow the EPA to retain a small                 SAP recommended that EPA should
                                                  rule. Specifically, EPA noted that it                   subset of existing chlorpyrifos food                  derive the point of departure for
                                                  issued the proposed rule in advance of                  uses.                                                 neurodevelopmental effects using the
                                                  completing a refined drinking water                                                                           ‘‘estimated peak blood concentration or
                                                                                                             EPA consulted the FIFRA SAP for                    time weighted average blood
                                                  assessment and without conducting                       scientific advice on its analysis of
                                                  additional analysis of the hazard from                                                                        concentration within the prenatal
                                                                                                          biomonitoring data at a meeting on                    period’’ (FIFRA SAP, 2016, p. 42).
                                                  chlorpyrifos in response to comments                    April 19–21, 2016, at which time, the                    After careful consideration of public
                                                  received on EPA’s December 2014                         public also had an opportunity to                     comments and the SAP’s
                                                  Revised Human Health Risk                               provide comment. The FIFRA SAP was                    recommendations, EPA has concluded
                                                  Assessment. Accordingly, EPA noted in                   asked to address the use of the                       the most appropriate path for
                                                  the proposed rule that it would update                  epidemiological study The Mothers and                 reconciling the SAP’s concerns is to
                                                  the proposal with any new or modified                   Newborn Study of North Manhattan and                  follow through on the SAP’s
                                                  analyses, as EPA completed additional                   South Bronx performed by the Columbia                 recommendation to use a time weighted
                                                  work after the proposal and, to the                     Children’s Center for Environmental                   average approach. The agency agrees
                                                  extent practicable, EPA would provide                   Health (CCCEH) at Columbia University                 with the 2016 FIFRA SAP (and previous
                                                  the public an opportunity to comment                    to establish a new toxicological                      SAPs) that there is a potential for
                                                  on that work prior to issuing a final rule.             endpoint and associated point of                      neurodevelopmental effects associated
                                                  Consistent with that commitment, EPA                    departure for chlorpyrifos based on                   with chlorpyrifos exposure to occur at
                                                  is today seeking comment on the                         observed adverse neurodevelopmental                   levels below 10% RBC AChE inhibition,
                                                  following documents that were not                       outcomes in children resulting from                   and that EPA’s existing point of
                                                  available for public comment during the                 prenatal exposure to chlorpyrifos. While              departure (which is based on 10% AChE
                                                  prior comment period on the proposed                    the residential uses that resulted in                 inhibition), is therefore not sufficiently
                                                  rule: Chlorpyrifos: Revised Human                       chlorpyrifos exposures in the CCCEH                   health protective.
                                                  Health Risk Assessment for Registration                 study were cancelled in 2000, EPA                        As detailed in Chlorpyrifos: Revised
                                                  Review (2016); the materials and final                  believes this study remains relevant in               Human Health Risk Assessment for
                                                  report from the 2016 Chlorpyrifos SAP;                  evaluating risks from exposure to                     Registration Review (2016), in order to
                                                  and Chlorpyrifos Registration Review                    currently registered uses. In its                     follow up on the SAP’s recommendation
                                                  Drinking Water Assessment.                              presentation to the SAP, EPA proposed                 that the point of departure should be
                                                     EPA’s revised analyses do not result                 to use biomonitoring data (cord blood                 based on blood concentrations at the
                                                  in a change to the EPA’s proposal to                    concentrations) identified in the CCCEH               time of exposure to chlorpyrifos (rather
                                                  revoke all tolerances but it does modify                study (Rauh et al., 2006 and Rauh et al.,             than based on cord blood at the time of
                                                  the methods and risk assessment used to                 2011) as the basis for its point of                   delivery), EPA evaluated the most likely
                                                  support that finding in accordance with                 departure. The FIFRA SAP provided                     chlorpyrifos application method to
                                                  the advice of the SAP. The revised                      feedback indicating that it did not                   determine peak exposures to the CCCEH
                                                  analysis indicates that expected                        believe using the cord blood data from                study cohort experiencing
sradovich on DSK3GMQ082PROD with PROPOSALS




                                                  residues of chlorpyrifos on most                        that study was appropriate to establish               neurodevelopmental effects in children.
                                                  individual food crops exceed the                        a new point of departure. The SAP’s                   EPA contacted the technical pest
                                                  ‘‘reasonable certainty of no harm’’ safety              primary criticism was that there was not              advisor responsible for overseeing New
                                                  standard under the Federal Food, Drug,                  enough data on the relationship                       York City’s housing authority in order to
                                                  and Cosmetic Act (FFDCA). In addition,                  between cord blood concentrations at                  confirm the application method used at
                                                  the majority of estimated drinking water                birth to exposures at and around the                  the time the CCCEH study was
                                                  exposures from currently registered                     time of chlorpyrifos application to                   conducted. Based on those
                                                  uses, including water exposures from                    support its use in quantitative risk                  conversations and a review of the


                                             VerDate Sep<11>2014   17:46 Nov 16, 2016   Jkt 241001   PO 00000   Frm 00036   Fmt 4702   Sfmt 4702   E:\FR\FM\17NOP1.SGM   17NOP1


                                                                      Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Proposed Rules                                          81051

                                                  registered uses available during that                   Human Health Risk Assessment for                      measured chlorpyrifos concentrations in
                                                  period, EPA concluded that crack and                    Registration Review (2016).                           surface water across the United States.
                                                  crevice treatments were the most likely                    EPA has also completed, and is                        Section IV of this Notice of Data
                                                  exposure pattern among those use                        making available for public comment,
                                                                                                                                                                Availability (NODA) describes all
                                                  patterns registered at the time of the                  Chlorpyrifos Registration Review
                                                                                                                                                                additional data and analyses and how
                                                  study and therefore has used these                      Drinking Water Assessment. EPA
                                                                                                                                                                they impact the EPA’s proposal. Note,
                                                  exposures as the basis for a new point                  conducted a national screening level
                                                                                                          drinking water assessment in 2014.                    however, that this NODA does not
                                                  of departure.                                                                                                 provide an exhaustive presentation of
                                                     EPA generally selects the dose at                    Because of the court decision ordering
                                                                                                          EPA to respond to the PANNA–NRDC                      the additional data and analysis that
                                                  which no toxicological effects are                                                                            EPA is placing in the associated docket
                                                  demonstrated to ensure our regulatory                   Petition by October 31, 2015, EPA was
                                                                                                          not able to complete a more refined                   and seeking comment on. All the
                                                  endpoint reflects a level of exposure                                                                         information subject to this notice can be
                                                  that does not present a risk concern.                   drinking water assessment for
                                                                                                          chlorpyrifos in advance of the proposed               accessed as described in section III of
                                                  However, the CCCEH study only
                                                                                                          rule. Since that time EPA conducted the               this notice.
                                                  supported the determination of a lowest
                                                  observed adverse effects level (LOAEL).                 refined drinking water assessment with                   EPA is providing notice on these
                                                  In situations where the agency selects a                the intention of providing a basis for                additional analyses to provide an
                                                  POD from a study where a no observed                    supporting a more tailored approach to                opportunity for the public to submit
                                                  adverse effects level (NOAEL) has not                   risk mitigation. In the proposal, EPA                 additional data or information for the
                                                  been identified, EPA generally will                     proposed revoking all tolerances largely              agency’s consideration as it develops
                                                  retain the Food Quality Protection Act                  because the agency could not make a                   the final rule. Since EPA is still in the
                                                  (FQPA) safety factor of 10X to account                  safety finding based on drinking water                process of deliberating the provisions of
                                                  for the uncertainty in using a LOAEL.                   exposure in highly-vulnerable                         a final rule, EPA cannot definitively
                                                  The 2016 revised risk assessment retains                watersheds. EPA reasoned if it could                  state whether this information will
                                                  this uncertainty factor for chlorpyrifos                better identify where such vulnerable                 provide support for any provision of the
                                                  and also applies a 10X uncertainty                      areas might be, it could be possible for              final rule, or that the agency has
                                                  factor for intraspecies variability                     registrants to amend product labeling in              determined that it is appropriate to rely
                                                  because of the lack of sufficient                       ways that might make unnecessary some
                                                                                                                                                                on this information in developing the
                                                  information to reduce or remove this                    number of the proposed tolerance
                                                                                                                                                                final rule.
                                                  factor.                                                 revocations.
                                                                                                             Chlorpyrifos Registration Review                      On December 10, 2015, the Ninth
                                                     The external exposure was calculated                 Drinking Water Assessment serves to                   Circuit issued a further order requiring
                                                  based on the assumptions and methods                    combine, update and complete the work                 EPA to complete any final rule and fully
                                                  outlined in the EPA’s 2012 Standard                     presented in the 2011 and 2014 drinking               respond to the PANNA and NRDC
                                                  Operating Procedures (SOPs) for                         water assessments for chlorpyrifos as                 petition by December 30, 2016. On June
                                                  Residential Pesticide Exposure                          part of the registration review process.              30, 2016, EPA sought a 6-month
                                                  Assessment and chemical-specific                        This document specifically focuses on                 extension to that deadline in light of the
                                                  exposure data, where available.                         the exposure estimates for surface water.             SAP’s recommendation at the meeting
                                                  Specifically, the 2012 Residential SOPs,                The 2014 assessment presented an                      and in order to allow EPA to fully
                                                  which were peer reviewed by the FIFRA                   approach for deriving more regionally-                consider the SAP’s written report. The
                                                  SAP in October 2009, were used to                       specific estimated drinking water                     FIFRA SAP report was finalized and
                                                  predict the potential exposures which                   exposure concentrations for chlorpyrifos              made available for EPA consideration
                                                  could have occurred to individuals in                   and chlorpyrifos-oxon for two water                   on July 20, 2016. The court rejected
                                                  the cohort for the indoor crack and                     resource regions, hydrologic unit code                EPA’s request for a 6-month extension
                                                  crevice pesticide use pattern.                          (HUC)-02. This assessment updates                     and ordered EPA to complete its final
                                                     EPA then used the chlorpyrifos                       those exposure assessments and                        action by March 31, 2017 (an extension
                                                  physiologically based pharmacokinetic                   provides estimates for the remaining                  of 3 months). The court also announced
                                                  (PBPK) model to estimate the study                      (i.e., 19) HUC-02 regions. Urban uses,                that no further extensions to that date
                                                  cohort mothers’ systemic dose related to                which had not previously been                         would be granted.
                                                  the LOAEL by (1) determining time-                      assessed, are included in this update.
                                                  weighted average (TWA) blood levels                     This assessment also includes statistical             III. Where can the information
                                                  from women exposed to chlorpyrifos                      analysis of all available monitoring data             identified in this document be found?
                                                  from indoor exposures to the cancelled                  for chlorpyrifos and chlorpyrifos-oxon.
                                                  crack and crevice use and (2) using the                 While this drinking water assessment is                  The information that EPA is be made
                                                  crack and crevice TWA blood level as                    more refined than the previous                        available for public review and
                                                  the internal dose for determining points                assessments, as a general matter, the                 comment can be found in the following
                                                  of departure for infants, children, and                 results did not allow for identification              dockets: EPA–HQ–OPP–2015–0653, the
                                                  adults exposed to chlorpyrifos using                    of many areas where potential                         docket for the proposed tolerance
                                                  current exposure potential. The use of                  exposures of concern to drinking water                revocations, and EPA–HQ–OPP–2016–
                                                  the PBPK model to assess internal                       can be ruled out. As a result, this                   0062, the FIFRA SAP docket, which
                                                  dosimetry from various exposure                         assessment does not significantly alter               contains the Chlorpyrifos Issue Paper
sradovich on DSK3GMQ082PROD with PROPOSALS




                                                  scenarios continues to be supported by                  the conclusions in the proposed rule                  and supporting materials. Both dockets
                                                  the SAP. This applies to the crack and                  regarding drinking water exposure and                 can be accessed through http://
                                                  crevice scenario identified as the most                 continues to indicate potential exposure              www.regulations.gov. As noted, EPA is
                                                  likely exposure pattern in the CCCEH                    to chlorpyrifos or chlorpyrifos-oxon in               also reopening the comment period to
                                                  study, where women were potential                       finished drinking water across the                    allow for comment on any aspect of the
                                                  exposed via the dermal, oral, and                       country based on currently labeled uses.              proposed revocation published on
                                                  inhalation routes. The detailed rationale               This is supported by both model                       November 6, 2015 (80 FR 69080) (FRL–
                                                  is presented in Chlorpyrifos: Revised                   estimated concentrations as well as                   9935–92).


                                             VerDate Sep<11>2014   17:46 Nov 16, 2016   Jkt 241001   PO 00000   Frm 00037   Fmt 4702   Sfmt 4702   E:\FR\FM\17NOP1.SGM   17NOP1


                                                  81052               Federal Register / Vol. 81, No. 222 / Thursday, November 17, 2016 / Proposed Rules

                                                  IV. What analysis and data are being                    Agricultural commodities, Pesticides                  consider comments or comment
                                                  noticed?                                                and pests, Reporting and recordkeeping                contents located outside of the primary
                                                     1. EPA is seeking comment on the                     requirements.                                         submission (i.e. on the web, cloud, or
                                                  following updates to the chlorpyrifos                     Dated: November 10, 2016.                           other file sharing system). For
                                                  human health risk assessment: (1) Use                   Richard P. Keigwin, Jr.,
                                                                                                                                                                additional submission methods, the full
                                                  of the crack and crevice scenario to                                                                          EPA public comment policy,
                                                                                                          Acting Director, Office of Pesticide Programs.
                                                  derive an exposure level for women in                                                                         information about CBI or multimedia
                                                                                                          [FR Doc. 2016–27552 Filed 11–16–16; 8:45 am]
                                                  the Columbia study; (2) using the                                                                             submissions, and general guidance on
                                                                                                          BILLING CODE 6560–50–P                                making effective comments, please visit
                                                  LOAEL from the Columbia study and
                                                  PBPK modeling to derive an endpoint                                                                           http://www2.epa.gov/dockets/
                                                  for use in quantitative risk assessment;                                                                      commenting-epa-dockets.
                                                                                                          ENVIRONMENTAL PROTECTION
                                                  (3) use of the 10X uncertainty factor for               AGENCY                                                FOR FURTHER INFORMATION CONTACT: Lisa
                                                  intraspecies variability; (4) use of the                                                                      Haugen, EPA Region 7, Enforcement
                                                  10X FQPA safety factor for LOAEL to                     40 CFR Part 271                                       Coordination Office, 11201 Renner
                                                  NOAEL extrapolation (please include                                                                           Boulevard, Lenexa, Kansas 66219,
                                                                                                          [EPA–R07–RCRA–2016–0637; FRL–9955–
                                                  your rationale for any alternative values                                                                     phone number: (913) 551–7877, or email
                                                                                                          24-Region 7]
                                                  suggested for this factor). Its analysis is                                                                   address: haugen.lisa@epa.gov.
                                                  included in the Chlorpyrifos: Revised                   State of Nebraska; Authorization of                   SUPPLEMENTARY INFORMATION: In the
                                                  Human Health Risk Assessment for                        State Hazardous Waste Management                      final rules section of the Federal
                                                  Registration Review (2016), which is                    Program                                               Register, EPA is authorizing the
                                                  available in the chlorpyrifos tolerance                                                                       revisions by a direct final rule. EPA did
                                                  revocation docket (EPA–HQ–OPP–                          AGENCY:  Environmental Protection                     not make a proposal prior to the direct
                                                  2015–0653).                                             Agency (EPA).                                         final rule because we believe this action
                                                     2. EPA is also making available for                  ACTION: Proposed rule.                                is not controversial and do not expect
                                                  comment the issue paper and associated                                                                        comments that oppose it. We have
                                                                                                          SUMMARY:   Nebraska has applied to the
                                                  materials presented to the April 2016                                                                         explained the reasons for this
                                                                                                          Environmental Protection Agency (EPA)
                                                  FIFRA SAP and the final report of the                                                                         authorization in the preamble of the
                                                                                                          for final authorization of revisions to its
                                                  SAP. The FIFRA SAP materials and                                                                              direct final rule. If no relevant adverse
                                                                                                          hazardous waste program under the
                                                  final report are available in the FIFRA                                                                       comments are received in response to
                                                                                                          Resource Conservation and Recovery
                                                  SAP docket (EPA–HQ–OPP–2016–                                                                                  this action, no further activity is
                                                                                                          Act (RCRA). EPA is proposing to grant
                                                  0062).                                                                                                        contemplated in relation to this action.
                                                     3. EPA is also seeking comment on                    final authorization to Nebraska.
                                                                                                                                                                If EPA receives relevant adverse
                                                  Chlorpyrifos Registration Review                        DATES: Comments on this proposed
                                                                                                                                                                comments, the direct final rule will be
                                                  Drinking Water Assessment, a highly                     action must be received in writing by                 withdrawn and all public comments
                                                  refined drinking water assessment that                  December 19, 2016.                                    received will be addressed in a
                                                  updates and completes the agency’s                      ADDRESSES: Submit your comments,                      subsequent final rule based on this
                                                  examination of exposure through                         identified by Docket ID No. EPA–R07–                  proposed action. EPA will not institute
                                                  drinking water for all registered uses of               RCRA–2016–0637, to http://                            a second comment period on this action.
                                                  chlorpyrifos. This assessment integrates                www.regulations.gov. Follow the online                Any parties interested in commenting
                                                  regionally specific (i.e., spatially                    instructions for submitting comments.                 on this action should do so at this time.
                                                  relevant) estimated drinking water                      Once submitted, comments cannot be                    Please note that if EPA receives adverse
                                                  concentrations and an extensive                         edited or removed from Regulations.gov.               comment on part of this rule and if that
                                                  evaluation of available surface water                   The EPA may publish any comment                       part can be severed from the remainder
                                                  monitoring data for chlorpyrifos and                    received to its public docket. Do not                 of the rule, EPA may adopt as final
                                                  chlorpyrifos-oxon. The assessment                       submit electronically any information                 those parts of the rule that are not the
                                                  considers both agricultural and non-                    you consider to be Confidential                       subject of an adverse comment. For
                                                  agricultural uses of chlorpyrifos, a                    Business Information (CBI) or other                   additional information, see the direct
                                                  sensitivity analysis for model estimated                information whose disclosure is                       final rule which is located in the rules
                                                  concentrations, and statistical                         restricted by statute. Multimedia                     section of this Federal Register.
                                                  evaluation of surface water monitoring                  submissions (audio, video, etc.) must be
                                                                                                          accompanied by a written comment.                       Dated: November 3, 2016.
                                                  data.
                                                                                                          The written comment is considered the                 Mark Hague,
                                                  List of Subjects in 40 CFR Part 180                     official comment and should include                   Regional Administrator, Region 7.
                                                   Environmental protection,                              discussion of all points you wish to                  [FR Doc. 2016–27683 Filed 11–16–16; 8:45 am]
                                                  Administrative practice and procedure,                  make. The EPA will generally not                      BILLING CODE 6560–50–P
sradovich on DSK3GMQ082PROD with PROPOSALS




                                             VerDate Sep<11>2014   17:46 Nov 16, 2016   Jkt 241001   PO 00000   Frm 00038   Fmt 4702   Sfmt 9990   E:\FR\FM\17NOP1.SGM   17NOP1



Document Created: 2016-11-17 03:00:31
Document Modified: 2016-11-17 03:00:31
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionProposed Rules
ActionProposed rule.
DatesSubmit comments on or before January 17, 2017.
ContactDana Friedman, Pesticide Re-Evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
FR Citation81 FR 81049 
CFR AssociatedEnvironmental Protection; Administrative Practice and Procedure; Agricultural Commodities; Pesticides and Pests and Reporting and Recordkeeping Requirements

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR