Docket Number EPA-HQ-OPP-2013-0749

    HYPERLINK http://www.regulations.gov/  www.regulations.gov







                   







Aminopyralid Preliminary Work Plan





Registration Review: Initial Docket

Case Number 7267





March 2014





































                                                                        
                        



Approved by:





Director

Pesticide Re-evaluation Division







                                                  



Date:

                                        







Aminopyralid Preliminary Work Plan - Table of Contents









OVERVIEW
........................................................................
............................................................4



AN'flCIPATED DATA NEEDS
........................................................................
.............................5



STATUTORY AND REGULATORY  AUTHORITY
...................................................................5



CHEMICAL FACTS
........................................................................
...............................................6



USE AND USAGE INFORMATION
........................................................................
.....................? RECENT ACTIONS
........................................................................
...............................................9

ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION
REVIEW.................................9



TIMELINE
........................................................................
............................................................11



NEXT STEPS
........................................................................
........................................................12





Appendix - Additional Areas Considered in the Aminopyralid Registration
Review ..............13











                                                     References:



This Preliminary Work Plan su mmarizes the Environmental Protection
Agency's current position based on the following documents:



1.  Registration Review: Problem Formulation for Environmental Fate,
Ecological Risk, Endangered Species, and Human Health Drinking Water
Exposure Assessments for Aminopyralid, Potassium Salt of Aminopyralid,
and Triisopropanolamine Salt of Aminopyralid. EFED!Edward Scollon, Ph.D.
and Katrina White, Ph.D. February 12, 2014.



2.  Aminopyralid. Human Health Assessment Scoping Document in Support of
Registration Review. HED/Douglas Dotson, Ph.D., Jaime D'Agostino, Ph.D.
and Zaida Figueroa, February 12, 2014.



3.  Aminopyralid:  Tier l Review of Human Incidents. Shanna Recore.
November 12, 2013.



4.   BEAD Chemical Profile (BCP )for Registration Review: Aminopyralid
Case Level

Composed of Aminopyralid (005100), Aminopyralid, Potassium Salt (005219)
and

Triisopropcmolamine Salt of Aminopyralid (005209). BEAD/Sunil Ratnayake,
Rafael A. Prieto and Stephen Smearman, March 31,2014.





5.  Aminopyralid (005100, 005209, 005219). Screening Level Usage
Analysis (S LUA ),

March 18, 2014.





6.  Environmental Fate and Effects Division Label Data Report
Spreadsheet:  PC Codes:

005100, 005209,005219. August 23, 2013.





7.  Health Effects Division Master Label Report Spreadsheet: PC Codes:
005100,

005209,005219. August 23, 2013.







These and other supporting documents for the aminopyralid registration
review case may be found in the docket EPA-HQ-OPP-2013-0749 at
http://www.re!!ulalions.gov.



OVERVIEW



The docket for aminopyralid is now open, initiating the first public
comment period for this registration rev iew (docket number
EPA-HQ-OPP-2013-0749). This case includes the aminopyralid acid along
with its potassium and triisopropanolamine salts.  Aminopyralid, 4-
amino-3,6-dichloro-2-pyridinecarboxylic acid, is a systemic herbicide
which is registered  for use to control a number of noxious and invasive
annual, biennial and perennial weed species.  This pesticide belongs to
the pyridine carboxylic acid family and is registered for use as a
precausing abnormal growth patterns in the plants.  Aminopyralid may be
applied via aircraft, ground sprayer, hand-held sprayer, and boom
sprayer.  Aminopyral id may also be applied to forest plantings via
broadcast, high volume spray, spot treatment, stump treatment, girdle
treatment, frill treatment, tree wound treatment, and tree injection. 
This  Preliminary Work Plan (PWP) document explains what EPA's Off ice
of Pesticide Progra ms knows about aminopyrlid, highlighting anticipated
data and assessment needs, identifying the types of information that
would be especially useful to the Agency in conducting the review, and
providing an anticipated timeline for completing the registration review
for aminopyralid.



The registration review process was designed to include a public
participation component to solicit input from interested stakeholders. 
The Agency intends, by sharing this information in the docket, to inform
the public of what it knows about aminopyralid and what types of new
data or other information would be helpful for the Agency to receive as
it moves toward a decision on aminopyralid.  The Agency encourages all
interested stakeholders to review the PWP and Appendix and to provide
comments and additional information that will help the Agency's
decision-making process for this chemical.  In addition to general areas
on which persons may wish to comment, there are some areas identified in
the PWP and Appendix about which the Agency specif ically seeks comments
and information.  Interested stakeholders could include: environmental
non-prof it or in terest groups; pesticide manufacturers; agricultural
labor or commodity groups; commercial, institutional, residential, and
other users of pesticides; or the public at large.



The Preliminary- Work Plan begins by listing the anticipated data needs
for aminopyralid.  Next, it discusses the statutory and regulatory
authority for Registration Review.  Then the document provides chemical
facts, use and usage information, recent actions, the anticipated risk
assessments, and a projected registration review timeline for
aminopyralid.  Finally, the Appendix to this document includes
identification and discussion of some areas that are considered
generally in Registration Review along with some additional chemical
case-specific information.



 ANTICIPATED DATA NEEDS



Table 1 below summarizes anticipated data needs for aminopyralid.  For
additional discussion of the anticipated data: needs, see the
Registration Review Problem Formulation for Environmental Fate,
Ecological Risk, Endangered Species, and Human Health Drinking Water
Exposure Assessments for Aminopyralid, Potassium Salt of Aminopyralid,
and Triisopropanolamine  Salt of Aminopyralid and the Human Health
Assessment Scoping Donrment in Support of Registration Review.































































                                      





















































TGAI ==  techmca l grade acttve mgredtent; TEP = typ1cal end-use product



 STATUTORY AND REGULATORY AUTHORITY



The Food Quality Protection Act (FQPA) of 1996 mandated a registration
review program.  All pesticides distributed or sold in the United States
(U.S.) generally must be registered by the Environmental Protection
Agency (EPA or the Agency), based on scientif ic data showing that they
will not cause unreasonable risks to human health or the environment
when used as directed





                                                     1 On June 27, 2012,
EPA announced certain revisions in harmon ized guideline series
850-Ecological Effects Tests

- incl uding re numberin g and other designations or changes for some
guideline studies.  See "Final Test Guidelines; OCSPP 850 Series; Notice
of Availability" 77 FR 38282, June 27,2012.

2 For these Guideline Numbers, data and/or waiver requests are currently
under review.

3 Data are anticipated to be needed for representative Typical End-Use
Products (TEPs) that conta in i) aminopyralid and 2,4-D; ii)
aminopyralid and triclopyr; iii) aminopyralid and clopyralid ; iv)
aminopyra lid and metsulfuron; and v) aminopyralid and
fluroxypyr-l-methylheptyl ester

on product labeling.  The registration review program is intended to
make sure that, as the ability to assess risk evolves and as policies
and practices change, all registered pesticides continue to meet the
statutory standard of no unreasonable adverse effects to human health or
the e.nvironment.  Changes in science, public policy, and pesticide use
practices will occur over time. Through the registration review program,
the Agency periodically reevaluates pesticides to make sure that as
change occurs, products in the marketplace can be used safely. 
Information on this program is provided on EPA's website.4



The Agency is implementing the registration review program pursuant to
Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide
Act(FIFRA), and will review each registered pesticide every 15 years to
determine whether it continues to meet the FIFRA standard for
registration.  The regulations governing registration review begin at 40
CPR 155.40.  The Agency will consider benefits information and data as
required by FIFRA.  The public phase of registration review begins when
the initial docket is opened for each case.  The docket is the

Agency's opportunity to state what it knows about the pesticide and what
additional risk analyses and data or information it believes are needed
to make a registration review decision.  After reviewing and responding
to comments and data received in the docket during this initial comment
period, the Agency will develop a Final Work Plan (FWP) and anticipated
schedule for the registration review of aminopyralid.



 CHEMICAL FACTS



Table 2 provides a summary of the chemical facts for aminopyralid.



 Table 2:  Chemical Facts for Aminopyralid PC codes 005100 (aminopyralid
acid), 005219 (aminopyralid potassium salt),   005209 (aminopyralid
triisopropanolamine [TIPA] salt) Case Number 7267 CAS Numbers
150114-71-9 (aminopyralid acid),  566192-87 (aminopyralid

potassium salt), 566191-89-7 (aminopyralid TIPA salt)Year first
registered2005Pesticide TypeHerbicideChemical classPyridine carboxylic
acidReregistration Eligibility

Decision (RED)Aminopyralid was registered after November 1984;
therefore, it

was not subject to reregistration.Tolerance Reassessment

Eligibility Decision (TRED)Aminopyralid was registered after November
1984; therefore, it

was not subject to tolerance reassessment.Cumulative groupNo cumulative
risk assessment is required at this time since the

Agency has not made a determination regarding a common mode of action.40
CFR CitationTolerances for aminopyralid are established in 40 CPRand has
no registered antimicrobial or bioNon-pesticidal usesThere are no
identified non-pesticidal uses of aminopyralid.



                                                     4     HYPERLINK
http://www.epa.gov/oppsrrd1/registration_review/ 
http://www.epa.gov/oppsrrd 1/registration_review/



 Table 2: Chemical Facts for Aminopyralid Pesticide Re-evaluation
Division, Chemical Review Manager 

Veronica Dutch,  HYPERLINK mailto:dutch.veronica@epa.gov
dutch.veronica@epa.gov,  (703) 308-8585Registration Division,

Product Manager

Kathryn Montague,  HYPERLINK mailto:montague.kathryn@ega.gov
montague.kathryn @ega.gov, (703) 305-1243

 USE AND USAGE INFORMATION



Table 3 summarizes the use and usage information for aminopyralid. 
Please see the BEAD Chemical Profile ( BCP) for Registration Review:
Aminopyralid Case Level Composed of Aminopyralid (005100), Aminopyralid,
Potassium Salt (005219) and Triisopropanolamine  Salt of Aminopyralid
(005209) in the registration review docket for more details.



 Table 3: Aminopyralid Use and Usage Information Summary of Use
Aminopyralid. is a systemic herbicide registered for broadleaf weed

management in agricultural and non-agricultural lands. Arninopyralid can
be applied as pre-emergence or post-emergence treatments using aerial
and ground application methods. Aminopyralid acts like a plant growth
regulator by mimicking natural plant growth hormones (auxins).Use
SitesUse sites for amlnopyralid are wheat, hay, and pasture crops.



Use sites for aminopyralid potassium salt are forestry plantings, wheat,
hay, and pasture crops.  It is also registered for use on Conservation
Reserve Program (CRP) lands, rights-of-way,  and fallow and
non-agricultural uncultivated areas, including seasonally flooded
wetland areas when dry.



Use sites for aminopyralid TIPA salt include forest plantings, wheat,
corn (silage, f ield), and hay and pasture crops.  It is also registered
for use on CRP areas, airports/landing fields, industrial and
construction areas, fallow and non-agricultural uncultivated
agricultural uncultivated areas, including seasonally flooded wetland
areas when dry.



The predominant use for these active ingredients is on pasture

(98+% of usage).Summary of UsageBased on proprietary data from
2006-2012, average usage was approximately 92,000 pounds of active
ingredient (a.i.) applied

annually on 1.3 million acres.  The average a.i. rate over this time
period was 0.07 pounds a.i./acre.  There are limited usage data
available for non-agricultural use sites.Formulation Type(s)Ami

Aminopyralid is formulated as an emulsifiable concentrate. nopyralid
potassium salt is formulated as a dry flowable and

 Table 3: Aminopyralid Use and Usage Information emulsifiable
concentrate. Aminopyralid triisopropanolainine salt is formulated as an
emulsifiable concentrate, liquid soluble concentrate, and flowable
concentrate. Application Method(s) Products can be applied as a
broadcast treatment by aircraft, ground

sprayer, or hand-held sprayer. Additional treatments are spot treatment,
stump treatment, girdle treatment, frill treatment, tree wound
treatment, and tree injection.Technical RegistrantDow Agro $ciences
LLCNo. of Registrations15 Section 3 products:> and 36 Special Local
Needs (SLN; Section

24c) registrations.Restricted UseNo

Guidance for Commenters:  Additional areas of use and usage related
information

requested for this registration review, and of particular interest to
EPA, are described  below.





•	Certain current labels with instructions for applications to trees
(e.g., cut surface, cut-stump treatment, tree injection, hack and squirt
treatment, and frill and girdle method) do not specify the maximum
amount of aminopyralid that may be applied per tree ( e.g ., as a
function of trunk diameter), or the maximum number of trees that may be
treated per acre. Maximum application rates (both single and seasonal)
in lbs a.i or a.e./A for modeling exposures resulting from these types
of uses may also be l acking as is the maximum number of applications
per year and minimum retreatment interval.

•	Some labels list nonspecific use sites.  Without specific use site
information, the Agency must employ the assumption that aminopyralid can
be used at any of the specif ic use sites that fall within the broad
range of agricultural, commercial, residential, and forest sites named
on the label, and  that applications may be made to both aquatic and
terrestrial environments.  The following are examples of nonspecific use
sites:

o 	Non-irrigation ditch banks, seasonally dry wetlands (such as flood
plains, deltas,

marshes, swamps, or bogs), transitional areas between upla nd and
lowland sites when dry, ditch bank weeds, shoreline weeds, non-cropland
areas, and natural areas.

•	Some label restrictions are specif ied on a product basis. rather
than on an a.i. basis.

•	Some labels Jack maximum annual or seasonal application rates,
maximum number of applications, and minimum retreatment intervals.

•	Some labels with multiple a.i.s provide application rate information
on an acid equivalent basis but do not specify to which a.i. the rates
apply.

•	Confirmation of additional label information:  application methods
and equipment, and geographic limitations on use.

•	Use distribution (e.g., acreage and geographical distribution of
relevant use sites).



                                                     5 Section 3 product
labels can be obtained from the Pesticide Product Label System (PPLS)
website

(http://oaCpub.epa.gln,foestlabllppls.home).

o 	Median and 90th percentile reported use rates (l bs ai/A) from usage
data - national, state, and county.

f) 	Typical application timing (date of first application and
application intervals)- national, state, and county.

o 	Usage/use information for non-agricultural sites.

o 	State or local use restrictions.

o 	Foreign technical registrantthat supply technical aminopyralid to the
US market.



RECENT ACTIONS



In 2013, an amendment to registration for a Section 3 new use of
aminopyralid for control of broadleaf and woody plants and annual weeds
in aquatic sites was submitted.  The proposed labels defined aquatic
sites as "non-irrigation ditch banks; seasonally dry wetlands such as
flood

plains, deltas, marshes, swamps, or bogs; transitional areas between
upland and lowland sites as well as along shorelines; and shallow areas
of still and moving water."  The submission is currently under review. .



ANTICIPATED RISK ASSESSMENTS FOR REGISTRATION REVIEW



The most recent comprehensive human health risk assessment for
aminopyralid was completed in 2009.  The most recent ecological and
environmental fate risk assessment was completed  in

2010.  Findings and conclusions from these risk assRegistration Review
Problem Formulation for Environmental Fate, Ecological Risk, Endangered
Species, and Human Health Drinking Water Exposure Assessments for
Aminopyralid, Potassium Salt of Aminopyralid, and Triisopropanolamine
Salt of Aminopyralid.



During registration review, the Agency anticipates the need to conduct a
comprehensive ecological risk assessment, including an endangered
species assessment, for all uses of aminopyral id. For human health, EPA
anticipates the need to conduct revised dietary and aggregate risk
assessments during registration review.  If toxicological endpoints or
points of departure are revised based on the data that are anticipated
to be required for registration review, they will be considered, as will
any changes to the standard operating procedures or default exposure
assumptions.

Table 4 below summarizes the anticipated registration review risk
assessments based on the

EFED Problem Formulation and HED Scoping Document.



 Table 4:  Anticipated Risk Assessments for the Aminopyralid
Registration Review Type of Risk Assessment Conduct? Notes Ecolofdcal
and Environ mental Fate Comprehensive ecological

(species to be assessed

include terrestrial and aquatic organisms), including endangered species



y

The Agency will cond uct a comprehensive ecological assessment,
including an endangered species assessment.  Effects of residues in
compost will be addressed.Incidents

Will check for updatesFor discussion of reported ecological incidents
for

a minopyral id, see page 17 of the Problem

Formulation.Human  HealthDietaryFood

yIf new policies are put into place, or new toxicity and

crop treated data become available, the Agency will revisit.Drinking
wateryDrinking water will be examined as part of registration
review.OccupationalHandlers (mixers, loaders, applicators)

yThe Agency will consider the need for a new handler

assessment to account for any policy changes that take place during
registration review.Post-application



NAn occupational quantitative post-application

assessment will not be necessary during registration review because a
dermal endpoint has not been selected for aminopyral
id.ResidentialHandlers

NAminopyralid is not applied by homeowners;

therefore, a residential handler assessment will not be conducted for
registration review.Post-application







yDuring registration review, a revised residential

exposure assessment that includes post-appl ication incidental oral
exposure to children (1 <2 years old) playing on treated recreational
sites may be needed. The Agency may determine that a bystander spray
drift risk assessment is needed for aminopyralid during registration
review.OtherAggregate

yIf food, drinking water, or residential port-application

reassessments are conducted, a new aggregate risk assessment may be
needed.

 Cumulative 

NAminopyralid has not been identified as belonging to

a cumulative group, so the Agency does not anticipate that a cumulative
risk assessment will be performed.TolerancesyThe Agency will revisit the
tolerances during

registration review.Incidents

Will check for updatesFor a discussion of reported human incidents for

aminopyralid, see page 10 of the Seeping Document and Aminopyralid: 
Tier I Review of Human Incidents.

Guidance for Commenters:  Additional ecological information requested
for this registration review, and of particular interest to EPA, is
described below.



o 	Ecological incidents (non-target plant damage and avian, fish,
rep_tilian, amphibian and mammalian mortalities) not already reported to
the Agency.

o 	The application of aminopyralid to vegetative matter that is
subsequently used as compost or animal feed has been found to retain
aminopyralid residues and affect

non-target plants. Residues in food items that end up in compost may
also be found in

compost.  The Agency is interested in additional information about this
issue, which may include incident reports and environmental fate data.

o 	Water quality monitoring data (see Appendix for further details).



TIMELINE



EPA has created the following estimated timeline for the completion of
the aminopyralid registration review in Table 5 below.



 Table 5:  Projected Aminopyralid Registration Review Timeline
Activities Estimated Date Opening the Docket Open Docket and 60-day
Public Comment Period March-2014 Close Public Comment May-2014 Case
Development Fi nal Work Plan August-2014 Issue DCI October-December-2014
Data Submission October-December-2016 60-day Public Comment Period for
Draft Risk Assessments0 April-June-2018 Registration Review Decision
60-day Public Comment Period for Proposed Registration

Review DecisionJanuary-March-2019Registration Review Decision and Begin
Post-Decision

Follow-up2020Total (years)6

                                                     6 The regu lations
governing Registration Review generally require the Agency to provide a
public comment period of at least 30 calendar days for draft risk
assessments; see 40 CFR Part 155.53(c).  For conventional pesticides,
the Agency plans to provide a 60 calendar day public comment period
generally for draft risk assessments.



NEXT STEPS



After the 60-day public comment period closes, the Agency will review
and respond to any comments received in a timely manner and then issue a
Final Work Plan for the registration review of aminopyralid.

Appendix - Additional Areas Considered in the Aminopyralid Registration
Review



.  PUBLIC COMMENTS  AND FEEDBACK:



Guidance for Commenters: The areas below highlight topics of special
interest to the Agency where your comments, data submissions, or
reference to sources of additional information could be of particular
use.



Trade Irritants:



Through the registration review process, the Agency intends to solicit
information on trade irritants and, to the extent feasible, take steps
toward facilitating irritant resolution.  The Agency will work to
harmonize tolerances and international maximum residue limits (MRLs) and
may modify tolerance levels to do so, when possible. Growers and other
stakeholders are asked to comment on any trade irritant issues resulting
from lack of MRLs or disparities between U.S. tolerances and MRLs in key
export markets, providing as much specificity as possible regarding the
nature of the concern.



Water Quality:



Aminopyralid is not identified as a cause of impairment for any
watebodies  listed as impaired under section 303(d) of the Clean Water
Act.7  In addition, no Total Maximum Daily Loads (TMDLs) have been
developed for aminopyralid.8  More information on impaired water bodies
and TMDLs can be found at the Agency's website.9 The Agency invites
submission of water quality data for this pesticide. To the extent
possible, data should conform to the quality

standards in Appendix A of the OPP Standard Operating Procedure:
Inclusion of Impaired Water Bod y and Other Water Quality Data in OPP's
Registration Review Risk Assessment and Management Proces/ 0 in order to
ensure they can be used quantitatively or qualitatively in

pesticide risk assessments.



Environmental Justice:



EPA seeks to achieve environmental justice, the fair treatment and
meaningful involvement of all people, regardless of race, color,
national origin, or income, in the development, implementation, and
enforcement of environmental laws, regulations, and policies.  To help
address potential environmental justice issues, V!e Agency seeks
information on any groups or segments of the population who, as a result
of their location, cultural practices, or other factors, may have
atypical, unusually high exposure to aminopyralid compared to the
general population.  Please comment if you are aware of any
sub-populations that may have atypical, unusually high exposure compared
to the general population.









                                                     7      HYPERLINK
http://ias.pub.epa.gov/tmdl   http://ias.pub.epa.gov/tmdl   waters I
0/attamnation  cyxause  detail  303d'?p  cause  group  id-!Hl5 	

8    HYPERLINK http://iaspub.cpa.gov/tmdl  http://iaspub.cpa.gov/tmdl
C'>aters I0/attains  nation.tmdl pollutant detail?p pollutant l!fOUQ
id-885&p pollutant

 group name=PESTICIDES

9     HYPERLINK http://www.epa.gov/owow/tmdl/ 
http://www.epa.gov/owow/tmdl/

10     HYPERLINK http://www.epa.gov/oppsnd   http://www.epa.gov/oppsnd 
!/registration reC ieCC /water quality '>Op.htm

 

ENDANGER ED SPECIES:



A risk assessment that supports a complete endangered species
determination has not been conducted for aminopyralid.  The ecological
risk assessment plaiUled during registration review will allow the
Agency to determine whether use of aminopyralid has "no effect" or "may
affect" and/or National Marine Fisheries Service (the Services), as
appropriate.



 ENDOCRINE DISRUPTOR SCREENING PROGRAM:



As required by FIFRA and FFDCA, EPA reviews numerous studies to assess
potential adverse outcomes from exposure to chemicals.  Collectively,
these studies include acute, subchronic and chronic toxicity, including
assessments of carcinogenicity, neurotoxicity, developmental,
reproductive, and general or systemic toxicity. These studies include
endpoints which may be  , susceptible to endocrine influence, including
effects on endocrine target organ histopathology, organ weights, estrus
cyclicity, sexual maturation, fertility, pregnancy rates, reproductive
loss, and sex ratios in offspring.  For ecological hazard assessments,
EPA evaluates acute tests and chronic studies that assess growth,
developmental and reproductive effects in different taxonomic groups. 
As part of its most recent registration decision for aminopyralid, EPA
reviewed these data and selected  the most sensitive endpoints for
relevant risk assessment scenarios from the existing hazard database. 
However, as required by FFDCA section 408(p), aminopyralid is subject to
the endocrine screening part of the Endocrine Disrupter Screening



EPA has developed the EDSP to determine whether certain substances
(including pesticide active and other ingredients) may have an effect in
humans or wildlife similar to an effect produced by a "naturally
occurring estrogen, or other such endocrine effects as the Administrator
may designate."  The EDSP employs a two-tiered approach to making the
statutorily required determinations. Tier 1 consists of a battery of 11
screening assays to identify the potential of a chemical substance to
interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal
systems.  Chemicals that go through Tier 1 screening and are found to
have the potential to interact with E, A, or T hormonal systems will
proceed to the next stage of the EDSP where EPA will determine which, if
any, of the Tier 2 tests are necessary based on the available data. Tier
2 testing is designed to identify any adverse endocrine-related effects
caused by the substance, and establish a dose-response relationship
between the dose and the E, A, or T effect.



Under FFDCA section 408(p), the Agency must screen all pesticide
chemicals.  Between October 2009 and February 2010, EPA issued test
orders/data call-ins for the first group of 67 chemicals, which contains
58 pesticide active ingredients and 9 inert ingredients.  A second list

of chemicals identified for EDSP screening was published on June 14,
20131 1  and includes some pesticides scheduled for registration review
and chemicals found in water.  Neither of these lists

should be construed as a list of known or likely endocrine disrupters.





                                                     11 See 
http://wCvw.regulation-,.gov/#!documcntDetaii:D-EPA-HO-OPPT-2009-0477-0
074 for the final second list of chemicals.



.   14

 

For further information on the status of the EDSP, the policies and
procedures, the lists of chemicals, future lists, the test guidelines
and the Tier 1 screening battery, please visit our website. 12



HUMAN STUDIES:



Past aminopyralid risk assessments rel y in part on data from studies in
which adult human subjects were intentionally exposed to a pesticide to
determine their dermal and inhalation exposure.  Many such studies,
involving exposure to many different pesticides, comprise generic
pesticide exposure databases such as the Pesticide Handlers Exposure
Database (PHED), the Agricultural Reentry Task Force (ARTF) Database,
and the Outdoor Residential Exposure Task Force (ORETF) Database.  EPA
has reviewed all the studies supporting these multi-pesticide generic
exposure databases, and has found no clear and convincing evidence that
the conduct of any of them was either fundamentally unethical or
significantly deficient relative to the ethical standards prevailing at
the time the research was conducted.  All applicable requirements of
EPA's Rule for the Protection of Human Subjects of Research (40 CFR Part
26) have been satisfied, and there is no regulatory barrier to continued
reliance on these studies.

















































































                                                     12     HYPERLINK
http://www.epa.gov/endo/  http://www.epa.gov/endo/





15

