&EPA
United States Environmental Prevention, Pesticides and EPA 738-R-07-07017
Protection Agency Toxic Substances (7508P) October 2007
Reregistration Eligibility
Decision (RED)
Naphthaleneacetic Acid, Its
Salts, Ester, and Acetamide
Revised October 2007
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REREGISTRATION ELIGIBILITY DECISION (RED)
For
Naphthaleneacetic Acid, Its Salts, Ester, and Acetamide
CASE 0379
Revised October 2007
Includes chemicals:
056001 1 -Naphthaleneacetamide
056002 1-Naphthalene acetic acid,
056003 Potassium 1-naphthaleneacetate
056004 Ammonium 1-naphthaleneacetate
056007 Sodium 1-naphthaleneacetate
056008 Ethyl 1-naphthaleneacetate
Approved by:
Steven Bradbury, Ph.D.
Director
Special Review and Reregistration Division
Date:
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Naphthalene Acetic Acid Reregistration Eligibility Decision
The Reregistration Eligibility Decision (RED) document for Naphthaleneacetic Acid, Its
Salts, Ester, and Acetamide ("NAA") was signed on May 26, 2004. The Environmental
Protection Agency (EPA or the Agency) concluded in the RED that the use of naphthalene
acetates (commonly referred to as NAA the most widely used naphthalene acetate) would have
no effect on any endangered or threatened species or their critical habitat from the uses currently
registered based on its screening-level assessment. However, the Agency was informed that one
very minor use, on olive trees as a chemical thinning agent, has an approved application rate
higher than assessed in the RED. Based on screening-level ecological and occupational
assessments of the higher use rate, calculated risk quotients (RQs) for NAA use on olive trees
now exceed the level of concern for endangered species and one worker exposure scenario
exceeds the occupational level of concern. The Agency is, therefore, issuing an Amended RED
for NAA.
The amended RED document and Overview include corrections, clarifications, and
updates as a result of the maximum application rate of NAA on olives and EPA's own review of
the document. Important revisions are summarized below; however, minor changes that are
insignificant, but which improve the clarity of the document, are not listed here. Further,
additional references to supporting documents were included to assist readers to find more
details on various assessments.
The Amended RED and supporting risk assessments can be found on the Federal Docket
Management System, available at http://www.regulations.gov (docket # EPA-HQ-OPP-2006-
0507) and in the Office of Pesticide Program's (OPP's) public docket for viewing. The OPP
docket is located in Room S-4400, One Potomac Yard (South Building); 2777 S. Crystal Drive,
Arlington, VA, and is open Monday through Friday, excluding legal holidays, from 8:30 AM to
4:00 PM.
RED Document Revisions:
• References to the docket and building address have changed. These are:
- The docket number has been changed to EPA-HQ-OPP-2006-0507.
New electronic docket system. The Federal Docket Management System (FDMS) has
replaced the older "E-Dockets" internet docket system. FDMS can be found at
www.regulations.gov.
New paper docket location. The Office of Pesticides Programs has moved and along
with it, its paper docket. The new location is Room S-4400, One Potomac Yard (South
Building); 2777 S. Crystal Drive; Arlington, VA; 22202.
• Throughout the Amended RED and Overview the units for application rates are now listed as
pounds of acid equivalents per acre (Ibs ae/A) rather than pounds of active ingredient per
acre (Ibs ai/A).
• In the RED (as amended) Section III. A. 5. Occupational Handler and Post-Application
Risks, the paragraph is amended to reflect that the estimated margin of exposure (MOE) for
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one occupational exposure scenario exceeds the screening-level of concern (below an MOE
of 100). Additional use information was provided to characterize these potential exposures.
• In the RED (as amended), Section III. B. 1. Risk to Non-Target Species, the section is
amended to reflect that for plants, the no risk of concern determination is only for non-
endangered, non-target plants.
• In the RED (as amended), Section III. B. 2. Endangered Species, the section is amended to
reflect the level of concern for endangered plants is exceeded when olive trees are treated at
the rate of 0.33 Ib ae/A. However, the Agency has not drawn any definitive conclusions
regarding whether naphthalene acetates have effects on listed plants that may be in the
vicinity of olive trees grown in the six California counties where NAA is used for fruit
thinning.
• In the RED (as amended), Section V. Label Changes. The bullet point for maximum single
application rate is amended to allow 0.33 Ib ae/A for use on olive trees.
Label Table Revisions:
• Table 4: Summary of Labeling Changes for Naphthalene Acetates was amended to allow the
use of up to 0.33 Ib NAA equivalent per acre on olive trees.
• The Spray Drift Management section was amended to include recommendations to minimize
the potential for off-target movement of NAA sprays.
Overview Revisions:
A number of updates have also been made to Section VI, Overview of Naphthaleneacetic
Acid, Its Salts, Ester, and Acetamide Risk Assessments of the RED. The updates to the
Overview include the following:
• The Use Profile Section was amended by adding information describing use and rates of
application.
• The Dietary Risk from Drinking Water section is amended in the second paragraph to
indicate drinking water risk is now assessed for the olive tree use, which now represents
higher potential environmental loading from this higher application rate. As a result, Table 2
Modeled 1-Naphthaleneacetic Acid Estimated Drinking Water Concentrations (EDWCs)
from Surface and Ground Water Sources and Table 4 Naphthalene Acetates Drinking Water
Levels of Comparison (DWLOC) and EDWCs are amended to reflect the potentially higher
concentrations of NAA in drinking water sources.
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• The occupational handler (mixer, loader, and applicator) and post-application risk estimates
(MOEs) were revised to reflect the higher olive tree application rate.
• In the Ecological Risk section, the 2nd and 3rd paragraphs are amended to reflect slight
changes in the risk quotients because of the higher use rate on olive trees.
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Naphthalene Acetates Team
Office of Pesticide Programs:
Health Effects Risk Assessment
Becky Daiss
Gary Otakie
Abdallah Khasawinah
Environmental Fate Risk Assessment
Jose Melendez
Dirk Young
Allen Vaughn
Biological and Economics Analysis Division
Julie Heflin
Nicole Zinn
Registration Division
John Bazuin
Tony Kish
Risk Management
Mark T. Howard
Neil Anderson
Veronica Dutch
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I. Determination of Reregistration Eligibility for the Naphthalene Acetates
Section 4(g)(2)(A) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)
calls for the Environmental Protection Agency (EPA or the Agency) to determine, after
submission of relevant data concerning an active ingredient, whether products containing the
active ingredient are eligible for reregi strati on, which is set forth in this reregi strati on eligibility
decision (RED). The Agency has previously identified and required the submission of the
generic (i.e., an active ingredient specific) data required to support reregi strati on of products
containing naphthalene acetate active ingredients.
The Agency has completed its assessment of the dietary, residential, occupational, and
ecological risks associated with the use of currently registered pesticide products containing
naphthalene acetate active ingredients. Based on a review of these data and registrant comments
on the Agency's assessments for the naphthalene acetate active ingredients, EPA has sufficient
information on the human health and ecological effects of the naphthalene acetates to make
decisions as part of the tolerance reassessment process under the Federal Food, Drug and
Cosmetic Act (FFDCA) and reregi strati on under FIFRA, as amended by the Food Quality
Protection Act (FQPA). The Agency has determined that the naphthalene acetates are eligible
for reregi strati on provided that: (i) current data gaps and additional data needs are addressed and
(ii) the label changes outlined in this document are adopted. Accordingly, should a registrant fail
to implement any of the label changes or other measures identified in this document, the Agency
may take further regulatory action for the naphthalene acetates.
II. Chemical Overview
A. Regulatory History
The first naphthalene acetate end-use product (with the naphthalene acetamide as the
active ingredient), Rootone Brand Rooting Hormone with Fungicide, was registered in 1952. Its
labeled use was to stimulate root growth of cuttings of a number of ornamental plants, vines and
shrubs, deciduous trees, and evergreens. Seven more naphthalene acetates, including
naphthalene acetic acid (NAA), were registered in the early to mid-1960s. There are six active
ingredients currently registered as part of the naphthalene acetates case.
In August 1981, EPA published a Registration Standard for "Naphthaleneacetic Acid its,
Salts, Ester, and Acetamide." This document described the uses and established the data
requirements to reregister the six supported naphthalene acetates. Tolerances were established
for NAA in/on apples, pears, quinces, olives, and pineapples (as the sodium salt); for the ethyl
ester of NAA in/on apples, pears, and olives; and for naphthaleneacetamide in/on apples and
pears. Data Call-ins (DCIs) were issued in October and November 1990 and October 1995. The
1990 DCIs mainly restated data requirements of the Registration Standard. The 1995 DCI
required data to discern post-application (reentry) occupational and residential exposure.
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B. Chemical Identification
• Common Family:
• Case number:
• Basic manufacturer:
Naphthalene acetates
0379
Amvac Chemical Company
Table 1. Naphthalene Acetates Nomenclature
Common name
NAA acetamide (NAAm)
NAA
Chemical structure
'NIL
Molecular Formula
C12HnNO
C12H1002
Molecular Weight
185.23
186.20
CAS name
1 -naphthaleneacetamide
1-naphthaleneacetic acid
CAS#
86-86-2
86-87-3
PC Code
056001
056002
Common name
Chemical structure
NAA potassium salt
O
O K
NAA ammonium salt
O
CfNHd
Molecular Formula
C12H1002K
C12H13N02
Molecular Weight
225.31
203.24
CAS name
1-naphthalene acetic acid, potassium
salt
1-naphthaleneacetic acid, ammonium salt
CAS#
15165-79-4
25545-89-5
PC Code
056003
056004
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Common name
Chemical structure
NAA sodium salt
O
O Na
NAA ethyl ester (NAA-OEt)
O
Molecular Formula
C12H10O2Na
Molecular Weight
209.2
214.26
CAS name
1-Naphthaleneacetic acid, sodium salt
1-Naphthaleneacetic acid, ethyl ester
CAS#
61-31-4
2122-70-5
PC Code
056007
056008
C. Use Profile and Estimated Use of Pesticide
1-Naphthaleneacetic acid (NAA), its salts, ester, and acetamide are plant growth
regulators (PGR) which are collectively referred to as naphthalene acetates. The PGR activity of
NAA is due to its structural similarity to the natural plant hormone indole acetic acid (IAA).
They are currently registered for use on various orchard and fruit crops including apple, cherry,
olive, orange, pear, tangelo, and tangerine. As plant growth regulators, they may be used on the
above-listed crops to prevent preharvest drop of fruits, thin fruit trees, and delay flower
induction. They can also stimulate growth and delay leaf drop on ornamentals.
Approximately 20,000 Ibs of the naphthalene acetate active ingredients are applied
annually in the U.S. The registered formulation classes of naphthalene acetates, which may be
used on food/feed crops, include wettable powder, dust, flowable concentrate, soluble
concentrate, and ready-to-use liquid. These formulations may be applied using broadcast ground
or aerial equipment, hand-held sprayers, paint brush, dip treatment or soil drench. The
naphthalene acetates are typically applied as a dilute (1-2%) spray solution, and the timing of
treatment vary depending on the purpose of treatments. The ethyl ester and acetamide of NAA
are used early in the season to control sprout formation and fruit set (thinning), respectively.
NAA or its ammonium, potassium, or sodium salts can be used either early in the season for fruit
thinning or later in the season for control of fruit drop.
III. Summary of Human Health and Environmental Risk Assessments
The Agency's human health and environmental risk findings for the naphthalene acetate
pesticides are summarized in the Overview of Naphthaleneacetic Acid Its Salts, Ester, and
Acetamide Risk Assessments, revised February 1, 2007, which is located in Section VI of this
document. The findings contained in the Overview are hereby incorporated in this RED. A
complete list of supporting documents detailing EPA's human health and ecological risk findings
and conclusions for the naphthalene acetates are provided in Appendix C. These technical
support documents for the naphthalene acetates are available on the Internet at
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http://www.regulations.gov (docket # EPA-HQ-OPP-2006-0507) and in the Office of Pesticide
Program's (OPP) public docket for viewing. The OPP docket is located in Room S-4400, One
Potomac Yard (South Building); 2777 S. Crystal Drive, Arlington, VA, and is open Monday
through Friday, excluding legal holidays, from 8:30 AM to 4:00 PM.
A. Human Health Risk Assessment
For the purpose of the human health risk assessment, all forms of the naphthalene
acetates are combined (1-Naphthaleneacetic acid (NAA), its salts, ester, and acetamide) because
they are structurally related and are metabolized to the acid form and eliminated from the body
as glycine and glucuronic acid conjugates within 48 hours after exposure. The Agency
conducted a screening-level risk assessment for the naphthalene acetates in which high-end
assumptions were used for most key parameters. Analyses of dietary (food), drinking water,
residential and occupational exposure pathways were evaluated in the naphthalene acetates risk
assessment. An aggregate assessment of risk from the combined food and drinking water
pathways was also conducted.
The Agency has reviewed all toxicity studies submitted and has determined that the
toxicity database is essentially complete to support a reregi strati on eligibility determination for
all currently registered uses of the naphthalene acetates. The naphthalene acetates show low
acute toxicity, are not mutagenic, and are not expected to be carcinogenic. The most common
effect (acute or short-term) from high exposure to the naphthalene acetates is reduced body
weight gain. Chronic effects include: vomiting, stomach lesions, and slight sinusoidal
histiocytosis in the livers of males. EPA has not identified any metabolites (break down
substances) of toxicological concern. A summary of the toxicological endpoints selected and
other factors used in the human health risk assessment are provided in Table 2.
Table 2. Summary of Toxicological Endpoints and Other Factors Used in the Risk
Assessment of the Naphthalene Acetates
Exposure
Scenario
Dose
(mg/kg/day)
Endpoint
Study
Uncertainty
Factor
FQPA
Safety
Factor
PAD-
(mg/kg/day)
Dietary Risk Assessment
Acute
Dietary
all
populations
Chronic
Dietary
all
populations
NOAEL= 50
LOAEL = 250
NOAEL = 15
LOAEL = 75
decreased
body weight
gain during
gestation
period.
vomiting,
stomach and
liver effects
Rat
Developmental
Chronic Dog
100
100
IX
IX
0.5
0.15
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Exposure
Scenario
Dose
(mg/kg/day)
Endpoint
Study
Uncertainty
Factor
FQPA
Safety
Factor
PAD-
(mg/kg/day)
Occupational and Residential Risk Assessment
Dermal
Short-Term
(1-30
days)
Inhalation
Short-Term
(1-30
days)
NOAEL = 300
LOAEL = 1000
NOAEL = 50*
LOAEL = 150
reduced body
weight gain
and food
efficiency
decreased
body weight
gain during
gestation
period.
21 -day Dermal
Rat
Oral
Developmental
Rat
100
100
IX
N/A
N/A
N/A
NOAEL = No Observable Adverse Effects Level LOAEL - Lowest Observable Adverse Effects Level
PAD = Population Adjusted Dose
No intermediate-term (1-6 Months) or long-term (> 6 Months) dermal or inhalation exposure scenarios were
identified - therefore, toxicity endpoints were not selected.
* Inhalation NOAEL is based on an oral study with route adjustment (adjust from oral/ingestion to inhalation
route)
The Food Quality Protection Act Safety Factor (FQPA SF) was removed (reduced to IX)
for all population subgroups. In the toxicology database, there was no quantitative or qualitative
evidence of increased susceptibility in rat or rabbit fetuses following in utero exposure to
naphthalene acetates or to pre- and post-natal exposure in rat reproduction studies. The Agency
determined that this safety factor is adequate to protect infants and children because there are no
residual uncertainties in the exposure databases, the toxicology database is complete, and the
endpoint and NOAELs/LOAEL for risk assessment were well defined.
1. Dietary Risk From Food
Acute (one day) and chronic (lifetime) dietary naphthalene acetates exposure and risk
estimates resulting from food intake were determined for the general U.S. population and various
population subgroups using conservative assumptions and two different computer models
(DEEM-FCID™ and Lifeline) that use surveys of U.S. dietary consumption patterns. Based on
analyses of estimated dietary risks for the general U.S. population and various population
subgroups, the acute and chronic dietary exposure estimates for naphthalene acetates are
significantly below EPA's level of concern for all supported commodities and not a risk of
concern; therefore, no measures are necessary to mitigate dietary risk from food. No cancer
dietary exposure assessment was performed because carcinogenicity studies do not indicate a
carcinogenic concern.
2. Dietary Risk from Water
Dietary exposures from drinking water contaminated with concentrations of the
naphthalene acetates can potentially occur from sources of ground water and surface water in
areas where these pesticides are used. EPA calculated estimated drinking water concentrations
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(EDWCs) for the naphthalene acetates using screening-level computer models that provide high-
end estimates of pesticide concentrations for surface water and ground water sources. Based on
these models, all EDWCs are low and do not pose risks of concern; therefore, no measures are
necessary to mitigate dietary risk from drinking water.
3. Residential Risks
Residential uses are limited to application of naphthalene acetates to stimulate root
growth (root dips and soil drench) and application of the ethyl ester of naphthalene acetates to
control sprouts and sucker growth on fruit and ornamental trees. Both uses are considered short-
term (1 - 30 days) exposure scenarios. Estimated dermal and inhalation margins of exposure
(MOEs) for the most highly exposed scenario of residential exposure to the naphthalene acetates
are well above the target MOE of 100 and do not pose risks of concern; therefore, no measures
are necessary to mitigate risk from residential uses.
4. Aggregate Risk
The aggregate risk assessment integrates the assessments conducted for food and
drinking water, and residential exposure where appropriate. Since there is potential for
concurrent exposure via the food, drinking water and short-term residential exposure pathways,
the combined exposures are estimated. The acute and chronic aggregate risk assessments for
naphthalene acetates include exposure from food and drinking water only. Both acute and
chronic aggregate risks are not of concern; therefore, no measures are necessary to mitigate risk
from the aggregation of dietary (food and drinking water) exposures. Short-term aggregate risk
cannot be estimated for dietary and residential exposures, because the toxicity endpoints selected
for the dietary routes of exposure and those selected for residential exposures of the naphthalene
acetates are not based on common effects.
5. Occupational Handler and Post-Application Risks
Based on actively registered labels for the naphthalene acetates, EPA assessed 12
scenarios for the naphthalene acetates RED. For all handler scenarios evaluated, except one,
both dermal and inhalation MOEs for occupational handlers are above the target MOE of 100,
and are not of concern, using baseline personal protective equipment (PPE), which includes
long-sleeved shirt, long pants, shoes, and socks. In one scenario, mixer/loaders with baseline
equipment handling NAA for aerial application, the MOE is estimated to be 44, based on a
maximum application rate of 0.33 Ib ae/A for olive trees and assuming 500 acres are treated in a
day. However, based on a review of California's Department of Pesticide Regulations (CA
DPR) Pesticide Use Data on olive trees, the Agency believes this scenario greatly overestimates
the potential exposure risk to handlers. According to the California Olive Commission,
primarily the Manzillo (and occasionally Ascolano and Mission) variety olives grown in Tulare,
Madera, Kern, Fresno, Glenn, and Tehama counties in California require up to 0.33 Ib ae/A of
naphthalene acetates for crop thinning. CA DPR data on naphthalene acetate use on olive trees
shows for the period 1990 - 2004 (the most recent year available), a range of 15 - 60 applications
occurred on 250 - 1500 acres annually. Moreover, aerial application has only occurred in one
year (2003), and in that year the few days it did occur, treatments were made to less than 100
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acres/day. As a result, aerial applications to olive trees are expected to be made to much less
than the assumed 500 acres per day; thus, the estimated MOE is expected to be much greater
than 44 for these types of applications. For example, if 100 acres of olives per day were treated
aerially, the estimated MOE for mixer/loaders would be 220 at the maximum application rate.
At least 300 acres per day would need to be treated in order for the estimated MOE to be less
than 100, which does not appear likely given the available use data. Therefore, the Agency
believes all naphthalene acetate handler risks are not of concern and all handlers will only be
required to wear baseline PPE.
For individuals who can be exposed to pesticides after entering areas previously treated
with pesticides and performing certain activities (also often referred to as reentry exposure), two
occupational post-application scenarios were assessed for the naphthalene acetates. Post-
application exposures are based on dermal routes only, inhalation exposure is not expected. The
MOEs for the two post-application exposure scenarios are well above the target MOE of 100 on
the day of application and, therefore, not of risk concern. As a result no measures are necessary
to mitigate risk from occupational exposures.
B. Environmental Risk Assessment
1. Risk to Non-Target Species
Based on the limited data set available, EPA believes that the naphthalene acetates risks
are not of concern to non-target organisms, including mammals, birds, aquatic organisms, and
non-endangered, non-target plants. Risks to terrestrial insects cannot be quantified, but the
available data do not suggest a substantial potential for adverse effects. Therefore, no measures
are needed to mitigate risk to non-target species and non-endangered, non-target plants.
2. Endangered Species Assessment
For endangered species, the Agency adopts lower levels of concern (LOCs) for risks to
some groups - i.e., 0.1 for mammals and birds and 0.05 for aquatic animals - relative to LOCs
for acute risks in non-endangered species - i.e., 0.5 for mammals and birds as well as aquatic
animals. Based on the environmental risk assessment, the Agency's LOCs for endangered and
threatened species for mammals, birds, aquatic animals and plants are not exceeded for the
naphthalene acetates, except for endangered plants, based on use on olive trees at a rate of 0.33
Ib ae/A. Hence, the Agency concludes that the use of NAA, except on olive trees at a rate of
0.33 Ib ae/A, will have no effect on any endangered or threatened species or their critical habitat,
from the uses currently registered.
Through the Agency's screening-level ecological risk assessment, the potential for effects
to listed plants from the use of naphthalene acetates on olive trees has been refined to a very
small geographic area. However, a species specific assessment for that area has not been
completed. Until such time as that assessment is completed, the Agency cannot draw any
definitive conclusions regarding whether the naphthalene acetates have effects on listed plants
that may be in the vicinity of olive trees grown in Tulare, Madera, Kern, Fresno, Glenn, and
Tehama counties in California. Further, potential indirect effects to any species dependent upon
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a species that experiences effects from use of naphthalene acetates on olive trees cannot be
precluded based on the screening-level ecological risk assessment. These findings are based
solely on EPA's screening-level assessment and do not constitute "may effect" findings under
the Endangered Species Act.
C. Cumulative Risk
The estimated risks summarized in this document are those that result only from the use
of the naphthalene acetates. FQPA requires that the Agency consider "available information"
concerning the cumulative effects of a particular pesticide's residues and "other substances that
have a common mechanism of toxicity." The reason for consideration of other substances is due
to the possibility that low-level exposures to multiple chemical substances that cause a common
toxic effect by a common toxic mechanism could lead to the same adverse health effect as would
a higher level of exposure to any of the substances individually. Unlike other pesticides for
which EPA has followed a cumulative risk approach based on a common mechanism of toxicity,
EPA has not made a common mechanism of toxicity finding for the naphthalene acetates. They
do not appear to produce a toxic metabolite produced by other substances. Therefore, for the
purposes of the risk assessments, EPA has not assumed that the naphthalene acetates have a
common mechanism of toxicity with other substances. For information regarding EPA's efforts
to determine which chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see the policy statements released by the EPA's Office of
Pesticide Programs concerning common mechanism determinations and procedures for
cumulating effects from substances found to have a common mechanism on EPA's website at
http://www.epa.gov/pesticides/cumulative/.
D. Endocrine Disrupter Effects
EPA is required under the FFDCA, as amended by FQPA, to develop a screening
program to determine whether certain substances (including all pesticide active and other
ingredients) "may have an effect in humans that is similar to an effect produced by a naturally
occurring estrogen, or other such endocrine effects as the Administrator may designate."
Following the recommendations of its Endocrine Disrupter Screening and Testing Advisory
Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of
the program, the androgen and thyroid hormone systems, in addition to the estrogen hormone
system. EPA also adopted EDSTAC's recommendation that the Program include evaluations of
potential effects in wildlife. When the appropriate screening and/or testing protocols being
considered under the Agency's EDSP have been developed and vetted, the naphthalene acetates
may be subjected to additional screening and/or testing to better characterize effects related to
endocrine disruption.
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E. Tolerance Summary
The Agency has determined that the terminal residues of concern in plants, resulting from
currently registered food/feed uses, are the parent compound, NAA and its conjugates. There are
several tolerance expressions for naphthalene acetates resulting from applications of NAA, its
salts, ester, and acetamide. Currently, the tolerances listed under 40 CFR §180.155 (a) are for
residues of 1-naphthaleneacetic acid. The tolerances listed under 40 CFR §180.155 (b) are for
residues of the ethyl ester of 1-naphthaleneacetic acid. The tolerances listed under 40 CFR
§180.309 are for residues of a-naphthaleneacetamide and its metabolite a-naphthaleneacetic acid
(calculated as a-naphthaleneacetic acid). According to 40 CFR §180.3(d)(7), for commodities
having both NAA and NAA metabolite tolerances, the total amount of residues, calculated as
NAA, shall not exceed the higher of the two tolerances.
EPA is now recommending that various NAA tolerance expressions under 40 CFR §180
be combined in §180.155(a). In 40 CFR §180.155, the Agency is recodifying paragraph (b) and
the table under it from (b) to (a). Also, to conform to current Agency practice, paragraphs (b),
(c), and (d) should be established and reserved as follows:
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
Consequently, 40 CFR §180.309 will be removed because that specific tolerance
expression is no longer needed since it is included in the recodified paragraph (a).
Available olive residue data using application rates representative of the use pattern in a
region where the naphthalene acetate products are commonly used, show residues of NAA range
from 0.306 to 0.604 ppm, which is above the current tolerance level of 0.1 ppm. Therefore, the
Agency is recommending that the tolerance on olive for combined residues of 1-
naphthaleneacetic acid, its ammonium, sodium, and potassium salts, ethyl ester, and acetamide
should be increased to 0.7 ppm in 40 CFR §180.155(a).
At this time, the Agency has tentatively determined that NAA is a Category 3 pesticide
(i.e., no reasonable expectations of finite residues of concern in meat and milk). This tentative
conclusion is reserved pending submission of the required citrus processing study and a
determination of the residues in the processed commodities of citrus fruits. When the requested
processing data are submitted, the Agency will re-evaluate NAA's Category 3 determination and,
if necessary, recalculate the estimated dietary burden for ruminants. There are no poultry feed
items associated with the currently registered food/feed uses of naphthalene acetates.
The reassessed tolerance for sweet cherry is contingent upon revising existing labels to
specify a 30-day pre-harvest interval. EPA is also recommending that the naphthalene acetate
tolerances currently established for apple, pear and quince be reassigned to fruit, pome; and the
tolerance level be lowered to 0.1 ppm because residue levels from field trial data never exceeded
0.06 ppm. A summary of the tolerance reassessments and the changes to occur under 40 CFR
§180.155 for the naphthalene acetates is presented in Table 3.
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Table 3.
Tolerance Reassessment Summary for Naphthalene Acetates.
Commodity
Current
Tolerance
(ppm)
Tolerance
Reassessment
(ppm)
Comment/
[Correct Commodity Definition]
Tolerances Listed Under 40 CFR §180.155 (a)
Apple
Cherry, sweet
Olive
Oranges, sweet
Pear
Pineapple (from
application of sodium
salt to growing crop)
Quince
Tangerine
1
0.1
0.1
0.1
1
0.05
1
0.1
Reassign
0.1
0.1
0.7
0.1
Reassign
0.1
0.05
Reassign
0.1
0.1
Crop group tolerance is being established at 0. 1 ppm based on
field trial data that indicate a range of O.02 (nondetectable) to
0.06 ppm residues for NAA-OEt, NAAm, and NAA-potassium
salt, [fruit, pome, group 1 1]
Residues of NAA in/on whole cherries were each
nondetectable (<0.04 ppm) in/on treated samples collected at 2
hours, 15 days, and 30 days post-treatment.
Residues of NAA ranged from 0.306 to 0.610 ppm in/on olives
harvested 102-112 days following the last of two sequential
treatments.
The maximum expected residue of NAA resulting from
registered uses on oranges is 0.05 ppm. [Orange]
Crop group tolerance is being established at 0. 1 ppm based on
field trial data that indicate a range of O.02 (nondetectable) to
0.06 ppm residues for NAA-OEt, NAAm, and NAA-potassium
salt, [fruit, pome, group 11]
Registrant is supporting tolerance for importation purposes
only.
Crop group tolerance is being established at 0. 1 ppm based on
field trial data that indicate a range of O.02 (nondetectable) to
0.06 ppm residues for NAA-OEt, NAAm, and NAA-potassium
salt, [fruit, pome, group 11]
The residue data that were submitted by IR-4 for tangerine and
in combination with orange, through PP#7E1956, are adequate
to support reregistration requirements.
Tolerances Currently Listed Under 40 CFR §180.155 (b)
** all tolerances in this section are to be reassigned to 40 CFR § 180. 155 (a) **
Apple
Pear
Olive
Reassign
0.1
Reassign
0.1
Reassign
0.7
See Comments for apple above under 40 CFR §180.155 (a).
[fruit, pome, group 11]
See Comments for pear above under 40 CFR §180.155 (a).
[fruit, pome, group 11]
See Comments for olive above under 40 CFR §180.155 (a).
Tolerances Currently Listed Under 40 CFR §180.309
** all tolerances in this section are to be reassigned to 40 CFR §180. 155 (a) **
Apple
Pear
„ 1 Reassign
0.1
Q j Reassign
0.1
See Comments for apple and pear above under 40 CFR
§180.155 (a), [fruit, pome, group 11]
10
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Codex/International Harmonization
No maximum residue limits (MRLs) for NAA, its salts, ester, and acetamide have been
established in the Codex Alimentarius, the food code established by the UN's World Health
Organization and the Food and Agriculture Organization; therefore, issues of compatibility
between Codex MRLs and U.S. tolerances do not exist. Moreover, no Canadian or Mexican
MRLs have been established for naphthalene acetates. For more information on Codex see
http ://www. codexalimentarius .net/standard_li st. asp.
IV. Confirmatory Generic Data Requirements
The generic database supporting the reregi strati on of the naphthalene acetates is
substantially complete, except for the following additional required confirmatory data:
- UV/Visible Absorption (OPPTS 830.7050)
Storage stability data on the processed commodities of apples (or citrus fruits) and olives.
(OPPTS 860.1380)
- Data depicting residues of NAA and its conjugates in the processed commodities of citrus
(dried pulp, oil, and juice). (OPPTS 860.1520)
The replenishment of analytical reference standards for all registered NAA acid salts,
ester, and acetamide as requested by the Repository. (OPPTS 860.1650)
V. Label Changes:
In order to be eligible for reregi strati on, all product labels are to be amended to
incorporate measures outlined in this RED document. Furthermore, many of the existing labels
for the naphthalene acetates need to be revised to provide clear use directions. EPA, through
discussions with the registrant, user groups, and USD A, determined the following maximum use
pattern information are to be clearly stated on naphthalene acetates product labels. Table 4
describes how language on the labels should be amended.
- Maximum single application rate: 0.11 Ib ae/acre
0.33 Ib ae/acre (olive trees only)
- Maximum application rate for all uses
per year or crop cycle: 0.33 Ib ae/acre/year or crop cycle
- Minimum re-treatment interval between applications: 5 days
- Restricted Entry Interval (REI): 48 hours for NAA; NAA Potassium
Salt; NAA Ammonium Salt; NAA
Sodium Salt; and NAA Acetamide
12 hours for NAA Ethyl Ester
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Table 4: Summary of Labeling Changes for Naphthalene Acetates
DESCRIPTION
AMENDED LABELING LANGUAGE
PLACEMENT ON
LABEL
Manufacturing Use Products
For all Manufacturing Use
Products
"Only for formulation into plant growth regulators for the following use(s) [fill blank only with
those uses that are being supported byMP registrant]"
Directions for Use
One of these statements may be
added to a label to allow
reformulation of the product for
a specific use or all additional
uses supported by a formulator
or user group
"This product may be used to formulate products for specific use(s) not listed on the MP label
if the formulator, user group, or grower has complied with U.S. EPA submission requirements
regarding support of such use(s)."
"This product may be used to formulate products for any additional use(s) not listed on the MP
label if the formulator, user group, or grower has complied with U.S. EPA submission
requirements regarding support of such use(s)."
Directions for Use
Environmental Hazards
Statements Required by the
RED and Agency Label Policies
"Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans,
or other waters unless in accordance with the requirements of a National Pollution Discharge
Elimination System (NPDES) permit and the permitting authority has been notified in writing
prior to discharge. Do not discharge effluent containing this product to sewer systems without
previously notifying the local sewage treatment plant authority. For guidance contact your
State Water Board or Regional Office of the EPA."
Precautionary
Statements
End Use Products Intended for Occupational Use
PPE Requirements Established
by the RED1 for All
Formulations
"Personal Protective Equipment (PPE)"
"All mixers, loaders, applicators, flaggers, and other handlers must wear:
Long-sleeved shirt and long pants,
Shoes plus socks."
Immediately
following^elow
Precautionary
Statements: Hazards to
Humans and Domestic
Animals
User Safety Requirements
"Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for
washables exist, use detergent and hot water. Keep and wash PPE separately from other
laundry."
Precautionary
Statements: Hazards to
Humans and Domestic
Animals immediately
following the PPE
requirements
12
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Table 4: Summary of Labeling Changes for Naphthalene Acetates
DESCRIPTION
AMENDED LABELING LANGUAGE
PLACEMENT ON
LABEL
End Use Products Intended for Occupational Use
User Safety Recommendations
"User Safety Recommendations
Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the
toilet.
Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly
and put on clean clothing.
Users should remove PPE immediately after handling this product. As soon as possible, wash
thoroughly and change into clean clothing."
Precautionary
Statements under:
Hazards to Humans and
Domestic Animals
immediately following
Engineering Controls
(Must be placed in a
box.)
Environmental Hazards
"For terrestrial uses: Do not apply directly to water, or to areas where surface water is present
or to intertidal areas below the mean high water mark. Do not contaminate water when
disposing of equipment washwater or rinsate."
Precautionary
Statements
immediately following
the User Safety
Recommendations
Restricted-Entry Interval for
Products Formulated with any of
the Following Active
Ingredients:
NAA
NAA Potassium Salt
NAA Ammonium Salt
NAA Sodium Salt
NAA Acetamide
"Do not enter or allow worker entry into treated areas during the restricted entry interval (REI)
of 48 hours."
Directions for Use,
Under Agricultural Use
Requirements Box
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Table 4: Summary of Labeling Changes for Naphthalene Acetates
DESCRIPTION
AMENDED LABELING LANGUAGE
PLACEMENT ON
LABEL
End Use Products Intended for Occupational Use
Early Entry Personal Protective
Equipment established by the
RED for the Following Active
Ingredients:
NAA
NAA Potassium Salt
NAA Ammonium Salt
NAA Sodium Salt
NAA Acetamide.
"PPE required for early entry to treated areas that is permitted under the Worker Protection
Standard and that involves contact with anything that has been treated, such as plants, soil, or
water, is:
* coveralls,
* shoes plus socks,
* chemical-resistant gloves made of any waterproof material,
* protective eyewear"
Direction for Use
Agricultural Use
Requirements box
Restricted-Entry Interval for
Products Formulated with
NAA Ethyl Ester
"Do not enter or allow worker entry into treated areas during the restricted entry interval (REI)
of 12 hours."
(Products containing NAA Ethyl Ester may be eligible for a 4 hour REI. Registrants are
required to submit the required certification statement to the Agency and formally request the
4-hour REI as specified in PR Notice 95-3.)
Directions for Use,
Under Agricultural Use
Requirements Box
Early Entry Personal Protective
Equipment established by the
RED for NAA Ethyl Ester
"PPE required for early entry to treated areas that is permitted under the Worker Protection
Standard and that involves contact with anything that has been treated, such as plants, soil, or
water, is:
* coveralls,
* shoes plus socks
* chemical-resistant gloves made of any waterproof material"
General Application Restrictions
"Do not apply this product in a way that will contact workers or other persons, either directly or
through drift. Only protected handlers may be in the area during application."
Place in the Direction
for Use directly above
the Agricultural Use
Box.
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Table 4: Summary of Labeling Changes for Naphthalene Acetates
DESCRIPTION
AMENDED LABELING LANGUAGE
PLACEMENT ON
LABEL
End Use Products Intended for Occupational Use
Other Application Restrictions
(Risk Mitigation)
"For broadcast use, the maximum application rate is 0.11 pound active ingredient per acre of
NAA equivalent for all uses, except olive trees which may use up to 0.33 pound active
ingredient per acre of NAA equivalent. [Registrant: state the maximum use rate as a maximum
rate of pounds or gallons of formulation per acre equivalent to 0.11 (or 0.33 for olive trees)
pound active ingredient per acre or less.]"
"The maximum application rate per year or crop cycle is not to exceed 0.33 pound active
ingredient per acre of NAA equivalent. [Registrant: state the maximum rate per year or crop
cycle as a maximum rate of pounds or gallons of formulation per acre equivalent to 0.33 pound
active ingredient per year or crop cycle or less.]"
"The minimum interval between applications is to be no less than 5 days."
Directions for Use
Spray Drift
"SPRAY DRIFT MANAGEMENT"
"A variety of factors including weather conditions (e.g., wind direction, wind speed,
temperature, relative humidity) and method of application (e.g., ground, aerial, airblast) can
influence pesticide drift. The applicator and grower must evaluate all factors and make
appropriate adjustments when applying this product."
Wind speed restriction:
"Do not apply when wind speeds are greater than 10 mph at the application site."
Specific language for orchard air blast:
"Sprays must be directed into the crop canopy."
"Outward pointing nozzles should be turned off at row ends and when spraying outer rows."
"For ground based applications and aerial applications, use only medium or courser spray
droplets (or nozzles) according to ASABE (S572) definition for standard nozzles."
Directions for Use
15
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Table 4: Summary of Labeling Changes for Naphthalene Acetates
DESCRIPTION
AMENDED LABELING LANGUAGE
PLACEMENT ON
LABEL
End Use Products Intended for Residential Use
Application Restrictions
Entry Restrictions
Environmental Hazards
"Do not apply this product in a way that will contact any person, or pet, either directly or
through drift. Keep people and pets out of the area during application."
Liquid:
"Do not allow people or pets to enter the treated area until sprays have dried."
"Do not apply directly to water. Do not contaminate water when disposing of equipment
washwaters or rinsate."
Directions for Use
under General
Precautions and
Restrictions
Directions for use
under General
Precautions and
Restrictions
1 PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document.
The more protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7.
16
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VI. Overview
The following Overview of Naphthaleneacetic Acid Its Salts, Ester, and Acetamide Risk
Assessments provides further details on the human health and environmental risk assessments
and conclusions.
Overview 17 NAA RED Amendment
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Overview of Naphthaleneacetic Acid,
Its Salts, Ester, and Acetamide
Risk Assessments
Revised October 16, 2007
Introduction
This section summarizes the Environmental Protection Agency's (EPA or the Agency)
human health risk and environmental assessments and conclusions for the chemicals collectively
referred to as the naphthalene acetates1. The naphthalene acetates are plant growth regulators
currently registered for use on various orchard and fruit crops and on ornamental trees.
Naphthalene acetates are used to stimulate growth, delay flower induction and leaf drop, prevent
preharvest fruit drop, thin fruit, and control sprout formation.
The purpose of this overview is to assist the reader by identifying the key features and
findings of the risk assessments, and to allow the reader to better understand the conclusions
reached in the assessments and in the Reregi strati on Eligibility Decision (RED). The Agency
developed this overview format in response to comments and requests from the public which
indicated that the risk assessments were difficult to understand, that they were too lengthy, and
that it was not easy to compare the assessments for different chemicals due to differing formats.
The Agency now has adequate information to make eligibility decisions for all of the
naphthalene acetate products. EPA has reviewed the data provided by the naphthalene acetates
registrant and data available in the public literature. Using this information, EPA has conducted
assessments of the human health and environmental risks for the labeled use of the naphthalene
acetate products. These assessments and all their supporting technical documents are posted on
the Internet (http://www.regulations.gov) under docket number EPA-HQ-OPP-2006-0507.
The estimated risks summarized in this section are those that result only from the use of
the naphthalene acetates. The Food Quality Protection Act (FQPA) requires that the Agency
consider "available information" concerning the cumulative effects of a particular pesticide's
residues and "other substances that have a common mechanism of toxicity." The reason for
consideration of other substances is due to the possibility that low-level exposures to multiple
chemical substances that cause a common toxic effect by a common toxic mechanism could lead
to the same adverse health effect as would a higher level of exposure to any of the substances
individually. Unlike other pesticides for which EPA has followed a cumulative risk approach
based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity
finding for the naphthalene acetates. They do not appear to produce a toxic metabolite produced
Naphthalene acetates include: 1-Naphthaleneacetamide, 1-Naphthalene acetic acid, Potassium 1-
naphthaleneacetate, Ammonium 1-naphthaleneacetate, Sodium 1-naphthaleneacetate, Ethyl 1-naphthaleneacetate
Overview 18 NAA RED Amendment
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by other substances. For the purposes of the risk assessments, therefore, EPA has not assumed
that the naphthalene acetates have a common mechanism of toxicity with other substances. For
information regarding EPA's efforts to determine which chemicals have a common mechanism
of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements
released by the EPA's Office of Pesticide Programs concerning common mechanism
determinations and procedures for cumulating effects from substances found to have a common
mechanism on EPA's website at http://www.epa.gov/pesticides/cumulative/.
Use Profile
The naphthalene acetates are plant growth regulators. The plant growth regulating
activity of the naphthalene acetates is due to their structural similarity to the auxin, indole acetic
acid (IAA), the most common, naturally occurring plant growth hormone. Auxins promote
growth in excised plant organs, induce adventitious roots, inhibits axillary bud growth, and
regulates gravitropism. Naphthalene acetates are used to stimulate growth, delay flower
induction and leaf drop, prevent preharvest fruit drop, thin fruit, and control sprout formation and
sucker growth.
Technical Registrant: AMVAC Chemical Company
Use Sites and Use Related Information:
• Approximately 20,000 Ibs of the naphthalene acetate active ingredients are applied annually
in the U.S.
• The naphthalene acetates are registered for use on apples, pears, citrus (mandarin, oranges,
tangelos, tangerines, and non-bearing), olives, cherries, some non-bearing fruit and nut trees,
ornamental plants (herbaceous, non-flowering trees, woody shrubs and vines) and shade
trees. They also have residential uses to stimulate root growth (root dips and soil drench) and
to control sprouts and sucker growth on fruit and ornamental trees.
• Apples and pears represent approximately 95% of the total active ingredient used annually
with all other registered use sites accounting for the remaining use.
Formulations:
• Thirty-Eight active products are currently registered for the naphthalene acetates with 12
Special Local Need registrations (FIFRA §24(c)) in California, Oregon and Washington.
• Current registered products include the following formulations: dust (0.2% active ingredient
or a.i.), emulsifiable concentrate (6.25-15.1% a.i.), wettable powder (7.1-8.4% a.i.), soluble
Overview 19 NAA RED Amendment
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concentrate/liquid (0.1-24.2% a.i.), ready-to-use (0.08-1.15% a.i.), flowable concentrate
(0.45-1.2% a.i.), and pressurized liquid (1% a.i.)
Application Methods and Equipment:
• Thinning and stop drop formulations - ground spray or aerial equipment.
• Sprout/sucker formation control - hand held sprayer and paint brush.
• Root growth stimulant - dilute root dip or soil drench.
Rates of Application:
• The maximum application rate is 0.33 pound of acid equivalent per acre (Ib ae/A) for olive
trees and 0.11 Ib ae/A for all other uses. The maximum annual application rate is 0.33 Ib
ae/A for all use sites.
Human Health Risk Assessment
Dietary Risk from Food
Acute and chronic dietary exposure assessments were conducted for all supported
naphthalene acetates food uses using both Dietary Exposure Evaluation Model software with the
Food Commodity Intake Database (DEEM-FCID™, Version 1.3) and Lifeline Model (Version 2)
software. The acute and chronic dietary (food) risk analyses were conducted using tolerance
values and assuming 100% crop treated (Tier 1). The acute and chronic dietary exposure and
risk estimates resulting from intake of food with residues of the naphthalene acetates were
determined for the general U.S. population and various population subgroups. No cancer dietary
exposure assessment was performed because carcinogenicity studies do not indicate a
carcinogenic concern. For detailed information on the dietary risk assessment see the Health
Effects Division's (FLED) November 20, 2003 Naphthalene Acetates Acute and Chronic Dietary
Exposure Assessment and the March 30, 2004 Naphthalene Acetates HED Risk Assessment.
The assessment concludes that, for all supported commodities, the acute and chronic
dietary exposure estimates are well below EPA's level of concern. Naphthalene acetate risks
from food consumption are summarized in Table 1 for the general U.S. population and various
population subgroups. Risks less than 100% of the Population Adjusted Dose (PAD), either
acute (aPAD) or chronic (cPAD), are not of concern to the Agency. The aPAD is the dose at
which a person could be exposed on any given day and no adverse health effects would be
expected. The cPAD is the dose at which an individual could be exposed over the course of a
lifetime and no adverse health effects would be expected.
Overview 20 NAA RED Amendment
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Table 1. Estimated Acute and Chronic Dietary Exposures and Risks-Naphthalene Acetates
Population Subgroup
U.S. Population
All Infants (< 1 yr old)
Children (1 -2 yrs)
Acute
(95th %-ile)
aPAD
(mg/kg/day)
0.5
0.5
0.5
Exposure
(mg/kg/day)
0.007763
0.039407
0.048857
%
aPAD
2
8
10
Chronic
(average exposure)
cPAD
(mg/kg/day)
0.15
0.15
0.15
Exposure
(mg/kg/day)
0.001689
0.008784
0.012100
%
cPAD
1
6
8
Acute Dietary Risk from Food
For acute dietary exposure and risk assessments, individual one-day food consumption
data are used on an individual-by-individual basis.
• The acute dietary exposure/risk analysis for all supported naphthalene acetate food uses were
conducted using conservative Tier 1 exposure assessments. Tier 1 analyses assume tolerance
level residues for all registered uses, 100% crop treated for all commodities with existing
tolerances, and default processing factors. Acute dietary risk was then calculated by
comparing dietary exposure to the aPAD.
• As shown in Table 1, risk estimates for all commodities are less than 100% of the aPAD for
all subpopulations when considering the 95th percentile of exposure. The highest exposed
subpopulation (children 1-2 years) is at 10% of the aPAD, and the general population is at
2% of the aPAD.
• EPA calculated the aPAD and acute dietary risk levels for the naphthalene acetates using the
following data:
- The toxicity endpoint selected for acute dietary food exposure is based on a
developmental study in rats with a No Observed Adverse Effect Level (NOAEL) of 50
mg/kg/day. Decreased body weight gain with no increase in resorptions during the
gestation period was observed at a Lowest Observed Adverse Effect Level (LOAEL) of
250 mg/kg/day.
The uncertainty factor (UF) is 100 for acute dietary risk, based on a 10X for standard
uncertainties in applying animal studies to humans (interspecies extrapolation) and a 10X
for varying effects among individuals (intraspecies variability).
The acute reference dose (acute RfD) is 0.5 mg/kg/day, calculated by dividing the
NOAEL (50 mg/kg/day) by the UF (100).
- The Food Quality Protection Act Safety Factor (FQPA SF) was removed (reduced to IX)
for all population subgroups. In the toxicology database, there was no quantitative or
Overview
21
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qualitative evidence of increased susceptibility in rat or rabbit fetuses following in utero
exposure to naphthalene acetates or to pre- and post-natal exposure in rat reproduction
studies. The Agency determined that this safety factor is adequate to protect infants and
children because there are no residual uncertainties in the exposure databases, the
toxicology database is complete, and the endpoint and NOAELs/LOAEL for risk
assessment were well defined.
- The aPAD is 0.5 mg/kg/day, and is calculated by dividing the acute RfD (0.5 mg/kg/day)
by the FQPA SF. Since the FQPA SF is IX, the aPAD and the acute RfD are identical.
- The acute dietary exposure analysis is based on the DEEM-FCID™, which uses exposure
and consumption data to calculate risk as a percentage of the PAD. The DEEM-FCID™
analysis evaluated individual food consumption as reported by respondents in the USDA
1994-1996 and 1998 Continuing Surveys of Food Intake by Individuals (CSFII). For
acute dietary risk assessments, the entire distribution of consumption events for
individuals is multiplied by a randomly selected distribution of residues (probabilistic
analysis, referred to as "Monte Carlo") to obtain a distribution of exposures.
- Acute dietary (food) risk was also estimated using the Lifeline model (Version 2.0). The
Lifeline model estimated acute exposure based on the acute 1-day dietary dose drawn
randomly from an age-specific seasonal profile of 1000 individuals. Results of the acute
dietary (food) Lifeline analysis are fully consistent with the DEEM-FCID results.
Chronic Dietary Risk from Food
Chronic dietary risk from food is calculated by using the average consumption value for
foods and average residue values on those foods over a 70-year lifetime. As previously shown in
Table 1, chronic dietary exposure for the naphthalene acetates in all populations subgroups is
equal to or less than 8% of the cPAD, and therefore not of concern to the Agency.
• The chronic dietary exposure/risk analysis for all supported naphthalene acetates food uses
were conducted using conservative Tier 1 exposure assessments: assuming tolerance level
residues for all registered uses, 100% crop treated for all commodities, and default
processing factors. Chronic dietary risk was then calculated by comparing dietary exposure
to the cPAD.
• EPA calculated the cPAD and dietary risk levels for the naphthalene acetates using the
following data:
- The toxicity endpoint selected for chronic dietary food exposure is based on a one-year
oral feeding study in dogs. The NOAEL was 15 mg/kg/day and a LOAEL of
75 mg/kg/day was based on stomach lesions and slight sinusoidal histiocytosis in the
livers of males.
Overview 22 NAA RED Amendment
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The uncertainty factor (UF) is 100, based on a 10X for standard uncertainties in applying
animal studies to humans (interspecies extrapolation) and a 10X for varying effects
among individuals (intraspecies variability).
The chronic reference dose (chronic RfD) is 0.15 mg/kg/day, calculated by dividing the
NOAEL (15 mg/kg/day) by the UF (100).
- The FQPA SF was removed (reduced to IX) for all population subgroups, as discussed in
the acute dietary section.
The cPAD is 0.15 mg/kg/day, and is calculated by dividing the chronic RfD
(0.15 mg/kg/day) by the FQPA SF. Because the FQPA SF is IX, the cPAD and the
chronic RfD are identical.
- The chronic dietary exposure analysis is also based on the DEEM-FCID™, as discussed
in the acute dietary section. For chronic dietary risk assessments, a 3-day average
consumption for each subpopulation is combined with average residues in commodities
to determine average exposures.
Dietary Risk from Drinking Water
Information on the determination of Estimated Drinking Water Concentrations (EDWCs)
may be found in the November 20, 2003, Naphthalene Acetates Acute and Chronic Dietary
Exposure Assessment; the March 30, 2004 Naphthalene Acetates HED Risk Assessment; and in
the Environmental Fate and Effects Division's (EFED) October 26, 2004, RevisedEFED Risk
Assessment for the Naphthaleneacetic Acid Reregistration Eligibility Decision: Revision Based
on Application at Higher Use Rates.
Drinking water exposure to pesticides can occur through surface and ground water
contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks
and uses either modeling or actual monitoring data, if available and of sufficient quality, to
estimate those risks. However, for the naphthalene acetates water monitoring data are not
available.
This section describes the EDWCs of the naphthalene acetates in drinking water. Output
values from computer modeling (FIRST and SCIGROW) are based on use of 1-naphthalenacetic
acid on olive trees, which represents the highest use rate scenario and results in the highest
potential environmental loading. Risks from exposure to these concentrations are discussed later
in the section titled "Aggregate Exposure and Risk."
• In the environment, the sodium, potassium, and ammonium salts, amide, and ester of NAA
are expected to rapidly degrade to the acid in the environment. Therefore, 1-
naphthalenacetic acid is the only residue of concern in drinking water.
Overview 23 NAA RED Amendment
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• The Agency calculated screening-level EDWCs (high-end estimates) for the naphthalene
acetates using computer modeling for both surface (FIRST) and ground water (SCIGROW)
sources. Both models provide estimates suitable for screening purposes. Table 2 presents
the modeled concentrations for 1-naphthalenacetic acid.
• For the purpose of estimating risks from surface water sources, EPA uses the 1 in 10 year
annual peak concentration of 1-naphthalenacetic acid generated by FIRST for acute
exposures. For evaluating reasonable worst case chronic concerns, the estimated 1 in 10 year
annual mean concentration of 1-naphthalenacetic acid in drinking water is used.
• For estimating both acute and chronic drinking water risks from ground water sources, EPA
uses the acute EDWC because NAA in ground water is assumed to be more stable than when
in surface water and less likely to exhibit different concentrations over time.
Table 2. Modeled 1-Naphthaleneacetic Acid EDWCs - Surface and Ground Water Sources
Drinking Water Source
Surface Water (FIRST)
Ground Water (SCIGROW)
Acute Peak (ppb)
17.8
0.001
Chronic Annual Average (ppb)
0.98
N/A
Residential Exposure and Risk
Residential uses of the naphthalene acetates are limited to applications to stimulate root
growth (dips and soil drench) of ornamentals, and spray applications to control sprouts and
sucker growth on fruit and ornamental trees. Only the spray application of naphthalene acetates
to control sprout and sucker growth was evaluated for the residential exposure assessment.
Residential exposures from root dip applications are expected to be significantly less than spray
applications for sucker growth because of the low concentration of NAA in root dip and soil
drench products, and the very short exposure duration and limited area of exposure associated
with use of these products. Further, only short-term exposures (<30 days) are expected for
residential applications of the naphthalene acetates. Post-application exposure to homeowners
reentering and children playing in treated areas is expected to be negligible based on the use
patterns and were, therefore, not assessed. For detailed information on the residential risk
assessment, see the March 10, 2004 Naphthalene Acetates Occupational and Residential
Exposure Assessment and the March 30, 2004 Naphthalene Acetates HED Risk Assessment.
To estimate residential risks, the Agency calculates a margin of exposure (MOE), which
is the ratio of the NOAEL selected for risk assessment to the estimated exposure. This MOE is
compared to a level of concern which is the same value as the uncertainty factor (UF) applied to
a particular toxicity study. The standard UF is 100X (10X to account for interspecies
extrapolation and 10X for intraspecies variation), plus any additional safety factor retained due to
concerns unique to the protection of infants and children under FQPA. A MOE less than the
target MOE, or level of concern (LOG), is generally a risk concern to the Agency.
Overview 24 NAA RED Amendment
-------
Residential handlers can be exposed to the naphthalene acetates by mixing, loading, or
applying products containing this active ingredient. Exposure assumptions for residential
handler included maximum label application rate for an aerosol spray application, application of
the entire contents (one quart) of the sprout inhibitor formulation available for residential use,
and no protective clothing. Estimated dermal and inhalation margins of exposure (MOEs) for
this residential exposure scenario to the naphthalene acetates are 3,800 and 58,000, respectively.
The combined MOE is 3,600. These MOEs are well above the target MOE of 100 and not of
risk concern.
Toxicity Summary
• Short-term dermal risk assessments for the naphthalene acetates are based on a 21-day
dermal toxicity study with a systemic NOAEL of 300 mg/kg/day, based on reduced body
weight gain and food efficiency at the LOAEL of 1000 mg/kg/day.
• Short-term inhalation risk assessments for the naphthalene acetates are based on an oral route
development study with a NOAEL of 50 mg/kg/day, based on decreased body weight gain
during gestation at the LOAEL of 150 mg/kg/day.
• Intermediate and long-term dermal and inhalation exposures from the use of naphthalene
acetates are not expected, since they are used only during growing seasons.
• The FQPA SF has been reduced to IX for the reasons explained above in the dietary section.
Therefore, the target MOE from dermal and inhalation exposures is 100.
Table3. Acute Toxicity Data of NAA
Guideline
No.
870.1100
Acute Oral
870.1200
Acute
Dermal
870.1300
Acute
Inhalation
870.2400
Primary Eye
Irritation
870.2500
Primary Skin
Irritation
Test Chemical
NAA
NAA acetamide
NAA Na Salt
NAA Ethyl Ester
NAA
NAA acetamide
NAA Na Salt
NAA Ethyl Ester
NAA
NAA acetamide
NAA Na Salt
NAA Ethyl Ester
NAA
NAA acetamide
NAA acetamide
NAA Na Salt
NAA Ethyl Ester
NAA
NAA acetamide
NAA Na Salt
NAA Ethyl Ester
MRID #(s)
00103128
43495901
00108829
43494101
00103129
43495902
00108829
43494102
43495903
43494103
00103127
00103051
43495904
00108829
43494104
00103127
00108829
00103053
Results
LD50 = 2520 mg/kg
LD50 = >5000 mg/kg
LD50 = 933-1 350 mg/kg
LD50 = 2186mg/kg
LD50 = > 2000 mg/kg
LD50 = > 2000 mg/kg
LD50 = > 2000 mg/kg
LD50 = > 2000 mg/kg
LC50 = >2.17mg/L
LC50 = >2.13mg/L
corrosive
corrosive
minimally irritating
corrosive
minimally irritating
not a skin irritant
not a skin irritant
not a skin irritant
Toxicity Category
III
IV
III
III
III
III
III
III
IV
IV
I
I
IV
I
IV
IV
IV
IV
Overview
25
NAA RED Amendment
-------
Guideline
No.
870.2600
Dermal
Sensitization
Test Chemical
NAA
NAA acetamide
NAA Na Salt
NAA Ethyl Ester
MRID #(s)
00153217
43495905
43494105
Results
not a skin sensitizer
not a skin sensitizer
not a skin sensitizer
Toxicity Category
NA
NA
NA
Aggregate Exposure and Risk
An aggregate risk assessment evaluates the combined risk from dietary exposure to
residues in food and drinking water and, if applicable, residential exposure to homeowners. For
aggregate risk, EPA typically considers combined exposures from food and residential sources
and calculates a drinking water level of comparison (DWLOC), which represents the maximum
allowable exposure through drinking water after considering food and residential exposures. If
the estimated drinking water concentrations (EDWCs) in water are less than the DWLOCs, EPA
does not have concern for aggregate exposure. If EDWCs are greater than DWLOCs, EPA will
conduct further analysis to characterize the potential for aggregate risk of concern.
While there is potential for concurrent naphthalene acetate exposure via the food, water,
and short-term residential exposure pathways, short-term aggregate risk cannot be estimated for
naphthalene acetates because the toxicity endpoints selected for the different exposure pathways
are not based on common effects. The toxicity endpoint for chronic dietary and the drinking
water routes of exposure are based on systemic effects, while those selected for residential
exposures (inhalation and dermal) are based on decreased body weight gain. Therefore, the
aggregate exposure assessment for the naphthalene acetates considers only food and drinking
water exposures.
Acute and chronic DWLOCs were calculated based on the dietary exposure estimates,
default body weights and water consumption figures, and are shown in Table 4. Peak (acute) and
average (chronic) modeled EDWCs for both surface water and groundwater are significantly
below the acute and chronic DWLOCs for all population subgroups. Hence, aggregate exposure
to naphthalene acetates in food and water do not present risks of concern.
Table 4. Naphthalene Acetates Drinking Water Levels of Comparison (DWLOC) and
Estimated Drinking Water Concentrations (EDWCs)
Acute Risk
Chronic Risk
Population
Subgroup
All
All
DWLOC (ppb)
>3000
>1400
Surface Water
Cone, (ppb)
17.8
0.98
Ground Water
Cone, (ppb)
0.001
0.001
Overview
26
NAA RED Amendment
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Occupational Risk
Workers can be exposed by mixing, loading, or applying (handlers) naphthalene acetates
or by entering a previously treated site (post-application). Worker risk is also measured as a
MOE, which determines how closely the occupational exposure comes to a NOAEL. For
detailed information on the occupational risk assessment, see the March 10, 2004 Naphthalene
Acetates Occupational and Residential Exposure Assessment; March 30, 2004 Naphthalene
Acetates HED Risk Assessment; and July 13, 2004 Naphthalene Acetates HED Risk Assessment
for Reregistration Eligibility Document (RED); Revised Assessment of Use of Naphthalene
Acetates on Olives.
Only short-term exposures (<30 days) are expected and assessed for occupational
exposure scenarios because exposures for more than 30 days is unlikely to occur based on use
patterns. Occupational toxicity endpoints and uncertainty factors are the same as those described
in the residential risk assessment. However, the Office of Pesticides Programs' policy is to not
apply the FQPA SF in occupational risk assessments. No chemical-specific handler or post-
application exposure data have been submitted by the registrant. Therefore, an exposure
assessment for each handler scenario was developed using PHED Version 1.1 and EPA Standard
Operating Procedures for agricultural exposure. The mixer/loader/handler/applicator exposure
scenarios were assessed utilizing liquid formulations for the risk assessment because those
products had the highest percentage of active ingredients and highest usage patterns when
compared to the dry formulations (wettable powder and dust).
Handler Exposure Assessment
• The term "handler" refers to individuals who mix, load, and apply the pesticide product.
Based on actively registered labels, EPA assessed 12 handler scenarios for the naphthalene
acetates. Mixing and loading for aerial sprayers resulted in the highest level of exposure.
• A target MOE of 100 for the dermal and inhalation routes is considered adequate for the
occupational handler risk assessment. Using baseline personal protective equipment (PPE),
combined dermal and inhalation MOEs are > 130 for all handler scenarios and not a risk of
concern, except for the mixer/loaders handling liquids in support of aerial applications to
olive trees. The estimated MOE is 44 for this aerial mixer loader scenario, based on a
maximum application rate of 0.33 Ib ae/A for olive trees, and treating 500 acres per day.
More information on this scenario is available in the July 13, 2004 Revised Assessment of
Use of Naphthalene Acetates on Olives. However, based on a review of California's
Department of Pesticide Regulation's (CA DPR) Pesticide Use Data on olives, which reflect
the only state where olives are grown, the Agency believes this scenario greatly
overestimates the potential exposure risk to handlers. This data shows for the period 1990 -
2004 (the most recent year available) that aerial application occurs rarely and on the few days
it did occur, aerial treatments were made to less than 100 acres/day. If 100 acres were treated
Overview 27 NAA RED Amendment
-------
per day at the 0.33 Ib ae/acre, the calculated MOE would be 220. Moreover, at least 300
acres per day would need to be treated in order for the estimated MOE to be less than 100.
Air blast treatment (of 40 acres per day) at 0.33 Ib ae/acre results in an MOE of 550 with
baseline PPE. Baseline PPE includes long pants, long sleeved shirts, shoes, socks, and no
respirator.
Post-Application Exposure Assessment
• "Post-application" is the term used to describe individuals who can be exposed to pesticides
after entering areas previously treated with pesticides and performing certain activities (also
often referred to as reentry exposure). Occupational post-application activities were assessed
for the naphthalene acetates uses expected to result in the highest exposures. Based on their
use on olives, apples and pears, EPA assessed the following post-application activities:
irrigation, scouting, weeding, harvesting, pruning, propping, training, and thinning for the
naphthalene acetates.
• For post-application exposures, EPA calculates the minimum length of time required
following an application before residues have dissipated to the level where the calculated
MOE reaches the target MOE. EPA uses this information to determine restricted entry
intervals (REIs), the time period after which workers are allowed to reenter a treated area.
• A target MOE of 100 for the dermal exposure route is considered adequate for the
occupational post-application risk assessment. No post-application inhalation exposure is
expected. The MOEs for the post-application exposure scenarios are > 1166, which are
significantly greater than the target MOE of 100, and not of risk concern on the day of
application.
• For the naphthalene acetates the current labels specify a 12 - 48 hour REIs. A minimum 48-
hour REI is required for 1-naphthaleneacetamide, 1-naphthalene acetic acid, potassium
1-naphthaleneacetate, ammonium 1-naphthaleneacetate, and sodium 1-naphthaleneacetate
because they are classified as Toxicity Category I for eye irritation. A 12-hour REI is
required for ethyl 1-naphthaleneacetate because it is classified as Toxicity Category III or IV
for all acute toxicity endpoints.
Occupational Incident Reports
The Agency has conducted a review and consulted the following databases of reported
poisoning incidents associated with human exposure from occupational uses of naphthalene
acetates: Office of Pesticide Programs (OPP) Incident Data System; Poison Control Center Data,
1993 through 1998; California Data, 1982 through 1998; and the National Pesticide Information
Center.
No incidents were reported from the use of naphthalene acetates in the Incident Data
System, Poison Control Center Data, and the National Pesticide Information Center. Detailed
descriptions of six cases submitted to the California Pesticide Illness Surveillance Program
Overview 28 NAA RED Amendment
-------
(1982-1998) were reviewed. Workers were exposed either through accidental spraying in the
face from broken equipment during treatment or from post-application contact with treated
foliage or fruit. These exposures resulted in eye or sinus irritation, chemical conjunctivitis,
dermatitis, and a rash. None of the incidents resulted in hospitalization.
Ecological Risk
For detailed information on the Environmental Risk Assessment, see the October 26,
2004 Revised EFED Risk Assessment for the Naphthaleneacetic Acid Reregistration Eligibility
Decision: Revision Based on Application at Higher Use Rates. To estimate potential ecological
risk, EPA integrates the results of the exposure and ecotoxicity data to evaluate the potential for
adverse ecological effects. The method divides exposure estimates, which are based on
maximum application rates (worst case), by ecotoxicity data to derive risk quotients (RQs) for
acute and chronic effects. These RQ values are then compared to the Agency's levels of concern
(LOCs), which indicate whether a chemical, when used as directed, has the potential to cause
adverse effects on non-target organisms. When the RQ exceeds the LOG for a particular
category, the Agency presumes a potential risk of concern to that category.
Environmental fate of all naphthalene acetates is expected to be similar. A detailed
discussion of the environmental fate, transport, and physical-chemical properties and chemical
structures of naphthaleneacetic acid, naphthaleneacetamide, and ethyl 1-naphthaleneacetate are
given in the October 26, 2004 Revised EFED Risk Assessment for the Naphthaleneacetic Acid
Reregistration Eligibility Decision: Revision Based on Application at Higher Use Rates (see
particularly Tables 2 and 3, pages 10 & 12). In the environment, the sodium, potassium, and
ammonium salts of NAA rapidly degrade to the acid. Physical and chemical properties suggest
moderate to low soil mobility. The major routes of dissipation appear to be volatilization (on
plants) and photolysis (on plants in water); and perhaps some through biodegradation although
quantitative data are not available.
Based on the data available and through the use of Structure Activity Relationships
(SAR), EPA believes that the naphthalene acetates present little or no potential for risks to
mammals, birds, and aquatic organisms, including threatened or endangered mammals, birds,
and aquatic organisms, and to non-endangered, non-target plants. However, there is a potential
risk of concern for threatened and endangered non-target plant species exposure to the
naphthalene acetates when used on olive trees. Specifically, endangered plants potentially
exposed from NAA applications to olive trees are estimated to have an RQ as high as 2.6. All
RQs for animals and all uses are below the Agency's LOG, and therefore are not of risk concern.
All acute RQs for birds, mammals and aquatic organisms are <0.08, while all chronic RQs are <
0.38. Risks to terrestrial insects cannot be quantified but the available data do not suggest a
substantial potential for adverse effects. Moreover, no ecological incidents have been reported
Overview 29 NAA RED Amendment
-------
for the naphthalene acetates. RQs for non-target plants are <0.44 for all uses, except for olive
trees where the RQ is 2.6.
Risks from the use of plant growth regulators (PGRs) are currently addressed using data
from plant studies that deal with growth endpoints. Currently, there are no validated tests which
address reproductive effects on plants. EPA recognizes that reproductive plant studies would be
useful to characterize potential reproductive risks to non-target plants, from herbicides as well as
PGRs. However, given the conservative nature of the ecological risk assessment and that the
RQs are generally, significantly below the LOG, EPA believes the assessments are adequately
protective.
Data Needs
Outstanding data needs include:
- UV/Visible Absorption (OPPTS 830.7050)
Storage stability data on the processed commodities of apples (or citrus fruits) and olives.
(OPPTS 860.1380)
Data depicting residues of NAA and its conjugates in the processed commodities of citrus
(dried pulp, oil, and juice). (OPPTS 860.1520)
- The replenishment of analytical reference standards for all registered NAA acid salts,
ester, and acetamide as requested by the Repository. (OPPTS 860.1650)
Overview 30 NAA RED Amendment
-------
APPENDIX A
NAA (CASE 0379) USE PATTERNS ELIGIBLE FOR REREGISTRATION
Summary for 1-Naphthaleneacetamide 056001
CROP/USE SITE
APPLE
PEAR
ORNAMENTAL AND/OR SHADE
TREES, ORNAMENTAL
HERBACEOUS PLANTS, &
ORNAMENTAL WOODY
SHRUBS AND VINES
Formulations
FLC
WP
FLC
WP
D
Maximum Application
Rates
/ application
O.lllbae/A
O.lllbae/A
O.lllbae/A
/year
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
MRI
5d
5d
5d
REI
48 h
48 h
48 h
PHI
2d
2d
NA
Use Directions & Limitations
(May not apply to all Reg. #s)
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Appendix A
Al
NAA RED Amendment
-------
APPENDIX A
NAA (CASE 0379) USE PATTERNS ELIGIBLE FOR REREGISTRATION
Summary for 1-Naphthalene acetic acid 56002
SITE
APPLE
PEAR
ORNAMENTAL AND/OR SHADE
TREES & ORNAMENTAL
GROUND COVER,
ORNAMENTAL HERBACEOUS
PLANTS, ORNAMENTAL
NONFLOWERING PLANTS,
ORNAMENTAL WOODY
SHRUBS AND VINES
(Includes indoor & residential uses)
Formulations
FLC
FLC
SC/L
RTU
Maximum Application Rates
/ application
O.lllbae/A
O.lllbae/A
O.lllbae/A
/year
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
MRI
5d
5d
5d
REI
48 h
48 h
48 h
PHI
2d
2d
NA
Use Directions & Limitations
(May not apply to all Reg. #s)
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Do not apply directly to water.
Do not apply through any type of irrigation system.
Do not apply to plant foliage.
Do not enter treated areas without protective clothing
until sprays have dried.
Proper ventilation required.
Appendix A
A2
NAA RED Amendment
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APPENDIX A
NAA (CASE 0379) USE PATTERNS ELIGIBLE FOR REREGISTRATION
Summary for Potassium 1-Naphthaleneacetate 56003
SITE
APPLE
CITRUS HYBRIDS OTHER THAN
TANGELO
OLIVE
ORANGE
PEAR
TANGELO
TANGERINES
HOLLY (SHELTERBELT)
ORNAMENTAL WOODY
SHRUBS AND VINES
Formulations
EC
SC/L
EC
SC/L
EC
SC/L
SC/L
EC
SC/L
EC
SC/L
EC
SC/L
SC/L
EC
SC/L
Maximum Application Rates
/ application
O.lllbae/A
O.lllbae/A
0.33 Ib ae/A
O.lllbae/A
O.lllbae/A
O.lllbae/A
O.lllbae/A
O.lllbae/A
O.lllbae/A
/year
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
MRI
5d
5d
5d
5d
5d
5d
5d
5d
5d
REI
48 h
48 h
48 h
48 h
48 h
48 h
48 h
48 h
48 h
PHI
2d
150 d
102 d
150 d
2d
150 d
150 d
NA
NA
Use Directions & Limitations
(May not apply to all Reg. #s)
Do not apply through any type of irrigation system.
Do not make more than 1 applications per year.
Make only 2 applications.
Geographic allowable: OR WA
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Do not make more than 1 applications per year.
Make only 2 applications.
This pesticide is toxic to aquatic invertebrates.
Geographic allowable: OR WA
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Appendix A
A3
NAA RED Amendment
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APPENDIX A
NAA (CASE 0379) USE PATTERNS ELIGIBLE FOR REREGISTRATION
Summary for Ammonium l-Naphthaleneacetate 56004
SITE
APPLE
CHERRY
OLIVE
ORANGE
PEAR
TANGELO
TANGERINES
ORNAMENTAL AND/OR SHADE
TREES
ORNAMENTAL OLIVE, PEAR, &
PLUM
Formulations
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
SC/L
Maximum Application Rates
/ application
O.lllbae/A
O.lllbae/A
0.33 Ib ae/A
O.lllbae/A
O.lllbae/A
O.lllbae/A
O.lllbae/A
O.lllbae/A
O.lllbae/A
/year
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
0.33 Ib ae/A
MRI
5d
5d
5d
5d
5d
5d
5d
5d
5d
REI
48 h
48 h
48 h
48 h
48 h
48 h
48 h
48 h
48 h
PHI
2d
30 d
102 d
150 d
2d
150 d
150 d
NA
NA
Use Directions & Limitations
(May not apply to all Reg. #s)
Geographic allowable: WA
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Do not graze livestock in treated orchards.
Geographic allowable: CA
Do not apply through any type of irrigation system.
Geographic disallowable- FL June
Geographical allowable:- FL May
Do not apply through any type of irrigation system.
Geographic allowable: WA
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Geographic disallowable- FL June
Geographical allowable:- FL May
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
.Do not apply through any type of irrigation system.
Appendix A
A4
NAA RED Amendment
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APPENDIX A
NAA (CASE 0379) USE PATTERNS ELIGIBLE FOR REREGISTRATION
Summary for Sodium 1-Naphthaleneacetate 56007
SITE
APPLE
OLIVE
PEAR
ORNAMENTAL AND/OR
SHADE TREES
Formulations
SC/L
WP
SC/L
SC/L
WP
SC/L
WP
Maximum Application
Rates
/ application
.lllbae/A
.33 Ib ae/A
.lllbae/A
.lllbae/A
/year
.33 Ib ae/A
.33 Ib ae/A
.33 Ib ae/A
.33 Ib ae/A
MRI
5
5
5
5
REI
48 h
48 h
48 h
48 h
PHI
2d
102 d
2d
NA
Use Directions & Limitations
(May not apply to all Reg. #s)
Do not apply through any type of irrigation system
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Geographic allowable: OR
Do not apply through any type of irrigation system.
Appendix A
A5
NAA RED Amendment
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APPENDIX A
NAA (CASE 0379) USE PATTERNS ELIGIBLE FOR REREGISTRATION
Summary for Ethyl 1-Naphthaleneacetate 56008
SITE
APPLE
OLIVE
CITRUS (Ornamental)
NECTARINE (Ornamental)
ORNAMENTAL WOODY
SHRUBS AND VINES AND/OR
SHADE TREES
POMEGRANATE (Ornamental)
Formulations
RTU
SC/L
EC
RTU
SC/L
EC
RTU
SC/L
RTU
SC/L
RTU
SC/L
EC
PRL
EC
Maximum Application
Rates
/ application
.lllbsae/A
.33 Ibs ae /A
.lllbsae/A
.lllbsae/A
.lllbsae
/A
.lllbsae/A
/year
.33 Ibs ae /A
33 Ibs ae /A
33 Ibs ae /A
33 Ibs ae /A
.33 Ibs ae
/A
33 Ibs ae /A
MRI
5
5
5
5
5
5
REI
12 h
12 h
12 h
12 h
12 h
12
PHI
NA
NA
NA
NA
NA
NA
Use Directions & Limitations
(May not apply to all Reg. #s)
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Geographic disallowable: CA
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Do not apply through any type of irrigation system.
Geographic allowable: CA
Appendix A
A6
NAA RED Amendment
-------
APPENDIX A
NAA (CASE 0379) USE PATTERNS ELIGIBLE FOR REREGISTRATION
HEADER ABBREVIATIONS
Site Name - The site name refers to the entity (crop, building, surface or article) where a pesticide is applied and/or which is being protected.
Limitations - Precautionary statements related to the use of the product(s).
Application Timing - The timing of pesticide application and is the primary application sort (not aggregated).
Application Type - The type of pesticide application (aggregated).
Application Equipment - The equipment used to apply pesticide (aggregated).
Max. Single Appl. Rate to a Single Site - Maximum Dose for a single application to a single site. System calculated.
Max Seasonal Rate - The maximum amount of pesticide that can be applied to a site in one growing season (/cc = crop cycle) and during the span of one
year (/yr).
Max. # Apps/cc & yr - Maximum Number of Applications per crop cycle and per year.
M RI - Minimum Retreatment Interval (days) (at any rate). The minimum interval between pesticide application (days).
R EI - ReEntry Interval - The minimum amount of time that must elapse before workers can reenter a treated area.
PHI/PGI/PSI Use Limitations (May not apply to all RegJs) - Preharvest/Pregrazing/Preslaughter Interval use limitations pertinent to the application.
ABBREVIATIONS
NA - Not Applicable
NS - Not Specified (on label)
FORMULATION CODES
D : Dust
EC : Emulsifiable Concentrate
F1C : Flowable Concentrate
PRL : Pressurized Liquid
RTU : Liquid-ready To Use
SC/L : Soluble Concentrate/liquid
WP : Wettable Powder
Appendix A A7 NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Guide to Appendix B
Appendix B contains listing of data requirements required by the Registration Standard
for Naphthaleneacetic Acid, Its Salts, Ester, and Acetamide, and the subsequent Data Call-ins
which support the reregi strati on for the naphthalene acetates active ingredients within this RED.
It contains generic data requirements that apply to the naphthalene acetates in all products,
including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following formats:
1. Data Requirement (Column 1, 2 & 3). The data requirements are listed by current and past
Guideline Number, then by its name. The Guideline Numbers accompanying each test refer to
the test protocols set in the Pesticide Assessment Guidance available from the National
Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161 (703) 487-4650.
2. Use Pattern (Column 4). This column indicates the use patterns for which the data
requirements apply. The following letter designations are used for the given use patterns.
A. Terrestrial Food H. Greenhouse Food
B. Terrestrial Feed I. Greenhouse Non-Food
C. Terrestrial Non-Food J. Forestry
D. Aquatic Food K. Residential
E. Aquatic Non-Food Outdoor L. Indoor Food
F. Aquatic Non-Food Industrial M. Indoor Non-Food
G. Aquatic Non-Food Residential N. Indoor Medical
O. Indoor Residential
3. Bibliographic Citation (Column 5). If the Agency has acceptable data in its files, this column
list the identify number of each study. This normally is the Master Record Identification (MRID)
number, but may be a "GS" number if no MRID number has been assigned. Refer to the
Bibliography appendix for a complete citation of the study.
4. Required by (Column 6). Source of data requirement for reregi strati on of NAA.
Requirements came from the August 1981 Reregi strati on ("Reg") Standard document describing
all understanding of risk, data received to that point, and data needed to complete a reregi strati on
eligibility decision, September 1991 Chemistry Update, or September 1990 and October 1995
follow up Data Call-Ins (DCIs).
Appendix B B1 NAA RED Amendment
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APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT
Use
Pattern
PC Code
Citation(s)
Required
by
PRODUCT CHEMISTRY
830.1550
830.1600
830.1620
830.1670
61-1
6 1-2 A
61-2B
Product Identity and Composition
Start. Mat. & Mfg. Process
AKA: Description of materials used to
produce the product
Description of production process
Formation of Impurities
All
All
All
All
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
CSFs, 44570401, Data Gap
CSFs, Letter, 40522901,
43877701, 43998301,
45009801, 45143001
Not Required
Not Required
CSF, Data Gap, 40523001,
letter
CSF, Data Gap
44570402,
40522901, 43877701,
43998301, 45009801, 45143002
45085501, 45086501
Data Gap
Data Gap, 40523001
Data Gap
44570403
40522901, 43877701,
43998301, 45009801, 45143003
45085501, 45086501
Data Gap
40523001, Data Gap
Data Gap
44570404
40522901, 43877701,
43998301, 45009801, 45143004
45085501, 45086501
Data Gap
40523001, Data Gap
Data Gap
1991
Chemistry
Update
Reg
Standard
1991
Chemistry
Update
Reg
Standard
Appendix B
B2
NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT
Use
Pattern
PC Code
Citation(s)
Required
by
PRODUCT CHEMISTRY
830.1700
830.1750
830.1800
830.6302
830.6303
62-1
62-2
62-3
63-2
63-3
Preliminary Analysis
Certification of limits
Analytical Method
Color
Physical State
All
All
All
All
All
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
44570405
40522902, 43877702,
43998302, 45009802, 45143005
45085501, 45086501
Data Gap
40523002, Data Gap
Data Gap
44570406
CSFs, Letter, 40522902,
43877702, 43998302,
45009802,45143005,
40523002, Data Gap
Not required
CSF, 40523002, letter, Data
Gap
Data Gap
44570405
40522902, 43877702,
43998302, 45009802
Not required
Not required
40523002, Data Gap
Data Gap
Data Gap
40522903, Data Gap
Data Gap
Data Gap
40523003, Data Gap
Data Gap
Data Gap
40522903, Data Gap
Data Gap
Data Gap
40523003, Data Gap
Data Gap
Reg
Standard
Reg
Standard
Reg
Standard
Reg
Standard
Reg
Standard
Appendix B
B3
NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT
Use
Pattern
PC Code
Citation(s)
Required
by
PRODUCT CHEMISTRY
830.6304
830.6313
830.6314
830.6315
830.6316
830.6317
63-4
63-13
63-14
63-15
63-16
63-17
Odor
Stability
Oxidizing/Reducing Action
Flammability
Explodability
Storage Stability
All
All
All
All
All
All
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
Data Gap
40522903, Data Gap
Data Gap
Data Gap
40523003, Data Gap
Data Gap
Data Gap
40522903, Data Gap
Data Gap
Data Gap
40523003, Data Gap
Data Gap
Data Gap
44169601, Data Gap
Not Required
Not Required
44169602, Data Gap
Data Gap
Data Gap
Not Required
Not Required
Not Required
Not Required, Data Gap
Data Gap
Data Gap
44169601, Data Gap
Not Required
Not Required
44 169602, Data Gap
Data Gap
Data Gap
43580402, 44100601, Data Gap
Not Required
Reg
Standard
Reg
Standard
1991
Product
Chemistry
Update
1991
Product
Chemistry
Update
1991
Product
Chemistry
Update
1991
Product
Chemistry
Appendix B
B4
NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT
Use
Pattern
PC Code
Citation(s)
Required
by
PRODUCT CHEMISTRY
830.6319
830.6320
830.7000
830.7050
830.7100
63-19
63-20
63-12
63-18
Miscibility
Corrosion characteristics
pH
UV Visible absorption
Viscosity
All
All
All
All
All
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
Not Required
43580401, 44100602, Data Gap
Data Gap
Data Gap
Not Required
Not Required
Not Required
Not Required, Data Gap
Data Gap
Data Gap
44100601, Data Gap
Not Required
Not Required
44100601, Data Gap
Data Gap
Data Gap
40522903, 40523003
Data Gap
Data Gap
40523003, Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Not Required
Not Required
Not Required
Not Required, Data Gap
Data Gap
Update
1991
Product
Chemistry
Update
Reg
Standard
1991
Product
Chemistry
Update
1991
Product
Chemistry
Update
Appendix B
B5
NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT
Use
Pattern
PC Code
Citation(s)
Required
by
PRODUCT CHEMISTRY
830.7200
830.7220
830.7300
830.7370
830.7550
63-5
63-6
63-7
63-10
63-11
Melting Point
Boiling Point
Density
Dissociation Constant
Octanol/Water Partition Coefficient
All
All
All
All
All
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
Data Gap
40522903
Data Gap
Data Gap
40523003, Data Gap
Data Gap
Data Gap
Not Required, Data Gap
Data Gap
Data Gap
Not Required, Data Gap
Data Gap
Data Gap
40522903, Data Gap
Data Gap
Data Gap
40523003, Data Gap
Data Gap
Data Gap
40522903, Letter
Data Gap
Data Gap
40523003, Letter, Data Gap
Data Gap
Data Gap
40522903, Not Required
Data Gap
Data Gap
40523003, Data Gap
Data Gap
Reg
Standard
Reg
Standard
Reg
Standard
Reg
Standard
Reg
Standard
Appendix B
B6
NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT
Use
Pattern
PC Code
Citation(s)
Required
by
PRODUCT CHEMISTRY
830.7840
830.7860
830.7950
63-8
63-9
Solubility
Vapor Pressure
All
All
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
Data Gap
40522903
Data Gap
Data Gap
40523003, Data Gap
Data Gap
Data Gap
40522903
Data Gap
Data Gap
40523003, Data Gap
Data Gap
Reg
Standard
Reg
Standard
Appendix B
B7
NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT
Use
Pattern
PC Code
Citation(s)
Required by
ECOLOGICAL EFFECTS
850.2100
850.2200
850.2200
850.2300
850.1075
850.1010
850.4225
850.4250
850.5400
850.4400
71-1
7 1-2 A
71-2B
7 1-4 A
72-1A
72-2A
122-1A
122-1B
122-1
122-2
122-2
Avian Acute Oral Toxicity
Avian Dietary Toxicity - Quail
Avian Dietary Toxicity - Duck
Avian Reproduction - Quail
Fish Toxicity Bluegill
Invertebrate Toxicity
Seed Germ./ Seedling Emergence
Vegetative Vigor
Effects on Terrestrial Macrophytes
Effects to Algae/Algal Toxicity
Aquatic Plant Growth
(Effects on Aquatic Macrophytes)
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
056002
056001
056002
056008
056002
056002
056008
056002
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
00065840
Data Gap
00085909
42584202
00083052
Open literature
00082527
42498101
00082526
42470801
Data Gap
Data Gap
42584203,43837401,
Data Gap
Data Gap
43803201,42589901
Data Gap
Data Gap
Data Gap
42564202,43141101,
43 168101, Data Gap
Data Gap
42564201,43168301,
Data Gap
Data Gap
No longer required
056003
056001
056002
056003
056004
056007
056008
42582203, Data Gap
Data Gap
Data Gap
42582202, Data Gap
Data Gap
42582204, Data Gap
Data Gap
Reg Standard
1990 DCI
Reg Standard
1990 DCI
Reg Standard
Not Required
Reg Standard
1990 DCI
Reg Standard
1990 DCI
1990 DCI
Reg Standard
1990 DCI
1990 DCI
1990 DCI
1990 DCI
1990 DCI
Reg Standard
1990 DCI
1990 DCI
1990 DCI
1990 DCI
Reg Standard
Reg Standard
1990 DCI
Reg Standard
1990 DCI
1990 DCI
1990 DCI
1990 DCI
Appendix B
B8
NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT Pattern PC Code Citation(s)
ECOLOGICAL EFFECTS
Required by
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT
Use Pattern
PC Code
Citation(s)
TOXICOLOGY
870.1100
870.1200
870.1300
870.2400
870.2500
870.2600
870.3100
870.3150
870.3200
81-1
81-2
81-3
81-4
81-5
81-6
82-1A
82-1B
82-2
Acute Oral Toxicity-Rat
Acute Dermal Toxicity -Rabbit/Rat
Acute Inhalation Toxicity-Rat
Primary Eye Irritation-Rabbit
Primary Skin Irritation
Dermal Sensitization
90-Day Feeding - Rodent
90-Day Feeding - Non-rodent
21 -Day Dermal - Rabbit/Rat
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
056001
056002
056004
056007
056008
056001
056002
056007
056008
056001
056002
056008
056001
056002
056004
056007
056008
056001
056002
056007
056008
056001
056002
056008
056001
056002
056007
056008
056001
056002
056007
056008
056001
056002
056003
056004
056007
056008
[Required by
43495901
00103128
Data Gap?
00108829
43494101
43495902
00103129
00108829
43494102
43495903
00128256
43494103
00103051,43495904
00103127
Data Gap?
00108829
43494104
00103050
00103127
00108829
00103053,
00103128
43495905
00153217
43494105
43896001
00043624
42932601
43896002
43895901
00136446
42983801
43914901
43581001
Data Gap
Data Gap
Data Gap
43134701
43581002
1990 DCI
Reg Standard
Reg Standard
Not Required
Reg Standard
1990 DCI
Reg Standard
Not Required
Reg Standard
1990 DCI
Reg Standard
Reg Standard
Reg Standard
Reg Standard
Reg Standard
Reg Standard
Reg Standard
1990 DCI
Reg Standard
Not Required
1990 DCI
1990 DCI
Reg Standard
1990 DCI
Not Required
Reg Standard
Not Required
Not Required
Not Required
Reg Standard
Not Required
Not Required
1990 DCI
1990 DCI
1990 DCI
1990 DCI
1990 DCI
1990 DCI
Appendix B
B9
NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
TTcp
REQUIREMENT _ T. PC Code Citation(s) Required by
i iittcm
ECOLOGICAL EFFECTS
870.4100
870.4100
870.4200
870.4200
870.3700
870.3700
870.3800
870.4300
870.5140
870.5265
870.5375
Various
83-1A
83-1B
83 -2 A
83-2B
83-3A
83-3B
83-4
83-5
84-2A
84-2B
84-4
Chronic Feeding Toxicity - Rodent
Chronic Feeding Toxicity - Non-Rodent
Oncogenicity - Rat
See combined chronic/carcinogenicity
study below.
Oncogenicity - Mouse
Developmental Toxicity - Rat
Developmental Toxicity - Rabbit
2-Generation Reproduction - Rat
Combined Chronic Toxicity/
Carcinogenicity
Gene Mutation (Ames Test)
Structural Chromosomal Aberration
Other Genotoxic Effects
See studies below:
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056008
056002
056008
056002
056008
056001
056002
056003
056004
056007
056008
056001
056002
056008
056001
056002
056008
056001
056002
056008
NCI Innes 1996
43744201
00042765
Data Gap
00137821, 00137822
Data Gap
43796301
44157501 (Rat)
43581006
00042761, 00042762
43581004
9/90 DCI
Reg Standard
9/90 DCI
9/90 DCI
9/90 DCI
9/90 DCI
9/90 DCI
Reg Standard
9/90 DCI
9/90 DCI
9/90 DCI
9/90 DCI
Reg Standard
9/90 DCI
9/90 DCI
9/90 DCI
9/90 DCI
9/90 DCI
Reg Standard
9/90 DCI
Reg Standard
9/90 DCI
Reg Standard
9/90 DCI
9/90 DCI
Reg Standard
9/90 DCI
9/90 DCI
9/90 DCI
9/90 DCI
Not Required
1990 DCI
Reg Standard
1990 DCI
1990 DCI
Reg Standard
1990 DCI
1990 DCI
Reg Standard
1990 DCI
Appendix B
BIO
NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT
ECOLOGICAL EFFECTS
870.5300
870.5395
870.5450
870.5575
870.7485
84-4
84-4
84-4
84-4
85-1
Use
Pattern
Gene mutation - mammalian: mouse
lymphoma cells
erythrocyte micronuleus - mice
Rodent dominant lethal assay
Mitotic gene conversion: Saccharomyces
cervisiae
General Metabolism
PC Code
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
Citation(s)
056001
056002
056008
056001
056002
056008
056001
056002
056008
056001
056002
056008
056001
056002
056007
056008
Required by
43580202
43580201
43581005
00042763
43581003
00042764, Data Gap
00042758,
00042759,
00042760, Data Gap
43963301
Dixonetal 1977
Lethco & Brouwer
1966
43961701
1990 DCI
Reg Standard
1990 DCI
1990 DCI
Reg Standard
1990 DCI
1990 DCI
Reg Standard
1990 DCI
1990 DCI
Reg Standard
1990 DCI
1990 DCI
Reg Standard
Not Required
1990 DCI
Appendix B
Bll
NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT
Use Pattern
PC Code
Citation(s)
Required by
OCCUPATIONAL/RESIDENTIAL EXPOSURE
875.2100
875.2400
875.2500
None
None
132-1A
133-3
133-4
231
232
Foliar Residue Dissipation
Dermal Passive Dosimetry Exposure
Inhalation Passive Dosimetry Exposure
Estimation of Dermal Exposure at
Outdoor Sites
Estimation of Inhalation Exposure at
Indoor Sites
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056003
056004
056002
056003
056004
056007
056008
Agricultural Reentry Task
Force (ARTF) data
Agricultural Reentry Task
Force (ARTF) data &
Outdoor Residential
Exposure Task Force
(ORETF, May 2000)
Pesticide Handlers
Exposure Database (PHED)
& Outdoor Residential
Exposure Task Force
(ORETF, May 2000)
Agricultural Reentry Task
Force (ARTF) data
Pesticide Handlers
Exposure Database (PHED)
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
90&95 DCI
Appendix B
B12
NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT
Use Pattern
PC
Code
Citation(s)
Required by
ENVIRONMENTAL FATE
None
835.2120
835.2240
835.2410
835.2370
835.4100
835.4200
835.4400
835.4300
835.1240
835.6100
835.1850
None
160-5
161-1
161-2
161-3
161-4
162-1
162-2
162-3
162-4
163-1
164-1
165-1
165-4
Chemical Identity
Hydrolysis
Photodegradation - Water
Photodegradation - Soil
Photodegradation - Air
Aerobic Soil Metabolism
Anaerobic Soil Metabolism
Anaerobic Aquatic Metabolism
Aerobic Aquatic Metabolism
Leaching/ Adsorption/Desorption
Terrestrial Field Dissipation
Confined Rotational Crop
Bioaccumulation in Fish
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
056001
056008
129382
Not Required
1990 DCI
Not Required
Not Required
Not Required
Not Required
Not Required
Not Required
Not Required
Not Required
Not Required
Not Required
Not Required
Not Required
Appendix B
B13
NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT
Use Pattern
PC Code
Citation(s)
RESIDUE CHEMISTRY
None
860.1200
860.1300
860.1300
860.1340
860.1340
171-2
171-4A
171-4B
171-4C
171-4D
Chemical Identity
Directions for Use
Nature of Residue - Plants
Nature of Residue - Livestock
Residue Analytical Method - Plants
Residue Analytical Method - Animals
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
056001
056002
056003
056004
056007
056008
non-
specific
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
Data Gap
43948501,43482101
05009008,05009108,
00004943, 00004948,
00159237, 05009196,
43482101,43948501,
44190501
43482101, 43948501,
44190501
00004942, 05007966,
05008052,43692301
05008057, 05008070
00004916,00004943
00004946, 00004949
00159237,05002768
05008121,05020083,
44555403, 44586502
GS0023012,
GS0023019,
GS0023036
ibid
Required by
Not Required
9/91 Chem
Update
9/90 DCI
Reg Standard
9/90 DCI
9/90 DCI
9/90 DCI
9/90 DCI
9/90 DCI
Reg Standard
9/90 DCI
9/90 DCI
9/90 DCI
9/90 DCI
Reg Standard
Reg Standard
Appendix B
B14
NAA RED Amendment
-------
APPENDIX B - GUIDELINE DATA REQUIREMENTS
Data Supporting Guideline Requirements for the Reregistration of
Naphthalene Acetates
REQUIREMENT
Use Pattern
PC Code
Citation(s)
RESIDUE CHEMISTRY
860.1360
860.1380
860.1480
860.1500
860.1500
860.1520
171-
4M
171-4E
171-4J
171-4K
171-4K
171-4L
Multiresidue Method
Storage Stability (Plant Commodities)
Magnitude of Residues - Meat/Milk/Poultry
/Egg
ABCKMO
ABCKMO
ABCKMO
056001
44184401
44660201, 44660202
44835301, Data Gap
Required by
Not Required
9/90 DCI
9/90 DCI
Crop Field Trials
Citrus Fruit Groups (Crop Group 10)
Orange
Tangerine
Pome Fruits (Crop Group 11)
Apple
Pear
Stone Fruits Group Cherry, sweet
ABCKMO
ABCKMO
ABCKMO
ABCKMO
ABCKMO
00051218,00060940,
00060941,00060942,
00060943,00161042
00051218,00060940
00060941,00060942
00060943,00161042
GS002336, 40884401
45283601
GS0023019, 40884402
45283602
00114389,00114390
9/90 DCI
9/90 DCI
Reg Standard
Reg Standard
Not Required
Crop Field Trials - Miscellaneous Commodities
Olive
Pineapple
ABCKMO
ABCKMO
00004943, 44555402
GS0023012
00004946
Reg Standard
Reg Standard
Processed Food/Feed
Processed Food (Olive)
Processed Food (Apple)
Processed Food (Fruit, Citrus, Group 10)
ABCKMO
ABCKMO
ABCKMO
44555401
44586501
00051218,00060940,
00060941,00060942,
00060943,00161042,
Data Gap
9/90 DCI
9/90 DCI
9/90 DCI
Appendix B
B15
NAA RED Amendment
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APPENDIX C: EPA's Technical Support Documents for Naphthalene Acetates
All technical support documents for the Naphthalene acetates RED may be viewed either
on paper at the OPP Public Docket or via the Internet. The paper documentation in support of
this RED is maintained in the OPP docket: Room S-4400, One Potomac Yard (South Building);
2777 S. Crystal Drive; Arlington, VA; 22202. It is open Monday through Friday, excluding
Federal holidays, from 8:30 am to 4 pm. Electronic copies of these documents are maintained at
the Federal Docket Management System (FDMS). FDMS can be found at www.regulations.gov
under docket number EPA-HQ-OPP-2006-0507. These documents include the following:
Human Health Risks:
Naphthalene Acetates HED Risk Assessment for Reregi strati on Eligibility Document (RED)
PC Codes: 056001, 056002, 056003, 056004, 056007, 056008; Revised Assessment of Use
of Naphthalene Acetates on Olives, dated July 13, 2004
Naphthalene Acetates HED Risk Assessment for Reregi strati on Eligibility Document (RED)
PC Codes: 056001, 056002, 056003, 056004, 056007, 056008; dated March 30, 2004
1-Naphthaleneacetic Acid (NAA), Its Salts, Ester, and Acetamide. RED - Reregi strati on
Eligibility Decision: Product Chemistry Considerations; dated March 10, 2004
1-Naphthaleneacetic Acid (NAA), its Salts, Ester, and Acetamide. Residue Chemistry
Considerations for Reregi strati on Eligibility Decision; dated March 10, 2004
Naphthalene Acetates Occupational and Residential Exposure Assessment for the
Reregi strati on Eligibility Decision (RED) Document; dated March 10, 2004
1-Naphthaleneacetic Acid (Including Esters and Salts): Revised HED Toxicology Chapter for
the Reassessment Eligibility Decision (RED) PC Codes 056001, 056002, 056007, 056008;
dated March 8, 2004
Naphthalene Acetates Acute and Chronic Dietary Exposure Assessment for the
Reregistration Eligibility Decision (RED) Document. PC Codes:056001, 056002, 056003,
056004, 056007, 056008; dated November 20, 2003
Review of Naphthaleneacetic Acid Incidents Report; dated October 9, 2003.
Environmental Fate and Effects
Amended Environmental Fate and Effects Risk Assessment for the Reregistration of
1-Naphthaleneacetic acid and Related Compounds as a Low Toxicity Substance, dated May
13, 2004
Tier I Estimated Driving Water Concentrations of 1-Naphthaleneacetic Acid for use in
Human Health Risk Assessment, dated September 25, 2003.
Appendix C Cl NAA RED Amendment
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APPENDIX D - BIBLIOGRAPHY
Appendix D. Citations Considered to be Part of the Database Supporting the
Reregistration Decision (Bibliography)
GUIDE TO APPENDIX D
CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies
considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the
Reregistration Eligibility Document. Primary sources for studies in this bibliography have been
the body of data submitted to EPA and its predecessor agencies in support of past regulatory
decisions. Selections from other sources including the published literature, in those instances
where they have been considered, are included.
UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of
published materials, this corresponds closely to an article. In the case of unpublished materials
submitted to the Agency, the Agency has sought to identify documents at a level parallel to the
published article from within the typically larger volumes in which they were submitted. The
resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for
purposes of review and can be described with a conventional bibliographic citation. The Agency
has also attempted to unite basic documents and commentaries upon them, treating them as a
single study.
IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by
Master Record Identifier, or "MRID" number. This number is unique to the citation, and should
be used whenever a specific reference is required. It is not related to the six-digit "Accession
Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4)
below for further explanation). In a few cases, entries added to the bibliography late in the
review may be preceded by a nine character temporary identifier. These entries are listed after all
MRID entries. This temporary identifying number is also to be used whenever specific reference
is needed.
FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of
a citation containing standard elements followed, in the case of material submitted to EPA, by a
description of the earliest known submission. Bibliographic conventions used reflect the standard
of the American National Standards Institute (ANSI), expanded to provide for certain special
needs.
1 Author. Whenever the author could confidently be identified, the Agency has chosen to
show a personal author. When no individual was identified, the Agency has shown an
identifiable laboratory or testing facility as the author. When no author or laboratory could be
identified, the Agency has shown the first submitter as the author.
2 Document date. The date of the study is taken directly from the document. When the date is
Appendix D Dl NAA RED Amendment
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APPENDIX D - BIBLIOGRAPHY
followed by a question mark, the bibliographer has deduced the date from the evidence
contained in the document. When the date appears as (1999), the Agency was unable to
determine or estimate the date of the document.
Title. In some cases, it has been necessary for the Agency bibliographers to create or
enhance a document title. Any such editorial insertions are contained between square
brackets.
Trailing parentheses. For studies submitted to the Agency in the past, the trailing parentheses
include (in addition to any self-explanatory text) the following elements describing the
earliest known submission:
1 Submission date. The date of the earliest known submission appears immediately
following the word "received."
2 Administrative number. The next element immediately following the word "under" is the
registration number, experimental use permit number, petition number, or other
administrative number associated with the earliest known submission.
3 Submitter. The third element is the submitter. When authorship is defaulted to the
submitter, this element is omitted.
4 Volume Identification (Accession Numbers). The final element in the trailing parentheses
identifies the EPA accession number of the volume in which the original submission of
the study appears. The six-digit accession number follows the symbol "CDL," which
stands for "Company Data Library." This accession number is in turn followed by an
alphabetic suffix which shows the relative position of the study within the volume.
Appendix D D2 NAA RED Amendment
-------
APPENDIX D - BIBLIOGRAPHY
MRID
CITATION
Product Chemistry
160552 Amvac Chemical Corp. (1986) [Product Chemistry of 1-Naphthalene Acetic
Acid]. Unpublished compilation. 26 p.
40522901 Feiler, W. (1988) NAA: Product Identity and Composition: 1-Naphthalene Acetic
Acid. Unpublished study prepared by Amvac Chemical Corp. 19 p.
40522902 Feiler, W. (1988) NAA: Analysis and Certification of Product Ingredients 1-
Naphthalene Acetic Acid. Unpublished study prepared by Amvac Chemical
Corp. 32 p.
40522903 Feiler, W. (1987) NAA: Physical and Chemical Characteristics. Unpublished
study prepared by Amvac Chemical Corp. 3 p.
40523001 Feiler, W. (1988) NAA Sodium Salt: Product Identity and Composition.
Unpublished study prepared by Amvac Chemical Corp. 13 p.
40523002 Feiler, W. (1988) NAA Sodium Salt: Analysis and Certification of Product
Ingredients. Unpublished study prepared by Amvac Chemical Corp. 16 p.
40523003 Feiler, W. (1987) NAA Sodium Salt: Physical and Chemical Characteristics.
Unpublished study prepared by Amvac Chemical Corp. 3 p.
43580401 Braden, G. (1995) Storage Stability of Technical Sodium Salt of 1-
Naphthaleneacetic Acid. Unpublished study prepared by Amvac Chemical Corp.
8 p.
43580402 Braden, G. (1995) Storage Stability of 1-Naphthaleneacetic Acid Technical.
Unpublished study prepared by Amvac Chemical Corp. 8 p.
43877701 Braden, G. (1995) NAA: Product Identity and Composition of 1-Napthaleneacetic
Acid: Lab Project Number: ING 013.1. Unpublished study prepared by AMVAC
Chemical Corp. 39 p.
43877702 Braden, G. (1995) NAA: Analysis and Certification of Ingredients in 1-
Napthaleneacetic Acid: Lab Project Number: PAN 013.1. Unpublished study
prepared by AMVAC Chemical Corp. 29 p.
Appendix D
D3
NAA RED Amendment
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APPENDIX D - BIBLIOGRAPHY
MRID
CITATION
43998301 Braden, G. (1996) NAA: Product Identity and Composition of 1-Napthaleneacetic
Acid: Lab Project Number: ING 013. Unpublished study prepared by AMVAC
Chemical Corp. 39 p.
43998302 Braden, G. (1996) NAA: Analysis and Certification of Ingredients in 1-
Naphthaleneacetic Acid: Lab Project Number: PAN 013. Unpublished study
prepared by Amvac Chemical Corp. 30 p.
44100601 Douglass, M.; Sweetapple, G. (1996) NAA - 1-Year 25 degree C Storage Stability
(and Corrosion Characteristics): Lab Project Number: 4506-95-0070-AS-001.
Unpublished study prepared by Ricerca, Inc. 51 p.
44100602 Douglass, M.; Sweet apple, G. (1996) NAA, Sodium Salt - 1-Year 25 degree C
Storage Stability (and Corrosion Characteristics): Lab Project Number: 4506-95-
0069-AS-001. Unpublished study prepared by Recherche, Inc. 52 p.
44169601 Wojcieck, B. (1995) NAA - Oxidation-Reduction and Impact Explodability: Lab
Project Number: 4506-95-0066-AS-001: 4506-95-0066-AS: 4506-95-0066-AS-
000. Unpublished study prepared by Recherche, Inc. 41 p.
44169602 Wojcieck, B. (1995) Sodium Salt of NAA - Oxidation-Reduction and Impact
Explodability: Lab Project Number: 4506-95-0065-AS-001: 4506-95-0065-AS:
4506-95-0065-AS-OOO. Unpublished study prepared by Recherche, Inc. 41 p.
44570401 Barden, G. (1998) Naphthaleneacetamide: Product Identity and Composition: Lab
Project Number: ING 011.2. Unpublished study prepared by AMVAC Chemical
Corporation. 10 p.
44570402 Braden, G. (1998) 1-Naphthaleneacetamide: Material Used for Production: Lab
Project Number: RAW 011.2. Unpublished study prepared by AMVAC
Chemical Corporation. 32 p.
44570403 Braden, G. (1998) 1-Naphthaleneacetamide: Production Process: Lab Project
Number: PROC 011.2. Unpublished study prepared by AMVAC Chemical
Corporation. 10 p.
44570404 Braden, G. (1998) Naphthaleneacetamide: Formation of Impurities: Lab Project
Number: IMP 011.2. Unpublished study prepared by AMVAC Chemical
Corporation. 10 p.
Appendix D
D4
NAA RED Amendment
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APPENDIX D - BIBLIOGRAPHY
MRID
CITATION
44570405 Harden, G. (1998) Preliminary Analysis of Ingredients in 1-
Naphthaleneacetamide: Lab Project Number: PAN 011.2. Unpublished study
prepared by AMVAC Chemical Corporation. 27 p.
44570406 Braden, G. (1998) 1-Naphthaleneacetamide: Certified Limits: Lab Project
Number: CL 011.2. Unpublished study prepared by AMVAC Chemical
Corporation. 9 p.
45009801 Hathorn, S. (1999) Pace International LLC Naphthalene Acetic Acid Technical
Product Chemistry: Product Identity and Composition, Description of Materials
Used to Produce the Product, Description of Production Process, and Discussion
of Formation of Impurities: Lab Project Number: PACE-99001. Unpublished
study prepared by Pace International LLC. 35 p.
45009802 Jacobson, S. (1999) Pace International LLC Naphthalene Acetic Acid Technical:
Product Chemistry: Preliminary Analysis, Certified Limits and Enforcement
Analytical Method(s): Lab Project Number: 99003. Unpublished study prepared
by Compliance Services International. 72 p.
45085501 Hathorn, S.; Whitehouse, J. (2000) Product Identity and Composition, Description
of the Materials Used to Produce the Product, Description of the Formulation
Process, and Discussion of the Formation of Impurities: SNAAP-8: Lab Project
Number: PACE-00001. Unpublished study prepared by Pace International LLC.
37 p.
45085502 Jacobson, S. (2000) Preliminary Analysis, Certified Limits and Enforcement
Analytical Method(s) Potassium Napthaleneacetate 24% LC: Lab Project
Number: 99004. Unpublished study prepared by Compliance Services
International. 51 p.
45086501 Hathorn, S.; Whitehouse, J. (2000) Product Identity and Composition, Description
of the Materials Used, Description of the Formulation Process and Discussion of
Formation of Impurities for SNAAP-2. Unpublished study prepared by Pace
International LLC. 35 p.
45086502 Jacobson, S. (2000) Potassium 1-Napthaleneacetate 6.25% LC-Product
Chemistry: Preliminary Analysis, Certified Limits, and Enforcement Analytical
Method(s): Lab Project Number: 99013. Unpublished study prepared by
Compliance Services International. 42 p.
Appendix D
D5
NAA RED Amendment
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APPENDIX D - BIBLIOGRAPHY
MRID
CITATION
45143001 Braden, G. (2000) Product Identity and Composition of Technical
Naphthaleneacetic Acid: Lab Project Number: ING 013.3. Unpublished study
prepared by AMVAC Chemical Corporation. 10 p.
45143002 Braden, G. (2000) Materials Used for Production of Technical Naphthaleneacetic
Acid: Lab Project Number: RAW 013.3. Unpublished study prepared by AMVAC
Chemical Corporation. 18 p.
45143003 Braden, G. (2000) Production Process for Technical Naphthaleneacetic Acid: Lab
Project Number: PROC 013.3. Unpublished study prepared by AMVAC
Chemical Corporation, lip.
45143004 Braden, G. (2000) Formation of Impurities in Technical Naphthaleneacetic Acid:
Lab Project Number: IMP 013.3. Unpublished study prepared by AMVAC
Chemical Corporation. 10 p.
45143005 Braden, G. (2000) Certification of Limits for Technical Naphthaleneacetic Acid:
Lab Project Number: CL 013.3. Unpublished study prepared by AMVAC
Chemical Corporation. 9 p.
Environmental Fate and Effects
00065839 Fink R. 1976a. Final Report: Acute Oral LD 50A-Mallard Duck: Project No.
113-124.. (Unpublished study received Sep 19, 1979 under 264-336; prepared by
Truslow Farms, Inc., submitted by Union Carbide Agricultural Products Co., Inc.,
Ambler, Pa.; CDL: 099029-B)
00042753 Fink R; Beavers JB; Grimes J; et al. 1979a. Final Report: Acute Oral LD50 -
Bobwhite Quail: Project No. 113-154. (Unpublished study received Sep 19, 1979
under 264-336; prepared by Wildlife International, Ltd. and Washington College,
submitted by Union Carbide Agricultural Products Co., Ambler, Pa.; CDL:
099029-H)
00042754 Fink R; Beavers JB; Grimes J; et al. 1979b. Final Report: Acute Oral LD50 -
Mallard Duck: Project No. 113-155.. (Unpublished study received Sep 19, 1979
under 264-336; prepared by Wildlife International, Ltd. and Washington College,
submitted by Union Carbide Agricultural Products Co., Ambler, Pa.; CDL:
099029-1)
Appendix D
D6
NAA RED Amendment
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APPENDIX D - BIBLIOGRAPHY
MRID
CITATION
00042755 Union Carbide Corporation. 1979. The Acute Toxicity of 72-A112 to the Water
Flea, Daphnia magna Straus: UCES Project No. 11506-24- 11. (Unpublished
study received Sep 19, 1979 under 264-336; submitted by Union Carbide
Agricultural Products Co., Ambler, Pa.; CDL:099029-J)
00042756 Morrissey AE. 1979. The Acute Toxicity of 72-A112 to the Rainbow
Trout,~Salmogairdneri~Richardson: UCES Proj ect No. 11506-24-10..
(Unpublished study received Sep 19, 1979 under 264-336; submitted by Union
Carbide Agricultural Products Co., Ambler, Pa.; CDL:099029-K)
00042757 Schneider C. 1979. The Acute Toxicity of 72-A112 to the Bluegill Sunfish,
Lepomis macrochirus Rafmesque: UCES Project No. 11506- 24-09.
(Unpublished study received Sep 19, 1979 under 264-336; submitted by Union
Carbide Agricultural Products Co., Ambler, Pa.; CDL:099029-L)
00042765 Miller, T.J.; McElroy, K. 1977. Teratology Study with NAA acid (Technical) by
Gavage in the Albino Rat. Huntingdon Research Center: HRC # R-4216-4 (1-
350). Prepared by Pharmakon Laboratories, Unpublished Study. January 14,
1977.
00065840 Fink R; Beavers JB. 1979. Final Report: Acute Oral LD 50 Bobwhite Quail:
Project No. 113-153. (Unpublished study received Sep 19, 1979 under 264-336;
prepared by Wildlife International, Ltd. and Washington College, submitted by
Union Carbide Agricultural Products Co., Inc., Ambler, Pa.; CDL:099029-C)
00072749 Fink R. 1976b. Final Report: Eight-Day Dietary LC50~Bobwhite Quail: Project
No. 113-118. (Unpublished study received Sep 19, 1979 under 264-336; prepared
by Truslow Farms, Inc., submitted by Union Carbide Agricultural Products Co.,
Ambler, Pa.; CDL: 099029-G)
00082525 Wessel RD. 1969. Letter sent to Harold G. Alford dated May 29, 1969 Fish
toxicity on coho salmon for Kling-title : File No. 706.11.. (Unpublished study,
including letter dated May 22, 1969 from H.G. Alford to R.D. Wessel, received
Jun 23, 1969 under 239-2169; submitted by Chevron Chemical Co., Richmond,
Calif; CDL:001458-A)
Appendix D
D7
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APPENDIX D - BIBLIOGRAPHY
MRID
CITATION
00082526 LeBlanc, G.A.; Surprenant, D.C. (1981) Acute Toxicity of Naphthaleneacetic
Acid to the Water Flea (Daphnia magna): Report #BW-81-4-866. (Unpublished
study received Oct 14, 1981 under 264-336; prepared by EG & G, Bionomics,
submitted by Union Carbide Agricultural Products Co., Inc., Ambler, Pa.;
CDL:246079-A)
00082527 LeBlanc GA; Sousa JV. 1981a. Acute Toxicity of NAA to Bluegill (Lepomis
macrochirus): Report #BW-81-4-867. (Unpublished study received Oct 14, 1981
under 264-336; prepared by EG & G, Bionomics, submitted by Union Carbide
Agricultural Products Co., Inc., Ambler, Pa.; CDL:246079-B)
00082528 LeBlanc GA; Sousa JV. 1981b. Acute Toxicity of NAA to Rainbow Trout
(Salmo gairdneri): Report #BW-81-4-876. (Unpublished study received Oct 14,
1981 under 264-336; prepared by EG & G, Bionomics, submitted by Union
Carbide Agricultural Products Co., Inc., Ambler, Pa.; CDL: 246079-C)
00083052 Fink R. 1976. Final Report: Eight-Day Dietary LC 50 Mallard Duck: Project
No. 113-119. (Unpublished study received Sep 19, 1979 under 264-336; prepared
by Truslow Farms, Inc., submitted by Union Carbide Agricultural Products Co.,
Ambler, Pa.; CDL: 099029-F)
00085909 Fink R. 1976. Final Report: Eight-day Dietary LC 50 Bobwhite Quail: Project
No. 113-122. (Unpublished study received Sep 19, 1979 under 264-336; prepared
by Truslow Farms, Inc., submitted by Union Carbide Agricultural Products Co.,
Inc., Ambler, Pa.; CDL:099029-D)
00103128 Mallory, V.; Matthews, R.; Naismith, R.; et al. 1982. Acute Oral Toxicity Study
in Rats (14-Day): Naphthalene Acetic Acid: Study No. PH 402-UC-001-82.
Pharmakon Research International, Inc. April 29, 1982. Unpublished.
00162239 Amvac Chemical Corp. 1986. [Product Chemistry of 1-Naphthalene Acetic
Acid]. Unpublished compilation. 23 p.
40522903 FeilerW. 1987. NAA: Physical and Chemical Characteristics. Unpublished
study prepared by Amvac Chemical Corp. 3 p.
42470801 Terrell Y. 1992. Technical 1-Naphthaleneacetic Acid, Ethyl Ester Acute Effects
on the Cladoceran, Daphnia magna: Lab Project Number: 92-330110-100-1: BR-
1895A. Unpublished study prepared by Aqua Survey, Inc. 95 p.
Appendix D
D8
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APPENDIX D - BIBLIOGRAPHY
MRID
CITATION
42498101 Terrell Y. 1992. Technical 1-Naphthaleneacetic Acid, Ethyl Ester: Acute Effects
on the Bluegill Sunfish, Lepomis macrochirus: Lab Project Number: 92-700110-
100-1: BR-1895B. Unpublished study prepared by Aqua Survey, Inc. 88 p.
42564201 HarnishW. 1992a. Fruit Fix Super Concentrate 800. (NAA-Ammonium 21.
4%) Tier I Non-target Plant Hazard Evaluation-terrestrial Vegetative Vigor Study:
Lab Project Number: 22925B002. Unpublished study prepared by Landis
International, Inc. and AMVAC Chemical Corp. 87 p.
42564202 Harnish W. 1992b. K-Salt Fruit Fix 800 (NAA-Potassium Salt 24.2%) Tier I
Non-target Plant Hazard Evaluation-terrestrial Vegetative Vigor Study: Lab
Project Number: 22925B004. Unpublished study prepared by Landis
International, Inc. and AMVAC Chemical Corp. 92 p.
42582202 Hughes J; Alexander M. 1992b. The toxicity of K-Salt Fruit Fix 800 to Lemna
gibba G3: Lab Project Number: BO 15-001-2. Unpublished study prepared by
Malcolm Pirnie, Inc. 36 p.
42582203 Hughes J; Alexander M. 1992c. The Toxicity of Fruit Fix Super Concentrate 800
to Selenastrum capricornutum: Lab Project Number: B015-001-3. Unpublished
study prepared by Malcolm Pirnie, Inc. 37 p.
42582204 Hughes J; Alexander M. 1992d. The Toxicity of Fruit Fix Super Concentrate 800
to Lemna gibba G3: Lab Project Number: BO 15-001-4. Unpublished study
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42584201 Campbell S; Jaber M. 1992a. Technical 1-Naphthaleneacetamide: A dietary
LC50 Study with the Northern Bobwhite: Lab Project Number: 246-108.
Unpublished study prepared by Wildlife International Ltd. 37
42584202 Campbell S; Jaber M. 1992. Technical 1-Naphthalene Acetic Acid Ethyl Ester:
A Dietary LC50 Study with the Northern Bobwhite: Lab Project Number: 246-
109R. Unpublished study prepared by Wildlife International Ltd. 37 p.
42584203 Harnish W. 1992. K-Salt Fruit Fix 800 (NAA-Potassuim 24. 2%): Tier I and Tier
II Non-Target Plant Hazard Evaluation: Terrestrial Seed Germination and
Seedling Emergence Study: Lab Project Number: 22925B003. Unpublished study
prepared by Landis International, Inc. 406 p. (NAA-Potassuim 24. 2%): Tier I
and Tier II Non-Target Plant Hazard Evaluation: Terrestrial Seed Germination
Appendix D
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APPENDIX D - BIBLIOGRAPHY
MRID
CITATION
and Seedling Emergence Study: Lab Project Number: 22925B003. Unpublished
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42589901 Harnish W. 1992. Fruit Fix Super Concentrate 800: Tier I and II Non-target
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43141101 Harnish W. 1994. K-Salt Fruit Fix 800 Tier II Non-Target Plant Hazard
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22925B006: 1231-93-229-02-25B-02. Unpublished study prepared by Landis
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43168101 Harnish W. 1994b. K-Salt Fruit Fix 800 (NAA-Potassium 24.2%): Tier I Non-
Target Plant Hazard Evaluation-Terrestrial Vegetative Vigor Study on Carrot:
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Unpublished study prepared by Landis International, Inc. 52 p.
43168301 Harnish W. 1994c. Fruit Fix Super Concentrate 800. (NAA-Ammonium
21.4%): Tier I Non-Target Plant Hazard Evaluation-Terrestrial Vegetative Vigor
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25B-02. Unpublished study prepared by Landis International, Inc. 52 p.
43494101 Kuhn, J. 1994. Acute Oral Toxicity Study in Rats: Technical 1-
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Unpublished study prepared by Still meadow, Inc. 21 p.
43495901 Kuhn, J. 1994. Acute Oral Toxicity Study in Rats: Technical 1-
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43744201 Kangas, L. 1995. A 52-Week Oral (Capsule) Toxicity Study of 1-
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43803201 Harnish W. 1995a. NAA: Determination of the Effects of NAA Ammonium
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Appendix D
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APPENDIX D - BIBLIOGRAPHY
MRID CITATION
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Pollution prevention and Toxics, Washington, D.C.
Oomen PA; Jobsen JA; Romeijn G; Wiegers GL. 1994. Side-effects of 107 pesticides on the
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Appendix D D13 NAA RED Amendment
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APPENDIX D - BIBLIOGRAPHY
MRID
CITATION
Toxicology Chapter References
PC 056001: NAAAcetamide
00103050 Myers, R.; Bellich, N.; Cardella, M.; et al. (1982) Naphthalene Acetic Acid
(NAA) Amide: Rabbit Skin Irritancy Study: Project Report 45-47. (Unpublished
study received Jun 3, 1982 under 264-29; submitted by Union Carbide
Agricultural Products Co., Inc., Research Triangle Park, NC; CDL:247605-H)
00103051 Mallory, V.; Matthews, R.; Naismith, R.; et al. (1982) Acute Eye Irritation Test in
Rabbits: NAA Acetamide: Study No. PH 421-UC- 001-82. May 11, 1982.
Pharmakon Research International, Inc. Unpublished.
00108832 Mallory, V.; Matthews, R.; Naismith, R.; et al. (1982) Acute Dermal Toxicity
Test in Rabbits: NAA Acetamide: PH 422-UC-002-82. Pharmakon Research
International, Inc. May 11, 1982. Unpublished.
00108833 Mallory, V.; Matthews, R.; Naismith, R.; et al. (1982) Acute Oral Toxicity Study
in Rats (14 Day): Naphthalene Acetamide: PH 402-UC-002-82. Pharmakon
Research International, Inc. April 26, 1982. Unpublished.
43495901 Kuhn, J. (1994) Acute Oral Toxicity Study in Rats: Technical 1-
Napthaleneacetamide: Final Report: Lab Project Number: 1346-94: S9-FF81-1.
Unpublished study prepared by Still meadow, Inc. 13 p.
43495902 Kuhn, J. (1994) Acute Dermal Toxicity Study in Rabbits: Technical 1-
Napthaleneacetamide: Final Report: Lab Project Number: 1347-94: S9-FF81-2.
Unpublished study prepared by Still meadow, Inc. 13 p.
43495903 Holbert, M. (1994) Acute Inhalation Toxicity Study in Rats: Technical 1-
Napthaleneacetamide: Final Report: Lab Project Number: 1348-94: S9-FF81-3.
Unpublished study prepared by Still meadow, Inc. 24 p.
43495904 Kuhn, J. (1994) Primary Eye Irritation Study in Rabbits: Technical 1-
Napthaleneacetamide: Final Report: Lab Project Number: 1349-94: S9-FF81-4-6.
Unpublished study prepared by Still meadow, Inc. 17 p.
43495905 Kuhn, J. (1994) Guinea Pig Maximization Test for Topically Applied Test
Material: Technical 1-Napthaleneacetamide: Final Report: Lab Project Number:
1350-94: S9-FF81-6M. Unpublished study prepared by Still meadow, Inc. 19 p.
Appendix D
D14
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APPENDIX D - BIBLIOGRAPHY
MRID
CITATION
43581006 San, R.H.C. and M.L. Klug (1995) Salmonella Plate Incorporation Mutagenicity
Assay (Ames Test) With a Confirmatory Assay; Microbiological Associates, Inc.,
Rockville, MD; Report No. G94AU54.501001; Study Completion Date: February
6, 1995. Unpublished.
43896001 Trimmer, G. (1995) 90-Day Subchronic Oral Toxicity Study in the Rat with 1-
Naphthaleneacetamide (1-NAD) (MRD-94-834): Final Report: Lab Project
Number: 183470B. Unpublished study prepared by Exxon Biomedical Sciences,
Inc. 305 p.
43895901 Farrell, D. (1995) A 13-Week Oral (Capsule) Toxicity Study of 1-Naphthalene
Acetic Acid (1-NAD) in the Beagle Dog: Lab Project Number: 86451.
Unpublished study prepared by Bio-Research Labs, Ltd. 340 p. Relates to letters
L0000032, L0000007.
43581001 Trimmer, G. (1995) 21-Day Repeated Dose Dermal Toxicity Study in the Rat
with 1-Naphthaleneacetamide (MRD-94-834): Final Report: Lab Project Number:
183410B. Unpublished study prepared by Exxon Biomedical Sciences, Inc.
145 p.
43580202 San, R.; Clarke, J. (1995) L5178Y/TK(+/-) Mouse Lymphoma Mutagenesis
Assay with a Confirmatory Assay: Technical 1-Naphthaleneacetamide: Final
Report: Lab Project Number: G94AU54.702001: SPGT702001. Unpublished
study prepared by Microbiological Associates, Inc. 41 p.
43581005 Putman, D.; Young, R. (1994) Micronucleus Cytogenetic Assay in Mice:
Technical 1-Naphthaleneacetamide: Final Report: Lab Project Number:
G94AU54.122. Unpublished study prepared by Microbiological Associates, Inc.
36 p.
43963301 McCorquodale, G.; Prout, M. (1996) The Metabolism of (carbon 14)-1-
Naphthaleneacetamide in the Rat Following Oral Administration: Lab Project
Number: IRI 154791: 12346: 154791. Unpublished study prepared by Inveresk
Re search Internati onal. 13 6 p.
Appendix D
D15
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APPENDIX D - BIBLIOGRAPHY
MRID
CITATION
PC 056002 NAA
00042759 Naismith, R.W.; Matthews, R.J.; Schneider, C.; et al. (1978) Summary Data:
00042758 Mitotic Crossing over-Saccharomyces. Pharmakon Laboratories. Unpublished
Study.
00042761 Naismith, R.W.; Matthews, R.J.; Hoffman, P.A. (1978) Summary Data: Primary
DNA Damage, Escherichia coli Plate Test. Pharmakon Laboratories. July 25,
1978.
00042762 Matthews, R.J.; Naismith, R.W.; Hoffman, P.A. (1978) Summary Data: Ames
Salmonella/Microsome Plate Test (with and without Metabolic Activation) on:
Amchem 1-Naphthalene acetic acid, Lot GN-2095, Millmaster Onyx.
Pharmakon Laboratories. May 11, 1978.
00042763 Naismith, R.W.; Matthews, R.J.; Dixon, R.H. (1979) Summary Data: Genetic
Toxicology Micronucleus Test (MNT): Study No. PH-309-AM19-NAA.
Pharmakon Laboratories. January 30, 1979.
00042764 Naismith, R.W.; Matthews, R.J.; Panasevich, R.E.; et al. (1979). Dominant
Lethal Study (1-Naphthalene acetic acid -16388): Study No. PH-307-AM-118
NAA. Final Report. February 28, 1979.
00042765 Miller, T.J.; McElroy, K. (1977) Teratology Study with NAA acid(Technical) by
Gavage in the Albino Rat. Huntingdon Research Center: HRC # R-4216-4 (1-
350). Prepared by Pharmakon Laboratories, Unpublished Study. January 14,
1977.
00043623 McElroy, K.E.; Ward, C.O. (1976). Ten-Day Range Finding Study with NAA by
Daily Gavage to Rats: HRC # R-4216-4. Huntingdon Research Center.
Unpublished Study. 8 pages. August 16, 1976.
00043624 Larson, E.J.; Germano, A. (1979) Ninety-Day Toxicity Study in Rats with
Technical Naphthalene acetic acid: Study No. CDC-AM-006-78. Final rept.
prepared by CDC Research, Inc. Unpublished Study. March 10, 1979.
Appendix D
D16
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APPENDIX D - BIBLIOGRAPHY
MRID CITATION
00103127 Myers, R.; Mika, E.; Fowler, E.; et al. (1982) Naphthalene Acetic Acid (NAA):
Skin and Eye Irritancy Study: Project Report 45-51. April 27, 1982. Pharmakon
Research International, Inc. Unpublished.
00103128 Mallory, V.; Matthews, R.; Naismith, R.; et al. (1982) Acute OralToxicity Study
in Rats (14-Day): Naphthalene Acetic Acid: Study No. PH 402-UC-001-82.
Pharmakon Research International, Inc. April 29, 1982. Unpublished.
00103129 Mallory, V.; Matthews, R.; Naismith, R.; et al. (1982) Acute Dermal Toxicity
Test in Rabbits: NAA: Study No. PH 422-UC-001-82. Pharmakon Research
International, Inc. May 11, 1982. Unpublished.
00136446 Morita, D.; Hepler, D.; Beck, L.; et al. (1979) Six Month Oral Toxicity Study of
Naphthalene Acetic Acid in Beagle Dogs: Project No. 1395. Elars Bioresearch
Laboratories. Unpublished Study. May 3, 1979.
00137821 Schardein, 1; Cuddeback, B.; Aldridge, D.; et al. (1983) Range-Finding
Teratology Study in Rabbits: (Naphthalene Acetic Acid): 369-111. International
Research and Development Corp., Unpublished Study. October 28, 1983.
00137822 Schardein, 1; Miller, L.; Allen, S.; et al. (1983) Teratology Study in Rabbits:
(Naphthalene Acetic Acid): 369-105. International Research and Development
Corp., Unpublished Study. November 28, 1983.
00153217 Myers, R.; Christopher, S. (1984) Naphthalene Acetic Acid (NAA): Dermal
Sensitization Study in the Guinea Pig: Project Report 47- 80. Unpublished study
prepared by Union Carbide Corporation Bushy Run Research Center. 26 p. July
11, 1984. Unpublished.
NAA Sodium Salt
00108829
42932601
Myers, R.; Christopher, S.; Belliah, N.; et al. (1982) NAA (Naphthalene Acetic
Acid) Sodium Salt: Acute Toxicity and Irritancy Studies: Project Report 45-45.
May 27, 1982 Unpublished.
Plutnick, R. (1993) 90-Day Dietary Toxicity Study in Rats with 1-
Naphthaleneacetic Acid-Sodium Salt (1-Na-NAA): Final Report: Lab Project
Number: 134970A: MRD-92-349. Unpublished study prepared by Exxon
Biomedical Sciences, Inc. 337 p. September 8, 1993. Unpublished.
Appendix D
D17
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APPENDIX D - BIBLIOGRAPHY
MRID CITATION
42983801 Kangas, L. (1993) A 13-Week Oral (Capsule) Toxicity Study of 1-
Naphthaleneacetic Acid Sodium Salt in the Beagle Dog: Lab Project Number:
85211. Bio-Research Labs, Inc. 382 p. October 8, 1993. Unpublished.
43134701 Trimmer, G. (1994) 21-Day Repeated Dose Dermal Toxicity Study in Rats with
1-Naphthaleneacetic Acid Sodium Salt (1-Na-NAA): Final Report: Lab Project
Number: 134910B. Exxon Biomedical Sciences, Inc. 213 p. February 8, 1994.
Unpublished.
43744201 Kangas, L. (1995) A 52-Week Oral (Capsule) Toxicity Study of 1-
Naphthaleneacetic Acid Sodium Salt in the Beagle Dog: Lab Project Number:
85212. Unpublished study prepared by Bio-Research Labs, Ltd. 517 p.
43796301 Trimmer, G. (1995) Two Generation Reproduction Toxicity Study in Rats With
1-Naphthaleneacetic Acid Sodium Salt (1-Na-NAA) (MRD-92-349). Exxon
Biomedical Sciences, Inc., East Millstone, New Jersey. Report no. 134935,
August 18, 1995. Unpublished.
44157501 Drummond, J. (1992) Two-Year Chronic Toxicity/Oncogenicity Study in Rats
with 1-Naphthaleneacetic Acid Sodium salt (1-Na-NAA) (MRD-92-349): Final
Report: Lab Project Number: 134970B. Unpublished study prepared by Exxon
Biomedical Sciences, Inc. 2823 p.
PC 056008 NAA Ethyl Ester
00103217 Mallory, V.; Matthews, R.; Naismith, R.; et al. (1982) Acute Eye I Irritation Test
in Rabbits: NAA Ethyl Ester: Study No. PH 421-UC-002-82. May 11, 1982.
Pharmakon Research International, Inc. Unpublished.
00103218 Myers, R.; Mika, E.; Cardella, M.; et al. (1982) Naphthalene Acetic Acid (NAA)
Ethyl Ester: Rabbit Skin Irritancy Study: Project Report 45-46. April 22, 1982.
Union Carbide Corporation, Bushy Run Research Center, Pennsylvania.
Unpublished.
00103052 Mallory, V.; Matthews, R.; Naismith, R.; et al. (1982) Acute Eye I
Irritation Test in Rabbits: NAA Ethyl Ester: Study No. PH 421-UC-002-82.
May 11, 1982. Pharmakon Research International, Inc. Unpublished.
Appendix D
D18
NAA RED Amendment
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APPENDIX D - BIBLIOGRAPHY
MRID CITATION
00103053 Myers, R.; Mika, E.; Cardella, M.; et al. (1982) Naphthalene Acetic Acid (NAA)
Ethyl Ester: Rabbit Skin Irritancy Study: Project Report 45-46. April 22, 1982.
Union Carbide Corporation, bushy Run Research Center, Pennsylvania.
Unpublished.
00108830 Mallory, V.; Matthews, R.; Naismith, R.; et al. (1982) Acute Dermal Toxicity
Test in Rabbits: NAA Ethyl Ester: PH 422-UC-003-82. Pharmakon Research
International, Inc. May 14, 1982. Unpublished.
00108831 Mallory, V.; Matthews, R.; Naismith, R.; et al. (1982) Acute Oral Toxicity Study
in Rats (14 Day): NAA Ethyl Ester: PH 402-UC-003- 82. Pharmakon Research
International, Inc. May 3, 1982. Unpublished.
43494101 Kuhn, J. (1994) Acute Oral Toxicity Study in Rats: Technical 1-
Naphthaleneacetic Acid, Ethyl Ester: Final Report: Lab Project Number: 1351-94.
Unpublished study prepared by Still meadow, Inc. 21 p.
43494102 Kuhn, J. (1994) Acute Dermal Toxicity Study in Rabbits: Technical 1-
Naphthaleneacetic Acid, Ethyl Ester: Final Report: Lab Project Number: 1352-
94. Unpublished study prepared by Still meadow, Inc. 14 p.
43494103 Holbert, M. (1994) Acute Inhalation Toxicity Study in Rats: Technical 1-
Naphthaleneacetic Acid, Ethyl Ester: Final Report: Lab Project Number: 1353-
94. Unpublished study prepared by Still meadow, Inc. 19 p.
43494104 Kuhn, J. (1994) Primary Eye Irritation Study in Rabbits: Technical 1-
Naphthaleneacetic Acid, Ethyl Ester: Final Report: Lab Project Number: 1354-94.
Unpublished study prepared by Still meadow, Inc. 17 p.
43494105 Kuhn, J. (1994) Guinea Pig Maximization Test for Topically Applied Test
Material: Technical 1-Naphthaleneacetic Acid, Ethyl Ester: Final Report: Lab
Project Number: 1355-94. Unpublished study prepared by Still meadow, Inc.
19 p.
43896002 Trimmer, G. (1995) 90-Day Subchronic Oral Toxicity Study in the Rat with 1-
Naphthaleneacetic Acid Ethyl Ester (1-NAAEt) (MRD-94-835): Final Report:
Lab Project Number: 183570. Unpublished study prepared by Exxon Biomedical
Sciences, Inc. 295 p.
Appendix D
D19
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APPENDIX D - BIBLIOGRAPHY
MRID CITATION
43914901 Farrell, D. (1995) A 13-Week Oral (Capsule) Toxicity Study of 1-
Naphthaleneacetic Acid, Ethyl Ester (1-NAAET) in the Beagle Dog: Lab Project
Number: 86452. Unpublished study prepared by Bio-Research Labs, Ltd. 334 p.
43581002 Trimmer, G. (1995) 21-Day Repeated Dose Dermal Toxicity Study in the Rat
with 1-Naphthaleneacetic Acid, Ethyl Ester (MRD-94-835): Final Report: Lab
Project Number: 18351 OB. Unpublished study prepared by Exxon Biomedical
Sciences, Inc. 145 p.
43580201 San, R.; Clarke, J. (1995) L5178Y/TK(+/-) Mouse Lymphoma Mutagenesis
Assay with a Confirmatory Assay: Technical 1-Naphthaleneacetic Acid, Ethyl
Ester: Final Report: Lab Project Number: G94AU53.702001: SPGT702001.
Unpublished study prepared by Microbiological Associates, Inc. 41 p.
43581003 Putman, D.; Young, R. (1994) Micronucleus Cytogenetic Assay in Mice:
Technical 1-Naphthaleneacetic Acid, Ethyl Ester: Final Report: Lab Project
Number: G94AU53.122. Unpublished study prepared by Microbiological
Associates, Inc. 36 p.
43581004 San, R.; Klug, M. (1994) Salmonella Plate Incorporation Mutagenicity Assay
(Ames Test) with a Confirmatory Assay: Technical 1-Naphthaleneacetic Acid,
Ethyl Ester: Final Report: Lab Project Number: G94AU53.501001. Unpublished
study prepared by Microbiological Associates, Inc. 56 p.
43581006 San, R.; Klug, M. (1995) Salmonella Plate Incorporation Mutagenicity Assay
(Ames Test) with a Confirmatory Assay: Technical 1-Naphthaleneacetamide:
Final Report: Lab Project Number: G94AU54.501001. Unpublished study
prepared by Microbiological Associates, Inc. 56 p.
43961701 McCorquodale, G.; Prout, M. (1996) The Metabolism of (carbon 14)-1-
Naphthaleneacetic Acid, Ethyl Ester in the Rat Following Oral Administration:
Lab Project Number: 154702: 12149. Unpublished study prepared by Inveresk
Research International. 124 p.
Appendix D
D20
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APPENDIX D - BIBLIOGRAPHY
MRID
CITATION
Published Literature
Dixon PAF; Caldwell J; Smith R. 1977. 1. The Fate of Naphthylacetic acid and its variation
with Species and Dose. Xenobiotica 7(11):695-706. (MRID 05008052)
Lethco EJ; Brouwer EA. 1966. The Metabolism of Naphthaleneacetic Acid-l-C14 in Rats. J
Agr. FoodChem. 14(5):532-535. (MRID 00004942)
Innes JR, Ulland BM, Valerio MG, Petrucelli L, Fishbein L, Hart ER, Pallotta AJ, Bates RR,
Falk HL, Gart JJ, Klein M, Mitchell I, Peters J. 1969. Bioassay of Pesticides and Industrial
Chemicals for Tumorigenicity in Mice: a Preliminary Note. J. Natl Cancer Inst. 42:1101-1114.
Fletcher, John. 2002. Endometrial Stromal Polyps. E-mail letter to William Burnam of
EPA/HED. 04/04/2002.
Residue Chemistry Chapter References
00004916 Zweig, G.; Gutnick, D.L.; Gulli, R.; Archer, T.E.; Hartmann, H.T. (1962) Residue
Determination of Naphthaleneacetic acid in Olives. Undated method.
(Unpublished study received Jan 25, 1963 under 642-149; prepared by Univ. of
California—Davis, Dept. of Pomology, and Agricultural Toxicology and Residue
Research Laboratory, submitted by Thompson Chemicals Corp., Carson, Calif;
CDL:119788-B)
00004942 Lethco, E.J.; Brouwer, E.A. (1966) The metabolism of naphthaleneacetic acid-1-
C14 in rats. Journal of Agriculture and Food Chemistry 14(5):532-535. (Also In
unpublished submission received Nov 25, 1970 under 1E1099; submitted by
Interregional Research Project No. 4, New Brunswick, N.J.; CDL:090859-A)
00004943 Crosby, D.G.; Bowers, J.B.; Shindy, W.W. (1970) 1-Naphthaleneacetic acid in
Olives. Includes two undated methods. (Unpublished study received Nov 25,
1970 under 1E1099; prepared by Univ. of California - Davis, Dept. of
Environmental Toxicology and Agricultural Experiment Station, submitted by
Interregional Research Project No. 4, New Brunswick, N.J.; CDL:090859-B)
Appendix D
D21
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APPENDIX D - BIBLIOGRAPHY
MRID CITATION
00004946 Young, H.Y.; Shimabukuro, S.; Aono, L. (1963) Spectrophotometric
microdetermination of 1-Naphthaleneacetic acid in pineapple. Agricultural and
Food Chemistry 11(2): 132-133. (Pineapple Research Institute of Hawaii,
Technical paper no. 284; also In unpublished submission received Nov 25, 1970
under 1E1099; submitted by Interregional Research Project No. 4, New
Brunswick, N.J.; CDL:090859-F)
00004948 Veen, H. (1966) Transport, immobilization and localization of Naphthylacetic
acid-l-14C in Coleus explants. Acta Botanica Neerlandica 15:419-433. (Also In
unpublished submission received Nov 25, 1970 under 1E1099; submitted by
Interregional Research Project No. 4, New Brunswick, N.J.; CDL:090859-H)
00004949 Zweig, G.; Gutnick, D.L.; Gulli, R.; Archer, T.E.; Hartmann, H.T. (1964) Residue
determination of Naphthaleneacetic acid in olives. Agricultural and Food
Chemistry 12(1):59-61. (Also In unpublished submission received Nov 25, 1970
under 1E1099; submitted by Interregional Research Project No. 4, New
Brunswick, N.J.; CDL:090859-I)
00051218 Markle, G.M. (1978) Letter sent to Clinton Fletcher dated Nov 21, 1978 Data to
support pesticide petition for NAA in citrus]. Includes methods entitled:
Determination of Bidrin, Azodrin, and their metabolites with the thermionic
detector and Determination of Napthaleneacetic acid (NAA) in oranges,
tangerines and processed products: High performance liquid chromatography with
fluorometric detection. (Unpublished study including published data, received on
unknown date under 7E1956; prepared in cooperation with U.S. Environmental
Protection Agency and others, submitted by Interregional Research Project No. 4,
New Brunswick, N.J.; CDL:097660-1)
00060940 Citation: Interregional Research Project Number 4 (1976?) Summary of Petition
Proposing a Tolerance for Residues of the Growth Regulator Alpha-
Naphthaleneacetic acid in or on Citrus Fruits. (Unpublished study received on
unknown date under 7E1956; CDL: 097660-A)
00060941 Coggins, C.W., Jr.; Jolliffe, V.A.; Shindy, W.W.; et al. (1972) Naphthaleneacetic
acid disappearance and residue studies in citrus. Journal of Agricultural and Food
Chemistry 20(l):76-78. (Incomplete; also~In~unpublished submission received
on unknown date under 7E1956; submitted by Interregional Research Project No.
4, New Brunswick, N.J.; CDL:097660-D)
Appendix D
D22
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APPENDIX D - BIBLIOGRAPHY
MRID CITATION
00060942 Interregional Research Project Number 4 (19??) NAA Disappearance and Residue
Data: Kinnow Mandarin]. (Unpublished study received on unknown date under
7E1956; CDL:097660-E)
00060943 University of Florida, Agricultural Research and Education Center (1975)
Residue Data of NAA in Fruits. (Compilation; unpublished study received on
unknown date under 7E1956; submitted by Interregional Research Project No. 4,
New Brunswick, N.J.; CDL: 097660-F)
00114389 Interregional Research Project No. 4 (1981) The Results of Tests on the Amount
of NAA Residues Remaining in or on Sweet Cherries, Including a Description of
the Analytical Method Used. Compilation; unpublished study received Sep 21,
1982 under 2E2760; CDL:071099-B.
00114390 Interregional Research Proj ect No. 4 (1972) Study: NAA Spray Efficacy on the
Cracking of Cherries. Compilation; unpublished study received Sep 21, 1982
under 2E2760; CDL:071099-C.
00159237 Shindy, W.; Jordan, L.; Jolliffe, V.; et al. (1973) Metabolism of
[C14]napthaleneacetic acid in Kinnow mandarin. Journal of Agricultural and
Food Chemistry 21(4):629-631.
00161042 Interregional Research Project #4 (1978) [Residues of Naphthalene- acetic Acid
in Citrus Fruits]. Unpublished compilation. 32 p.
05002768 Randall, R.C. (1970) UV determination of naphthaleneacetic acid in apples and
potatoes. Journal of the Association of Official Analytical Chemists 53(1): 149-
151.
05007966 French, M.R.; Bababunmi, E.A.; Golding, R.R.; Bassir, O.; Caldwell, J.; Smith,
R.L.; Williams, R.T. (1974) The conjugation of phenol, benzoic acid, 1-
naphthylacetic acid and sulphadimethoxine in the lion, civet and genet. FEES
Letters 46(1): 134-137.
05007967 Sigrist, R.; Temperli, A.; Hurter, J. (1974) A fluorometric method for the
determination of residues of 1-naphthaleneacetamide and 1-naphthaleneacetic
acid on apples. Journal of Agricultural and Food Chemistry 22(4):568-570.
Appendix D
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APPENDIX D - BIBLIOGRAPHY
MRID CITATION
05008052 Dixon, P.A.F.; Caldwell, I; Smith, R.L. (1977) Metabolism of arylacetic acids:
1_ The fate of 1-naphthylacetic acid and its variation with species and dose.
Xenobiotica 7(11):695-706.
05008057 Dixon, P.A.F.; Caldwell, I; Woods, C.J.; Smith, R.L. (1976) Influence of
chemical structure on the pattern of conjugation in vivo and in vitro of some
arylacetic acids in the rat. Biochemical Society Transactions 4(1): 143-145.
05008068 Bache, C.A.; Edgerton, L.J.; Lisk, DJ. (1962) Determination of naphthaleneacetic
acid in apples. Journal of Agricultural and Food Chemistry 10(5):365-366.
05008070 Idle, J.R.; Millburn, P.; Williams, R.T.; Zini, G. (1976) The conjugation of
arylacetic acids in the pigeon compared with the hen. Biochemical Society
Transactions 4(1): 141-143.
05008090 Shindy, W.W.; Jordan, L.S.; Joliffe, V.A.; Coggins, C.W., Jr.; Kumamoto, J.
(1973) Metabolism of [14C]naphthaleneacetic acid in Kinnow mandarin. Journal
of Agricultural and Food Chemistry. 21 (4):629-631.
05008121 Cochrane, W.P.; Lanouette, M. (1979) High pressure liquid chromatographic
determination of naphthaleneacetic acid residues in apples. Journal of the
Association of Official Analytical Chemists 62(1): 100-106.
05009008 Morris, D.A.; Thomas, A.G. (1974) The specificity of auxin transport in intact
pea seedlings (Pimm sativum L.). Planta 118(3):225-234.
05009108 Brenner, M.L.; Tonkinson, T.R.C. (1974) Extraction and identification of L-N-
[(1-naphthyl) acetyl] glutamic acid, a major product of naphthaleneacetic acid
metabolism. Pages 759-764, In Mechanisms of Regulation of Plant Growth.
Edited by R.L. Bieleski, A.R. Ferguson, and M.M. Cresswell. Wellington, New
Zealand: Royal Society of New Zealand Bulletin No. 12; Minnesota Agricultural
Experiment Station Scientific Journal Series Paper No. 8409.
05009196 Bukovac, M.J.; Flore, J.A.; Goren, R. (1976) Conjugation of foliar absorbed by
NAA by selected fruit crops. Hort. Science 11(4):389-390.
05020083 Cochrane, W.P.; Lanouette, M.; Grant, R. (1980) High pressure liquid
chromatographic determination of naphthaleneacetamide residues in apples.
Journal of the Association of Official Analytical Chemists 63(1): 145-148.
Appendix D
D24
NAA RED Amendment
-------
APPENDIX D - BIBLIOGRAPHY
MRID
CITATION
40884401 Nygren, R. (1988) NAA-NAA Amide: Apples Section D Residues: Project ID:
860R10; File No. 40380. Unpublished study prepared by Rhone-Poulenc Ag Co.,
and Morse Laboratories, Inc. 74 p.
40884402 Nygren, R. (1988) NAA-NAA Amide: Pears Section D Residues: Project ID:
860R10; File No. 40337. Unpublished study prepared by Rhone-Poulenc Ag Co.,
and Morse Laboratories, Inc. 73 p.
43482101 Obrist, J. (1994) NAA Bridging Study: Determination of the Half-life of
Naphthaleneacetic Acid, (NAA), Naphthaleneacetamide, and Naphthaleneacetic
Acid Ethyl Ester on Apple Leaves: Lab Project Number: 94399. Unpublished
study prepared by Pan-Agricultural Labs, Inc. 136 p.
43692301 Krautter, G.; Downs, J.; Marsh, J. (1995) The Metabolism of (carbon 14)-1-
Naphthylacetic Acid in the Lactating Goat: Lab Project Number: 870: 1673.
Unpublished study prepared by PTRL East, Inc. 95 p.
43948501 Obrist, J.; Crabtree, K.; Larson, J. (1996) NAA: Apple Metabolism Study Using
Naphthaleneacetic Acid, Naphthaleneacetamide and Naphthaleneacetic Acid,
Ethyl Ester: Final Report: Lab Project Number: 95457: ABC/CA# 95457:
6083.38. Unpublished study prepared by ABC Labs., California. 124 p.
44184401 Hathaway, M. (1996) Analysis of Apple, Pear, and Olive Fruit Tissue (Raw
Agricultural Commodity (RAC)) for Naphthaleneacetamide by Protocol C, D, and
E, Appendix II, FDA Pesticide Analytical Manual Vol. I, 3rd Edition: Lab Project
Number: AA960315: 4-96-1. Unpublished study prepared by Southern Testing
and Research Labs., Inc. 44 p.
44190501 Obrist, J.; Crabtree, K.; Larson, J. (1996) NAA: Olive Metabolism Study Using
Naphthaleneacetic Acid and Naphthaleneacetic Acid, Ethyl Ester: Final Report:
Lab Project Number: 95458. Unpublished study prepared by ABC Labs., CA 107
P-
44555401 Singer, G. (1998) Magnitude of the Residue of Napthaleneacetic Acid in/on Olive
Processed Commodities: Lab Project Number: AA960305: 4-97-4: AA960304.
Unpublished study prepared by American Agricultural Services, Inc., Southern
Testing and Research Laboratories, Inc. 228 p. (OPPTS 860.1520}.
Appendix D
D25
NAA RED Amendment
-------
APPENDIX D - BIBLIOGRAPHY
MRID CITATION
44555402 Singer, G. (1998) Magnitude of the Residue of Napthaleneacetic Acid in/on Olive
Raw Agricultural Commodities: Lab Project Number: AA960306: 4-97-5.
Unpublished study prepared by American Agricultural Services, Inc., Southern
Testing and Research Labs., Inc. 136 p. (OPPTS 860.1500}
44555403 Sterling, J. (1997) Independent Laboratory Validation of Analytical Method
NAA-AM-002 Recommended Analytical Residue Method for 1-
Naphthaleneacetic Acid, 1-Naphthaleneacetamide, and/or 1-Naphthaleneacetic
Acid Ethyl Ester, in Olive and Olive Oil Matrices: Lab Project Number:
AA970303: 4-97-3: NAA-AM-002. Unpublished study prepared by Southern
Testing and Research Laboratories, Inc. 71 p. {OPPTS 860.1340}
44586501 Singer, G. (1997) Magnitude of the Residue of Naphthaleneacetic Acid in/on
Processed Apple Commodities: Final Report: Lab Project Number: AA960304: 4-
96-3: AA950304. Unpublished study prepared by American Agricultural
Services, Inc. and Southern Testing and Research Labs., Inc. 212 p. {OPPTS
860.1520}
44586502 Hathaway, M.(1997) Independent Laboratory Validation of Analytical Method
NAA-AM-001: Recommended Analytical Residue method 1-Naphthaleneacetic
Acid, 1-Naphthaleneacetic, and/or 1-Naphthaleneacetic Acid Ethyl Ester, in
Apple and Pear Matrices: Lab Project Number: AA960319: 4-96-2:NAA-AM-
011. Unpublished study prepared by Southern Testing and Research labs., Inc. 72
p. {OPPTS 860.1340}
44660201 Hathaway, M. (1998) Frozen Storage Stability of Naphthaleneacetic acid in
Apples: Lab Project Number: AA970301: 4-97-1: NAA-AM-001. Unpublished
study prepared by Southern Testing and Research Laboratories, Inc. 78 p.
{OPPTS 860.1380}
44660202 Hathaway, M. (1998) Frozen Storage Stability of Naphthaleneacetic acid in Pears:
Lab Project Number: AA970302: 4-97-2: NAA-AM-001. Unpublished study
prepared by Southern Testing and Research Laboratories, Inc. 79 p. {OPPTS
860.1380}
44835301 Hathaway, M. (1999) Frozen Storage Stability of Naphthaleneacetic Acid in
Olives: Lab Project Number: 4-97-6: AA970304. Unpublished study prepared by
Southern Testing and Research Laboratories, Inc., North Carolina. 66 p.
Appendix D
D26
NAA RED Amendment
-------
APPENDIX D - BIBLIOGRAPHY
MRID CITATION
45283601 Lange, B. (2000) Determination of the Magnitude of the Residue of
Naphthaleneacetic Acid on Apples Following the Sequential Applications of
Various Formulations Ethyl 1-naphthylacetate, 1-naphthylacetamide, and 1-
naphthyleneacetic Acid: Lab Project Number: ERS-99075: 45648: WAI.
Unpublished study prepared by Excel Research Services, Inc. 196 p. (OPPTS
860.1500}
45283602 Lange, B. (2000) Determination of the Magnitude of the Residue of
Naphthaleneacetic Acid on Pears Following the Sequential Applications of
Various Formulations Ethyl 1-naphthylacetate, 1-naphthylacetamide, and 1-
naphthyleneacetic Acid: Lab Project Number: ERS-99076: 45409: WAI.
Unpublished study prepared by Excel Research Services, Inc. 195 p. {OPPTS
860.1500}
GS0023012 Amchem Products (1978) Determination of residues of 1-naphthaleneacetic acid
(NAA) and 1-naphthaleneacetic acid, ethyl ester (EtNAA) in olives. April, 1978.
[Document 4783A3; PP#OF2277 OF2277, CDL:099028; SectD-3; pages 1
through 16.]
GS0023019 Amchem Products (1978) Analysis of pear samples for possible residues of NAA
and NAA ethyl ester [PP#OF2277; CDL:099028; EPA Reg. No. 264-336; Sec D-
4.]
GS0023036 Amchem Products (1978) Analysis of apple samples for possible residues of
NAA and NAA methyl ester [PP#OF2277; CDL:099028; EPA Reg. No. 264-336;
SecD-5.]
Occupational & Residential Exposure
Pesticide Handlers Exposure Database (PHED) Surrogate Exposure Guide; US
EPA; August 1998
Outdoor Residential Exposure Task Force (ORETF) data; May 2000.
Label & Usage Information System (LUIS); US EPA; January 2000
Appendix D
D27
NAA RED Amendment
-------
APPENDIX E - DRAFT GENERIC DATA CALL-IN FORMS
The following pages contain a draft version of the Generic Data Call-In for products
containing any of the following active ingredients: 1-Naphthaleneacetamide (PC Code 056001),
1-Naphthalene acetic acid (PC Code 056002), Potassium 1-naphthaleneacetate (PC Code
056003), Ammonium 1-naphthaleneacetate (PC Code 056004), Sodium 1-naphthaleneacetate
(PC Code 056007), Ethyl 1-naphthaleneacetate (PC Code 056008).
Appendix E El NAA RED Amendment
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-010?
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0379 Napthaleneacetic Acid DD-MMM-YYYY
NO STREET ADDRESS Chemical # and Name 056001 GENERIC
NO CITY, XX 00000 . 1 -Naphthaleneacetamide
ID# GDCI-056001-NNNNN
4. EPA
Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
I agree to sat sfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any g pate
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company ^ Rhone Number
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.7050
860.1380
860.1520
860.1520
860.1520
860.1520
860.1520
860.1650
2. Case # and Name 3. Date and Type of DCI and Number
0379 Napthaleneacetic Acid DD-MMM-YYYY
Chemical # and Name 056001 GENERIC
1-Naphthaleneacetamide ,D # QDCI-056001-NNNNN
5. Study Title
Product Chemistry Data Requirements (Conventional
Chemical)
UV/Visible absorption
Residue Chemistry Data Retirements for Food Uses
(Conventional Chemical)
Storage stability data
Processed food/feed(CITRUS)
(1 ,2 ,3 ,4)
(5,6)
Processed food/feed(CITRUS, DRIED PULP) (7 ,8)
Processed food/feed(CITRUS, JUICE)
Processed food/feed(CITRUS, MEAL)
Processed food/feed(CITRUS, OIL)
(9,10)
(13,14)
(11,12)
Submittal of analytical reference standards (15)
P
R
O
T
O
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
7. Test
Substance
TGAI/PAI
TEP or res of concrn
TEP
TEP
TEP
TEP
TEP
PAI & res of concern
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
12. Name of Company
8. Time
Frame
(Months)
8
24
24
24
24
24
24
24
9. Registrant
Response
11. Date
13. Phone Number
-------
DRAFT COPY _ . _,
Page 1 of 2
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: GDCI-056001-NNNNN
Key: PAI & res of concern = Pure Active Ingredient and Residue of Concern; TEP = Typical End Use Product [TEP]; TEP or res of concrn = Typical End-Use Product or Residue of Concern; TGAI/PAI:
Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop K - Residential
B - Terrestrial feed crop
C - Terrestrial nonfood crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Required for residential outdoor use on food crops if home gardens are to be treated or the home garden use is different from the agricultural use pattern on which the tolerance is established.
2 Data are required for any magnitude of the residue study unless analytical samples are stored frozen for 30 days or less, and the active ingredient is not known to be volatile or labile.
3 No storage stability data on the processed commodities of apples (or citrus fruits) and olives are available, and these data are required for reregistration. The requested storage stability data
for apple and olive processed commodities should reflect up to 143 and 283 days of freezer storage, respectively, since these were the maximum storage intervals of samples in the respective
processing studies.
4 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
5 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
6 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
7 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
8 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
9 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
10 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
11 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
12 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
13 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
14 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
-------
DRAFT COPY
Page 2 of 2
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: GDCI-056001-NNNNN
Key: PAI & res of concern = Pure Active Ingredient and Residue of Concern; TEP = Typical End Use Product [TEP]; TEP or res of concrn = Typical End-Use Product or Residue of Concern- TGAI/PAI
Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop K - Residential
B - Terrestrial feed crop
C - Terrestrial nonfood crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
15 Material safety data sheets must accompany standards as specified by OSHA in 29 CFR 1910.1200.
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-010?
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0379 Napthaleneacetic Acid DD-MMM-YYYY
NO STREET ADDRESS Chemical # and Name 056002 GENERIC
NO CITY, XX 00000 1 -Naphthaleneacetic acid |Q # GDCI_056002_NNNNN
4. EPA
Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any g Date
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company 11. Phone Number
-------
-xv^ t_ v,^r i Pagelof!
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.7050
860.1380
860.1520
860.1520
860.1520
860.1520
860.1520
860.1650
2. Case # and Name 3. Date and Type of DCI and Number
0379 Napthaleneacetic Acid DD-MMM-YYYY
Chemical # and Name 056002 GENERIC
1 -Naphthaleneacetic acid |Q # GDCI.o56oo2-NNNNN
5. Study Title
Product Chemistry Data Reauirements (Conventional
Chemical)
UV/Visible absorption
Residue Chemistrv Data Reauirements for Food Uses
Conventi9nal Qhemical)
Storage stability data (1 ,2 ,3 ,4)
Processed food/feed(CITRUS) (5 ,6 ,7)
Processed food/feed(CITRUS, DRIED PULP) (8 ,9,10)
Processed food/feed(CITRUS, JUICE) (1 1 ,12 ,13)
Processed food/feed(CITRUS, MEAL) (17,18,19)
Processed food/feed(CITRUS, OIL) (14 ,15 ,16)
Submittal of analytical reference standards (20)
R
O
T
O
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, K, M, O
A, B, C, K, M, O
A, B, C, K, M, O
A, B, C, K, M, O
A, B, C, K, M, O
A, B, C, K, M, O
A, B, C, K, M, O
A, B, C, K, M, O
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
7. Test
Substance
TGAI/PAI
TEP or res of concrn
TEP
TEP
TEP
TEP
TEP
PAI & res of concern
8. Time
Frame
(Months)
8
24
24
24
24
24
24
24
9. Registrant
Response
11. Date
13. Phone Number
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: GDCI-056002-NNNNN
Tunica
Use Categories Key:
A - Terrestrial food crop
B - Terrestrial feed crop
C - Terrestrial nonfood crop
TEP " - °f C°nCm =
End'Use PradUC< Or Residue °f Concern; TGA,/PA, =
K - Residential
M - Indoor nonfood use
O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
Required for residential outdoor use on food crops if home gardens are to be treated or the home garden use is different from the agricultural use pattern on which the tolerance is established.
Data are required for any magnitude of the residue study unless analytical samples are stored frozen for 30 days or less, and the active ingredient is not known to be volatile or labile.
nrn«»«aH ' HV h w « °' apples (Or C'1rUS fmits) and olives are available' and tnese data are required for reregistration. The requested storage stability data
processed commodities should reflect up to 143 and 283 days of freezer storage, respectively, since these were the maximum storage intervals of samples in the respecL
4
5
6
7
8
9
10
12
13
14
Must be conducted on apple and/or citrus
hinhth 'eVel °- "f dTS in Pr°cessed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing. iterance
An acceptable food processing study has been completed for apple.
Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agncultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing. ^P3™6 wwraroe
Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
An acceptable food processing study has been completed for apple.
h-3,!? °?hthe,hattUrf *hnd l6Vel °- rlSidU,6S in Processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing. romance
Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
An acceptable food processing study has been completed for apple.
'eVel °' re;SidU,eS in pr°cesstd food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: GDCI-056002-NNNNN
**
™ °' "» °f °°nCm =
Use Categories Key:
A - Terrestrial food crop
B - Terrestrial feed crop
C - Terrestrial nonfood crop
K - Residential
M - Indoor nonfood use
O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
15 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
16
17
18
19
20
An acceptable food processing study has been completed for apple.
Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing. sePa™e tolerance
Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
An acceptable food processing study has been completed for apple.
Material safety data sheets must accompany standards as specified by OSHA in 29 CFR 1910.1200.
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-010?
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address 2. Case* and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0379 Napthaleneacetic Acid DD-MMM-YYYY
NO STREET ADDRESS Chemical # and Name 056003 GENERIC
NO CITY, XX 00000 Potassium 1 -naphthaleneacetate
ID # GDCI-056003-NNNNN
4. EPA
Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
I agree to sat sfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any 9 Date
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company ^ phone Number
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-010?
Agency Washington, D.C. 20460 OMB APProval 2070-0057
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.7050
860.1380
860.1520
860.1520
860.1520
860.1520
860.1520
860.1650
2. Case # and Name 3. Date and Type of DCI and Number
0379 Napthaleneacetic Acid DD-MMM-YYYY
Chemical # and Name 056003 GENERIC
Potassium 1 -naphthaleneacetate |D # QDCI-056003-NNNNN
5. Study Title
Product Chemistry Data Reaulrements (Conventional
Chemical)
UV/Visible absorption
Residue Chemistry Data Reauirements for Food Uses
(Conventional Chemical)
Storage stability data
Processed food/feed(CITRUS)
(1 ,2 ,3 ,4)
(5 ,6)
Processed food/feed(CITRUS, DRIED PULP) (7 ,8)
Processed food/feed(CITRUS, JUICE)
Processed food/feed(CITRUS, MEAL)
Processed food/feed(CITRUS, OIL)
(9,10)
(13,14)
(11 ,12)
Submittal of analytical reference standards (15)
P
R
O
T
O
C
0
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
7. Test
Substance
TGAI/PAI
TEP or res of concrn
TEP
TEP
TEP
TEP
TEP
PAI & res of concern
8. Time
Frame
(Months)
8
24
24
24
24
24
24
24
9. Registrant
Response
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any 11. Date
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
12. Name of Company
13. Phone Number
-------
DRAFT COPY _ H tn
Page 1 of 2
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: GDCI-056003-NNNNN
Key: PAI & res of concern = Pure Active Ingredient and Residue of Concern; TEP = Typical End Use Product [TEP]; TEP or res of concrn = Typical End-Use Product or Residue of Concern- TGAI/PAI:
Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop K - Residential
B - Terrestrial feed crop
C - Terrestrial nonfood crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Required for residential outdoor use on food crops if home gardens are to be treated or the home garden use is different from the agricultural use pattern on which the tolerance is established.
2 Data are required for any magnitude of the residue study unless analytical samples are stored frozen for 30 days or less, and the active ingredient is not known to be volatile or labile.
3 No storage stability data on the processed commodities of apples (or citrus fruits) and olives are available, and these data are required for reregistration. The requested storage stability data
for apple and olive processed commodities should reflect up to 143 and 283 days of freezer storage, respectively, since these were the maximum storage intervals of samples in the respective
processing studies.
4 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
5 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
6 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
7 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
8 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
9 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
10 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
11 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
12 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
13 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
14 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
-------
DRAFT COPY „ „ .„
Page 2 of 2
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
PCI Number; GDCI-056003-NNNNN
Key: PAI & res of concern = Pure Active Ingredient and Residue of Concern; TEP = Typical End Use Product [TEP]; TEP or res of concrn = Typical End-Use Product or Residue of Concern- TGAI/PAI =
Technical Grade Active Inaredient. Pure Active Inaredient
Use Categories Key:
A - Terrestrial food crop K - Residential
B - Terrestrial feed crop
C - Terrestrial nonfood crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
15 Material safety data sheets must accompany standards as specified by OSHA in 29 CFR 1910.1200.
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. EPA
Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
2. Case # and Name 3. Date and Type of DCI and Number
0379 Napthaleneacetic Acid DD-MMM-YYYY
Chemical # and Name 056004 GENERIC
Ammonium 1 -naphthaleneacetate
ID # GDCI-056004-NNNNN
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any q Datp
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company 11. Phone Number
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.7050
860.1380
860.1520
860.1520
860.1520
860.1520
860.1520
860.1650
2. Case # and Name 3. Date and Type of DCI and Number
0379 Napthaleneacetic Acid DD-MMM-YYYY
Chemical # and Name 056004 GENERIC
Ammonium 1 -naphthaleneacetate |D# QDCI-056004-NNNNN
5. Study Title
Product Chemistrv Data Reauiremgrjt? (Conventional
Chemical)
UV/Visible absorption
Residue Chemistrv Data Reauirements for Food Uses
'Conventional Chemical)
Storage stability data
Processed food/feed(CITRUS)
(1 ,2 ,3 ,4)
(5,6)
Processed food/feed(CITRUS, DRIED PULP) (7 ,8)
Processed food/feed(CITRUS, JUICE)
Processed food/feed(CITRUS, MEAL)
Processed food/feed(CITRUS, OIL)
(9 ,10)
(13,14)
(11 ,12)
Submittal of analytical reference standards (15)
P
R
0
T
O
C
u
L
Progress
Reports
1
2
3
6. Use
Pattern
A, C
A, C
A,C
A, C
A,C
A, C
A,C
A,C
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
12. Name of Company
7. Test
Substance
TGAI/PAI
TEP or res of concrn
TEP
TEP
TEP
TEP
TEP
PAI & res of concern
8. Time
Frame
(Months)
8
24
24
24
24
24
24
24
9. Registrant
Response
11. Date
13. Phone Number
-------
DRAFT COPY
Page 1 of 2
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: GDCI-056004-NNNNN
Key: PAI & res of concern = Pure Active Ingredient and Residue of Concern; TEP = Typical End Use Product [TEP]; TEP or res of concrn = Typical End-Use Product or Residue of Concern- TGAI/PAI •
Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop
C - Terrestrial nonfood crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Required for residential outdoor use on food crops if home gardens are to be treated or the home garden use is different from the agricultural use pattern on which the tolerance is established.
2 Data are required for any magnitude of the residue study unless analytical samples are stored frozen for 30 days or less, and the active ingredient is not known to be volatile or labile.
3 No storage stability data on the processed commodities of apples (or citrus fruits) and olives are available, and these data are required for reregistration. The requested storage stability data
for apple and olive processed commodities should reflect up to 143 and 283 days of freezer storage, respectively, since these were the maximum storage intervals of samples in the respective
processing studies.
4 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
5 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
6 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
7 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
8 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
9 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
10 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
11 Date on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
12 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
13 Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
14 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
-------
DRAFT COPY
Page 2 of 2
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: GDCI-056004-NNNNN
Key: PAI & res of concern = Pure Active Ingredient and Residue of Concern; TEP = Typical End Use Product [TEP]; TEP or res of concrn = Typical End-Use Product or Residue of Concern- TGAI/PAI
Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop
C - Terrestrial nonfood crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
15 Material safety data sheets must accompany standards as specified by OSHA in 29 CFR 1910.1200.
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0379 Napthaleneacetic Acid DD-MMM-YYYY
NO STREET ADDRESS Chemical # and Name 056007 GENERIC
NO CITY, XX 00000 Sodium 1 -naphthaleneacetate
ID # GDCI-056007-NNNNN
4. EPA
Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Spec fie Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any 9 Date
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
10. Name of Company „ Phone Number
-------
~IVrtI l "wr ' Pagelofl
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.7050
860.1380
860.1520
860.1520
860.1520
860.1520
860.1520
860.1650
2. Case # and Name 3. Date and Type of DCI and Number
0379 Napthaleneacetic Acid DD-MMM-YYYY
Chemical # and Name 056007 GENERIC
Sodium 1 -naphthaleneacetate |D # GDC|.056007-NNNNN
5. Study Title
Product Chemistry Data Reauirements [Conventional
Chemical)
UV/Visible absorption
Residue Chemistrv Data Reauirements for Food Uses
Conventional Chemical)
Storage stability data
Processed food/feed(CITRUS)
(1 ,2 ,3 ,4)
(5,6)
Processed food/feed(CITRUS, DRIED PULP) (7 ,8)
Processed food/feed(CITRUS, JUICE)
Processed food/feed(CITRUS, MEAL)
Processed food/feed(CITRUS, OIL)
(9 ,10)
(13,14)
(11 ,12)
Submittal of analytical reference standards (1 5)
R
O
T
U
C
U
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
A, B, C, K
10. uertitication I certify that the statements made on this form and all attachments are true, accurate, and complete. 1 acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
12. Name of Company
7. Test
Substance
TGAI/PAI
TEP or res of concrn
TEP
TEP
TEP
TEP
TEP
PAI & res of concern
8. Time
Frame
(Months)
8
24
24
24
24
24
24
24
9. Registrant
Response
11. Date
13. Phone Number
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: GDCI-056007-NNNNN
Tunica*, Se^ °' C°nCem; TEP = ^ ** "" ^ ^ TEP " "* * °°nCm = ^ Ent4Jn ***« " ReSldUe °f C°nce^
Use Categories Key:
A- Terrestrial food crop K- Residential
B - Terrestrial feed crop
C - Terrestrial nonfood crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
1 Required for residential outdoor use on food crops if home gardens are to be treated or the home garden use is different from the agricultural use pattern on which the tolerance is established.
2 Data are required for any magnitude of the residue study unless analytical samples are stored frozen for 30 days or less, and the active ingredient is not known to be volatile or labile.
3 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
No storage stability data on the processed commodities of apples (or citrus fruits) and olives are available, and these data are required for rereqistration The reauested storaae stability rtata
^roffinS'Sudiel.'''008886'1 C°mmOditieS Sh°uld reflect up to 143 and 283 ^ of treezer Stora9e' respectively, since these were the maximum storage intervals of samples in the respective
Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing. tolerance
Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
hSifpMtan «SlUrf i^l8™1 °- r1SidTS 'n Pr°?-fSeoCl f°od/ffd are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing. "J'erdnoe
Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
hinhtMhrn6^^^ l6Vel °- 'If'dTS in processed 'ood/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing. romance
1 o Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
hinlfpMh'Ilfth^th'1111 'eVel °f ^f'dU,eS 'n processf^ f°°d/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
12 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
13 hin1hao??htrnethattUrethnd l6Vel °- re!f idu.es in Processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing.
14 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate.
-------
DRAFT COPY
ge 2 of 2
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: GDCI-056007-NNNNN
Use Categories Key:
A- Terrestrial food crop K- Residential
B - Terrestrial feed crop
C - Terrestrial nonfood crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
15 Material safety data sheets must accompany standards as specified by OSHA in 29 CFR 1910.1200.
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
DATA CALL-IN RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
Chemical # and Name 056008
Ethyl 1 -naphthaleneacetate
3. Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID # GDCI-056008-NNNNN
4. EPA
Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
NNNNNN-NNNNN
N.A.
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete.
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
acknowledge that any
9. Date
10. Name of Company
11. Phone Number
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
Chemical # and Name 056008
Ethyl 1 -naphthaleneacetate
3. Date and Type of DCI and Number
DD-MMM-YYYY
GENERIC
ID# GDCI-056008-NNNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
Product Chemistry Data Requirements (Convention;
Chemical)
830.7050
860.1380
860.1520
860.1520
860.1520
860.1520
860.1520
860.1650
UV/Visible absorption
Residue Chemistry Data Requirements for Food Uses
'Conventional Chemical!
Storage stability data
Processed food/feed{CITRUS)
'rocessed food/feed(CITRUS, DRIED PULP)
'rocessed food/feed(CITRUS, JUICE)
'rocessed food/feed(CITRUS, MEAL)
'rocessed food/feed(CITRUS, OIL)
Submittal of analytical reference standards
(1 ,2 ,3 ,4 ,5)
(6 ,7 ,8)
(9,10,11)
(12,13,14)
(18,19,20)
(15,16,17)
(21)
A, B, C
A, B, C
A, B,C
A, B, C
A.B.C
A, B, C
A, B,C
A, B, C
TGAI/PAI
TEP or res of concrn
TEP
TEP
TEP
TEP
TEP
PAI & res of concern
24
24
24
24
24
24
24
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
iignature and Title of Company's Authorized Representative
11. Date
12. Name of Company
13. Phone Number
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: GDCI-056008-NNNNN
Page 1 of 2
Residue of Concem =
Use Categories Key:
A - Terrestrial food crop
B - Terrestrial feed crop
C - Terrestrial nonfood crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Required for residential outdoor use on food crops if home gardens are to be treated or the home garden use is different from the agricultural use pattern on which the tolerance is established.
2 Data are required for any magnitude of the residue study unless analytical samples are stored frozen for 30 days or less, and the active ingredient is not known to be volatile or labile.
3 This study must be done on olive.
4 aSate^ a'S° may ^ C°nducted °n Citrus but is not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene
No storage stability data on the processed commodities of apples (or citrus fruits) and olives are available, and these data are required for reregistration. The requested storage stability data
for apple and olive processed commodities should reflect up to 143 and 283 days of freezer storage, respectively, since these were the maximum storage intervals^iS^^r!S2S«
h-nIl0?hthethalUrf »hnd 'evel °- f(f dl?S in Pro
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: GDCI-056008-NNNNN
°f °°ncm =
Use Categories Key:
A - Terrestrial food crop
B - Terrestrial feed crop
C - Terrestrial nonfood crop
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Data on the nature and level of residues in processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing tolerance
16 An acceptable food processing study has been completed for olive
17 An acceptable food processing study has been completed for olive
18 hinH^J^rTf ,h"d l6Vel °f r1fidU,eS in Processed food/feed are required if residues could potentially concentrate on processing thus requiring the establishment of a separate tolerance
higher than that of the raw agricultural commodity. Studies, however, may be waived if it can be demonstrated that residues do not concentrate on processing. tolerance
19 Not required for this chemical if acceptable storage stability and food processing studies, both on citrus, are done on another naphthalene acetate
20 An acceptable food processing study has been completed for olive.
21 Material safety data sheets must accompany standards as specified by OSHA in 29 CFR 1910.1200.
-------
APPENDIX F - DRAFT PRODUCT SPECIFIC DATA CALL-IN FORMS
The following pages contain a draft version of the Product (specific) Data Call-In for
products containing any of the following active ingredients: 1-Naphthaleneacetamide (PC Code
056001), 1-Naphthalene acetic acid (PC Code 056002), Potassium 1-naphthaleneacetate (PC
Code 056003), Ammonium 1-naphthaleneacetate (PC Code 056004), Sodium
1-naphthaleneacetate (PC Code 056007), Ethyl 1-naphthaleneacetate (PC Code 056008).
Appendix F F1 NAA RED Amendment
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DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, B.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0379 Napthaleneacetic Acid DD-MMM-YYYY
NO STREET ADDRESS Chemical # and Name 056001 PRODUCT SPECIFIC
NO CITY, XX 00000 1 -Naphthaleneacetamide |Q# pDC|.056001.NNNN
4. EPA
Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any 9 Qale
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company 11. Phone Number
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DRAFT COPY
Page 1 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
EPA Reg. No. NNNNNN-NNNNN
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-056001-NNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
Product Chemistry Data Requirements (Conventional
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
Chemical)
Product Identity and composition
(5)
Description of materials used to produce the product (6)
Description of production process
Description of formulation process
Discussion of formation of impurities
Preliminary analysis
Certified limits
Enforcement analytical method
Color
Physical state
Odor
(2)
d)
(3)
(7 ,8 ,9)
(10,11)
(12)
(13)
(14)
(15)
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
TGAI/MP/EP
TGAI/MP/EP
TGAI
MP/EP
TGAI/MP/EP
TGAI
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
11. Date
12. Name of Company
13. Phone Number
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DRAFT COPY
Page 2 of 4
United States Environmental Protection OMB Approval 2070-010?
Agency Washington, D.C. 20460 OMB Approval 2070-0057
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.6313
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7050
830.7100
830.7200
2. Case # and Name 3. Date and Type of DCI and Number
0379 Napthaleneacetic Acid DD-MMM-YYYY
PRODUCT SPECIFIC
,T0A r, K, K,K,K,K,K,K, K,K,K,K,k, I D # PDCI-Q5600 1 -NNNN
EPA Reg. No. NNNNNN-NNNNN
5. Study Title
Stability to sunlight, normal and elevated (16,17)
temperatures, metals, and metal ions
Oxidizing or reducing action (1 8)
Flammability (19)
Explodability (20)
Storage stability of product (21 )
Miscibility (22)
Corrosion characteristics (23)
Dielectric breakdown voltage (24)
pH of water solutions or suspensions (25 ,26)
UV/Visible absorption
Viscosity (27)
Melting point/melting range (28 ,29)
p
R
o
T
O
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C,D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
TGAI
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
TGAI/MP/EP
TGAI/PAI
MP/EP
TGAI
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
8
8
8
9. Registrant
Response
Date
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DRAFT COPY
Page 3 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
EPA Reg. No. NNNNNN-NNNNN
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-056001-NNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
830.7220
830.7300
830.7370
830.7550
830.7570
830.7840
830.7860
830.7950
870.1100
870.1200
870.1300
Boiling point/boiling range
Density/relative density
Dissociation constant in water
(30 ,31)
(32 ,33)
(34 ,35)
Partition coefficient (n-octanol/water), shake flask (36)
method
3artition coefficient (n-octanol/water), estimation by (4)
iquid chromatography
Water solubility: Column elution method, shake flask (37)
method
Water solubility, generator column method (38)
Vapor pressure (39 ,40)
Toxicology Data Requirements (Conventional Chemical)
A, B, C, D
J, K, L, M,
A, B, C, D
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D
J, K, L, M,
A, B, C, D,
J, K, L, M,
E, F, G, H, I,
N.O
E, F, G, H, I,
N, O
E, F, G, H, I,
N, O
E, F, G, H, I,
N, O
E, F, G, H, I,
N, O
E, F,G, H, I,
N, O
E, F, G, H, I,
N.O
E, F, G,H, I,
N, O
Acute Oral Toxicity
Acute dermal toxicity
Acute inhalation toxicity
(41)
(42 ,43)
(44)
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
TGAI
TGAI/MP/EP
TGAI/PAI
TGAI/PAI
TGAI/PAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
Initial to indicate certification as to information on this page
(full text of certification is on page one).
Date
-------
DRAFT COPY
Page 4 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
OMB Approval 2070-0107
OMB Approval 2070-0057
1. Company Name and Address 2. Case* and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0379 Napthaleneacetic Acid DD-MMM-YYYY
NO STREET ADDRESS PRODUCT SPECIFIC
NO CITY, XX 00000 m a pnri n^finm MMMM
EPA Reg. No. NNNNNN-NNNNN ID # PDC|-°56001 'NNNN
4. Guideline
Requirement
Number
870.2400
870.2500
870.2600
5. Study Title
Acute eye irritation (45)
Acute dermal irritation (46 ,47)
Skin sensitization (48 ,49)
p
R
O
T
0
c
o
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
8. Time
Frame
(Months)
8
8
8
9. Registrant
Response
Date
-------
DRAFT COPY
Page 1 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056001-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D - Aquatic food crop G - Aquatic non-food residential J - Forestry use M - Indoor nonfood use
B - Terrestrial feed crop E - Aquatic nonfood outdoor use H - Greenhouse food crop K - Residential N - Indoor medical use
C - Terrestrial nonfood crop F - Aquatic nonfood industrial use I - Greenhouse nonfood crop L - Indoor food use O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
2 Data must be provided in accordance with the "Description of Production Process" Section.(158.162)
3 Data must be provided in accordance with the "Description of Formation of Impurities" Section(158.167)
4 Required if the TGAI or PAI is organic and non-polar.
5 Data must be provided in accordance with the "Product Composition" Section.(158.155)
6 Data must be provided in accordance with the "Description of Materials used to Produce the Product" Section.(158.160)
7 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
8 Required for TGAIs and products produced by an integrated system.
9 Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
10 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
11 Data must be provided in accordance with the "Certified Limits" Section(158.175)
12 Data must be provided in accordance with the "Enforcement Analytical Method" Section.(158.180)
13 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
14 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
-------
DRAFT COPY
Page 2 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056001 -NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D - Aquatic food crop G - Aquatic non-food residential J - Forestry use M - Indoor nonfood use
B - Terrestrial feed crop E - Aquatic nonfood outdoor use H - Greenhouse food crop K - Residential N - Indoor medical use
C - Terrestrial nonfood crop F - Aquatic nonfood industrial use I - Greenhouse nonfood crop L - Indoor food use O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
15 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
16 Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
17 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
18 Required if the product contains an oxidizing or reducing agent
1 g Required when the product contains combustible liquids.
20 Required when the product is potentially explosive.
21 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
22 Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
23 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
24 Required if the end-use product is a liquid and is to be used around electrical equipment.
25 Required if the product is dispersible with water.
26 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
27 Required if the product is a liquid.
28 Required when the TGAI is solid at room temperature.
-------
DRAFT COPY
Page 3 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056001-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D - Aquatic food crop G - Aquatic non-food residential J - Forestry use M - Indoor nonfood use
B - Terrestrial feed crop E - Aquatic nonfood outdoor use H - Greenhouse food crop K - Residential N - Indoor medical use
C - Terrestrial nonfood crop F - Aquatic nonfood industrial use I - Greenhouse nonfood crop L - Indoor food use O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
29 " the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
30 Required if the TGAI is liquid at room temperature.
31 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
32 True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
33 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
34 Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).
35 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
36 Required if the TGAI or PAI is organic and non-polar.
37 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
38 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
39 Not required for salts.
40 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
41 Not required if test material is a gas or a highly volatile liquid.
42 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
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DRAFT COPY „ , , „
Page 4 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056001-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient;
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D - Aquatic food crop G - Aquatic non-food residential J - Forestry use M - Indoor nonfood use
B - Terrestrial feed crop E - Aquatic nonfood outdoor use H - Greenhouse food crop K - Residential N - Indoor medical use
C - Terrestrial nonfood crop F - Aquatic nonfood industrial use I - Greenhouse nonfood crop L - Indoor food use O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
43 Not required if test material is a gas or a highly volatile liquid.
44 Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).
45 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
46 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
47 Not required if test material is a gas or a highly volatile liquid.
48 Required if repeated dermal exposure is likely to occur under conditions of use.
49 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection OMB Approval 2070-010?
Agency Washington, D.C. 20460 OMB Approval 2070-0057
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0379 Napthaleneacetic Acid DD-MMM-YYYY
NO STREET ADDRESS Chemical # and Name 056002 PRODUCT SPECIFIC
NO CITY, XX 00000 1 -Naphthaleneacetic acid
ID # PDCI-056002-NNNN
4. EPA
Product
Registration
NNNNNN-NNNNN
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
N.A.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
N.A.
7. Product Specific Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any g pate
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
10. Name of Company n Phone Number
-------
DRAFT COPY
Page 1 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
EPA Reg. No. NNNNNN-NNNNN
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-056002-NNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
Product Chemistry Data Requirements (Conventional
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
Chemical!
Product Identity and composition
(D
Description of materials used to produce the product (2)
Description of production process
Description of formulation process
Discussion of formation of impurities
3reliminary analysis
Certified limits
Enforcement analytical method
Color
Physical state
Odor
(6)
(7)
(8)
(3 ,4 ,5)
(9,10)
(11)
(12)
(13)
(14)
A, B, C, D
J, K, L, M,
A, B, C, D
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D
J, K, L, M,
A, B, C, D,
J, K, L, M,
, E, F, G, H, I,
N,O
, E, F, G, H, I,
N.O
E, F, G, H, I,
N, O
E, F, G, H, I,
N,O
E, F, G, H,l,
N, O
E, F,G, H, I,
N,O
E, F, G, H, I,
N, O
E, F, G, H, I,
N,O
E, F, G, H, I,
N, O
E, F, G, H, I,
N,O
E, F, G, H, I,
N, O
TGAI/MP/EP
TGAI/MP/EP
TGAI
MP/EP
TGAI/MP/EP
TGAI
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
11. Date
12. Name of Company
13. Phone Number
-------
DRAFT COPY
Page 2 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
EPA Reg. No. NNNNNN-NNNNN
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-056002-NNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
830.6313
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7050
830.7100
830.7200
Stability to sunlight, normal and elevated
temperatures, metals, and metal ions
Oxidizing or reducing action
Flammability
Explodability
Storage stability of product
Vliscibility
Corrosion characteristics
Dielectric breakdown voltage
aH of water solutions or suspensions
JV/Visible absorption
Viscosity
vlelting point/melting range
(15,16)
(17)
(18)
(19)
(20)
(21)
(22)
(23)
(24 ,25)
(26)
(27 ,28)
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
F, G, H, I,
O
F, G,H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H,l,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F.G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
TGAI
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
TGAI/MP/EP
TGAI/PAI
MP/EP
TGAI
Initial to indicate certification as to information on this page
(full text of certification is on page one).
Date
-------
DRAFT COPY
Page 3 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.7220
830.7300
830.7370
830.7550
830.7570
830.7840
830.7860
830.7950
870.1100
870.1200
870.1300
2. Case # and Name 3. Date and Type of DCI and Number
0379 Napthaleneacetic Acid DD-MMM-YYYY
PRODUCT SPECIFIC
EPA Reg. No. NNNNNN-NNNNN ID * ™-056002-NNNN
5. Study Title
Boiling point/boiling range
Density/relative density
Dissociation constant in water
(29 ,30)
(31 ,32)
(33,34)
Partition coefficient (n-octanol/water), shake flask (35)
method
'artttion coefficient (n-octanol/water), estimation by (36)
liquid cnromatography
Water solubility: Column elution method, shake flask (37)
method
Water solubility, generator column method (38)
Vapor pressure
(39 ,40)
Toxicoloav Data Reauirements (Conventional Chemical)
Acute Oral Toxicity
Acute dermal toxicity
Acute inhalation toxicity
(41)
(42 ,43)
(44)
R
O
T
0
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
TGAI
TGAI/MP/EP
TGAI/PAI
TGAI/PAI
TGAI/PAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
j
)
9. Registrant
Response
Date
-------
DRAFT COPY
Page 4 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
870.2400
870.2500
870.2600
2. Case # and Name 3. Date and Type of DCI and Number
0379 Napthaleneacetic Acid DD-MMM-YYYY
PRODUCT SPECIFIC
EPA Reg. No. NNNNNN-NNNNN 'D # ™-056002-NNNN
5. Study Title
Acute eye irritation
Acute dermal irritation
Skin sensitization
(45)
(46 ,47)
(48 ,49)
P
R
O
T
O
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
8. Time
Frame
(Months)
8
8
8
9. Registrant
Response
Date
-------
DRAFT COPY
1of4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056002-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M- Indoor nonfood use
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential N- Indoor medical use
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O- Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Data must be provided in accordance with the "Product Composition" Section.(158.155)
2 Data must be provided in accordance with the "Description of Materials used to Produce the Product" Section.(158.160)
If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
4 Required for TGAIs and products produced by an integrated system.
5 Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
6 Data must be provided in accordance with the "Description of Production Process" Section.(158.162)
7 Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
8 Data must be provided in accordance with the "Description of Formation of Impurities" Section(158.167)
9 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
10 Data must be provided in accordance with the "Certified Limits" Section(158.175)
11 Data must be provided in accordance with the "Enforcement Analytical Method" Section.(158.180)
12 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
13 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
14 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
-------
DRAFT COPY Page2of4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056002-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient;
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D - Aquatic food crop G - Aquatic non-food residential J - Forestry use M - Indoor nonfood use
B - Terrestrial feed crop E - Aquatic nonfood outdoor use H - Greenhouse food crop K - Residential N - Indoor medical use
C - Terrestrial nonfood crop F - Aquatic nonfood industrial use I - Greenhouse nonfood crop L - Indoor food use O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
15 Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
16 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
17 Required if the product contains an oxidizing or reducing agent
1 s Required when the product contains combustible liquids.
19 Required when the product is potentially explosive.
20 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
21 Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
22 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
23 Required if the end-use product is a liquid and is to be used around electrical equipment.
24 Required if the product is dispersible with water.
25 I* the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
26 Required if the product is a liquid.
27 Required when the TGAI is solid at room temperature.
28 ^ the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
-------
DRAFT COPY
!3of4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
PCI Number; PDCI-056002-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TO.AI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M- Indoor nonfood use
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential N- Indoor medical use
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O- Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
29 Required if the TGAI is liquid at room temperature.
30 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
31 True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
32 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
33 Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).
34 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
35 Required if the TGAI or PAI is organic and non-polar.
36 Required if the TGAI or PAI is organic and non-polar.
37 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
38 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
39 Not required for salts.
40 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
41 Not required if test material is a gas or a highly volatile liquid.
42 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
-------
DRAFT COPY
Page 4 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056002-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient;
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D - Aquatic food crop G - Aquatic non-food residential J - Forestry use M - Indoor nonfood use
B - Terrestrial feed crop E - Aquatic nonfood outdoor use H - Greenhouse food crop K - Residential N - Indoor medical use
C - Terrestrial nonfood crop F - Aquatic nonfood industrial use I - Greenhouse nonfood crop L - Indoor food use O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
43 Not required if test material is a gas or a highly volatile liquid.
44 Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).
45 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
46 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
47 Not required if test material is a gas or a highly volatile liquid.
48 Required if repeated dermal exposure is likely to occur under conditions of use.
49 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
OMB Approval 2070-0107
OMB Approval 2070-0057
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
Chemical # and Name 056003
Potassium 1 -naphthaleneacetate
4. EPA
Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID # PDCI-056003-NNNN
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
Knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
iignature and Title of Company's Authorized Representative
9. Date
0. Name of Company
11. Phone Number
-------
.FT
Page 1 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
EPA Reg. No. NNNNNN-NNNNN
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID * PDCI-056003-NNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
Product Chemistry Data Reauirements (Conventional
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
Product Identity and composition (5)
Description of materials used to produce the product (6)
Description of production process
Description of formulation process
Discussion of formation of impurities
Preliminary analysis
ertified limits
Enforcement analytical method
Color
Physical state
Odor
(1)
(2)
(3)
(7 ,8 ,9)
(10,11)
(12)
(13)
(14)
(15)
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
TGAI/MP/EP
TGAI/MP/EP
TGAI
MP/EP
TGAI/MP/EP
TGAI
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
'GAI/MP/EP
GAI/MP/EP
8
8
8
8
8
8
8
|8
10. (Jertitication I certify that the statements made on this form and all attachments are true, accurate, and complete. 1 acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
11. Date
12. Name of Company
13. Phone Number
-------
DRAFT COPY
Page 2 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
EPA Reg. No. NNNNNN-NNNNN
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-056003-NNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
830.6313
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7050
830.7100
830.7200
Stability to sunlight, normal and elevated
temperatures, metals, and metal ions
Oxidizing or reducing action
Flammability
Explodability
Storage stability of product
Miscibility
Corrosion characteristics
Dielectric breakdown voltage
pH of water solutions or suspensions
UV/Visible absorption
Viscosity
Melting point/melting range
(16,17)
(18)
(19)
(20)
(21)
(22)
(23)
(24)
(25 ,26)
(27)
(28 ,29)
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N.O
TGAI
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
TGAI/MP/EP
TGAI/PAI
MP/EP
TGAI
Initial to indicate certification as to information on this page
(full text of certification is on page one).
Date
-------
I,*,* r i ^r i Page3of4
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0379 Napthaleneacetic Acid DD-MMM-YYYY
NO STREET ADDRESS PRODUCT SPECIFIC
NO CITY, XX 00000 ln , Drv-i nce/wj MMMM
EPA Reg. No. NNNNNN-NNNNN ID * PDCI-056003-NNNN
4. Guideline
Requirement
Number
830.7220
830.7300
830.7370
830.7550
830.7570
830.7840
830.7860
830.7950
870.1100
870.1200
870.1300
5. Study Title
Boiling point/boiling range (30 ,31)
Density/relative density (32 ,33)
Dissociation constant in water (34 ,35)
Partition coefficient (n-octanol/water), shake flask (36)
method
'artition coefficient (n-octanol/water), estimation by (4)
liquid chromatography
Water solubility: Column elution method, shake flask (37)
method
Water solubility, generator column method (38)
Vapor pressure (39 ,40)
Toxicoloav Data Reauirements (Conventional Chemical)
Acute Oral Toxicity (41 )
Acute dermal toxicity (42 ,43)
Acute inhalation toxicity (44)
R
O
T
O
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N,O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
Initial to indicate certification as to information on this page
full text of certification is on page one).
7. Test
Substance
TGAI
TGAI/MP/EP
TGAI or PAI
TGAI or PAI
TGAI/PAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
Date
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
8
8
9. Registrant
Response
-------
DRAFT COPY
Page 4 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
870.2400
870.2500
870.2600
2. Case # and Name
0379 Napthaleneacetic Acid
EPA Reg. No. NNNNNN-NNNNN
5. Study Title
Acute eye irritation
Acute dermal irritation
Skin sensitization
(45)
(46 ,47)
(48 ,49)
P
R
O
T
O
C
0
L
Progress
Reports
1
2
3
6. Use
Pattern
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-056003-NNNN
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H. I.
J, K, L, M, N, O
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
8. Time
Frame
(Months)
8
8
8
9. Registrant
Response
Date
-------
DRAFT COPY
Page 1 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056003-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D - Aquatic food crop G - Aquatic non-food residential J - Forestry use M - Indoor nonfood use
B - Terrestrial feed crop E - Aquatic nonfood outdoor use H - Greenhouse food crop K - Residential N - Indoor medical use
C - Terrestrial nonfood crop F - Aquatic nonfood industrial use I - Greenhouse nonfood crop L - Indoor food use O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Data must be provided in accordance with the "Description of Production Process" Section.(158.162)
2 Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
3 Data must be provided in accordance with the "Description of Formation of Impurities" Section(158.167)
4 Required if the TGAI or PAI is organic and non-polar.
5 Data must be provided in accordance with the "Product Composition" Section.(158.155)
6 Data must be provided in accordance with the "Description of Materials used to Produce the Product" Section.(158.160)
7 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
8 Required for TGAIs and products produced by an integrated system.
9 Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
10 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
11 Data must be provided in accordance with the "Certified Limits" Section(158.175)
12 Data must be provided in accordance with the "Enforcement Analytical Method" Section.(158.180)
13 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
14 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
PCI Number; PDCI-056003-NNNN
Tr^MP/PP™^nLT9~»USe P,?dUD' HUr! ActiveJn9red,ient: JGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M- Indoor nonfood use
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential N- Indoor medical use
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O- Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
15 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
16 Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
17 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
18 Required if the product contains an oxidizing or reducing agent
19 Required when the product contains combustible liquids.
20 Required when the product is potentially explosive.
21 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830 6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
22 Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
23 ™ea*e**e attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
24 Required if the end-use product is a liquid and is to be used around electrical equipment.
25 Required if the product is dispersible with water.
26 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
27 Required if the product is a liquid.
28 Required when the TGAI is solid at room temperature.
-------
DRAFT COPY
Page 3 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056003-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D - Aquatic food crop G - Aquatic non-food residential J - Forestry use M - Indoor nonfood use
B - Terrestrial feed crop E - Aquatic nonfood outdoor use H - Greenhouse food crop K - Residential N - Indoor medical use
C - Terrestrial nonfood crop F - Aquatic nonfood industrial use I - Greenhouse nonfood crop L - Indoor food use O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
29 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
30 Required if the TGAI is liquid at room temperature.
31 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
32 True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
33 I' the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
34 Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).
35 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
36 Required if the TGAI or PAI is organic and non-polar.
37 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
38 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
39 Not required for salts.
40 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
41 Not required if test material is a gas or a highly volatile liquid.
42 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
-------
DRAFT COPY
Page 4 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056003-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D -
B - Terrestrial feed crop E -
C - Terrestrial nonfood crop F -
Aquatic food crop G - Aquatic non-food residential J - Forestry use
Aquatic nonfood outdoor use H - Greenhouse food crop K - Residential
Aquatic nonfood industrial use I - Greenhouse nonfood crop L - Indoor food use
M - Indoor nonfood use
N - Indoor medical use
O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
43
44
45
46
47
48
49
Not required if test material is a gas or a highly volatile liquid.
Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or paniculate).
Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
Not required if test material is a gas or a highly volatile liquid.
Required if repeated dermal exposure is likely to occur under conditions of use.
Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
DATA CALL-IN RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
OMB Approval 2070-0107
OMB Approval 2070-0057
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. EPA
Product
Registration
2. Case # and Name
0379 Napthaleneacetic Acid
Chemical # and Name 056004
Ammonium 1 -naphthaleneacetate
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID # PDCI-056004-NNNN
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
N.A.
N.A.
8. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative,
9. Date
0. Name of Company
11. Phone Number
-------
DRAFT COPY
Page 1 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
EPA Reg. No. NNNNNN-NNNNN
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-056004-NNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
Product Chemistry Data Requirements (Conventional
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
Chemical)
Product Identity and composition
(5)
Description of materials used to produce the product (6)
Description of production process
Description of formulation process
Discussion of formation of impurities
Preliminary analysis
Certified limits
Enforcement analytical method
Dolor
Physical state
Ddor
(1)
(2)
(3)
(7 ,8 ,9)
(10,11)
(12)
(13)
(14)
(15)
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
O
F, G, H, I,
O
F, G, H, I,
O
F.G.H.I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
TGAI/MP/EP
TGAI/MP/EP
TGAI
MP/EP
TGAI/MP/EP
TGAI
TGA!
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative __
11. Date
12. Name of Company
13. Phone Number
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DRAFT COPY
Page 2 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
EPA Reg. No. NNNNNN-NNNNN
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-056004-NNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
830.6313
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7050
830.7100
830.7200
Stability to sunlight, normal and elevated
temperatures, metals, and metal ions
Oxidizing or reducing action
Flammability
Explodability
Storage stability of product
Miscibility
torrosion characteristics
Dielectric breakdown voltage
pH of water solutions or suspensions
UV/Visible absorption
Viscosity
Melting point/melting range
(16 ,17)
(18)
(19)
(20)
(21)
(22)
(23)
(24)
(25 ,26)
(27)
(28 ,29)
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
A, B, C, D, E,
J, K, L, M, N,
F, G, H, I,
O
F.G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
F, G, H, I,
O
TGAI
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
TGAI/MP/EP
TGAI/PAI
MP/EP
TGAI
nitial to indicate certification as to information on this page
full text of certification is on page one).
Date
-------
i^/in ^un Page3of4
United States Environmental Protection OMB Approval 2070-010?
Agency Washington, D.C. 20460 OMB Approval 2070-0057
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1 . Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0379 Napthaleneacetic Acid DD-MMM YYYY
NO STREET ADDRESS PRODUCT SPECIFIC
NO CITY, XX 00000 |n pn_. «„„„. ..........
EPAReg.No.NNNNNN-NNNNN ID * PDCI-056004-NNNN
4. Guideline
Requirement
Number
830.7230
830.7300
830.7370
830.7550
830.7570
830.7840
830.7860
830.7950
870.1100
870.1200
870.1300
5. Study Title
Boiling point/boiling range (30,31)
Density/relative density (32 ,33)
Dissociation constant in water (34 ,35)
Partition coefficient (n-octanol/water), shake flask (36)
method
'artition coefficient (n-octanol/water), estimation by (4 ,37)
liquid chromatography
Water solubility: Column elution method, shake flask (38)
method
Water solubility, generator column method (39)
Vapor pressure (40 ,41 )
"oxicoloav Data Reauirements (Conventional Chemical)
Acute Oral Toxicity (42)
Acute dermal toxteity (43 ,44)
Acute inhalation toxicity (45)
R
O
T
O
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B,C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
Initial to indicate certification as to information on this page
full text of certification is on page one).
7. Test
Substance
TGAI
TGAI/MP/EP
TGAI/PAI
TGAI/PAI
TGAI/PAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
Date
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
8
8
9. Registrant
Response
-------
DRAFT COPY
Page 4 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
OMB Approval 2070-0107
OMB Approval 2070-0057
1. Company Name and Address 2. Case # and Name 3. Date and Type of DCI and Number
SAMPLE COMPANY 0379 Napthaleneacetic Acid DD-MMM-YYYY
NO STREET ADDRESS PRODUCT SPECIFIC
NO CITY, XX 00000 MMMMMM MK1MMk, ID # PDCI-056004-NNNN
EPA Reg. No. NNNNNN-NNNNN
4. Guideline
Requirement
Number
870.2400
870.2500
870.2600
5. Study Title
Acute eye irritation (46)
Acute dermal irritation (47 ,48)
Skin sensitization (49 ,50)
P
R
O
T
0
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
Initial to indicate certification as to information on this page
(full text of certification is on page one).
7. Test
Substance
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
8. Time
Frame
(Months)
8
8
8
9. Registrant
Response
Date
-------
DRAFT COPY
f4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056004-NNNN
Key: rr l!/MD/cDnUf.a.cturi"9-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D -
B - Terrestrial feed crop E -
C - Terrestrial nonfood crop F -
Aquatic food crop
Aquatic nonfood outdoor use
Aquatic nonfood industrial use
G - Aquatic non-food residential J - Forestry use
H - Greenhouse food crop K - Residential
I - Greenhouse nonfood crop L - Indoor food use
M - Indoor nonfood use
N - Indoor medical use
O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
Data must be provided in accordance with the "Description of Production Process" Section.(158.162)
8
9
10
11
12
13
14
Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
Data must be provided in accordance with the "Description of Formation of Impurities" Section(158.167)
Required if the TGAI or PAI is organic and non-polar.
Data must be provided in accordance with the "Product Composition" Section.(158.155)
Data must be provided in accordance with the "Description of Materials used to Produce the Product" Sectlon.(158.160)
If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
me concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
Required for TGAIs and products produced by an integrated system.
Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
Data must be provided in accordance with the "Certified Limits" Section(158.175)
Data must be provided in accordance with the "Enforcement Analytical Method" Section.(158.180)
If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
-------
DRAFT COPY
Page 2 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056004-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient fTGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M- Indoor nonfood use
B - Terrestrial feed crop E - Aquatic nonfood outdoor use H - Greenhouse food crop K - Residential N - Indoor medical use
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O- Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
15 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
16 Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
17 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
18 Required if the product contains an oxidizing or reducing agent
19 Required when the product contains combustible liquids.
20 Required when the product is potentially explosive.
21 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
22 Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
23 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
24 Required if the end-use product is a liquid and is to be used around electrical equipment.
25 Required if the product is dispersible with water.
If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
27 Required if the product is a liquid.
28 Required when the TGAI is solid at room temperature.
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DRAFT COPY
3 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
PCI Number: PDCI-056004-NNNN
_
Key: TS,D/conUff«CtUriJlg"Use Pr°duct| Pure Active In9redient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient
I bAl/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M- Indoor nonfood use
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential N- Indoor medical use
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O- Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
29 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
30 Required if the TGAI is liquid at room temperature.
31 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
tne concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
32 True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
33 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
34 Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).
35 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
36 Required if the TGAI or PAI is organic and non-polar.
37 Required if the TGAI or PAI is organic and non-polar.
38 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
39 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
40 Not required for salts.
41 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
42 Not required if test material is a gas or a highly volatile liquid.
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DRAFT COPY
_^ Page 4 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number; PDCI-056004-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient 'ngredlent'
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M- Indoor nonfood use
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential N- Indoor medical use
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O- Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
43 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
44 Not required if test material is a gas or a highly volatile liquid.
45 Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or paniculate).
46 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
47 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
48 Not required if test material is a gas or a highly volatile liquid.
49 Required if repeated dermal exposure is likely to occur under conditions of use.
50 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
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DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
DATA CALL-IN RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
Chemical # and Name 056007
Sodium 1-naphthaleneacetate
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID # PDCI-056007-NNNN
4. EPA
Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claim ing a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
NNNNNN-NNNNN
N.A.
N.A.
i. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete.
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
acknowledge that any
9. Date
10. Name of Company
11. Phone Number
-------
DRAFT COPY
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
INS i HUO i luixib. Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
830.6302
830.6303
830.6304
2. Case # and Name 3. Date and Type of DCI and Number
0379 Napthaleneacetic Acid DD-MMM-YYYY
PRODUCT SPECIFIC
EPA Reg. No. NNNNNN-NNNNN ID * PDCI-056007-NNNN
5. Study Title
Product Chemistrv Data Requirements /Conventional
Chemical)
Product Identity and composition
(5)
Description of materials used to produce the product (6)
Description of production process
Description of formulation process
Discussion of formation of impurities
Preliminary analysis
Certified limits
Enforcement analytical method
Color
Physical state
Odor
d)
(2)
(3)
(7 ,8 ,9)
(10,11)
(12)
(13)
(14)
(15)
P
R
0
I
O
c
u
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
lu. L-ermication i certify that the statements made on this form and all attachments are true, accurate, and complete I acknowledge that any
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
7. Test
Substance
TGAI/MP/EP
TGAI/MP/EP
TGAI
MP/EP
TGAI/MP/EP
TGAI
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
3
9. Registrant
Response
11. Date
13. Phone Number
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS
STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INs, i MUO i luiMb. Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form.
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.6313
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7050
830.7100
830.7200
2. Case # and Name 3. Date and Type of DCI and Number
0379 Napthaleneacetic Acid DD-MMM-YYYY
PRODUCT SPECIFIC
EPA Reg. No. NNNNNN-NNNNN '° * PDCI-056007-NNNN
5. Study Title
Stability to sunlight, normal and elevated (16,17)
temperatures, metals, and metal ions
Oxidizing or reducing action
Flammability
Explodability
Storage stability of product
Miscibility
Corrosion characteristics
Dielectric breakdown voltage
>H of water solutions or suspensions
UV/Visible absorption
Viscosity
Melting point/melting range
(18)
(19)
(20)
(21)
(22)
(23)
(24)
(25 ,26)
(27)
(28 ,29)
P
R
O
T
O
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, 1,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, 1,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, 1,
J, K, L, M, N, O
A, B, C, D, E, F.G, H, 1,
J, K, L, M, N, O
Initial to indicate certification as to information on this page
full text of certification is on page one).
7. Test
Substance
TGAI
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
TGAI/MP/EP
TGAI/PAI
MP/EP
TGAI
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
5
*
g
9. Registrant
Response
Date
-------
DRAFT COPY
Page 3 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
EPA Reg. No. NNNNNN-NNNNN
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-056007-NNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registrant
Response
830.7220
830.7300
830.7370
830.7550
830.7570
830.7840
830.7860
330.7950
570.1100
70.1200
70.1300
Boiling point/boiling range
Density/relative density
Dissociation constant in water
(30 ,31)
(32 ,33)
(34 ,35)
Partition coefficient (n-octanol/water), shake flask (36)
method
'artition coefficient (n-octanol/water), estimation by (4 ,37)
iquid chromatography
Water solubility: Column elution method, shake flask (38)
method
Water solubility, generator column method (39)
Vapor pressure (40 ,41)
•oxicoloqy Data Requirements ^Conventional Chemical!
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D,
J, K, L, M,
A, B, C, D
J, K, L, M,
Acute Oral Toxicity
xsute dermal toxicity
.cute inhalation toxicity
(42)
(43 ,44)
(45)
E, F, G, H, I
N, O
E, F, G, H, I
N, O
E, F, G, H, I
N, O
E, F, G, H, I.
N,O
E, F, G, H, I,
N, O
E, F, G, H, I,
N, O
E, F, G, H, I,
N, O
E, F, G, H, I,
N, O
H, I,
A, B, C, D, E, F, G
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
TGAI
TGAI/MP/EP
TGAI/PAI
TGAI/PAI
TGAI/PAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
TGAI/MP/EP
GAI/MP/EP
GAI/MP/EP
8
8
8
8
8
8
8
8
8
8
nitial to indicate certification as to information on this page
full text of certification is on page one).
Date
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS. Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
870.2400
870.2500
870.2600
2. Case # and Name
0379 Napthaleneacetic Acid
EPA Reg. No. NNNNNN-NNNNN
5. Study Title
Acute eye irritation
Acute dermal irritation
Skin sensitization
(46)
(47 ,48)
(49 ,50)
P
R
0
T
O
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G,
J, K, L, M, N, O
A, B, C, D, E, F, G,
J, K, L, M, N, O
A, B, C, D, E, F, G, I
J, K, L, M, N, O
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-056007-NNNN
H, I,
H, I,
H, I,
Initial to indicate certification as to information on this page
full text of certification is on page one).
7. Test
Substance
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
8. Time
Frame
(Months)
8
8
8
9. Registrant
Response
Date
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056007-NNNN
Tr^/MP/PpnU MCtUr«ng;USe Pn dUo' ^Ure ADCtive ln?redient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient lngredient'
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M- Indoor nonfood use
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential N- Indoor medical use
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O- Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Data must be provided in accordance with the "Description of Production Process" Section.(158.162)
2 Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
3 Data must be provided in accordance with the "Description of Formation of Impurities" Section(158.167)
4 Required if the TGAI or PAI is organic and non-polar.
Data must be provided in accordance with the "Product Composition" Section.(158.155)
Data must be provided in accordance with the "Description of Materials used to Produce the Product" Section.(158.160)
!n?coTnceAn\raaton°oHhfJS innrlT FT* °P *? *!****! *quivalent of the TGAI
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056007-NNNN
Key: Trl^/MP/PP™MCtUrifn9;USe P,r?dUn' ^Ure ADCtiVe In9redient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient In9reaient'
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M- Indoor nonfood use
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential N- Indoor medical use
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O- Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
!hlh™TGA'tCatnn0t "?f.isolated' data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
16 Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
Jhlh™G^rftn,?0t be isolated'data are ^quired on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
18 Required if the product contains an oxidizing or reducing agent
19 Required when the product contains combustible liquids.
20 Required when the product is potentially explosive.
21 plnH?,MS!n attact!fd "Addition^ Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
22 Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
23 p'^sets|e attaclled "Addit1ional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830.6320) Data Requirements of the
Product Specific Data Call-ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
24 Required if the end-use product is a liquid and is to be used around electrical equipment.
25 Required if the product is dispersible with water.
26 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
27 Required if the product is a liquid.
28 Required when the TGAI is solid at room temperature.
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
PCI Number: PDCI-056007-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient lngreaient'
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M- Indoor nonfood use
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential N- Indoor medical use
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O- Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
29 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
30 Required if the TGAI is liquid at room temperature.
31 !hlh^GA'tCatnn0t "?fhisolated' data are ^ ed on the Practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
32 True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
33 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
34 Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).
35 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
36 Required if the TGAI or PAI is organic and non-polar.
37 Required if the TGAI or PAI is organic and non-polar.
38 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
39 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
40 Not required for salts.
41 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
42 Not required if test material is a gas or a highly volatile liquid.
-------
DRAFT COPY
4 of 4
United States Environmental Protection
Agency Washington, B.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
PCI Number; PDCI-056007-NNNN
_
rr ^/MP/PnnUMCtUrifn9;USe P,TdUo ' ^Ure An°tiVe ln?redient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient mgrea'enl'
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M- Indoor nonfood use
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential N- Indoor medical use
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O- Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
43 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
44 Not required if test material is a gas or a highly volatile liquid.
45 Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or particulate).
46 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
47 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
48 Not required if test material is a gas or a highly volatile liquid.
49 Required if repeated dermal exposure is likely to occur under conditions of use.
50 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
-------
DRAFT COPY
Page 1 of 1
United States Environmental Protection
Agency Washington, D.C. 20460
DATA CALL-IN RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
Chemical*and Name 056008
Ethyl 1 -naphthaleneacetate
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID # PDCI-056008-NNNN
4. EPA
Product
Registration
5. I wish to
cancel this
product regis-
tration volun-
tarily
6. Generic Data
6a. I am claiming a Generic
Data Exemption because I
obtain the active ingredient
from the source EPA regis-
tration number listed below.
6b. I agree to satisfy Generic
Data requirements as indicated
on the attached form entitled
"Requirements Status and
Registrant's Response."
7. Product Specific Data
7a. My product is an MUP and
I agree to satisfy the MUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
7b. My product is an EUP and
I agree to satisfy the EUP
requirements on the attached
form entitled "Requirements
Status and Registrant's
Response."
NNNNNN-NNNNN
N.A.
N.A.
3. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete.
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law.
Signature and Title of Company's Authorized Representative
acknowledge that any
9. Date
10. Name of Company
11. Phone Number
-------
DRAFT COPY
Page 1 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
OMB Approval 2070-0107
OMB Approval 2070-0057
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
2. Case # and Name
0379 Napthaleneacetic Acid
EPA Reg. No. NNNNNN-NNNNN
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-056008-NNNN
4. Guideline
Requirement
Number
5. Study Title
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registran
Response
Product Chemistry Data Requirements (Conventional
Chemical!
830.1550
830.1600
830.1620
830.1650
830.1670
830.1700
830.1750
830.1800
330.6302
330.6303
330.6304
Product Identity and composition (4)
Description of materials used to produce the product (5)
Description of production process
Description of formulation process
Discussion of formation of impurities
Preliminary analysis
Certified limits
Enforcement analytical method
lolor
'hysical state
Odor
(1)
(2)
(3)
(6 ,7 ,8)
(9,10)
(11)
(12)
(13)
(14)
A, B, C, D, E, F, G, H,
J, K, L, M, N, O
A, B, C, D, E, F, G, H,
J, K, L, M, N, O
A, B, C, D, E, F, G, H,
J, K, L, M, N, O
A, B, C, D, E, F, G, H,
J, K, L, M, N, O
A, B, C, D, E, F, G, H,
J, K, L, M, N, O
A, B, C, D, E, F, G, H,
J, K, L, M, N, O
A, B, C, D, E, F, G, H,
J, K, L, M, N, O
A, B, C, D, E, F, G, H,
J, K, L, M, N, O
A, B, C, D, E, F, G, H,
J, K, L, M, N, O
A, B, C, D, E, F, G, H,
J, K, L, M, N, O
A, B, C, D, E, F, G, H,
J, K,L, M, N,O
TGAI/MP/EP
TGAI/MP/EP
TGAI
MP/EP
TGAI/MP/EP
TGAI
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
GAI/MP/EP
GAI/MP/EP
10. Certification I certify that the statements made on this form and all attachments are true, accurate, and complete.
knowingly false or misleading statement may be punishable by fine, imprisonment or both under applicable law
Signature and Title of Company's Authorized Representative
acknowledge that any
11. Date
2. Name of Company
13. Phone Number
-------
^rtr i ^^r i Page2of4
United States Environmental Protection OMB APprovai 2070-010?
Agency Washington, D.C. 20460 OMB Approval 2070-0057
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1 . Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.6313
830.6314
830.6315
830.6316
830.6317
830.6319
830.6320
830.6321
830.7000
830.7050
830.7100
830.7200
2. Case* and Name 3. Date and Type of DCI and Number
0379 Napthaleneacetic Acid DD-MMM-YYYY
PRODUCT SPECIFIC
EPA Reg. No. NNNNNN-NNNNN '° # PDCI-056008-NNNN
5. Study Title
Stability to sunlight, normal and elevated (15,16)
temperatures, metals, and metal ions
Oxidizing or reducing action (1 7)
Flammability (1$)
Explodability (19)
Storage stability of product (20)
Miscibility (21)
Corrosion characteristics (22)
Dielectric breakdown voltage (23)
pH of water solutions or suspensions (24 ,25)
UV/Visible absorption
Viscosity (26)
Melting point/melting range (27 ,28)
R
O
T
O
C
O
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C,D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
Initial to indicate certification as to information on this page
full text of certification is on page one).
7. Test
Substance
TGAI
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
MP/EP
TGAI/MP/EP
TGAI/PAI
MP/EP
TGAI
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
8
8
t
9. Registrant
Response
Date
-------
~xx«t , ^r i Page3of4
United States Environmental Protection OMB Approval 2070-0107
Agency Washington, D.C. 20460 OMB Approval 2070-0057
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
INSTRUCTIONS: Please type or print in ink. Please read carefully the attached instructions and supply the information requested on this form
Use additional sheet(s) if necessary.
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
830.7220
830.7300
830.7370
830.7550
830.7840
830.7860
830.7950
870.1100
870.1200
870.1300
870.2400
2. Case # and Name 3. Date and Type of DCI and Number
0379 Napthaleneacetic Acid DD-MMM-YYYY
PRODUCT SPECIFIC
EPA Reg. No. NNNNNN-NNNNN ID * PDCI-056008-NNNN
5. Study Title
Boiling point/boiling range (29 ,30)
Density/relative density (31 ,32)
Dissociation constant in water (33 ,34)
Partition coefficient (n-octanol/water), shake flask (35)
method
Water solubility: Column elution method, shake flask (36)
method
Water solubility, generator column method (37)
Vapor pressure (33 ,39)
Toxicoloov Data Reauirements (Conventional Chemieah
Acute Oral Toxicity
Acute dermal toxicity
Acute inhalation toxicity
Acute eye irritation
(40)
(41 ,42)
(43)
(44)
P
R
0
T
O
C
o
L
Progress
Reports
1
2
3
6. Use
Pattern
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
A, B, C, D, E, F, G, H, I,
J, K, L, M, N, O
Initial to indicate certification as to information on this page
full text of certification is on page one).
7. Test
Substance
TGAI
TGAI/MP/EP
TGAI/PAI
TGAI/PAI
TGAI or PAI
TGAI or PAI
TGAI or PAI
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
TGAI/MP/EP
8. Time
Frame
(Months)
8
8
8
8
8
8
8
8
8
i
9. Registrant
Response
Date
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE
'" '
Carefu"y the attached instructions and supply the information requested on this form.
Page 4 of 4
OMB Approval 2070-0107
OMB Approval 2070-0057
1. Company Name and Address
SAMPLE COMPANY
NO STREET ADDRESS
NO CITY, XX 00000
4. Guideline
Requirement
Number
2. Case # and Name
0379 Napthaleneacetic Acid
EPA Reg. No. NNNNNN-NNNNN
5. Study Title
3. Date and Type of DCI and Number
DD-MMM-YYYY
PRODUCT SPECIFIC
ID# PDCI-056008-NNNN
Progress
Reports
6. Use
Pattern
7. Test
Substance
8. Time
Frame
(Months)
9. Registran
Response
870.2500
870.2600
Acute dermal irritation
Skin sensitization
(45 ,46)
(47 ,48)
A, B, C, D, E, F, G, H, I,
J, K.L.M.N, O
A, B, C, D, E, F, G, H,
J, K, L, M, N, O
TGAI/MP/EP
TGAI/MP/EP
litial to indicate certification as to information on this page
ull text of certification is on page one).
Date
-------
DRAFT COPY
Page 1 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056008-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A - Terrestrial food crop D - Aquatic food crop G - Aquatic non-food residential J - Forestry use M - Indoor nonfood use
B - Terrestrial feed crop E - Aquatic nonfood outdoor use H - Greenhouse food crop K - Residential N - Indoor medical use
C - Terrestrial nonfood crop F - Aquatic nonfood industrial use I - Greenhouse nonfood crop L - Indoor food use O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
1 Data must be provided in accordance with the "Description of Production Process" Section.(158.162)
2 Data must be provided in accordance with the "Description of Formulation Process" Section.(158.165)
3 Data must be provided in accordance with the "Description of Formation of Impurities" Section(158.167)
4 Data must be provided in accordance with the "Product Composition" Section.(158.155)
5 Data must be provided in accordance with the "Description of Materials used to Produce the Product" Section.(158.160)
6 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
7 Required for TGAIs and products produced by an integrated system.
8 Data must be provided in accordance with the "Preliminary Analysis" Section.(158.170)
9 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
10 Data must be provided in accordance with the "Certified Limits" Section(158.175)
11 Data must be provided in accordance with the "Enforcement Analytical Method" Section.(158.180)
12 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
13 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
14 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters,
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
PCI Number; PDCI-056008-NNNN
T^/Mo/conU MCtUrlng"USe P,?dUCt' Pure Act'Ve ln?redient: TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M - Indoor nonfood use
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential N- Indoor medical use
C - Terrestrial nonfood crop F - Aquatic nonfood industrial use I - Greenhouse nonfood crop L - Indoor food use O - Residential Indoor use
Footnotes: [The following notes are referenced in column two (5. Study File) of the REQUIREMENTS STATUS AND REGISTRANTS RESPONSE form.]
15 Data on the stability to metals and metal ions is required only if the active ingredient is expected to come in contact with either material during storage.
16 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
17 Required if the product contains an oxidizing or reducing agent
18 Required when the product contains combustible liquids.
19 Required when the product is potentially explosive.
20 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830 6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
21 Required if the product is an emulsifiable liquid and is to be diluted with petroleum solvents.
22 Please see attached "Additional Information and Requirements Pertaining to Storage Stability (OPPTS 830.6317) and Corrosion Characteristics (OPPTS 830 6320) Data Requirements of the
Product Specific Data Call-Ins issued under the Reregistration Eligibility Decision (RED)/lnterim Reregistration Eligibility Decision (IRED) Documents."
23 Required if the end-use product is a liquid and is to be used around electrical equipment.
24 Required if the product is dispersible with water.
25 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
26 Required if the product is a liquid.
27 Required when the TGAI is solid at room temperature.
28 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
-------
DRAFT COPY
3 of 4
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
PCI Number; PDCI-056008-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient-
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M- Indoor nonfood use
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential N- Indoor medical use
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O- Residential Indoor use
iOtr,Gtes: [The following notes, arc referenced in column two (5. Study Tile) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
29 Required if the TGAI is liquid at room temperature.
30 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
31 True density or specific density are required for all test substances. Data on bulk density is required for MPs that are solid at room temperature.
32 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
33 Required when the test substance contains an acid or base functionality (organic or inorganic) or an alcoholic functionality (organic).
34 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
35 Required if the TGAI or PAI is organic and non-polar.
36 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
37 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
38 Not required for salts.
39 If the TGAI cannot be isolated, data are required on the practical equivalent of the TGAI (i.e., if the active ingredient is either an acid, base or ionic form, and it is formulated into salts or esters
the concentration of the active ingredient in these products must be expressed in acid equivalent or active equivalent).
40 Not required if test material is a gas or a highly volatile liquid.
41 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
42 Not required if test material is a gas or a highly volatile liquid.
-------
DRAFT COPY
United States Environmental Protection
Agency Washington, D.C. 20460
FOOTNOTES AND KEY DEFINITIONS FOR GUIDELINE REQUIREMENTS
Case # and Name: 0379 Napthaleneacetic Acid
DCI Number: PDCI-056008-NNNN
Key: MP/EP = Manufacturing-Use Product, Pure Active Ingredient; TGAI = Technical Grade Active Ingredient [TGAI]; TGAI or PAI = Technical Grade of the Active Ingredient or Pure Active Ingredient
TGAI/MP/EP = Manufacturing-Use Product, Pure Active Ingredient and Technical Grade Active Ingredient; TGAI/PAI = Technical Grade Active Ingredient, Pure Active Ingredient lngredlent'
Use Categories Key:
A- Terrestrial food crop D- Aquatic food crop G- Aquatic non-food residential J- Forestry use M- Indoor nonfood use
B- Terrestrial feed crop E- Aquatic nonfood outdoor use H- Greenhouse food crop K- Residential N- Indoor medical use
C- Terrestrial nonfood crop F- Aquatic nonfood industrial use I- Greenhouse nonfood crop L- Indoor food use O- Residential Indoor use
GlriGtes: [The follow;;-,^ notea are referenced in column tvvo (5. Study Pile) of the REQUIREMENTS STATUS AND REGISTRANT'S RESPONSE form.]
43 Required if the product consists of, or under conditions of use will result in, a respirable material (e.g., gas, vapor, aerosol, or paniculate).
44 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
45 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
46 Not required if test material is a gas or a highly volatile liquid.
47 Required if repeated dermal exposure is likely to occur under conditions of use.
48 Not required if test material is corrosive to skin or has a pH of less than 2 or greater than 11.5.
-------
APPENDIX G - LIST OF REGISTRANTS TO RECEIVE DATA CALL-IN NOTICES
Appendix G Gl NAA RED Amendment
-------
Co. Nr.
264
5481
LIST OF
Case # and
Company Name
BAYER CROPSCIENCE LP
AMVAC CHEMICAL
United States Environmental Protection
Agency Washington, D.C. 20460
ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Name: 0379, Napthaleneacetic Acid r^^*/" /I,'- i 4 /I /' ,,L4J, /.„-,. -j~ . /
( * -> (e Ut' 1 l~ /i/i~:A\f\T>'l&'{*<~*l^ <-<(-•? ( >wci£
~ *- It'
Agent For
Address
2 T.W. ALEXANDER DRIVE
4695 MACARTHUR COURT, SUITE 1250
City & State
RESEARCH
TRIANGLE PARK
NEWPORT BEACH
Zip
NC 27709
CA 926601706
CORPORATION
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS
Case # and Name: 0379,Napthaleneacetic Acid
Co. Nr. Company Name Agent For
DATA CALL-IN NOTICE
o«
Address
OUZ. ^~ /V-- ^+"a ^ "-*&{-*-~t' *•
City & State
1
Zip
5481
5887
7401
8002
43905
64388
68719
72639
75851
82437
AMVAC CHEMICAL
CORPORATION
VALUE GARDENS SUPPLY, LLC
VOLUNTARY PURCHASING
GROUPS, INC.
LIQUINOX COMPANY
EARTH SCIENCE PRODUCTS
CORP.
DIP'N GROW, INC.
MARCO INDUSTRIES
INCORPORATED
LT BIOSYN, INC.
TECHNAFLORA PLANT
PRODUCTS LTD.
K & W AGRICHEMICALS, INC.
PYXIS REGULATORY CONSULTING, INC.
KELLER AND HECKMAN LLP
SYNTECH GLOBAL LLC
4695 MACARTHUR COURT, SUITE 1250
PO Box 585
PO Box 460, 230 FM 87
221 W MEATS AVENUE
PO Box 327
PO Box 1888 15140 SE 82ND DRIV, STE 21OE
9220 S.E. STARK ST
4110 136THST, NW
1001 G STREET, NW, SUITE 500 WEST
PO Box 640
NEWPORT BEACH CA 926601706
SAINT JOSEPH
BONHAM
ORANGE
WILSONVILLE
CLACKAMAS
PORTLAND
GIG HARBOR
WASHINGTON
HOCKESSIN
MO 64502
TX 75418
CA 92665
OR 97070
OR 970151888
OR 97216
WA 98332
DC 20001
DE 197070640
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0379,Napthaleneacelic Acid f\ i*--/ £jfj->
\_y -~^f W' *-' ~j
~ /
Co. Nr.
Company Name
Agent For
Address
City & State
Zip
5481
AMVAC CHEMICAL
CORPORATION
4695 MACARTHUR COURT, SUITE 1250
NEWPORT BEACH CA 926601706
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case#and Name: 0379,Napthaleneacetic Acid
Co. Nr. Company Name Agent For Address City & State Zip
5481 AMVAC CHEMICAL 4695 MACARTHUR COURT, SUITE 1250 NEWPORT BEACH CA 926601706
CORPORATION
34704 LOVELAND PRODUCTS, INC. PO Box 1286 GREELEY CO 806321286
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case#andName: 0379,Napthaleneacetic Acid () $ & 0 b'~? $c,s
Co. Nr.
Company Name
Agent For
Address
City & State
Zip
5481
AMVAC CHEMICAL
CORPORATION
4695 MACARTHUR COURT, SUITE 1250
NEWPORT BEACH CA 926601706
-------
United States Environmental Protection
Agency Washington, D.C. 20460
LIST OF ALL REGISTRANTS SENT THIS DATA CALL-IN NOTICE
Case # and Name: 0379,Napthaleneacetic Acid Q % ^ ^ ^h j
_ /^ ^ f /
Co. Nr.
Company Name
Agent For
Address
City & State
Zip
5481
7401
AMVAC CHEMICAL
CORPORATION
VOLUNTARY PURCHASING
GROUPS, INC.
4695 MACARTHUR COURT, SUITE 1250
PO Box 460, 230 FM 87
NEWPORT BEACH CA 926601706
BONHAM TX 75418
-------
APPENDIX H - PRODUCT BATCHING
EPA's Batching Of Naphthalene Acetate Products For Meeting Acute Toxicity Data
Requirements For Reregistration
In an effort to reduce the time, resources and number of animals needed to fulfill the
acute toxicity data requirements for reregi strati on of products containing NAA as the active
ingredient, the Agency has batched products which can be considered similar for purposes of
acute toxicity. Factors considered in the sorting process include each product's active and inert
ingredients (identity, percent composition and biological activity), type of formulation (e.g.,
emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal
word, use classification, precautionary labeling, etc.). Note that the Agency is not describing
batched products as "substantially similar" since some products within a batch may not be
considered chemically similar or have identical use patterns.
Using available information, batching has been accomplished by the process described in
the preceding paragraph. Not with-standing the batching process, the Agency reserves the right
to require, at any time, acute toxicity data for an individual product should the need arise.
Registrants of products within a batch may choose to cooperatively generate, submit or
cite a single battery of six acute toxicological studies to represent all the products within that
batch. It is the registrants' option to participate in the process with all other registrants, only some
of the other registrants, or only their own products within a batch, or to generate all the required
acute toxicological studies for each of their own products. If a registrant chooses to generate the
data for a batch, he/she must use one of the products within the batch as the test material. If a
registrant chooses to rely upon previously submitted acute toxicity data, he/she may do so
provided that the data base is complete and valid by today's standards (see acceptance criteria
attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the
formulation has not been significantly altered since submission and acceptance of the acute
toxicity data. Regardless of whether new data is generated or existing data is referenced,
registrants must clearly identify the test material by EPA Registration Number. If more than one
confidential statement of formula (CSF) exists for a product, the registrant must indicate the
formulation actually tested by identifying the corresponding CSF.
In deciding how to meet the product specific data requirements, registrants must follow
the directions given in the Data Call-In Notice and its attachments appended to the RED. The
DCI Notice contains two response forms which are to be completed and submitted to the Agency
within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant
will meet the data requirements for each product. The second form, "Requirements Status and
Registrant's Response," lists the product specific data required for each product, including the
standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide
whether he/she will provide the data or depend on someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must select one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
Appendix H HI NAA RED Amendment
-------
APPENDIX H - PRODUCT BATCHING
Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's
data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or
Citing an Existing Study (Option 6). If a registrant does not want to participate in a batch, the
choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to
participate in a batch does not preclude other registrants in the batch from citing his/her studies
and offering to cost share (Option 3) those studies.
Thirty eight products were found which contain NAA as the active ingredient. These
products have been placed into 6 sections: NAD (PC Code 056001 - contains 4 products placed
in a No Batch group); NAA (PC Code 056002 - contains 15 products placed in 3 batches and a
No Batch group); Potassium 1-naphthaleneacetate (PC Code 056003 - contains 5 products
placed in 2 batches and a No Batch group); Ammonium 1-naphthaleneacetate (PC Code
056004 - contains 4 products placed in 1 batch and a No Batch group); Sodium 1-
naphthaleneacetate (PC Code 056007 - contains 4 products placed in 2 batches); Ethyl 1-
naphthaleneacetate (PC Code 056008 - contains 7 products placed in 1 batch and a No Batch
group). All were placed in these batches in accordance with the active and inert ingredients and
type of formulation. Furthermore, the following bridging strategies are deemed acceptable for
this chemical:
Batching Instructions:
PC Code 056002:
Batch 2 - EPA Reg. No. 5887-169 must conduct own eye study.
Batch 3 - EPA Reg. No. 43905-1 may not cite data conducted with EPA Reg. No. 64388-1.
PC Code 056003:
Batch 1 - studies should be conducted with EPA Reg. No. 5481-497.
PC Code 056007:
Batch 2 - studies should be conducted with EPA Reg. No. 5481-541 and both products in batch
must conduct own acute inhalation study.
NOTE: The technical acute toxicity values included in this document are for informational
purposes only. The data supporting these values may or may not meet the current acceptance
criteria.
Appendix H H2 NAA RED Amendment
-------
APPENDIX H - PRODUCT BATCHING
1-Naphthaleneacetamide or NAD (PC Code 056001)
No Batch
EPA Reg. No.
264-499
5481-426
5481-431
5481-473*
Percent Active Ingredient
NAD: 0.20
Thiram: 4.04
8.40
97.00
NAD: 1.20
NAA: 0.45
*also listed in PC Code 056002 No Batch
1-Naphthalene acetic acid or NAA (PC Code 056002)
Batch 1
EPA Reg. No.
5481-219
5481-430
5481-498
Percent Active Ingredient
95.0
95.5
99.0
Batch 2
EPA Reg. No.
5481-337
5887-169
7401-337
Percent Active Ingredient
0.11
0.10
0.10
Batch 3
EPA Reg. No.
43905-1
64388-1
Percent Active Ingredient
NAA: 0.66
IB A: 1.03
NAA: 0.50
IB A: 1.00
Appendix H
H3
NAA RED Amendment
-------
APPENDIX H - PRODUCT BATCHING
1-Naphthalene acetic acid or NAA (PC Code 056002) (continued)
No Batch
EPA Reg. No.
5481-473*
8002-1
68719-2
72639-11
75851-1
82437-1
82437-2
Percent Active Ingredient
NAA: 0.450
NAD: 1.200
0.040
NAA: 0.076
IBA: 0.133
NAA: 0.200
IBA: 0.850
Kinetin: 0.150
NAA: 0.001
Kinetin: 0.001
NAA: 0.025
IBA: 0.050
NAA: 0.010
IBA: 0.040
Kinetin: 0.008
*also listed in PC Code 056001 No Batch
Potassium 1-naphthaleneacetate (PC Code 056003)
Batch 1
EPA Reg. No.
5481-413
5481-497
Percent Active Ingredient
24.2
24.0
Batch 2
EPA Reg. No.
5481-414
5481-496
Percent Active Ingredient
6.25
6.25
No Batch
EPA Reg. No.
5481-428
Percent Active Ingredient
24.2
Appendix H
H4
NAA RED Amendment
-------
APPENDIX H - PRODUCT BATCHING
Ammonium 1-naphthaleneacetate (PC Code 056004)
Batch 1
EPA Reg. No.
5481-66
5481-129
34704-382
Percent Active Ingredient
5.68
5.68
5.68
No Batch
EPA Reg. No.
5481-130
Percent Active Ingredient
21.00
Sodium 1-naphthaleneacetate (PC Code 056007)
Batch 1
EPA Reg. No.
5481-218
5481-432
Percent Active Ingredient
95.0
95.0
Batch 2
EPA Reg. No.
5481-427
5481-541
Percent Active Ingredient
3.5
3.5
Ethyl 1-naphthaleneacetate (PC Code 056008)
Batch 1
EPA Reg. No.
5481-434
5481-452
5481-459
5481-460
Percent Active Ingredient
1.15
1.15
1.15
1.15
No Batch
EPA Reg. No.
5481-429
5481-433
7401-387
Percent Active Ingredient
15.0
95.0
1.0
Appendix H
H5
NAA RED Amendment
-------
APPENDIX I: LIST OF AVAILABLE RELATED DOCUMENTS &
ELECTRONICALLY AVAILABLE FORMS
Pesticide Registration Forms are available at the following EPA internet site:
http://www.epa.gov/opprd001/fortns/.
Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader)
Instructions:
1. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out
on your computer then printed.)
2. The completed form(s) should be submitted in hardcopy in accord with the existing
policy.
3. Mail the forms, along with any additional documents necessary to comply with EPA
regulations covering your request, to the following address for the Document Processing
Desk.:
Document Processing Desk (distribution code)*
Office of Pesticide Programs (7504P)
Environmental Protection Agency
1200 Pennsylvania Ave, NW
Washington, DC 20460-0001
* Distribution Codes are as follows:
(APPL) Application for product registration
(AMEND) Amendment to existing registration
(CAN) Voluntary Cancellation
(EUP) Experimental Use Permit
(DIST) Supplemental Distributor Registration
(SLN) Special Local Need
(NEWCO) Request for new company number
(NOTIF) Notification
(PETN) Petition for Tolerance
(XFER) Product Transfer
DO NOT fax or e-mail any form containing "Confidential Business Information" or "Sensitive
Information."
If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-
5551 or by e-mail at williams.mcole@epamail.epa.gov. If you want these forms mailed or faxed
to you, please contact Lois White, white.lois@epa.gov or Floyd Gayles, gayles.floyd@epa.gov.
If you have any questions concerning how to complete these forms, please contact OPP's
ombudsperson for conventional pesticide products: Linda Arlington, (703) 305-5446
Appendix I II NAA RED Amendment
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APPENDIX I: LIST OF AVAILABLE RELATED DOCUMENTS &
ELECTRONICALLY AVAILABLE FORMS
The following Agency Pesticide Registration Forms are currently available via the Internet at the
following locations:
8570-1
8570-4
8570-5
8570-17
8570-25
8570-27
8570-28
8570-30
8570-32
8570-34
8570-35
8570-36
8570-37
Application for Pesticide
Registration/ Amendment
Confidential Statement of Formula
Notice of Supplemental Registration of
Distribution of a Registered Pesticide
Product
Application for an Experimental Use
Permit
Application for/Notification of State
Registration of a Pesticide To Meet a
Special Local Need
Formulator's Exemption Statement
Certification of Compliance with Data
Gap Procedures
Pesticide Registration Maintenance
Fee Filing
Certification of Attempt to Enter into
an Agreement with other Registrants
for Development of Data
Certification with Respect to Citations
of Data (in PR Notice 98-5)
Data Matrix (in PR Notice 98-5)
Summary of the Physical/Chemical
Properties (in PR Notice 98-1)
Self-Certification Statement for the
Physical/Chemical Properties (in PR
Notice 98-1)
http://www.epa.sov/opprd001/forms/8570-l.pdf
http://www.epa.sov/opprd001/forms/8570-4.pdf
http://www.epa.sov/opprd001/forms/8570-5.pdf
http://www.epa.sov/opprd001/forms/8570-17.pdf
http://www.epa.sov/opprd001/forms/8570-25.pdf
http://www.epa.sov/opprd001/forms/8570-27.pdf
http://www.epa.sov/opprd001/forms/8570-28.pdf
http://www.epa.sov/opprd001/forms/8570-30.pdf
http://www.epa.sov/opprd001/forms/8570-32.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
5.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
http://www.epa.sov/opppmsdl/PR Notices/pr98-
l.pdf
Appendix I
12
NAA RED Amendment
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APPENDIX I: LIST OF AVAILABLE RELATED DOCUMENTS &
ELECTRONICALLY AVAILABLE FORMS
Pesticide Registration Kit http://www.epa.gov/pesticides/registrationkit/
Dear Registrant:
For your convenience, we have assembled an online registration kit which contains the
following pertinent forms and information needed to register a pesticide product with the U.S.
Environmental Protection Agency's Office of Pesticide Programs (OPP):
1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food,
Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act
(FQPA)of 1996.
2. Pesticide Registration (PR) Notices
a. 83-3 Label Improvement Program-Storage and Disposal Statements
b. 84-1 Clarification of Label Improvement Program
c. 86-5 Standard Format for Data Submitted under FIFRA
d. 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems
(Chemigation)
e. 87-6 Inert Ingredients in Pesticide Products Policy Statement
f. 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement
g. 95-2 Notifications, Non-notifications, and Minor Formulation Amendments
h. 98-1 Self Certification of Product Chemistry Data with Attachments (This document
is in PDF format and requires the Acrobat reader.)
Other PR Notices can be found at http://www.epa.gov/opppmsdl/PR_Notices.
3. Pesticide Product Registration Application Forms (These forms are in PDF format and
will require the Acrobat reader.)
a. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment
b. EPA Form No. 8570-4, Confidential Statement of Formula
c. EPA Form No. 8570-27, Formulator's Exemption Statement
d. EPA Form No. 8570-34, Certification with Respect to Citations of Data
e. EPA Form No. 8570-35, Data Matrix
4. General Pesticide Information (Some of these forms are in PDF format and will require
the Acrobat reader.)
a. Registration Division Personnel Contact List
b. Biopesticides and Pollution Prevention Division (BPPD) Contacts
c. Antimicrobials Division Organizational Structure/Contact List
d. 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements
(PDF format)
e. 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF
format)
f. 40 CFR Part 158, Data Requirements for Registration (PDF format)
g. 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985)
Appendix I 13 NAA RED Amendment
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APPENDIX I: LIST OF AVAILABLE RELATED DOCUMENTS &
ELECTRONICALLY AVAILABLE FORMS
Before submitting your application for registration, you may wish to consult some
additional sources of information. These include:
1. The Office of Pesticide Programs' Web Site
2. The booklet "General Information on Applying for Registration of Pesticides in the
United States", PB92-221811, available through the National Technical Information
Service (NTIS) at the following address:
National Technical Information Service (NTIS)
5285 Port Royal Road
Springfield, VA 22161
The telephone number for NTIS is (703) 605-6000.
3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's
Center for Environmental and Regulatory Information Systems. This service does charge
a fee for subscriptions and custom searches. You can contact NPIRS by telephone at
(765) 494-6614 or through their website.
4. The National Pesticide Telecommunications Network (NPTN) can provide information
on active ingredients, uses, toxicology, and chemistry of pesticides. You can contact
NPTN by telephone at (800) 858-7378 or through their website: http://npic.orst.edu
The Agency will return a notice of receipt of an application for registration or amended
registration, experimental use permit, or amendment to a petition if the applicant or
petitioner encloses with his submission a stamped, self-addressed postcard. The postcard
must contain the following entries to be completed by OPP:
• Date of receipt
• EPA identifying number
• Product Manager assignment
Other identifying information may be included by the applicant to link the
acknowledgment of receipt to the specific application submitted. EPA will stamp the date
of receipt and provide the EPA identifying File Symbol or petition number for the new
submission. The identifying number should be used whenever you contact the Agency
concerning an application for registration, experimental use permit, or tolerance petition.
To assist us in ensuring that all data you have submitted for the chemical are properly
coded and assigned to your company, please include a list of all synonyms, common and
trade names, company experimental codes, and other names which identify the chemical
(including "blind" codes used when a sample was submitted for testing by commercial or
academic facilities). Please provide a CAS number if one has been assigned.
Appendix I 14 NAA RED Amendment
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