United States Prevention, Pesticides EPAr?30-R-Q4&
Environmental Protection And Toxic Substances November 1998 .
Agency . (7508C)
vvEPA Reregistration
Eligibility Decision (RED)
Propachlor
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United States
Environmental Protection
Agency
Prevention, Pesticides
And toxic Substances
(7508C)
EPA-738-F-98-013
November 1998
R.E.D. FACTS
Pesticide
Reregistration
Use Profile
PROPACHLOR
All pesticides sold or distributed in the United States must be registered
by EPA, based on scientific studies showing that they can be.used without
posing unreasonable risks to people or the environment." Because of advances
in scientific .knowledge, the law requires that pesticides which were first
registered before November 1, 1984, be reregistered to ensure that they meet
today's more stringent standards.
In evaluating pesticides for reregistration, EPA obtains and reviews a
complete set of studies from pesticide producers, describing the human health
arid environmental effects of each pesticide. To implement provisions of the
Food Quality Protection Act of 1996, EPA considers the special sensitivity of
infants and children to pesticides, as well as aggregate exposure of the public
to pesticide residues from all sources, and the cumulative effects of pesticides
and other compounds with common mechanisms of toxicity. The Agency
develops any mitigation measures or regulatory controls needed to effectively
reduce each pesticide's risks. EPA then reregisters pesticides that meet the
safety standard of the FQPA and can be used without posing unreasonable
risks to human health or the environment.
When a pesticide is eligible for reregistration, EPA explains the basis for
its decision in a Reregistration Eligibility Decision (RED) document. This fact
sheet summarizes the information in the RED document for reregistration case!
(0177), propachlor. ' • • /
Propachlor is a herbicide used to control grasses and broadleaf weeds in
the first season (growth1 establishment phase). Propachlor is used on grain
. sorghum (milo), field corn, hybrid seed corn, silage corn, and for onion seed in
Washington and Oregon.
Formulation types registered include: manufacturing product (93% and
96.5% a.i.); a flowable concentrate (31.5% and 42% a.i. formulated with
atrizme); and a granular (20% a.i.),
Propachlor can be applied with groundbooni sprayers, tractor-drawn
broadcast spreaders, and granular row planters.
Application rates vary from 3.0 to 6.0 pounds of active ingredient per
acre depending upon the application scenario.
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Regulatory Propachlor was first registered as a pesticide in the U.S. in 1964. EPA
HIStory issued a Registration Standard for propachlor in December, 1984. A
September, 1991 Data Call-In (DCI) required additional generic and product-
specific chemistry data for the Monsanto 96.5% Technical. Currently, eight
propachlor products are registered.
Human Health Toxicity
Assessment In studies using laboratory animals, propachlor is highly toxic to the
eyes. The Agency has placed propachlor in Toxicity Category I (the highest of
four categories) for this effect.
[NOTE: For acute oral, dietary, mammalian/avian/aquatic toxicity:
Category I = very highly or highly toxic
Category II = moderately toxic
Category III = slightly toxic
Category IV = practically non-toxic]
Sufficient data are available to assess the acute, subchronic, chronic
toxicity and carcinogenic potential of propachlor. Propachlor has been
classified as a "Likely" human carcinogen, based on the (a) rare stomach
tumor in male Fischer 344 rats; (b) thyroid rumors in male and ovarian
granulosa/theca cell rumors in female Sprague-Dawley rats at doses that were
not adequate to assess carcinogeniciry; c) hepatocellular tumors in male CD-I
mice; (d) in vitro clastogenic activity; and (e) tumors observed at one or more
of the same sites with three strupturally-related chloroacetanilide compounds.
Dietary Exposure
People may be exposed to residues of propachlor through the diet.
Tolerances or maximum residue limits have been established for propachlor
(see 40 CFR 180.211). EPA has reassessed the propachlor tolerances and
updated a list of raw agricultural and processed commodities and feedstuffs
derived from crops. Due to these changes, some commodity definitions must
be corrected. In addition, tolerances for which there are currently'no
registered uses of propachlor are being proposed for revocation.
EPA has assessed the acute dietary risk posed by propachlor. MOE's
(food and drinking water exposure combined) for adult males and females
range from 17,000 to 53,000. Given the magnitude of the calculated Margins
of Exposure, cancer risk does not seem to be of concern.
For the overall U.S. population, chronic exposure from all current
propachlor tolerances represents less than 1% of the Reference Dose (RfD), or
amount believed not to cause adverse effects if consumed daily over a 70-year
lifetime. Therefore, it appears that chronic dietary risk is minimal.
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Occupational and Residential Exposure
Based on current use patterns, handlers (mixers, loaders, and applicators)
may be exposed to propachlor in agricultural settings during and after normal
use of the pesticide. - j
The Agency has determined that there are potential exposures to mixers,
loaders, applicators, and other handlers during usual use-patterns associated
with propachlor. Based on the use patterns, five major exposure scenarios
were assessed for propachlor:
(1) mixing/loading liquids for groundboom application;
(2) mixing/loading dry fiowables for groundboom application;
(3) loading granulars for tractor-drawn spreader application; ,
(4) applying sprays with groundboom equipment; and
(5) applying granulars with a tractor-drawn spreader.
For worker protection, the Agency will require the use of additional
personal protective equipment (chemical resistant gloves, apron, and chemical
resistant shoes) and engineering controls under certain conditions.
Human Risk Assessment
The Agency considers propachlor to be classified as a likely human
carcinogen. The Agency's Cancer Review Assessment Review Committee
has classified propachlor as a "Likely" human carcinogen, based on (a) the
observance of multiple tumors at multiple sites, including the rare stomach
tumor in a male Fischer 344 rat, thyroid rumors in male and ovarian
granulosa/theca cell tumors in female Sprague-Dawley rats, and hepatocellular
tumors in CD-I mice; (b) in vitro clastogenic activity; (c) tumors observed at
one or more of the same sites with three structurally-related chloroacetanilide
compounds (alachlor, acetochlor, and butachlor); (d) lack of data on mode of
action; and (e) the relevance of the observed tumors to human exposure.
Because dietary exposure to propachlor residues in foods is extremely
low. The acute, chronic, and cancer exposure risk is also low to the general
population. , •
., There is concern for the risk posed to propachlor handlers, particularly
mixers/loaders/applicators, and field workers who come into contact with
treated areas following application of this herbicide. Exposure and risk to -
workers will be mitigated by the use of Personal Protective Equipment (PPE)
required by the WPS, supplemented by additional PPE and closed systems as
required by this RED. Post-application reentry workers will be required to
observe a 48-hour Restricted Entry Interval, the basis for this decision being
that propachlor is classified as a toxicity category I (severe) for eye irritation -
potential and is also classified as a strong dermal sensitizer.
FQPA Considerations
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Determination of safety includes consideration of special sensitivity to
children, potential cumulative effects with pesticides that have a common mode
of toxicity and aggregate risks resulting from exposure to dietary residues,
residues in drinking water, and residential sources.
-The database for developmental and reproductive toxicity of propachlor
is considered to be complete at this time. A developmental neurotoxicity study
was not required. There is no unique or special sensitivity for pre- or post-natal
exposure. Based on these three factors, the Agency has concluded that there is
not a basis for retaining the additional 10X safety factor from FQPA. An
uncertainty factor of 100 will adequately protect infants and children.
The Agency has determined that consideration of a common mode of
toxicity with other chemicals such as acetochlor, butachlor, metolachlor, and
alachlor is not appropriate at this time. Tolerance reassessments have occurred
in the RED as a result of new data on the concentrations of propachlor
residues present in food. As a result, the existing and unsupported tolerances
will be revoked in conjunction with this RED.
There are no residential uses of propachlor. The aggregate risk
assessment from exposure to propachlor in food and water, does not result in
aggregate risk that exceeds the Agency's level of concern.
Thus, the agency concludes that there is a reasonable certainty of no
harm to infants and children, and adults from consuming potential residues of
propachlor. This conclusion encompasses residues from aggregate exposure
(food and water).
Propachlor is a member of the acetanilide class of herbicides. It is
structurally similar to acetochlor, butachlor, metolachlor, and alachlor.
Section 408(b)(2)(D)(v) of FQPA requires that, when considering
whether to establish, modify, or revoke a tolerance, 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 Agency believes that "available information" in this context
might include not only toxicity, chemistry, and exposure data, but also policies
and methodologies for conducting cumulative risk assessments. For most
pesticides, the Agency has some information in its files that may turn out to be
helpful in eventually determining whether a pesticide shares a common
mechanism of toxicity with any other substances.
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However, at this time the Agency does not have the methodology to
resolve the scientific issues concerning common mechanism of toxicity in a
meaningful way. The Agency has begun a pilot process to study this issue
further through the examination of particular classes of pesticides. Hopefully,
the results of this pilot process will enable the Agency to develop, and apply
policies for evaluating the cumulative effects of chemicals having a common
mechanism of toxicity. At present, however, the Agency does not know how
to apply the information in its files concerning common mechanism, issues to
most risk assessments. Exceptions include pesticides that are lexicologically
and structurally dissimilar to existing chemical substances (in which case the
Agency can conclude that it is unlikely that a pesticide shares a common.
mechanism of activity with other substances) and pesticides that produce a
common toxic metabolite (in which case the metabolite must be assessed as
part of a common mechanism assessment). ,
In making individual tolerance decisions, the Agency will determine
whether: '
, . 1) it has sufficient information to determine that a pesticide does not
appear to share a common mechanism of toxicity with other substances;
- 2) it is unable to conclude that a pesticide does not share a common
mechanism of toxicity wim other substances; or
3) it is able to conclude that a pesticide does share a common
mechanism of activity with other substances.
Due to the structural similarities with acetochlor, metolachlor,
butachlor, and alachlor, propachlor may fall into the second category.'
However, at this time the Agency has not yet made a final decision concerning
a possible common mechanism of toxicity for these five chemicals to
scientifically apply that information to the tolerance decision. The process has
begun, but is hot yet completed. Therefore, for the purposes of this decision
document, the tolerance decision will be reached based upon the best available
and useful information for propachlor only. The risk assessment has been
performed for propachlor only assuming that no common mechanism of
toxicity exists. However, these decisions will be reexamined after
methodologies and procedures for integrating information concerning common
mechanism of toxicity into risk assessments are developed by the Agency.
Environmental
Assessment Environmental Fate
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The environmental fate assessment for propachlor shows that:
• The three major degradates appear to be very mobile and persistent due
mainly to its low affinity to adsorb soil.
• While highly mobile, propachlor is not expected to persist substantially
on the soil surface under most conditions.
• The major routes of dissipation for the parent propachlor are aerobic soil
metabolism and, in the absence of an active microbial population,
leaching. A half life of <3 days is observed with 50% field dissipation
rate occurring within 1 to 6 days.
• Propachlor may be more persistent in low moisture conditions, in soils
with low microbial activity, or under anaerobic conditions.
• Due to its high solubility and low affinity for adsorption, propachlor is
likely to dissipate rapidly from plant and soil surfaces.
Water Resources Assessment
The water resources assessment concludes that:
• The Agency has determined that the parent propachlor does not pose a
significant threat to ground-water quality under most conditions.
However, the three acid degradates have a high potential to leach and to
persist in ground.water.
• " Detections of propachlor and/or its metabolites have been reported
(0.02-3.5 ppb) in some wells, suggesting that this chemical or its
degradates reach ground water under certain conditions.
• Propachlor is most likely to reach ground water in soils which have little
microbiological activity, high permeability, and a shallow water table.
• Based upon limited fate data, the three major acid degradates of
propachlor appear to be available for runoff longer than the parent,
moving primarily by dissolution in runoff water.
Ecological Effects
The available toxicity of propachlor suggest that:
• Moderately toxic to birds on both an acute oral and chronic basis.
• Practically non-toxic to mammals on an acute oral basis.
• Practically non-toxic to bees on an acute oral basis and a subacute
dietary basis.
• Moderately to highly toxic to freshwater fish on an acute basis. The
technical grade material (TGAI) is more toxic to rainbow trout than the
formulated product however, the formulated product is more toxic to
bluegill sunfish than the technical grade material.
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• No aquatic invertebrate studies have been performed however, a
comparative analysis yielded a Risk Quotient (RQ) factor which does not
, trigger me need for any further testing for freshwater fish.
Environmental Risk Characterization
' An evaluation of the risk to nontarget organisms from the use of propachlor
products, combining toxicity data with potential exposure, indicates that:
• The overall lexicological spectrum for propachlor suggests that it is
slightly to moderately toxic to most non-target organisms (the Agency
. has no reported incidences of adverse impacts on non-target organisms
...'•'• from the use of propachlor.
;• The granular formulations pose the greatest risk to non-target organisms.
• The potential for chronic (long-term) exposure of non-target organisms
to propachlor is reduced because it is not persistent under most
conditions and because the pesticide is only applied once in a growing
season. , • . '
Risk Mitigation To lessen the human health, ecological, water and food quality risk
posed by propachlor, EPA is requiring mitigation measures that will: protect
non-target species, control surface water and ground water contamination, and
protect workers.
Additional Data , EPA is requiring the following additional generic studies for propachlor
Required to. confirm its regulatory assessments and conclusions:
• 72-3 (a) Acute toxicity to estuarine and marine fish
: • 72-3 (b) Acute toxicity to estuarine and marine mollusks .
• 72-3 (c) Acute toxicity to esturarine and marine shrimp
• 123-2 Aquatic Plant Growth on four of the five required species is still
outstanding: Lemna gibba, Skeletonema costatum, Anabaena flos-
aquae, and freshwater diatom.
• 162-1 Aerobic Soil Metabolism. An additional study is needed to better
| characterize the rate of dissipation of pr6pachlor.
• 162-4 Aerobic Aquatic Metabolism •
• 165-1 Limited Field rotational Crop ,
, . The, Agency also is requiring product-specific data including product
chemistry and acute toxicity studies, revised Confidential Statements of
Formula (CSFs), and revised labeling for reregistration.
Product Labeling All propachlor end-use products must comply with EPA's current
pesticide product labeling requirements and with the following. Fora
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Changes Required comprehensive list of labeling requirements, please see the propachlor RED
document.
• Ground water advisory language must be, placed on all propachlor labels.
• ' Surface water advisory language must be placed on all propachlor labels.
• Advisory statement for the Environmental Hazards of toxicity to
terrestrial and aquatic plants, fish and aquatic invertebrates for both
• manufacturing use and end use products.
• Advisory statement for toxicity to non-target organisms for granular
products.
• Spray Drift labeling Language.
• Product labels for all uses must be amended include a skin sensitization
statement.
• The label for the Personal Protective Equipment for the mixing/loading
for all liquid products containing propachlor must include
-Chemical resistant gloves.
• For the mixing/loading of granular products, the label must reflect the
following Personal Protective Equipment:
-Long-sleeved shirt, long pants
-Chemical-resistant apron
-Chemica^ resistant footwear
-Chemical resistant gloves
/ - • •
• For the applicator Personal Protective equipment for all propachlor
granular products, the label will reflect:
-Long-sleeved shirt, long pants
-Chemical resistant apron
-Chemical resistant footwear
,> ' ,
-Chemical resistant gloves
• Labels referring to the engineering controls for application of all liquid
formulations must specify:
-A closed system
• Labels for all products must contain User Safety Requirements for the
cleaning and maintenance of Personal Protective Equipment.
• Each label must have an Environmental Hazard Statement in reference to
fish, aquatic invertebrate, and wildlife toxicity.
• An Environmental Hazard Statement for granular formulations must be
included requiring that spilled granules must be covered or incorporated.
• Rotational crop label amendment stating that only crops for which there
are registered propachlor uses may be rotated to treated fields.
• A 48 hour restricted entry interval (REI) is required for uses within the
scope of WPS. This is based on he acute toxicity of the active ingredient
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Regulatory
Conclusion
1 - • • • • ' ' '
(category I for primary eye irritation). Personal protective Equipment
required for early entry, is: : .
-Protective eyewear . ;
EPA has determined that the reassessed tolerances for propachlor meet
the safety standard under trie FQPA, and that there is a reasonable certainty
that no harm will result to infants and children or to the general population
from aggregate exposure to propachlor residues. The use of currently
registered products containing propachlor in accordance with approved .
labeling will not pose unreasonable risks or adverse effects to humans or the
environment. Therefore, the use of the liquid and granular formulations of
propachlor are eligible for reregistration provided labeling changes described in
the RED are followed. Propachlor products will be reregistered once the
required product-specific data, revised Confidential Statements of Formula,
and revised labeling.are received and accepted by the EPA. The use of
currently registered products containing propachlor in accordance with
approved labeling will not pose unreasonable risks or adverse effects to '• ...
humans or the environment Therefore, all liquid and granular uses of these
products are eligible for reregistration;
The Agency had concerns for the occupational risk posed to
mixers/loaders of the dry flowahles. The registrant has agreed to voluntarily
cancel their formulation of the dry flowable product.
For More
Information
EPA is requesting public comments on the Reregistration Eligibility
Decision (RED) document for propachlor during a 60-day time period, as
announced in a Notice of Availability published in the Federal Register. To
obtain a copy of the RED document or to submit written comments, please
contact the Pesticide Docket, Public Information and Records Integrity
Branch, Information Resources and Services Division (7502C), Office of
Pesticide Programs (OPP), US EPA, Washington, DC 20460, telephone
703-305-5805.
Electronic copies of the RED and this fact sheet are available on the
Internet. See http://www.epa.gov/REDs. • . -"••..
Printed copies of the' RED and fact sheet can be obtained from EPA's
National Center for Environmental Publications and Information . -
(EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-2419, telephone "l-800-
490-9198; fax 513-489-8695. '-.-'.
Following the comment period, the propachlor RED document also will
be available from the National Technical Information Service (NTIS), 5285
Port Royal Road, Springfield, VA 22161, telephone 703-605-6000.
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For more information about EPA's pesticide reregistration program, the
propachlor RED, or reregistration of individual products containing
propachlor, please contact the Special Review and Reregistration Division
(7508C), OPP, US EPA, Washington, DC 20460, telephone 703-308-8000.
For information about the health effects of pesticides, or for assistance in
recognizing and managing pesticide poisoning symptoms, please contact the
National Pesticides Telecommunications Network (NPTN). Call toll-free 1-
800-858-7378, from 6:30 am to 4:30 pm Pacific Time, or 9:30 am to 7:30 pm
Eastern Standard Time, seven days a week.
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
s • OFFICE OF
PREVENTION, PESTICIDES
, AND TOXIC SUBSTANCES
CERTIFIED MAIL NOV I 2 !998
Dear Registrant:
I am pleased to announce that the Environmental Protection Agency has completed its
reregistration eligibility review and decisions on the pesticide chemical case propachldr. The
enclosed Reregistration Eligibility Decision (RED), which was approved on September 30,1998,
contains the Agency's evaluation of the data base of these chemicals, its conclusions of the
potential human health and environmental risks of the current product uses, and its decisions and
conditions under which these uses and products will be eligible for reregistration. The RED
includes the data and labeling requirements for products for reregistration. It also includes
requirements for additional generic data on propachlor to confirm the risk assessments.
To assist you with a proper response, read the enclosed document entitled "Summary of
Instructions for Responding to the RED." This summary also refers to other enclosed documents
which include further instructions. You must follow all instructions and submit complete and
timely responses. The first set of required responses is due 90 days from the date of your
receipt of this letter. The second set of required responses is due 8 months from the date of
your receipt of this letter. Complete and timely responses will avoid the Agency taking the
enforcement action of suspension against your products.
Please note that the Food Quality Protection Act of 1996 (FQPA) became effective on
August 3,1996, amending portions of both pesticide law (FIFRA) and the food and drug law
(FFDCA). This RED takes into account, to the extent currently possible, the new safety standard
set by FQPA for establishing and reassessing tolerances. However, it should be noted mat in
continuing to make reregistration determinations during the early stages of FQPA
implementation, EPA recognizes that it will be necessary to make decisions relating to FQPA
before the implementation process is complete. In making these early case-by-case decisions,
EPA does not intend to set broad precedents for the application of FQPA. Rather, these early
determinations will be made on a case-by-case basis and will not bind EPA as it proceeds with
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further policy development and any rulemaking that may be required.
If EPA determines, as a result of this later implementation process, that any of the
determinations described in this RED are no longer appropriate, the Agency will pursue whatever
action may be appropriate, including but not limited to reconsideration of any portion of this
RED.
If you have questions on the product specific data requirements or wish to meet with the
Agency, please contact the Special Review and Reregistration Division representative Anne
Overstreet at (703) 308-8068.
Sincerely,
*er, Associate J?irector
:ial Review and
''Reregistration Division
Enclosures
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SUMMARY OF INSTRUCTIONS FOR RESPONDING TO
THE REREGISTRATION ELIGIBILITY DECISION (RED)
1. DATA CALL-IN (PCD OR "90-DAY RESPONSE"-If generic data are required for
reregistration, a DCI letter will.be enclosed describing such data. If product specific data are
required, a DCI letter will be enclosed listing such requirements. If both generic and product
specific data are required, a combined Generic and Product Specific DCI letter will be enclosed
describing such data. However, if you are an end-use product registrant only and have been
granted a generic data exemption (GDIs) by EPA, you are being sent only the product specific
response forms (2 forms) with the RED. Registrants responsible for generic data are being sent
response forms for both generic and product specific data requirements (4 forms). You. must
submit the appropriate response forms (following the instructions provided) within 90 days
of the receipt of this RED/DCI letter; otherwise, your product may be suspended.
2. TIME EXTENSIONS AND DATA WAIVER REOUESTS-No time extension requests
wili.be granted for the 90-day response. Time extension requests may be submitted only with
respect to actual data submissions. Requests for time extensions for product specific'data should
be submitted in the 90-day response. Requests for data waivers must be submitted as part of the
90-day response. All data waiver and time extension requests must be,accompanied by a full
justification. All waivers and time extensions must be granted by EPA in order to go into effect.
3. APPLICATION FOR REREGISTRATION OR "8-MONTH RESPONSE"-You must
submit the following items for each product within eight months of the date of this letter
(RED issuance date).
., • a. Application for Reregistration (EPA Form 8570-1). Use only an original application
form. Mark it "Application for Reregistration." Send your Application for Reregistration (along
with the other forms listed in b-e below) to the address listed in item 5.
b. Five copies of draft labeling which complies with the RED and current regulations
and requirements, Only make labeling changes which are required by the RED and current
regulations (40 CFR 156.10) and policies. Submit any other amendments (such as formulation
changes, or labeling changes not related to reregistration) separately. You may, but are not
required to, delete uses which the RED says are ineligible for reregistration. For further labeling
guidance, refer to the labeling section of the EPA publication "General Information on Applying
•for Registration in the U.S., Second Edition, August 1992" (available from the National Technical
Information Service, publication #PB92-221811; telephone number 703-605-6000 or 800-553- ,
6847). ' ; ' '
c. Generic or Product Specific Data. Submit all data in a format which complies with
PR Notice 86-5, and/or submit citations of data already submitted and give the EPA identifier
(MRID) numbers. Before citing these studies, you must make sure that they meet the
Agency's acceptance criteria (attached to the DCI).
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d. Two copies of the Confidential Statement of Formula TCSF^ for each hasm
each alternate formulation. The labeling and CSF which you submit for each product must
comply with P.R. Notice 91-2 by declaring the active ingredient as the nominal concentration.
You have two options for submitting a CSF: (1) accept the standard certified limits (see 40 CFR
§158.175) or (2) provide certified limits that are supported by the analysis of five batches. If you
choose the second option, you must submit or cite the data for the five batches along with a
certification statement as described in 40 CFR §158.175(e). A copy of the CSF is enclosed;
follow the instructions on its back.
e- Certification With Respect to Data Compensation Requirements Complete and
sign EPA form 8570-31 for each product.
4. COMMENTS IN RESPONSE TO FEDERAL REGISTER NOTICE-Comments
pertaining to the content of the RED may be submitted to the address shown in the Federal
Register Notice which announces the availability of this RED.
5. WHERE TO SEND PRODUCT SPECIFIC PCI RESPONSES r90-DAY^ AND
APPLICATIONS FOR REREGISTRATION fS-MONTH RESPONSES^
BvlLS.Mail:
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
EPA, 401 M St. S.W.
Washington, D.C. 20460-0001
By express;
Document Processing Desk (RED-SRRD-PRB)
Office of Pesticide Programs (7504C)
Room 266A, Crystal Mall 2
1921 Jefferson Davis Hwy.
Arlington, VA 22202
6. EPA'S REVIEWS-EPA will screen all submissions for completeness; those which are not
complete will be returned with a request for corrections. EPA will try to respond to data waiver
and tune extension requests within 60 days. EPA will also try to respond to all 8-month
submissions with a final reregistration determination within 14 months after the RED has been
issued.
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REREGISTRATION ELIGIBILITY DECISION
PROPACHLOR
LIST A
CASE 0177
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TABLE OF CONTENTS
PROPACHLOR REREGISTRATION ELIGIBILITY DECISION TEAM . . . . . . i
-J . " • • ' '
ABSTRACT .....'. ...-••••• iv
L INTRODUCTION .... .;•...'... :. .... .. 1
II. CASE OVERVIEW 2
A- Chemical Overview . 2
B. Use Profile '. ,."..' : '.. 3
C. Estimated Usage of Pesticide .4
D. Data Requirements and Regulatory History 5
HI. SCIENCE ASSESSMENT ......:...... , • • •'• • .-<....... 6
A. Physical Chemistry Assessment 6
B. Human Health Risk Assessment 7
1. Toxicology Assessment 7
a. Acute Toxicity 9
b. Subchronic Toxicity . 10
c. Chronic Toxicity and Carcinogenicity 11
d. Other Carcinogenic Issues ........ . . ... . . . . . . 14
e. , Developmental Toxicity Studies 14
f. Reproduction Toxicity Studies 16
g. Mutagenicity Studies 18
h. Other Genotoxic Effects 18
i. Metabolism . . 19
j. Neurotpxicity Studies ,19
2. Dose/Response Assessment 20
a. Consideration of FQPA Issues for Propachlor 20
b. Reference Dose.[R£D] '. .. 21
c. ,FAO/WHO . . -..'...'. ... .22
d. Carcinogenicity Classification and Risk Quantification 22
e. Assessment of Reproductive/Developmental Toxicity ..... . 23
f. Dermal Absorption Factor -23
g. Toxicological Endpoints of Concern for Use in Human Risk
Assessment 24
3. Toxicological Endpoints for Risk Assessment . . 25
a. Acute Dietary 25
b. Chronic (non-cancer) Dietary Risk Assessment. :'....' 25
c. Carcinogenic Dietary Risk ...25
d. Dermal Absorption ........ ... .............:.. 25
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e. Occupational and Residential 26
4. Risk Assessment 28
a. . Dietary 28
(1) Directions for Use 29
(2) Nature of the Residue - Plants 30
(3) Nature of the Residue - Livestock 30
(4) Residue Analytical Methods 30
(5) Multiresidue Methods . .31
(6) Storage Stability Data 31
(7) Crop Field Trials . 31
(8) Processed Food/Feed 32
(9) Meat, Milk, Poultry, Eggs 32
(10) Water, Fish, and Irrigated Crops 34
(11) Food Handling 34
(12) Confined Accumulation in Rotational Crops 34
(13) Field Accumulation in Rotational Crops . 35
b. Occupational and Residential 45
C. Environmental Assessment 72
1. Use Characterization . 72
a. Application Rates and Methods 72
b. Use in Corn Areas 72
c. Use in Sorghum Areas 72
2. Ecological Toxicity Data 73
a. Toxicity to Terrestrial Animals 73
(1) Birds, Acute and Subacute 73
(2) Birds, Chronic 74
(3) Mammals, acute and chronic 74
(4) Insects ...'.' 75
b. Toxicity to Aquatic Animals 76
(1) Freshwater Fish, Acute 76
(2) Freshwater Fish, Chronic ..: 76
(3) Freshwater Invertebrates, Acute .... 77
(4) Freshwater Invertebrate, Chronic 77
(5) Estuarine and Marine Fish, Acute 78
(6) Estuarine and Marine Fish, Chronic 78
(7) Estuarine and Marine Invertebrates, Acute 78
(8) Estuarine and Marine Invertebrates, Chronic 78
c. Toxicity to Plants 78
(1) Terrestrial 78
(2) Aquatic Plants . . 80
3. Environmental Fate Characteristics 81
a. Degradation 82
b. Metabolism .83
c. Mobility/Leachability 85
d. Fate of Propachlor and its Degradates in the Field . 87
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e. Bioaccumulation 92
t Spray Drift...;....,...;... ...... 93
4.; Water Resource Assessment .93
a. Surface Water Assessment .. 93
b. Ground Water Assessment ..........................,'. 94
c. Aquatic Exposure Assessment 95
5. Estimated Water Concentrations For Drinking Water .96
a. Ground Water Sources .... 96
b. Surface Water Sources . . .... .96
c. Use of Screening Estimates for Drinking Water Assessments 97
• 6. Comparative Assessment With Other Acetanilid.es .............. 97
a. Avian Species : 104
b. Mammalian Species .....: 105,
c. Fish Species 105
d. Aquatic Invertebrates ,: 105
7. Environmental Risk Assessment ........................... 105
a. Risk Quotients and Levels of Concern ; 105
b. Exposure and Risk to Nontarget Terrestrial Animals 107
" (1) Birds... '.../. ....109
(2) Mammals .:..... 110
(3) Beneficial Insects 111
c. Exposure and Risk to Nontarget Aquatic Animals .......111
(1) Freshwater Fish .,.-..' . .. .111
(2) Freshwater Invertebrates Ill
(3) Estuarine and Marine Animals ................. 112
(4) Data Gaps for Degradate Exposure and Risk to
Non-target Aquatic Animals 112
d. Exposure and Risk to Nontarget Plants 113
: (1) EECs for terrestrial plants inhabiting areas adjacent
to treatment sites ..... 113
(2) EECs for semi-aquatic plants inhabiting adjacent
wet, low-lying areas . . . 113
(3) Aquatic Plants 116
e. Exposure and Risk to Endangered Species ............. 116
8. Environmental Risk Characterization 117
IV. RISK MANAGEMENT AND REREGISTRATION DECISION .............' 118
A. Determination of Eligibility . 118
B. Determination of Eligibility .... ... 118
1. Eligibility Decision .118
2. Eligible and Ineligible Uses 119
C. Regulatory Position .\......... 119
1. Food Quality Protection Act Findings ..... 120
a. Determination of Safety for U.S. Population ..120
b., Determination of Safety for Infants and Children ....... .120
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c. Endocrine Disrupter Effects 121
2. Tolerance Reassessment 121
a. Codex Harmonization , 124
D. Summary of Risk Management Decisions 124
1. Human Health 124
2. Worker (Mixer/Loader/Applicator) 125
3. Environmental 126
E. Occupational and Residential Labeling Rationale/Risk Mitigation 129
1. Restricted Use Classification 129
2. Reference Dose Exceedance 129
3. Occupational Labeling Rationale 129
4. Endangered Species Statement 132
5. Other Labeling Requirements 132
6. Spray Drift Advisory 133
1 '•-.,•' ' :
V. ACTIONS REQUIRED OF REGISTRANTS .' ?..... 133
A. Manufacturing-Use Products 133
1. Additional Generic Data Requirements 133
2. Labeling Requirements for Manufacturing-Use Products 133
3. End-Use Products 134
a. Additional Product-Specific Data Requirements 134
b. Labeling Requirements for End-Use Products 134
4. Required Labeling Changes Summary Table ....135
5. Spray Drift Labeling 140
B. Tolerance Revocation and Import Tolerances 140
C. Existing Stocks 141
VI. APPENDICES .. 143
APPENDIX A. Table of Use Patterns Subject to Reregistratlon . 144
APPENDIX B. Table of the Generic Data Requirements and Studies Used
to Make the Reregistration Decision 153
APPENDIX C. Citations Considered to be Part of the Data Base Supporting
the Reregistration of Propachlor 160
APPENDIX D. Combined Generic and Product Specific Data Call-In 171
Attachment 1. Chemical Status Sheets .191
Attachment 2. Combined Generic and Product Specific Data Call-In
Response Forms (Form A inserts) Plus Instructions 193
Attachment 3. Generic and Product Specific Requirement Status and
Registrant's Response Forms (Form B inserts) and
Instructions 197
Attachment 4. EPA Batching of End-Use Products for Meeting Data
Requirements for Reregistration 213
Attachment 5. List of All Registrants Sent This Data Call-in (insert)
Notice ..215
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Attachment 6. Cost Share, Data Compensation Forms, Confidential
Statement of Formula Form and Instructions .... .216
APPENDIX E. List of Available Related Documents . ...; ..... .227,
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GLOSSARY OF TERMS AND ABBREVIATIONS
PROPACHLOR REREGISTRATION ELIGIBILITY DECISION TEAM
Office of Pesticide Programs:
Biological and Economic Analysis Assessment
Alan Halvorson
James Saulmon
Economic Analysis Branch
Herbicide and Insecticide Branch
Environmental Fate and Effects Risk Assessment
' Jose Melendez .
Nelson Thurman
Richard Felthousen ,
Sid Abel
MikeRexrode
Health Effects Risk Assessment
Kathryn Boyle
William Hazel
Linda Taylor
Christina Swartz
Registration Support Risk Assessment
Jim Tompkins
Risk Management
Environmental Risk Branch IV
Environmental Risk Branch IV
Environmental Risk Branch IV
Environmental Risk Branch IV
Environmental Risk Branch IV
Risk Characterization and Analysis Branch
Chemistry and Exposure Branch I
Toxicology Branch II
Chemistry and Exposure Branch II
Herbicide Branch
J. Anne Overstreet
Reregistration Branch III
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GLOSSARY OF TERMS AND ABBREVIATIONS
ADI
AE
a.i.
ARC
CAS
CI
CNS
CSF
DFR
DRES
DWEL
EEC
EP
EPA
FAO/WHO
FDA
FIFRA
FFDCA
FQPA
FOB
GLC
GM
GRAS
HA
HOT
LD,
SO
LEL
LOG
LOD
LOEL
MATC
MCLG
"g/g
Mg/L
mg/L
MOE
MP
MPI
MRID
Acceptable Daily Intake. A now defunct term for reference dose (RfD).
Acid Equivalent
Active Ingredient
Anticipated Residue Contribution
Chemical Abstracts Service
Cation ,
Central Nervous System
Confidential Statement of Formula
Dislodgeable Foliar Residue .
Dietary Risk Evaluation System
Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e. drinking
water) lifetime exposure at which adverse, non carcinogenic health effects are not anticipated to
occur.
Estimated Environmental Concentration. The estimated pesticide concentration in an environment,
such as a terrestrial ecosystem.
End-Use Product
U.S. Environmental Protection Agency
Food and Agriculture Organization/World Health Organization
Food and Drug Administration
Federal Insecticide, Fungicide, and Rodenticide Act
Federal Food, Drug, and Cosmetic Act
Food Quality Protection Act
Functional Observation Battery
Gas Liquid Chromatography
Geometric Mean
Generally Recognized as Safe as Designated by FDA
Health Advisory (HA). The HA values are used as informal guidance to municipalities and other
organizations when emergency spills or contamination situations occur.
Highest Dose Tested
Median Lethal Concentration. A statistically derived concentration of a substance that can be
expected to cause death in 50% of test animals. It is usually expressed as the weight of substance per
weight or volume of water, air or feed, e.g., mg/1, mg/kg or ppm.
Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of
the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as
a weight of substance per unit weight of animal, e.g., mg/kg.
Lethal Dose-low. Lowest Dose at which lethality occurs.
Lowest Effect Level
Level of Concern
Limit of Detection
Lowest Observed Effect Level
Maximum Acceptable Toxicant Concentration
Maximum Contaminant Level Goal (MCLG) The MCLG.is used by the Agency to regulate
contaminants in drinking water under the Safe Drinking Water Act.
Micrograms Per Gram
Micrograms per liter
Milligrams Per Liter
Margin of Exposure
Manufacturing-Use Product
Maximum Permissible Intake
Master Record Identification (number). EPA's system of recording and tracking studies submitted.
U
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GLOSSARY OF TERMS AND ABBREVIATIONS
N/A NotAppIicable ' , . - ;.,
NOEC No Observable Effect Concentration
NPDES National Pollutant Discharge Elimination System
, NOEL No Observed Effect Level
NOAEL No Observed Adverse Effect Level • _.
OP ' Organophosphate
OPP Office of Pesticide Programs
Pa ' pascal, the pressure exerted by a force of one newton acting on an area of one square meter.
PADI Provisional Acceptable Daily Intake , ; • ••
PAG Pesticide Assessment Guideline -
PAM . Pesticide Analytical Method
PHED . Pesticide Handler's Exposure Data
PHI Preharvest Interval ,
ppb Parts Per Billion
PPE , . Personal Protective Equipment •
ppm Parts Per Million , , . ':'•.'•'
. PRN Pesticide Registration Notice •• ' '
Q*! The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model
RBC RedBloodCell • • .
RED Reregistration Eligibility Decision •
REI , Restricted Entry Interval
RfD Reference Dose
RS Registration Standard ,. -. '
RUP Restricted Use Pesticide
SLN Special Local Need (Registrations Under Section 24 © of FIFRA)
TC Toxic, Concentration. The concentration at which a substance produces a toxic effect.
TD • Toxic Dose. The dose at which a substance produces atoxic effect.
TEP , . Typical End-Use Product
TGAI Technical Grade Active Ingredient
TLC Thin Layer Chromatography ' .
TMRC Theoretical Maximum Residue Contribution •
torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions.
WP Wettable Powder >•
WPS Worker Protection Standard
ill
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ABSTRACT
The U.S. Environmental Protection Agency has completed its reregistration eligibility decision
for the pesticide propachlor and determined that most uses, when labeled and used as specified in this
document, are eligible for reregistration. This decision includes a comprehensive reassessment of the
required target data base supporting the use patterns of currently registered products. This decision
considered the requirements of the "Food Quality Protection Act of 1996" (FQPAJ which amended
the Federal Food Drug and Cosmetic Act and the Federal Insecticide Fungicide and Rodenticide Act,
the two Federal statutes that provide the framework for pesticide regulation in the United States.
FQPA became effective immediately upon signature and all reregistration eligibility decisions (REDs)
signed subsequent to August 3, 1996 are accordingly being evaluated under the new standards
imposed by FQPA.
Propachlor is a pre-emergent herbicide used to control grasses and broadleaf weeds in
sorghum, corn and onion seed (registered for use only in Washington and Oregon). The pesticide
can be applied with a groundboom sprayer, tractor-drawn broadcast spreader and granular row
planter. Propachlor was first registered as a pesticide in the U.S. in 1964. Propachlor is produced
by the Monsanto Company, which currently holds most registrations.
Registration Eligibility
The Agency has concluded under the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) that most uses, as prescribed in this document, will not cause unreasonable adverse effects
on human health or the environment and therefore most products are eligible for reregistration. In
developing this decision, the registrant has agreed to various risk mitigation measures and to
voluntarily cancel the registrations of dry flowable formulations. Among other labeling changes, the
registrant has agreed to require a closed mixing/loading system for liquid applications on corn and
sorghum; an enclosed cab for goundboom spraying operations; and a double layer body covering
ensemble for mixing/loading and applying the granular formulation to corn and sorghum. Workers
who re-enter treated fields within the 48 hour restricted entry interval (REI) must wear eye
protection. In addition, the registrant has agreed to limit .the rotation of crops on propachlor-treated
fields to those crops for which there are registered propachlor uses. To address uncertainties
associated with the environmental fate profile and certain ecological hazards of propachlor, the
Agency is calling-in additional aerobic soil and aquatic metabolism studies, and some acute toxicity
studies.
Tolerance Reassessment
In establishing or reassessing tolerances, FQPA requires the Agency to consider aggregate
exposures to pesticide residues, including all anticipated dietary exposures and other exposures for
which there is reliable information, as well as the potential for cumulative effects from a pesticide,and
other compounds with a common'mechanism of toxicity. The FQPA further directs the Agency to
consider the potential for increased susceptibility of infants and children to the toxic effects of
IV
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pesticide residues, and to develop a screening program to determine whether pesticides produce
endocrine disrupting effects. . •
Although propachlor is structurally similar to the following acetanilides: acetochlor, butachlor,;
metolachlor, and alachlor, the Agency has not yet made a final decision concerning a possible
common mechanism of toxicity for Ihese five chemicals to scientifically apply that information to the
tolerance decision. The process has begun, but is not yet completed. Therefore, for the purposes of
this decision document, the tolerance decision will be reached based upon the best available and
useful information for propachlor only. The risk assessment has been performed for propachlor only
assuming that no common mechanism of tbxiciry exists. However, these decisions will be reexamined
after methodologies and procedures for integrating information concerning common mechanism of
toxicity into risk assessments are developed by the Agency.
The,Agency has reassessed propachlor food tolerances under the standards ofFQPA and
determined, based on available information, that there is a reasonable certainty of no harm will result
to infants and children or to the general population from aggregate exposure to propachlor residues.
Propachlor is not registered for residential uses. Thus, for the, purposes of tolerance reassessment
the only routes of exposure to humans are through food and water residues. Combining the exposure
to propachlor in food and water, the Agency found that the aggregate risk did not exceed the
Agency's level of concern. In addition, as a result of new data on the concentrations of propachlor
residues in food and because of the existence of certain obsolete tolerances, some existing tolerances
have been refined and the unsupported tolerances will be revoked in conjunction with this action.
Toxicology of Propachlor -
The Agency has reviewed the available toxicology data and found the information sufficient
for assessing the acute, sub-chronic, chronic toxicity and carcinogenic potential of propachlor.
Propachlor has been classified as a "Likely" human carcinogen (or B2), based on the (1) rare stomach
tumor hi male Fischer 344 rats- (2) thyroid tumors in male and ovarian granulosa/theca cell tumors
in female Sprague-Dawley rats at doses that were not adequate to assess carcinogenicity; (3)
hepatocellular tumors in male CD-I mice; (4) in vitro clastogenic activity; and (5) tumors observed
at one or more of the same sites with three structurally-related chloroacetanilide compounds.
Because propachlor is highly toxic to the eye, the Agency has placed propachlor in Toxicity Category
I (the highest of four categories) for this effect.
The Agency has found the database for developmental and reproductive toxicity of propachlor
to be complete at this time. A developmental neurotoxicity study was not required. Nor is there a
unique or special sensitivity for pre- or post-natalexposure. Based on these factors, the Agency has
concluded that there is not a basis for retaining the additional 1QX safety factor from FQPA. An
uncertainty factor of 100 will adequately protect infants and children. ,
The Agency has decided to use a Q, * approach for assessing the carcinogenic risk of chronic
exposure to propachlor. The Reference Dose (PvfD) for propachlor was determined by the Agency
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to be 0.054 mg/kg/day, based on the rat chronic toxicity study (NOEL = 5.4 mg/kg/day) and a
standard uncertainty factor of 100.
Human Health Risk (Dietary Riskf) .
The general public may be exposed to residues of pfopachlor through the diet because
propachlor is used on number of food and/or feed crops and the pesticide has the potential to reach
ground and surface waters. The Agency, however, has determined that neither the parent propachlor
nor its degradates pose a significant threat to ground-water quality under most conditions.
Three acid degradates of propachlor have the potential to leach and to persist in ground water.
Detections of propachlor and/or its metabolites have been reported (0.02-3.5 ppb) in some wells,
suggesting that this chemical or its degradates reach ground water under certain conditions.
Propachlor is most likely to reach ground water in soils which have little microbiological activity, high
permeability, and a shallow water table. In addition, based upon limited fate data, the three major
acid degradates of propachlor appear to be available for runoff longer than the parent, moving
primarily by dissolution in runoff water. Thus, in some cases propachlor residues are detectable in
surface waters. To address uncertainties associated with the environmental fate profile of propachlor,
the Agency is calling-in additional aerobic soil and aquatic metabolism studies.
For the purposes of conducting dietary risk assessments, the Agency estimated the dietary
exposure to propachlor residues on the bases of acute and chronic exposure scenarios.
The Agency assessed the acute dietary risk posed by propachlor and found Margins of Exposure
(MOE) for food residues within acceptable ranges. In addition, when combining food residues and
anticipated drinking water exposure, the Agency calculated the MOE's for acute dietary risk for adult
males and females in the range of 17,000 to 53,000.
The chronic dietary risk is also within acceptable limits, even when using conservative
assumptions. For the overall U.S. population, chronic (non-cancer) risk from all current propachlor
tolerances represents less than 1% of the Reference Dose (RfD), or an amount believed not to cause
adverse effects if propachlor residues are consumed daily over a 70-year lifetime. In addition, the
Agency calculated the lifetime cancer risk from exposure to dietary residues of propachlor (combined
food and water sources) to be 9.3 x 10"7 for females and 9.0 x 10"7 for males.
The Agency was also concerned about potential exposure to propachlor from residues taken
up by rotational food and/or feed crops grown on propachlor-treated fields. The Agency, concluded
that it would be prudent to limit the rotation of crops on propachlor-treated fields to only those crops
for which there are registered propachlor uses.
Human Health Risk (Occupational)
The Agency is concerned about the risk posed to propachlor handlers, particularly
mixers/loaders/applicators, and field workers who come into contact with treated areas following
VI
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application of this herbicide. In accordance with this decision, exposure and risk to workers will be
mitigated by the use of Personal Protective Equipment (PPE) as required by the Worket Protection
Standards, and supplemented by requiring the use of additional PPE, enclosed cabs and closed
mixing/loading systems. The Agency is also requiring that post-application reentry workers observe
a 48-hour Restricted Entry Interval based',on propachlor's classification as a toxicity category I
(severe) for eye irritant and strong dermal sensitizer. .
Based on current use patterns, the Agency determined that propachlor has the potential to
expose handlers (mixers, loaders, and applicators) in agricultural settings during and after normal use
of the pesticide. The Agency assessed the following major exposure scenarios for propachlor: (1)
mixing/loading liquids for groundboom application; (2) mixing/loading dry flowables forgroundboom
application; (3) loading granulars for tractor-drawn spreader application; (4) applying sprays with
groundboom equipment; and (5) applying granulars with a tractor-drawn spreader. The Agency
found that some of these scenarios resulted in high exposure without taking additional exposure
reduction measures.
In developing this decision document, the registrant has agreed to various risk mitigation
measures to address those scenarios with the potential to expose workers. Regarding the highest
occupational, risk calculated by'the Agency, the registrant agreed to voluntarily cancel the dry
flowable formulation. Among other labeling changes, the registrant has agreed to require a closed
mixing/loading system for liquid applications on corn and sorghum; an enclosed cab for goundboom
spraying operations; and a double layer body covering ensemble for mixing/loading and applying the
granular formulation to corn and sorghum. Workers who re-enter treated fields within the 48 hour
restricted entry interval (REI) must wear eye protection.
Environmental Fate and Ecological Risk
Propachlor poses some risk to non-target organisms, but is'generally considered to be a low
to moderate concern in the environment. The Agency has no reported incidences of adverse impacts
on non-target organisms from the use of propachlor. The available toxicity date on propachlor
suggests that the compound is (1) mdderately toxic to birds:on both an acute oral and chronic basis;
(2) practically non-toxic to mammals on an acute oral basis; (3) practically non-toxic to bees on an
acute oral basis and a subacute dietary basis; and (4) moderately to highly toxic to freshwater fish on
an acute basis. Although no aquatic invertebrate studies have been performed, a comparative analysis
yielded a Risk Quotient (RQ) factor which does not trigger a need for any further testing on
freshwater fish. .
The granular formulations of propachlor pose the greatest risk to non-target organisms. The
potential for chronic (long-term) exposure of propachlor to non-target organisms, however, is
tempered because the pesticide is not persistent under most conditions and because the pesticide is
only applied once per growing season: '
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The Agency is requiring the submission of additional environmental fate and ecological effects
data, including the following guideline (GLN) studies:
II. GLN 72-3 (a): Acute toxicity to estuarine and marine fish
• GLN 72-3 (b): Acute toxicity to estuarine and marine mollusks
• GLN 72-3 (c): Acute toxicity to esturarine and marine shrimp
• GLN 123-2: Aquatic Plant Growth on four of the five required species is still
outstanding: Lemna gibba, Skeletonema costatum, Anabaena flos-aquae, and a
freshwater diatom.
• GLN 162-1: Aerobic Soil Metabolism. An additional study is needed to better
characterize the rate of dissipation of propachlor.
• GLN 162-4: Aerobic Aquatic Metabolism
• GLN 165-1: Limited Field rotational Crop
Product Reregistration
Before reregistering the products containing propachlor, The Agency is requiring that product
specific date, revised Confidential Statements of Formula (CSF) and revised labeling be submitted
within eight months of the issuance of this document. These date include product chemistry and
acute toxicity testing for each registration. After reviewing these date and any revised labels and
finding them acceptable in accordance with Section 3(c)(5) of FIFRA, the Agency will reregister the
products. Those products which contain other active ingredients will be eligible for reregistration
only when the other active ingredients are determined to eligible for reregistration.
vm
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I. INTRODUCTION
' !
. In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregistration of products with active ingredients registered prioir to November 1, 1984.
The amended Act provides a schedule for the reregistration process to be completed in nine years.
There are five phases to the reregistration process. The first four phases of the process focus on
identification of data requirements to support the reregistration of an active ingredient and the
generation and submission of data to fulfill the requirements. The fifth phase is a review by the U.S.
Environmental Protection Agency (referred to as "the Agency") of all data submitted to support
reregistration. .'••'.' '..'.-.';.
F, 1FRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for reregistration" before calling hi data on
products and either reregistering products or taking "other appropriate regulatory action." Thus,
reregistration involves a thorough review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide, to determine the need for additional data on health and
environmental effects, and to determine whether the pesticide meets the "no unreasonable adverse
effects" criterion of FIFRA.
OnAugustS, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA), 21
U.S.C. 301 etseq., and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S:C.
136 etseq. The FQPA amendments went into effect immediately. As a result, EPA is embarking on
an intensive process, including consultation with registrants, States, and other interested stakeholders,
to make decisions on the new policies and procedures that will be appropriate as a result of enactment
of FQPA. This process will include a more in-depth analysis of the new safety standard and how it
should be applied to both food and non-food pesticide applications. The FQPA did not, however,
amend any of the existing reregistration deadline^ in section 4 of FIFRA. Therefore, the Agency will
continue its ongoing reregistration program while it continues to determine how best to implement
FQPA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of propachlor, including the risk to infants and children for any potential dietary,
drinking water, dermal or oral exposures, and cumulative effects as stipulated under the FQPA. The
document consists of six sections. Section I is the introduction. Section II describes propachlor, its
uses, data requirements and regulatory history. Section III discusses the human health and .
environmental assessment based on the data available to the Agency. Section IV presents the
reregistration decision for propachlor. Section V discusses the reregistration requirements for -
propachlor. Finally, Section VI is the Appendices which support this Reregistration Eligibility ,
Decision. Additional details concerning the Agency's review of applicable data are available on
request. . ' ,
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II. CASE OVERVIEW
.»
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility Decision:
• Common Name: Propachlor
• Chemical Name: 2-chloro-N-isopropylacetanilide
• Chemical Family: Acetanilide
• CAS Registry Number: 1918-16-7
• OPP Chemical Code: 019101
• Empirical Formula: C,,Hi4ClNO
• Trade and Other Names: n/a
• Basic Manufacturers: Monsanto Agricultural Company
Chemical Profile
Physical state: solid
Color: light brown (TGAI)
Odor: pungent
Solubility: water (613 ppm at 25°C)
At 20°C the following solubilities in g/100 mL
acetone 30.9 benzene 50.0
Ccl4 14.8 ethanol 29.0
xylene 19.3 chloroform soluble
toluene soluble ethyl ether soluble
Vapor pressure: 7.9x10"5 mm Hg
Calc. Henry's Law Constant: 3.59xlO'8 atm nrVmol
Octanol/water partition coefficient: 201
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Nomenclature for the parent propachlor and its major degradation products:
Propachlor = 2-chloro-N-isopippylacetanilide " ,
. propachlor oxanilic acid = [(l-methylethyl)phenylamino]oxoacetic acid.
propachlor sulfonic acid = 2-[(l-methylethyl)phenylamino]-2-oxoethanesulfoniQ acid
prppachlor sulfiny lacetic acid = (([(1 -methylethy l)phenylamino]acetyl)sulfmyl)acetic acid
,hydroxypropacWor (sometimes called propachlor alcohol) = 2-hydroxy-N-(l-methyl-ethyl)-N-
phenylacetamide % ;
propachlor methylsulfone = N-(l -methylethy l)-2T(methylsulfonyl)-N-phenylacetamide
' ' t '
' • ". • ' • ' , '
norchloropropachlor = N-(.l-methylethyl)-N-phenylacetamide • ;
B. UseProfile
The following is information on the currently registered uses with an overview of use
sites and application methods. ,
For propachlor: ,
Type of Pesticide: Herbicide
Use Sites: Corn, Sorghum, and Onions grown for seed in Washington and
Oregon (non-food)
. Target Organisms: According to, the labels, the formulated products .control or
. reduce competition from the following weeds: ,
Broadleaf Weeds: wild buckwheat; butfonweed; carpetweed; cocklebur; groundsel;
jimsonweed; kochia; ladysthumb; lambsquarters; annual morningglory; mustard;
nightshade, black, hairy; pigweed; purslane; Florida pusley; smartweed, Pennsylvania;
and velvet.
Grasses: barriyardgrass; crabgrass; foxtail, giant,, green, and yellow; goosegrass; wild
• millet; fall panicum; sandbur; and broadleaf signalgrass.
Formulation Types Registered: manufacturing product (93% and 96.5% A.I.); a
flowable concentrate (31.5% and 42% A.I.); a dry flowable (48.1 % A.I. formulated
with atrizine) and 'a granular (20% A.I.) . .
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Method and Rates of Application:
Equipment - Propachlor can be applied with groundboom sprayers, tractor
drawn broadcast spreaders, and granular row planters.
Method and Rate -Application rates vary from 3.0 to 6.0 pounds active
ingredient per acre depending upon the application scenario.
Timing - pre-emergent
Use Practice Limitations: All labels include hazard statements for humans and
domestic animals requiring that the product be kept away from humans, domestic
animals, and pets.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of propachlor.
These estimates are derived from a variety of published and proprietary sources available to the
Agency. The data, reported on an aggregate and site (crop) basis, reflect annual fluctuations in use
patterns as well as the variability in using data from various information sources.
Based on available pesticide usage information for 1987 through 1996, average annual
domestic usage of propachlor is approximately 2.1 million pounds active ingredient (a.L). In terms
of pounds a.i., total usage is allocated primarily to sorghum (75%) and field corn (24%). On average,
6% of sorghum acreage is treated, while less than 1% of field corn, and bulb crops (including onions)
were treated. Except for sorghum, usage generally has been declining over the past few years based
on the raw usage data.
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Table 1: Various U.S. Crops Treated Annually with Propachlor
•• '• -• " v, ".:.'.' '"",'
'Site ' ' '" "-
4
(000)
Acres >
•vQrown,
AcresJreated *
~,(000)-,
Weighted
Average
' 'Est
Max
% of Crop Treated'
/•
Weighted
Average
Est--
Max
, JLB'AI Applied
(000)
Weighted
Average*
Est
Max
- Application
Rates
Ibai/
acre/yr
# ap.pl
/year
Ib ai/A/
appl
States of Most
Usage
% of Total
Ib/ai used at
these sites
AGSITES •,-;••..•'•
Bulb Crops '
Corn, Sweet
Sorghum
TOTAL
• 194
805
10,932
1
3
693
948
1
4
878
1,548
0.4%
0.4%
6%
1%
0.5%
t
8%
1.
6
l',584
.2,115
2 '
8
2,283
3,765
1.5
1,9 -
2.3
1.0
1.0
1.0
1.5
1.9.''
2.3
OH (100%)
MN.OR(92%)
NE KS AR
MO (80%)
1 Bulb crops consist of garlic, leeks, arid onions
COLUMN HEADINGS
-Weighted averages: the most recent years and more reliable data are weighted more heavily. ;
-Average application rates are calculated by dividing average pounds a.i. by average acre-treatments or acres treated.
NOTES ON TABLE DATA
-Usage data cover 1987-1996.
-Calculations of some of the above numbers maynot appear to agree because of rounding. • , .
-A dash (-) indicates that information is NOT available in EPA sources or Is insufficient for estimation. '
-Any crops not included in the table receive little or no treatment (<1% of crop treated) according to data sources.
SOURCES: EPA data, USDA, and National Center for Food and Agricultural Policy..
1 ' , • • •
D. Data Requirements and Regulatory History
Propachlor was registered in the United States in 1964 for use as a herbicide. A Data Call-In
was issued for propachlor requiring additional data to complete the risk assessment. A Registration
Standard for propachlor was issued in December 1984. These documents summarized the regulatory
conclusions based on the available residue chemistry data, and specified the additional data required
for reregistration purposes. Data submitted and evaluated following the Update are incorporated into
this Reregistration Eligibility Decision, which outlines the Residue Chemistry Science Assessments
with respect to the reregistration of propachlor. The .conclusions are based on the use patterns
supported by the basic producer, Monsanto Agricultural Company.
-------
SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Propachlor [2-chloro-N-isopropylacetanilide] is a selective herbicide used for the preemergence
control of grasses and certain broadleaf weeds in corn and sorghum.
CH
Empirical Formula:
Molecular Weight:
CAS Registry No.:
PC Code No.:
CnH14ClNO
211.69
1918-16-7
019101
1. Identification of Active Ingredient
Propachlor is a light tan/brown solid with a melting point of 67-76 C. Propachlor is practically
insoluble in water (0.058 g/100 g at 20 C) andTreadily soluble in organic solvents including acetone,
benzene, chloroform, carbonteterachloride, ethanol, ethyl ether, toluene, and
xylene.
2. Manufacturing-use Products
A search of the Reference Files System (REFS) conducted 2/27/97 identified two
manufacturing-use products (MPs): the Monsanto Agricultural Company 96.5% technical product
(T; EPA Reg. No. 524-310) and the Drexel Chemical Company 93% T (EPA Reg. No. 19713-163).
3. Regulatory Background
The Propachlor Guidance Document (dated 12/84) required additional generic and
product-specific product chemistry data for the Monsanto 96.5% T. The Propachlor
Reregistration Standard Update (dated 4/10/90) reviewed data submitted in response to the Guidance
Document and summarized the product chemistry database for,the Monsanto 96.5% T; data for the
Drexel 93% T were not reviewed in the Update because this product was registered subsequent to
issuance of the Guidance Document. Additional data were required concerning GLNs 61-3, 62-2,
and 63-20 (now OPPTS 830.1670, 830.1750, and 830.6320) for the Monsanto 96.5% T.
-------
4. Conclusions
All pertinent data requirements are satisfied for the Monsanto and Drexel prppachlor Ts, except
for a new data requirement concerning UV/visible absorption for the PAI (OPPTS 830.7050), which
applies to the Monsanto 96.5% T., Provided that Monsanto submits the data required in the attached
data summary table for the 96.5% T and either certifies that the suppliers of beginning materials and
the manufacturing process have not changed since the last comprehensive product chemistry review
or, submits a complete updated product chemistry data package, the Agency has no objections to the
reregistration of propachlor with respect to product chemistry data requirements. ;
B. Human Health Risk Assessment
1. Toxicology Assessment
Toxicology data are used, by the Agency to assess the hazards to humans and domestic animals.
The data are derived from a variety of acute, subchronic, and chronic toxicity tests;
developmental/reproductive tests; and tests to assess mutagenicity dnd~ pesticide metabolism.
Reregistration eligibility decisions require that-the Agency have sufficient information to select the
appropriate end-points for performing a human health risk assessment. This requires a toxicological
database that is not only complete, but of acceptable quality.
The toxicology profile for propachlor is summarized below. The toxicology, database on
propachlor is complete and will support reregistration eligibility.
Table 2; Toxicology Profile
Guideline
81-1
81-2
81-3
- 81-4
81-5
8-1-6
' 81-7 '
81-8 '•'.
82-1
OPPTS #
870.1100
870.1200
870.1300
870.2400 ,
870.2500
870.2600
870.6100
870.6200 ,
870.3100
Study Type
acute oral - rats
acute dermal - rabbits
acute inhalation - rats
primary eye irritation
primary dermal irritation
dermal sensitization
acute delayed neurbtoxicity - hen .
acute neurotoxicity - rat
subchronic feeding - rats
subchronic feeding - mice
, MRID#
00104350
00104351
41986001
00151787
00104353
00151789
'-
42584702
00152151
00152865
Required
yes
yes
yes. .
no
no.
no
no •
yes
yes
no
Satisfied
yes
yes
yes
yes
, yes
yes
no
yes
no1
no2
7
-------
Guideline
82-1
82-2
82-5
83-1 (a)
83-1 (b)
83-2
83-3(a)
83-3(b)
83-4
83-5
84-2
84-2
84-2
85-1
85-2
86-1
OPPTS .#
870.3150
870.3200
870.6100
870.4100
870.4100
870.4200
870.3700
870.3700
870.3800
870.4300
870.5140
870.5385
870.5500
870.7485
870.7600
870.7200
Study Type:
subchronic feeding - dog
21-day dermal - rats
subchronic neurotoxicity - rats
chronic toxicity - rats
chronic toxicity - dog
carcinogenicity - mice
developmental toxicity - rat
developmental toxicity - rabbits
2-generation reproduction - rats
chronic toxicity/carcinogenicity - rat
gene mutation
chromosomal aberration
other genotoxic effects
metabolism
dermal penetration
domestic animal safety
MRID#
00157852
44590801
43575701
44168301
40081601
40162501
40248701
44069801
44158001
00115136
00150936
40113801
40398301
42348002
42584701
' 00157168
43226701
43862901
40473101
44168301
00153939
00153-940
40312701
00144512
40068401
43221801
00157496-
00157500
00157502-
00157507
-
-
Required
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
no3
waived
Satisfied
yes
no4
yes
yes
yes
yes '
yes
yes
yes
yes
yes
yes
yes
yes
no
no
1 Classified unacceptable, but there is a chronic toxicity study available and a repeat of the subchronic study is not required.
2 Classified unacceptable, but there is a carcinogenicity study available and a repeat of the subchronic study is not required
-------
I. INTRODUCTION
In 1988, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended to
accelerate the reregistration of products 'with active ingredients registered prior to November 1, 1984.
The amended Act provides a schedule for the reregistration process to be completed in nine years.
There are five phases to the reregistration process. The first four phases of the process focus on
identification of -data requirements to support the reregistration of an active ingredient and the
generation and submission of data to fulfill the requirements. The fifth phase is a review by the U.S.
Environmental Protection Agency (referred to as "the Agency") of all data submitted to support
reregistration. ; . '. .
FIFRA Section 4(g)(2)(A) states that in Phase 5 "the Administrator shall determine whether
pesticides containing such active ingredient are eligible for reregistration" before calling in data on
products and either reregistering products or taking "other appropriate regulatory action." Thus,
reregistration involves a thorough review of the scientific data base underlying a pesticide's
registration. The purpose of the Agency's review is to reassess the potential hazards arising from the
currently registered uses of the pesticide, to determine the need for additional data on health and
environmental effects, and to determine whether the pesticide meets the "no unreasonable adverse
effects" criterion of FIFRA.
On Augusts, 1996, the Food Quality Protection Act of 1996 (FQPA) (Public Law 104-170)
was signed into law. FQPA amends both the Federal Food, Drug, and Cosmetic Act (FFDCA),. 21
U.S.C. 301 et seq., and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), 7 U.S.C.
136 et-seq. The FQPA amendments went into effect immediately. As a result, EPA is embarking on
an intensive process^ including consultation with registrants, States, and other interested stakeholders,,
to make decisions on the new policies and procedures that will be appropriate as a result of enactment
of FQPA.- This process will include a more in-depth analysis of the new safety standard and how it
should be applied to both food and non-food pesticide applications. The FQPA did not, however,
amend any of the existing reregistration deadlines in section 4 of FIFRA. Therefore, the Agency will
continue its ongoing reregistration program while it continues to determine how best to implement
FQPA.
This document presents the Agency's decision regarding the reregistration eligibility of the
registered uses of propachlor, including .the risk to infants and children for any potential dietary,
drinking water, dermal or oral exposures^ and cumulative effects as stipulated under the FQPA. The
document consists of six sections. Section I is the introduction. Section II describes propachlor> its
uses, data requirements and regulatory history. Section III discusses the human health and
environmental assessment based on the data available to the Agency. Section IV presents the
reregistration decision for propachlor. Section V discusses the reregistratiorr requirements for
propachlor. Finally,,Section VI is the Appendices which support this Reregistration Eligibility
Decision. Additional details 9oncerning the Agency's review of applicable data are available on
request. • ,. \ ''' "•
-------
II. CASE OVERVIEW
A. Chemical Overview
The following active ingredient is covered by this Reregistration Eligibility Decision:
• Common Name: Propachlor
• Chemical Name: 2-chloro-N-isopropylacetanilide
• Chemical Family: Acetanilide
• CAS Registry Number: 1918-16-7
• OPP Chemical Code: 019101
• Empirical Formula: CUH14C1NO
• Trade and Other Names: n/a
• Basic Manufacturers: Monsanto Agricultural Company
Chemical Profile
Physical state: solid
Color: light brown (TGAI)
Odor: pungent
Solubility: water (613 ppm at 25 ° C)
At 20 ° C the following solubilities in g/100 mL
acetone 30.9 benzene 50.0
Ccl4 14.8 ethanol 29.0
xylene 19.3 chloroform soluble
toluene soluble ethylether soluble
Vapor pressure: 7.9x10"s mm Hg
Calc. Henry's Law Constant: 3.59xlO"8atmm3/mor
Octanol/water partition coefficient: 201
-------
Nomenclature for the parent propachlor and its major degradation products:
Propachlor = 2-chloro-N-isopropylacetanilide
propachlor oxanilic acid = [(l-methylethyl)phenylamino]oxpacetic acid
• . . '. i ' ' ' "
propachlor sulfonic acid = 2-[(l-methylethyl)phenylarnino]-2-oxoethanesulfonic acid
propachlor sulfinylacetic acid - (([(l-methylethyl)phenylamino]acetyl)sulfinyl)acetic acid
bydroxypropachlor (sometimes called propachlor alcohol) = 2-hydroxy-N-( 1 -methy 1-ethy 1)-N-
phenylacetamide _ •".-.".-.. , •
propachlor methy Isulfone = N-( 1 -methylethyl)-2-(methylsulfonyi)-N-phenylacetamide
norchloropropachlor = N-(l-methy lethyl)-N-phenylacetamide
B. Use Profile
, The following is information on the currently registered uses with an overview of use
sites and application methods. r , •
' For propachlor:
Type of Pesticide: Herbicide
Use Sites: Corn, Sorghum, and Onions grbwn for seed in Washington and
Oregon (non-food) ,
> ' • • . - ' •'.'-• * '
Target Organisms: According to the labels, the formulated products control or
reduce competition from the following weeds:
Broadleaf Weeds: wild buckwheat; buttonweed; carperweed; cocklebur; groundsel;
jimsonweed; kochia; ladysthumb; lambsquarters; annual morningglory; mustard;
• ..'• nightshade, black, hairy; pigweed; purslanes-Florida pusley; smartweed, Pennsylvania;
and velvet -
Grasses: barnyardgrass: crabgrass: foxtail giant green, and yellow: goosegrass: wild
millet; fall panicum; sandbur; andbroadleaf signalgrass., •
Formulation Types Registered: manufacturing product (93% and 96.5% A.I.); a
: flowable concentrate (31.5% and 42% A.I.); a dry flowable (48.1% A.I. formulated
with atrizine) and a granular (20% A.I.)
-------
Method and Rates of Application:
Equipment- Propachlor can be applied with groundboom sprayers, tractor
drawn broadcast spreaders, and granular row planters.
Method and Rate -Application rates vary from 3.0 to 6.0 pounds active
ingredient per acre depending upon the application scenario.
Timing - pre-emergent
Use Practice Limitations: All labels include hazard statements for humans and
domestic animals requiring that the product be kept away from humans, domestic
animals, and pets.
C. Estimated Usage of Pesticide
This section summarizes the best estimates available for the pesticide uses of propachlor.
These estimates are derived from a variety of published and proprietary sources available to the
Agency. The data, reported on an aggregate and site (crop) basis, reflect annual fluctuations in use
patterns as well as the variability in using data from various information sources.
Based on available pesticide usage information for 1987 through 1996, average annual
domestic usage of propachlor is approximately 2.1 million pounds active ingredient (a.i.). In terms
of pounds a.i., total usage is allocated primarily to sorghum (75%) and field corn (24%). On average,
6% of sorghum acreage is treated, while less than 1% of field corn, and bulb crops (including onions)
were treated. Except for sorghum, usage generally has been declining over the past few years based
on the raw usage data.
-------
Table 1: Various U.S. Crops Treated Annually with Propachlor
"%*"*• **
Site * -
. (000)
Acres
Grown
Acres Treated '
' (000)
Weighted
Average
V*
Est
Max
% of Crop Treated
Weighted
Average
Est
Max
LB-AI Applied
(000)'
Weighted
> Average
Est
Max
Application
Rates
Ib ai/
acre/yr ~
#appl
/year
Ib ai/A/
appl
States of Most
Usage
% of Total
Ib/ai used at
these sites
AG SITES ; - • ' . , -."-.••.
Bulb Crops '
Com, Sweet
Sorghum
TOTAL
194
805
10,932
.1
. 3
693
948
1
4 ;
878
1,548
0.4%
0.4%
6%
1% ..
0.5%
8%
1
6
1,584
2,115
2
8
2,283
'3,765
1.5
1.9
2.3
1.0
- 1.0
r.o.
1.5
1.9
2.3
OH (100%)
MNOR(92%)
NE KS AR
MO (80%)
"
1 Bulb crops consist of garlic, leeks, and onions
COLUMN HEADINGS , - .
-Weighted averages:'the most recent years and'more reliable data are weighted more heavily.
-Average application rates are calculated by dividing average pounds a.i. by average acre-treatments or acres treated.
'•*.'*', •
NOTES ON TABLE DATA .
-Usage data cover 1987-1996.
-Calculations of some of the above numbers may not appear to agree because of rounding. •
-:A dash (-) indicates that information is NOT available in EPA sources or is insufficient for estimation.
-Any crops not included in the table receive little or no treatment (<1% of crop treated) according to data sources.
SOURCES: EPA .data, USD A, and National Center for Food and Agricultural Policy.
D. , Data Requirements and Regulatory History '
Propachlor was registered in the United States in 1964 for use as a herbicide. A Data Call-In
was issued for propachlor requiring additional data to complete the risk assessment. A Registration
Standard for propachlor was issued in December 1984. These documents summarized the regulatory
conclusions based on the available residue chemistry data, and specified the additional data required
for reregistration purposes. Data submitted and evaluated following the Update are incorporated into
this Reregistration Eligibility Decision, which outlines the Residue Chemistry Spience Assessments
with respect to the reregistration of propachlor. The conclusions are based on the use patterns
supported by the,basic producer, Monsanto Agricultural Company.
-------
HI. SCIENCE ASSESSMENT
A. Physical Chemistry Assessment
Propachlor [2-cUoro-N-isopropylacetanilide] is a selective herbicide used for the preemergence
control of grasses and certain broadleaf weeds in corn and sorghum. •'
Empirical Formula:
Molecular Weight:
CAS Registry No.:
PC Code No.:
CUH14C1NO
211.69
1918-16-7
019101
1. Identification of Active Ingredient
Propachlor is a light tan/brown solid with a melting point of 67-76 C. Propachlor is practically
insoluble in water (0.058 g/100 g at 20 C) and readily soluble in organic solvents including acetone,
benzene, chloroform, carbonteterachloride, ethanol, ethyl ether, toluene, and
xylene.
2. Manufacturing-use Products
A search of the Reference Files System (REFS) conducted 2/27/97 identified two
manufacturing-use products (MPs): the Monsanto Agricultural Company 96.5% technical product
(T; EPA Reg. No. 524-310) and the Drexel Chemical Company 93% T (EPA Reg. No. 19713-163).
3. Regulatory Background
The Propachlor Guidance Document (dated 12/84) required additional generic and
product-specific product chemistry data, for the Monsanto 96.5% T. The Propachlor
Reregistration Standard Update (dated 4/10/90) reviewed data submitted in response to the Guidance
Document and summarized the product chemistry database for the Monsanto 96.5% T; data for the
Drexel 93% T were not reviewed in the Update because this, product was registered subsequent to
issuance of the Guidance Document. Additional data were required concerning GLNs 61-3, 62-2,
and 63-20 (now OPPTS 830.1670, 830.1750, and 830.6320) for the Monsanto 96.5% T.
-------
4. Conclusions
All pertinent data requirements are satisfied for the Monsanto and Drexel propaqhlor Ts, except
for a new data requirement concerning UV/visible absorption for the PAI (OPPTS 830.7050), which
applies to the Monsanto 96.5% T. Provided that Monsanto submits the data required in the attached
data summary table for the 96.5% T and either certifies mat the suppliers of beginning materials and
the manufacturing process have not changed since the last comprehensive product chemistry review
or submits a complete updated product chemistry data package, the Agency has no objections to the
reregistration of propachlor with respect to product chemistry data requirements.
B. Human Health Risk Assessment
1. Toxicology Assessment
Toxicology data are used by'the Agency to assess the hazards to humans and domestic animals.
The data are derived from a variety of acute, subchronic, and chronic toxicity tests;
developmental/reproductive tests; and tests to assess mutagenicity and pesticide'metabolism.
Reregistration eligibility decisions require that the Agency have sufficient information to select the
appropriate end-points for performing a human health risk assessment. This requires a toxicological
database that is not only complete; but of acceptable quality.
The toxicology profile for propachlor is summarized below. The toxicology database on
propachlor is complete and will support reregistration eligibility.
Table 2: Toxicology Profile
Guideline
81-1
81-2
, . 81-3
81-4
81-5
81-6
81-7
81-8
82-1 •
.OPPTS # .
870.1100
870.1200
870.1300 '
870.2400
870.2500
870.2600
870.6100
870.6200
870.3100
Study Type
acute oral - rats
acute dermal - rabbits ' , '.. .
acute inhalation - rats
primary eye irritation
primary dermal irritation ~
dermal sensitization
acute delayed neurotoxicity - hen
acute neurotoxicity - rat
subchronic feeding - rats
subchronic feeding - mice
MRID#
00104350 ,
00104351
41986001
00151787
00104353
00151789 .,
•
42584702
00152151
00152865
Required
yes
yes
yes
no
no
no
no
yes
yes.
no
.Satisfied
yes -
yes
; . yes
yes
yes
yes
no
• yes
no1
no2
-------
Guideline
82-1
82-2
82-5
83-l(a)
83-l(b)
83-2
83-3(a)
83-3(b)
83-4
83-5
84-2
84-2
84-2
85-1
85-2
86-1
OPPTS #
870.3150
870.3200
870.6100
870.4100
870.4100
870.4200
870.3700
870.3700
870.3800
870.4300
870.5140
870.5385
870.5500
870.7485
870.7600
870.7200
Study Type
subchronic feeding - dog
21 -day dermal - rats
subchronic neurotoxicity - rats
chronic toxicity - rats
chronic toxicity - dog
carcinogenicity - mice
developmental toxicity - rat
developmental toxicity - rabbits
2-generation reproduction - rats
chronic toxicity /carcinogenicity - rat
gene mutation
chromosomal aberration
other genotoxic effects
metabolism
dermal penetration
domestic animal safety
MRID#
00157852
44590801
43575701
44168301
40081601
40162501
40248701
44069801
44158001
00115136
00150936
40113801
40398301
42348002
42584701
00157168
43226701
43862901
40473101
44168301
00153939
00153940
40312701
00144512
40068401
43221801
00157496-
00157500
00157502-
00157507
-
-
Required
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
yes
no3
waived
Siitisfied
yes
no"
yes
yes
yes
yes
yes
yes
yes •
• yes
yes
yes
yes
. yes
no
no
1 Classified unacceptable, but there is a chronic toxicity study available and a repeat of the subchronic study is not required.
2 Classified unacceptable, but there is a carcinogenicity study available and a repeat of the subchronic study is not required
-------
3 Generally, a dermal penetration study is required for a chemical with a significant route of human exposure for which the
assumption of 100% absorption does not produce an adequate margin of exposure. For propachlor additional information,
such as a dermal absorption factor is necessary to refihe the occupational assessment.
4 The 21-day sermal toxicity study is classified as unacceptable but upgradeable. It does not satisfy the guideline
requirement for a repeated dose [21-day] dermal toxicity study in rats. This study can be upgraded with the submission of
an examination of the spleens in the rats of both sexes at the two lower dose levels. • -
a. Acute Toxicity >
-'"."• • • ' f
Sufficient data are available on' the acute toxicity of propachlor. Acute toxicity values and
categories for propachlor are summarized in Table 3, The acute toxicity data requirements [§81-1,
through §81-8] are satisfied. =
Table 3; Acute Toxicity of Propachlor
Guideline/
' OPPTS#
/ . JStudyType
81-1
'870.1100
Acute Oral - rat
81-2
870.1200
Acute Dermal-'
rabbit
81-3 :
870.1300
Acute Inhalation - rat
81-4
870.2400
Primary Eye Irritation - rabbit
81-5
870.2500
Primary- Skin Irritation - rabbit
81-6
870.2600
Dermal Sensitization - guinea pig
81-8
870.6200
Acute Neurotoxicity - rat
MRID i
00104350
00104351
. 41986001
00151787,
00104353
00151789
, 42584702
Results
s
LD50=1.8g/kg
LDso>20g/kg
LC50 = >1.2mg/L
severe irritant.
slight irritant
strong dermal sensitizer
systemic NOEL = 175 mg/kg, systemic LOEL =
350 mg/kg, based on an increase in landing foot
splay at 7 hours [peak effect time]
Toxicity
Category
m
- IV
III '
I
IV
'
• , -
Propachlor is highly toxic via the ocular route of exposure. In a primary eye irritation study
with rabbits, the test material was a severe irritant. This is toxicity category I. In a dermal
sensitization study in guinea pigs, propachlor was found to be a strong dermal sensitizer. The acute
oral neurotoxicity study in the rat is discussed in the section on Neurotoxicity Studies.
-------
b. Subchroriic Toxicity
Although the mouse and rat studies were classified as unacceptable, sufficient data for the
purposes of reregistration are available on the chronic toxiciry of propachlor.
In a 21-day dermal toxicity study (MRID 44590801), propachlor [98.25% a.i.j was
administered to 10 rats/sex/dose via the skin [=10% of the body surface area] at dose levels of 0, 40,
150, and 500 mg/kg/day for 21 days [five days per week for three consecutive weeks]. All rats
survived until study termination. There was a dose-related increase in the frequency of the dermal
response [very slight erythema, very slight edema, focal/pinpoint eschar, and slight to moderate
disquamation], and the males displayed a greater response than did the females. Body-weight gain
fluctuated throughout the study, with the high-dose males and the mid-dose females displaying a
significant decrease during the last week of dosing, and the high-dose females displaying a significant
decrease during the first week of dosing. The overall body-weight gain for the high-dose males was
91% of the control value. The overall body-weight gain for the females was 82% of control for the
mid-dose females and 81% of control for the high-dose females. There was no adverse effects on
body weight, food consumption, hematology, clinical chemistry, and organ weights, and gross
microscopic findings were comparable among the groups for both sexes, although both sexes
displayed congestion of the spleen at the high-dose level. This 21-day dermal study is classified as
unacceptable but upgradeable, and it does not satisfy the guideline for a repeated dose [21-day]
dermal toxiciry study [OPPTS 870.3200] in rats.
In a subchronic feeding study [MRID 00152151], 30 Sprague-Dawley rats/sex/group were
administered propachlor [96.1%] via the diet at dose levels of 0, 300 ppm [-15 mg/kg/day], 1500
ppm [75 mg/kg/day], and 7500 ppm [375 mg/kg/day] for 90 days [standard conversion ratio]. There
were no deaths. During the first month only, hyperactivity was displayed by the high-dose rats. There
was a dose-related decrease in body weight throughout the study [terminal sacrifice: males 90% and
39% of control/females 92% and 63% of control for the mid- and high-dose, respectively]. There was
a negative body-weight gain during the first week hi both sexes at the high-dose level, and overall
[males 13% of control/females 31% of control]. Food consumption was decreased during the first
4-5 weeks at the high-dose level [both sexes]. Effects [increasing cholesterol, decreasing glucose,
decreasing protein, decreasing organ weights] observed at the high dose are attributed to poor
nutrition, due to the poor palatabiliry of the test material and not to a toxic effect. No adverse effects
were observed at the mid- and low-dose levels in either sex. The NOEL is 1500 ppm [=75
mg/kg/day]. This guideline [§82-1] study is classified Unacceptable due to the lack of effects at dose
levels that were palatable and the lack of pair-fed controls for comparison with the dose level that was
not palatable. Since sufficient data from a chronic toxicity study in rats are available, an additional
subchronic feeding study in rats is not required.
In a subchronic feeding study [MRID 00157852], 6 Beagle dogs/sex/group were administered
propachlor [96.1%] via the diet at dose levels of 0, 100 ppm [=2.5 mg/kg/day; standard conversion
factor used], 500 ppm [=12.5 mg/kg/day], and 1500 ppm [=37.5 mg/kg/day] for 90 days. There were
no deaths. Throughout the study, decreased body weight was observed at all dose levels in both
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Sexes, although there was no dose-response. The mid-dose level of both sexes displayed the lowest
terminal body weight [males 85%/females 87% of control]. Overall, decreased body-weight gain was
observed at alldose levels of both sexes [males: 46%, 26%, and 37%/females: 91%, 18%, and 27%
of control at the low-, mid-, and .high-dose levels, respectively]. At the high-dose level in both sexes,
•food consumption was decreased throughout the study. There were no dose-related effects observed
in hematology, clinical chemistry, urinalysis, ophthalmoscopic, gross, or microscopic examinations
in either sex., The NOEL is 37.5 mg/kg/day, the highest dose tested (HDT). This guideline [§82-1]
subchronic toxicity study in dogs is classified Acceptable. ;
- - ' • , - -N
In a subchronic feeding study [MRID 00152865], 30 CrI:CD®-l (ICR)BR mice/sex/group
'were administered Propachlor [96.1%] via the diet at dose levels of 0, 500 ppm [-75 mg/kg/day],
1500 ppm [~225 mg/kg/day]; and 5000 ppm [=750 mg/kg/day] for 90 days. There were no deaths.
There was a dose-related decrease in body weight of the males .throughout the Study [week 13: 95.6%
and 91.1% of control for the mid- and high-dose, respectively]. In females, there was a dose-related
decrease in body weight during the first 6 weeks [week 6: 93.3% and 91.6% of control at the mid-;
and .high-dose levels, respectively], but during the last half of the study, the midrdose females
displayed the lowest body Weight compared to the control [week 13: 92.2% and 95.8% of control
at the mid- 'and high-dose levels, respectively]. Food consumption was decreased mainly in females
at the high dose. There .was a dose-related decrease in leukocytes in both sexes at week 7, and a
decrease was observed in the mid- and high-dose males at study termination. There was a dose-
related decrease in kidney weight in males that was statistically significant at all dose levels and
. relative kidney weight was significantly decreased in the high-dose males. Liver weight was increased
in the mid- and high-dose males and in the high-dose females. There was a dose-related increase in
relative liver weights in both sexes. Centrilobular hepatocyte enlargement was observed at all dose
levels in the males [dose-related] and in the high-dose females. . ,
There is no NOEL for this study. This guideline [§82-1] subchronic feeding study in the
mouse is classified Unacceptable, because a NOEL could not be set due to questions regarding liver
effects raised during a data audit that were not addressed by the study author. Since there- are
sufficient data available on long-term exposure [mouse carcinogenicity study] in the mouse, an
additional mouse subchronic study is not required at this tune.
c. Chronic Toxicity and Carcinogenicity
Sufficient data are available to assess the chronic toxicity and carcinogenic potential of
propachlor. Propachlor has been classified as a "Likely" human carcinogen, based'on the (a) rare
stomach tumor in male Fischer 344 rats; (b) thyroid tumors in male and ovarian ,granulosa/theca cell
tumors in female Sprague-Dawley rats at doses that were not adequate'to assess carcinogenicity; (c)
, hepatocellular tumors in male CD-I mice; (d) in vitro clastogenic activity; and (e).tumors observed
at one or more of the same sites with .three structurally-related chloroacetanilide compounds. '
GLN 83-5: Combined Chronic Toxicitv/Carcinogenicitv. Study in Rats
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In the combined chronic toxicity/carcinogenicity study in rats [MRID 44168301], Propachlor
[97.83% a.L] was administered to 60 F-344 rats/sex/dose via the diet at dose levels of 0, 100, 300,
1000, and 2500 [males]/5000 [females] ppm [males 0,5.4,16.1,53.6, and 125.3/females 0, 6.4, 19.3,'
65.5, and 292.1 mg/kg/day, respectively] for 24 months. Due to palatability problems, the high dose
level was attained by ramping the dose from 1000 ppm initially to the desired level by increasing by
500 ppm each week.
There were no adverse effects on survival or clinical signs in either sex. Both sexes at the
highest dose level displayed decreased body weight throughout most of the study [males 93%/females
72% of control value at study termination], which was accompanied by a decreased food intake
[attributable to poor palatability of the test material]. Small decreases in body weight [males 96-
97%/females 93-97% of control] and food consumption were observed in both sexes at the 1000 ppm
dose level also. Body-weight gains at the two highest dose levels of both sexes were significantly
decreased throughout much of the study, with the deficit for the first 3-month interval being
93%/89% of the control for males/females at 1000 ppm and 82%/79% of the control for
males/females at the highest dose level, respectively. Several clinical pathology findings [initial
decrease in red cell indices suggesting a mild anemia, increases in platelets/WBC in females, decreases
in serum enzymes, increased GOT levels] may be treatment-related, although wide variability
occurred in both sexes. At both the 12-month and terminal sacrifices, increased liver weight [absolute
and relative-to-brain] was observed in females at the highest dose level, but males at the highest dose
level displayed increased liver weight only at the interim sacrifice. At the highest dose level, kidney
weights [absolute and relative-to-brain] were decreased in both sexes at the terminal sacrifice. At
study termination, increased testicular weight was observed in males at the highest dose level and
decreased thyroid weight was observed in females at the highest dose level. In the stomach, herniated .
mucosal glands [submucosa/tunica muscularis], mucosal hyperplasia of the pylorus, and pyloric
cyst(s) were observed only in treated rats of both sexes, and the incidence and severity increased with
dose in males. Females at the 65.5 mg/kg/daydose level and both sexes at the highest dose level also
displayed erosion/ulceration of the glandular mucosa of the stomach. The incidence and severity of
hepatocellular hypertrophy (centrilobular/midzonal) were increased in a dose-related manner in both.
sexes. There was no increase in the incidence of hepatocellular tumors in either sex. One male at the
highest dose level displayed a glandular stomach carcinoma and, because of the other lesions observed
in this organ, it could not be ruled out and appeared to be treatment related. At the doses tested, with
the exception of the uncommon stomach tumor in one high-dose male, there was no apparent
treatment-related increase in tumors in the treated rats when compared to the control rats. Dosing
was considered adequate, based on the known poor palatability of propachlor and the demonstrated
decrease in food consumption and a concomitant decrease in body-weight gain.
The NOEL in males is 5.4 mg/kg/day and in females is 6.4 mg/kg/day. The LOEL in
males is 16.1 mg/kg/day and in females is 19.3 mg/kg/day, based on stomach lesions in males
and liver lesions in both sexes. This guideline [§83-5] chronic toxicity/carcinogenicity study in the
rat is Acceptable.
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In another 2-year feeding study pyCRILJ 40473101], 60 Sprague-Dawley CD®-Crl:CD(SD)BR
rats/sex/group were administered propachlor [96.1 %] via the diet at dose levels of 0,10. ppm [males
0.48/females 0.60 mg/kg/day], 50 ppm [males 2.39/females 3.04 mg/kg/day], and 500 ppm [males
23.88/females 30.05 mg/kg/day] for 104 weeks. Survival was comparable among the groups of both
sexes, and there were no adverse effects observed on any parameter monitored, with the exception
of a slight increase in the incidence of thyroid and ovarian tumors. It was concluded that the dose
levels were hot adequate, and a repeat study [cited above] was performed. This study was considered
in the weight of evidence considerations on propachlor.
GLN 83-1 rb): Chronic Toxicity Study in Dogs
In a chronic feeding study [MRID 40081601], 6 Beagle dogs/sex/ group were administered
Propachlor [97.1%] yja the diet at dose levels of 0, 25 ppm [=0.025 mg/kg/day], 250-ppm [=6.25
mg/kg/day], and 1000 ppm [=25 mg/kg/day] for 12 months. There were no deaths. Estrus occurred
more frequently in the treated females than in the controls. Throughout the study, decreased body
weight was observed at the mid- and high-dose levels in males and at the high-dose level in females.
At termination, the decreases in body weight were 94%. of control for the mid-dose males and high-
dose females and 84% of control for the high-dose males. At the high-dose level in both sexes, food
consumption was decreased throughout the study. Low-dose females and mid-dose males consumed
less food than the controls from week 6 on, and the mid-dose females consumed less food from week
13 on. There was a dose-related decrease in body-weight gain in both sexes [high-dose males were
37% of control during the 1-92 day interval; high-dose females were 47% of control for the same
interval]. There were no dose^-related effects observed in hematology, clinical chemistry, urinalysis,
ophthalmoscopic, gross, or microscopic examinations in either sex. The NOEL is 6.25 ing/kg/day.
The LOEL is 25 mg/kg/day, based on decreased body weight, body-weight gain, and food
consumption. This guideline [§83-1 (b)] chronic dog study is classified Acceptable.
GLN 83-2: Carcinogenicity Study in Mice
In a carcinogeniciry study (MRID 44069801), propachlor [97.8% a.i.] was administered in the
diet to 60 CD-I mice/sex/dose for 18 months at dose levels of 0, 100, 500, 1500, or 6000 ppm (0,
14.6, 75.0, 222.9, or 847.3 mg/kg/day, respectively, in males; 0, 19.3, 100.0, 276.7, or 1006.9
mg/kg/day, respectively, in females). Due to palatability problems, the high-dose level was attained
by ramping the dose from 1500 initially to the desired level of 6000 ppm by increasing by 500 ppm
each week. > .
, There were no adverse effects on survival or clinical signs in either sex. Decreased body weight
[males 89%/females 86% of control value at study termination] and body-weight gains [overall gain
males 72%/females 68% of control] were observed in males at 276.7 mg/kg/day and hi both sexes
at the highest dose level throughout most of the study following the ramping phase of the dosing
procedure. These decreases were accompanied by decreases in food consumption. This latter effect
can be attributed to the known poor palatability of the test material. Comparable increases in platelet
counts were observed in both sexes at the highest dose level compared to the controls. At both .the
. -' . • , 13 ,
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12-month and terminal sacrifices in both sexes, there was a dose-related increase in liver weight At
the highest dose level, kidney weights [absolute and relative-to-brain] were decreased in males at both
the 12-month and terminal sacrifices and.in females at the terminal sacrifice. In the stomach, herniated
mucosal glands into the submucosa/tunica muscularis were observed in both sexes at the highest dose
level and in some males at the next highest dose level. Males at the highest dose level also displayed.
erosion/ulceration of the glandular mucosa of the stomach. Several non-neoplastic lesions indicative
of liver toxicity were observed in the liver in both sexes at the highest dose level and in males at the
next highest dose level. These included hepatocellular hypertrophy (centrilobular/midzonal), necrosis
of individual hepatocytes, eosinophilic foci, telangiectasis, and pigment deposition in Kupffer cells
in the males and hepatocellular hypertrophy (periportal), mononuclear cell infiltrate, and pigment
deposition in Kupffer cells in the females. Treatment-related increases in liver tumors [hepatocellular
adenomas, carcinomas, adenomas and/or carcinomas combined]. There were no treatment-related
tumors in female mice. Dosing was considered adequate, based on the known poor palatability of
propachlor and the demonstrated decrease in food consumption and a concomitant decrease in body-
weight gain. The NOEL in males is 14.6 mg/kg/day and in females is 19.3 mg/kg/day. The
LOEL in males is 75 mg/kg/day and in females is 100 mg/kg/day, based on increased liver
weights and microscopic lesions in the liver. This guideline [§83-2] carcinogenicity study in the
mouse is Acceptable.
In another mouse study [MRID 40162501], 60 CD-I mice/sex/group were administered
propachlor [96.1%] via the diet at dose levels of 0 ppm, 10 ppm [males 1.62/females 2.01
mg/kg/day], 50 ppm [males 8.12/females 10.03 mg/kg/day], and 500 ppm [males 81.25/females
104.89 mg/kg/day] for 78 weeks. There were no treatment-related effects observed on survival, body
weight/gain, food consumption, hematology, gross pathology, or histopathology in either sex, and
there were no apparent treatment-related increases in tumors in either sex compared to the controls.
The dose levels were determined to be inadequate for assessing the carcinogenic potential of
propachlor. A repeat study [cited above] was performed. This study was considered in the weight
of evidence considerations on propachlor.
d. Other Carcinogenic Issues
Propachlor induced tumors in rats at the same sites [stomach and thyroids] as structurally-
related acetanilides; alachlor [stomach/thyroids], acetochlor [thyroids], and butachlor
[stomach/thyroids]. In rats, propachlor did not induce tumors in the liver, as. observed with
metolachlor and SAN 582H, or nose/ turbinates, as seen with acetochlor, alachlor, and butachlor. The
hepatocellular tumors seen with propachlor in mice were observed only with acetochlor.
e. Developmental Toxicity Studies
Developmental studies are designed to identify possible adverse effects on the developing
organism which may result from the mother's exposure to the pesticide during pre-natal development.
<3LN 83-3(V): Developmental Toxicitv in Rats
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Under the conditions of the study [MRID 00115136], 25 pregnant Charles River COBS CD
rats [rriated 1:1] were administered propachlor [technical] at dose levels of 0 [corn oil], 20, 60, and
200 mg/kg/day via gavage from day 6 through 19 of gestation. On day 20 of gestation, the dams were
sacrificed via CO2 inhalation. The one death that occurred [at 200 mg/kg/day]. was attributed to
intubation error. Body .weights, were comparable among the groups. There were no significant •
differences observed in the mean number of viable fetuses, postimplantation loss, total' implantations,
corpora lutea, fetal body weights, or sex ratio. Soft tissue and skeletal malformations were
comparable among the groups, and the occurrence-of unossified sternebrae, 14th rudimentary ribs, arid
renal papillae not developed and/or distended ureter were comparable among the groups also.
Although no effects were observed in this study, it was determined that a repeat rat study was not
required hi light of the fact that maternal toxic effects were observed in the rabbit developmental
toxicity study at 100 mg/kg/day and the rabbit developmental NOEL was 5 8.3, mg/kg/day compared
.to the rat NOEL for maternal and developmental toxicity hi this study was equal to or greater than
200 mg/kg/day. Additionally, severe maternal toxiciry [moribund appearance, loss of righting reflex,,
inactivity, dilated pupils,cool to touch] was observed in a range-finding study in rats at 600
mg/kg/day. The NOEL is 200 mg/kg/day, the highest dose tested. This guideline [§83-3(a)] rat
developmental toxicity study is classified Acceptable. - . <- '
-' • - - ' ' *
GLN 83-3ry>: Developmental Toxicitv Study in Rabbits
In the range-finding study pvlRID 42348002] in rabbits, dose levels of 0, 25, 75, 125,
175, and 225 mg/kg/day propachlor [96.8%]/kg body weight/day to 7 artificially inseminated New
Zealand rabbits/group during days 7 through 19 of gestation via gavage resulted in (1) death and
gross pathological lesions of the stomach and liver at dose levels of 12-5 mg/kg/day and greater; (2)
reduced defecation and soft stool at doses of 125 mg/kg/day and greater; and (3) decreased body-
weight gain and, corrected body weight at 175 mg/kg/day and above. Pregnancy rate was 57.1% at
175 and 225 mg/kg/day. There were no differences observed in any Cesareaii section parameter
monitored among groups with gravid does at the scheduled sacrifice. No external malformation or
developmental variation was observed in any of the fetuses. Maternal tpxicity was observed at 125 ,
mg/kg/day and above, expressed mainly as deaths. Developmental toxicity was not observed at any
dose level with available animals [25, 75, and 125 mg/kg/day]. From these results, dose levels of 5,
5.0, and 100 mg/kg/day were chosen.for the definitive study [cited below].
Under the conditions of the study. [MRID 00150936], 16 artificially inseminated New Zealand
female rabbits were administered Propachlor [96.5%] at dose levels of 0 [corn oil], 5, 15, and 50
mg/kg/day via gavage from day 7 through 19 of gestation. On day 29 of gestation, the does were
sacrificed. There were numerous deaths [all groups], apparently due to disease. There were no
maternal toxic effects reported at any dose level, and the clinical observations and necropsy findings
[nasal and ocular discharge, lung congestion, foci] suggest a possible infection [or dosing problem].
There was no adverse effect on body weight due to treatment, and in fact the control group showed'
a negative body-weight gain compared to positive gains in the treated groups. There was no apparent
adverse effect on pregnancy rate, although due to deaths and abortions, the low-dose group had only
8 lifters. The number of corpora lutea were comparable among the groups, but the number of
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implantation sites/doe and live fetuses/doe were decreased at the mid- and high-dose levels.
Preimplantation loss was increased at all dose levels, and the incidence exceeded historical control.
Postimplantation loss was also increased, with the incidence being the highest at the mid-dose level.
Because there was an insufficient number of litters at the low-dose level, no developmental toxicity
NOEL could be set. The rabbit developmental toxicity study was repeated [cited below].
Under the conditions of the study [MRID 42348002 and 42584701], 20 artificially inseminated
New Zealand female rabbits were administered propachlor [96.8%] at dose levels of 0 [0.5% aqueous
methylcellulose], 5,50, and 100 mg/kg/day [analytical doses of 5.8, 58.3, and 116.7 mg/kg/day] via
gavagefiom day 7 through 19 of gestation. On day 29 of gestation, the does were sacrificed via an
i.v. injection of T-61®. There were 2 deaths at the high-dose level [on day 10], and both were
considered treatment-related. One control doe died on day 12, and this was attributed to intubation
error. Salivation was displayed immediately after dosing in several high-dose does, and reduced
defecation occurred in the majority of these does during the treatment period. Thrashing,
vocalization, prostration, labored breathing, and convulsions were displayed prior to death by the two
does that died at the high dose. Negative body-weight gain occurred at the high-dose level
throughout the dosing period, and the corrected overall gain was ~27% of the control value. The
high-dose does displayed decreased food consumption throughout the dosing period and for 5 days
thereafter [77% of control]. Gravid uterine weight was decreased at the high-dose level [86% of
control] compared to the control. There were no significant differences observed in the pregnancy
rate among the groups. One low- and one high-dose does aborted [day 24], but only the abortion at
the high dose was considered treatment-related, since none of the mid-dose does aborted and the
high-dose doe displayed considerable weight loss and reduced food intake during treatment. One
high-dose doe delivered prematurely on day 29. The number of corpora lutea were comparable
among the groups, but the number of implantation sites and live fetuses were decreased at the high-
dose level, and the mid- and high-dose does displayed an increased number [dose related] of
resorptions [total and per doe] compared to the control. Postimplantation loss was increased in a
dose-related manner, but statistical significance was not attained, A subsequent assessment of the data
with respect to resorptions/postimplantation losses determined that the apparent increase was due to
total Utter resorption in one mid-dose doe and two high-dose does, which was within the historical
control incidence. Although the number of fetuses per litter and fetal body weight were comparable
among the groups, the high dose displayed the smallest number and weight. There were no
statistically significant increases in the incidence of any external, visceral, or skeletal malformation
or variation at any dose level that could be attributed to treatment. The developmental toxicity
NOEL is 58.3 mg/kg/day. The developmental toxicity LOEL is 116.7 mg/kg/day, based on the
slightly reduced mean fetal body weight. The maternal NOEL is 58.3 mg/kg/day. The maternal
LOEL is 116.7 mg/kg/day, based on decreased body-weight gain and food consumption. This
guideline [§83-3(b)] developmental toxicity study is classified Acceptable.
f. Reproduction Toxicity Studies
Reproduction studies are designed to provide general information concerning the effects of a
test substance on mating behavior, conception, parturition, lactation, weaning, and growth and
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development of the offspring. , .
GLN 83-4: Two-Generation Reproduction Study in Rats
In a two-generation reproduction study [MRID 43862901], propachlor [97.83%] was
administered to Sprague-Dawley (CD) rats [30 rats/sex/group] via the diet during pre-mating [F010
weeks/F1A 11 weeks] and through gestation and lactation [one litter/generation] at dose levels of 0,
100 ppm [males 7. I/females 8.2 mg/kg/day], 1000 ppm [males 69.6/females 80.1 mg/kg/day], and
males 2500 ppm/females 5000 ppm [males 140.7/females 315.1 mg/kg/day]. Maternal toxicity was
observed at the high-dose level, as .evidenced by (1) decreased, body weight [86% of control at
mating; 75% of control at day 21 of gestation; 72% of control at, day 21 of lactation], (2) decreased
body-weight gain (60% of control for premating period; 48% of control during gestation; 56% of
control during lactation), (3) decreased food consumption, and (4) decreased lifter size at birth. This
dose level was.discontinued after the first generation due to,severe toxicity. Reproductive effects
occurred at the high-dose level, as evidenced by decreased (1) litter size at birth, (2) F,A pup body
, weight, and (3) pup viability. Offspring viability and growth were adversely affected at the highest
dose level, as evidenced by the fact that at day 21, the pups were too small [body weight -32% of
the control] to be weaned, and the majority [11/14] of those weaned at day 21 died within one day.
At the 1000 ppm dose level, slight maternal toxicity was observed, as evidenced by a decrease in body
weight [90% of control] in the F1A females at mating and a decrease in body-weight gain in both the
F0 [86% of control] and F1A [82% of control] females during the mating period. No consistent
decrease in body weight or bqdy-weight gain was displayed by the F0 and F1A dams at 1000 ppm
during gestation or lactation. At 1000 ppm in both generations, decreased pup body weight was
observed at weaning [88% of control]. There were no adverse effects on mating or fertility at any
dose level. At terminal sacrifice, centrilobular hepatocellular hypertrophy was observed in the liver
of the adults in both sexes in both generations at the 69.6 mg/kg/day dose level. The NOEL for
maternal/paternal toxicity in males is 7.1 mg/kg/day and in females is 8.2 mg/kg/day. The
LOEL in males is 69.6 mg/kg/day and in females is 80.1 mg/kg/day based on decreased body
weight/gain and food consumption. The NOEL for effects oh the offspring in males is 7.1
mg/kg/day and in females is 8.2 mg/kg/day. The LOEL in males is 69.6 mg/kg/day. and in
females is 80.1 mg/kg/day based on decreased body weight at weaning. The NOEL for
reproductive/ developmental effects in males.is 69.6 mg/kg/day and in females is 80.1
mg/kg/day. The LOEL for reproductive/developmental effects in males is 140.7 mg/kg/day and
in females is 315.1 mg/kg/day based on reduced litter size, decreased offspring growth, and
decreased pup viability at the highest dose level in the first generation.
In another 2-generation reproduction study [MRID 00157168], Fischer 344 rats [30
rats/sex/group] were administered propachlor yja the diet [F0 for 100 days/Fj for 120 days premating;
through gestation and lactation] at dose levels of 0.3, 3.0, and 30 mg/kg/day for two generations [1
litter for F0; 2 litters for Fj due to low fertility at the 2 highest dose levels]. Propachlor did not
produce any adverse effects on the ability of the rats to mate, reproduce, and nurse their offspring.
Although initially it was concluded that the rats had riot been challenged adequately to assess the
' potential of propachlor to produce reproductive..effects, a subsequent/assessment of the data
° ' ' 17 . '
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determined that the absolute and relative liver weight decreases and the increased centrilobular
hepatocyte eosinophilia accompanied by very slight hypertrophy in the females demonstrated an effect
level. The maternal/systemic NOEL is 3.0 mg/kg/day. The LOEL is 30 mg/kg/day, based om
liver toxicity. The reproductive NOEL is equal to or greater than 30 mg/kg/day, the highest
dose tested.
g. Mutagenicity Studies
Sufficient data are available to satisfy data requirements for mutagenicity testing. There is
evidence that propachlor has genotoxic activity and analogue data are supportive of a mutagenicity
concern for propachlor.
GLN84-2: Gene Mutation
In a Chinese hamster ovary [CHO] cells HGPRT forward gene mutation assay [MRID
00153939], propachlor induced a concentration-dependent increase in mutant frequency to over a
doubling of ethanol control frequency at the HGPRT locus of CHO cells at 50 ug/mL with metabolic
activation only. This was supported by appropriate toxicity (14% relative survival)at. this
concentration, an increase in absolute colony numbers, and the relatively tight spontaneous
background reported in the testing lab. There was no apparent increase without metabolic activation
(dose levels of 10 - 60 ug/mL).
GLN 84-2: Chromosomal Aberration Assay-
In a Chinese hamster ovary [CHO] cell/chromosomal aberration assay [MRID 40312701],
propachlor was found to induce a clastogenic effect under metabolic activation conditions at the
highest dose tested, 15 ug/mL, and was negative for aberrations in this in vitro assay in CHO cells
without metabolic activation, dose levels of 5 -15 ug/mL.
In an in vivo rat bone marrow cytogenetic assay [MRID 00153940], Propachlor was not shown
to be clastogenic in bone marrow cells of Fischer 344 rats. Cytotoxicity was not observed at the i.p.
doses tested (0.05,0.2, or 1.0 mg/kg), and slightly higher dosing may have been appropriate. In other
studies [open literature], propachlor was positive for aberrations in mouse bone marrow.
h. Other Genotoxic Effects
In an in vitro unscheduled DNA assay [MRID 00257647], propachlor was not shown to be
genotoxic at doses up to 25 ug/mL; higher doses were cytotoxic.
In an hi vivo-in vitro rat hepatocyte DNA repair assay [MRID 40068401], propachlor was not
shown to be genotoxic at the concentrations [25-1000 mg/kg] tested.
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In a dominant lethal assay [MRID 43221801] in Sprague-Dawley rats, there was no indication
of a dominant lethal effect associated with'dietary exposure to propachlor at dose levels up to 2500
ppm for approximately 10 weeks, an acceptably high dose.
i. Metabolism
Sufficient data are available on the metabolism of propachlor in the rat.
In a metabolism study in rats in which single doses of 25 mg propachlor/kg of body weight
were administered orally, 91% of the dose was recovered in 56 hours, with 68% of the dose being
excreted in urine, 10% in the feces, and 4% was found in the carcass. Eleven metabolites were
identified. The metabolic fate of propachlor depends to a large extent on the presence of the intestinal
rnicroflora. Propachlor metabolites can make 3 or more cycles in the enterohepatic circulation. In the
first cycle, propachlor is metabolized via the mercapturic acid pathway and the conjugates are
excreted in the bile. The second cycle is initiated when the biliary mercapturic acid pathway
metabolites are metabolized by a rnicroflora C-S lyase to reabsorbable metabolites, which are then
metabolized to glucuronides that are secreted with the bile. Subsequent cycles result from microfloral
p-glucuronidase activity. Propachlor appears to undergo rapid absorption, distribution, metabolism,
and excretion with little, if any, tissue retention in rats. From the studies available [MRID 00157496-
00157500, 00157501-00157507], it can be stated that, following initial glutathione conjugation,
metabolism proceeds primarily via the mercapturic acid pathway with concurrent oxidative reactions
and glucuronic acid conjugation. Initially-formed metabolites undergo extensive excretion and
enterohepatic circulation.
j. Neurotoxicity Studies
GLN 81-8: Acute Neurotoxicitv Study .-•',••
In an acute neurotoxicity study [MRID 42584702], 10 Sprague-Dawley CD rats/sex/ group
were administered a single dose of propachlor via gavage at dose levels of 0, 175, 350, and 700
mg/kg. At the 700 mg/kg dose level, deaths occurred in both'sexes, and several clinical signs
suggestive of general systemic toxicity and/or neurological involvement [increased foot splay,
myoclonic jerks, slightly abnormal gait, and decreased forelimb grip strength] were observed at the
mid- and/or high-dose levels. The NOEL is 175 mg/kg, and the LOEL is 350 mg/kg, based on an
increase in landing foot splay at 7 hours [peak effect time] in females. This guideline [§81-8]
acute neurotoxicity study in rats is classified Acceptable.
GLN 82-5: Subchronic Neurotoxicirv Study
In a subchronic neurotoxicity study [MRID 43575701], 10 Sprague-Dawley CD rats/sex/group
were administered propachlor at dose levels of 100 ppm [males 5.5/females 6;8 mg/kg/day], 1000
ppm [males 55.8/females 6.3 mg/kg/day], and 2500 ppm [males 120.6 mg/kg/day]/5000 ppm [females
316.4 mg/kg/day] for at least 13 weeks. There were decreases in (1) body weight of both sexes
• • -. '• -'-19 ' ' . ' • .-.'•..
-------
[males 86%/females 77% of control] at their respective high-dose levels, (2) overall body-weight gain
in both sexes at the same dose levels [males 76%/females 57% of control], and (3) food consumption
in both sexes [males 79-91%/females 75-93% of control], which are likely to be related to the poor
palatabiliry of propachlor. None of the neurotoxicity parameters examined was affected by treatment
in either sex. The NOEL in males is 55.8 mg/kg/day and in females is 66.3 mg/kg/day. The
LOEL in males is 120.6mg/kg/day and in females is 316.4 mg/kg/day based on decreased body
weight/gain and food consumption. Propachlor does not appear to be a neurotoxin. This
guideline [§82-5] subchronic neurotoxicity study, in rats is classified Acceptable.
2. Dose/Response Assessment
a. Consideration of FQPA Issues for Propachlor
FQPA directs the Agency to "ensure that there is a reasonable certainty that no harm will result
to infants and children" from aggregate exposure to a pesticide chemical residue in setting and
reassessing tolerances. The law further states that :in the case of threshold effects, for purposes of
providing this reasonable certainty of no harm, "an additional tenfold margin of safety for the
pesticide chemical residue and other sources of exposure shall be applied for infants and children to
take into account potential pre- and post-natal toxicity and completeness of the data with respect to
exposure and toxicity to infants and children. Notwithstanding such requirement for an additional
margin of safety, the Administrator may use a different margin of safety for the pesticide residue only
if, on the basis of reliable data, such margin will be safe for infants and children."
In determining what safety factor is appropriate for assessing risks to infants and children, EPA
considers all available reliable data and makes a decision using a weight-of-evidence approach. This
approach takes into account the completeness and adequacy of the toxicity and exposure data bases,
the nature and severity of the effects observed in pre- and post-natal studies, and other information
such as epidemiological data.
OPP's Health Effects Division RfD Committee met on May 7, 1997, (1) to evaluate the
reproductive, developmental, and neurotoxicity data for propachlor, and (2) to address the sensitivity
of infants and children from exposure to propachlor as required by FQPA.
Adequacy of data: An acceptable two-generation reproduction study in rats and acceptable prenatal
developmental toxicity studies in rats and rabbits have been submitted to the Agency, meeting basic
data requirements, as defined for a food-use chemical by 40 CFR Part 158. Based upon a weight-of-
the-evidence evaluation, the Committee determined that a developmental neurotoxicity study would
not be required for propachlor. The following information was utilized in the decision. No structural
anomalies of the developing central nervous system were observed in the prenatal developmental
toxicity studies in rats and rabbits. No structural anomalies of the central nervous system were
reported in the two-generation reproduction study in rats. There were no effects of propachlor
administration on the organ weight and/or histopathology data of the nervous system in any of the
long term studies in rats, mice, or dogs. Although relative brain weight was increased (due to body
20
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. weight losses) in the subchronic toxicity studies in rats and mice, the subchronic neurotoxicity study
in rats was negative for neurotoxic effects. In the acute neurotoxicity study in rats, an increase in
landing foot splay was noted for females at 7 hours posttreatment; this was the only indication of
neurotoxic potential. Therefore, based, upon consideration, of the toxicity profile for propachlor, a
developmental neurotoxicity study in rats was not recommended. The Committee concluded that
there are no data gaps, for the assessment of the effects-of propachlor following in utero or early
postnatal exposure.
Susceptibility issues: The data demonstrated no indication of increased sensitivity of rats to in utero
and/or postnatal exposure to propachlor. In the two-generation reproduction study in rats (MRID
43862901), the parental and offspring systemic NOELs and LOELs were equivalent at 100 ppm
(7.1/8.2 mg/kg/day in M/F) and 1000 ppm (69.6/80.1 mg/k'g/day in M/F), respectively. In the prenatal
developmental toxicity study in rats with propachlor (MRID 00115136), no maternal or
developmental toxicity was noted up to the highest dose tested of 200 mg/kg/day. However, data
from the 2-generation reproduction study indicate that the developmental NOEL in rats is estimated
to be within the range of 200 to 315 mg/kg/day, with the caveat that this is an extrapolation from two
separately conducted studies in the same strain of rats, with different routes (gavage vs. dietary) and'
different durations of in utero exposure. • . .
The data demonstrated no indication of increased sensitivity of rabbits to in utero exposure to
propachlor. In the prenatal developmental toxicity study in rabbits, the maternal and developmental
NOELs and LOELs were equivalent at 58.3 mg/kg/day and 116:7 mg/kg/day, respectively.
Uncertainty factor: The RfD Committee determined that for propachlor, the 10-fold uncertainty
factor required by FQPA for the protection of infants and children could be removed, based upon the
following information: (1) The data base was complete for the evaluation of potential hazard to
perinatal animals following pre- and/or postnatal exposure to propachlor. (2) Based upon a weight
of the evidence determination, as described previously in this document, there was no concern
regarding the potential for-effects on functionardevelopment following in utero exposure.to
.propachlor, and a developmental neurotoxicity study was not required. (3) The studies demonstrated
no indication of increased sensitivity of rats to in utero and/or postnatal exposure to propachlor and
rabbits to in utero exposure to propachlor'. ,
Therefore, an uncertainty factor of 100 (10 for interspecies extrapolation and 10 for intraspecies
variability) is appropriate, and will adequately protect infants and children. .
b. Reference Dose [RfD]
A Reference Dose (RfD) represents the quantity of a substance which if absorbed on a daily -
basis over a lifetime, is not expected to pose significant risk of adverse health effects.
The RfD for propachlor was first established in 1986 based on a 90 day feeding study in rats
that was conducted with the 65% wettable powder. The NOEL was 13'.3 mg/kg/day. The LOEL
• . '. '••.''-.• •." 21 : \ ' .
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was 133.3 mg/kg/day based on decreased weight gain, food consumption, and increased relative liver
weights. An uncertainty factor of 1000 (10x10x10) was used to account for inter- and
inteaspecies differences, and the insufficient duration of the study to fully assess chronic effects. The
Agency's Integrated Risk information System (IRIS) gave the 1986 propachlor data base a low
confidence rating. Therefore, there was low confidence in the 1986 RfD of 0.013 mg/kg/day.
On May 7,1997, after reviewing chronic studies in rats, mice, and'dogs, the RfD for propachlor
was determined to be 0.054 mg/kg/day, based on the rat chronic toxicity study [MRID 44168301]
with a NOEL of 5.4 mg/kg/day. (The LOEL was 16.1 mg/kg/day, based on stomach lesions in males
and liver lesions in both sexes.) An uncertainty factor of 100 (previously determined appropriate by
the HED RfD Committee) was applied to account for both inter-species extrapolation and intra-
species variability.
c. FAO/WHO
Propachlor has not been reviewed by the FAO/WHO Joint Committee Meeting on Pesticide
Residues (JMPR) or the International Agency for Research on Cancer (IARC).
d. Carcinogenicity Classification and Risk Quantification
Lifetime feeding studies in two species of laboratory animals are conducted to screen pesticides
for cancer effects. When evidence of increased tumor incidence is noted hi these studies, the Agency
conducts a weight of the evidence review of all relevant toxicological data including short-term and
mutagenicity studies and structure activity relationship.
The carcinogenic potential of propachlor was evaluated by the HED Cancer Assessment
Review Committee on July 30, 1997. The Committee determined that propachlor be classified as a
"Likely" human carcinogen, based on (a) the observance of multiple tumors at multiple sites,
including the rare stomach tumor in .a male Fischer 344 rat, thyroid tumors in male and ovarian
granulosa/theca cell tumors in female Sprague-Dawley rats, and hepatocellular tumors in CD-I mice;
(b) in vitro clastogenic activity; (c) tumors observed at one or more of the same sites with three
structurally-related chloroacetanilide compounds (alachlor, acetochlor, and butachlor); (d) lack of
data on mode of action; and (e) the relevance of the observed tumors to human exposure.
The Committee also recommended a linear low-dose approach for human risk assessment with
extrapolation being based on both the neoplastic [ovarian tumors in rats and liver tumors in male
mice] and non-neoplastic [liver hypertrophy in mice] lesions.
Since a linear low-dose approach for human risk assessment was recommended, cancer
potency factors for propachlor were calculated for 2 tumor types and a combined tumor/ hyperplasia
finding. These cancer potency factors were calculated using the Tox_Risk 4.0_K. Crump model and
converted from animals to humans by the use of the 3/4's scaling factor.
22
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.For male mouse liver tumors the Qj* was estimated to be 5.0 x 1C"3 (mg/kg/dayj "'in human
equivalents. .
For male mouse liver tumors and liver hyperplasia the Q," was estimated to be 1.4 x 10"2
(mg/kg/day)"1 in human equivalents.
For female rat ovarian tumors the Qt* was estimated to be 3.2 x 1.0"2 (mg/kg/day)"1 in human
equivalents. , ' •
For risk assessment, the largest Qj* (based on female rat ovarian rumors) of 3.2 x 10'2
(mg/kg/day)"1 will be used. Note that this Qj*~will also be used for the adult male population even
though the Qj* is based on female rat ovarian tumors. ' ;
e. Assessment of Reproductive/Developmental Toxicity
The database for developmental toxicity and reproductive toxicity is considered to be complete
at this time. There was no indication of reproductive or developmental .effects. The data
demonstrated no indication of increased sensitivity of rats to in utero and/or postnatal exposure to
propachlor. The data demonstrated no indication of increased sensitivity of rabbits to in utero
exposure to propachlor. Therefore, the RfD Committee did not refer propachlor to the
Developmental/Reproductive SARC. .
, - '-'.'-
. f. Dermal Absorption Factor
Two dermal studies were reviewed to determine if either study was appropriate for use in this
assessment. One of the studies is an IBT study which was performed using a combination of
propachlor and atrazine. This study was classified INVALID.
A 21-day dermal .study conducted on fats (MRID No. 44590801) was submitted to the Agency
and found to be unacceptable but upgradeable. A NOEL could not be determined due to the lack of
an examination of the spleens at the low and mid-dose levels despite the spleen congestion observed
in the high-dose rats of both sexes which was considered to be treatment-related. The NOEL for
minor dermal changes was 40 mg/kg/day, and the LOEL was 150 mg/kg/day. This study could not
be used in an assessment of dermal absorption because no common endpoint was observed between
this .dermal exposure study and any of the fat oral studies. The registrant is currently working
towards submitting an upgraded study for the 21-day dermal study to refine the risk assessment.
Another study [MRID No. 104299], performed using- a 65% wettable powder formulation of
propachlor, was determined to be inadequate for use in estimating the dermal absorption "of
propachlor. This was a 1963 study that was performed using only two dose levels. The percent of the
body surface area exposed was not provided, no stability/ homogeneity/dose preparation data were
provided, no hematology or clinical chemistry parameters were monitored, eye examinations were
not performed, and the age of the rabbits at study initiation was hot provided. Only 5
23
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rabbits/sex/group were tested [although 10/sex were exposed to the high-dose level, 5/sex of these
were held for two weeks after exposure ended before they were sacrificed and examined
histologicalry]. No toxic effects were produced at either dose level; however, the limit dose was not
tested, and there was no discussion as to how the dose levels were chosen.
Given the deficiencies in the 21-day dermal toxicity study, the repeated dose dermal study on
the 65% wettable powder and the lack of acute data in the same species with which to estimate
dermal absorption, the default estimate of 100% must be utilized pending submission of the upgraded
21-day dermal toxicity study which Monsanto is expected to submit.
g. Toxicological Endpoints of Concern for Use in Human Risk Assessment
The lexicological effects of a pesticide can vary with different exposure durations. The
Agency considers the entire toxicity data base, and based on the effects seen for different durations
and routes of exposure, determines which risk assessments should be done to assure that the public
is adequately protected from any pesticide exposure scenario. Exposure scenarios can be dietary or
non-dietary. Both short and long durations of exposure as well as routes of exposure are always.
considered. Typically, risk assessments include "acute", "short-term", "intermediate-term", and
"chronic" risks. These assessments are defined as follows:
Acute risk results from a one day or single event consumption of food and water, and reflects
toxicity which could be expressed following oral exposure to the pesticide residues. High-end
exposure to food and water residues are assumed.
Short-term risk results from exposure to the pesticide for a period of 1-7 days, and therefore
overlaps with the acute risk assessment. Historically, this risk assessment was intended to
address primarily dermal and inhalation exposure which could result, for example, from
occupational pesticide applications. Since enaction of FQPA, this assessment has been
expanded. The assessment will be performed when there are primary dermal and inhalation
exposures that result from residential or occupational exposures lasting from 1-7 days.
However, the analysis for residential exposures will now address both dietary and non-dietary
sources of exposure, and will typically consider exposure from food, water, and residential
uses when reliable data are available. In a short term assessment, risks from average food
• and water exposure, and high-end residential exposure, are aggregated. High-end exposures
from all three sources are not typically added because of the very low probability of this
occurring in most cases, and because the other assumptions built into the assessment assure
adequate protection of public health.
Intermediate-term risk results from exposure for 7 days to several months. This assessment
is handled in a manner similar to the short-term risk assessment.
24
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Chronic risk assessment describes risk which could result from several months to a lifetime
of exposure. For this assessment, risks are aggregated considering average exposure from
all sources for representative population subgroups including infants and children.
The Agency's Toxiciry Endpoint Selection Committee met on May 7, 1997 and the Hazard
Identification Committee (HIARC) on December 5, 1997, to determine the endpoints for use in the
propachlor risk assessment.
3. Toxicological Endpoints for Risk Assessment
a. Acute Dietary Risk Assessment
An acute dietary risk assessment-is required. The NOEL of 175 mg/kg from a single dose
acute neurotoxicity study in rats will be used in estimating the MOE. The LOEL was 350 mg/kg,
based on an increase in landing foot splay at 7 hours [peak effect time] in female rats. An acute
neurotoxicity study is pertinent for an acute dietary assessment because the test animals receive a
single oral administration of the pesticide4 and therefore all toxicological effects can be attributed to
that one dose. This effect, landing foot splay, is appropriate for all population sub-groups, including
1 infants and children. An MOE of 100 will adequately protect, all population sub-groups including
infants and children.
b. Chronic (non-cancer) Dietary Risk Assessment
The RfD is the% traditionally accepted endpoint for a chronic (non-cancer) dietary risk
assessment. The RfD of 0.054 mg/kg/day will be used for estimating chronic (non-cancer) dietary
risk for all population sub-groups from exposure through both food and water. A percent RfD of less
than 100 is considered protective. .• •
c. Carcinogenic Dietary Risk
The Qi* of 3.2 x 10"2 (mg/kg/day)"1 based on female rat ovarian tumors will be used for
estimating carcinogenic dietary risk from exposure through both food and water. Carcinogenic risk
is estimated for adults only. A risk of less than 1 x 10"6 is considered protective for dietary exposures.
- - ,' ' • \
d. Dermal Absorption '
A dermal penetration study has not been submitted. (See discussion on dermal absorption
factor.) No acceptable data were available to estimate a dermal absorption factor. Therefore, 100%
dermal absorption is assumed. ,
25
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e. Occupational and Residential
Residential
Propachlor is a restricted use pesticide; therefore, propachlor can be used only by certified
applicators and cannot be purchased or used by the general public. .The Agency has not identified any
propachlor products that are intended for home use, or uses in/around schools, parks, or other public
areas. Therefore, residential risk assessments are not appropriate.
Short-Term (1-7 days) Occupational Risk Assessment
A short-term occupational risk assessment is required. Generally end-point selection should
be made using toxicity generated by the same route as the likely exposure - in this case dermal.
However, the upgraded results from the 21-day dermal study have yet to be submitted to the Agency
for review. Therefore, an acceptable dermal study was not available for selecting a NOEL. The
NOEL of 175 mg/kg from a single dose acute neurotoxicity study in rats will be used hi estimating
the MOE. The LOEL was 350 mg/kg, based on an increase in landing foot splay at 7 hours [peak
effect time] in female rats. This effect is appropriate for all population sub-groups. An MOE of 100
will adequately protect adult workers. Since the NOEL is from an oral study and dermal absorption
data are not available, a dermal absorption factor of 100% must be used in estimating the risk until
which time Monsanto submits an upgraded 21-day dermal study.
Intermediate-Term (1 week to several months) Occupational Risk Assessment
An intermediate term occupational risk assessment is required. Generally end-point selection
should be made using toxicity generated by the same route as the likely exposure - in this case dermal.
However, no dermal study was available for selecting a NOEL. The subchronic (90 day) feeding
study in the dog, the subchronic neurotoxicity study hi rats, and the 2-generation reproduction study
hi rats were considered. All of these studies exhibit decreased body weight gain and food
consumption. As noted previously there are palatibility problem with propachlor; therefore, the
HIARC concluded that the decreased body weight gain and food consumption should not be used
for regulatory purposes.
In the 2-generation reproduction study liver lesions, characterized as contrilobular
hepatocellular hypertrophy were observed in both the F0 and F la generation in both sexes at 69.6
mg/kg/day. The NOEL for this effect was 7.1 mg/kg/day. This was supported by' the 2 year rat study
at the interim (1 year) sacrifice in which liver lesions, characterized as hepatocellular hypertropy were
observed. The observance of liver lesions in both studies at approximately the same time period (i.e.,
after several months of exposure) and therefore was deemed appropriate for the intermediate-term
exposure (i.e., 7 days to several months). Therefore, the maternal/paternal NOEL of 7.1 mg/kg/day
from the 2-generation reproduction study in rats will be used in estimating the MOE. The effect (liver
lesions) is appropriate for all population sub-groups. An MOE of 100 will adequately protect adult
26
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'workers. Since the NOEL is from an oral study and dermal absorption data are not available, a
dermal absorption factor of 100% must be vised in estimating the risk.
Chronic (non-cancer)(several months to lifetime) Occupational Risk Assessment:.
As part of the hazard assessment process, an endpoint of concern was determined for the
chronic occupational assessment. However, during the exposure assessment process, the: exposures
which would result from the use of propachlor were determined to be of an intermittent nature. The
frequency and duration of these exposures vdo not exhibit a chronic exposure pattern. The exposures
do not occur bften^enough to be considered a chronic exposure, i.e. a continuous exposure that
occurs for at least several months. Therefore, performing a chronic occupational assessment.is not
appropriate.,
If a chronic scenario can be identified, then this assessment is required. No chronic dermal
toxicity studies are available. The NOEL of 5.4 mg/kg/day from the combined oral chronic
toxicity/carcinogenicity study in rats will be used in estimating the MOE. (Note that this study was
used to establish the RfD.) The LOEL is 16.1 mg/kg/day, based on stomach lesions in males and liver
lesions in both sexes. This effect is appropriate for all population sub-groups. An MOE of 100 will
adequately protect adult workers. Since the NOEL is from an oral study and dermal absorption data
are not available, a dermal absorption factor of 100% must be used in estimating the risk.
Carcinogenic Occupational Risk Assessment
• . . N
Since a linear low-dose approach for carcinogenic risk assessment was recommended, the
assumption is made that any exposure to propachlor during a 70 year lifetime leads to an increase in
the carcinogenic risk that is linearly proportional to the exposure level, regardless of the pattern
(frequency and level of dosing). All exposures .even those of an intermittent nature should be
assessed. Therefore, a carcinogenic risk assessment for workers is appropriate.' The Q,* of 3.2 x 10~2
(mg/kg/day)"1 will be used for estimating carcinogenic occupational risk. A risk within the ranges
of 10"4 to 10"6 (or lower) per the Non-Dietary 'Cancer Risk Policy (8/14/96) is considered protective
for adult workers. ' ,
Inhalation '•-..-
The inhalation exposure will be added to the dermal exposure for all occupational risk
assessments. . . < •
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Table 4: Summar
Exposure
Duration
Acute
Chronic
Carcinogenic
Short-Term
Occupational
Intermediate-Term
Occupational
Chronic-Term
Occupational
(only if scenario
identified)
Carcinogenic
Occupational
(adult only)
v of Toxicological Endpoints for Propachlor
Exposure.Route
Dietary
(food and water)
Dietary
(food and water)
Dietary
(food and water)
Dermal and Inhalation
Dermal and Inhalation
Dermal and Inhalation
Dermal and Inhalation
.'.'-,. ', . D0se . , "• ;.- :
(mg/lcg/day) /••
NOEL =175
RfD.= 0.054
(calculated from
NOEL = 5.4 using UF
= 100)
Q,* = 3.2xlO-2
NOEL =175
NOEL = 7.1
NOEL = 5.4
Q,' = 3.2xlO-2
: Endpoint
Increase in landing
foot splay at 7 hours
post treatment
(based on a rat acute
neurotoxiciry study)
Stomach lesions and
liver lesions
(based on a rat
chronic toxicity study)
Based on female rat
ovarian tumors
(based on a 2-year
oral rat study)
Increase in landing
foot splay at 7 hours
post treatment ,
(based on a rat acute
neurotoxiciry study)
Liver lesions in F0 and
Fla generations
supported by liver
lesions at the interim
sacrifice in the 2-year
rat study
(based on a 2-
generation rat
reproduction study)
,' Level of
Concern
MOE equal to
or greater than
100 is
protective
less than 100%
of the RfD is
protective
Less than
1 x 10'6 is
protective
MOE equal to
or greater than
100 is
protective
MOE equal to
or greater than
100 is
protective
Based on the use pattern (pre-plant)
chronic exposure is not anticipated,
therefore, this risk assessment will not be
performed
Based on female rat
ovarian tumors
Within the
ranges of
10-4tolO-6(or
lower) is
protective
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4. Risk Assessment
a. Dietary
Propachlor [2-chloro-N-isopropylacetanilide] is a selective herbicide manufactured by Monsanto
Agricultural Company under the trade name Ramrod®. A search of the Reference Files System
(REFS) conducted on 02/27/97 indicated that propachlor is federally registered for uses on corn and
sorghum. The granular '(G), flowable concentrate (F1C), and dry flowable (DF) are the propachlor
formulation classes registered for, use on these crops. These formulations are applied preemergence
to the soil using ground equipment.
There are also SLNs (Special Local Needs) for the use of propachlor on onions grown for
seed (non-food use) in Oregon and Washington.
Propachlor was the subject of a Reregistration Standard Guidance Document dated 12/84.
The Residue Chemistry Chapter Update of the Propachlor Reregistration Standard was issued on
4/10/90. These documents summarized the regulatory conclusions based on available residue
chemistry data, and specified the additional data required for reregistration purposes. Data submitted
and evaluated following the Update are incorporated into this document, which outlines the Residue
Chemistry Science Assessments with respect to the reregistration of propachlor. The conclusions are
based on the use patterns supported by the basic producer, Monsanto Agricultural Company.
a. Dietary Exposure (Food Source)
The residue chemistry database includes information on the pesticide residues found in plants
and animals, the levels of the detected pesticide residues, and a description of the analytical methods
used. Residue chemistry data are used by the Agency to determine the residues of concern and to
establish tolerances, in food and feed. Tolerances are pesticide residue levels that should not be
exceeded hi or on a raw agricultural commodity in the channels of interstate commerce when the
pesticide is applied according to label directions.
The residue chemistry database for propachlor is adequate and will support reregistration
eligibility, provided the necessary label changes are made.
(1) Directions for Use
Four propachlor end-use products (EPs) are registered under FIFRA Section 3 to Monsanto.
These EPs, includmg.the associated Special Local Need (SLN) registrations under FIFRA Section
24 (c), are listed in the table below. . ' "-...•-.
29
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Table 5: Pro]
EPA Reg. No.
524-152
524-328
524-331 '
524-423
Dachlor EPs with Food/Feed Uses Registered to Monsanto.
Label Acceptance Date
11/16/94
4/26/94
10/2/96
6/16/96
Formulation
20% G
3 Ib/gal F1C
41b/galFlC
48.1% DF2
Product Name
Granular Ramrod® 20 Selective Herbicide
Ramrod® and Atrazine Flowable Herbicide Mixture
Ramrod® Flowable Herbicide
Ramrod® + Atrazine Dry Flowable Herbicide
Including SLNNos. OR950022 and WA950031.
REFs lists EPA Reg. No. 524-423 as an F1C formulation; however, upon examination of the product label, it was
determined that the formulation is more correctly described as a DF.
(2)
Nature of the Residue - Plants
The qualitative nature of the residue in plants is adequately understood, based on an
acceptable [14C]propachlor metabolism study in sorghum. The sorghum study results have shown
that propachlor was not detectable in any edible sorghum commodity. The principal metabolite hi
sorghum grain and foliage was propachlor oxanilic acid; in addition, all of the propachlor metabolites
identified in sorghum commodities contained the N-isopropylaniline (NIPA) moiety.
Radiotracer studies on corn, sorghum, soybeans, and sugar beets conducted using
[3H]propachlor, indicated that degradation of propachlor was rapid. In these studies, no intact .
propachlor was observed 5-7 days following application. Based on the available metabolism data,
the Agency has determined that the residues of concern (i.e. those to be regulated in the tolerance
expression) in plant commodities are propachlor and all metabolites containing the N-isopropylaniline
(NIPA) moiety. (MRID numbers: 40068601, 42140301)
(3). Nature of the Residue - Livestock
The qualitative nature of the residue in livestock is adequately understood. The Agency has
determined that ruminant, swine, and poultry metabolism studies in which animals were fed a mixture
of radiolabeled metabolites (rather than radiolabeled propachlor) are acceptable since no radiolabeled
propachlor was detected in the sorghum metabolism study. (See Meat, Milk, Poultry, Eggs Section
for a description of the studies) The residues of concern in livestock commodities are propachlor and
its metabolites containing the NIPA moiety. (MRID numbers: 40123101,401293014)
(4) Residue Analytical Methods
Adequate methods are available for data collection and tolerance enforcement in plant and
livestock commodities. The Pesticide Analytical Manual (PAM) Vol. II lists two GC methods, using
flame ionization detection, for the determination of propachlor and its metabolites containing the N-
isopropylaniline moiety in animal tissues and milk (Method I) and in plant commodities and eggs
(Method A). The registrant has proposed a GC method using thermionic specific detection for
30
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tolerance enforcement in plant and livestock commodities. This method is a modification of current
enforcement methods and has successfully undergone Agency method validation. The Agency has
concluded that the proposed method is adequate for tolerance enforcement provided the registrant
incorporates the comments made .by BEAD/ACB. The methods used for data collection were GC
methods similar to the current enforcement methods. (MRID numbers: 40584004, 43028601,
430286026,43251801,40584004,430286026,432518017)
(5) Multiresidue Methods
The 1/94 FDA PESTDATA database (PAM Volume I, Appendix I) indicates that propachlor
is completely recovered (>80%) .using Multiresidue Method Section 3 02,(Luke method; Protocol D)
but is not recovered using Multiresidue Methods Section 303 (Mills, Onley, Gaither method; Protocol
E, non-fatty foods) and Section 304 (Mills method; Protocol E, fatty foods). The registrant has
submitted the results of multiresidue methods testing of the acid metabolites of propachlor
(propachlor oxanilic acid, propachlor sulfinyl lactic acid, propachlor sulfonic acid, and propachlor
acetic acid) which have been forwarded to FDA for review; the acid metabolites of propachlor were,
not adequately recovered by any of the multiresidue method protocols. (MRID number: 43 028501)
(6) Storage Stability Date
Adequate storage stability data are available to support reregistration. Storage stability data
indicate that residues of propachlor oxanilic acid are stable inborn and sorghum matrices for up to
29-32 months of frozen storage, and residues of propachlor oxanilic acid, propachlor sulfinyl lactic
1 acid, and propachlor sulfonic acid are stable for up to -28 months of frozen storage in eggs and the
kidney, liver, muscle, and fat of swine, poultry, and cattle. Residues of propachlor oxanilic' acid,
propachlor sulfinyl lactic acid, and propachlor sulfonic acid are stable for up to -18 months of frozen
storage in milk and residues of 4-hy droxyacetanilide are -stable for up to 26 months in milk.. Storage
stability data for propachlor per se were not required because propachlor was not detected in the
sorghum metabolism study. (MRID numbers: 40081701, 40085301, 40584005,'42121302,
421213039,421403023) • •
(7) Crop Field Trials
Crop field trials are used'to assess the magnitude of the pesticide residue in/on a-commodity
at'the time of harvest. These studies usually involve application of the pesticide to a crop in
accordance with label directions in a manner which would expose the crop to the maximum legal
amount of the pesticide. This information is used to set pesticide tolerances.
• - ' ' ; ->
The Agency has received adequate field trial data depicting propachlor residues of concern
in field corn and sorghum commodities following applications made in accordance with the maximum
registered use patterns. '
'. '.31-
-------
Corn: Following treatment at IX, residues were < 0.02 - 0.04 ppm in grain and < 0.02 - 0.52,
in forage except for one grain sample in which residues were 0.19 ppm, and three forage samples in
which residues were 1.53 - 2.12 ppm (One sample was from the same trial that yielded the 0.19 ppm
grain sample.).
Sorghum: Following treatment at 0.8X or 1.2 X, residues were 0.08 - 3.77 ppm in forage and
0.05 - 2.78 ppm in fodder except for one forage sample at 7.67 ppm, and one fodder sample at 10.59
ppm. The Agency has determined based on available data for supported use patterns, that no
tolerances are required for resides in processed commodities of field corn and sorghum. Processing
was required to support the previously registered uses on barley, oats, soybean, and wheat grown for
seed. Since these uses have not been supported through reregistration, these processing studies are
no longer required.
Label revisions are required for sorghum in order to reflect current Agency policies.
Requirements for residue data in aspirated grain fractions were waived because propachlor
applications are made preemergence; thus, there is little likelihood that gram will contain surface
residues of this chemical.
Although tolerances are listed at 40 CFR §180^211, there are no registered uses on cotton,
flax, peas, pumpkins, sweet corn, and sugar beets. Therefore, no field trial data are required for these
crops. (MRID numbers: 40085301,40081701,40085301,40081701)
(8) Processed Food/Feed
Adequate corn and sorghum processing studies have been submitted. Residues of propachlor
and its NIPA-containing metabolites, calculated as propachlor, did not concentrate in starch, crude
oil(dry- and wet-milled), refined oil (dry- and wet-milled), and concentrated insignificantly in flour
(l.lx), grits (1.2x), and meal (1.3x) processed from field corn grain bearing detectable propachlor
residues following treatment with a single preemergence application of the 4 lb./gal F1C formulation
at3.3x. ,
The Agency has determined that no tolerances are required for residues in the processed
commodities of field corn or sorghum. There are no federally registered uses on crops grown for
seed; therefore, no processing study data are required for these crops. (MRID numbers: 40085302,
42962501,40081702).
(9) Meat, Milk, Poultry, Eggs
Acceptable ruminant and swine feeding studies are available to reassess the established
tolerances for residues in milk and in the fat, meat, and meat byproducts of cattle, goats, hogs, horses,
and sheep. An acceptable poultry feeding study is available to determine the need for tolerances for
32
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residues in eggs and the fat, meat, and meat byproducts of poultry. A summary of the required
tolerances for residues in livestock commodities is presented below. • •'.
Milk and the fat, meat, and meat byproducts of cattle, goats, hogs, horses, and sheep: The
maximum theoretical dietary burdens of propachlorto beef and dairy cattle are 11.99 and 12.91 ppm,
respectively (see Table below). The maximum theoretical dietary burden of propachlor to swine is
0.25 ppm based on a diet consisting of 90% sorghum grain and 10% corn milled byproducts. ,
Table 6: Calculation of Maximum Ruminant Dietary Burden for Propachlor.
~ t °* **
Feed Commodity t
Sorghum grain
Sorghum forage
Sorghum stover ;
Reassessed .
Tolerance
(ppm)
0.25
8.0
12.0-1
,
%Dry
Matter
86
35
88
TOTAL
Beef Cattle
% of Diet
40
,'40
20
100
Burden1
(ppm)
. 0.116
9.143
2.727
11.986
Dairy Cattle
% of Diet
40
50
10
100
Burden1;
(ppm)
0.116
1L429
1,364
.12.909
1
Burden (ppm) = (% of diet)(reassessed tolerance)/(%dry matter)
An adequate dairy cattle feeding study was reviewed in the" Propachlor Reregistration
Standard Update; this study reflected dosing with a mixture of propachlor metabolites (oxanilic.acid,
sulfinyl lactic acid, and sulfonic acid at a 6:3:1 ratio) at -0.4X, 1.3X, and 4X (5, 15, and 50 ppm,
respectively) for 28 days. The 15 ppm (1.3X) most closely approximates the estimated total dietary
burden. Propachlor metabolite residues were O.02-0.02 ppm in milk samples from'both the 1.3X
and 4X,dosing levels. In tissues, residues were -O.02-0.04 ppm in liver, 0.09-0.12 ppm in kidney,
<0.02 ppm in muscle, and <0.02:0.04 ppm in fat at the 1.3X dosing level.
Based on the maximum theoretical dietaryburden, and based on residues in milk and ruminant
tissues, the following revised tolerances are proposed: 0.05 ppm for residues in the meat byproducts
. (except kidney) and fat and 0.2 ppm for. residues in the kidney of cattle, horses, goats and sheep.
Existing tolerances for residues in milk and in the meat of cattle, horses, goats and sheep are
adequate. .
An adequate swine feeding study was reviewed in the Propachlor Reregistration Standard
Update; this study reflected dosing with a mixture of propachlor metabolites at ~20X, 60X, and 200X
(5, 15, and 50 ppm, respectively) for 28 days. At the 20X dosing level, propachlor metabolite
residues were 0.02-0.04 ppm in liver, 0.04-0.06 ppm in kidney, <0.02 ppm in muscle, and <0.02 ppm
in fat. Based on these date, the existing tolerances of 6.02 ppm for propachlor residues in hog meat,
fat, and meat by-products are adequate.
Eggs and the fat, meat, and meat byproducts of poultry: The maximum theoretical dietary burden
of propachlor to poultry is 0.24 ppm.
33
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Table 7: Calculation of Maximum Poultry Dietary Burden for Propachlor
Poultry Feed Commodity
Field corn grain
Sorghum grain
Reassessed Tolerance (ppm)
0.20
0.25
TOTAL
% of Diet
20
80
100
Burden1 (ppm)
0.040
0.200
0.240
1 Burden (ppm) = (%of diet) (reassessed tolerance) ' \
An adequate poultry feeding study was reviewed in the Propachlor Reregistration Standard
Update; the study reflected dosing with a mixture of propachlor metabolites at ~20X, 60X, and 200X
(5, 15, and 50 ppm, respectively) for 28 days. At the 20X and 60X dosing levels, propachlor
metabolite residues were <0.02 ppm in eggs, and <0.02-0.02 ppm in fat, kidney, liver, and muscle.
Based on this study, HED concludes residues in poultry commodities can be classified under Category
3 of 40 CFR §180.6(a), i.e. there is no reasonable expectation of detectable residues; therefore, no
tolerances are needed for residues in poultry commodities. (MRID numbers: 40584001, 40584003)
(10) Water, Fish, and Irrigated Crops
Propachlor is not registered for direct use on water and aquatic food and feed crops;
therefore, no residue chemistry data are required under this guideline topic. (MRID number:
43064501)
(11) Food Handling
Propachlor is not registered for use in food-handling establishments; therefore, no residue
chemistry data are required under this guideline topic.
(12) Confined Accumulation in Rotational Crops
The nature of the residue in rotational crops is adequately understood, based on an acceptable
confined rotational crop study. Following application of [14C]propachlor to sandy loam soil at 6.0
Ib ai/A (IX the maximum rate), lettuce, radishes, and wheat planted were planted at 30-, 120-, and
365- day plantback intervals (PBIs). Lettuce, and radishes (roots and tops), as well as immature and
mature wheat, were harvested and analyzed for total radioactive residues (TRR). Accumulation of
radioactive residues was highest in samples planted 30 and 120 days after treatment (DAT) and.
decreased at the 365-DAT planting interval. Radioactive residues (expressed as [14C]propachlor
equivalents) were highest hi wheat straw at 9.630, 5.281, and 1.704 ppm at the 30-, and 120-, and
365-DAT intervals, respectively, and lowest in lettuce at 0.124, 0.161, and 0.049 ppm, respectively..
Propachlor residues of concern were present in rotational crops at 30-, 120-, and 365-day plantback
intervals (PBIs).
The confined rotational crop study indicates that the metabolism of propachlor in rotational
crops is similar to that in primary plants; metabolites containing the NIPA moiety were observed in
34
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both studies. Propachlor residues of concern are the parent and all metabolites containing the N-
isopropyl aniline (NIPA) moiety. , Parent propachlor was not detected in any rotational crop
commodity at any rotational interval. The major metabolite identified in all matrices at all three
plantback intervals was oxanilic acid. Based on identification of NIPA-containing residues at 68%
TRR in grain, and 43%,TRR in straw of wheat from the 365-day plantback interval, residues of
concern hi rotational crops were 0.48, 0.39, and 0.73 ppm in forage,.grain and straw, respectively.
Given that the residues in rotational grain were 0.48 ppm, and given that tolerances for residues in
primary crops are 6.1 ppm in corn grain and 0.25 ppm in grain sorghum, the Agency believes that
residues of concern above 0.01 ppm could be present in rotational grains at plantback intervals of up
to 365 days. In addition, residues of concern above 0.01 ppm were identified in all rotational crop
matrices at the 365-day PEL, Therefore, the Agency will not support unrestricted crop rotation; only
crops for which there are registered propachlor uses may be rotated to treated fields.
(13) Field Accumulation in Rotational Crops
' The reregistration requirement for data pertaining to field accumulation in rotational crops
is'not fulfilled. The confined rotational crop data indicate that limited field rotational crop studies
must be conducted. The limited field trials must be conducted on representative crops of the root and
tuber vegetables, leafy vegetables, and small grains at two site's per crop for a total of six trials.
This requirement should not affect the reregistration eligibility decision for propachlor;
however, the registrant must amend the product labels to add a rotational crop restriction stating that
only crops for which there are registered propachlor uses may ,be rotated to treated fields,
b. Dietary Risk Assessment (Food Source)
. Analyses were performed to estimate acute and chronic dietary risk for propachlor. The
Agency uses the Dietary Risk Evaluation System (DRES) to combine the pesticide residue data with
food consumption data. Thus, dietary (food source) exposure is equal to pesticide residues present
hi food multiplied by consumption data for the food item. . • , • -
The consumption information used in this analysis is derived from USDA's 1977-78
Nationwide Food Consumption Survey (NFCS). Over 30,000 respondents were surveyed over three
days as to what foods they ate, with each individual's consumption information being associated with
their body weight, sex, age, ethnicity and other sociodemographic information. Individual
. consumption estimates were weighted to be nationally representative. From these data single day and
3 day average consumption estimates were,derived for the U.S. population and select population
subgroups. Three day average information is used in the DRES chronic exposure analyses. The
Agency acknowledges that the data from this survey are becoming dated. However,, at this time, the !
data are the best information available to the Agency. ,
Note that; a'tiered approach is used for dietary risk assessment. , The pesticide residue
component is progressively refined proceeding from worst-case assumptions (such as tolerance level
-------
residues) to more realistic assumptions (such as use of monitoring data). Refinement of pesticide
residues continues until no risk concern is indicated or a determination is made that mitigation is
required. This tiering approach conserves Agency resources.
Acute - Tier 1 - Point Estimates
A Tier 1 acute assessment was performed to estimate the risk of consuming a large amount
of propachlor residues in the food consumed on a single day. The assessment uses a single high-end
residue estimate, which is usually the tolerance, together with a distribution of individual food
consumption values as reported by respondents in the USDA 1977-78 Nationwide Food
Consumption Survey. Thus, exposure to the chemical is accumulated for each commodity to estimate
a worst-case single-day's exposure. It is assumed that propachlor is uniformly distributed in the food
supply at the tolerance level. Note that a Tier 1 acute dietary asessment does not account for blended
commodities or percent crop treated data.
As previously discussed the appropriate endpoint for an acute dietary assessment is 175
mg/kg/day.
Acute Dietary Risk = 175 mg/kg/day/ high-end exposure = MOE
The Margin of Exposure (MOE) is a measure of how close the high-end exposure comes to
the NOEL. An MOE greater than 100 will adequately protect all population sub-groups including
infants and children. The acute dietary MOEs (rounded to two significant figures) for food source
exposure to propachlor for various population sub-groups are given below.
Table 8: Acute MOE's
Population Sub-Groups
Infants < 1 year
Child (1-6 years)
Females (13+ years)
Males (13+ years)
General Population
" '
High-End Exposure
:! ,'.'.; ; j,(mg/lcg/aay.);
0.01
0.004
0.0012
0.001
0.003
MOE'
18,000
44,000
150,000
180,000
58,000
The MOE's for all population sub-groups greatly exceed 100. Therefore, the Agency has no
concerns for acute dietary (food) exposure for all population sub-groups.
Chronic Dietary (food source)
A chronic (non-carcinogenic) dietary assessment is performed to estimate the lifetime risk of
consuming an average amount of propachlor residues. The assessment uses 3 day average
36
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consumption values from USDA's 1977-1978 Nationwide Food Consumption Survey. Chronic
dietary risk is calculated for the U.S. population and 22 population sub-groups using DRES (Dietary
Risk Evaluation System). As previously discussed, the appropriate endpoint for the chronic
assessment is the RfD, 0.054 mg/kg/day. Chronic risk is reported as the percent of the RfD that is
taken up by the estimated exposure. ,
Tolerance level residues were used for corn and sorghum. .However, the agency refined its
assessment by using percent crop treated (%CT) information for these two commodities. OPP's
Biological and Economic Analysis Division supplied the %CT information, which was obtained from
various public and proprietary sources. The following values were used: corn 2%, and sorghum 8%.
This analysis assumes thatpropachlor is uniformly distributed in the food supply at the tolerance level
adjusted for the percent crop treated. . ,
Section 408(b)(2)(F) requires that if a tolerance relies on percent crop-treated data, that the
Agency make a determination as to the reliability of the data. Percent crop-treated estimates are
derived from federal and private market survey data. Typically, a7 range is assumed for the exposure
assessment. By using this upper end estimate of percent crop treated, the Agency is reasonably
certain that exposure is not understated for any significant population sub-group. Additionally, the
DRES (Dietary Risk Evaluation System) modeling used in estimating chronic dietary risk uses
regional consumption information to estimate exposure for four population sub-groups that are
geographically based regions of the United States. To provide for the periodic evaluation of these,
estimates of percent crop treated, the Agency will require under Section 408(b)(2)(F) for periodic
re-evaluation of the percent crop treated data as long as the tolerances remain in force.
Anticipated residues were estimated for meat and milk by re-estimating the dietary burden
using the percent crop treated data. . .
37
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Table 9: Re-Estimation of Ruminant Dietary Burden for Propachlor Using Percent Crop
Treated Data
Feed Item
Sorghum
grain
Sorghum
forage
Sorghum
stover
TOTAL
Reassessed
Tolerance
(mg/kg)
0.25
8.0
12.0
%Dry
Matter
86
35
88
%Crop :
Treated
8
8
8
,:Bee'f Cattle ' .'.
% of Diet
40
40
20
100
Burden1
(mg/kg) , :
0.0093
0.731
0.218
0.958
-,'',_
Dairy;Gattle
% of Diet '
40
50
10
100
: Burden1
(rrtg/kg)
0.0093
0.914
0.109
1.03
Burden (ppm) = (%of diet)(reassessed tolerance)(%CT) / % dry matter
The dietary burden for ruminants is now 1.0 mg/kg, as compared to the previous estimation
of 13 mg/kg. In the previously described feeding studies, at the mg/kg feeding level (5X), residues
were not detected (<0.02 mg/kg) in milk, muscle, fat, and liver. Residues were 0.03 - 0.05 mg/kg
in kidney. At the 15X feeding level, residues were detected in kidney (0.12 mg/kg), fat (0.04 mg/kg),
and liver (0.04 mg/kg), but not in milk or muscle (<0.02 mg/kg). Thus, the anticipated residues are
for use in dietary risk estimation are: milk 0.001 mg/kg, meat 0.001 mg/kg, fat 0.003 mg/kg, liver
0.003 mg/kg, and kidney 0.01 mg/kg. These anticipated residues are based on the finite residues or
limits of quantitation found at the exaggerated feeding levels. Note that the residues in kidney, the
only commodity with finite residues at three feeding concentrations, were approximately linear with
feeding level: 0.05 mg/kg at 5X; 0.12 mg/kg at 15X; and 0.53 mg/kg at 50X.
Section 408(b)(2)(E) requires that if a tolerance relies on anticipated or actual residue levels.
that the Agency make a determination every five years as to the reliability of the data, i.e. that the.
current residue levels are not above the levels relied on. For anticipated residues for meat and milk,
instead of using tolerances as the level of propachlor present in the feed items, anticipated residues
as estimated for food /feed crops were used in the calculation. To provide for the periodic evaluation
of these anticipated residues, the Agency will require under Section 408(b)(2)(E) residue data to be
evaluated after the first five years.
38
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Table 10; Chronic (Non-Carcinogenic) Dietary Risk
-V-"*"* «-••• -ff~ J3 "y"', iJ^J* fys f fa ^ "
'SubgrctatJ.** * — «^u l-<
~ "• '' '''VWfe1 •*( t l.fc^i -^Ji*1* ~ EW~~ ^ 1
U.S. population
Children (1-6 years)
Non-nursing infants ....
Adult Females (20+ years)
Adult Males (20+ years)
^ "U.^ = *A ^ ^ M*m™ ^t P
Exposure(m§/kg/da^ "• r^
0.000018
0.000045
0.000073
0.000009
0.000011
•<-' j^-. ^4
:0.03
0.08 :
0.1
0.02
0.02 .
The %RfDs for all population sub-groups are less than 1%, which is much less than the Agency's
level of concern of 100%.
Carcinogenic Dietary (Food Source) .
• A carcinogenic dietary assessment is performed to estimate the lifetime carcinogenic risk from
consuming an average amount of propachlor residues. The assessment uses 3 day average
consumption values from USDA's 1977-1978 Nationwide Food Consumption Survey. The exposure
(mg/kg/day) is the same as that estimated by DRES for the chronic dietary assessment. Carcinogenic
dietary risk is calculated for the adult U.S. population. As previously discussed, the appropriate
endpoint for the carcinogenic assessment is the Q,*3 0.032 (mg/kg/day)"!. This analysis also assumes
that propachlor residues are uniformly distributed in the food supply. , .
Carcinogenic dietary risk is estimated by: ' •
Exposure (mg/kg/day) x _Q,* (0.032 (mg/kg/day)'1) = Risk
For propachlor, carcinogenic risk for adult females is: .
(0.000009 mg/kg/day)((0.032 (mg/kg/day)-1) = 2.9 x 10'7
For propachlor, carcinogenic risk for adult males is:
(0.00001 lmg/kg/day)((0.032 (mg/kg/day)1)-3.5 xlO'7
These estimates of carcinogenic dietary risk are less than 1 x 10"6. .
Data for Use in Risk Assessment
Surface water monitoring data are primarily limited by the lack of correlation between
sampling date and the use patterns of the pesticide within the study's drainage basin. Additionally,
the sample locations were not associated with actual drinking water intakes for surface water.
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The monitored wells were not associated with known groundwater drinking water sources.
The monitoring data presented in this document provides verification that propachlor is found
in surface and ground waters of the U.S. However, the lack of correlation between use and sampling
and sampling and mitigation measures that may have occurred over time make it difficult to rely on
the data for quantitative risk assessment purposes without further analysis. Review of the data did
not provide evidence as to whether the data were representative of vulnerable areas, peaks, long term
means, or other important factor in determining the extent of impact on an aquatic environment.
The Agency believes that the monitoring data should be used only for illustrative purposes;
while still acknowledging that the monitoring data and the model-derived estimated values were
within the same order of magnitude. For quantifying risks to the general population, including infants
and children, SCI-GROW and PRZM2.3/EXAM2 Estimated Environmental Concentrations (EEC's)
are recommended.
Since all surface water numbers exceed the groundwater estimate of 0.027 ppb, only the
surface water estimates will be used in the risk assessment. For propachlor, the acute exposure will
be estimated using the highest of the estimated values which is 64 ppb estimated by
PRZM2.3/EXAMS2 for grain sorghum. The chronic and carcinogenic exposure will be estimated
using the highest of the estimated values which is 0.6 ppb estimated by PRZM2.3/EXAMS2 for grain
sorghum.
c. Tier n EEC Estimations
Tier II EEC's were estimated using environmental models (PRZM2.3/EXAMS2.97) for use
in drinking water exposure estimates. A ten-hectare drainage basin with a 1 hectare pond 2 meters
deep does not adequately reflect the dynamics in a watershed which is large enough to support a
drinking water utility. A drinking water utility with a basin of adequate size would not be planted
entirely in a single crop nor would it be treated entirely with the pesticide being modeled.
Additionally, the pesticide would more than likely be applied over several days to weeks rather than
on a single day within a given basin. This would in effect reduce the magnitude of the peak
concentrations, but would broaden them, reducing the acute exposure but perhaps increasing the
chronic exposure. The final overriding concern with the use of estimates derived from
PRZM/EXAMS is that the simulated pond has no outlet where as any water body capable of
supporting a drinking water utility would have some flow through (rivers) or turnover (reservoirs).
See section 6 for a full discussion of modeling and monitoring results.
d. Dietary Exposure (Drinking Water)
Adult Female .
The exposure estimate for an adult female (13+ years) is calculated by the following equation:
40
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Exposure = (chemical concentration in ug/L;in consumed water) X (10"3 mg/ug) •*•
(60 kg body weight) X (2L water consumed/day). .
The 2 Liters of water is a default assumption used by the Agency. The ,60 kilograms is the
Agency's default female body weight.
Adult Male ., .
The exposure estimate for an adult male is calculated by the following equation:
Exposure = (chemical concentration in ug/L in consumed.water) X (10~3 mg/ug) +
(70 kg body weight) X (2L water consumed/day) •
The 2 Liters of water is a default assumption used by the Agency. The 70 kilograms is the
Agency's default male body weight ,
Child (1 - 6 years)
. The exposure estimate for a child (1-6 years) is calculated by the following equation:
,' , <••"•, '
Exposure = (chemical concentration hi ug/L in consumed water) X (10"3 mg/ug) +•
(10 kg body weight) X (lL water consumed/day)
The 1 Liter of water is a default assumption used by the Office of Water. The 10 kilograms
is an assumption per memo of D. Edwards. ...-../,
The other assumption used is assuming that water from the same source containing the same
contaminant level is consumed throughout a 70 year lifetime. Most of the US population moves at
some time during their life and does not live in the same area nor drink from the same water source
for a 70 year lifetime. It could be considered as either an over-estimation or an under-estimation of
risk depending on the contaminant levels in thejDther sources of drinking water.
Acute Exposures *
For propachlor, acute exposure for adult females is:
(64 ug/L)(0.001)(2 L)7 60 kg = 0.002133 mg/kg/day
For propachlor. acute exposure for adult males is:
(64 ug/L)(0.001)(2 L) / 70 kg = 0.001829 mg/kg/day
For propachlor, acute exposure for children (1 - 6 years) is: . ,-. -
•'•'•• : ' . '•'-. '41' ' ' * .."-• .. '. ' : .
-------
(64ug/L)(0.001)(lL)/10kg= 0.0064 mg/kg/day
Chronic/Carcinogenic Exposures
For propachlor, chronic/carcinogenic exposure for adult females is:
(0.6 ug/L)(0.001)(2 L) / 60 kg = 0.00002 mg/kg/day
For propachlor, chronic/carcinogenic exposure for adult males is:
(0.6ug/L)(0.001)(2L)/70kg = 0.000017 mg/kg/day
For propachlor, chronic/carcinogenic exposure for children (1 - 6 years) is:
(0.6 ug/L)(0.001)(l L) /10 kg = 0.00006 mg/kg/day
e. Dietary Drinking Water Risk
'• ' S
Acute Risk
As previously stated, the NOEL for use in estimating acute dietary risk is 175 mg/kg/day.
MOE = NOEL/exposure .
For propachlor, acute risk for adult females is:
175 mg/kg/day / 0.002133 mg/kg/day = 82,000
For propachlor, acute risk for adult males is:
175 mg/kg/day / 0.001829 mg/kg/day = 96,000
For propachlor, acute risk for children (1-6 years^ is:
175 mg/kg/day / 0.0064 mg/kg/day = 27,000
All MOEs greatly exceed 100. Therefore, the Agency has no concerns for acute drinking
water dietary exposure.
42
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Chronic Risk
As previously stated, the RfD of 0.054 mg/kg/day will be used in estimating chronic (non-
cancer) dietary risk.
Exposure/RfD x 100 = % RfD
For propachlor, chronic risk for adult females is:
0.00002 mg/kg/day/0.054 mg/kg/day x 100 = 0.04%
For propachlor. chronic risk for adult males is:
0.000017-mg/kg/day / 0.054 mg/kg/day x 100 = 0.03% '-..'•
For propachlor. chronic risk for children (1-6 years'} is:
0.00006 mg/kg/day / 0.054 mg/kg/day x 100 = 0.1%
\ •
All %R£Ds are less than 1%, which ismuch less than the Agency's level of concern of 100%.
Carcinogenic Risk
As previously stated, the Qi* of 0.'032 (mg/kg/day)"1 will be used in estimating carcinogenic
dietary risk. By concentration, the; carcinogenic risk is estimated for the adult population only.
(Exposure)(Qi*) = risk
For propachlor, carcinogenic risk for adult females is: .
(0.00002 mg/kg/dayX0.032 (mg/kg/day)-1 )= 6.3 x 10-7 '••';'.'
For propachlor, carcinogenic risk for adult males is: .
(0.000017 mg/kg/dayX0.032 (mg/kg/day)-1) =5.4 xlO'7
• These risks are less than 1 x 10"6, the Agency's level of carcinogenic concern.
f. Total Dietary (Food and Water) Assessment
Propachlor residues can be consumed in both food and drinking water, Therefore, a total
dietary assessment that accounts for both is appropriate. Conservative estimates of acute dietary risk,
43
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chronic dietary risk, and carcinogenic dietary risk from consumption of propachlor residues in food
and in water were estimated previously in this document. .
Per current EPA policy, dietary drinking water risk can be estimated only for adult females.,
adult males, and child (1-6 years). Therefore, only aggregate risk pertaining to these population
sub-groups are assessed. MOEs and carcinogenic risk are rounded to two significant figures. Chronic
risk is rounded to one significant figure.
Table 11: Total Dietary Acute MOEs
Population
Sub-Group
adult female
Population
Sub-Group
adult male
child
(1-6 years)
Food Exposure
(mg/kg/day)
0.0012
Food Exposure
(mg/kg/day)
0.001
0.004
Water Exposure
(mg/kg/day)
0.002133
Water Exposure
(mg/kg/day)
0.001829
0.0064
Total Dietary
Exposure
(mg/kg/day)
0.003333
Total Dietary
Exposure
(mg/kg/day)
0.002829
0.0104
Total Dietary Acute
MOEs
53,000
Total Dietary Acute
MOEs
62,000
17,000
All total dietary MOEs greatly exceed 100. Therefore, the Agency has no concerns for total acute
dietary exposure.
Table 12; Total Chronic (non-carcinogenic) Dietary %RfD
Population
Sub-Group
adult female
adult male
child
(1-6 years)
Food Exposure
(mg/kg/day)
0.000009
0.000011
0.000045
Water Exposure
(mg/kg/day)
0.00002
0.000017
0.00006
Total Dietary
Exposure
(mg/kg/day)
0.000029
0.000028
0.000105
Total Dietary RfD
0.05
0.05
0.2
All total dietary RfDs are much less than the Agency's level of concern of 100%.
44
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Table 13; Total Dietary Carcinogenic Risk
^Population
Sub-Group
adult female
adult male
Pood Exposure
(mg/kg/day)
0.000009
0.000011
Water Jixposuie
(mg/kg/day)
* {
0.00002'
0.000017 .
Total Dietary
JExposure
(mg/kg/day)
0.000029
0.000028
TotalDietary ,.
Carcinogenic:Risk
9.3 xlO"7
9.0 xlO'7
,-6
The carcinogenic ;risk is less than HED's level of concern of 1 x 10
There are no registered residential uses of propachlor. Therefore, an aggregate assessment
due to exposure from residues of propachlor in food and water, and from residential uses is not
meaningful. Therefore, these total dietary (food and water) assessments are the aggregate
assessments for the purposes of FQPA. ;
g. Dietary Risk Characterization
The acute, dietary food source assessment was performed at tolerance level and did not
consider any. blended commodities, anticipated residues, or percent crop treated data. Therefore,
actual residues are,likely to be lower, which would correspondingly increase the MOEs (decreasing
risk). ' . ' •
The chronic/carcinogenic food source assessments were performed at tolerance level with
-percent crop treated data for corn and sorghum. Anticipated residues were estimated for meat and
milk. These assessments are more refined than Tier 1 (tolerance level assessments), and merefore are
a more realistic assessment, hdwever, further refinement could occur.
The drinking water .assessments are considered to be over-estimates since surface water
modeling numbers are from PRZM2.3/EXAMs2 which is an ecological model., It does hot necessarily
represent drinking water that would be obtained from a treatment plant. ,
The Agency considers that the data used to perform these assessments were adequate.
Overall, the Agency does not consider any^ of these estimates to under-represent residue levels and
corresponding risk estimates. .
b. Occupational and Residential
Occupational Exposure Assessment
An occupational and/or residential exposure assessment is required for an active ingredient
if (1) certain toxicological criteria are triggered and (2) there is potential exposure to handlers
(mixers, loaders, applicators) during use or to persons entering treated sites after application is
complete. In the case of propachlor, the above indicators have been met. The toxicological criterion
45
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is triggered by the determination that propachlor is a "likely" human carcinogen and the potential for
exposure exists.
Use Patterns
Propachlor, 2-chloro-N-isopropylacetanilide, is a selective herbicide used in commercial
settings for the preemergence weed control of annual grasses and broadleaf weeds in grain sorghum
(milo), field corn, hybrid seed corn, and silage corn, and for weed control "in the first season, growth-
establishment phase" for onion seed use in Washington and Oregon. Propachlor is formulated as a
manufacturing product (93 and 96.5 percent active ingredient), a flowable concentrate liquid (31.5
and 42 percent active ingredient), a dry flowable (48.1 percent active ingredient), and as a granular
(20 percent active ingredient).
Propachlor can be applied with groundboom sprayers, tractor drawn granular broadcast
spreaders, and granular row planters. Application rates vary from 3.0 to 6.0 pounds active ingredient
per acre depending upon the application scenario. Propachlor can be applied to the following crops/
areas: field corn, hybrid seed com, silage corn, grain sorghum (milo), and onions grown for seed.
Occupational-use Products and Homeowner Use Products
Currently registered products containing propachlor are intended for occupational uses. Due
to the absence of residential uses, a residential assessment has not been performed.
Acute Toxicology Categories
Guideline studies for acute toxicity indicate that the technical grade of propachlor is classified.
as category I for primary eye irritation and category IV for primary skin irritation.
Under the Worker Protection Standard (WPS), interim restricted entry intervals (REI) for
all uses within the scope of the WPS are based on the acute toxicity of the active ingredient. The
WPS requires a 48 hour REI for pesticides belonging to toxicity category I for primary eye irritation.
Other Endpoints of Concern
The propachlor Toxicology Endpoint Selection (TES) document, dated May 7, 1997,
indicates that there are toxicological endpoints of concern for propachlor. (See Dose-Response
Section)
Epidemiological Information
The OPP Incident Data System, the Toxic Exposure Surveillance System (National Poison
Control Centers), California Department of Food and Agriculture/Department of Pesticide Regulation
Database, and the National Pesticide Telecommunications Network were searched for poisoning
46
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incident data on the active ingredient propachlor. In these databases, no serious illnesses have been
reported due to exposure to propachlor, although there are reports of dermatitis and skin sensitivity.
The World Health Organization (1993) reported,a case concerning a 29 year old agricultural
worker who had been in contact with propachlor for 8 days and experienced contact eczema on the
palms, wrists, and forearms. The skin lesions disappeared after contact ceased. In another 1993
WHO report concerning a patch test of 17 farmers, there were seven cases that had a positive patch
test reaction, and five cases that had an irritant reaction to propachlor. In a study of 79 workers
manufacturing 65% propachlor, 19% of the workers showed contact dermatitis due to propachlor
exposure. . _ .
Handler Exposure Assessment
The Agency has determined that there' are potential exposures to mixers, loaders, applicators,
and other handlers during usual, use-patterns associated with propachlor. Based on the use patterns,
.five major exposure scenarios were identified for propachlor:
/ • ' ' s
(1) mixing/loading liquids for groundboom application; •
(2) mixing/loading dry flowables for groundboom application;
(3) loading granulars for tractor-drawn spreader application;
(4) applying sprays with groundboom equipment; and
(5) applying granulars with a tractor-drawn spreader.
Dermal and inhalation exposures are presented in Table 14. No chemical-specific data were
submitted; therefore, Table 14 was developed using the Pesticide Handlers; Exposure Database
(PHED), Version. 1,1 surrogate data as estimated in the PHED Surrogate Exposure Guide, May,
1997. The PHED was developed by Health Canada, the American Crop Protection Association, and
EPA. PHED was initially released for public use in 1992. PHED is a generic/surrogate exposure
database containing a large number of measured values of dermal and inhalation exposure for
pesticide workers .(e.g., mixers, loaders, and applicators) involved in the handling or application of
pesticides in the field. The database currently contains data for over 2000 monitored exposure
events. Use of surrogate or generic data is appropriate since it is generally believed that the'physical
parameters of the .handling and application process (e.g. the type of formulations, the method of
application, and the type of clothing), not the chemical properties of the pesticide, control the amount
of dermal and inhalatipn exposure. Thus, PHED .typically allows exposure and risk assessments to
be conducted with a much larger number of observations than available from a single exposure study.
PHED also contains algorithms that allow the user to complete surrogate task-based exposure
assessments beginning with one of the four main data files contained in the .system (i.e., mixer/loader,
applicator, flagger, and mixer/loader/applicator). Users select data from each file and construct
exposure scenarios that are representative of the use of the chemical. The Agency, in conjunction
with the PHED task force, has evaluated all of the data currently in PHED, and developed -a surrogate
• '•'. ' : • : ' , -47. ' •
-------
exposure table that contains a series of standard exposure estimates for various scenarios. These
standard unit exposure values are the basis for this assessment. The standard exposure values (i.e.,
the unit exposure values included in the exposure and risk assessment tables) axe based on the "best
fit" values calculated by PHED. PHED calculates "best fit" exposure values by assessing the
distributions of exposures for each body part included in datasets selected for the assessment (e.g.,
chest or forearm) and then calculates a composite exposure value representing the entire body. PHED
categorizes distributions as normal, lognormal, or in an "other" category. Generally, most data
contained in PHED are lognormally distributed or fall into the PHED "other" distribution category.
If the distribution is lognormal, the geometric mean for the distribution is used in the calculation of
the "best fit" exposure value. If the data are an "other" distribution, the median value of the dataset
is used in the calculation of the "best fit" exposure value. As a result, the surrogate unit exposure
values that serve'as the basis for this assessment generally range from the geometric mean to the
median of the selected dataset.
The Agency's first step in performing a handler exposure assessment is to complete a baseline
exposure assessment The baseline scenario generally represents a handler wearing long pants, a long-
sleeved shirt, and no chemical-resistant gloves. If, the level of concern is met or exceeded, then
increasing levels of risk mitigation, such as PPE (personal protective equipment) and engineering
controls, are used to recalculate the MOE's until exposure is sufficiently reduced to achieve an
appropriate margin of exposure or cancer risk.
The formulas for all calculations are given in the foot-notes in the various Tables.
48
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Occupational Risk Assessment
Handler Risk Assessment
x
All risks (MOEs and cancer estimates) are reported to 2 significant figures. The baseline daily
exposures were divided by 70 kg to estimate the baseline dose. It was necessary to use PPE
(personal protective equipment) to achieve a MOE greater than 100 for scenario 1, mixing/loading
liquid formulations.
54
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Table 16; ShortrTerm Risks to Propachlor
^ -*
Exposure Scenario '
(Scenario #)
s
* >. *
*. <* »,
'Baseline
' TDose
(mg/kg/day)a
\
K Baseline
MOE"
*t
*i *S
RiskMitigation Measures
Additional PPE,
PPE
Dermal Unit
Exposure.
(mg/Ib ai)c
PPE
Inhalation
Unit
Exposure
(ug/lb ai)c
PPE
Daily Dose
(mg/kg/day)a
PPE
MOEb
- " -VH, "' Mixer/Loader Risk . ..', '
Mixing/Loading
Liquids for
Groundboom
Application (1)
Mixing/Loading Dry
Flowables for
Groundboom
Application (2)
Loading Granulars .
for Tractor-Drawn •
Spreader Application
(3)
20 (corn)
17
(grain
sorghum
and onions)
0.39
(corn and
grain -
sorghum)
0.07 (corn)
0.06 (grain
sorghum)
9
10
450
2,750
3,100
. 0.017
1,2.
NA
NA , .
0.12
0.10
NA ;
• , NA,,
1,400
1,700
NA
NA:
o Applicator Risk
Applying Sprays
with a Groundboom
Sprayer (4)
Applying Granulars
with a Tractor-
Drawn Spreader (5)
0.1 (corn)
0.08
(grain
sorghum
and onions)
0.08 (corn)
0.06 (grain
sorghum)
1,800
2,100
2,300
2,800
NA
NA
. , NA
- 'NA
NA
NA • "
NA not applicable. MOE for the previous scenario is greater than 100; therefore, additional
mitigation is not necessary.
a Total Dose (mg/kg/day) = Dermal exposure (mg/day) + Inhalation exposuie (mg/day) / Body weight
(70 kg). There is no dermal absorption factor; therefore, 100% dermal absorption is assumed; 100%
inhalation absorption is assumed. . *
b MOE = (NOEL (175 mg/kg/day) / Daily Dose (mg/kg/day)).
0 Additional PPE: Double layer of clothing and chemical resistant gloves; no respirator..
55
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Propachlor is used as a preemergent on corn and sorghum. Therefore, the Agency believes
that the intermediate-term scenario is the most typical and appropriate, since available information
indicates that for pre-plant herbicide applications that a "window" of approximately 28 days is
available once the weather and field conditions are right and the equipment can enter the fields. This
is supported by information that indicates that an early-season corn herbicide applied once per season
would result in 20 days of exposure per year to commercial handlers. An early-season sorghum
pesticide applied once per season would result in 14 days of exposure per year to commercial
handlers.
Cancer risks were estimated beginning with the scenario for which intermediate term MOEs
were greater than 100, since this level of mitigation would be required based on the risk assessment
for the intermediate scenario. The Agency's default female body weight of 60 kg was used since the
Qj* of 0.032 (mg/kg/day)"1 was based on female rat ovarian tumors. No information on typical, actual
use rates are available; therefore, maximum use (label) rates were used.
56
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Post-Application Exposure Assessment
No .residue dissipation, data (e.g., DFR (dislodgeable foliar residue)) or exposure monitoring
data were submitted for propachlor. However, the Agency believes that the potential for post-
application worker exposure is low, provided the 48 hour Restricted Entry Interval (REI - based on
propachlor's classification as toxicity category I for primary eye irritation) is observed. Therefore,
there is low potential for exposure due to the timing of applications. Propachlor is applied to the soil
and/or soil incorporated pre-emergent for com and grain sorghum. This is well before the plants are
mature, which likely mitigates 'the potential for post-application exposure due to contact with treated
foliage. Additionally, most agricultural operations for corn and sorghum, particularly early in the
season, are mechanical which minimizes the potential for contact. Significant exposure to .propachlor
during harvesting, or any other late season activities, is not likely since propachlor is applied pre-
emergent. Therefore, the Agency does not require that any post-application exposure .or residue
dissipation monitoring data be generated to support the reregistration of propachlor.
Occupational Summary of Risks
Note that the PHED data confidence for dermal exposure and the use of any protection
factors (PF) is in parenthesis. ,
Short-Term Risk
The estimations of short-term dermal and inhalation risk indicate that the ,MOEs are more than
100 at baseline for the following scenarios:
• (2) mixing/loading dry flowables for groundboom application
(Based-on low confidence data and.no PF);
• (3) loading granulars for tractor drawn spreader application
(Based on low confidence data and no PF); • .
• (4) applying sprays with groundboom sprayer , .. '
(Based on high confidence data and no PF);
• (5) applying granulars with a tractor-drawn spreader ,
(Based on low confidence data and no PF); :
The estimations of short-term dermal and inhalation risk indicate that the MOEs are more than
JOO with additional PPE for the remaining scenario: .•'.•',
• (1) mixing/loading liquids for groundboom application
(Based on high confidence data and a 50% PF).
63
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Intermediate-Term Risk
The estimations of intermediate-term dermal and inhalation risk indicate that the MOEs are
more than 100 at baseline for the following scenarios:
• (3) loading granulars for tractor-drawn spreaders,
(Based on low confidence data and no PF);
• (5) applying granulars to sorghum with a tractor-drawn spreader
(Based on low confidence data and no PF).
The estimations of intermediate-term dermal and inhalation risk indicate that the MOEs are
more than 100 with additional PPE for:
• (4) applying sprays to sorghum and onions with a groundboom sprayer
(Based on medium confidence data and no PF).
• (5) applying granulars to corn with a tractor-drawn spreader
(Based on low confidence data and no PF).
The estimations of intermediate-term dermal and inhalation risk indicate that the MOEs are
more than 100 with engineering controls for:
• (1) mixing/loading liquids for groundboom application
(Based on medium confidence data and no PF).
• (2) mixing/loading dry flowables for groundboom application.
(Based on low confidence data and a 90% PF)
• (4) applying sprays to corn with a groundboom sprayer
(Based on medium confidence data and no PF).
Cancer Risks
The estimations of cancer risks are within the 10"5 or 10"6 risk range for the following scenarios:
• (1) mixing/loading liquids for groundboom application with engineering
controls (Based on medium confidence data and no PF);
• (2) mixing/loading dry flowables for groundboom application with engineering
controls (Based on low confidence data and a 90% PF);
• (3) loading granulars for tractor-drawn spreader application at baseline (Based
on low confidence data and no PF), with additional PPE (Based on low
confidence data and no PF), and with engineering controls (Based on low
confidence data and a 90% PF);
• (4) applying sprays with a groundboom sprayer with additional PPE (Based on
medium confidence data and a 50%. PF) and with engineering controls
(Based on medium confidence data and no PF); and,
64
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(5) applying granulars with a tractor-drawn spreader at baseline (Based on low
' confidence data and no PF), with additional PPE (Based on low confidence
data and two PFs - 90% and 50% PF), and with engineering controls (Based
on low confidence data and no PF), - . '
Although all risks are within the 10'5 risk range, going across Tables 22A and 22B, there is
a steady reduction of the magnitude by an approximate factor of 2 with each progression from
baseline to PPE to engineering controls.
Post-Application Risk
The Agency believes that, based on the current uses of propachlor, post-application exposure
will be low and therefore is not requiring post-application exposure studies at this time.
Occupational Risk Characterization
Several .issues must be considered when interpreting the occupational exposure and the resultant risk
assessment. '.
• No chemical-specific exposure data were submitted. As a result all risk estimates
were performed using surrogate data in PHED.
• Several handler assessments were completed using "low quality " PHED data due to
the lack of a more acceptable dataset.
• , Several generic protection factors were used to calculate handler exposures. These
' protection factors are in general use, but have not been completely evaluated by the
' Agency. .
• Acres treated per day for each application method are standard values used by the
Agency, due to a lack of pertinent data. These values are based on the best
professional judgement of the Agency staff and were arrived at after much internal
discussion. The values are considered to represent typical values regardless of
regional variability.
•• A chemical-specific dermal absorption factor was not available. Therefore, 100%
dermal absorption was assumed.
\_
• A chemical-specific inhalation absorption factor was not available. Therefore, 100%
inhalation absorption was assumed. . . '
• Application rates are the maximum labeled rates for the sites and treatment scenarios
used in the assessment. However, it is acknowledged that actual application rates can
, 65 ...
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vary. It is the Agency's policy that the maximum application rate be used for the
short-term and intermediate-term scenarios, but that a typical application rate can be
used for a carcinogenic assessment. The Agency has inadequate information on
typical application rates for propachlor.
Further refinement to this risk assessment could occur if the registrant supplied any or all of
the following information:
(1) a dermal absorption factor
(2) an acceptable 21-day dermal study
(3) additional information on number of days of exposure
(4) additional information on the systems/equipment typically used by M/L/As, especially the
equipment used on large acreage farms
(5) additional information on typical use rates
There are two intermediate-risk scenarios for which MOEs of 92 and 96 were obtained. In
all probability a dermal absorption factor or 21 day dermal study would allow the agency to use less
than 100%, thus achieving MOEs greater than 100. Therefore, the Agency can go forward with this
Reregistration Eligibility Decision at this time. Although the Agency is not requiring a 21-day dermal.
study, the registrant is currently providing an update to an unacceptable but upgradeable study for
the further refinement of the risk assessment.
However, in the absence of such information, for mixer/loaders to mitigate for both the dermal
intermediate-term scenario and the carcinogenic scenario, the following is required:
• (1) mixing/loading liquids for groundboom application requires a closed
mixing/loading system, and chemical resistant gloves.
• (2) mixing/loading dry flowables for groundboom requires the use of engineering
controls. However, the registrant has agreed to voluntarily cancel this formulation.
• (3) mixing/loading granulars for sorghum for tractor-drawn spreader application can
be performed at baseline; mixing/loading granulars for corn for tractor drawn spreader
application requires use of PPE. The Agency notes that the label currently requires
the use of gloves; therefore, it seems prudent to require the use of PPE for both corn
and sorghum.
For applicators to mitigate for both the intermediate-term scenario and the carcinogenic
scenario, the following is required:
• (4) applying sprays with a groundboom requires the use of mitigation: PPE for
sorghum and engineering controls for corn.
• (5) applying granulars with a tractor-drawn spreader can be performed at baseline for
/ sorghum and with PPE for corn
J - -'.,'. .'
66
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5. FQPA Considerations
a. Cumulative Effects
Propachlor is a member of the acetanilide class of herbicides. It is structurally similar to
acetochlor, butachlor, metolachlor, arid alachlbr.
Section 408(b)(2)(D)(v) of FQPA requires that, when considering whether to establish,
modify, or revoke a tolerance, 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 Agency believes that "available information" in this context might include not only'
toxicity, chemistry, and exposure data, but also policies and methodologies for conducting cumulative
risk assessments. For most pesticides, the Agency has some information in its files that may turn out
to be helpful in eventually determining whether a pesticide shares a common mechanism of toxicity
with any other substances.
However., at this time the Agency does not have the methodology to resolve the scientific
issues concerning common mechanism of toxicity in a meaningful way. The Agency has begun a pilot
process to study this issue further through the examination of particular classes of pesticides.
Hopefully, the results of this pilot process will enable the Agency to develop and apply policies for
evaluating the cumulative effects of chemicals having a common mechanism of toxicity. At present,
however, the Agency does not know how to apply the information in its files concerning common
mechanism issues to most risk assessments. Exceptions include pesticides that are toxicologically and
structurally dissimilar to existing chemical substances,(in which case the Agency can conclude that
it is unlikely that a pesticide shares a common mechanism of activity with other substances) and
pesticides that produce a common toxic metabolite (in which case the metabolite must be assessed
as part of a common mechanism assessment). .
In making individual tolerance decisions, the Agency will determine whether:
, 1) it has sufficient information to determine that a pesticide does not appear to share a
• common mechanism of toxicity with other substances;
2) it is unable to conclude that a pesticide does not share a common mechanism of toxicity
with other substances; or i " "
• 3) it is able to conclude that a pesticide does share a common mechanism of activity with
other substances.
Due to the structural similarities with acetochlor, metolachlor, butachlor, and alachlor,-'
propachlor may fall into the second category. However, at this tune the Agency has not yet made
a final decision concerning a possible common mechanism of toxicity for these five chemicals to
scientifically apply that information to the tolerance decision. The process has begun, but is not yet
. 67
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completed. Therefore, for the purposes of this decision document, the tolerance decision will be
reached based upon the best available and useful information for propachlor only. The risk
assessment has been performed for propachlor only assuming that no common mechanism of toxicity
exists. However, these decisions will be reexamined after methodologies and procedures for
integrating information concerning common mechanism of toxicity into risk assessments are
developed by the Agency.
Monsanto must submit, upon EPA's request and according to a schedule determined by the
Agency, such information as the Agency directs to be submitted in order to evaluate issues related
to whether propachlor shares a common mechanism of toxicity with any other substance and, if so,
whether any tolerances for propachlor need to be modified or revoked.
b. Endocrine Disrupter Effects
The Agency is required to develop a screening program to determine whether certain
substances (including all pesticides and inerts) "may have an effect in humans that is similar to an
effect produced by a naturally occurring estrogen, or such other endocrine effect..." The Agency is
currently working with interested stakeholders, including other government agencies, public interest
groups, industry and research scientists hi developing a screening and testing program and a priority
setting scheme to implement this program. Congress has allowed 3 years from the passage of FQPA
(August 3,1996) to implement this program. At that time, EPA may require testing of propachlor
for endocrine disruptor effects.
c. Determination of Safety
FFDCA section 408(b)(2)(A)(I) allows EPA to establish a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that the tolerance is "safe".
FFDCA section 408(b)(2)(A)(ii) defines "safe" to mean that "there is a reasonable certainty that no
harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated
dietary exposures and all other exposures for which there is reliable information." This includes
exposure through drinking water and residential exposures, but does not include occupational
exposure. Section 408(b)(2)(C) requires EPA to give special consideration to exposure of infants
and children to pesticide chemical residue in establishing a tolerance and to "ensure that there is a
reasonable certainty that no harm will result to infants and children from aggregate exposure to the
pesticide chemical residue..."
Determination of safety includes consideration of special sensitivity to children, potential
cumulative effects with pesticides that have a common mode of toxicity and aggregate risks resulting
from exposure to dietary residues, residues in drinking water, and residential sources.
The database for developmental and reproductive toxicity of propachlor is considered to be
complete at this time. A developmental neurotoxicity study was not required. There is no unique or
special sensitivity for pre- or post-natal exposure. Based on these three factors, the Agency has
68
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concluded that the results of these data did not raise concerns regarding the use of 100 as the
uncertainty factor. An uncertainty factor of 100 will adequately protect infants and children.
-The Agency has determined that consideration of a common mode of toxicity .with other
chemicals such as acetochlor, butachlor, metolachlor, and alachlor is not appropriate at this time.
, Tolerance reassessments have occurred in the RED as a result of new data on the concentrations of
propachlor residues present in food. As a result, the existing and unsupported tolerances will be
revoked in conjunction with this RED. ,
'<
There are no residential uses of propachlor. The aggregate risk assessment from exposure
to propachlor in food and water, does not result in aggregate risk that exceeds the Agency's level of
concern. ,
Thus, the agency concludes that there is a reasonable certainty of no harm to infants and
children, and adults from consuming potential residues of propachlor. This conclusion encompasses
residues from aggregate exposure (food and water).
Table 21: Residue Chemistry Science Assessments for Reregistration of Propachlor.
GLN: Data,Requirements
^*- A *
860.1200: Directions for Use
860.1300: Plant Metabolism
860.1300: Animal Metabolism
'Current
Tolerances, ppm
[40 CFR
§180.211]
N/A = Not
Applicable
. N/A
N/A
860.1340: Residue Analytical Methods
- Plant commodities
- Animal commodities
860.1360: Multiresidue Methods
860.1380: Storage Stability Data
N/A'
N/A
' N/A
N/A
Must Additional
DataBe^
Submitted?
Yes1
. No
No •
No2
No
No
.' . No
860.1500: Crop Field Trials .
Root and Tuber Vegetables Group
- Sugar beet, roots
Revoke
No 4 '
References . ; .."
40068601,42140301
40123101,40129301
• • .
40584004,43028601,
43028602,43251801
40584004, 43028602,
43251801
43028501 3
40081701,40085301,
40584005,42121302,
42121303,42140302
Leaves of Root and Tuber Vegetables Group
- Sugar beet, tops
Revoke
No 5
69
-------
GLN: Data Requirements
Current ;
Tolerances, ppm
[40;CFR
§180:211]
Legume Vegetables (Succulent or Dried) Group
-Peas
Foliage of Legume Vegetables Group
- Peas vines and hay
Cucurbit Vegetables Group
- Pumpkins
Cereal Grains Group
- Com, field, grain
- Corn, sweet (K+CWHR)
- Sorghum, grain
Revoke
Revoke
Revoke
0.1
Revoke
0.25
Forage, Fodder, and Straw of Cereal Grains
- Com, field, forage and stover
- Com, sweet, forage and stover
- Sorghum forage and stover
Miscellaneous Commodities
- Cotton, seed and gin byproducts
- Flax seed
- Crops grown solely for seed
1.5, forage
1.5, forage
5.0, forage
5.0, fodder
Revoke
Revoke
None established
Must Additional
Data Be
"Submitted?
No5
No5
.No5
No
No5
No
No
No5
No
No5
No5
No6
References
40085301
40081701
40085301
40081701
860.1520: Processed Food/Feed
- Com, field
- Cottonseed
- Flax seed
None established
None established
None established
No
No6
No6
40085302,42962501
70
-------
/ _ '
GLN; Data Requirements " . ,"
\ 4
"> *
- Sorghum
- Sugar beet
Current
- Tolerances, ppm
[40 CFR -
* §180.211] "
None established
None established
Must Additional
DataBe
'Submitted?
No
No*
References
40081702 ,
860.1480: Meat, Milk, Poultry, Eggs , • . .
- Milk and the Fat, Meat, and Meat
Byproducts of Cattle, Goats," Hogs,
Horses, and Sheep
- Eggs and the Fat, Meat, and Meat
Byproducts of Poultry
860. 1400: Water, Fish, and Irrigated
Crops
860.1460: Food Handling
860.1 850: Confined Rotational Crops
860.1900: Field Rotational Crops
0.02
0.02
None established
None established
N/A
None established
' No
, -, No
N/A
N/A • '
No"
.Yes7
40584001,40584003 ' .,
40584002 ,
-• . '
43064501
1. Product labels with uses on Sorghum must be amended to remove the restriction against the grazing or feeding of sorghum
forage or silage from treated fields to dairy animals, since the Agency no longer considers such restrictions to be practical.
Until adequate field rotational crop data have been submitted, product labels with uses on rotatable crops should be amended
to specify that only crops that are listed on the label may be rotated to fields treated with propachlor.
, 2. Provided that the comments made by ACB are incorporated into the method, CBRS concluded that the.propdsed enforcement
method (Monsanto Report No. MSL-12679) is suitable for the enforcement of tolerances for plant and animal commodities.
3. These data were forwarded to FDA for review (memo from L. Edwards to H. Hundley dated 5/18/94).
4. There are currently no registered uses on this crop. The established tolerance(s) will be revoked.
5. There are no registered uses ,on this crop. , .•-''-.'
'6. Propachlor was previously registered for use on barley, oats, soybeans, and wheat grown for seed. Because these uses have
been-removed from product labels, data are no longer required to support these uses; -----
7. The available confined rotational crop data indicate that limited field rotational crop studies must be conducted.
71 .
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C. Environmental Assessment
1. Use Characterization
; • •' • '
a. Application Rates and Methods
I; , J ' , (
Propachlor is registered for pre-emergent weed control on corn (field, silage, and hybrid), grain
sorghum, and onions grown for seed (in Washington and Oregon only). End use products include
flowable concentrate, granular, and water-dispersible granule (dry flowable) formulations. The
pesticide may be applied by ground broadcast (boom spray or spreader) or band treatment. The
maximum application rate is 6 Ib a.i./acre on corn and sorghum (Section II .B, pg. 2, and current
labels). Only one application of propachlor is allowed per season.
b. Use in Corn Areas
Com is grown in almost every state in the continental U.S. Major corn-growing areas include the
Midwest and Great Plains states (from Ohio west to Nebraska and from southern
Minnesota/Wisconsin south to Illinois/Missouri), the Mississippi River Valley, and the East Coast
(fiom southeastern Pennsylvania to North Carolina) (USDA National Agricultural Statistics Service,
1996 Harvested Acres by County). These regions include such wildlife-rich areas as the Prairie
Pothole region, Sandhills Lake region of Nebraska, and coastal/estuarine regions of the Delmarva
peninsula and North Carolina. Many of these areas are used by waterfowl and shorebirds as breeding,
feeding, and migratory resting grounds. In addition, corn may be grown in the vicinity of freshwater
and estuarine/marine aquatic habitats. This can lead to exposure of aquatic resources from the off-
site movement of chemicals applied to cornfields near such habitats.
The corn-growing region includes localized areas which have a high potential vulnerability for
contamination of shallow ground water with pesticides (Kellog et al. 1992.). Such vulnerable areas
include the eastern coastal plain from southern Georgia to New Jersey, eastern Nebraska, and
southern portions of the Great Lakes region. While the majority of corn-growing areas are dominated
by soils which have a moderate runoff potential and moderate infiltration and permeability (also
referred to as Hydrologic Group B soils), localized regions are more susceptible to runoff (Kellog et
al., 1992). Areas with significant percentages of soils with moderately high to high runoff potential
(Group C and D soils) include the Gulf Coast region of Texas, the lower Mississippi River Valley,
the Missouri River Valley hi South Dakota, the extreme eastern coastal plain of Georgia, South
Carolina, and North Carolina, and portions of the Ohio River Valley. These soils are more prone to
runoff because of slow permeability (low saturated hydraulic conductivities) and/or a relatively
shallow water table. ,
c. Use in Sorghum Areas
Major sorghum-growing areas in the U.S. are the central and southern Great Plains (from Nebraska
south to Texas and from eastern Colorado east to Missouri) and the Mississippi River Valley from
72 '
-------
southern Illinois to Louisiana (USDA National Agricultural Statistics Service, 1996 Harvested Acres
by County). The number of acres planted to sorghum appears to be increasing in the coastal plains
of the Carolinas and Georgia. While me geographic extent of the sorghum area is less than that of
corn, it does include significant areas of wildlife habitat. It may also be found in the vicinity of
estuarine/marine habitats, especially along the Gulf Coast region of Texas. Potential exposure of
aquatic resources may occur from the off-site movement of chemicals applied to sorghum fields near
such habitats. '
Sorghum is more tolerant of dry conditions than corn and is typically grown in warmer climates which
have a lower rainfall than the corn region. Overall, the major sorghum areas also have a lower
potential vulnerability for contamination of shallow ground water, except in the southeastern U.S.,
where the acreage of sorghum is increasing (Kellog et al. 1992). Large areas of Texas and the
Mississippi River Valley are dominated by the high runoff potential Hydrologic Group C and D soils.
In such areas, the adjacent aquatic habitats may be vulnerable to off-site movement of chemicals from
runoff ; .-.'•'"
2. Ecological Toxicity Data
a. Toxicity to Terrestrial Animals
Propachlor is moderately toxic to birds on an acute oral basis but practically nontoxic on a
subacute dietary basis. The pesticide is considered practically nontoxic to mammals (based on tests
' on rats) and honey bees. Both the active ingredient and the formulated use product are considered
moderately to highly toxic to freshwater fish and invertebrates on an acute basis. A comparison of ,
acute LD50 data with the appropriate time-averaged PRZM/EXAMS EECs. indicate that chronic
toxicity or life-cycle studies for aquatic organisms is not required. Among nontarget terrestrial plants,
lettuce and ryegrass exhibited the highest sensitivity in terms of seedling emergence and vegetative
vigor. No data are available for any of the degradates of propachlor.
(1) Birds, Acute and Subacute
An acute oral toxicity study using the technical grade of the active ingredient (TGAI) is required
to establish the toxicity of propachlor to birds. The preferred test species is either mallard duck (a
waterfowl) or bob white quail (an upland game bird).
Table 22: Avian Acute Oral Toxicity
Species
Bobwhite quail
%a.i. /'
96.6
LD50
(mg/kg)
88.0
Toxicity Category
Moderately toxic
MRIDNo.
Author/Yr
00132907
Study
Classification1
Core
1 Core study (satisfies the guideline)
With an LD50 in the range of 50-100 mg/kg, propachlor is considered to be moderately toxic to
avian species ,on an acute oral'basis. The guideline (71-1) is fulfilled (MRID 00132907).
73
-------
Two subacute dietary studies using the TGAI are required to establish the toxicity of propachlor
to birds. The preferred test species are mallard duck and bobwhite quail.
Table 23; Avian Subacute Dietary Toxicity
Species
Northern bobwhite quail
(Colinus virginianus)
Bobwhitequail
Mallard duck
Mallard duck
(Anas platyrhynchos)
%ai
>96.5
90
90
>96.5
5-Day LC50
(ppm)1
>5620
>5000
>5000
>5423
• •• . ..''•'
Toxieity Category
practically non-
toxic
practically non-
toxic
practically non-
toxic
practically non-
toxic
MRIDNo. .
Author/Year ;
00132908/
Wild. Int./ 1983
00104335/
1973
00108087/
1980
00134006/
Wild. Int./ 1 983
Study
^Classification; -
core
core
core
core
1 Test organisms observed an additional three days while on untreated feed.
With an LC50 greater than 5000 ppm and no observed effects, propachlor is considered practically
non-toxic to avian species on a subacute dietary basis. The guideline (71-2) is fulfilled (MRIDs
00132908,00104335,00108087,00134006).
(2) Birds, Chronic
Propachlor is moderately toxic (LD50, the lethal dose which affects 50% of the test population, was
in the range of 50-100 mg/kg) to avian species on an acute oral basis and practically non-toxic (LC50,
the lethal concentration affecting 50% of the test population, is greater than 5000 ppm) to avian
species on a subacute dietary basis. Both the acute oral (MRID 00132907) and subacute dietary
(MRIDs 00132908,00104335, 00108087, 00134006) guideline requirements are fulfilled. Chronic
avian toxicity data are not required for propachlor because repeated or prolonged exposure to the
chemical is not expected (the label calls for one application/year and the fate data suggest that
propachlor is not highly persistent in most terrestrial environments).
(3) Mammals, acute and chronic
Wild mammal testing is required on a case-by-case basis, depending on the results of lower tier
laboratory mammalian studies, intended use pattern and pertinent environmental fate characteristics.
In most cases, rat or mouse toxicity study values were substituted for wild mammal testing.
74
-------
Table 24; Mammalian Toxicity
Species/
Study Duration
laboratory rat
(Rattus rattus)
%ai
94.5
Test
Type
LD50
Toxicity
Value
1800mg/kg ,
Affected
Endpoints
mortality
MRIDNo.
00104350
Propachlor is practically non-toxic (LD50 of 1800 mg/kg) to mammalian species on an acute oral
basis (MRID 00104350).
(4) Insects
A honey bee acute contact study using the TGAI is required for propachlor because its use (on
corn and sorghum) will result in honey bee exposure. .
Table 25; Nontarget Insect Acute Contact Toxicity
Species'
Honey bee
(Apis mellifera)
%ai
98
ED50
Cug/bee)
>25 .
Toxicity Category
practically non-toxic
MRID No.
Author/Year
431477-06.
Hoxteretaiy 1993
Study
Classification
Core
The results indicate that propachlor is practically non-toxic to bees on an acute contact basis. The
guideline (141-1) is fulfilled. (MRID#431477-06). '.-.'•
A honey bee tbxicity of residues on foliage study for the typical end-use product is required for
propachlor if its use will result hi honey bee exposure and the acute contact honey bee LD50 is less
than 0.11 ug/bee. Because results of the acute contact test show an LD50 of greater than 25 ug/bee,
the (141-2) guideline study is not required for propachlor. However, this study was completed and
the results are shown in the following table:
Table 26: Nontarget Insect Subacute Dietary Toxicity Study
3
Species
Honey bee
(Apis mellifera)
%ai
98
LC50
(ppm)
>1,000
•?.
Toxicity Category
practically non-toxic
MRIDNo.
Author/Year
431477-05 ."
Hoxteretaiy 1993
Study
Classification
Core
Propachlor is practically non-toxic (>25 ug/bee) to bees on an acute contact (MRID 431477-06)
and subacute dietary basis (MRID 431477-05). The (141-1) guideline requirements have been
fulfilled. Since the acute contact honey bee LD50 is greater than 0.11 wg/bee, the 141-2 guideline
study for honey bee toxicity of residues on foliage is not required.
75 '
-------
b. Toxicity to Aquatic Animals
(1) Freshwater Fish, Acute
i
Two freshwater fish toxicity studies using the TGAI are required to establish the toxicity of
propachlor to fish. The preferred test species are rainbow trout (a coldwater fish) and bluegill sunfish
(a warmwater fish).
Table 27: Freshwater Fish Acute Toxicity
Species
Rainbow trout
(Oncorhynchus mykiss)
Bluegill sunfish
(Lepomis macrochirus)
Channel catfish
(Ictalurus punctatus)
Bluegill sunfish
(Lepomis macrochirus)
Rainbow Trout
(Onchoryhncus mykiss)
Channel catfish
(Ictalurus punctatus)
%ai
96.6
94.9
94.5
42.9
42.9
47.9
; 96-hour
LC50(ppb)
170
>1400
230
420
1600*
280
Toxicity :
Category
highly toxic
moderately
toxic
highly toxic
highly toxic
moderately
toxic
highly toxic
MRIDNo. '."•
Author/Year
Thompson, 1980
00041335
Morrill,1973
00104337
Mayer, Ellersiek, 1986
40098001
Thompson, 1980
00041337
Thompson,1980
00041338
Mayer, Ellersiek, 1986
40098001
Stuoy
Classification
Core
Supplemental
Core
Core
Supplemental
Supplemental
* 72-hour LC50
With a 96-hour LC50 for the technical grade material (TGAI) within the range of 0.17 to > 1.4 ppm,
propachlor is moderately to highly toxic to freshwater fish on an acute basis. Since the 96-hour LC50
is between 0.28 to 1.6 ppm, the formulated products of propachlor are considered moderately to
highly toxic to freshwater fish on an acute basis. The guideline (72-1) requirements are fulfilled for
the TGAI (MRIDs 00041335, 00104337, GS01140003) and formulated product (00041338,
00041337, GS01140003). The TGAI was more toxic to rainbow trout than the formulated product;
however, the formulated product was more toxic to the bluegill sunfish than the TGAI.
(2) Freshwater Fish, Chronic
No early life-stage studies with freshwater fish are available for propachlor. A comparison
between the 56/60-day EEC generated by PRZM/EXAMS (7.6 ppb for sorghum at 6.0 Ib ai/acre) and
the most toxic LC50 for freshwater fish (170 ppb for rainbow trout) gives a RQ equivalent of 0.044.
This does not trigger the need for any further chronic testing for freshwater fish.
76
-------
(3) Freshwater Invertebrates, Acute
A freshwater aquatic invertebrate toxicity test using the TGAI isutilized to establish the toxicity
of propachlor to aquatic invertebrates. The preferred test species is Daphnia magna.
Table 28: Freshwater Invertebrate Acute Toxicity
s. -*
Species/(Static or Flow-
through)
Waterflea
(Daphnia magna)
Waterflea
(Daphnia magna) .
Chironomus
(Chironomus plumosus)
Waterflea ,
(Daphnia magna)
Waterflea
(Daphnia magna)
Species/(Static or Flow-
through)
Chironomus
(Chironomus plumosus) ,
%'ai
>96.6
94.5
94.5
42.9
47.9 .
%ai
47.9
48-hr LC50/
EC50 (ppm)
7.8 EC50
6.9 EC50 ;
0.79 EC50
13.4LC50
6.9 LC50
48-hr LC50/
EC50 (ppm)
0.79 LC50
Toxicity
Category
moderately toxic
moderately toxic
highly toxic
slightly toxic
moderately toxic
. Toxicity
Category
highly toxic
MRIDNo. v";
Author/Year
00041336
Thompson, 1980
40098001
Mayer &
Ellersiek/1986
40098001
Mayer &
Ellersiek/1986
00041339
Thompson, 1980
40098001 ,-
Mayer &
Ellersiek/1986
MRIDNo.
Author/Year
40098001
Mayer & ,
Ellersiek/1986
; Study
Classification
core
core
core
core
core
Study
Classification
core
With the EC56 of the TGAI from 0.79 to 7.8 ppm, propachlor is-considered moderately to highly
" toxic to aquatic.invertebrates on an acute basis. Guideline requirement 72-2 is fulfilled (MRIDs '
40098001,00041336). .Because the LG50 range is equal to or less than the maximum environmental
concentration, which ranges from 4.4 ppm in 6 inches of water to 0.4 ppm in.6 feet of water,
formulated product testing is utilized as the next tier of data evaluation.
• The EC50 values for formulated products range from 0.79 to 13.4 ppm. The formulated product
is thus considered slightly to highly toxic to aquatic invertebrates. The guideline for the .technical end
product.(TEP) is fulfilled (MRIDs 40098001, 00041339). '.. , ,
(4) Freshwater Invertebrate, Chronic
No chronic aquatic invertebrate toxicity data are available for propachlor. -A comparison between
the 21-day EEC generated by PRZM/EXAMS (19.1 ppb for sorghum at 6.0 Ib ai/acre) and the most
toxic EC50 for aquatic invertebrates (790 ppb for Chironomus) gives a RQ equivalent of 0.024. This
does not trigger the need for any further chronic testing for aquatic invertebrates.
77
-------
(5) Estuarine and Marine Fish, Acute
Acute toxicity testing with estuarine/marine fish using the TGAI is required for propachlor because
the end-use product is expected to reach this environment because of its use in coastal counties.
Because propachlor is registered for use on sorghum and corn, two crops associated with estuarine
and marine environments, the 72-3a guideline is required. Since no studies were submitted, the 72-3a
guideline requirement is not fulfilled.
(6) Estuarine and Marine Fish, Chronic
Although propachlor may be expected to reach estuarine or marine environments due to its use
on com and sorghum, the need for an estuarine/marine fish early life-stage study is deferred until the
results of an acute study, 72-3a, are submitted.
(7) Estuarine and Marine Invertebrates, Acute
Acute toxicity testing with estuarine/marine invertebrates using the TGAI is required for
propachlor because the end-use product is expected to reach this environment because of its use in
coastal counties. The preferred test species are mysid shrimp and eastern oyster. Because propachlor
is registered for use on sorghum and corn, two crops associated with estuarine and marine
environments) the 72-3b and 72-3c guideline is required. Since no studies were submitted, the 72-3 b
and 72-3c guideline requirements are not fulfilled..
(8) Estuarine and Marine Invertebrates, Chronic
Although propachlor may be expected to reach estuarine and marine environments due to its use
on com and sorghum, the need for an estuarine/marine invertebrate life cycle study is deferred until
the results of an acute study are submitted. No data have been submitted for these studies and the
guideline requirements are not fulfilled.
c. Toxicity to Plants
(1) Terrestrial
Terrestrial plant testing (seedling emergence and vegetative vigor) is required for herbicides that
have terrestrial non-residential outdoor use patterns and that may move off the application site
through volatilization (vapor pressure >1.0 x 10'5mm Hg at 25°C) or drift (aerial or irrigation) and/or
that may have endangered or threatened plant species associated with the application site.
For seedling emergence and vegetative vigor testing the following plant species and groups should
be tested: (1) six species of at least four dicotyledonous families, one species of which is soybean
(Glycine max) and the second is a root crop, and (2) four species of at least two monocotyledonous
families, one of which is corn (Zea mays).
.78
-------
Terrestrial Tier II studies are required for all low dose herbicides (those with the maximum use
rate of 0.5 Ibs ai/A or less) and any pesticide showing a negative response equal to or greater-than
25% in Tier I tests. These studies are intended to measure the response of plants,-relative to a control,
and,five or more test concentrations. In the case of propachlor,' only Tier II studies were submitted
and reviewed. Results from these toxicity tests on the technical/TEP material are tabulated below.
Table 29: Nontarget Terrestrial Plant Seedling Emergence Toxicity (Tier II)
Species
Monocot- Corn
Monocot-oats
Monocot- ryegrass
Monocot- onion
Dicot-lettuce '
Dicot- Soybean
Dicot- radish •
Dicot-tomato
Dicot- cucumber
Dicot- cabbage
%ai
97.1
97.1
97.1
97.1
97.1
97.1
97.1
97.1
97.1
97.1
*EC25
(lbs.aX/A)
>6.0
0.08
0.021
1.8
0.07 ,
6.2
6.1
0.7
0.13
1.1
1 Affected
Endpoints
ND1
Dry weight
Dry weight
Dry weight
Plant height
Plant height
Dry weight
Dry weight
Dry weight
Dry weight
MRIDNo.
Author/Year
424857-05
Chetram(1992)
11
11
II
tt
II
„•.'
II -
II
H -
Study Classification
Core
Core
Core
Core '.','•
Core
, Core
Core
Core
Core
Core
1) Not determined
For Tier II seedling emergence, lettuce is the most sensitive dicot (EC25 = 0,07 Ibs ai/A) and
ryerass is the most sensitive monocot (EC25 = 0.021 Ibs ai/A). The guideline (123-1) is fulfilled
(MRID 424857-05). , "-'..'
Table 30: Nontarget Terrestrial Plant Vegetative Vigor Toxicity (Tier II)
i, ~> f •> ^
Species
Monocot- Corn
Monocot-Onion
Dicot- Cabbage ;
Monocot-Oat
Dicot-Radish
Dicot- Soybean
Monocot- Ryegrass
%ai
97.1
97.1
97.1
97.1
97.1
97.1
97.1
EC25
libs. a.i/A)
6.0
>6.0
>6.0
2.0
>6.0
>6.0
0.059
Affected
Endpoints
ND1
ND
ND
ND
Plant height
ND
Dry weight
MRIDNo.
Author/Year
424857-06
Chetram (1992)
II
n
11
II
II
»'
Study
Classification
Core
Core
Core .
Core
Core
Core
Core
79
-------
Table 30; Nontarget Terrestrial Plant Vegetative Vigor Toxicity (Tier II)
Species
Dicot-lettuce
Dicot- tomato
Dicot- cucumber
% ai
97.1
97.1
97.1
EC25
(Ibs.a.i/A)
0.59
0.49
>6.0
Affected . ;
Endpoints
Dry weight
Dry weight
ND
MRIDNo.
Author/Year
ti
It
•„
Study
Classification
Core
Core
Core
1) Not determined
For Tier II vegetative vigor, tomato appears to be the most sensitive dicot (EC25 = 0.49 Ibs ai/A)
and ryegrass is the most sensitive monocot (EC25 = 0.059 Ibs ai/A). The guideline (123-1) is fulfilled.
(MRID #424857-06).
(2) Aquatic Plants
Aquatic plant studies (tier II) are required for propachlor because its outdoor terrestrial uses may
result in runoff to aquatic areas. The following species should be tested at Tier II: Kirchneria
subcapitata (Selenastrum capricornutum), Lemna gibba, Skeletonema costatum, Anabaena flos-aquae,
and a freshwater diatom.
Table 31: Nontarget Aquatic Plant Toxicity (Tier II)
Species
Green algae
Kircheria subcapitata
%ai :
97.9
EC50/
EC05 (ppb)
13.5(EC05)
MRIDNo.
Author/Year
425847-03
Hughes (1992)
Study Classification
Core
The Tier II results indicate that the EC50 of propachlor to green algae (Kircheria subcapitata), non-
vascular aquatic plant is 13.5 ppb. However, testing on the other four species of aquatic plants has
not been submitted. Therefore, the guideline requirement (123-2) is partially fulfilled (MRID
#425847-03).
Aquatic plant data on technical propachlor are outstanding for four additional species: Lemna
gibba, Skeletonema costatum, Anabaena flos-aquae, and a freshwater diatom.
For Tier II seedling emergence on nontarget terrestrial plants, lettuce is the most sensitive dicot
(EC2S = 0.07 Ib ai/acre) and ryegrass is the most sensitive monocot (EC25 = 0.021 Ib ai/acre). For
Tier II vegetative vigor, tomato appears to be the most sensitive dicot (EQs := 0.49 Ib ai/acre) and
ryegrass isthe most sensitive monocot (EC25 = 0.059 Ib ai/acre). The guideline (123-1) for Tier II
seedling emergence and vegetative vigor is fulfilled (MRIDs 424857-05 and -06). The Tier II results
for aquatic plants indicate that the EC50 of propachlor to Kircheria subcapitata, a non-vascular aquatic
plant, is 13.5 ppb. The guideline (123-2) is partially fulfilled (MRID #425847-03). Testing on four
other species of aquatic plants has not been fulfilled.
80
-------
3. Environmental Fate Characteristics
Exposure Characterization
, While highly mobile, propachlor is not expected to persist substantially on the soil surface under
most conditions (aerobic soil metabolism half-life of <3 days; 50% field dissipation,rates, of 1 to 6
days). The major dissipation routes are aerobic soil metabolism and, in the absence of an active
microbiai population, leaching. Propachlor may be more persistent under low moisture conditions,
in soils with low microbiai activity, or under anaerobic conditions. Mobility will be influenced by
climate (especially rainfall) and crop management factors that influence leaching and runoff. Because
of its high solubility and low affinity for adsorption, propachlor is likely to dissipate rapidly from plant
and soil surfaces. '
Rropachlor has three major degradates ~ propachlor oxanilic acid, propachlor sulfinylacetic acid,
and propachlor sulfonic acid (the analog of this degradate for alachlor and acetochlor is referred to
as ESA) — that appear to be persistent and very mobile. These three degradates have carboxylic or
sulfonic acid functional groups, which render a negative (anionic) character to the molecules under
normal environmental conditions. These degradates have a high mobility in soils and, based on
laboratory aerobic soil metabolism and terrestrial field dissipation studies, appear to persist much
longer than the. parent compound. All three degradates were detected through the lowest soil depth
interval sampled in the field dissipation studies.
Propachlor is expected to be highly mobile because of its low affinity to adsorb to soil. Microbiai
degradation under most conditions substantially reduces the potential for propachlor to reach ground
water or surface water. However, detections of propachlor and/or its degradates have been reported
(0.02-3.5 ppb),in some wells, suggesting that the chemical or its degradates may reach ground water
under some conditions. Propachlor is most likely to reach ground water in soils which have little •
microbiological activity, high permeability, and a shallow water table. If leaching rainfalls occur
shortly after application, propachlor may move to subsurface soil layers where microbiai populations
are lower, resulting hi an increase in persistence. Propachlor is likely to be more persistent under
anaerobic conditions common to ground water. While the potential propachlor use area would
encompass highly vunerable ground-water areas of the Dehnarva penisula, eastern coastal plain, and
Florida, .current use is minimal in these areas. Small, localized areas vunerable to ground-water
contamination still may occur within the major propachlor use area.
Propachlor would most likely contaminate surface water if runoff-producing rain events occur
within the first few days to weeks after application. Propachlor's low soil/water partitioning and high
solubility suggest it will primarily be dissolved in runoff water and in the water body. Areas with the
highest vulnerability to runoff, and thus 'the highest potential for propachlor contamination in surface
waters, include the Gulf Coast region of Texas, the lower Mississippi River Valley, the'Missouri River
Valley in South Dakota, the extreme eastern coastal plain of Georgia, South Carolina, and North
Carolina, and portions of the Ohio River Valley. Except for the Missouri River Valley, propachlor
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is not currently used extensively in these highly vunerable areas. However, localized areas of highly
vunerable soils and watersheds may occur in major propachlor use areas.
Once it reaches surface water, the fate of propachlor is uncertain. Soil metabolism studies
suggest a susceptibility to biodegradation; the persistence of propachlor in surface waters with high
microbiological activities may therefore be limited. However, the extent of metabolic degradation
in water is uncertain because of an absence of aerobic aquatic metabolism data. For this reason,
model predictions of estimated environmental concentrations (EECs) in aquatic environments
assumed that propachlor was more stable than the observed half-life from the aerobic soil metabolism
study.
The three major acid degradates appear to be very mobile and persistent. Based upon limited fate
data, these degradates appear to be available for runoff longer than the parent propachlor, moving
primarily by dissolution hi runoff water. Furthermore, these degradates have characteristics of
chemicals that are known to leach to ground water. The reported- detections of propachlor in surface
and ground waters may be all or in part due to the presence of these persistent degradates.
Data Gaps and Uncertainties in the Exposure Assessment:
The persistence characterization of propachlor is based largely on the results of one aerobic soil
metabolism study, which showed a non-first order dissipation pattern. The model from which the t1/2
was derived overestimates initial dissipation but underestimates long-term dissipation. A single study
is not adequate to determine whether a biphasic dissipation pattern is typical for propachlor. EFED
is requesting additional aerobic soil metabolism data to better characterize the dissipation pattern and
rate for propachlor in aerobic soils.
While soil studies indicate that metabolism is a major mode of dissipation, such data is not
available for aerobic aquatic conditions. Since propachlor may reach surface waters under certain
conditions, an aerobic aquatic metabolism study is required to better characterize the fate of
propachlor in such environments.
The additional studies are needed to reduce the degree of uncertainty in the environmental fate
characterization of propachlor. A decision on pursuing further water monitoring studies would be
deferred pending the results of these metabolism studies.
a. Degradation
Propachlor is a soluble molecule (613 ppm in water at 25°C), with an octanol/water partition
coefficient of 201, and a vapor pressure of 7.9xlO"5 mm Hg. Propachlor was stable in aqueous
buffered solutions at pH's 5,7, and 9 in the dark. It did not photodegrade significantly in water when
exposed to natural sunlight for 30 days. Photolysis in soil does not appear to be an important
degradation pathway. In a supplemental soil photolysis study, propachlor degraded faster in the dark
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control than in the irradiated samples. The differences may have been due to,differences in moisture
between the irradiated and the dark samples.
161-1 Hvdrolvsis •fMRID#4248S701)
This study is acceptable and can be used to satisfy the Hydrolysis data requirement. No additional
data are required. ;
[14C]-Propachlor, at 9.4-10.0 ppm, did not hydrolyze in sterile aqueous pH 5, 7, and 9 buffer
solutions that were incubated at 20.0-25.5°C in the dark for 30 days. , ' '
161-2 Photolysis in Water (MRID# 4252740 n
This study is acceptable and-can be used to satisfy the Photolysis in Water data requirement. No
additional data are required.
[14C]-Propachlor, at 10.93 ppm, did not photodegrade significantly in sterile aqueous pH 7 buffered
solution that was irradiated with natural sunlight for 30 days at 22.1-28.3 °C. At 30 days
posttreatment, propachlor comprised 89.0-92.1% in the irradiated sample and 91.5-92.2% in the dark
control.
161-3 Photolysis on Soil fMRID# 42527402) ,
This study provides supplemental information about the photodegradation of propachlor on soil.
The study does not fulfill the data requirement because the degradation of propachlor in the dark
control was faster than in the irradiated samples. In addition, the results of the dark control do not
agree with the aerobic soil metabolism study. Since the absorption spectrum of propachlor shows •
no significant peaks above 290 nm and the aqueous photolysis study shows little or no photolysis
during the 30 days irradiation, the Agency-believes that photolysis on soil does not constitute an
important route of degradation for propachlor. No additional data are required at this time.
[14C]-Propachlor, at 6.51 Ib a.i./A, degraded slowly, with an estimated half-life of 57 days on sandy
loam soil incubated in natural sunlight at 18.7-3i.7°C for 30 days.. In contrast, [14C]-propachlor
degraded with a calculated half-life of 19.2 days in a dark control. The degradate, 2-hydroxy-N-(l-
methylethyl)-N-phenylacetamide (hydroxypropachlor), was observed hi both the irradiated and dark
control samples at 4.3% of the applied during the course of the study.
b. Metabolism
Aerobic soil metabolism is the most important degradation route for propachlor. In a sandy loam soil,
propachlor degraded with a fitted half-life (t1/2) of approximately 2.7 days, calculated using the
Gustafson and Holden (1990) model to fit the data. The data show a biphasic degradation pattern
that is not well-represented by a first-order degradation .model.' The fitted model appears to
•••••' 83' ' .
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overestimate the rate of degradation in the initial days, but underestimates long-term degradation.
The observed 50% dissipation time (DT50) was 5 days. A single study is not adequate to characterize
the aerobic soil metabolism of propachlor. Additional studies would show whether the biphasic
pattern is typical for propachlor or is an exception. In addition, the slow degradation noted in the soil
photolysis study may suggest that propachlor is more persistent under certain conditions.
Two major degradates were observed. Propachlor oxanilic acid was a maximum average of 33% of
the applied at 1 month and remained at 29% after 12 months, Propachlor sulfonic acid was a
maximum average of 19% of the applied at 1 month and remained at 14% after 12 months. Other
metabolites were identified but comprised <10% of the applied at all test intervals.
Under anaerobic conditions, propachlor degraded slowly from a clay loam sediment; lake water
system. The calculated half life under the testing conditions was 4.9 months (146-days).
Hydroxypropachlor was the major degradate observed, which increased steadily to a maximum
average of 37% of the applied 9 months after treatment.
162-1 Aerobic Soil Metabolism CMRID# 42962502)
This study is acceptable and can be used to satisfy the Aerobic Soil Metabolism data requirement.
[14C]-Propachlor, at 6.0 ppm, degraded with a calculated non-linear regression t]/2 of 2.7 days, in a
sandy loam soil incubated in the dark at 24.0-26.0 °C. The observed DT50 was 5 days. Propachlor
was 94.6-99.6% of the applied immediately posttreatment, 50.1-55.1% of the applied at day 5
posttreatment, and 1.3% of the applied after 365 days incubation. Two major degradates were
observed:
[(l-methylethyl)phenylamino]oxoacetic acid (propachlor oxanilic acid), which increased to a
maximum average of 33.3% of the applied at 1 month posttreatment, and stayed approximately
at that level throughout the rest of the study (it averaged 29.0% of the applied at 12 months).
2-[(l-methylemyl)phenylamino]-2-oxoethanesulfonic acid (propachlor sulfonic acid), which
increased to a maximum average of 19.1% of the applied at 1 month; it averaged 12.1% of the
applied at all the remaining test interval; at 12 months posttreatment it averaged 14.2% of the
applied. .
Various minor degradates were observed:
(([(l-methylethyl)phenylamino]acetyl)sulfinyl)acetic acid (propachlor sulfinylacetic acid), which
was observed at low levels all throughout the study, with a maximum average of 6.7% of the
applied at 1 month after treatment
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2-hydroxy-N-(l-methylethyl)-N-phenylacetamide(hydroxypropachlor), which was observed at
low levels all throughout the study, with a maximum average of 6.0% of the applied on day 5 after
treatment. , , ,
N-(l-methyle1hyl)-2-(memylsulfonyl)-N-phenylacetaniide (propachlor methyl sulfone), which was
observed at low levels all throughout the study, with a maximum average of 3.2% of the applied
at 4 months after treatment.
N-(l-methylethyl)-N-phenylacetamide (norchlpropropachlor), which was observed at low levels
all'throughout the study (average 1.2% of the applied).
After 12 months of incubation 9.5-10.6% of the applied radioactivity was recovered in the NaOH
traps (corresponding to 14CO2). <21.4% of the applied was unextfactable radioactivity.
162-2 Anaerobic Soil Metabolism (MRID# 42962503^
This study is acceptable and can be used to-satisfy the Anaerobic Soil Metabolism data
requirement. No additional data are required.
[14C]Propachlor, at 5.9 ppm, degraded slowly, with a registrant-calculated half-life of 146 days (4.9
months) for a lake water-sediment system incubated under anaerobic conditions in the dark at 24-
26°C for 12 months. [14C]Propachlor averaged 98.1% of the applied on day 0, it averaged 60.6%
of the applied 4 months after treatment, and it averaged 20.2% of the applied 12 months after
treatment. The major degradate observed was:
,. 2-hydroxy-N-(l-methylethyl)-N-phenylacetamide (propachlor alcohol), which increased steadily
to a maximum average of 37.3% of the applied 9 months after treatment. .
Several minor degradates were detected sporadically and quantified.
c. Mobility/Leachability
Propachlor and its oxanilic acid and sulfonic acid degradates are very mobile. While the parent
degraded relatively quickly under aerobic soil metabolism, the degradates appear to be more
persistent and may leach substantially under normal conditions:
163-1 Mobility - Column Leaching (MRID# 00087854^ -"..-.
This study had been previously reviewed and the portion related to parent propachlor was found
to be acceptable. This study provides useful information about the mobility of parent propachlor.
Based on column leaching studies, [14C]-propachlor, at approximately 6 Ib a.i./A, was determined
to be very mobile, (>40% of the applied in leachate) in 30-cm columns of loamy sand, sandy loam, and
.85 / -
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silt loam soils, and mobile (approximately 5% in leachate) in columns of silty clay loam soil that were
leached with 20 inches of water. Increasing .mobility appeared to be correlated with decreasing soil
organic matter.
163-1 Mobility - Batch Equilibriumibr Parent Propachlor (MRID# 42485702')
This study is acceptable and can be used to partially satisfy the Mobility data requirement. The
study provides information about the mobility of parent propachlor. No additional information about
the mobility of parent propachlor are required.
Based on batch equilibrium studies, [14C]-Propachlor was determined to be very mobile in loamy
sand, sandy loam, loam, and silty clay loam soii:solution slurries (1:3) equilibrated in the dark for 24
hours at 25°C. Freundlich K^ and K^ values, and respective K^ values are summarized in the table
below:
Table 32: Adsorption-desorption values for Propachlor.
Soil type
loamy sand
sandy loam
loam
Soil type
silty clay
loam
average
%OC
0.40
1.79
1.11
%OC
0.61
N/A
K**
0.45
1.30
1.39
K^
0.84
1.00
KQC for adsorption
113
73
125
KQC for adsorption
138
112
Kdes .
4.36
4.12
5.49
Kde,
3i06
426
Koeibr desorptibn
1090
230
495 '
KQC for desorption
502
679
163-1 Mobility - Batch Equilibrium for Propachlor Oxanilic Acid TMRIDff 42485703)
This study is acceptable and can be used to partially satisfy the Mobility data requirement. The
study provides information about the mobility of one major degradate of propachlor, propachlor
oxanilic acid. No additional information about the mobility of propachlor oxanilic acid is required.
Based on batch equilibrium studies, [14C]-propachlor oxanilic acid was determined to be very
mobile in loamy sand, sandy loam, loam and silty clay loam soihsolution slurries equilibrated in the
dark for 24 hours at 25 °C. Freundlich K^ and K^ values, and respective KQC values are summarized
in the table below.
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Table 33: Adsorption-desorption values for Propfichlor Oxanilic Acid.
^Soiltype
loamy sand
sandy loam
loam
silly clay loam
average
%OC~' . , _
0.40
3.40
2.11
1.16
N/A
K,*
0.03
0.04
0.08
0.06
0.05
KOC for adsorption
8
2
7
10
7
Kde,
4.48
15.86
4.34
20.91
•V,
.11.40
KOC for
desorption
1120
886 .
391
3428 •
1456
163-1-Mobility - Batch Equilibrium for Propachlor Sulfonic Acid (MRID# 42485704)
This study is acceptable and can be used to partially satisfy the Mobility data requirement. The
study provides information about the mobility of one major degradate of propachlor, propachlor
sulfonic acid. No additional information about the mobility of propachlor sulfonic acid are required.
Based on batch equilibrium studies, [14C]-propachlor sulfonic acid was determined to be very
mobile in sand, sandy loam, loam, and silty clay loam soilcsolution slurries equilibrated in the dark for
24 hours at 25 °C. Freundlich K^ and Kdes, and respective KOC values are summarized in the table
below.
Table 34: Adsorption-desorption values for Propachlor Sulfonic Acid.
Soil type
sand
sandy loam
loam
silty clay loam
average
%©C
0.42
1.00
1.11
2.59
N/A
Kads
0:03
0.06
0.05
0.07
0.05
KOC for
adsorption
7
6
5 "
3
5
Kdes
1.33
6.24
1.73
1.23
2.63
KOC for
desorption
317
624
156
47'
286
d. Fate of Propachlor and its Degradates in the Field
The registrant submitted three Terrestrial Field Dissipation studies, conducted in Janesville, Iowa;
York, Nebraska; and Uvalde, Texas. At each of the three locations two plots were treated with
Ramrod® 4L and Ramrod® 20G. The studies were conducted on clayey to sandy loam surface soils
(full soil classification was not provided). The dissipation half-lives (DT50) observed for propachlor
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in the field were of the same order of magnitude as the half-life observed in the aerobic soil
metabolism study:
aerobic soil metabolism DT50=~5 days; t]/2 = 2.7 days
Janesville, Iowa DT50=1.0-1.7days
York, Nebraska DTso=5.0-5.8 days
Uvalde, Texas DT50=2.3-2.8 days
The range in values in the three field dissipation studies represent differences in the granular and
flowable formulations of propachlor. Differences in DT50 values between sites were greater than.
differences between formulations on the same site, suggesting that the site conditions have a greater
effect on dissipation than the formulation. Detections of propachlor were largely in the upper 0-6
inch soil layer in all the three sites. Some minor detections in lower soil depths were reported.
The degradates observed in the field at high concentrations were propachlor oxanilic acid,
propachlor sulfinylacetic acid, propachlor sulfonic acid, and hydroxypropachlor. Of these degradates.,
the first mree are acids that under normal environmental conditions are negatively charged and have
high mobility (as also evidenced hi the mobility studies). These degradates leached substantially,
especially in the Janesville, Iowa, and Uvalde, Texas sites; the degradates were observed as deep as
36-42 inch soil depth, which is the lowest soil depth interval tested In the York, Nebraska site, the
level of leaching was not as extensive as in the other two sites. All the acid metabolites appeared to
persist much more than the parent propachlor.
The degradate hydroxypropachlor, a minor degradate in the aerobic soil metabolism study but the
major degradate in the anaerobic soil metabolism study, was present at relatively high concentrations
in all three study sites; however, it did not persist long, with all detections observed generally on or
before day 30 after application. Hydroxypropachlor remained in the upper 0-6 inch soil depth.
Two minor degradates, norchloropropachlor and propachlor methylsulfone, were also detected.
Only norchloropropachlor reached relatively high levels (average 0.101-0.104 ppm) in the Uvalde,
Texas plot only. Norchloropropachlor was largely confined to the upper 0-6 inch soil depth.
Propachlor methylsulfone, although present at low levels, appeared to be more persistent and
somewhat mobile, with detections through 552 days in Janesville, Iowa; 120 days in York, Nebraska;
and 365 days in Uvalde, Texas.
164-1 Terrestrial Field Dissipation CMRID# 4352510n
This study is acceptable and can be used to satisfy the Terrestrial Field Dissipation data
requirement for propachlor. The study provides information about the dissipation of propachlor in
three sites (Iowa, Nebraska, Texas). It also provides information about the formation and decline of
three acid metabolites (propachlor oxanilic acid, propachlor sulfinylacetic acid, and propachlor
sulfonic acid) and three neutral metabolites (hydroxypropachlor, norchloropropachlor, and propachlor
methylsulfone) of propachlor. No additional information is required.
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Janesville. Iowa . , , . ,
Propachlor (Ramrod® 4L and Ramrod® 20G), applied once at 6 Ib a.i./A, dissipated with a
registrant-calcvilated DT50 of 1.0-1.7 days and DT90 of 6.8-8.8 days from a bareground plot of loamy
sand soil in Janesyille, Iowa. In the 0-6 inch soil depth of the plot treated with Ramrod® 4L,
propachlor averaged a maximum of 2.402 ppm on day 3 after application,, 1.729 ppm on day 7, and
0.359 on day 14 after application. In the 0-6 inch soil depth of the plot treated'with Ramrod® 20G,
propachlor averaged a maximum of 2.031 ppm on day 0,1.246 ppm on day 3, and 0.135 ppm on day
14 after application. Propachlor remained in the upper 0-6 inch soil layer.
, ;' * ''
The degradates monitored in the field were as follows: .
Propachlor oxanilic acid, which was a maximum of 0.525 and 0.308 ppm at 14 days after
application hi the plot treated with Ramrod® 4L and Ramrod® 20G, respectively. This degradate
was observed as deep as 36-42 inch soil depth (the lowest depth interval tested, on day 61 after
application) for the plot treated with Ramrod® 4L, and 30-36 inch soil depth (day 61 and 125 after
application) for the plot treated with Ramrod® 20G. Detections were reported through day 180 after
application. .' ' . . ;
Propachlor sulfinylacetic acid, which was a maximum of 0.169 and 0.130 ppm at 14 days after
application in the plots treated with Ramrod® 4L, and Ramrod®20G, respectively. This degradate
leached as deep as 36-42 inch soil depth, with a detection averaging 0.012 ppm on day 180 after
application in the plot treated with Ramrod® 20G- The majority of the detections occurred prior to
or on day 61 after application.
Propachlor sulfonic acid averaged a maximum of 0.230 arid 0.150 ppm on day 14 after application
in the plot treated with Ramrod® 4L and Ramrod® 20G, respectively. It appears that substantial
leaching occurred between the day 14 and 21 after application in both plots. On day 21 after
application, this degradate averaged 0.153 and 0.141 ppm in the 6-12 inch soil depth in the plots
treated with Ramrod® 4L and Ramrod® 20G, respectively. Detections of propachlor sulfonic acid
were reported as deep as 36-42 inch soil depth (the lowest depth interval tested) on day 61 after
application in both plots, treated with Ramrod® 4L and Ramrod® 20G. Detections appear to be
consistent through .day 61 after application for the plot treated with Ramrod® 4L and through day
125 for the plot treated with Ramrod® 20G, ' :
The neutral degradate observed at high concentrations was hydroxypropachlor, -which was a
maximum of 0.351 arid 0.201 ppm on day 3 after application in the plots treated with Ramrod® 4L
and Ramrod® 20G, respectively. Hydroxy-propachlor reinained in the 0-6 inch soil depth. The last
detection of this degradate occurred on day 30 and 180 days after application for both plots treated
with Ramrod® 4L and Ramrod® 20G, respectively. , ,
Norchloropropachlor and propachlor methylsulfone reached relatively low values through the
study ( 0.053 ppm). Norchloropropachlor remained in the upper 0-6 inch soil depth. Detections of
89 .'••'.
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methylsulfone were reported in the 12-18 inch soil depth on days 180, 364, and 552 after application,
averaging 0.010-0.011 ppm.
York. Nebraska
Propachlor (Ramrod® 4L and Ramrod® 20G), applied once at 6 Ib a.i./A, dissipated with a
registrant-calculated DT50 of 5.0-5.8 days and DT90 of 16.5-19.1 days from a bareground plot of a
loam soil in York, Nebraska. In the 0-6 inch soil depth of the plot treated with Ramrod® 4L,
prdpachlor averaged a maximum of 2.078 ppm on day 3 after application, 1.134 ppm on day 7 after
application, and 0.145 ppm on day 14 after application. In the 0-6 inch soil depth of the plot treated.
with Ramrod® 20G, propachlor averaged a maximum of 2.314 ppm on day 3 after application, 1.744
ppm on day 7 after application, and 0.145 ppm after application.
Propachlor remained largely in the upper 0-6 inch soil layer. One detection was reported in the
6-12 inch soil layer in the plot treated with Ramrod® 4L (average 0.048 ppm, day 1 after
application). In the plot treated with Ramrod® 20G, detections were reported in the 6-12 inch soil
depth from day 0 to day 14 after treatment (0.010-0.046 ppm), and one detection in the 12-18 inch
soil depth on day 14 after application (average 0.021 ppm).
The following degradates were monitored in the soil:
Propachlor oxanilic acid was the degradate present at highest concentrations in the soil. It was
a maximum of 0.295 and 0.472 ppm on day 21 after application in the fields treated with Ramrod®
4L and Ramrod®20G, respectively. The degradate remained largely in the 0-6 inch soil depth for
both plots. Detections were observed through day 120 after application in both plots.
Propachlor sulfinylacetic acid reached a maximum average of 0.130 ppm on day 14 after
application in the plot treated with Ramrod® 4L and 0.188 ppm on day 21 after application in the
plot treated with Ramrod® 20G. The degradate remained largely in the 0-6 inch soil depth for both
plots. Detections were observed through day 60 after application.
Propachlor sulfonic acid reached a maximum average of 0.178 ppm on day 30 after application
in the plot treated with Ramrod® 4L and 0.302 ppm on day 21 after application in the plot treated
with Ramrod® 20G. In the plot treated with Ramrod® 4L, the sulfonate remained largely in the 0-6
inch soil depth; detections were reported through 365 days after application. In the plot treated with
Ramrod® 20G, there were various observations of the sulfonate in the 6-12 inch soil depth through
365 days after application and there was one observation in the 12-18 soil depth (average 0.015 ppm
on day 21 after application).
Hydroxypropachlor was a maximum average of 0.160 ppm on day 3 after application in the plot
treated with Ramrod® 4L; it was a maximum average of 0.177 ppm on day 7 after application in the
' plot treated with Ramrod® 20G. In both plots, it appears that the degradate was not very persistent,
90
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with detections reported through 30 days after application. In all cases, hydroxypropachlor stayed
in the upper 0-6 inch soil layer.
Norchloropropachlor and propachlor methylsulfone were present at relatively low levels (average
0.078 ppm) through the study in both plots. Norchloropropachlor was detected through day 30
after application and methylsulfone was detected through day 120 after application. All detections
occurred in the upper 0-6 inch soil depth. ,
Uvalde. Texas
Propachlor (Ramrod® 4L and Ramrod® 20G), applied once at 6 Ib a.i./A, dissipated with
registrant calculated DT50 of 2.3-2.8' days and DT90 of 7.6-9.1 days from a bareground plot of clay
soil in Uvaide, Texas. In both plots, treated with Rarnrod® 4L and Ramrod® 20G, propachlor was
a maximum on day 0 .after application (averages of 2.130 and 3.038 ppm, respectively). By day 8
after application, the level of propachlor had decreased substantially (0.062 and 0.417 ppm).
Propachlor remained in the upper 0-6 inch soil layer in both plots, treated with. Ramrod® 4L and
Ramrod® 20G.
• ' ' * " ' \
The following degradates were monitored in the soil:
*• ' '" . ,,."..'
Propachlor oxanilic acid reached a maximum average of 0.452 and 0.668 ppm on day 8 after
application in the plots treated with Ramrod® 4L and Ramrod® 20G, respectively. Most detections
occurred prior to or on day 62 after application. Detections were observed to a depth of 24-30 inch
(with a reported average of 0.013 ppm on day 16 after application in the plot treated with Ramrod®
20G). '...'•• -
Propachlor sulfinylacetic acid was a maximum average of 0.148 and 0.201 ppm on day 8 after
application, in the plot treated with Ramrod® 4L and Ramrod® 20G, respectively. Detections of this
degradate were observed through 62 days after application in both plots. Various detections were
reported in the 6-12 inch soil layers, and one minor detection averaging 0.012 ppm was observed in
the 12-18 inch soil depth on day 16 after application in the plot treated with Ramrod® 20G.
Propachlor sulfonic acid was a maximum average of 0.326 and 0.416 ppm on day 8 after
application for the plots treated with Ramrod® 4L and Ramrod® 20G, respectively; Various
detections were reported in the 6-12, 12-18, and 18-24 inch soil layers. In the plot treated with
Ramrod® 20G, detections in the 24-30 inch were reported on days 16 and 62 days after application.
Additionally on day 62 after application, a minor detection averaging 0.014 ppm was reported in the
30-36 inch soil depth in the plot treated with Ramrod® 20G. The majority of the detections were
observed prior to, or oh day 62 after application. ,
Hydroxypropachlor was a maximum average of 0.206 ppm on day 0 after application in the plot
treated with Ramrod® 4L; it was a maximum average of 0.180,ppm on day 3 after application in the :
plot treated with Ramrod® 20G. All the detections of hydroxypropachlor were confined to the upper
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0-6 inch soil layer in both plots. All detections on day 16 after application and thereafter were 0.023
ppm.
Norchloropropachlor was a maximum on day 8 after application for both plots , treated with
Ramrod® 4L and Ramrod® 20G, with averages of 0.104 and 0.101 ppm, respectively.
Norchloropropachlor was largely confined to the upper 0-6 inch; however, detections averaging
0.019 ppm were reported on days 16 and 31 in the 6-12 inch layer of the plot treated with Ramrod®
4L, and on day 8 (12-18 inch soil layer) and 16 (6-12 inch soil layer) of the plot treated with
Ramrod® 20G.
Propachlor methylsulfone was 0.046 ppm at all test intervals and was observed in the 0-6 and
6-12 inch soil layer through day 365 after application.
• e. Bioaccumulation
The octanol/water partition coefficient of 201 for propachlor predicts a slight potential for
bioaccumulation. The laboratory results indicate a low bioaccumulation potential. Maximum
bioconcentration factors for propachlor residues in bluegill sunfish were 13X for edible tissues, 7IX
for nonedible tissues, and 37X for whole fish. Depuration was fast (84% of the accumulated residues
were released into water by day 3). The 14C residues contained the cysteine and mercapruric acid
conjugates of propachlor.
165-4 Bioaccumulation in Fish fMRIPff 42711801)
This study is acceptable and can be used to satisfy the Bioaccumulation in Fish data requirement.
No additional data are required.
Propachlor residues accumulated in bluegill sunfish that were continuously exposed to [14C]-
propachlor, at 14 ^g/L. The maximum bioconcentration factors observed were 13X for edible
tissues, 71X for nonedible tissues, and 37X for the whole fish. By day 3 of the depuration period,
84% of the accumulated residues had been eliminated from the whole fish. Two major propachlor
degradates were identified in the edible and nonedible tissues:
Cysteine conjugate was 47.7-64.9% of the [14C] residues in the edible tissue, and 24.9-29.6% of
the recovered in the nonedible tissues.
Mercapturic acid conjugate was 6.2-7.2% of the [14C] residues in the edible tissue, and 59.5-
62.3% of the [14C] residues recovered in the nonedible fish tissues. -
f. Spray Drift
The labels indicate that propachlor may be applied by ground spray boorn equipment but not
aerially. No propachlor-specific ground spray drift studies were reviewed. The Spray Drift Task
92
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Force (SDTF), a consortium of pesticide registrants, has completed and submitted to, the Agency a
series of studies which are intended to characterize spray drift potential due to various factors,
including application methods, application equipment, meteorological conditions, crop geometry, and
droplet characteristics. EPA is evaluating these studies, which include ground spray as well as aerial
. application methods. After its review of the studies, the Agency will determine whether a reassess-
ment of the potential risks from the application of propachlbr to nontarget organisms is warranted.
4. Water Resource Assessment
a. Surface Water Assessment
Propachlor can contaminate surface water via runoff if runoff-producing rain events occur within
the first few days to weeks post application. A very low soil/water partitioning of prbpachlor .
'(Ka^O.45-1.39), and its solubility in water (613 ppm) suggest that propachlor will primarily move
via dissolution in runoff water (as opposed to adsorption, to eroding soil). It appears that the
persistence of prbpachlor in surface waters with high microbiological activities may be limited by its
susceptibility to biodegradation. In Waters with short hydrological residence times, its persistence
is limited by flow out of the system. However, its resistance to abiotic hydrolysis and photolysis,
coupled with its low volatilization potential (vapor pressure 7.9xiO~5 mm Hg, calculated Henry's law
constant 3.59xlO"8 atm nrVmol) should make it more persistent in waters with low microbiological
activities and long hydrological residence times (e.g., lakes and reservoirs).
'.''.-'. •..
Surface water monitoring data collected and reported to the STORET system on the occurrence
of propachlor between 1978 and-1997 indicates its presence in surface water in association with
known use areas. Concentrations above the LOQ were reported for approximately 295 samples; the
maximum being 10 ppb. More than 16,000 samples were reported as either below the LOQ ,(ca. 95,
percent of samples) or below the LOD (ca. 5 percent of samples). The LOQs ranged from 0.001 to
1.3 ppb and LODs ranged from 0.002, to 0.5 ppb. Sample locations were dominated by streams,
lakes, and reservoirs. No association with drinking water intakes could be confirmed for the sample
sets.
The data collected on the occurrence of propachlor in surface water may represent both the parent
and its degradates. The analytical procedures used in several of the studies, where the authors could
be contacted, indicated that it wasn't possible to distinguish between the parent and several of the
more mobile1 and structurally similar degradates or the results were reported as both the parent and
known degradates. Therefore, it is possible that concentrations reported to STORET include both
the parent and/or several of the related degradates.
', - ' . f '• ' . : ' ' - ' •
The major acid degradates of propachlor in the aerobic soil metabolism study were propachlor
oxanilic acid, propachlor sulfonic acid, and propachlor sulfinylacetic acid. Even though complete data
are not available to fully assess the fate of such degradates, based on the low adsorption coefficient
for propachlor oxanilic acid and propachlor sulfonic acid (K^ 0.08), it appears that such degradates
are only weakly adsorbed to soil surfaces. Based on the results of the aerobic soil metabolism and
93 ! . -
-------
the terrestrial field dissipation studies, it appears that these major degradates may be available for
runoff longer than parent propachlor and will probably runoff primarily by dissolution in runoff water.
Available metabolism studies suggest that these degradates may also persist longer in surface waters
as well.
b. Ground Water Assessment
Based on the laboratory and field studies conducted, it appears that the parent propachlor does
not pose a significant threat to ground-water quality under most conditions. The chemical has a high
mobility (5^=0.45-1.39) but is susceptible to aerobic soil metabolism (t1/2 <3 days; DTSO ~5 days).
The terrestrial field dissipation studies also suggest that propachlor does not persist long enough to
exhibit substantial leaching (DT50 1-7 days). However, the three acidic degradates have a high
potential to leach to and persist in ground water.
Ground-water monitoring data collected and reported to the STORET system on the occurrence
of propachlor between 1980 and 1997 indicates its presence in ground water in association with
known use areas. Concentrations above the level of quantification were reported for 10 samples; the
maximum being 0.17 ppb. More than 7500 samples were collected and reported to STORET as either
below the level of quantification (LOQ) which ranged from 0.004-0.4 ug/L (ca. 75 percent of 7500
samples) or below the level of detection (LOD) which ranged from 0.004-0.012 ug/L (ca. 25 percent
of 7500 samples). A substantial number of the samples could not be correlated with time of
application and, in some instances, it could not be Confirmed that sampling occurred in known use
areas.
The data collected on the occurrence of propachlor in ground water may represent both the parent
and its degradates. The analytical procedures used in several of the studies, where the authors could
be contacted, indicated that it wasn't possible to distinguish between the parent and several of the
more mobile and structurally similar degradates or the results were reported as both the parent and
known degradates. Therefore, it is possible that concentrations reported to STORET include both
the parent and/or several of the closely related degradates.
Interpretation of STORET ground water monitoring data and perhaps the Pesticide in Ground
Water Database data may be complicated by the presence of closely related parent metabolites.
Degradates such as hydroxypropachlor, propachlor oxanilic acid, and propachlor sulfonic acid may
have been detected and reported as propachlor due to the limitations of the analytical methods or, in
the case of STORET data, a lack of an appropriate input parameter value for data storage.
Additionally, metabolites of propachlor tend to be more persistent and mobile which may explain the
presence of propachlor hi ground water if the method or lack of parameter values results in the
metabolite being reported as the parent.
Ground-water monitoring data from the EPA's Pesticides in Ground Water Database reported
samples collected over 6 years in 11 states representing 2718 samples. Concentrations above the LOD
were reported hi 33 of the wells in 5 states as 0.02 to 3.5 ppb. Positive results were obtained in
94
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several of the major corn and sorghum growing regions. As indicated above, the uncertainty of the
reported values as parent, parent and degradate, or degradate applies to these data as well.
Three acidic degradates of propachlor (propachlor oxanilic acid, propachlor sulfonic acid and
propachlor sulfinyl acetic acid) were observed both in the aerobic soil metabolism and the terrestrial
field dissipation studies. In the laboratory, under aerobic soil metabolism conditions, it appeared that
propachlor oxanilic acid and propachlor sulfonic acid were persistent. In the field, the three
degradates appeared to persist and leach substantially (to a 36-42 inch soil depth).
c. Aquatic Exposure Assessment
Preliminary aquatic EECs are estimated using GENEEC, a screening model that provides an
upper-bound estimate of EECs on a high exposure site. The GENEEC program uses basic
environmental fate values (adsorption to soil, degradation in soil before runoff and in water) and
pesticide label information (rates, .intervals, incorporation, method of application) to estimate the
EECs in a one-hectare, two-meter .deep pond following the treatment of a 10 hectare field. The
runoff event occurs two days after the last application. The model accounts for direct deposition of
spray drift onto the water body (assuming 5% of the application rate for aerial spray applications and
1% for ground spray applications). When risk quotients (RQs) for aquatic organisms are exceeded,
refined aquatic EECs are calculated using PRZM/EXAMS. /
Table 35: Environmental fate parameters used to predict propachlor EECs.
I *
Barameter
water solubility (ppm):
Koc: . . -
aerobic soil metabolism, tl/2:
hydrolysis tl/2, pH 7:
aerobic aquatic metabolism, tl/2
i
aqueous photolysis tl/2:
Value
613 ppm
112
8.1 days'
Stable
Not available
Stable >, :
'The calculated aerobic soilmetabolism half-life was 2.7 days. The value was multiplied by a factor of 3 to account for
variability with such studies and the absence of more than one study.
The Pesticide Root Zone Model (PRZM2.3) simulates pesticides in field runoff on daily time steps,
incorporating runoff, infiltration, erosion, and evapotranspiration. The model calculates foliar
dissipation and runoff, pesticide uptake by plants, microbial transformation, volatilization, and soil
dispersion and retardation. The Exposure Analysis Modeling System (EXAMS II) simulates pesticide
fate and transport in an aquatic environment (one hectare body of water, two meters deep).
95
-------
Table 36: Estimated Environmental Concentrations (EECs) For Aquatic Exposure from Aerial Application
on Selected Uses Using GENEEC and PRZM7EXAMS.
''Site
Application
Rate x No/
Interval (da)
- — Estimated Environmental Concentrations (EECs), ug/1
Peak
4-day
21-day ,
56/60-day
90-day
long-term avg
: \, •;' , TierlrGENEEC
Corn / Sorghum
3.0x1
6.0x1
101
202
100
201
99
199
97
193
„
__
_
.. : i • Tier 2: ERZM2.3/EXAM H 1 in lOyeafEBCs-
Com
Sorghum
6.0x1
6.0 x 1
44.0
64.0
35.6
46.7
16.3
19.1
6.4
7.6
4.3
5.1
0.5
0.6
5. Estimated Water Concentrations For Drinking Water
4
The estimated concentrations for drinking water provided below. They are for the parent
propachlor only.
a. Ground Water Sources
A preliminary ground water assessment was made using SCI-GROW to estimate the "maximum"
ground-water concentration from the application of a pesticide to crops. SCI-GROW is based on the
fate properties of the pesticide, the application rate, and the existing body of data from small-scale
ground-water monitoring studies. The model assumes that the pesticide is applied at its maximum rate
in areas where the ground water is particularly vulnerable to contamination. In most cases, a
considerable portion of any use area will have ground water that is less vulnerable to contamination
than the areas used to derive the SCI-GROW estimates. As such, the estimated "maximum"
concentration derived using SCI-GROW should be considered a high-end to bounding estimate of
"acute" exposure. The concentration for parent propachlor estimated using SCI-GROW is
approximately 0.03 ppb. The results of this model should be compared to available monitoring data
when determining the potential for human exposure.
b. Surface Water Sources
Tier II surface water drinking water EECs were calculated using PRZM 2.3 to simulate the
agricultural field and Exams II for fate and transport in surface water. Spray drift was simulated using
the assumption that 1% of applied propachlor reached surface water at the time of application and
95% of the chemical deposited on the target site. The remaining 4% either remained airborne or
deposited on the ground beyond the drainage basin for the pond.
The scenarios chosen for propachlor were a corn field in Pottawattamie County, Iowa and a
sorghum field hi Neosho County, Kansas. Scenarios were chosen to represent sites that were
96
-------
expected to produce runoff greater than 90% of the sites where the appropriate crop is grown. Model
simulations were made with the maximum application rate. Tier II one-in-ten year (upper tenth
percentile) EECs are presented in Table 36. The EECs have been calculated so that in any given year,
there is a 10% probability that the maximum average concentration of that duration in that year will
equal or exceed the EEC at the site.
The overall upper 90% confidence bound on the mean concentrations of propachlor were 0.5 ug/1
from the application to corn, and 0.6 ug/1 from the application to grain sorghum. These upper 90%
confidence bounds are the best value to use in cancer risk assessments as they are the best estimate
of lifetime mean concentrations. The maximum 1 in 10 year concentrations are 44 ug/L from the
application to corn and 64 ug/L from the application to grain sorghum. These values are the
suggested value for use in acute risk assessments. •
c. Use of Screening Estimates for Drinking Water Assessments
: EFED recommends that the EECs generated from SCI-GROW (for ground water sources) and
from PRZM/EXAMS (for surface water sources) be used for drinking water risk assessments for the
parent propachlor. The monitoring data reported here are not considered reliable for use in drinking
water assessments because they were not well-correlated with the use patterns for propachlor or to
drinking water intakes. The model predictions provide a screen to eliminate those chemicals that are
not likely to causb drinking water problems. Exceedances in drinking water risk assessments using
the screening model estimates do not necessarily mean a problem actually exists but point to the need
for better data (such as monitoring studies specifically designed to relate water concentrations to
usage) on which to make a decision. It is possible that the additional data will show no problem; it
is also possible that the data will show that in some instances a problem may still' exist. If degradates
are to be included in the tolerance expression, the monitoring data may have to be re-evaluated for
usefulness and/or the modeling data will have to be re-calculated to include the -appropriate
degradates.
6. Comparative Assessment With Other Acetanilides
Propachlor appears to be similar in mobility but less persistent than the acetanilides alachlor,
acetochlor, and metolachlor. However, the available half-life and DT50 values for the four chemicals
are within the same order of magnitude. ,
A table summarizing the environmental fate characteristics of the four acetanilides follows this
discussion. An inspection of the physico-chemical characteristics of these chemicals reveals that
propachlor .has a smaller molecular weight because there are no substitutions in the phenyl ring.
Propachlor has the highest solubility in water. All the compounds have relatively low octanol/water
partition coefficients, low vapor pressures, low calculated Henry's Law constants, and relatively small
bioaccumulation factors.
97
-------
Further investigation of the environmental fate characteristics reveals that all four chemicals are
relatively stable to hydrolysis and photolysis in 'vater. Three of the compounds are stable to
photolysis on soil while metolachlor has a half-life of 8 days. In general, it appears that the important
routes of dissipation for these compounds are aerobic soil metabolism and leaching. The aerobic soil
metabolism 50% dissipation rates range from 2.7 days for propachlor to 67 days for metolachlor.
The available studies indicate that anaerobic soil metabolism is not an important route of degradation
for the acetanilides. All four compounds have high mobility.
The half-lives observed in the field are of the same order of magnitude of the half-lives of aerobic
soil metabolism studies in all cases. Results of the field studies confirm aerobic soil metabolism as
an important route of dissipation for the four compounds.
The following tables provide a comparison of environmental fate and ecological toxicity data for the
acetanilides alachlor, acetochlor, metolachlor, and propachlor.
The environmental fate data for the four acetanilides come from a combination of data reported
in the EFED Environmental Fate One-Liner Database and from recently-completed environmental
fate assessments.
The comparative analysis of the ecotoxicity data for propachlor, alachlor, acetochlor, and
metolachlor is based on data taken from the OPP/EFED Pesticide Ecotoxicity Data Base-1997. Only
those studies classified as Core data were used in the analysis. Study identification numbers are shown
as either an MRID#, Accession No., or an EPA ID# (Fiche No.). Category terminology was taken
directly from Brooks, et al. (1973).
9.8
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Table 39: Comparison of avian subacute dietary LC50 data (ppm) for propachlor, acetochlor,
alachlor and metolachlor.
Chemical
Propachlor
Alachlor
Acetochlor
Metolachlor
Avian LC50
>5000
>5423
>5620
>5000
>5620
>5620
>4171
>4610
>5620
>5620
>10000
>10000
Category
Practically Non-toxic
Practically Non-toxic
Practically Non-toxic
Practically Non-toxic
Practically Non-toxic
Practically Non-toxic
Slightly toxic
Slightly toxic
Practically Non-toxic-
Practically Non-toxic
Practically Non-toxic
Practically Non-toxic
JD# ;': ., •;.'•'
00108087
00104335
00134006
00132908
"00093660
00106553
00106554
41565130
41565131
0006471 1
00064710
0016425
0016426
Classification
Core
Core
Core
Core
Core
Core
Core
Core
Core
Core
Core
Core
Technical Grade Material
Table 40: Comparison of freshwater fish 96-hr LCSO data (ppm) for propachlor, acetochlor,
alachlor and metolachlor.
Chemical
Propachlor
Alachlor
Acetochlor
Metolachlor
96-hrLC50*
0.23
0.17
1.0
5.6
2.8
4.3
2.4
1.2
1.5
0.38
1.6
3.9
Category
Highly toxic
Highly toxic
Highly toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Highly toxic
Moderately toxic
Moderately toxic
ID #'
40098001
00041335
234628
234628
00023615
40094602
40094602
41963306
41565133
41565132
41565133
0018722
Classification
Core
Core .
Core
Core
Core
Core
Core
Core
Core
Core
Core
Core
102
-------
•^ Chemical
" 96-hr LC50*
4.9
8.0 '-• • .
10.0
Category
Moderately toxic
Moderately toxic
Moderately toxic
ID#
0015534
40098001
00018723
Classification
/
Core
Core
Core
Table 41: Comparison of aquatic invertebrate 48-hour LC50 data (ppm) for propachlor,
acetochlor, alachlor and metolachlor.
/•
Chemical
Propachlor
Alachlor
Acetochlor
Metolachlor
48-hr LC50*
0.79
7.8 • ,
6.9
21.0
3.2
8.2
14.0
25'. 1.
23.5
3.8
Category
Highly toxic \
Moderately toxic
Moderately toxic.
Slightly toxic
Moderately toxic
Moderately toxic
Slightly toxic
Slightly toxic
.Slightly toxic .
Moderately toxic
ID#
40098001
00041336 •
40098001
40098001
40098001
41565134
- 00064714
226955
40098001
40098001
Classification
Core
Core
Core
Core
Core
Core
Core
Core
Core '
Core
* Technical grade material
Table 42: Comparison of estuarine fish 48-hour LC50 data (ppm) for propachlor, acetochlor,
alachlor and metolachlor.
/ ^
Chemical
Alachlor
Propachlor
Acetochlor
•
Metolachlor
48-hr LC50*
3.9
No Data
2.1
3.9 .
9.8
^Category
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
ID# •' •'.-• '•':•:-:•: 'I;
44524301
42713102
41565137
43487101
Classification
Core
Core
Core
Core
103
-------
Table 43: Comparison of estuarine invertebrate 96-hour LCSO /EC50 data (ppm) for
propachlor, acetochlor, alachlor and metolachlor.
Chemical
Alachlor
Alachlor
Propachlor
Acetochlor
Metolachlor
48-hr 'LC50*
2.4
1.6
No Data
2.2
8.0
5.3
3.82
4.9
L6
• '•• '•''•''• ':'',' '---
Category
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
ID#. ; '•'•'•• ' '
44524302
44524303
42713101
41565136
41565135
42713103
43487103
43487102
Classification
Core
Core
Core
Core
Core
Core
Core
Core
Table 44: Comparison of mammalian acute oral LDso data (rag/kg) for propachlor, acetochlor,
alachlor and metolachlor.
Chemical
Propachlor
Alachlor
Acetochlor
Metolachlor
96-hr LD50*
1800
No Data
2.2
8.0
5.3
3.82
4.9
1.6
Category
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
Moderately toxic
ID# . . , ": '."
00104350
42713101
41565136
41565135
42713103
43487103
43487102
'Classification
Core
Core
Core
Core
Core
Core
Core
* Technical grade material
a. Avian Species
On an acute oral basis, the toxicity data suggest that acetochlor is the most toxic of the four
herbicides (49 mg/kg), followed .in order by propachlor, alachlor and metolachlor. The avian
subacute dietary data suggest that acetochlor is slightly more toxic (4171 ppm) than the other three
herbicides. In general, both the acute and subacute avian toxicity data indicate that all four herbicides
are practically non-toxic to slightly toxic to avian species on both an acute and subacute basis. These
data suggest a low risk to most avian species from either acute or subacute exposure from the use
of these four herbicides.
104
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b. Mammalian Species
Available toxicity data suggest that propachlor is practically nontoxic while acetochlor and
metolachlor are moderately toxic to mammalian species. No mammalian toxicity data are available
for alachlor.
c. Fish Species
The freshwater fish 96-hour LC50 data suggest that propachlor is the most toxic of the four
herbicides. The 96-hour LC50 values generally indicate that propachlor is highly toxic while alachlor,
acetochlor and metolachlor are moderately toxic to freshwater fish species. No estuarine fish toxicity
data are available for propachlor. However, the toxicity data for acetochlor, alachlor, and
metolachlor suggest that propachlor is only moderately toxic to estuarine fish species.
d. Aquatic Invertebrates
The freshwater aquatic invertebrate 48-hour LC50/EC50 data suggest that propachlor is the most
toxic (0.79 ppm) of the four herbicides, ranging from moderately to highly toxic to freshwater
invertebrates. The 48-hour LC50 values generally indicate that alachlor, acetochlor and metolachlor
are moderately to slightly toxic to freshwater invertebrate species. There are no estuarine
invertebrate toxicity data for propachlor. However, the available toxicity data for acetochlor, alachlor,
and metolachlor indicate that propachlor is only moderately toxic to estuarine invertebrate species.
7. Environmental Risk Assessment .
Propachlor is moderately toxic to birds on an acute oral basis but practically nontoxic on a
subacute dietary basis. The pesticide is considered practically nontoxic to mammals (based on tests
on rats) and honey bees. Both the active ingredient and the formulated use product are considered
moderately to highly toxic to freshwater fish,and invertebrates on an acute basis. A comparison of
acute LD50 data with the appropriate time-averaged PRZM/EXAMS EECs (table 36) indicate that
chronic toxicity or life-cycle studies for aquatic organisms is not required. Among nontarget
terrestrial plants, lettuce and ryegrass exhibited the highest sensitivity in terms of seedling emergence
and vegetative vigor. No data are available for any of the degradates of propachlor.
To evaluate the potential risk to nontarget organisms from the use of propachlor products, risk
quotients (RQs) are calculated from the ratio of estimated environmental concentrations (EECs) to
ecotoxicity values. RQs are then compared to levels of concern (LOCs) used by the Agency to
indicate potential risk to nontarget organisms and the need to consider regulatory action.
105
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a. Risk Quotients and Levels of Concern
A means of integrating the results of exposure and ecotoxicity data is called the quotient method.
Risk quotients (RQs) are calculated by dividing estimated exposure concentrations (EECs) by
ecotoxicity values, both acute and chronic.
RQ = EXPOSURE/TOXICITY
Rqs are then compared to levels of concern (LOCs). These LOCs are used by OPP to indicate
potential risk to nontarget organisms and the need to consider regulatory action. The criteria indicate
that a pesticide used as directed has the potential to cause adverse effects on nontarget organisms.
LOCs address the following risk presumption categories:
(1) acute high - potential for acute risk is high, regulatory action may be warranted in addition
to restricted use classification,
(2) acute restricted use - the potential for acute risk is high, but this may be mitigated through
restricted use classification,
(3) acute endangered species - the potential for acute risk to endangered species is high,,
regulatory action may be warranted, and
(4) chronic risk - the potential for chronic risk is high, regulatory action may be warranted.
The Agency does not perform assessments for chronic risk to plants, acute or chronic risks to
nontarget insects, or chronic risk from granular/bait formulations to mammals or birds.
The ecotoxicity test values (i.e., measurement endpoints) used in the acute and chronic risk
quotients are derived from the results of required studies. Examples of ecotoxicity values derived
from short-term laboratory studies that assess acute effects are:
(1) LC50, the lethal concentration for 50% of the test population (fish and birds),
(2) LD50, the lethal dose for 50% of the test population (birds and mammals),
(3) ECjQ, Hie concentration resulting in an adverse effect for 50% of the test population (aquatic
plants and aquatic invertebrates), and
(4) EC^s, the concentration resulting in an adverse effect for 50% of the test population (terrestrial
plants).
Examples of toxicity test effect levels derived from long-term laboratory studies that assess chronic
effects are:
(1) LOEC, lowest observed effect concentration (birds, fish, and aquatic invertebrates),
(2) NOEC, no observed effect concentration (birds, fish and aquatic invertebrates), and
(3) MATC, geometric mean of the NOEC and LOEC (fish and aquatic invertebrates). '
For birds and mammals, the NOEC value is used as the ecotoxicity test value hi assessing chronic
effects. Other values may be used when justified. Generally, the MATC (defined as the geometric
mean of the NOEC and LOEC) is used as the ecotoxicity test value in assessing chronic effects to fish
and aquatic invertebrates. However, the NOEC is used if the measurement end point is production
of offspring or survival. .. .
106
-------
The table below gives the corresponding RQs and LCs for each of the risk presumption categories
Table 45: Risk Presumptions for Non-Target Organisms
Risk Presumption
RQ^
LOG
- - Birds
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EEG'/LC50 or LD50/sqft2 or LD50/day3
EEC/LC50 or LD50/sqft or LD50/day (or LD50 < 50
mg/kg) ...
EEC/LC50 or LD50/sqft or LD50/day
EEC/NOEC
0.5
0.2
0.1
1 ' . •
»j* [ s 1 -'••'.
Wild Mammals -""
Acute High Risk
Acute Restricted Use '
Acute Endangered Species
Chronic Risk
EEC/LC50 orLD50/sqft or LD50/day
EEC/LC50 or LD50/sqft or LD50/day (or LD50 < 50
mg/kg)
EEC/LC50 or LD50/sqft or LD50/day
EEC/NOEC
0.5
0.2
0.1
1
Aquatic Animals
Acute High Risk
Acute Restricted Use
Acute Endangered Species
Chronic Risk
EEC3/LC50orEC50
EEC/LC50orEC50
EEC/LC50orEC50
EEC/MATCorNOEC
0.5
0.1
0.05
1
Terrestrial and Semi-Aquatic Plants ?
Acute High Risk
Acute Endangered Species
EEC4/EC25
EEC/EC05brNOEC
1
1
Aquatic Plants
Acute High Risk
Acute Endangered Species
EEC5/EC50
EEC/EC05orNOEC
1
1
1 abbreviation for Estimated Environmental Concentration (ppm) on avian/mammalfan food items
2 -mg/ft2 3 mg of toxicant consumed/day
. LD50 * wt. of bird - LD50 * wt. of bird
3 EEC = (ppm or ppb) in water
4 EEC = lbsai/A •
5 EEC = (ppb/ppm) in water • >
b. Exposure and Risk to Nontarget Terrestrial Animals
Nongranular applications: The terrestrial exposure assessment is based on the methods of Hoerger
and Kenaga (1972) as modified by Fletcher et al. (1994). Terrestrial .estimated environmental
107
-------
concentrations (EECs) for nongranular formulations were derived from maximum application rates
(6.0 Ib ai/acre).
Table 46: Estimated Environmental Concentrations on Avian and Mammalian Food
Items (ppm) Following a Single Application at 1 and 6 Ib ai/A*
* •''•,.' .. •'••• ,.
Food Items
Short grass
Tall grass
Broadleaf plants and small insects
Fruits, pods, seeds, and large insects
EEC (ppm) Max. Residue for 1
and 6 Ib ai/acre.
240
110
135
15
1,440
660
810
75
EEC (ppm) Mean Residue
for 1 and 6 Ib ai/acre
85
36
45
7
510
216
270
42
"(Hoerger and Kenaga, 1972, as modified by Fletcher et al, 1994)
Granular applications: EECs for broadcast granular applications are calculated on the basis of mass
(in mg) per area (square foot), corrected for the fraction of the pesticide left on the surface. The
maximum EEC for a broadcast granular formulation is 62.5 mg/ft2 at the maximum 6.0 Ib ai/acre
application rate. For unincorporated broadcast applications, the entire fraction of the pesticide is
assumed to remain on the surface. The label for granular formulation prescribes adjusting the desired
application rate by the fraction: .
band width (inches) / row spacing (inches)
^ '
Propachlor is not concentrated in the bands. The banded application reduces the area treated while
the EECs remain the same within the treated band width.
LOG exceedances for nontarget terrestrial animals are summarized below.
108
-------
Table 47: Summary of Acute Level of Concern (LOC) Exceedances For Non-Target
Terrestrial Animals From the Use of Products Containing Propachlor.
Site/App. MethV *
Tonnuiy Rate-
Non-Target Organism
Food Items
Acute RQ ,
Trigger(s) Exceeded
\
Corn, sorghum /Broaycast/ Granular „ _
6.0 Ib ai/acre
3.0 Ib ai/acre
Songbird (20 g body wt)
Upland game bird
(180 g)
Mammal ,(15-35g wt),
based on rat study
Songbird (20 g)
Upland game bird
(180-g)
Mammal (15-35 g)
granules on the
surface
granules on the
surface
granules on the
surface
granules on the
surface
granule's on the
surface
granules on the
surface
34.44
3.94
2.31-0.99
17-22'
1.97
1.16-0.50
acute restricted use & high
risk, endangered species
acute restricted use & high
risk, endangered species
acute restricted use & high
risk, endangered species
acute restricted use & high
risk, endangered species '
acute restricted use & high
risk, endangered species
acute restricted use & high
risk, endangered species
^ * ft •* J '.''".'.•'.-.•••••.,"'. ',.'/", ' - ... -
Corn, sorghum /Ground spray /Non-granular ' : /
6.0 Ib ai/acre
3.0 Ib ai/acre
Mammal (15-35g wt),
based on rat study
Mammal (1 5-35 g)
Short grass
Forage/ small insects
Short grass
Forage/ small insects
0.76-0.53
0.43-0.30
0.38-0.27
0.21-0.15
acute restricted use & high
risk, endangered species
acute restricted use,
endangered species
, acute restricted use,
endangered species
acute restricted use,
endangered species
(1) Birds
- Non-granular Risk: Actual risk quotients for applications of the nongranular formulation of
propachlor were not calculated since all reported L,C50 values were greater than 5,000 ppm.
However, terrestrial EECs (1,440 ppm for short grasses) are well below the avian LC50 values so it
is unlikely that dietary risk to avian species will occur. In addition, the Agency has no reported
incidents involving propachlor and any avian species.
Granular Risk: Birds may be exposed to granular pesticides by ingesting granules when foraging
for food or by other routes, such as by walking on exposed granules or drinking water contaminated
109.
-------
by granules. The number of lethal doses (LD50s) available within one square foot immediately after
application (LDy£/fP is used as the risk quotient for granular products. Risk quotients are calculated
for three separate weight classes: 1000 g (e.g., waterfowl), 180 g (e.g., upland game bird) and 20 g
(e.g., songbird).
Banded applications of granular formulations will result in a reduction of the area treated with no
concentration of herbicide within the bands (the label prescribes reducing the application rate in Ibs
ai/acre by the fraction of the treated area). As a result, the EEC and subsequent RQ will be the same
in the treated areas as with the broadcast applications. However, the area available for exposure is
reduced roughly by the fraction of the area treated. Furrow applications which incorporate a portion
of the applied pesticide reduce the overall fraction of propachlor exposed at the surface, reducing the
EEC and RQ.
For broadcast applications of granular formulations of propachlor, avian acute high risk LOG are
exceeded for songbird and upland game bird species at application rates equal to or greater than 3
Ib a.i./acre, while the application of propachlor at 6 Ib a.L/acre results in exceedences of the acute
high risk LOG for all avian species. Banded applications of granular formulations reduce the area
treated without concentrating the herbicide within the bands. As a result, the EEC and RQ in the
treated areas will be the same as with the broadcast applications. Furrow applications which
incorporate a portion of the applied pesticide would reduce the .overall fraction of propachlor exposed
at the surface, reducing the EEC and RQ.
(2) Mammals
Non-granular Risk: Estimating the potential for adverse effects to wild mammals is based upon
the Agency's draft 1995 SOP of mammalian risk assessments and methods used by Hoerger and
Kenaga (1972) as modified by Fletcher et al. (1994). The concentration of propachlor in the diet that
is expected to be acutely lethal to 50% of the test population (LC50) is determined by dividing the
LDjo value (usually a rat LD50) by the decimal fraction of body weight consumed. A risk quotient is
calculated by dividing the EEC by the derived LC50 value. Risk quotients are calculated for three
separate weight classes of mammals (15, 35, and 1000 g), each presumed to consume four different
lands of food (grass, forage, insects, and seeds).
Broadcast applications of nongranular formulations of propachlor at rates of 3 Ib. a.i./acre or more
exceed the endangered species and acute restricted use LOCs for herbivores and insectivores. The
maximum rate of 6 Ib. a.i./acre exceeds the endangered species, acute restricted use and acute high
risk LOG for herbivores and insectivores but does not exceed .any LOG for granivores.
Granular Risk: Mammalian species may be exposed to granular pesticides by ingesting granules
or other routes, such as by walking on exposed granules or drinking water contaminated by granules.
The number of lethal doses (LD50s) available within one square foot immediately after application can
be used as a risk quotient for exposure to granular pesticides. Risk quotients are calculated for three
separate weight classes of mammals: 15,g, 35 g and 1000 g.
110
-------
For granular products, mammalian acute high risk, acute restricted use and endangered species
LOCs are exceeded for small mammals (35 grams or less) at application rates equal to or greater than
3 Ibs. a.i./acre.
(3) Beneficial Insects
Currently, the Agency does not assess risk to nontarget insects. Results of acceptable studies are
used for recommending appropriate label precautions.
c. Exposure and Risk to Nontarget Aquatic Animals
Table 48: Summary of Acute Level of Concern (LOC) Exceedances For Non-Target Aquatic
Animals From the Use of Products Containing Propachlor.
4 - t * '
Crop/App. Meth/KRate
(Ib ai/Ac) "
Corn / ground/ (a) 6.0
(b)3.0 .
Sorghum/ground (a) 6.0
(b)3.0
Corn/ ground/ 6.0
Sorghum/ ground/ 6.0
f
Nori-Target Organism
Freshwater fish, (rainbow trout)
Freshwater fish (rainbow trout)
Freshwater invertebrate (daphnia)
Freshwater invertebrate (daphnia)
Acute RQ
(a) 0.26
(b)0.13
(a) 0.38
(b) 0.19
0.06
0.08
Trigger(s) Exceeded
acute restricted use,
endangered species
acute restricted use,
endangered species
acute restricted use,
endangered species /
acute restricted use,
endangered species
endangered species
endangered species
(1) Freshwater Fish
. Using refined EECs (generated with' PRZM/EXAMS), acute RQs exceeded the endangered
species .and acute restricted use LOCs for freshwater fish at a maximum application rate equal to or
greater than 3 Ibs. a.i./acre. No chronic RQs were calculated since life-cycle or early life stage tests
for freshwater fish are hot required. .
(2) Freshwater Invertebrates
With refined EECs, acute, RQs exceeded the endangered species, and acute restricted use LOCs
for freshwater invertebrates at a maximum application rate equal to or greater than 6 Ibs. a.i./acre.
, No chronic RQs were calculated since life-cycle tests for freshwater invertebrates are not required.
Ill
-------
(3) Estuarine and Marine Animals
Because of a lack of toxicity data for estuarine and marine fish and invertebrates, potential LOG
exceedences for estuarine and marine animals could not be determined.
(4) Data Gaps for Degradate Exposure and Risk to Non-
target Aquatic Animals
Acute LCSO tests conducted with the analogous sulfonic acid and oxanilic acid degradates of
alachlor indicate these degradates were practically nontoxic to rainbow trout (MRIDs 437747-04 and
437747-06). If the same toxicity trend between the parent and degradate holds true for propachlor
and its degradates, further studies regarding the toxicity of propachlor degradates are not required.
To evaluate toxicity data gaps for the degradates, the Agency performed a Quantitative Structure
Activity Relationship (QSAR) analysis for parent propachlor and its six identified degradates. The
QSAR analysis estimated toxicity data for rainbow trout and Daphnia magna. QSAR assessments
are generally more reliable for neutral organics than for acetanilide pesticides and their degradates
primarily due to me multiple subclasses within this group of chemicals. Because of the uncertainty,
QSAR was coupled with available data and a comparative assessment with the other acetanilides only
as a screen to determine whether additional testing for the degradates was required. It was not
intended to take the place of actual toxicity tests.
Table 49: Comparison of Aquatic Toxicity Values Estimated From QSAR Analyses and
Actual Toxicity Studies for Propachlor.
Toxicity Study
Fish 96-hour LCSO
Aquatic Invert. 48-hr EC50
Parent/Degradate " ..
Propachlor
Propachlor oxanilate
Propachlor sulfonate
Propachlor sulfinyl acetate
Hydroxy propachlor
Propachlor methyl sulfone
Norchloropropachlor
Propachlor
Propachlor oxanilate
Propachlor sulfonate
Propachlor sulfinyl acetate
Hydroxy propachlor
Propachlor methyl sulfone
Norchloropropachlor
QSAREstimate
0.70 ppm
>1000 ppm
>1000 ppm
> 1000 ppm
650 ppm
>100 ppm
310 ppm
0.34 ppm
>1000ppm
>1000 ppm
>1000 ppm
670 ppm
>100ppm
330 ppm
•: -- . -
Actual Studies
0.17 ppm
0.79 ppm
The QSAR analysis estimated acute toxicity values for propachlor that were in the same order of
magnitude as actual measured acute toxicity values. The estimates for acute toxicity from the QSAR
112
-------
analysis suggests that the degradates were more than two orders of magnitude less toxic than the
estimated toxicity for the parent. ,,: .
d. Exposure and Risk to Nontarget Plants
(1) EECs for terrestrial plants inhabiting areas adjacent to treatment sites
Unincorporated ground application:
Runoff = maximum application rate (Ibs ai/A) x runoff value
Drift = maximum application rate x 0.01
Total Loading = runoff (Ibs ai/acre) + drift (Ibs ai/A)
Incorporated ground application:
Runoff = [maximum application rate (Ibs ai/A) •*•
minimum incorporation depth (in.)] x runoff value
Drift = maximum application rate x 0.01
(Note: drift is not calculated if the product is incorporated at the time of application.) '
; Total Loading = runoff (Ibs ai/A) + drift (Ibs ai/A)
Aerial, airblast, forced-air, and chemigation applications:
Runoff = maximum application rate (Ibs ai/A) x 0.6
(60% application,efficiency assumed) x runoff value
Drift = maximum application rate (Ibs ai/A) x 0.05
Total Loading = runoff (Ibs ai/A) + drift (Ibs ai/A)
Calculating EECs for semi-aquatic plants inhabiting wet, low-lying areas
(2) EECs for semi-aquatic plants inhabiting adjacent wet, low-lying areas
Unincorporated ground application:
Runoff= maximum application rate (Ibs ai/A) x runoff value x 10 acres
Drift = maximum application rate x 0.01
Total Loading = runoff (Ibs ai/A) + drift (Ibs ai/A)
Incorporated ground application:
Runoff = [maximum application rate (Ibs ai/A)/minimum incorporation depth (in.)]
x runoff value x 10 acres
Drift— maximum application rate x 0.01
(Note: drift is not calculated if the product is incorporated at the time of application.)
Total Loading = runoff (Ibs ai/A) + drift (Ibs ai/A) ,
Aerial, airblast, and forced-air applications: •
Runoff = maximum application rate (Ibs ai/acre) x 0.6
113 , '
-------
(60% application efficiency assumed) x runoff value x 10 acres
Drift = maximum application rate (Ibs ai/A) x 0.05
Total Loading^ runoff (lbsai/A) + drift (Ibsai/A) .
(3) Terrestrial and Semi-Aquatic Plants
Terrestrial and semi-aquatic plants may be exposed to pesticides from runoff, spray drift or
volatilization. Semi-aquatic plants are those that inhabit low-lying wet areas that may be dry at
certain times of the year. The Agency's runoff scenario is: (1) based on a pesticide's water solubility
and the amount of pesticide present on the soil surface and its top one inch; (2) characterized as
"sheet runoff1 (one treated acre to an adjacent acre) for terrestrial plants; (3) characterized as
"channelized runoff' (10 treated acres to a distant low-lying acre) for semi-aquatic plants; and (4)
based on % runoff values of 0.01, 0.02, and 0.05 for water solubility of <10 ppm, 10-100 ppm, and
>100 ppm, respectively.
Current labels for propachlor only allow for the unincorporated ground application of propachlor
as a preemergent herbicide for corn and grain sorghum. Spray drift exposure from ground
application is assumed to be 1% of the application rate. Spray drift from aerial, airblast, forced-air,
and chemigation applications is assumed to be 5% of the application rate.
The ECjs value of the most sensitive species in the seedling emergence and vegetative vigor study
is compared to runoff plus drift exposure to determine the risk quotient (ECC/toxicity). Analysis of
propachlor plant data show that after a single application, plant acute high risk and endangered
species levels of concern are exceeded for terrestrial plants in dry and semi-aquatic areas at a
registered single application rate equal to or greater than 3.0 Ibs ai/A.
EECs are calculated for the following application methods: (1) unincorporated ground
applications, (2) incorporated ground application, and (3) aerial, airblast, forced-air, and chemigation
applications. Estimated environmental concentrations for dry and semi-aquatic areas are tabulated
below.
* • ' - , . '
Table 50; EECs (Ibs ai/A) For Dry and Semi-Aquatic Areas for a Single Application
Site/
Application
Method/ Rate
of Application
in Ibs ai/A
Corn/
Unincorp.
Ground / 6.0
Corn/
Unincorp.
Ground / 3.0
Minimum
Incorp.
Depth
(cm)'
0
0
Runoff
Value
0.05
0.05
Sheet Run-
off (Ibs
ai/A)
0.30
0.15
Channelized
Runoff
(Ibs ai/A)
3.00
1.50
Drift
(Ibs
ai/A)
0.06
0.03
Ttl Loading to
Adjacent Area
'(Sheet
Runoff-KDrift)
0.36
0.18
Ttl Loading to
Semi-aquatic
Area (Channel
Run-off+
Drift)
3.06
1.53
114
-------
Table 51: Acute High Risk Quotients from a Single Application for Terrestrial Plants in
Dry and Semi-Aquatic Areas*
Site/
Method,
Appl.
Rate(lbs *
ai/A) "
Corn/
Unincorp
."Ground
/6.0
Com/
Unincorp
. Ground
/3.0 "•'
Seedling
Emerg-
ence
JEC25
(Ibs
ai/A)
0.021
0.021
Vegetative ••
Vigor
EC25 (Ibs
ai/A)
* ^
,0.059
0.059
Drift
(Ibs'
ai/A"
)
0.06
0.03
Tti Loading to
Adjacent Area
'(Sheet
RunofB-Drift)
>
0.36
0.18
Ttl Loading
to Semi-
aquatic Area
(Channeliz-
ed Runoff+
Drift)
.3:06
1.53
Emer-
gence
RQ,1
Dry
Area
17.14
*
.8.57*
Emer-
gence
RQ1 '
Semi-
Aquatic
Area
145.71
*
72.86*
Vegetative -
Vigor RQ1,'
Both
Areas :
1.02* ,
0.51
* exceeds acute high risk LOC (1)
1 Based On a (Rygrass) Emergence EC25 of 0.021 Ibs ai/A and a (Rygrass) Vegetative Vigor EC25 of 0.059 Ibs ai/A.
The NOEC or EC^ (if NOEC is unavailable) value of the most sensitive species in the seedling
emergence study is compared to runoff and drift exposure to determine the endangered species risk
quotient. The NOEC or EC05 value of the most sensitive species in the vegetative vigor study is
compared to the drift exposure to determine the endangered species risk quotient.
EECs and acute (endangered species) risk quotients for terrestrial plants based on a single
application are tabulated below.
Table 52: Acute Endangered Species Risk Quotients from a Single Application for
Terrestrial Plants in Dry arid Semi-Aquatic Areas*
Site,
Method
Appl.
Rate (Ibs
ai/A)
p
Corn/.
Unincorp.
Ground/ .
6.0
Corn /
Unincorp.
Ground /
3.0
Seedling
Emergence s
NOEC or
EC05
(Ibs-ai/A)
~
'
0.019
0.019
Vegetative
Vigor
'NOEC or
'ECOS (ibs
ai/A>
0.037
0.037
Drift
(Ibs
ai/A)
0.05
0.05
Ttl
Loading^
to
' Adjacent
Area
(Sheet
Runoff*
Drift)
0.36
0.18
Ttl Loading
Semi-aquatic
Area (Chan-
nelized
Runoff* Drift),
3.06
1.53
Emer- ;,
'gence
RQ1
Dry
Area ;
18.95*
9.47*
-Erner- ;
gence
RQ-
Semi-
Aquati
c Area
>,
161.05
*
!
80.53*
Vegeta-
tive
Vigor
RQ1
.Both ,
Areas
1.35*
1.35* ,
115
-------
* exceeds endangered species (1).
1 BasedOna(Rygrass) Emergence NOEC of 0.019 Ibs ai/A and a (Rygrass) Vegetative Vigor NOEC of 0.037 Ibs ai A.
An analysis of the results indicate that for a single application, plant acute high risk and endangered
species levels of concern are exceeded for terrestrial plants in dry and semi-aquatic areas at a
registered maximum single application rate equal to or greater than 3.0 Ibs ai/A. Currently, the
Agency does not perform chronic risk assessments for terrestrial plants.
(3) Aquatic Plants
Aquatic plant testing (tier II) is required for propachlor because of its outdoor nonresidential uses
that may result in the compound moving off-site by runoff and by spray drift. The following species
should be tested at Tier II: Kirchneria subcapitata, Lemna gibba, Skeletonema costatum, Anabaena
flos-aquae, and a freshwater diatom. Results of the Tier II toxicity testing on technical propachlor
are tabulated below.
Table 53: Acute Risk Quotients for Aquatic Plants
Site/ Application Method/
Rate of Application
(Ibs ai/A)
Corn (unincorporated,
ground) 6.0 Ibs ai/A
Corn (unincorporated,
ground) 3.0 Ibs ai/A
Species
K. subcapitata
K. subcapitata
EC» '''.
(ppm)
0.0135
0.0135
EEC1
(ppm)
0.044
0.022
NOEC
•(ppm)
0.0035
0.0035
: Endangered
Species RQ2.
:(EEC/NOEC)
3.85*
6.29*
Non-target
plant RQ
(EEC/EC50)
3.25*
1.63*
1 PRZM/EXAMS Model
* exceeds endangered species and acute high risk (1)
2 Based upon a nonvascular plant (Kircheria subcapitata) EC 50 of 0.0135 ppm ai. For endangered species, the NOEC
=0.0035 ppm ai.
The outdoor use of propachlor may result in exposure to nontarget aquatic plants through runoff
or spray drift from adjacent sites. As a result, tier II plant testing is required on aquatic vascular
plants (duckweed, Lemna gibba) and aquatic non-vascular species (three algae species Kirchneria
subcapitata, Skeletonema costatum, and Anabaena flos-aquae, and a diatom). Runoff and drift
exposure are computed using the PRZM/EXAMS model. Although only one study (aquatic algae)
was submitted, the data suggest that plant acute high-risk and endangered species levels of concern
are exceeded at the registered maximum rates equal to or greater than 3 Ibs ai/A.
e. Exposure and Risk to Endangered Species
The use of propachlor on corn and sorghum exceeds the endangered species level of concern for
birds, mammals, freshwater fish and invertebrates, and plants. The Endangered Species Protection
Program is expected to become final in the future. Limitations in the use of propachlor .will be
required to protect endangered and threatened species, but these limitations have not been defined
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and may be formulation specific. EPA anticipates that a future consultation with the Fish and Wildlife
Service will be conducted in accordance with the species-based priority approach described in the
Program. After completion of that consultation, registrants will be informed if any required label
modifications are necessary. Such modifications would most likely consist of the generic label
statement referring pesticide users to use limitations contained hi county Bulletins. " '
8. Environmental Risk Characterization
The risk assessment for propachlor is based on a single seasonal application to corn or soybeans
by ground broadcast or band treatment at a maximum rate of 6.0 Ib. a.i./acre. The end products
include flowable concentrate, granular, and water-dispersible granule formulations.
Information provided by the registrant (Suba, L.A. 1998. Monsanto's Response to the HED,
EFED and Occupational Exposure Assessment Chapters for the Propachlor RED dated March 9,
1998. DP Barcode D246291) shows that the current major propachlor uses are in the Midwest —
Nebraska, Kansas, Minnesota, Missouri, and Iowa. Little or no propachlor use is reported in the
eastern coastal plain; minor use is reported in Delaware and New Jersey. Based on current use
information, the extent of propachlor use is smaller than the potential area covered by the labeled
uses.
Even though some LOG triggers were exceeded, the overall toxicological spectrum for propachlor
suggests that it is slightly to moderately toxic to most nontarget organisms. The Agency has no
reported incidences of adverse impacts on nontarget organisms from the use of propachlor. The
" granular formulations posed the greatest risk to nontarget organisms. The granular assessment was
based on an unincorporated broadcast application at a maximum rate of 6 Ib a.i/acre, This scenario
would likely result in a greater potential exposure to most avian and mammalian species than would
the banded application. While the banded application would result in similar EECs and RQs within
the treated area, banding would reduce the treated area per acre. A comparison with the acetanilides
alachlor, acetochlor, and metolachlor suggests that propachlor is slightly 'more toxic to fish and
aquatic invertebrates on an acute basis than are the other herbicides. • . .
The potential chronic (long-term) exposure of nontarget organisms to propachlor is reduced
because it is not persistent under most conditions and because the pesticide is only applied once in '
a growing season. This evaluation does not preclude the possibility that chronic effects may occur
from a one-time exposure to propachlor. However, based on the weight of toxicological evidence
for propachlor, the Agency believes such effects are unlikely. • ' :
The degradates of propachlor, particularly the oxanilic acid, sulfonic acid, and sulfinylacetic acid
degradates, are more persistent than.the parent. However, based on the QSAR analysis, they also
appear to be less toxic (by at least two orders of magnitude).
11. Recommended Risk Reduction Measures and Labeling'
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The existing precautionary statements for propachlor, as modified for consistency in label
language, should be maintained. Specific labeling requirements are detailed in section five of this
document
IV. RISK MANAGEMENT AND REREGISTRATION DECISION
A. Determination of Eligibility
Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submission of relevant data
concerning an active ingredient, whether products containing the active ingredients are eligible for
reregistration. The Agency has previously identified and required the submission of generic (i.e.,
active ingredient specific) data to support reregistration of products containing propachlor active
ingredients. The Agency has completed its review of these generic data, and has determined that the
data are sufficient to support reregistration of all products containing propachlor. Appendix B
' identifies the generic data requirements that the Agency reviewed as part of its determination of
reregistration eligibility of propachlor, and lists the submitted studies that the Agency found
acceptable.
The data identified in Appendix B were sufficient to allow the Agency to assess the registered uses
of propachlor and to determine that propachlor can be used without resulting in unreasonable adverse
effects to humans and the environment. The Agency therefore finds that all products containing
propachlor as the active ingredient are eligible for reregistration provided that terms and conditions
as set forth ha this RED document are met. The reregistration of specific products is addressed in
Section V of this document.
The Agency made its reregistration eligibility determination based upon the target data base
required for reregistration, the current guidelines for conducting acceptable studies to generate such
data, published scientific literature, etc. and the data identified in Appendix B. Although the Agency
has found that all uses of propachlor are eligible for reregistration, it should be understood that the
Agency may take appropriate regulatory action, and/or require the submission of additional data to
support the registration of products containing propachlor, if new information comes to the Agency's
attention or if the data requirements for registration (or the guidelines for generating such data)
change.
B. Determination of Eligibility
1. Eligibility Decision
Based on the reviews of the generic data for the active ingredient propachlor, the Agency has
sufficient information on the health effects of propachlor and on its potential for causing adverse
effects in fish and wildlife and the environment. The Agency has determined that propachlor
products, labeled and used as specified in this Reregistration Eligibility Decision, will not pose
unreasonable risks or adverse effects to humans or the environment. Therefore, the Agency
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concludes that products containing propachlor for all liquid and granular formulations are eligible for
reregistration. . x
The Agency had concerns for the occupational risk posed to mixers/loaders of the dry-fiowables.
The registrant has agreed to voluntarily cancel their formulation of .the dry flowable product.
Appendix B identifies the generic data requirements that the Agency reviewed as part of its
determination of reregistration1 eligibility of propachlor, and lists the submitted studies that the
Agency found acceptable. :
2. Eligible and Ineligible Uses
The Agency has determined that all uses of propachlor are eligible for reregistration with the
exception of the dry flowable formulation which the registrant has agreed to voluntarily cancel.
C. Regulatory Position
• V
The following is a summary of the regulatory positions and rationales for propachlor. To lessen
the risks posed by propachlor, EPA is requiring the following mitigation measures for propachlor-
containing products. These measures are the new conditions of registration.
To Protect Non-Target Species:
-The label must now include warning statements referencing hazards to birds, wildlife, aquatic
invertebrates, and other organisms. Label language is specified in section V.
To Control Ground and Surface Water Contamination:
-Labels must contain advisory language intended to minimize contamination of drinking water
sources and aquatic habitats, including implementation of spray drift best management practices.
To Protect Workers:
-The Agency is requiring, in certain scenarios, the increased use of personal protective e^iprai
and engineering controls to reduce exposure.
To Protect Food Quality:
-Until the required rotational crop data are received and reviewed, rotation'to crops not
specified on the label is prohibited.
-Tolerances have been reassessed and obsolete tolerances for which the registrant no longer
supports will be proposed for revocation! .
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1. Food Quality Protection Act Findings
a. Determination of Safety for U.S. Population
EPA has determined that the established tolerances for propachlor, with amendments and changes
as specified in this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(D) that there is a reasonable certainty of no harm for the general population. In reaching
this determination, EPA has considered the available information on the aggregate exposures (both
acute and chronic) from non-occupational sources, food and drinking water.
Because there are no propachlor products registered for home use, or for use in or around schools,
parks or other public areas, a residential exposure assessment was not conducted. Nor is there a
residential exposure assessment to aggregate with the total dietary assessment.
Propachlor, alachlor, acetochlor, butachlor and metolachlor are structurally similar and therefore
may share a common mechanism of toxiciry. However, at this time the Agency has not yet made a
final decision concerning a possible commom mechanism of toxicity for these five chemicals to
scientifically apply that information to the tolerance decision. The process has begun, but is not yet
completed. Therefore, for the purposes of this decision document, the tolerance decision will be
reached upon the best available and useful information of propachlor only. The propachlor risk
assessment has been performed assuming that no common mechanism of toxicity exists.
Thus, for the purpose of the tolerance reassessments in this RED, EPA has .assumed that
propachlor does not have a common mechanism of toxicity with other substances. Therefore, the risk
assessments in this RED consider only the toxic effects of propachlor. However, these decisions will
be reexamined after the Agency (1) completes the process for determining that a common mechanism
for toxiciry does exist for these chemicals, (2) determines the appropriate methodology for
combining exposures, and (3) after reviewing the use information/patterns, determines for which of
the exposures/scenarios for which of the five chemicals that cummulative exposure does exist. Once
the methodologies and procedures for integrating information concerning common mechanism of
toxicity into the risk assessment are developed, then the Agency can determine the appropriateness
of a cumulative assessment
b. Determination of Safety for Infants and Children
EPA has determined that the established tolerances for propachlor, with amendments and changes
as specified hi this document, meet the safety standards under the FQPA amendments to section
408(b)(2)(C), that there is a reasonable certainty of no harm for infants and children. The safety
determination for infants and children considers the factors noted above for the general population,
but also takes into account the possibility of increased dietary exposure due to the specific
consumption patterns of infants and children, as well as the possibility of increased susceptibility to
the toxic effects of propachlor residues in this population subgroup.
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In determining whether or not infants and children are particularly susceptible to toxic effects from
• propachlor residues, EPA considered the completeness of the database for developmental and
reproductive effects, the nature of the effects observed, and other information.
Based on the current data requirements, propachlor has a complete database for developmental
and reproductive toxicity. Reliable studies cited earlier in this document indicate no special sensitivity
of young organisms to propachlor (see Section Illb.). The Agency has determined that the additional
ten-fold margin of safety for the protection of infants and children is not necessary hi this case.
Therefore, the Agency has concluded that an overall uncertainty factor of 100 is adequate for
assessing the risks of propachlor.
In,deciding to' continue to make reregistration determinations during the early stages of FQPA
implementations, EPA recognizes that it will be necessary to make decisions relating to FQPA before
the implementation process is complete. In making these early, case-by-case decisions, EPA does
_ not intend to set broad precedents for the application of FQPA to its regulatory determinations.
Rather, these early decisions will be made on a case-by-case basis and will not bind EPA as it
proceeds with further policy development and rulemaking that may be required.
. If EPA determines, as a result of this later implementation process, that any of the determinations
described in this RED are no longer appropriate, the Agency will consider itself free to pursue
whatever action may be appropriate, including but not limited to, reconsideration of any portion of
this RED. , ......
c. Endocrine Disrupter Effects
EPA is required to develop-a screening program to determine whether certain substances
(including all pesticides and inerts) "may have an effect in humans that is similar to an effect produced
by a naturally occurring estrogen, or such other endocrine effect..." The Agency is currently working
with interested stakeholders, including other government agencies, public interest groups, industry
and research scientists in .developing a screening and testing program and a priority setting scheme
to implement this program. Congress has allowed 3 years from the passage of FQPA (August 3,
1999) to implement this program. At that.time, EPA may require further testing of this active
ingredient and end use products for endocrine disrupter effects^ .
N,. ' . , '
2. Tolerance Reassessment
Tolerances are currently established in or on corn and sorghum for residues of the herbicide
propachlor and its metabolite, 2-chloro-N-isopropylacetanilide, from 40 CFR § 180.211.
Tolerance Reassessment Summary , .
Tolerances for propachlor residues (40 CFR §180.211) are presently expressed in terms of
residues of propachlor and its metabolites, calculated as propachlor. Based on new metabolism data, •
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the Agency has determined that the propachlor residues to be regulated in plant and livestock
commodities are those which contain the NIPA moiety. The Agency has determined that the residues
of concern (i.e. those to be regulated in the tolerance expression) in plant and animal commodities
are propachlor and all metabolites containing the N-isopropylaniline (NIPA) moiety. Therefore, the
tolerances should be expressed in terms of the combined residues of propachlor and its metabolites
containing the N-isopropylaniline moiety, calculated as propachlor.
* ' „• . i ' ' ... ' • • ' -
The Agency has recently updated the list of raw agricultural and processed commodities and
feedstuff's derived from crops (Table 1, OPPTS GLN 860.1000). Due to these changes, some
commodity definitions must be corrected. In addition, tolerances for commodities for which there
are currently no registered uses of propachlor need to be revoked, and the "N" notation next to some
tolerance levels designating negligible residues should be deleted. A summary of reassessed
tolerances is presented below.
Table 54; Tolerance Reassessment Summary for Propachlor.
Commodity
Current Tolerance,
ppm
ToleranceReassessmentj
/-• : ]?Pm v
Comment/ ,
[Correct Commodity Definition]
Tolerances lasted Under 40 CTR §180.211
Beets, sugar, roots
Beets, sugar, tops
Cattle, fat
Cattle, mbyp
Cattle, meat
Com, grain
Corn, sweet (K + CWHR)
Cotton seed
Flax, seed
0.2
1.0
0.02 (N)
0.02 (N)
0.02 (N)
0.1 (N)
0.1 (N)
0.1 (N)
3.0
Revoke
0.05
0.05
0.02
0.2
Revoke
Revoke
Revoke
There are currently no registered
uses of propachlor on this
commodity.
The tolerance increase is based on
residues detected in a dairy cattle
feeding study and an estimation of
maximum ruminant dietary burden
[Cattle, mbyp (except kidney)]
The tolerance increase is based on
residues detected in a dairy cattle
feeding study and an estimation of
maximum ruminant dietary burden.
[Corn, field, grain]
Highest residue detected in com
grain in a IX field trial is 0.19 ppm.
There are currently no registered
uses of propachlor on this
commodity.
There are currently no registered
uses of propachlor on this
commodity.
There are currently no registered
uses of propachlor on this
commodity.
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.V •*
f •* ^ •<*
*- 1 , Commodity
Current Tolerance,
ppm
Tolerance Reassessment,
1 * ppm '
Comment/
[Correct Commodity Definition]
< ., Tolerances ListedtUnder 40 CFR §180.211
Flax, straw
Goats, fat . ' . :
41 Goats, mbyp
Goats, meat ;
Hogs, fat
Hogs, mbyp
Hogs, meat
Horses, fat
Horses, meat ,
Milk
Peas (with pods)
Peas, forage
Pumpkins
Sheep, fat
Sheep, mbyp
10.0
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N) '
0.02 (N)
0.2
1.5
0.1
0.02 (N)
0.02 (N)
Revoke
0.05
0.05
0.02 ..
0.02
0.02
0.02
0.05
0.02
0.02
Revoke
Revoke
• Revoke
o.os ;
0.05
There are currently no registered
uses of propachlor on this
commodity.
The tolerance increase is based on
residues detected in a dairy cattle
feeding study and an estimation of
maximum ruminant dietary burden.
[Goats, mbyp (except kidney)]
The tolerance increase is based on
residues detected in a dairy cattle
feeding study and an estimation of
maximum ruminant dietary burden.
' - -
,
[Hogs, mbyp (except kidney)]
The tolerance increase is based on
residues detected in a dairy cattle
feeding study and an estimation of
maximum ruminant dietary burden.
There are currently no registered
uses of propachlor on this
commodity.
There are currently no registered
uses of propachlor on this
commodity.
There are currently no registered .
uses .of propachlor on this
commodity.
The tolerance increase is based on
residues detected in a dairy cattle
feeding study and an estimation of
maximum ruminant dietary burden.
[Sheep, mbyp (except kidney)]
The tolerance increase is based on
residues detected in a dairy cattle
feeding study and ah estimation of
maximum ruminant dietary burden.
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Commodity
Current Tolerance, •
ppm
Tolerance Reassessment^
ppm
Comment/
[Correct Commodity Definition]
TolerancesListedtJnder 40 CFR §180.211
Sheep, meat
Sorghum, fodder
Sorghum, forage
Sorghum, grain
Eggs
Poultry, fat
Poultry, mbyp
Poultry, meat
Cattle, kidney
Goats, kidney
Hogs, kidney
Horses, kidney
Sheep, kidney
Com, field, stover
0.02 (N)
5.0
5.0
0.25
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
0.02 (N)
-
0.02
12.0
8.0
0.25
Revoke
0.2
0.2
0.02
0.2
0.2
1.0
[Sorghum, stover]
Highest residue detected in sorghum
fodder in a .8X or 1.2X field trial is
10.59 ppm.
Highest residue detected in sorghum
forage in a .8X or 1 .2X field trial is
7.67 ppm.
Based on the available data, residues
in poultry commodities can be
classified under Category 3 of 40
CFR §180.6(a); therefore, tolerances
for residues in poultry commodities
are not required.
Feeding study data indicate that
separate tolerances for residues in
kidney are required.
a. Codex Harmonization
There are no Codex MRLs established for propachlor; therefore, issues of compatibility with U.S.
tolerances do not exist.
D. . Summary of Risk Management Decisions
, 1. Human Health
(1) Dietary
Acute Dietary
An acute dietary risk assessment was performed to estimate the risk of consuming a large amount
of propachor residues in the food consumed on a single day. The assessment, a tiered approach, uses
a single high-end residue estimate, usually the tolerance, combined with a distribution of individual
food consumption values.
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Using a Margin of Exposure approach and a NOEL of 175mg/kg/day, the MOE's for adult females
was 53,000,62,000 for adult males and 17,000 for children between the ages of one and six. Since
all population sub-groups greatly exceed 100J the Agency has no concerns for acute dietary exposure.
Chronic Dietary faon-carcinogenic)
A chronic dietary assessment was performed to estimate the lifetime risk of consuming an average
amount of propachlor residues. Using the DRES (Dietary Risk Evaluation System) modeling and
percent crop-treated estimates derived from Federal and private market survey data, chronic dietary
risk is calculated for the U.S. population and 22 sub-groups.
The chronic (non-carcinogenic dietary risk) %RfD for all of the following sub-groups: U.S.
population, children (l-6years), 0.20%, adult females (20+ years)/0.05%, and adult males (20+
years), 0.05%, totaled less than 1 % which is much less than EPA's'level of concern of 100%,
Chronic Dietary rcarcino genie)
The chronic dietary assessment was performed to estimate the additional lifetime carcinogenic risk
of consuming an average amount of propachlor residues. The exposure (mg/kg/day) is the same as
that estimated by DRES for the chronic dietary assessment. Carcinogenic dietary risk is calculated
for the U.S. population (for both males and females) by using the Q,* approach.
The Qj* of 0.032 (mg/kg/day)'1 which was used to quantify the total dietry carcinogenic risk, when
calculated for both adult males ,(9.0x10'7) and females (9.3x10'7) , the dietary risk is below the
Agency's IxlO'6 level of concern.
2. Worker (Mixer/Loader/Applicator)
Acute rShort-Terrri) and Intermediate Term ,
An occupational exposure assessment was conducted for propachlor based upon the toxicological
criteria which were triggered by the determination that propachlor is a "likely" human carcinogen.
The potential for exposure does exist. ,, .
In the short-term risk assessment, the end-point selection is usually made using toxicity generated
by the same route as the likely exposure - in this case dermal: However, no dermal study was
available for selecting the NOEL therefore, a dermal absorption factor of 100% was used in
estimating the risk. The MOE's for the short-term dermal and inhalation risk assessment were all
greater than 100 with the exception of one scenario, the mixing/loading of liquids for groundboom
application which required additional PPE.
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As in the short-term assessment, the intermediate-term dermal and inhalation risk assessment
assumed a 100% dermal absorption factor in estimating the risk. The risk assessment indicates that
the MOE's are greater than 100 at baseline for the loading of granulars for tractor-drawn spreaders
and the application of granulars to sorghum with tractor-drawn spreaders. Additional PPE is required
to reduce exposure and to raise the MOE's above 100 for both the application of sprays to sorghum
with a groundboom sprayer and the application of granulars to corn with tractor-drawn spreaders.
Enginering controls are required to raise the MOE's above 100 for the last three scenarios: the
mixing/loading of liquids for groundboom application, the mixing/loading of dry flowables for
groundboom application, and the application of sprays to corn with groundboom sprayers.
Post-Application
EPA believes that, based on the current uses of propachlor, post-application exposure will be
negligible. Therefore, the Agency is not requiring post-application studies.
3. Environmental
(1) Avian
Acute and Chronic
Propachlor is considered to be moderately toxic to avian species on an acute oral basis and is
considered to be practically nontoxic to avian species on a subacute dietary basis. Application of
granular formulations of propachlor exceed acute risk levels of concern for small birds (20g weights,
representative of songbirds) and medium-sized birds (180g weights, representative of upland game
birds). However, even though some LOG triggers were exceeded, the overall lexicological spectrum
for propachlor suggests that it is slightly to moderately toxic to most nontarget organisms. The
Agency has no reported incidences of adverse impacts on nontarget organisms from the use of
propachlor.
The potential chronic (long-term) exposure of nontarget organisms to propachlor is reduced
because it is not persistent under most conditions and because the pesticide is only applied once in
a growing season. However, based on the weight of toxicological evidence for propachlor, the
Agency believes such effects are unlikely.
Chronic avian toxicity data are not required for propachlor because repeated or prolonged
exposure to the chemical is not expected. The label calls for one application per year and the fate
data suggest that propachlor is not highly persistent in most terrestrial environments.
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(2) Mammals
Acute and Chronic
Prppachlor is practically non-toxic to mammalian species on an acute oral or chronic basis.
(3) Insects '
Results indicate that propachlor is practically non-toxic to honey bees on an acute contact basis
and a subacute dietary basis. , • .
(4) Freshwater Fish
Acute and Chronic
Propachlor is considered moderately to highly toxic to freshwater fish on an acute basis. While,
the technical grade material (TGAI) is more toxic to rainbow trout than the formulated product, the
formulated product is more toxic to bluegill sunfish than the technical grade material.
No early life-stage studies with freshwater fish are available for propachlor. Yet, a comparative
analysis generated by PRZM / EXAMS yields an RQ value which does not trigger the need for any
further chronic testing for freshwater fish.
(5) Aquatic invertebrates
Propachlor is considered moderately to highly toxic to aquatic invertebrates on an acute basis. No
chronic aquatic invertebrate toxicity data are available for propachlor. Yet, a comparative analysis
generated by PRZM / EXAMS yields an RQ value which does not trigger the need for any further
chronic testing for aquatic invertebrates.
(6) Estuarine and Marine Organisms
Estuarine and Marine Fish.Acute .
The toxicity testing with marine / estuarine fish is required for propachlor because the end-use
product is expected to reach this environment because of its use in coastal counties. No studies have
been submitted, therefore guideline 72-3a is not fulfilled.
Estuarine and Marine Fish. Chronic
Propachlor may be expected to reach estuarine or marine environments due to its use-on corn and
sorghum, the need for an estuarine / marine fish early-life stage study is deferred until the results of
an acute study, 72-3a, is submitted.
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Estuarine and Marine Invertebrates. Acute
Acute toxicity testing with estuarine / marine invertebrates is required for propachlor due to similar
end-product use patterns as stated above. Since no studies were submitted, guidelines 72-3b and 72"
3 c are not fulfilled.
Estuarine and Marine Invertebrates. Chronic
Because propachlor is registered on crops associated with marine environemnts, studies are
required to assess the toxicity to estuarine / marine fish and invertebrates. No data have been
submitted, therefore guideline 72-3 is not fulfilled. ' ' .
"'„ ' '
(7) Nontarget Plants (Terrestrial, Semi-Aquatic, and Aquatic)
Terrestrial, semi-aquatic, and aquatic plants may be exposed to propachlor from runoff, spray drift
or volatilization. An analysis of the results indicate that for a single application, plant acute high risk
and endangered species levels of concern are exceeded at a registered single application rate equal
to or greater than 3.0 Ibs ai/A. However, even though some LOG triggers were exceeded, the overall
lexicological spectrum for propachlor suggests that it is slightly to moderately toxic to most
nontarget organisms. The Agency has no reported incidences of adverse impacts on nontarget
organisms from the use of propachlor.
• The potential chronic (long-term) exposure of nontarget organisms to propachlor is reduced
because it is not persistent under most conditions and because the pesticide is only applied once in
a growing season. However, based on the weight of toxicological evidence for propachlor, the
Agency believes such effects are unlikely.
(8) Surface Water
Under certain conditions, propachlor and/or its metabolites may have a potential for runoff into
surface water for several days to weeks after application. These include poorly draining or wet soils
with readily visible slopes toward adjacent surface water, areas with in-field canals or ditches that
drain to surface water, areas not separated from adjacent surface waters with vegetated filter strips,
and areas overlaying tile drainage systems that drain to surface water.
(9) Ground Water
Propachlor and /or its metabolites are known to leach through soil into ground water under certain
conditions as a result of label use. Use of this chemical in areas where soils are permeable,
particularly where the water table is shallow, may result in ground water contamination.
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E. Occupational and Residential Labeling Rationale/Risk Mitigation
1. Restricted Use Classification
There are no residential uses of propachlor.
2. Reference Dose Exceedance
Current propachlor usage does not exceed the reference dose limits established by available data
and current tolerances. All %RfD's are less than 1% which is much less than the Agency's level of
concern of 100%. ... '
3. Occupational Labeling Rationale
Occupational and Residential Labeling Rationale/Risk Mitigation
The Worker Protection Standard (WPS)
, The 1992 Worker Protection Standard for Agricultural Pesticides (WPS) established certain
worker-protection requirements (personal protective equipment, restricted-entry intervals, etc.) to
be specified on the label of all products that contain uses within the scope of the WPS. Uses within
the scope of the WPS include all commercial (non-homeowner) and research uses on farms, forests,
.nurseries, and greenhouses to produce agricultural plants (including food, feed, and fiber plants, trees,
turf grass, flowers, shrubs, ornamentals, and seedlings). Uses within scope, include not only uses on
plants, but also uses on the soil or planting medium the plants are (or will be) grown in.
Personal Protective Equipment for Handlers (Mixers, Loaders, Applicators, etc.)
For each end-use product, PPE requirements for pesticide handlers are set during reregistration
in one of two ways: ,
1. If EPA determines that no regulatory action must be taken as the result of the acute effects or other
adverse effects of an .active ingredient, the PPE for pesticide handlers will be based on the acute
toxicity of the end-use product. For occupational-use products, PPE must be established using the
process described in PR Notice 93-7 or more recent EPA guidelines.
2. If EPA determines that regulatory action on an active ingredient must be taken as the result of very
high acute toxicity or certain other adverse effects, such as allergic effects or systemic effects (cancer,
developmental toxicity, reproductive effects, etc.):
• In the RED for that active ingredient, EPA may establish minimum or "baseline" handler PPE
requirements that pertain to all.or most end-use products containing that active ingredient.
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• These minimum PPE requirements must be compared with the PPE that would be designated
on the basis of the acute toxicity of the end-use product.
" The more stringent choice for each type of PPE (chemical resistant apron, chemical resistant
gloves and chemical resistant footwear) must be placed on the label of the end-use product.
Personal protective equipment requirements usually are set by specifying one or more pre-
established PPE units — sets of items that are almost always required together. For example, if
chemical-resistant gloves are required, then long-sleeve shirts, long pants, socks, and shoes are
assumed and are also included in the required minimum attire. If the requirement is for two layers
of body protection (coveralls over a long- or short-sleeve shirt and long or short pants), the minimum
must also include (for all handlers) chemical-resistant footwear and chemical-resistant headgear for
overhead exposures and (for mixers, loaders, and persons cleaning equipment) chemical-resistant
aprons.
Occupational Use Products
For the mixing and loading of liquids for groundboom application, the Agency is requiring workers
to use a closed mixing/loading system and to wear chemical resistant gloves. This requirement is
based upon a combination of both the carcinogenic and the intermediate-term risk assessment for
propachlor which requires the use of a closed system and the use of chemical resistant gloves to
achieve an acceptable Margin of Exposure.
For the application of liquids, the Agency has determined that acceptable MOE's can not be
achieved for applicators without requiring the use of a closed cab system. These mitigation measures
are based upon both the carcinogenic and the intermediate term exposure scenarios for the application
of liquids. The Agency does not differentiate between crops for mitigation purposes. Therefore, the
most protective personal protective equipment and engineering controls are chosen for both the
mixing/loading and the application to all commodities.
For the loading of granulars for tractor-drawn spreader application, based upon both the
carcinogenic and intermediate term exposure assessment, a double layer of clothing and chemical
resistant gloves are required to achieve an acceptable Margin of Exposure. Instead of requiring
mixers and loaders to wear a coverall garment over their long sleeved shirt and long pants, EPA
requires mixer/loaders to wear a chemical-resistant apron and chemical-resistant footwear (plus
chemical resistant gloves). Although EPA has no data to specifically assess the exposure reduction
to mixers and loaders afforded by a chemical-resistant apron, the Agency is persuaded that the
exposure reduction would be significant. Available data indicate that the preponderance of non-hand
exposure to mixers and loaders is to the front torso. Therefore, for mixers and loaders the use of a
chemical-resistant apron is probably approximately equivalent to double-layer body protection.
For the application of granulars with a tractor-drawn spreader, applicators must wear additional
personal protective equipment consisting of a double layer of clothing, and chemical resistant gloves.
EPA has found the Margins of Exposure to be above an acceptable limit when these PPE are used.
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Post-Application/Entry Restrictions
Occupational-Use Products ("WPS Uses)
Restricted-Entry Interval: Under the Worker Protection Standard (WPS), interim restricted-
entry intervals (REI's) for all vises within the scope of the WPS are based on the acute toxiciry of the
active ingredient. The toxicity categories of the active ingredient for acute dermal toxiciry, eye
irritation potential, and skin irritation potential are used to determine the interim WPS REI. If one
or more of the three acute toxiciry effects are in toxiciry category I, the interim WPS REI is
established at 48 hours. If none of the acute toxicity effects are in category I, but one or more of the
three is classified as category II, the interim WPS REI is established at 24 hours. If none of the three
acute toxicity effects are in category I or II, the interim WPS REI is established at 12 hours. A 48-
hour REI is increased to 72 hours when an prganophosphate pesticide is applied outdoors hi arid
areas. In addition, the. WPS specifically retains two types of REI's-established by the, Agency prior
to the promulgation of the WPS: (1) product-specific REI's established on the basis of adequate data,
and (2) interim REI's that are longer than those that would be established under the WPS.
During the reregistration process, EPA considers all relevant product-specific information to
decide whether there is reason to shorten or lengthen the previously established REI. Accordingly,
EPA determined that the restricted-entry interval for all occupational-use products that contain
propachlor are within the scope of the Worker Protection Standard for Agricultural Pesticides (WPS)
should be 48 hours. The basis for this decision is that propachlor is categorized as toxicity category
I (severe) for eye irritation potential and also is classified as a strong dermal sensitizer.
Earty-Entry PPE: The WPS establishes very specific restrictions on entry by workers to areas
that remain under a restricted-entry interval, if the entry involves contact with treated surfaces.
Among those restrictions are a prohibition of routine entry to perform hand labor tasks and a
requirement that personal protective equipment be worn. . ,
During the reregistration process, EPA considers all relevant product-specific information to
decide whether there is reason to set personal protective' equipment requirements that differ from
those set through the WPS. ,
The RED requirements for early-entry personal protective equipment are set in one of two ways:
1. If EPA determines that no regulatory action must betaken as the result of the acute effects or
other adverse effects of an active ingredient, it establishes the early-entry PPE requirements on the
basis of the acute dermal toxicity category, skin irritation potential category, and eye irritation
potential category of the active ingredient.
2. If EPA determines that regulatory action on an active ingredient must be taken as the result of very
high acute toxicity or to certain other adverse effects, such as allergic effects or delayed effects
-' , . ' • 131. ' .'•'.-•-• ' ..'..'•
-------
(cancer, developmental toxicity, .reproductive effects), it may establish early-entry PPE
requirements that are more stringent than would be established otherwise.
3. Since propachlor is classified as category I (severe irritant) for eye irritation potential, protective
eyewear is required.
WPS Double Notification Statement:
"Double" notification is the statement on the labels of some pesticide products requiring employers
to notify workers about pesticide-treated areas orally as well as by posting of the treated areas. The
interim WPS "double" notification requirement is imposed if the active ingredient is classified as
toxicity category I for acute dermal, toxicity or skin irritation potential. EPA has determined that
double notification is not required for propachlor end-use products.
Occupational-Use Products (NonWPS Uses)
Since EPA has concerns about post-application exposures to persons after nonWPS occupational
uses of propachlor (classified as toxicity category I for eye irritation potential and is a strong skin
sensitizer), EPA is establishing entry restrictions for all nonWPS occupational uses of propachlor end-
use products. Entry will be restricted until sprays have dried and dusts have settled. For specific
requirements, refer to Section V of this document.
4. Endangered Species Statement
Currently, the Agency is developing a program ("The Endangered Species Protection Program")
to identify all pesticides whose use may cause adverse impacts, on endangered and threatened species
and to implement mitigation measures that will eliminate the adverse impacts. The program would
require use restrictions to protect endangered and threatened species at the county level.
Consultations with the Fish and Wildlife Service may be necessary to assess risks to newly listed
species or from proposed new uses. In the future, the Agency plans to publish a description of the
Endangered Species Program in the Federal Register and have available voluntary county-specific
bulletins. Because the Agency is taking this approach for protecting endangered and threatened
species, it is not imposing label modifications at this time through the RED. Rather, any requirements
for product use modifications will occur in the future under the Endangered Species Protection
Program.
5. Other Labeling Requirements
Label amendments are required to support uses of propachlor on sorghum and crops which can
be rotated. Grazing and feeding restrictions are no longer considered to be practical by the Agency,
and must be removed from any labels allowing application to sorghum. Registered labels must be
amended to include a statement restricting crop rotation to either com or sorghum, the only food
132
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crops for which there are registered uses of propachlor, pending submission of limited field rotational
crop studies. * ,• *
6. Spray Drift Advisory
The Agency has been working with the Spray Drift Task Force, EPA Regional Offices and State
Lead Agencies for pesticide regulation to develop the best spray drift management practices. The
Agency is now requiring interim measures that must be placed on product labels/labeling as specified
in Section V. Once the Agency completes its evaluation of the new data base submitted by the Spray
Drift Task Force, a membership of U.S. pesticide registrants, the Agency may Impose further
refinements in spray drift management practices to further reduce off-target drift and risks associated
• with this drift.
V. ACTIONS REQUIRED OF REGISTRANTS
This section specifies the data requirements and responses necessary for the reregistration of both
manufacturing-use and end-use products.
A. Manufacturing-Use Products
1. -Additional Generic Data Requirements
The generic data base supporting the reregistration of propachlor for the above eligible .uses has
been reviewed and determined to be substantially complete. The following studies are required to
.be conducted on the generic active ingredient:
• 72-3 (a) Acute toxicity to estuarine and marine fish "
• 72-3 (b) Acute toxicity to estuarine and marine mollusks ^
• 72-3 (c) Acute toxicity to esturarine and marine shrimp . :
• 123-2 Aquatic Plant Growth on four of the five required species is still outstanding:
Lemria gibba, Skeletonema costatum, Anabaena flos-aquae, and freshwater diatom.
• 162-1 Aerobic Soil Metabolism; An additional study is needed to better
characterize the rate of dissipation-of propachlor. ,
• 162-4 Aerobic Aquatic Metabolism
• 165-1 Limited Field rotational Crop '.
2. Labeling Requirements for Manufacturing-Use Products
To remain in compliance with FIFRA, manufacturing use product (MP)'labeling must be revised
to comply with all current EPA regulations, PR Notices and applicable policies. The MP labeling
must bear the labeling contained in table 55 at the end of this section. Any use instructions on current
labels that conflict with those listed below should be removed.
133
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All products distributed or sold by registrants and distributors (supplemental registrants)
should bear labeling that is consistent with this notice within 26 months from receipt date of this
RED and all products distributed or sold by persons other than registrants or supplemental
registrants after 50 months should bear correct labeling.
3. End-Use Products
For. sole-active-ingredient end-use products that contain propachlor:
-• Revise the product labeling to adopt the handler personal protective equipment/engineering
control requirements set forth hi this section.
• Revise the product labeling to adopt the entry restrictions set forth in this section.
For multiple-active-ingredient end-use products that contain propachlor:
• Compare the handler personal protective equipment/engineering control requirements set forth
hi this section to the requirements on the current labeling.
• Retain the more protective requirements. (For guidance on which requirements are considered
more protective, see PR Notice 93-7.)
• Compare the entry restrictions set forth hi this section to the entry restrictions on the current
labeling.
» Retain the more protective restrictions. (A specific time period hi hours or days is considered
more protective than "sprays have dried" or "dusts have settled".)
a. Additional Product-Specific Data Requirements
Section 4(g)(2)(B) of FIFRA requires the Agency to obtain any needed product-specific data
regarding the pesticide after a determination of eligibility has been made. Registrants must review
previous data submissions to ensure that they meet current EPA acceptance criteria and if not,
commit to conduct new studies. If a registrant believes that previously submitted data meet current
testing standards, then study MRID numbers should be cited according to the instructions in the
Requirement Status and Registrants Response Form provided for each product.
b. Labeling Requirements for End-Use Products
All end-use products should have clear, concise and complete labeling instructions. Proper labels
can improve reader understanding, thereby reducing misuse and the potential for incidents. Towards
this end, the agency is requiring the following:
'b * \
Directions for Use:
t • .
Directions for Use must be stated in terms that can easily be read and understood by the average
person likely to use or supervise the use of the pesticide. It must be presented in a format that is easy
to understand and follow. The Directions for Use section of a pesticide label must provide necessary
134
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information to answer four major questions regarding the use of the pesticide. These four questions
are: - . , •.--•..-•
(1) Why is the pesticide being used? For what pest(s) or problems?
(2) Where is the pesticide applied? (Where should it not be applied?)
(3) How is the pesticide applied? (What special precautions must the user take? How
much should they use?)
(4) When should the pesticide be applied?
In addition, the Agency encourages the use of graphic symbols whenever possible, to clarify the
written label. ' ,
National Pesticide Telecommunications Network (NPTN) Hotline Number :
All propachlor labels must refer consumers to the NPTN number for additional information. ,This
reference must bear the labeling contained in the'table at the end of this section.
/, • .'•''"
First Aid (Statement of Practical Traetment)
• The Agency is requiring that all labels with Statement of Practical Treatment sections be amended
so that these sections are entitled: "First Aid". First aid statements must be brief, clear, simple and
in straightforward language (conforming to the labeling required by the Agency) so that the average
person can easily and quickly understand the instructions. These statements should be appropriate
for all ages or, when necessary, should include distinctions between the treatments for different ages.
4. Required Labeling Changes Summary Table _ '
Table 55 summarizes the labeling requirements being imposed by this RED for propachlor
products. Any use instructions on current labels that conflict with the following table should be
removed. ~ ,
135
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Summary Table of Labeling Changes for Propachlor Products
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(NPDES) permit and the permitting authority has been notified in writing prior to
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"Follow the manufacturer's instructions for cleaning/maintaining PPE. If no such
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separately from other laundry."
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this product's concentrate. Do not reuse them."
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and put on clean clothing."
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gloves before removing. As soon as possible, wash thoroughly and change into clean
clothing." '
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"This product is toxic to fish, aquatic invertebrates, and wildlife."
"Do not apply directly to water or to areas where surface water is present or to intertidal
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neighboring areas
"Do not contaminate water when disposing of equipment washwater or rinsate."
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Worker Protection Standard
Any product whose labeling reasonably permits use in the production of an agricultural plant on
any farm, forest, nursery, or greenhouse must, comply with the labeling requirements of PR Notice
93-7, "Labeling Revisions Required by the Worker Protection Standard (WPS), and PR Notice 93--
11, "Supplemental Guidance for PR Notice 93-7, which reflect the requirements of EPA' s labeling
regulations for worker protection statements (40 CFR part 156, subpart K). These labeling revisions
are necessary to implement the Worker Protection Standard for Agricultural Pesticides (40 CFR part
170) and must be completed in accordance with, and within the deadlines specified in, PR Notices
93-7 and 93-11. Unless otherwise specifically directed in this RED, all statements required by PR
Notices 93-7 and 93-11 are to be on the product label exactly as instructed in those notices. The
labels and labeling of all products must comply with EPA's current regulations and requirements as
specified in 40 CFR § 156.10 and other applicable notices.
Effluent Discharge Labeling Statements
Refer to table 55 for labeling requirements for effluent discharge.
5. Spray Drift Labeling
The current labels indicate that propachlor may be applied by ground boom spray equipment but not
aerially. No propachlor-specific ground spray drift studies were reviewed. The Spray Drift Task
Force (SDTF), a consortium of pesticide registrants, has completed and submitted to the Agency a
series of studies which are intended to characterize spray drift potential due to various factors,
including application methods, application equipment, meteorological conditions, crop geometry, and
droplet characteristics. EPA is evaluating these studies, which include ground spray as well as aerial
application methods. After its review of the studies, the Agency will determine whether a reassess-
ment of the potential risks from the application of propachlor to nontarget organisms is warranted.
B. Tolerance Revocation and Import Tolerances
It is EPA's policy to propose revocation of a tolerance, and/or food/feed additive regulation,
following the deletion of a related food use from a registration, or following the cancellation of a
related food-use registration. As a result, any parties interested in supporting the tolerance/regulation
for import purposes in the absence of a registered U.S. use should notify EPA as soon as possible.
In responding, EPA will provide detailed information on the outstanding data requirements for
these tolerances and/or regulations. The Agency will consider commitments made to generate data
to support such tolerances/regulations and the timeliness of data submissions in its assessment of
whether the tolerances/regulations should be retained. Persons interested in establishing a new
tolerance for import purposes only, or retaining a current tolerance for import purposes following
cancellation of the related use, must submit a petition along with the appropriate fees and supporting
data.
140
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C. Existing Stocks >
- Registrants may generally distribute and sell products bearing old labels/labeling for 26 months
from the date of the issuance of this Reregistration Eligibility Decision (RED). Persons other than the
.registrant may generally distribute or sell such products for 50 riionths from the date of the issuance
of this RED. However, existing stocks time frames will be established case-by-case, depending on
the number of products involved, the number of label changes, and other factors. Refer to "Existing
Stocks of Pesticide Products; Statement of Policy"; Federal Register. Volume 56, No. 123, June 26,
1991.
The Agency has determined that registrants may distribute and sell propachlor products bearing
old labels/labeling for 26 months from the date of issuance of this RED. Persons other than the
registrant may distribute or sell such products for 50 months from the date of the issuance of this
RED. Registrants and persons other than registrants remain obligated to.meet pre-existing Agency
imposed label changes and existing stocks requirements applicable to products they sell or distribute.
141
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142
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VI. APPENDICES
143
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GUIDE TO APPENDIX B
Appendix B contains listings of data requirements which support the reregistration for active ingredients within the case
p'ropachlor covered by this Reregistration Eligibility Decision Document. It contains generic data requirements that apply
to propachlor in all products, including data requirements for which a "typical formulation" is the test substance.
The data table is organized in the following format: •
1. Data Requirement (Column 1). The data requirements are listed in the order in which mey appear in 40 CFR
Part 158. the reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment
Guidelines, which are .available from the National Technical Information Service, 5285 Port Royal Road, Springfield VA
22161(703)605-6000. ..' . • '..
2. Use Pattern (Column 2). This column indicates the use patterns for which the data requirements apply. The
following letter designations are used for the given use patterns:
I A Terrestrial food
B Terrestrial feed
C Terrestrial non-food • *
D Aquatic food '
E Aquatic non-food outdoor
F . Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse,food
' I .Greenhouse non-food , • ,
J Forestry
K Residential ., .• • •
L Indoor food . .
M Indoor non-food
N Indoor medical
O Indoor residential
3. Bibliographic citation (Column 3). If the Agency has acceptable, data in its files, this column lists the
identifying 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.
153
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-------
GUIDE TO APPENDIX C
1. • 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.
2. 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 j 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.
3. 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. .
4. 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.
a 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.
b. Document date. The date of the study is taken directly from the document. When the date is followed by
a question mark, the bibliographer has deduced the date from the evidence contained in the document.
When the date appears as (19??), the Agency was unable to determine or estimate the date of the
document.
c. 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.
d. 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 me earliest known submission appears immediately following the
word "received."
160
-------
(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.
161
-------
MRID
BIBLIOGRAPHY
CITATION
00041335 Thompson, C.M.; Forbis, A.D.; Oleson, F.B.; et.al. (1980) Acute Toxicity of Propachlor (AB-79-080) to
Rainbow Trout (-j-Salmo -]~gairdneri~|): Static Acute Bioassay Report # 24019. (Unpublished study
including letter dated Nov 13, 1979 from F.B. Oleson to W.D. Carpenter, received Sep 19, 1980 under
524-310; prepared in cooperation with Analytical Bio Chemistry Laboratories, Inc., submitted by
Monsanto Co., Washington, D.C.; CDL:099654-B)
00041336 Thompson, C.M.; Forbis, A.D.; Fuhremann, t.W. (1980) Acute Toxicity of Propachlor (AB-79-250)
to~Daphnia magna-^: Static Acute Bioassay Report 24708. (Unpublished study including letter dated Jan
8,1980 from T.W. Fuhremann to W.D. Carpenter, received Sep 19, 1980 under 524-310; prepared in
cooperation wrfli Analytical Bio Chemistry Laboratories, Inc., submitted by Monsanto Co., Washington,
D.C.; CDL:099654-C)
00041337 Thompson, C.M.; Forbis, A.D.; Oleson, F.B.; et al. (1980) Acute Toxicity of Ramrod-
-------
BIBLIOGRAPHY
MRID
CITATION
00104337
"00104338
00104350
00104351
00104353
00104354
00108087
00115136
00132908
00134006
00014452
Morrill, L. (1973) Acute Toxicity of Ramrod to Bluegill (Lepomis macrochirus). (Unpublished study
received Jul 3,1979 under 524-331; prepared by Bionomics, Inc., submitted by Monsanto Co.,
Washington, DC; CDL:238764-F)
Barrows, M. (1974) Exposure of Fish to 14C-Ramrod: Accumulation, Distribution, and Elimination of
14C-residues. (Unpublished study received Jul 3,1979 under 524-331; prepared by Bionomics, EG & G,
Inc., submitted by Monsanto Co., Washington, DC; CDL: 238764-G)
Heenehan, P.; Rinehart, W.; Braun, W. (1979) Acute Oral Toxicity Study in Rats: Project No. 4887-77;
BDN-77-430. Rev. (Unpublished study received Oct 16,1979 under 524-152; prepared by
Bio/dynamics, Inc., submitted by Monsanto Co., Washington, DC; CDL:241292-J)
Braun, W.; Rinehart, W. (1978) Acute Dermal Toxicity Study in Rabbits: Project No. 4888-77;
BDN-77-430. (Unpublished study received Oct 16,1979 under 524-152; prepared by Bio/dynamics, Inc.,
submitted by Monsanto Co., Washington, DC; CDL:241292-K)
Heenehan, P.; Braun, W.; Rinehart, W. (1979) Primary Dermal Irritation Study in Rabbits: Project No.
4890-77; BDN-77-430. Rev. (Unpublished study received Oct 16, 1979 under 524-152; prepared by
Bio/dynamics, Inc., submitted by Monsanto Co., Washington, DC; CDL:241292-M)
Monsanto Co. (1979) jiChemistry of Propachlor|. (Compilation; unpublished study received Jul 3, 1979
under 524-331; CDL:238763-A)
Fletcher, D. (1973) Report to Monsanto Company:. 8-day Dietary LC50 Study with Ramrod Technical in
Mallard Ducklings: IBT No. 65102840. (Unpublished study received May 24, 1973. under unknown
admin, no.; prepared by Industrial Bio-Test Laboratories, Inc., submitted by Monsanto Co., Washington,
DC;CDL:131662-A)
Schardein, J.; Wahlberg, D.; Allen, S.; et al. (1982) Teratology Study in Rats (IR-81-264): 401-171.
(Unpublished study received Aug 21, 1972 under 524-152; prepared by International Research and
Development Corp., submitted by Monsanto Co., Washington, DC; CDL:248368-A)
Beavers, J.; Jaber, M.; Joiner, G.; etal. (1983) An Eight-day Dietary LC50 in Bobwhite Quail with
Propachlor: Project No. 139-217. Final rept. (Unpublished study received Dec 2, 1983 under 524-152;
prepared by Wildlife International Ltd., submitted by Monsanto Co., Washington, DC; CDL:251864-B)
Beavers, J.; Jaber, M.; Joiner, G.; et al. (1983) An Eight-day Dietary LC50 in Mallard Ducks with
Propachlor: Project No. 139-216. Final rept. (Unpublished study received Dec 2, 1983 under 524-152;
prepared by Wildlife International Ltd., submitted by Monsanto Co., Washington, DC; CDL:251864-C)
Dow Chemical Company (1961) A Study of Total Bromide Residues in California Strawberries from
Preplant Soil Fumigation with Trizone. (Unpublished study received Jul 5, 1962 under 5F0426;
CDL:090462-F) .
163
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MRID
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prepared by Bio/dynamics Inc. 13 p.
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00157852 Naylor, M.; Ruecker, F. (1985) Subchronic Study of.Propachlor Administered in Feed to Dogs: DMEH
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Synthesis in the in vivo-in vitro Rat Hepatocyte DNA Repair Assay: Laboratory Project No. LSC-2021:
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'Laboratory Project No. MSL-6213: Study No. 8406. Unpublished study prepared by Monsanto
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40081701 Lottman, C.; Cowell, J. (1986) Propachlor Residues in Sorghum from Preemergent Treatments of Ramrod
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40113 801 Zeelers, J. (1985) INF-53 84: Developmental Toxicity Study in Rabbits Dosed by Gavage on Days 7-19 of
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108 p.
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Characterization, and Quantification of Metabolites: R. D. No. 755: Laboratory Project No. MSL-5909.
Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. in cooperation with Monsanto
Agricultural Co. 537 p. '" •
40162501 Hamada, N. (1987) Oncogenicity Study in Mice: Propachlor: Lab. Proj. No. 241-159. Unpublished study
prepared by Hazleton Laboratories America, Inc. 1629 p.
40248701 Hamada, N. (1987) Oncogenicity Study in Mice: (Test Material-Propachlor): Study No. 241-159:
(Monsanto No. HL-83-349). Unpublished study prepared by Hazelton Laboratories. 5 p.
40312701 Li, A.; Meyers, C. (1987) In Vitro Cytogenetics Study of Propachlor: R.D. No. 807: Laboratory Project
I.D. EHL 86047. Unpublished study prepared by Monsanto Environmental Health Laboratory. 24 p.
40398301 Keller, K. (1987) Historical Control Data, Individual Maternal Necropsy Data and Definitions of
Terminology Used in Reporting Observations: ^Additional Information Relating to the Previously
Submitted Study: Teratology Study hi Rabbits with Propachlor: R.D. No. 832. Unpublished study
prepared by International Research and Development Corp. 47 p.
40473101 Hamada, N. (1987) Combined Chronic Toxicity and Oncogenicity Study in Rat (Propachlor): Lab. Proj.
No. 241-160. Unpublished study prepared by Hazleton Laboratories America, Inc. 2470 p.
40584001 Lottman, C.; Leyes, G. (1988) Determination of Residues of Propachlor Metabolites in Tissues of Swine
Following A 28 Day Feeding Study: Project No. MSL-7371: R.D. No. 858. Unpublished study prepared
by Monsanto Agicultural Co., and Hazleton Laboratory Americas, Inc. 174 p.
41986001 Bechtel, C. (1991) Acute Inhalation Study of Propachlor Technical: Lab Project Number: ML-91-2/EHL
90242: MSL-11114: R.D. 1055. Unpublished study prepared by Monsanto Environmental Health Lab.
51 p. •
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Lottman, C. (1989) Storage Stability Study of Propachlor Residues in Corn and Sorghum Forage, Fodder
and Grain: Lab Project No: MSL-8288: RD 1067. Unpublished study prepared by Monsanto
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Adam, G. (1992) Rabbit Teratology Study with Propachlor: Lab Project Number: SB-9186: 3044.182:
WI-91-1. Unpublished study prepared by Springborn Laboratories, Inc. and WIL Research Laboratories,
Inc. 400 p. ' .
Jalali-Araghi, K.; Ruzo, L.; Shepler, K. (1992) Hydrolysis of ^carbon 14|-,Propachlor at pH 5,7, and 9:
Lab Project Number: MSL-12156: 351W: RD 1133. Unpublished study prepared by PTRL-West Inc.
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Atkins, R. (1992) Soil Adsorption/Desorption of ^carbon 14|-Propachlor by the Batch Equilibrium
Method: Lab Project Number: MSL-12210: 664: RD 1133. Unpublished study prepared by
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Atkins, R. (1992) Soil Adsorption/Desorption of 0carbon 14|-Propachlor Oxanilic Acid by the Batch
, Equilibrium Method: Lab Project Number: MSL-12228: 653: 1133. Unpublished study prepared by
PTRL-East, Inc. 107 p.
Atkins, R. (1992) Soil Adsorption/Desorption of 0carbon 14|-Propachlor Sulfonic Acid by the Batch
Equilibrium Method: Lab Project Number: MSL-12229: 654: RD 1133. Unpublished study prepared
by PTRL-East Inc. 96 p.
White, T. (1992) Tier 2 Seed Germination/Seedling Emergence Nontarget Phytotoxicity Study Using
Propachlor: Lab Project Zealand White Rabbits-Teratology Study SLS 3044.182: Supplement to MRID
42348002: Lab Project Number: RD 1147. Unpublished study prepared by Monsanto Co. 6 p.
Li, A.; Raju, N.; Branch, D.; et al. (1992) Acute Neurotoxicity Study of Propachlor in Sprague-Dawley
Rats: Lab Project Number: ML-92-111: 92008: 92015. Unpublished study prepared by Monsanto Co.
421 p.
Hughes, J.; Williams, T. (1992) The Toxicity of Propachlor Technical to Selenastrum capricornutum: Lab
Project Number: B092-032-1: XX-92-173: RD 1147. Unpublished study prepared by Malcolm Pimie,
Inc. and Monsanto Co. 34 p.
Klemm, G. (1993) The Metabolism of Propachlor in Bluegill Sunfish: Lab Project Number: MSL-12385:
RD 1167. Unpublished study prepared by Monsanto Company-The Agricultural Group. 147 p.
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42828101 Fisher, A. (1993) Product Chemistry Data to Support the Continued Registration of Propachlor
(2-chloro-N-isopropyl-N-phenylacetamide): Supplemental: Lab Project Number: MSL-3446: MSL-4890:
KD 630. Unpublished study prepared by Monsanto. 10 p.
42962502 Purdue, D.; King, D.; Atkins, R. (1993) Aerobic Metabolism of (Carbon-14) Propachlor in Sandy Loam
Soil: Lab Project Number: 662: 1543: 1184. Unpublished study prepared by PTRL East, Inc. 205 p.
42962503 Lawrence, B.; King, D.; Atkins, R. (1993) "Anaerobic Aquatic Metabolism of (carbon 14) Propachlor":
Lab Project Number: 663: 1544: 1184. Unpublished study prepared by PTRL East, Inc. 144 p.
43028501 Lyford, S.; El-Banna, S.; McCort, M. (1993) FDA Multiresidue Method Testing of Propachlor and its
Major Metabolites: FinalReport: Lab Project Number: 6103-165: MSL-13151: HWI 6103-165.
Unpublished study prepared by Hazleton Wisconsin, Inc. 168 p
43028601 Gibson, K. (1993) Radiolabeled Validation of the Proposed Enforcement Method for Residues of
Propachlor in Sorghum Raw Agricultural Commodities: Lab Project Number: MSL/13013: P373W:
93-15-R-l. Unpublished study prepared by The Agricultural Group of Monsanto Co. and PTRL West,
Inc. 132 p.
•., '" ; '
43028602 Gibson, K.; Lau, P. (1993) Regulatory Enforcement Method for the Determination of Propachlor
Residues in Raw Agricultural Commodities of Corn and Sorghum, and Animal Products: Lab Project
Number: MSL-12679:1188: 92-15-R-4. Unpublished study prepared by The Agricultural Group of
Monsanto Co. 94 p.
43147705 Hoxter, K.; Bernard, W.; Beavers, J. (1993) Technical Grade Propachlor: A Dietary LC50 Toxicity Study
with the Honey Bee: Final Report: Lab Project Number: 139-340: WL-92-266. Unpublished study
prepared by Wildlife International Ltd. 14 p.
43147706 Hoxter, K.; Bernard, W.; Beavers, J. (1993) Technical Grade Propachlor: An Acute Grade Toxicity Study
with the Honey Bee: Final Report: Lab Project Number: 139-341: WL-92-267. Unpublished study
prepared by Wildlife International Ltd. 15 p.
43226701 Weppelman, R. (1994) Letter Sent to Office of Pesticide Programs dated 5/9/94: (Regarding two
generation reproduction study with rats: propachlor). Prepared by Monsanto Agricultural Group. 1 p.
43221801 Naylor, M. (1994) Dominant Lethal Study of Propachlor in Sprague-Dawley Rats: Lab Project Number:
ML-93-145: EHL 93050: MSL-13505. Unpublished study prepared by Monsanto Co., The Agricultural
Group. 378 p.
* i -
43251801 Lucas, L. (1994) Independent Laboratory Confirmation of the Enforcement Method for Determining
Propachlor and Its NIP A-Yielding Metabolites in Corn, Sorghum, and Animal Products According to PR
Notice 88-5 Guidelines: Final Report: Lab Project Number: 41375: RD/1249: MSL/13518. Unpublished
study prepared by ABC Laboratories, Inc. 103 p.
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43525101 Lao, P. (1995) Dissipation of Propachlor and Its Metabolites in Field Soils: Lab Project Number:
MSL-13832:41384: R.D. 1290. Unpublished study prepared by Monsanto Co.; ABC Labs, Inc.; and
Stewart Agricultural Research Services, Inc. 1181 p. .
'43575701 Branch, D.; Thake, D.; Li, A. et al. (1995) Subchronic Neurotoxicity Study of Propachlor Administered in
' Feed to CD Rats: Lab Project Number: ML/94/075: EHL/94005: RD/1291. Unpublished study prepared
by Monsanto Environmental Health Lab. 41 Op.
Lemen, J.; Thake, D. (1995) Two Generation Reproduction Study of Propachlor Administered in the Diet
to Albino Rats: Lab Project Number: ML-93-304: EHL 93121: R.D. 1332. Unpublished study prepared
by Ceregen Lab (a Unit of Monsanto Co.). 937 p. .
Naylor, M.; Ruecker, F. (1996) Oncogenicity Study of Propachlor Administered in Feed to CD-I Mice for
18 Months: Lab Project Number: ML-93-191: EHL 93076: 14744. Unpublished study prepared by
Ceregen (Monsanto) Environmental Health Laboratory (EHL); Experimental Pathology Laboratories, Inc.
(EPL); and Colorado Histo-Prep, Inc. 1567 p. ,
Heydens, W. (1996) Historical Control Information from 18 Month Chronic Mouse Studies Conducted at
the Monsanto Environmental Health Laboratory: (Propachlor): Lab Project Number: 1362: ML-93-191.
Unpublished study prepared by Monsanto Co. 8 p.
44315501 Rages, D. (1997) Storage Stability/Corrosion Study for Technical, Grade Propachlor: (Final Report):. Lab
Project Number: MSL-14813: PC15-94-8-D: 1385. Unpublished study prepared by Monsanto Co. 59 p.
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1 Number: 3044. 681: SB-98-061: SB98-061. Unpublished study prepared by Springborn Labs., Inc. 345 p.
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drinking water from ground water sources." USEPA/OPP/EFED, September, 1997.
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chain (Kenaga) nomogram, and instrument for estimating pesticide residues on plants. Environ. Tox. Chem.
13:1383-1391. . . . '
Gustafson, D.I., and L.R. Holden. 1990. Nonlinear pesticide dissipation in soil: A new model based on
spatial vaiability. Environ. Sci. Technol. 24:1032"1038.
Hoerger, F., and E.E. Kenaga. 1972. Pesticide residues on plants: Correlation of representative data as a
basis for estimation of their magnitude in the environment. In F. Coulston and F. Korte, eds., Environmental
Quality and Safety: Chemistry, Toxicology, and Technology, Georg Thieme Publ, Stuttgart, West Germany,
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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, B.C. 20460
OFFICEOF
PREVENTION, PESTICIDES
AND TOXIC SUBSTANCES
GENERIC AND PRODUCT SPECIFIC
DATA CALL-IN NOTICE
CERTIFIED MAIL
Dear Sir or Madam:
This Notice requires you and other registrants of pesticide products containing the active
ingredient identified in Attachment A of this Notice, the Data Call-In Chemical Status Sheet, to
submit certain data as noted herein to the U.S. Environmental Protection Agency (EPA, the
Agency). These data are necessary to maintain the continued registration of your product(s)
containing this active ingredient. Within 90 days after you receive this Notice you must respond as
set forth in Section III below. Ypur response must state: ,
1. How you will comply with the requirements set forth in this Notice and its Attachments 1
through 6; or
2. Why you believe you are exempt from the requirements listed in this Notice and in
Attachment 3 (for both generic and product specific data), the Requirements Status and
Registrant's Response Form, (see section III-B); or :
3. Why you believe EPA should not require your submission of data in the manner specified by
this Notice (see section III-D).
. • t - -
If you do not respond to this Notice, or if you do not satisfy .EPA that you will comply with its
requirements or should be exempt or excused from doing so, then the registration of your
product(s) subject to this Notice will be subject to suspension. We have provided a list of all of
your products subject to this Notice in Attachment 2. All products are listed on both the generic
and product specific Data Call-in Response Forms. Also included is a list of all registrants who
were sent this Notice (Attachment 5). , ' '
The authority for this Notice is section 3(c)(2)(B) of the Federal Insecticide, Fungicide and
Rodenticide Act as amended (FIFRA), 7 U.S.G. section 136a(c)(2)(B)..Collection of this
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information is authorized under the Paperwork Reduction Act by OMB Approval No. 2070-0107
and 2070-0057 (expiration date 3-31-99).
This Notice is divided into six sections and six Attachments. The Notice itself contains
information and instructions applicable to all Data Call-In Notices. The Attachments contain
specific chemical information and instructions. The six sections of the Notice are:
Section I - Why You are Receiving this Notice
Section II - Data Required by this Notice
Section III - Compliance with Requirements of this Notice
Section IV - Consequences of Failure to Comply with this Notice
Section V - Registrants' Obligation to Report Possible Unreasonable Adverse Effects
Section VI - Inquiries and Responses to this Notice
f • • i *• .
The Attachments to this Notice are: -
1- Data Call-In Chemical Status Sheet
2- Generic Data Call-in and Product Specific Data Call-in Response Forms with
Instructions (Form A)
3 - Generic Data Call-In and Product Specific Data Call-in Requirements Status and
Registrant's Response Forms with Instructions (Form B)
4- EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistration
5 - List of Registrants Receiving This Notice
6- Cost Share and Data Citation Forms
SECTION!. WHY YOU ARE RECEIVING THIS NOTICE
The Agency has reviewed existing data for this active ingredient(s) and reevaluated the data
needed to support continued registration of the subject active ingredient(s). This reevaluation
identified additional data necessary to assess the health and safety of the continued use of
products containing this active ingredient(s). You have been sent this Notice because you have
product(s) containing the subject active ingredient(s).
SECTION II. DATA REQUIRED BY THIS NOTICE
II-A. DATA REQUIRED
The data required by this Notice are specified in the Requirements Status and Registrant's
Response Forms: Attachment 3 (for both generic and product specific data requirements).
Depending on the results of the studies required in this Notice, additional studies/testing may be
required.
TT-R. SCHEDULE FOR SUBMISSION OF DATA
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You are required to submit the data or otherwise satisfy the data requirements specified in the
Requirements Status and Registrant's Response Forms (Attachment 3) within the timeframes
provided/ " '
II-C. TESTING PROTOCOL
All studies required under this Notice mustbe conducted in accordance with test standards
outlined in the Pesticide Assessment Guidelines for those studies for which guidelines have been
established. . . -
These EPA Guidelines are available from the National Technical Information Service (NTIS),
Attn: Order Desk, 5285 Port Royal Road, Springfield, VA 22161 (Telephone number
703-605-6000).
Protocols approved by the Organization for Economic Cooperation and Development (OECD)
are also acceptable if the OECD recommended test standards conform to those specified in the
Pesticide Data Requirements regulation (40 CFR § 158.70). When using the OECD protocols,
they should be modified as appropriate so that the data generated by the study will satisfy the
requirements of 40 CFR § 158. Normally, the Agency will not extend deadlines for complying
with data requirements when the studies were not conducted in accordance with acceptable
standards. The OEGD protocols are available from OECD, 2001 L Street, N.W., Washington,
D.C. 20036 (Telephone number 202-785-6323; Fax telephone number 202-785-0350).
All new studies and proposed protocols submitted in respqnse to this Data Call-in Notice must
be in accordance with Good Laboratory Practices [40 CFR Part 160].
II-D. REGISTRANTS RECEIVING PREVIOUS SECTION 3(cY2}(E} NOTICES ISSUED BY
THE AGENCY .
Unless otherwise noted herein, this Data Call-In does not in any way supersede or change the
requirements of anv previous Data Call-Msl or any other agreements entered into with the •
Agency pertaining to such prior Notice. Registrants must comply with the requirements of all
Notices to avoid issuance of a Notice of Intent to Suspend their affected products.
SECTION HI. COMPLIANCE WITH REQUIREMENTS OF THIS NOTICE
You must use the correct forms and instructions when completing your response to this
Notice. The type of Data Call-in you must comply with (Generic or Product Specific) is specified
initem number 3 on the four Data Call-In forms (Attachments 2 and 3).
III-A. , SCHEDULE FOR RESPONDING TO THE AGENCY
The appropriate responses initially required by this Notice for generic and product specific data
must be submitted to the Agency within 90 days after your receipt of'this Notice. Failure to
adequately respond to this Notice within 90 days of your receipt will be a basis for issuing a
173
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Notice of Intent to Suspend (NOIS) affecting your products. This and other bases for issuance of
NOIS due to failure to comply with this Notice are presented in Section IV-A and IV-B.
III-B. OPTIONS FOR RESPONDING TO THE AGENCY
1. Generic Data Requirements
The options for responding to this Notice for generic data requirements are: (a) voluntary
cancellation, (b) delete use(s), (c) claim generic data exemption, (d) agree to satisfy the generic
data requirements imposed by this Notice or (e) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option, the Delete
Use(s) option or the Generic Data Exemption option is presented below. A discussion of the
various options available for satisfy ing the generic data requirements of this Notice is contained in
Section III-C. A discussion of options relating to requests for data waivers is contained in Section
III-D.
Two forms apply to generic data requirements, one or both of which must be used in
responding to the Agency, depending upon your response. These two forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form, (contained in
Attachments 2 and 3, respectively).
The Data Call-in Response Forms must be submitted as part of every response to this Notice.
The Requirements Status and Registrant's Response Forms also must be submitted if you do not
qualify for a Generic Data Exemption or are not requesting voluntary cancellation of your
registration(s). Please note that the company's authorized representative is required to sign the
first page of both Data Call-In Response Forms and the Requirements Status and Registrant's
Response Forms (if this form is required) and initial any subsequent pages. The forms contain
separate detailed instructions on the response options. Do not alter the printed material. If you
have questions or need assistance in preparing your response, call or write the contact person(s)
identified in Attachment 1.
a. Voluntary Cancellation -
You may avoid the requirements of this Notice by requesting voluntary cancellation of your
produces) containing the active ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit completed Generic and Product Specific Data
Call-in Response Forms (Attachment 2), indicating your election of this option. Voluntary
cancellation is item number 5 on hnth Data Call-in Response FormCsX If you choose this option,
these are the only forms that you are required to complete. •
If you chose to voluntarily cancel your product, further sale and distribution of your product
after the effective date" of cancellation must be in accordance with the Existing Stocks provisions
of this Notice, which are contained in Section IV-C.
b. Use Deletion -
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You may avoid the requirements of this Notice by eliminating the uses of your product to
which the requirements apply. If you wish to amend your registration to delete uses, you must
submit the Requirements Status and Registrant's Response Form (Attachment 3), a completed
application for amendment, a copy of your proposed amended labeling, and all other information
required for processing the application. Use deletion is option number 7 under item 9 in the
instructions for the Requirements Stains and Registrant's Response Forms, You must also
complete a Data Call-in Response Form by signing the certification, item number 8. Application
forms for amending registrations may be obtained from the Registration Support Branch,
Registration Division, Office of Pesticide Programs, EPA, by calling (703) 308-8358.
If you choose to delete the use(s) subject to this Notice or uses subject to specific data
requirements, further sale, distribution, or use of your product after one year from the due date of
your 90 day response, is allowed only if the product bears an amended label.
c. Generic Data Exemption - •
Under section 3(c)(2)(D) of FIFRA, an applicant for registration of a product is exempt from
the requirement to submit or cite generic data concerning an active ingredient if the active
ingredient in the product is derived exclusively from purchased, registered pesticide products,
containing the active ingredient. EPA has concluded, as an exercise of its discretion, that it
normally will not suspend the registration of a product which would qualify and continue to
qualify for the generic data exemption in section 3(c)(2)(D) of FIFRA. To qualify, all of the
following requirements must be met:
(i). The active ingredient ha your registered product must be present solely because of
incorporation of another registered product which contains the subject active ingredient and is
purchased from a source not connected with you;
w
(ii). Every registrant who is the,ultimate source of the active ingredient in your product
subject to this DCI must be in compliance with the requirements of this Notice and must
remain in compliance; and
(iii). You must have provided to EPA an accurate and current "Confidential Statement of
Formula" for each of your products to which this Notice applies.
To apply for the Generic Data Exemption you must submit a completed Data Call-in Response
Form, Attachment 2 and all supporting documentation. The Generic Data Exemption is item
number 6a on the Data Call-In Response Form. If you claim a generic data exemption you are not
required to complete the Requirements Status and Registrant's Response Form. Generic Data
Exemption cannot be selected as an option for responding to product specific data requirements.
If you are granted a Generic Data Exemption, you rely on the efforts of other persons to
provide the Agency with the required data. If the registrant(s) who have committed to generate
and submit the required data fail to take appropriate steps to meet requirements or are no longer
in compliance with this Data Call-In Notice, the Agency will consider that both they and you are
'not compliance and will normally initiate proceedings to suspend the registrations of both your
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and their product(s), unless you commit to submit and do submit the required data within the
specified time. In such cases the Agency generally will not grant a time extension for submitting
the data.
d. Satisfying the Generic Data Requirements of this Notice
There are various options available to satisfy the generic data requirements of this Notice.
These options are discussed in Section III-C.l. of this Notice and comprise options 1 through 6 of
item 9 in the instructions for the Requirements Status and Registrant's Response Form and item
6b on the Data Call-In Response Form. If you choose item 6b (agree to satisfy the generic data
requirements), you must submit the Data Call-in Response Form and the Requirements Status and
Registrant's Response Form as well as any other information/data pertaining to the option chosen
to address the data requirement. Your response must be on the forms marked "GENERIC" in
item number 3.
e. Request for Generic Data Waivers.
Waivers for generic data are discussed hi Section III-D.l. of this Notice and are covered by
options 8 and 9 of item 9 hi the instructions for the Requirements Status and Registrant's
Response Form. If you choose one of these options, you must submit both forms as well as any
other information/data pertaining to the option chosen to address the data requirement.
2. Product Specific Data Requirements
The options for responding to this Notice for product specific data are: (a) voluntary
cancellation, (b) agree to satisfy the product specific data requirements imposed by this Notice or
(c) request a data waiver(s).
A discussion of how to respond if you choose the Voluntary Cancellation option is presented
below. A discussion of the various options available for satisfying the product specific data
requirements of this Notice is contained in Section III-C.2. A discussion of options relating to
requests for data waivers is contained in Section III-D.2.
Two forms apply to the product specific data requirements one or both of which must be used
La responding to the Agency, depending upon your response. These forms are the Data-Call-in
Response Form, and the Requirements Status and Registrant's Response Form, for product
specific data (contained hi Attachments 2 and 3, respectively). The Data Call-In Response Form
must be submitted as part of every response to this Notice. In addition, one copy of the
Requirements Status and Registrant's Response Form also must be submitted for each product
listed on the Data Call-In Response Form unless the voluntary cancellation option is selected.
Please note that the company's authorized representative is required to sign the first page of the
Data Call-In Response Form and Requirements Status and Registrant's Response Form (if this
form is required) and initial any subsequent pages. The forms contain separate detailed
instructions on the response options. Do not alter the printed material. If you have questions or
need assistance in preparing your response, call or write the contact person(s) identified in
Attachment 1.
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a. Voluntary Cancellation
You may avoid the requirements of this Notice by requesting voluntary cancellation of your
produces) containing the active ingredient that is the subject of this Notice. If you wish to
voluntarily cancel your product, you must submit a completed Data Call-in Response Form.,
indicating your election of this option. Voluntary cancellation is item number 5 on both the '
Generic and Product Specific Data Call-In Response Forms. If you choose this option, you must
complete both Data Call-In response forms. These are the only forms that you are required to
complete. .
If you choose to voluntarily cancel your product, further sale and distribution of your product
after the effective date of cancellation must be in accordance with the Existing Stocks provisions
of this Notice which are contained in Section IV-C.
' >- •
b. -Satisfying the Product Specific Data Requirements of this Notice
There are various options available to satisfy the product specific data requirements of this
Notice. These options are discussed in Section III-C. of this Notice and comprise options 1
through 6 of item 9 in the instructions for the product specific Requirements Status and
Registrant's Response Form and item numbers 7a and 7b (agree to satisfy the product specific
data requirements for an MUP or EUP as applicable) on the product specific Data Call-in
Response Form. Note that the options available for addressing product specific data requirements
differ slightly from those options for fulfilling generic data requirements. Deletion of a use(s) and
the low volume/minor use option are not valid options for fulfilling product specific data
requirements. It is important to .ensure that you are using the correct forms and instructions when
completing your response to the Reregistration Eligibility Decision document.
c. Request for Product Specific Data Waivers. '
Waivers for prpduct specific data are discussed in Section III-D.2, of this Notice and are '
covered by option 7 of item 9 in the instructions for the Requirements Status and Registrant's
Response Form. If you choose this option, you must submit the Data Call-in Response Form and
the Requirements Status and Registrant's Response Form as well as any other information/data
pertaining to the option chosen to address the data requirement. Your response must be on the '
forms marked "PRODUCT SPECIFIC" in item number 3.
III-C SATISFYING THE DATA REQUIREMENTS OF THIS NOTTCF.
1. Generic Data
If you acknowledge on the Generic Data Call-In Response Form that you agree to satisfy the
generic data requirements (i.e. you select item number 6b), then you must select one of the six
options on the Generic Requirements Status and Registrant's Response Form related to data
production for each data requirement. Your option selection should be entered under item number
9, "Registrant Response." The six options related to data production are the first six options
discussed under item 9 in the instructions for completing the Requirements Status and Registrant's
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Response Form. These six options are listed immediately below with information in parentheses to
guide you to additional instructions provided in this Section. The options are:
(1) I will generate and submit data within the specified timeframe (Developing Data)
(2) I have entered into an agreement with one or more registrants, to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
(6) I am citing an existing study that EPA has classified as acceptable or an existing study
that has been submitted but not reviewed by the Agency (Citing an Existing Study)
Option 1. Developing Data
If you choose to develop the required data it must be in conformance with Agency guidelines
and with other Agency requirements as referenced herein and hi the attachments. All data
generated and submitted must comply with the Good Laboratory Practice (GLP) rule (40 CFR
Part 160), be conducted according to the Pesticide Assessment Guidelines (PAG) and be in
conformance with the requirements of PR Notice 86-5. In addition, certain studies require Agency
approval of test protocols in advance of study initiation. Those studies for which a protocol must
be submitted have been identified in the Requirements Status and Registrant's Response Form
and/or footnotes to the form. If you wish to use a protocol which differs from the options
discussed hi Section II-C of this Notice, you must submit a detailed description of the proposed
protocol and your reason for wishing to use it. The Agency may choose to reject a protocol not
specified in Section II-C. If the Agency rejects your protocol you will be notified in writing,
however, you should be aware that rejection of a proposed protocol will not be a basis for
extending the deadline for submission of data.
A progress report must be submitted for each study within 90 days from the date you are
required to commit to generate or undertake some other means to address that study requirement,
such as making an offer to cost share or agreeing to share in the cost of developing that study.
This 90-day progress report must include the date the study was or will be initiated and, for
studies to be started within 12 months of commitment, the name and address of the
laboratory(ies) or individuals who are or will be conducting the study.
In addition, if the time frame for submission of a final report is more than 1 year, interim
reports must be submitted at 12 month intervals from the date you are required to commit to
generate or otherwise address the requirement for the study. In addition to the other information
specified hi the preceding paragraph, at a minimum, a brief description of current activity on and
the status of the study must be included as well as a full description of any problems encountered
since the last progress report. •
The time frames in the Requirements Status and Registrant's Response Form are the time
frames that the Agency is allowing for the submission of completed study reports or protocols.
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The noted deadlines run from the date of the receipt of this Notice by the registrant. If the data
are not submitted by the deadline, each registrant is subject to receipt of a Notice of Intent to
Suspend the affected registration(s).
If you cannot submit the data/reports to the Agency in the time required by this Notice and
intend to seek additional time to meet the requirements(s), you must submit a request to the
Agency which includes: (1) a detailed description of the expected difficulty and (2) a proposed
schedule including alternative dates for meeting such requirements on. a step-by-step basis. You
must explain any technical or laboratory difficulties and provide documentation from the
laboratory performing the testing. While EPA is considering your request, the original deadline
remains. The Agency will respond to your request in writing. If EPA does not grant your request,
the original deadline remains. Normally, extensions can be requested only in cases of
extraordinary testing problems beyond the expectation or control of the registrant. Extensions will
not.be given in submitting the 90-day responses. Extensions will not be considered if the request
for extension is not made in a timely fashion; in no event shall an extension request be considered
if it is submitted at or after the lapse of the subject deadline.
Option 2. Agreement to Share in Cost to Develop Data .
If you choose to enter into an.agreement to share in the cost of producing the required data but
will hot be submitting the data yourself, you must provide the name of the registrant who will be
submitting the data. You must also provide EPA with documentary evidence that an agreement
has been formed. .Such evidence may be your letter offering to join in an agreement and the other
registrant's acceptance of your offer, or a written statement by. the parties that an agreement
„ exists. The agreement to produce the data need not specify all of the terms of the final :
arrangement between the parties or the mechanism to resolve the terms. Section 3(c)(2)(B)
provides that if the parties cannot resolve the terms of the agreement they may resolve their.
differences through binding arbitration.
Option 3. Offer to Share in the Cost of Data Development . •
If you have made-an offer to pay in an attempt to enter into an agreement or amend an existing
.agreement to meet the requirements of this Notice and have been unsuccessful, you may request
EPA (by selecting this option) to exercise its discretion not to suspend your registrations),
although you did not comply with the data submission requirements of this Notice. EPA has
determined that as a general policy, absent other relevant considerations, it will not suspend the
registration of a product of a registrant who has in good faith sought and continues to seek to
enter into a joint data development/cost sharing program, but the other registrant(s) developing
the data has refused to accept the offer. To qualify for this option, you must submit
documentation to the Agency proving that you have made an offer to another registrant (who has
an obligation to submit data) to share in the burden of developing that data. You must also submit
to the Agency a completed EPA Form, 8570-32, Certification of Offer to Cost Share in the
Development of Data, Attachment 6. In addition, you must demonstrate that the other registrant
to whom the offer was made has not accepted your offer to enter into a cost-sharing agreement by
including a copy of your offer and proof of the other registrant's receipt of that offer (such as a
certified mail receipt). Your offer must, in addition to anything else, offer to share in the burden of
producing the data upon terms to be agreed to or, failing agreement, to be bound by binding
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arbitration as provided by FIFRA section 3(c)(2)(B)(iii) and must not qualify this offer. The other
registrant must also inform EPA of its election of an option to develop and submit the data
required by this Notice by submitting a Data Call-in Response Form and a Requirements Status
and Registrant's Response Form committing to develop and submit the data required by this
Notice.
In order for you to avoid suspension under this option? you may not withdraw your offer to
share in the burden of developing the data. In addition, the other registrant must fulfill its
corrimitment to develop and submit the data as required by this Notice. If the other registrant fails
to develop the data or for some other reason is subject to suspension, your registration as well as
that of the other registrant normally will be subject to initiation of suspension proceedings, unless
you commit to submit, and dp submit, the required data in the specified time frame. In such cases,
the Agency generally will not grant a time extension for submitting the data.
Option 4. Submitting an Existing Study
If you choose to submit an existing study in response to this Notice, you must determine that
the study satisfies the requirements imposed by this Notice. You may only submit a study that has
not been previously submitted to the Agency or previously cited by anyone. Existing studies are
studies which predate issuance of this Notice. Do not use this option if you are submitting data to
upgrade a study. (See Option 5).
You should be aware that if the Agency determines that the study is not acceptable, the
Agency will require you to comply with this Notice, normally without an extension of the required
date of submission. The Agency may determine at any time that a study is not valid and needs.to
be repeated.
To meet the requirements of the DCI Notice for submitting an existing study, all of the
following three criteria must be clearly met:
a. You must certify at the time that the existing study is submitted that the raw data and
specimens from the study are available for audit and review and you must identify where
they are available. This must be done in accordance with the requirements of the Good
Laboratory Practice (GLP) regulation, 40 CFR Part 160. As stated in 40 CFR 160.3, Raw
data means any laboratory worksheets, records, memoranda, notes, or exact copies thereof,
that are the result of original observations and activities of a study and are necessary for the
reconstruction and evaluation of the report of that study. In the event that exact transcripts
of raw data have been prepared (e.g., tapes which have been transcribed verbatim, dated,
and verified accurate by signature), the exact copy or exact transcript may be substituted for
the original source as raw data. 'Raw data' may include photographs, microfilm or
microfiche copies, computer printouts, magnetic media, including dictated observations, and
recorded data from automated instruments." The term "specimens", according to 40 CFR
160.3, means "any material derived from a test system for examination or analysis."
.b. Health and safety studies completed after May 1984 must also contain all GLP-required
quality assurance and quality control information pursuant to the requirements of 40 CFR
Part 160. Registrants also must certify at the time of submission of the existing study that
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such GLP information is available for' post May 1984 studies by including an appropriate
statement on or attached to the study signed by an authorized official or representative of
the registrant.
c. You must certify that each study fulfills the acceptance criteria for the Guideline relevant to
the study provided in the FIFRA Accelerated Reregistration Phase 3 Technical Guidance
and that the study has been conducted according to the Pesticide Assessment Guidelines
(PAG) or meets the purpose of the PAG (both documents available from NTIS). A study
not conducted according to the PAG may be submitted to the Agency for consideration if
" the registrant believes that the study clearly meets the purpose of the PAG. The registrant is
referred to 40 CFR 158.70 which states the Agency's policy regarding acceptable protocols.
If you wish to submit the study, you must, in addition to certifying that the purposes of the
PAG are met by the study, clearly articulate the rationale why you believe the study .meets
the purpose of the PAG, including copies of any supporting information or data. It has been'
the Agency's experience that studies completed prior to January 1970 rarely satisfied the
purpose of the PAG and that necessary raw data usually are not available for such studies.
If you submit an existing study, you must certify that the study meets all requirements of the
criteria outlined above.
If EPA has previously reviewed a protocol for a study you are submitting, you must identify
any action taken by the Agency on the protocol and must indicate, as part of your certification,
the manner in which all Agency comments, concerns, or issues were addressed in the final
protocol and study.
• !
If you know of a study pertaining to any requirement in this Notice which does not meet the
criteria outlined above'but does contain factual information regarding unreasonable adverse
effects, you must notify the Agency of such a study. If such a study is in the Agency's files, you'
need only cite it along .with the notification. If not in the Agency's files, you must submit a
summary and copies as required by PR Notice 86-5. -
Option 5. Upgrading a Study
If a study has been classified as partially acceptable and upgradeable, you may submit data to
upgrade that study. The Agency will review the data submitted and determine if the requirement is
satisfied. If the Agency decides the requirement is not satisfied, you may still be required to
submit new data normally without any time extension. Deficient, but upgradeable studies will
normally be classified as supplemental. However, it is important to note that not'all studies
classified as supplemental are upgradeable. If you have questions regarding the classification of a
study or whether a study may be upgraded, call or write the contact person listed in Attachment 1.
If you submit data to upgrade an existing study you must satisfy or supply information to correct
all deficiencies in the study identified by EPA. You must provide a clearly articulated rationale of
how the deficiencies have been remedied or corrected and why the study should be rated as
acceptable to EPA. Your submission must also specify the MRID number(s) of the study which
you are attempting to upgrade and must be in conformance with PR Notice 86-5.
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Do not submit additional data for the purpose of upgrading a study classified as unacceptable
and determined by the Agency as not capable of being upgraded.
This option also should be used to cite data that has been previously submitted to upgrade a
study, but has not yet been reviewed by the Agency. You must provide the MRID number of the
data submission as well as the MRID number of the study being upgraded.
The criteria for submitting an existing study, as specified in Option 4 above, apply to all data
submissions intended to upgrade studies. Additionally, your submission of data intended to
upgrade studies must be accompanied by a certification that you comply with each of those
criteria, as well as a certification regarding protocol compliance with Agency requirements.
Option 6. Citing Existing Studies
If you choose to cite a study that has been previously submitted to EPA, that study must have
been previously classified by EPA as acceptable, or it must be a study which has not yet been
reviewed by the Agency. Acceptable toxicology studies generally will have been classified as
"core-guideline" or "core-rninimum.'1 For ecological effects studies, the classification generally
would be a rating of "core." For all other disciplines the classification would be "acceptable." With
respect to any studies for which you wish to select this option, you must provide the MRID
number of the study you are citing and, if the study has been reviewed by the Agency, you must
provide the Agency's classification of the study.
If you are citing a study of which you are not the original data submitter, you must submit a
p.nmpleted copy of EPA Form 8570-31. Certification with Respect to Data Compensation
Requirements.
2. Product Specific Data
If you acknowledge on the product specific Data Call-In Response Form that you agree to
satisfy the product specific data requirements (i.e. you •select option 7a or 7b), then you must
select one of the six options on the Requirements Status and Registrant's Response Form related
to data production for each data requirement. Your option selection should be entered under item
number 9, "Registrant Response." The six options related,to data production are the first six
options discussed under item 9 in the instructions for completing the Requirements Status and
Registrant's Response Form. These six options are listed immediately below with information in
parentheses to guide registrants to additional instructions provided in this Section. The options
are:
(1) I will generate and submit data within the specified time-frame (Developing Data)
(2) I have entered into an agreement with one or more registrants to develop data jointly
(Cost Sharing)
(3) I have made offers to cost-share (Offers to Cost Share)
(4) I am submitting an existing study that has not been submitted previously to the
Agency by anyone (Submitting an Existing Study)
(5) I am submitting or citing data to upgrade a study classified by EPA as partially
acceptable and upgradeable (Upgrading a Study)
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(6) I am citing an existing study that EPA has classified as acceptable or an existing study
that has been submitted but not reviewed by the Agency (Citing an Existing Study)
Option 1. Developing Data — The requirements for developing product specific data are the same
as those described for generic data (see Section III.C. 1, Option 1) except that normally no
protocols or progress reports are required.
Option 2. Agree to Share in Cost to Develop Data — If you enter into an agreement to cost share,.
the same requirements apply to product specific data as to generic data (see Section III.C. 1,
Option 2). However, registrants may only choose this option for acute toxicity data and certain
efficacy 'data and only if EPA has indicated in the attached data tables that your product and at
least one other product are similar for purposes of depending on the same data. If this is the case,
data may be generated for just one of the products in the group. The registration number of the
product for which data will be submitted must be noted in the agreement to cost share by the
registrant selecting this option. ,
Option 3. Offer to Share in the Cost of Data Development —The same requirements for generic
data (Section III.C.L, Option 3) apply to this option. This option only applies to acute toxicity
and certain efficacy data as described in option 2 above. .
Option 4. Submitting an Existing Study ~ The same requirements described for generic data (see
Section III.C. 1., Option 4) apply to this option for product specific data.
Option 5. Upgrading a Study — The same requirements described for generic data (see Section
III.C.l., Option 5) apply to this option for product specific data.
Option 6. Citing Existing Studies — The same requirements described for generic data (see
Section III.C. 1., Option 6) apply to this option for product specific data. ' ,
Registrants who, select one of the above 6 options must meet all of the requirements described
in the instructions for completing the Data Call-In Response Form and the Requirements Status
and Registrant's Response Form, and in the generic data requirements section (III.C.l.), as
appropriate.
III-D REQUESTS FOR DATA WAIVERS
1. Generic Data •
There are two types of data waiver responses to this Notice. The first is a request for a low
volume/minor use waiver and the second is a waiver request based on your belief that the data
requirements) are not appropriate for your product..
a. Low Volume/Minor Use Waiver
Option 8 under item 9 on the Requirements Status and Registrant's Response Form. Section
3(c)(2)(A) of FIFRA requires EPA to consider the appropriateness of requiring data for low .
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volume/minor use pesticides. In implementing this provision, EPA considers low volume
pesticides to be only those active ingredients whose total production volume for all pesticide
registrants is small. In determining whether to grant a low volume, minor use waiver, the •
Agency will consider the extent, pattern and volume of use, the economic incentive to conduct
the testing, the importance of the pesticide, and the exposure and risk from use of the
pesticide. If an active ingredient is used for both high volume and low volume uses, a low
volume exemption will not be approved. If all uses of an active ingredient are low volume and
the combined volumes, for all uses are also low, then ah exemption may be granted, depending
on review of other information outlined below. An exemption will not be granted if any
registrant of the active ingredient elects to conduct the testing. Any registrant receiving a low
volume/minor use waiver must remain witihin the sales figures in their forecast supporting the
waiver request in order to remain qualified for such waiver. If granted a waiver, a registrant
will be required, as a condition of the waiver, to submit annual sales reports. The Agency will
respond to requests for waivers in writing.
To apply for a low volume/minor use waiver, you must submit the following information, as
applicable to your product(s), as part of your 90-day response to this Notice:
(i). Total company sales (pounds and dollars) of all registered product(s) containing the
active ingredient If applicable to the active ingredient, include foreign sales for those products
that are not registered in this country but are applied to sugar (cane or beet), coffee, bananas,
cocoa, and other such crops. Present the above information by year for each of the past five
years.
(ii) Provide an estimate of the sales (pounds and dollars) of the active ingredient for each
major use site. Present the above information by year for each of the past five years.
(iii) Total direct production cost of product(s) containing the active ingredient by year for
the past five years. Include information on raw material cost, direct labor cost, advertising,
• sales and marketing, and any other significant costs listed separately.
(iv) Total indirect production cost (e.g. plant overhead, amortized plant and equipment)
charged to product(s) containing the active ingredient by year for the past five years. Exclude
all non-recurring costs that were directly related to the active ingredient, such as costs of initial
registration and any data development.
(v) A list of each data requirement for which you seek a waiver. Indicate the type of waiver
sought and the estimated cost to you (listed separately for each data requirement and
associated test) of conducting the testing needed to fulfill each of these data requirements.
(vi) A list of each data requirement for which you are not seeking any waiver and the
estimated cost to you (listed separately for each data requirement and associated test) of
conducting the testing needed to fulfill each of these data requirements.
(vii) For each of the next ten years, a year-by-year forecast of company sales (pounds and
dollars) of the active ingredient, direct production costs of product(s) containing the active
ingredient (following the parameters in item 2 above), indirect production costs of product(s)
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containing the active ingredient (following the parameters in item 3 above), and costs of data
development pertaining to the active ingredient. :
(viii) A description of the importance and unique benefits of the active ingredient to users.
Discuss the use patterns and the effectiveness of the active ingredient relative to registered
alternative chemicals and non-chemical control strategies. Focus on benefits unique to the
active ingredient, providing information that is as quantitative as possible. If you do not have
quantitative data upon which to base your estimates, then present the reasoning used to derive
your estimates. To assist the Agency in determining the degree of importance of the active
ingredient in terms of its benefits, you should provide information on any of the following
factors, as applicable to your product(s): (a) documentation of the usefulness of the active
ingredient in Integrated Pest Management, (b) description of the beneficial impacts on the
environment of use of the active ingredient, as opposed-to its registered alternatives, (c)
information on the breakdown of the active ingredient after use and on its persistence in the
environment, and (d) description of its usefulness against a pest(s) of public health significance.
Failure to submit sufficient information for the Agency to make a determination regarding a
request for a low volume/minor use waiver will result in denial of the request for a waiver.
b. Request for Waiver of Data
Option 9, under Item 9, on the Requirements Status and Registrant's Response Form. This
- option may be used if you believe that a particular data requirement should not apply because
the requirement is inappropriate. You must submit a rationale explaining why you believe the
data requirements should not apply. You also must submit the current label(s) of your
produces) and, if a current copy-of your Confidential Statement of Formula is not already on
file you must submit a current copy. .
You will be informed of the Agency's decision in writing. If the Agency determines that the
data requirements of this Notice are not appropriate to your product(s), you will not be
required to supply the data pursuant to section 3(e)(2)(B). If EPA determines that the data are
required for vour prbductrsX you must choose a method of meeting the requirements of this
Notice within the time frame provided bv this Notice. Within 30 days of your receipt of the
Agency's written decision, you must submit a revised Requirements Status and Registrant's
Response Form indicating the option chosen.
2. Product Specific Data
If you request a waiver for product specific data because you believe it is inappropriate, you
must attach a complete justification for the request including technical reasons, data and
references to relevant EPA regulations, guidelines or policies. (Note: any supplemental data
must be submitted-in the format required by PR Notice 86-5). This will be the only opportunity
'to state the reasons or provide information in support of your request. If the Agency approves
your waiver request, you will not be required to supply the data pursuant to section 3(c)(2)(B)
of FIFRA. If the Agency denies yourwaiver request, you must choose an option for meeting
the data requirements of this Notice within 30 days of the receipt of the Agency's decision.
You must indicate and submit the option chosen on the product specific Requirements Status
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and Registrant's Response Form. Product specific data requirements for product chemistry,
acute toxicity and efficacy (where appropriate) are required for all products and the Agency
would grant a waiver only under extraordinary circumstances. You should also be aware that
submitting a waiver request will not automatically extend the due date for the study in
question. Waiver requests submitted without adequate supporting rationale will be denied and
the original due date will remain in force.
SECTION IV. CONSEQUENCES OF FAILURE TO COMPLY WITH THIS NOTICE
IV-A NOTICE OF INTENT TO SUSPEND
The Agency may issue a Notice of Intent to Suspend products subject to this Notice due to
failure by a registrant to comply with the requirements of this Data Call-in Notice, pursuant to
FIFRA section 3(c)(2)(B). Events which may be the basis for issuance of a Notice of Intent to
Suspend include, but are not limited to, the following:
1. Failure to respond as required by this Notice within 90 days of your receipt of this Notice.
2. Failure to submit on the required schedule an acceptable proposed or final protocol when
such is required to be submitted to the Agency for review.
3. Failure to submit on the required schedule an adequate progress report on a study as
required by this Notice.
4. Failure to submit on the required schedule acceptable data as required by this Notice.
5. Failure to take a required action or submit adequate information pertaining to any option
chosen to address the data requirements (e.g., any required action or information pertaining
to submission or citation of existing studies or offers, arrangements, or arbitration on the
sharing of costs or the formation of Task Forces, failure to comply with the terms of an
agreement or arbitration concerning joint data development or failure to comply with any
terms of a data waiver).
6. Failure to submit supportable certifications as to the conditions of submitted studies, as
required by Section III-C of this Notice.
7. Withdrawal of an offer to share in the cost of developing required data.
8. Failure of the registrant to whom you have tendered an offer to share in the cost of
• developing data and provided proof of the registrant's receipt of such offer or failure of a
registrant on whom you rely for a generic data exemption either to:
a. Inform EPA of intent to develop and submit the data required by this Notice on a Data
Call-in Response Form and a Requirements Status and Registrant's Response Form.
b. Fulfill the commitment to develop and submit the data as required by this Notice; or
186
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c. Otherwise take appropriate steps to meet the requirements stated in this Notice, unless
you commit to submit and do submit the required data in the specified time frame.
9. Failure to take any required or appropriate steps, not mentioned above, at any time
following the issuance of this Notice.
IV-B. BASIS FOR DETERMINATION THAT SUBMITTED STUDY IS
UNACCEPTABLE
The Agency may determine that a study (even if submitted within the required timeyis
unacceptable and constitutes a basis for issuance of a Notice of Intent to Suspend. The grounds
; for suspension include, but are not limited to, failure to meet any of the following:
1) EPA requirements specified in the Data Call-In Notice or other documents incorporated by
reference (including, as applicable, EPA Pesticide Assessment Guidelines, Data Reporting
Guidelines, and GeneTox Health Effects Test Guidelines) regarding the design, conduct, and
reporting of required studies. Such requirements include, but are not limited to, those relating
to, test material, test procedures, selection of species, number of animals, sex and distribution
of animals, dose and effect levels to be tested or attained, duration of test, and; as applicable,
Good Laboratory Practices.
. 2) EPA requirements regarding the submission of protocols, including the incorporation of any
changes required by me Agency following review. '
3) EPA requirements regarding the reporting of data, including the manner of reporting, the
completeness of results, and the adequacy of any required supporting (or raw) data, including,
but not limited to, requirements referenced or included in this Notice or contained in PR 86-5.
All studies must be submitted in the form of a final report; a preliminary report will not be
considered to fulfill the submission requirement.
IV-C EXISTING STOCKS OF SUSPENDED OR CANCELLED PRODUCTS
EPA has statutory authority to permit continued sale, distribution and use of existing stocks of
a pesticide product which has been suspended or cancelled if doing so would be consistent with
the purposes of the Act.
The Agency has determined that such disposition by registrants of existing stocks for a
suspended registration when a section 3(c)(2)(B) data request is outstanding generally would not
be consistent with the Act's purposes. Accordingly, the Agency anticipates granting registrants
permission to sell, distribute, or use existing stocks of suspended product(s) only in exceptional
circumstances. If you believe such disposition of existing stocks of your product(s) which may be
suspended for failure to comply with this Notice should be permitted, you have the burden of
clearly demonstrating to EPA that granting such permission would be consistent with the Act.
You also must explain why an "existing stocks" provision is necessary, including a statement of
the quantity of existing stocks and your estimate of the tune required for their sale, distribution,
and use. Unless you meet this burden, the Agency will not consider any request pertaining to the
continued sale, distribution, or use of your existing stocks after suspension.
• ' 187 . ' ' . .
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If you request a voluntary cancellation of your product(s) as a response to this Notice and your
product is in full compliance with all Agency requirements, you will have, under most
circumstances, one year from the date your 90 day response to this Notice is due, to sell,
distribute, or use existing stocks. Normally, the Agency will allow persons other than the
registrant such as independent distributors, retailers and end users to sell, distribute or use such
existing stocks until the stocks are exhausted. Any sale, distribution or use of stocks of voluntarily
cancelled products containing an active ingredient for which the Agency has particular risk
concerns will be determined on a case-by-case basis.
Requests for voluntary cancellation received after the 90 day response period required by this
Notice will not result in the agency granting any additional time to sell, distribute, or use existing
stocks beyond a year from the date the 90 day response was due, unless you demonstrate to the
Agency that you are in full compliance with all Agency requirements, including the requirements
of this Notice. For example, if you decide to voluntarily cancel your registration six months before
a 3-year study is scheduled to be submitted, all progress reports and other information, necessary
to establish that you have been conducting the study in an acceptable and good faith manner must
have been submitted to the Agency, before EPA will consider granting an existing stocks
provision.
SECTION V.
REGISTRANTS' OBLIGATION TO REPORT POSSIBLE
UNREASONABLE ADVERSE EFFECTS
Registrants are reminded that FIFRA section 6(a)(2) states that if at any time after a pesticide
is registered a registrant has additional factual information regarding unreasonable adverse effects
on the environment by the pesticide, the registrant shall submit the information to the Agency.
Registrants must notify the Agency of any factual information they have, from whatever source,
including but not limited to interim or preliminary results of studies, regarding unreasonable
adverse effects on man or the environment. This requirement continues as long as the products
are registered by the Agency.
SECTION VL INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding the requirements and procedures established by this
Notice, call the contact person(s) listed in Attachment 1, the Data Call-in Chemical Status Sheet.
All responses to this Notice must include completed Data Call-In Response Forms
(Attachment 2)and completed Requirements Status and Registrant's Response Forms (Attachment
3), for both (generic and product specific data) and any other documents required by this Notice,
and should be submitted to the contact person(s) identified in Attachment 1. If the voluntary
cancellation or generic data exemption option is chosen, only the Generic and Product Specific
Data Call-in Response Forms need be submitted.
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The Office of Compliance (OC) of the Office of Enforcement and Compliance Assurance
(OECA), EPA, will be monitoring the data being generated in response to this Notice.
Sincerely yours,
Lois A. Rossi, Director
Special Review and
Reregistration Division
Attachments
The Attachments to this Notice are:
1 - Data Call-In Chemical Status Sheet
2- , Generic Data Call-In and Product Specific Data Call-In Response Forms with
Instructions
3 - Generic Data Call-In and Product Specific Data Call-In Requirements Status and
Registrant's Response Forms with Instructions
4 - EPA Batching of End-Use Products for Meeting Acute Toxicology Data
Requirements for Reregistratiori .......
5- List of Registrants Receiving This Notice
6- Confidential Statement of Formula. Cost Share and Data Citation Forms
189
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190
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PROPACHLOR DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION '
You have been sent this Product Specific Data Call-In Notice because you have product(s)
containing propachlor.
This Product Specific Data Call-In Chemical Status Sheet, contains an overview of data required
by this notice, and point of contact for inquiries pertaining to the reregistration of propachlor. This
attachment is to be used in conjunction with (1) the Product Specific Data Call-In Notice, (2) the
Product Specific Data Call-In Response Form (Attachment 2), (3) the Requirements Status and
Registrant's Response Form (Attachment 3), (4) EPA's Grouping of End-Use Products for Meeting
Acute Toxicology Data Requirement (Attachment 4), (5) a list of registrants receiving this DCI
(Attachments) and (6) the Cost Share and Data Compensation Forms in replying to this propachlor
Product Specific Data Call-In .(Attachment 6). Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE ,
The additional data requirements needed to complete the database for propachlor are contained
in the Requirements Status and Registrant's Response. Attachment 3. The Agency has concluded that
additional data on propachlor are needed for specific products. These data are required to be
submitted to the Agency within the time frame listed. These data are needed to fully complete the
reregistration of all eligible propachlor products.
INQUIRIES AND RESPONSES TO THIS NOTICE
If you have any questions regarding this product specific data requirements and procedures
established by this Notice, please contact Mark Perry at (703) 305-9548.
All responses to this Notice for the Product Specific data requirements should be submitted to:
.' Mark Perry
Chemical Review Manager Team 81
Product Reregistration Branch
Special Review and Reregistration Branch (7508C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460 '
RE: propachlor
191
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PROPACHLOR DATA CALL-IN CHEMICAL STATUS SHEET
INTRODUCTION
You have been sent this Generic Data Call-In Notice because you have product(s) containing
propachlor.
This Generic Data Call-in Chemical Status Sheet contains an overview of data required by this
notice, and point of contact for inquiries pertaining to the reregistration of propachlor. This
attachment is to be used in conjunction with (1) the Generic Data Call-In Notice, (2) the Generic Data
Call-in Response Form (Attachment 2), (3) the Requirements Status and Registrant's Response Form
(Attachment 3), (4) a list of registrants receiving this DCI (Attachment 5), and (5) the Cost Share and
Data Compensation Forms in replying to this propachlor Generic Data Call In (Attachment 6).
Instructions and guidance accompany each form.
DATA REQUIRED BY THIS NOTICE
The additional data requirements needed to complete the generic database for propachlor are
contained in the Requirements Status and Registrant's Response. Attachment C. The Agency has
concluded that additional product chemistry data on propachlor are needed. These data are needed
to fully complete the reregistration of all eligible propachlor products.
INQUIRIES AND RESPONSES TO THIS NOTICE
i'1 •• ' • .
If you have any questions regarding the generic data requirements and procedures established by
this Notice, please contact Anne Mitchell at (703) 308-8068.
All responses to this Notice for the generic data requirements should be submitted to:
Anne Mitchell, Chemical Review Manager
Reregistration Branch 3
Special Review and Registration Division (7508C)
Office of Pesticide Programs
U.S. Environmental Protection Agency
Washington, D.C. 20460
RE: propachlor
192
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Instructions For Completing The "Data Call-In Response Forms" For The Generic And
Product Specific Data Call-In
INTRODUCTION
These instructions apply to the Generic and Product Specific "Data Call-In Response Forms" and
are to be used by registrants to respond to generic and product specific Data Call-Ins as part of
EPA's Reregistration Program under the Federal Insecticide, Fungicide, and Rodenticide Act. If
you are an end-use product registrant only and have been sent this DCI letter as. part of a RED
document you have been sent just the product specific "Data Call-In Response Forms." Only
registrants responsible for generic data have been sent the generic data response form. The type
of Data Call-In (generic or product specific) is indicated in item number 3 ("Date and Type
of DCI") on each form.
Although the form is the same for both generic and product specific data, instructions for -
completing these forms are different. Please read these instructions carefully before filling out the
forms. .,'•''
EPA has developed these forms individually for each registrant, and has preprinted these forms
with a number of items. DO NOT use these forms for any other active ingredient.
Items 1 through 4 have been preprinted on the form. Items 5 through 7 must be completed by the
registrant as appropriate. Items 8 through 11 must be completed by the registrant before
submitting a response to the Agency.
The public reporting burden for this collection of information is estimated to average 15 minutes
per response, including time for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the collection of information.
Send comments regarding the burden estimate or. any other aspect of this collection of
information, including suggestions for reducing this burden, to Chief, Information Policy Branch,
Mail Code 2137, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, D.C.
20460; and to the Office of Management and Budget, Paperwork Reduction Project 2070-0107,
Washington, D.C. 20503. .
193,
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 1. ON BOTH FORMS: This item identifies your company name, number and address.
Item 2. ON BOTH FORMS: This item identifies the case number, case name, EPA
chemical number and chemical name. ,
" - "' i , , '.'''.'
Item 3. ON BOTH FORMS:' This item identifies the type of Data Call-in. The date of
issuance is date stamped.
Item 4. ON BOTH FORMS: This item identifies the EPA product registrations relevant to
the data call-in. Please note that you are also responsible for informing the Agency of
your response regarding any product that you believe may be covered by this Data
Call-in but that is not listed by the Agency in Item 4. You must bring any such
apparent omission to the Agency's attention within the period required for submission
of this response form.
Item 5. ON BOTH FORMS: Check this item for each product registration you wish to
cancel voluntarily. If a registration number is listed for a product for which you
previously requested voluntary cancellation, indicate in Item 5 the date of that
request. Since this Data Call-In requires both generic and product specific data, you
must complete item 5 on both Data Call-In response forms. You do not need to
complete any item on the Requirements Status and Registrant's Response Forms.
Item 6a. ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
generic data as indicated in Item 3 and you are eligible for a Generic Data Exemption
for the chemical listed in Item 2 and used in the subject product. By electing this
exemption, you agree to the terms and conditions of a Generic Data Exemption as
. explained in the Data Call-In Notice.
If you are eligible for or claim a Generic Data Exemption, enter the EPA registration
Number of each registered source of that active ingredient that you use in your product.
Typically, if you purchase an EPA-registered product from one or more other producers
(who, with respect to the incorporated product, are in compliance with this and any other
outstanding Data Call-in Notice), and incorporate that product into all your products, you
may complete this item for all products listed on this form. If, however, you produce the
active ingredient yourself, or use any unregistered product (regardless of the fact that some
of your sources are registered), you may not claim a Generic Data Exemption and you may
not select this item. ,
194
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-in
Item 6b. ON THE GENERIC DATA FORM: Check this Item if the Data Call-In is for
generic data as indicated in Item 3 and if you are agreeing to satisfy the generic data
requirements of this Data Call-in. Attach the Requirements Status and Registrant's
Response Form that indicates how you will satisfy
NOTE: Item 6a and 6b are not applicable for Product Specific Data.
Item7a. ON THE PRODUCT SPECIFIC DATA FORM: For each manufacturing use
product (MUP) for which you wish to maintain registration, you must agree to satisfy
the data requirements by responding "yes." . ••..,'
Item 7b. For each end use product (EUP) for which you wish to maintain registration, you
must agree to satisfy the data requirements by responding "yes."
FOR BOTH MUP and EUP products '
You should also respond "yes" to this item (7a for MUP's and 7b for EUP's) if your product
is identical to another product and you qualify for a data exemption. You must provide the
EPA registration numbers of your source(s); do not complete the Requirements Status and
Registrant's Response form. Examples of such products include repackaged products and
Special Local Needs (Section 24c) products which are identical to federally registered
products. '
If you are requesting a data waiver, answer "yes" here; in addition, on the "Requirements
Status and Registrant's Response" form under Item 9, you must respond with option 7
(Waiver Request) for each study for which you are requesting a waiver.
NOTE: Item 7a and 7b are not applicable for Generic Data.
195
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INSTRUCTIONS FOR COMPLETING THE DATA CALL-IN RESPONSE FORMS
Generic and Product Specific Data Call-In
Item 8. ON BOTH FORMS: This certification statement must be signed by an authorized
representative of your company and the person signing must include his/her title.
Additional pages used in your response must be initialled and dated in the space
provided for the certification.
Item 9. ON BOTH FORMS: Enter, the date of signature.
Item 10. ON BOTH FORMS: Enter the name of the person EPA should contact with
questions regarding your response.
Item 11. ON BOTH FORMS: Enter the phone number of your company contact.
Note: You may provide additional information that does not fit on this form in a signed letter that accompanies your response. For example, you may wish to
report that your product has already been transferred to another company or that you have already voluntarily canceled this product. For these cases, please
supply all relevant details so that EPA can ensure that its records are correct.
196
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200
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
Item 1. ON BOTH FORMS: This item identifies your company name, number and address.
Item 2. ON THE GENERIC DATA FORM: This item identifies the case number, case
name, EPA chemical number and chemical name.
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the case number,
case name, and the, EPA Registration Number of the product for which the Agency is
requesting product specific data.
Item 3. ON THE, GENERIC DATA FORM: This item identifies the type of Data Call-in.
The date of issuance is date stamped.
> ••'"''• • • • .
ON THE PRODUCT SPECIFIC DATA FORM: This item identifies the type of Data
Call-In. The date of issuance is also date stamped- Note the unique identifier number (ID#)
assigned by the Agency. This ID number must be used in the transmittal document for any
data submissions in response to this Data Call-in Notice.
Item 4. ON BOTH FORMS: This item identifies the guideline reference number of studies
required. These guidelines, in addition to the requirements specified in'the Data Call-
in Notice, govern the conduct of the required studies. Note that series 61 and 62 in
product chemistry are now listed under 40 CFR 158.155 through 158.180, Subpart c.
ItemS. ON BOTH FORMS: This item identifies the study title associated with the
guideline reference number and whether protocols and 1, 2, or 3-year progress
reports are required to be submitted in connection with the study. As noted in
Section III of the Data Call-In Notice, 90-day progress reports are required for all
studies.
If an asterisk appears in Item 5, EPA has attached information relevant to this guideline
reference number to the Requirements Status and Registrant's Response Form.
201
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INSTRUCTIONS FOR COMPLETING THE "REQUIREMENTS STATUS AND
REGISTRANT'S RESPONSE FORMS"
Generic and Product Specific Data Call-In
Item 6. ON BOTH FORMS: This item identifies the code associated with the use pattern of
the pesticide. In the case of efficacy data (product specific
requirement), the required study only pertains to products which have the use sites and/or
pests indicated. A brief description of each code follows:
A Terrestrial food
B Terrestrial feed
C Terrestrial non-food
D Aquatic food
E Aquatic non-food outdoor
F Aquatic non-food industrial
G Aquatic non-food residential
H Greenhouse food
I Greenhouse non-food crop
J Forestry i
K Residential
L Indoor food
M Indoor non-food
N Indoor medical
O Indoor residential
Item 7. ON BOTH FORMS: This item identifies the code assigned to 'the substance that
must be used for testing. A brief description of each code follows:
EUP End-Use Product "
MP Manufacturing-Use Product
MP/TGAI Manufacturing-Use Product and Technical Grade Active Ingredient
PAI Pure Active Ingredient
PAI/M Pure Active Ingredient and Metabolites
PAI/PAIRA Pure Active Indredient or Pute Active Ingredient Radiolabelled
PAIRA Pure Active Ingredient Radiolabelled
PAIRA/M Pure Active Ingredient Radiolabelled and Metabolites
PAIRA/PM Pure Active Ingredient Radiolabelled and Plant Metabolites
TEP Typical End-Use Product
TEP % Typical End-Use Product, Percent Active Ingredient Specified
TEP/MET Typical End-Use Product and Metabolites
TEP/PAI/M Typical End-Use Product or Pure Active Ingredient and Metabolites
TGAI Technical Grade Active Ingredient
TGAI/PAI Technical Grade Active Ingredient or Pure Active Ingredient
TGAI/PAIRA Technical Grade Active Ingredient or Pure Active Ingredient
Radiolabelled .
TGAI/TEP Technical Grade Active Ingredient or Typical End-Use Product
' ' 202
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•MET Metabolites . ... .
IMP Impurities
DEGR , Degradates
* See: guideline comment
' : ' . 5
ItemS. This item completed by the Agency identifies the time frame allowedfor submission
of the study or protocol identified in item 5.
' .'>.„.',
ON THE GENERIC DATA FORM: The time frame runs from the date of your receipt
of the Data Call-In notice.
ON THE PRODUCT SPECIFIC DATA FORM: The due date for submission of
product specific studies begins from the date stamped on the letter transmitting the .
Reregistration Eligibility Decision document, and not from the date of receipt. However,
your response to the Data Call-in itself is due 90 days from the date of receipt.
Item 9. ON BOTH FORMS: Enter the appropriate Response Code .or Codes to show how
you intend to comply with each data requirement. Brief descriptions of each code
follow. The DataCall-In Notice contains a fuller description of each of these options.
Option 1. ON BOTH FORMS; (Developing Data) I will conduct a new study and
'submit it within the time frames specified in item 8 above. By indicating that I
have chosen this option, I certify that I will comply with all the requirements
pertaining to the conditions for submittal of this study as outlined in the Data
Call-In Notice and that I will provide the protocols and progress reports
required in item 5 above. ,
Option 2. ON BOTH.FORMS: (Agreement to Cost Shared I have entered into an
agreement with one or more registrants to develop data jointly. By indicating
that I have chosen this option, I certify that! will comply with all the
requirements pertaining to sharing in the cost of developing data as outlined in
the Data Call-In Notice.
However, for Product Specific Data, I understand that this option is available
for acute toxicity or certain efficacy data ONLY if the Agency indicates in an
attachment to this notice that my product is similar enough to another product to
qualify for this option. I certify that another party in the agreement is committing to
submit or provide me required data; if me required study is not submitted on time, my
product may be subject to suspension. ' •- . '
Option 3. ON BOTH FORMS: • (Offer to-Cost Share) I have made an offer to enter into
an agreement with one or more registrants to develop data jointly. I am also
.submitting a completed "Certification of offer to Cost Share in the
Development of Data" form. I am submitting evidence that I have made an
offer to another registrant (who has an obligation to submit data) to share in the
cost of that data. I am including a copy of my offer and proof of the other
registrant's receiptof that offer. I am identify ingthe party which is committing
, " ' 203
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to submit or provide the required data; if the required study is not submitted on
time, my product may be subject to suspension. I understand that other terms
under Option 3 in the Data Call-In Notice apply as well.
However, for Product Specific Data, I understand that this option is available
only for acute toxicity or certain efficacy data and only if the Agency indicates in an
attachment to this Data Call-In Notice that my product is similar enough to another
product to qualify for this option.
, > ' .
Option 4. ON BOTH FORMS: f Submitting Existing Data) I will submit an existing
study by the specified due date that has never before been submitted to EPA.
By indicating that I have chosen this option, I certify that this study meets all'
the requirements pertaining to the conditions for submittal of existing data
outlined in the Data Call-In Notice and I have attached the needed supporting
information along with this response^
OptionS. ON BOTH FORMS: (Upgrading a Study) I will submit by the specified due
date, or will cite data to upgrade a study that EPA has classified as partially
acceptable and potentially upgradeable. By indicating that I have chosen this
option, I certify that I have met all the requirements pertaining to the conditions
for submitting or citing existing data to upgrade a study described in the Data
Call-In Notice. I 'am indicating on attached correspondence the Master Record
Identification Number (MRID) that EPA has assigned to the data that I am
citing as well as the MRID of the study I am attempting to upgrade.
Option 6. ON BOTH FORMS: (Citing a Study) I am citing an existing study that has
been previously classified by EPA as acceptable, core, core minimum, or a
study that has not yet been reviewed by the Agency. If reviewed, I am providing
the Agency's classification of the study.
However, for Product Specific Data, I am citing another registrant's study. I
understand that mis option is available ONLY for acute toxicity or certain efficacy
data and ONLY if the cited study was conducted on my product, an identical product
of a product which the Agency has "grouped" with one or more other products for
purposes of depending on the same data. I may also choose this option if I am citing
my own data. In either case, I will provide the MRID or Accession number (s). If I
cite another registrant's data, I will submit a completed "Certification With Respect
To Data Compensation Requirements" form.
FOR THE GENERIC DATA FORM ONLY; The following three options (Numbers 7,
8, and 9) are responses that apply only to the "Requirements Status and Registrant's
Response Form" for generic data.
Option 7. (Deleting Uses) I am attaching an application for amendment to my registration
deleting the uses for which the data are required.
204
-------
Option 8. (Low Volume/Minor Use Waiver Request) I have read the statements
concerning low volume-minor use data waivers in the Data Call-In Notice and I
request a low-volume minor use waiver of the data requirement. I am attaching
a detailed justification to support this waiver request including, among other
things, all information required to support the request. I understand that, unless
modified by the Agency in writing, the data requirement as stated in the Notice
•governs.
Option 9. (Request for Waiver of Data) I have read the statements concerning data
waivers other than lowvolume minor-use data waivers in the Data Call-In
Notice and I request a waiver of the data requirement. I am attaching a
rationale explaining why I believe the data requirements do not apply. I am also
submitting a copy of my current labels. (You must also submit a copy of your
Confidential Statement of Formula if not already on file with EPA). I
' understand that, unless modified by the Agency in writing, the data requirement
as stated in the Notice governs.
FOR PRODUCT SPECIFIC DATA; The following option (number 7) is a response that
applies to the "Requirements Status and Registrant's Response Form" for product
specific data.
Option 7. (Waiver Request) I request a waiver for this study because it is inappropriate
for my product. I am attaching a complete justification for this request,
including technical reasons, data and references to relevant EPA regulations,
guidelines or policies. [Note: any supplemental data must be submitted in the'
format required by P.R. Notice 86-5]. I understand that this is my only
opportunity to state me reasons or provide information in support of my
request. If the Agency approves my waiver request, I will not be required to
supply the data pursuant to Section 3(c) (2) (B) of FIFRA. If the Agency denies
my waiver request, 1 must choose a method of meeting the data requirements of
this Notice by the due date stated by this Notice. In this case, I must, within 30
days-of my receipt of the Agency's written decision, submit a revised
"Requirements Status" form specifying the option chosen. I also understand that
the deadline for submission of data as specified by the original Data Call-In
notice will not change. . - '
Item 10. ON BOTH FORMS: This item must be signed by an authorized representative of
your company. The person signing must include .his/her title, and must initial and date
all other pages of this form.
Item 11. ON BOTH FORMS: Enter the date of signature. " .
Item 12. ON BOTH FORMS: Enter the name of the person EPA.should contact with '
questions regarding your response.
Item 13. ON BOTH FORMS: Enter the phone number of your company contact.
205
-------
NOTE: You may provide additional information that does not fit on this form in a signed letter that accompanies this your response. For example, you may
wish to report that your product has already been transferred to another company or that you have already voluntarily cancelled this product. For these
206
-------
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EPA'S BATCHING OF PROPACHLOR 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 reregistratioii of products containing propachlor 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. Notwithstanding-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 hi. 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'batcb, 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 oh someone else to do so. If a registrant supplies
the data to support a batch of products, he/she must selept one of the following options:
Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing
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
213 '
-------
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.
Six active products were found which contain propachlor as the active ingredient. Two
products have been placed hi batch 1 while the other four products were placed in the "no batch"
category based on the active/inert ingredients and formulation type. The following bridging
schemes may also be employed:
- EPA Reg. No. 524-152 may be supported by any category III/IV acute mammalian toxicity data
performed with technical propachlor.
- EPA Reg. No. 524-331 may be supported by category.III/lV acute oral, acute dermal and acute
inhalation toxicity data performed with technical propachlor.
At a minimum, the acute data cited or submitted to support these products should meet the
acceptance criteria included in this document. In addition, the acute toxicity values for propachlor
[also included in this document] are for informational purposes only, and the data supporting
these values may or may not meet the acceptance criteria.
Batch
1
EPA Reg. No.
524-310
19713-163
% Active Ingredient
96.5
93.0
Formulation Type
Solid
Solid
No
Batch
EPA Reg. No.
524-152
524-328
524-331
524-423
% Active Ingredient
20.0
31.5
42.0
48.1
Formulation '
Type
Solid
Liquid
Liquid
Solid
214
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Attachment 5 List of All Registrants Sent This Data Call-In (insert) Notice
THIS PAGE MUST BE REMOVED PRIOR TO PRINTING AND REPLACED WITH THE
REGISTRANT LISTING PRODUCED FROM THE DCI MODULE.
215
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Instructions for Completing the Confidential Statement of Formula
The Confidential Statement of Formula (CSF) Form 8570-4 must be used/Two legible, signed copies
of the form are required. Following are basic instructions:
a. All the blocks on the form must be filled in and answered completely.
b. If any block is not applicable, mark it N/A.
c. The CSF must be signed, dated and the telephone number of the responsible party must be
provided.
d. All applicable information which is on the product specific data submission must also be
reported on the CSF.
e. All weights reported under item 7 must be in pounds per gallon for liquids and pounds per
cubic feet for solids.
f. Flashpoint must be in degrees Fahrenheit and flame extension in inches.
g. For all active ingredients, the EPA Registration Numbers for the currently registered source
products must be reported under column 12.
h. , The Chemical Abstracts Service (CAS) Numbers for all actives and inerts and all common
names for the trade names must be reported.
i. For the active ingredients, the percent purity of the source products must be reported under
column 10 and must be exactly the same as on the source product's label.
j. All the weights in columns 13.a. and 13.b. must be in pounds, kilograms, or grams. In no case
will volumes, be accepted. Do not mix English and metric system units (i.e., pounds and
kilograms).
k. All the items under column 13.b. must total 100 percent.
,,!' ' " ', " " ' '•• '.•' ' '" •' ' '
I. All items under columns 14.a. and 14.b. for the active ingredients must represent pure active
form.
m. The upper and lower certified limits for ail active and inert ingredients must follow the 40 CFR
158.175 instructions. An explanation must be provided if the proposed limits are different than
standard certified limits
n. When new CSFs are submitted and approved, all previously submitted CSFs become obsolete
for that specific formulation.
216
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United States Environmental Protection Agency
Washington, D.C. 20460
Certification of Offer to Cost
Share in the Development of Data
Form Approved
OMB No. 2070-0106,
2070-0057
Approval Expires
3-31-99
Public reporting burden for this collection of information is estimated to average 15 minutes per response, including
time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and
completing and reviewing the collection of information. Send comments regarding the'burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden to, Chief Information Policy
Branch, PM-233, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460; and to the Office of
Management and Budget, Paperwork Reduction Project (2070-0106), Washington, DC 20503.
Please fill in blanks below:
Company Name
Company Number
Product Name
EPA Reg. No.
I Certify that:
My company is willing to develop and submit the data required by EPA under the authority of the Federal
Insecticide, Fungicide and Rodenticide Act (FIFRA), if necessary. However my company would prefer to
enter into an agreement with one or more registrants to develop jointly or share in the cost of developing
data.
V •-''.'
My firm has offered in writing to enter into such an agreement. That offer was irrevocable and included an
an offer to be bound by arbitration decision under section 3(c)(2)(B)(Hi) of FIFRA if final agreement on all
terms could not be reached otherwise. This offer was made to the following firms on the following
date(s):
Name of Firm(s)
Date of Offer
Certification:
I certify that I am duly authorized to represent the company named above, and that the statements that I have made on
this form and all attachments therein are true, accurate, and complete. I acknowledge that any knowingly false or
misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature of Company's Authorized Representative
Date
Name and Title (Please Type or Print)
EPA Form 8570-32 (5/91) Replaces EPA form 8580 which is obseiete
219
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220
-------
Form Annrnvpri OIWIR Kin- 9(Y7n.
•0060
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
401 M Street, S.W.
WASHINGTON, D.C. 20460
Paperwork Reduction Act Notice: The public reporting burden for this collection of information is estimated to average 1.25 hours per response for registratio
and 0.25 hours per response for reregistration and special review activities, including time for reading the instructions and completing the necessary forms. Sen
comments regarding burden estimate or any other aspect of this collection of information, including suggestions for reducing the burden to: Director, OPPE
Information Management Division (2137), U.S. Environmental Protection Agency, 401 M Street, S.W., Washington, DC 20460. '' ,
Do not send the completed form to this address.
Certification with Respect to Citation of Data
Applicant's/Registrant's Name, Address, and Telephone Number
Active Ingredients) and/or representative test compound(s)
General Use Pattern(s) (list all those claimed for this product using'40 CFR Part 158)
EPA Registration Number/File Symbol '
Date
Product Name
. NOTE: If your product is a 100% repackaging of another purchased EPA-registered product labeled for all the same uses on your label, you do not need to
submit this forrri. You must submit the Formulator's Exemption Statement (EPA Form 8570-27).
I am responding to a Data-Call-in Notice, and have included with this form a list of companies sent offers of compensation (the Data Matrix form should
be used for this purpose).
SECTION 1: METHOD OF DATA SUPPORT (Check one method only)
D
I am using the cite-all method of support, and have included with this form
a list of companies sent offers of compensation (the Data Matrix form
should Be used for this purpose). ,
Q
I am using the selective method of support (or cite-all option
under the selective method), and have included with this form a
completed list of data requirements (the Data Matrix form must be
used). . ,
SECTION II: GENERAL OFFER TO PAY
[Required if using the cite-all method or when using the cite-all option under the selective method to satisfy one or more data requirements]
| I I hereby offer and agree to pay compensation, to other persons, with regard to the approval of this application, to the extent required by FIFRA.
SECTION HI: CERTIFICATION
I certify that this application for registration, this form for reregistration, or this Data-Call-in response is supported by all data submitted or cited in the
application for registration, the form for reregistration, or the Data-Call-in response. In addition, if the cite-all option or cite-all option under the selective method is
indicated in Section I, this application is supported by all data in the Agency's files that (1) concern the properties or effects of this product or an identical or
substantially similar product, or one ,or more of the ingredients in this product; and (2) is a type of data that would be required to be submitted under the data
requirements in effect on the date of approval of this application if the application sought the initial registration of a product of identical or similar composition and
uses.
I certify that for each exclusive use study cited in support of this registration or reregistration, that I am the original data submitter or that I have
obtained the written permission of the original data submitter to cite that study. •
I certify that for each study cited in support of this registration or reregistration that iSinot an exclusive use study, either (a) I am the original data
submitter; (b) I have obtained the permission of the original data submitter to use the study in support of this application; (c) ail periods of eligibility for
compensation have expired for the study; (d) the study is in the public literature; or (e) .1 have notified in writing the company that submitted the study and have
offered (I) to pay compensation to the extent required by sections 3(c)(1 )(F) and/or 3(c)(2)(B) of FIFRA; and (ii) to commence negotiations to determine the
amount and terms of compensation, if any, to be paid for the use of the study.
I certify that in all instances where an offer of compensation is required, copies of all offers to pay compensation and evidence of their delivery in
accordance with sections 3(c)(1)(F) and/or 3(c)(2)(B) of FIFRA are available and will be submitted to the Agency upon request. Should I fail to produce such
evidence to the Agency upon request, I understand that the Agency may initiate action to deny, cancel or suspend the registration of my product in conformity wi
FIFRA.
I certify that the statements I have made on this form and all attachments to it are true, accurate, and complete. I acknowledge that any
knowingly false or misleading statement may be punishable by fine or imprisonment or both under applicable law.
Signature • •
Date
Typed or Printed Name and Title
EPA Form 8570-34 (9-97) Electronic and Paper versions available. Submit only Paper version.
221
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The following is a list of available documents for propachlor that my further assist you in responding to this
Reregistration Eligibility Decision document. These documents may be obtained by the following methods:
Electronic ,! ;
File format: Portable Document Format (.PDF) Requires Adobe!) Acrobat or compatible reader. Electronic copies are
available on our website at www.epa.gov/REDs, or contact Anne Mitchell at (703)-308-8068.
*" 1. PR Notice 86-5.
, ' 2. PR Notice 91-2 (pertains to the Label Ingredient Statement).
3. A full copy of this RED document.
, 4. A copy of the fact sheet for propachlor. ,
The following documents are part of the Administrative Record for propachlor and may included in the EPA's
Office of Pesticide Programs Public Docket Copies of these dpcuments are not available electronically, but may be obtained
by contacting the person listed on -the Chemical Status Sheet.
1 .Health and Envkonmental Effects Science Chapters.
2.Detailed Label Usage Information System (LUIS) Report.
The following Agency reference documents are not available electronically, but may be obtained by contacting
the person listed on the Chemical Status Sheet of 'this RED document.
1. The Label Review Manual.
2. EPA Acceptance Criteria . ,
227
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