Docket Number: EPA-HQ-OPP-2011-0662 

www.regulations.gov 

Propamocarb Hydrochloride Summary Document 

Registration Review: Initial Docket 

September 2011 

TABLE OF CONTENTS 

 Page 

I. Preliminary Work Plan (PWP) 4 

II. Fact Sheet 12 

III. Summary of Data Gaps 19 

________________________________________ 

Please Note 

This Preliminary Work Plan and Fact Sheet summarize the Environmental Protection 

Agency's current position based on the following documents: 

1. Registration Review – Preliminary Problem Formulation for Ecological Risk and 

Environmental Fate, Endangered Species, and Drinking Water Assessments for 

Propamocarb-HCl. September 20, 2011. 

2. Propamocarb Hydrochloride: Human-Health Assessment Scoping Document in Support 

of Registration Review. September 14, 2011. 

3. Propamocarb hydrochloride: Review of Human Incidents. May 18, 2011. 

4. Propamocarb HCl (119302) Screening Level Usage Analysis (SLUA). November 23, 

2010. 

5. BEAD Chemical Profile for Registration Review: Propamocarb-HCl (119302). April 7, 

2011. 

6. Appendix A: Food/Feed & Non-Food/Non-Feed Uses Considered in Registration Review 

Work Planning. March 3, 2011. 

Additional supporting documents for propamocarb may be found in the registration review 

docket EPA-HQ-OPP-2011-0662 located on the internet at www.regulations.gov.

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I. PRELIMINARY WORK PLAN – Propamocarb Hydrochloride 

Introduction:

The Food Quality Protection Act (FQPA) of 1996 mandated a registration review program. All 

pesticides sold or distributed in the United States generally must be registered by the 

Environmental Protection Agency (EPA or the Agency), based on scientific data showing that 

they will not cause unreasonable risks to human health or the environment when used as directed 

on product labeling. The registration review program is intended to make sure that, as the ability 

to assess risk evolves and as policies and practices change, all registered pesticides continue to 

meet the statutory standard of no unreasonable adverse effects to human health or the 

environment. Changes in science, public policy, and pesticide use practices will occur over time. 

Through the registration review program, the Agency periodically reevaluates pesticides to make 

sure that as change occurs, products in the marketplace can be used safely. Information on this 

program is provided at: http://www.epa.gov/oppsrrd1/registration_review/. 

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. The Agency will consider benefits information and data as required by FIFRA. The 

public phase of registration review begins when the initial docket is opened for each case. The 

docket is the Agency’s opportunity to state what it knows about the pesticide and what additional 

risk analyses and data or information it believes are needed to make a registration review 

decision. After reviewing and responding to comments and data received in the docket during 

this initial comment period, the Agency will develop and commit to a final work plan and 

schedule for the registration review of propamocarb hydrochloride. 

Propamocarb hydrochloride is a carbamate fungicide that targets several Oomycetes species, 

including Phytophthora, Pythium, and downy mildew, which cause foliar diseases and seedling, 

seed, root, foot, and stem rot in various edible and ornamental crops. It disrupts formation of 

fungal cell walls by interfering with the synthesis of fatty acids and phospholipids, thus affecting 

mycelia cell growth, spore production, and germination. Propamocarb hydrochloride is not an 

N-methyl carbmate and does not share a common mechanism of toxicity with the N-methyl 

carbamate group. Propamocarb hydrochloride was first registered in 1984, and a Reregistration 

Eligibility Decision (RED) was completed in 1995. The first food use, potatoes, was registered 

in 2000. Promamocarb is currently registered as emulsifiable-concentrate (EC) formulations for 

use on potatoes, lettuce, cucurbit vegetables, and fruiting vegetables, as well as golf courses, 

ornamental turf/plants, sod farms, and in nurseries/greenhouses. It is formulated with other 

fungicides, including chlorothalonil and fluopicolide. There are nine FIFRA Section 3 product 

registrations for propamocarb hydrochloride, including two registrations for manufacturing use 

products. There are six Section 24(c) Special Local Need registrations for propamocarb 

hydrochloride. 

In 2009, EPA received a request for a new use of propamocarb hydrochloride on lima beans. 

The risk assessments conducted to evaluate the requested new use identified risks of concern for 

the existing use of propamocarb hydrochloride on ornamentals. Certain propamocarb 

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hydrochloride labels are unclear with respect to application parameters (e.g., the maximum 

seasonal application rate, or maximum applications per crop cycle) and the Agency believes that 

the identified risks of concern can be mitigated through label changes. In the absence of clear 

label information, EPA must employ conservative assumptions to complete risk assessments. 

The Agency encourages clear and consistent label language for the sake of all stakeholders and 

encourages the technical registrants to review the product labels for clarity. EPA is currently 

working with registrants to mitigate these risk concerns. 

Anticipated Risk Assessment and Data Needs:

The Agency anticipates requiring data for use in conducting a comprehensive ecological risk 

assessment, including an endangered species risk assessment, for all uses of propamocarb 

hydrochloride. The Agency also anticipates requiring additional data for use in conducting a 

comprehensive human health risk assessment for all uses of propamacarb. A summary of the 

issues relevant to the registration review of propamocarb hydrochloride is given below. 

Ecological Risk: 

• The most recent comprehensive, national-level ecological risk assessment for 

propamocarb hydrochloride was completed in 1995 in support of the RED. In addition, 

limited ecological risk assessments were completed in 2000 to support the registration of 

the first propamocarb food use on potatoes and, in 2004, to support the registration of 

propamocarb hydrochloride use on cucurbits, lettuce, peppers, and tomatoes. 

• The Agency has not conducted a risk assessment that supports a complete endangered 

species determination for propamocarb hydrochloride. The ecological risk assessment 

planned during registration review will allow the Agency to determine whether 

propamocarb hydrochloride use has “no effect” or “may affect” federally listed 

threatened or endangered species (listed species) or their designated critical habitats. 

When an assessment concludes that a pesticide’s use “may affect” a listed species or its 

designated critical habitat, the Agency will consult with the U.S. Fish and Wildlife 

Service and/or National Marine Fisheries Service (the Services), as appropriate. 

• On January 19, 2011, the Center for Biological Diversity and the Pesticide Action 

Network North America filed a lawsuit in the United States District Court for the 

Northern District of California, against EPA for allegedly failing to undergo consultation 

with the Services regarding the effects of over 350 pesticides, including propamocarb, on 

over 200 endangered and threatened species throughout the United States (Center for 

Biological Diversity, et al. v. EPA, et al., No. C 11-00293 (N.D.Cal.)).

• The Agency anticipates requiring the following data for propamocarb hydrochloride for 

use in conducting a comprehensive national ecological risk assessment, including an 

endangered species assessment: 

• GDLN 835.1230 – Adsorption/Desorption 

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• GDLN 835.4300 – Aerobic Aquatic Metabolism (two additional soils) 

• GDLN 835.4400 – Anaerobic Aquatic Metabolism (one additional soil) 

• GDLN 850.1350 – Aquatic Invertebrate Life-Cycle Toxicity 

(estuarine/marine) 

• GDLN 850.1400 – Fish Early Life Stage (estuarine/marine) 

• GDLN 850.2100 – Avian Oral Toxicity (bobwhite quail and passerine) 

• GDLN 850.2200 – Avian Dietary Toxicity (bobwhite quail and mallard duck) 

• EPA required a freshwater invertebrate life cycle study (GDLN 850.1300) in a Data Call 

In (DCI) associated with the reregistration of propamocarb (GDCI-119302-17298). 

Although one study (MRID 45894308) submitted to fulfill this requirement was 

determined to be invalid, another study (MRID 45727801) has been submitted and is 

currently in review. This will be considered as a data gap until the data have been 

reviewed and found to be acceptable. 

• Please refer to the September 20, 2011 document, Registration Review – Preliminary 

Problem Formulation for Ecological Risk and Environmental Fate, Endangered Species, 

and Drinking Water Assessments for Propamocarb-HCl, located in docket EPA-HQOPP-2011-0662 for a detailed discussion of the anticipated risk assessment and data 

needs and for a more detailed discussion of uncertainties on certain product labels.

Human Health Risk:

• The most recent comprehensive human health risk assessment for propamocarb 

hydrochloride was completed in February 2004 in support of use on lettuce, fruiting 

vegetables, and cucurbits. These uses were granted on August 4, 2004 and tolerances 

were established for the associated food commodities. An occupational and residential 

risk assessment was completed on November 5, 2009 to support a proposed use on lima 

beans. To date, EPA has not established tolerances for propamocarb hydrochloride in/on 

lima beans. The 2009 risk assessment identified occupational (handler and postapplication) exposure and potential drinking water exposure risk concerns associated with 

an existing use of propamocarb hydrochloride on ornamentals. The Agency is currently 

working with the registrants to mitigate these risk concerns. 

• The Agency anticipates requiring the following data for propamocarb hydrochloride for 

use in reevaluating toxicological endpoints (points of departure), safety/uncertainty 

factors and updating the human health toxicity profile: 

• GDLN 870.7800 – Immunotoxicity 

• GDLN 870.3465 – Inhalation Toxicity 

• During registration review, the Agency anticipates revising the dietary risk assessment to 

incorporate refined estimated drinking water concentrations (EDWCs), updated 

6 
anticipated food residues and Pesticide Data Program (PDP) data, and any changes to 

toxicological points of departure, or uncertainty factors. 

• The residential and occupational exposure databases for propamocarb hydrochloride are 

adequate; and therefore, at this time, EPA does not anticipate the need for additional 

residential or occupational exposure data to support registration review. 

• During registration review, the Agency anticipates revising the residential handler and 

bystander risk assessments if data are identified which may impact the points of departure 

or the FQPA safety factor; or if revisions are made to any of EPA’s exposure and/or risk 

assessment policies and procedures. EPA may also conduct a bystander risk assessment 

to address potential exposure via spray drift. 

• EPA anticipates revising the aggregate assessment to incorporate changes to the dietary 

exposure estimates from food and/or drinking water (e.g., updated EDWCs). In addition, 

an aggregate assessment is anticipated as being needed if data are identified which may 

impact the points of departure or the FQPA safety factor; or if revisions are made to any 

of EPA’s exposure and/or risk assessment policies and procedures. 

 

• EPA anticipates that it will reevaluate all occupational dermal and inhalation exposure 

assessments using standards and policies that are in place at the time of registration 

review. Revised occupational handler and post-application assessments may be needed 

in the event of changes to toxicological points of departure, receipt of new data, or 

changes to default exposure assessment assumptions. 

• The tolerance expression in 40 CFR §180.499 will be reviewed during registration review 

to ensure that it appropriately covers the metabolites and degradates of propamocarb 

hydrochloride and that it specifies the residues to be measured for each commodity. The 

Agency will modify tolerance levels as needed, and work to harmonize tolerances/ 

maximum residue limits (MRL), where possible, in key export markets during 

registration review. 

• The following residue chemistry data are needed to establish tolerances for livestock 

commodities. These data were previously identified as being needed by the Agency in 

support of propamocarb use on potatoes, which are a livestock feed commodity. EPA 

granted a conditional use of propamocarb on potatoes, which has been extended to March 

31, 2012. 

o GDLN 860.1360 - Multi-residue testing, 2-hydroxy and glucuronide metabolites. 

o GDLN 860.1380 - Storage stability for livestock commodities, glucuronide 

metabolite. 

7 
• Please refer to Propamocarb Hydrochloride. Human Health Scoping Document in 

Support of Registration Review, September 14, 2011, located in the docket, for a detailed 

discussion of the anticipated risk assessment and data needs.

Endocrine Disruptor Screening Program

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse 

outcomes from exposure to chemicals. Collectively, these studies include acute, subchronic and 

chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, 

reproductive, and general or systemic toxicity. These studies include endpoints which may be 

susceptible to endocrine influence, including effects on endocrine target organ histopathology, 

organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, 

and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and 

chronic studies that assess growth, developmental and reproductive effects in different 

taxonomic groups. As part of its most recent registration decision, EPA reviewed these data and 

selected the most sensitive endpoints for relevant risk assessment scenarios from the existing 

hazard database. However, as required by FFDCA section 408(p), propamocarb hydrochloride is 

subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). 

EPA has developed the EDSP to determine whether certain substances (including pesticide 

active and other ingredients) may have an effect in humans or wildlife similar to an effect 

produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator 

may designate.” The EDSP employs a two-tiered approach to making the statutorily required 

determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a 

chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal 

systems. Chemicals that go through Tier 1 screening and are found to have the potential to 

interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA 

will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 

testing is designed to identify any adverse endocrine-related effects caused by the substance, and 

establish a dose-response relationship between the dose and the E, A, or T effect. 

Under FFDCA section 408(p), the Agency must screen all pesticide chemicals. Between 

October 2009 and February 2010, EPA issued test orders/data call-ins for the first group of 67 

chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. Propamocarb 

hydrochloride is not among the group of 58 pesticide active ingredients on the initial list to be 

screened under the EDSP. Accordingly, as part of registration review, EPA will issue future 

EDSP orders/data call-ins, requiring the submission of EDSP screening assays for propamocarb 

hydrochloride. For further information on the status of the EDSP, the policies and procedures, 

the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please 

visit our website: http://www.epa.gov/endo/. 

Timeline:

EPA has created the following estimated timeline for the completion of the propamocarb 

hydrochloride registration review. 

8 
Projected Registration Review Timeline for Propamocarb Hydrochloride

Activities Estimated Date 

Opening the Docket 

Open Docket and Public Comment Period 2011 – September 

Close Public Comment 2011 – November 

Case Development 

Final Work Plan 2012 – February 

Issue DCI 2012 – Oct. – Dec. 

Data Submission 2014 – Oct. – Dec. 

Open Public Comment Period for Draft Risk Assessments 2016 – April – June 

Close Public Comment Period 2016 – July – Sept. 

Registration Review Decision 

Open Public Comment Period for Proposed Registration Review 

Decision 

 2016 – Oct. – Dec. 

Close Public Comment Period 2017 – Jan. – March 

Registration Review Decision and Begin Post-Decision Follow-up 2017 

Total (years) 6 

Guidance for Commenters:

The public is invited to comment on EPA’s preliminary work plan and rationale. The Agency 

will carefully consider all comments, as well as any additional information or data provided in a 

timely manner, prior to issuing a Final Work Plan for propamocarb hydrochloride. 

Trade Irritants:

Through the registration review process, the Agency intends to solicit information on trade 

irritants and, to the extent feasible, take steps toward facilitating irritant resolution. Growers and 

other stakeholders are asked to comment on any trade irritant issues resulting from lack of MRLs 

or disparities between U.S. tolerances and MRLs in key export markets, providing as much 

specificity as possible regarding the nature of the concern. 

Water Quality:

Propamocarb hydrochloride is not identified as a cause of impairment for any water bodies listed 

as impaired under section 303(d) of the Clean Water Act1

. In addition, no Total Maximum Daily 

Loads (TMDL) have been developed for propamocarb hydrochloride2

. More information on 

impaired water bodies and TMDLs can be found on the Agency’s website3

. The Agency invites 

submission of water quality data for this pesticide. To the extent possible, data should conform 

to the quality standards in Appendix A of the OPP Standard Operating Procedure: Inclusion of 

Impaired Water Body and Other Water Quality Data in OPP’s Registration Review Risk 

 

1 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885 2 http://iaspub.epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant_group_name=PESTICIDES 3 http://www.epa.gov/owow/tmdl/

9 
Assessment and Management Process4

 in order to ensure they can be used quantitatively or 

qualitatively in pesticide risk assessments. 

Environmental Justice:

EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all 

people, regardless of race, color, national origin, or income, in the development, implementation, 

and enforcement of environmental laws, regulations, and policies. To help address potential 

environmental justice issues, the Agency seeks information on any groups or segments of the 

population who, as a result of their location, cultural practices, or other factors, may have 

atypical, unusually high exposure to propamocarb hydrochloride, compared to the general 

population. Please comment if you are aware of any sub-populations that may have atypical, 

unusually high exposure compared to the general population. 

Additional Information:

Stakeholders are also specifically asked to provide information and data that will assist the 

Agency in refining its risk assessments, including any species-specific ecological effects 

determinations. The Agency is interested in receiving the following information: 

1. confirmation on the following label information 

a. sites of application 

b. formulations 

c. application methods and equipment 

d. maximum application rates 

e. frequency of application, application intervals, and maximum number of 

applications per season and per year 

f. geographic limitations on use 

2. use or potential use distribution (e.g., geographical distribution of relevant uses) 

3. use history and reason for changes in use 

4. median and 90th percentile reported use rates (lbs ai/1000 sq ft) from usage data – 

national, state, and county 

5. application timing (date of first application and application intervals) by use site – 

national, state, and county 

6. sub-county use site location data 

7. usage/use information for non-agricultural uses, especially turf and ornamentals 

8. directly acquired county-level usage data (not derived from state level data) 

a. maximum reported use rate (lbs ai/1000 sq ft) from usage data – county 

b. percent use site treated – county 

c. median and 90th percentile number of applications – county 

d. total pounds per year – county 

e. the year the pesticide was last used in the county/sub-county area 

f. the years in which the pesticide was applied in the county/sub-county area 

 

4 http://www.epa.gov/oppsrrd1/registration_review/water_quality_sop.htm

10 
9. typical application interval (days) 

10. state or local use restrictions 

11. information on plants resistant to this herbicide 

12. ecological incidents (non-target plant damage and avian, fish, reptilian, amphibian and 

mammalian mortalities) not already reported to the Agency 

13. monitoring data.

Next Steps:

After the 60-day comment period closes, the Agency will review and respond to any comments 

received in a timely manner, and expects to issue a Final Work Plan for propamocarb 

hydrochloride. 

11 
II. FACT SHEET 

 

Background Information:

• Registration review case number: 3124 

• PC code: 119302 

• The first pesticide containing propamocarb hydrochloride was registered in the U.S. in 

1984. 

• A Reregistration Eligibility Decision (RED) for propamocarb hydrochloride was 

completed in September 1995. 

• Technical registrants: Bayer CropScience and Agriphar SA. 

• There are nine FIFRA Section 3 product registrations for propamocarb hydrochloride, 

including two registrations for manufacturing use products. There are six Section 24(c) 

Special Local Need registrations for propamocarb hydrochloride. 

• Tolerances for residues of propamocarb hydrochloride in or on lettuce, leaf and head; 

potato; tomato, paste; vegetable, cucurbit, crop group 9; and vegetable, fruiting, crop 

group 8 are codified in 40 CFR §180.499. 

• Pesticide Re-evaluation Division (PRD) Chemical Review Manager (CRM): Christina 

Scheltema, scheltema.christina@epa.gov. 

• Registration Division (RD) Product Manager (PM): Mary Waller, waller.mary@epa.gov. 

Use & Usage Information: 

• Propamocarb hydrochloride is a carbamate fungicide registered for use on potatoes, 

lettuce, cucurbit vegetables, and fruiting vegetables; as well as golf courses, ornamental 

turf/plants, sod farms, and in nurseries/greenhouses. The first food use for propamocarb 

hydrochloride (on potatoes) was registered on September 29, 2000 (65 FR 58390). 

Additional food uses of propamocarb hydrochloride on lettuce, cucurbits, fruiting 

vegetables, peppers, and eggplants (crop group 8); and tomato paste were registered on 

August 4, 2004 (69 FR 47013). 

• Propamocarb hydrochloride is formulated as an emulsifiable concentrate (EC). It is 

applied via chemigation, soil surface spray, foliar spray, band treatment, and drench 

treatment. It is also applied to potted ornamentals by soil and foliar sprays, drenches, and 

dips. 

• According to the most recent usage data, approximately 240,000 pounds of propamocarb 

hydrochloride active ingredient (a.i.) are used on approximately 220,000 acres (A) of 

agricultural crops. Propamocarb hydrochloride is typically applied at a rate of 0.7 to 1.4 

lbs ai/A. The greatest amount of propamocarb hydrochloride was applied to lettuce (52% 

of lbs applied), cucumbers (37%), squash (3%), peppers (3%), and pumpkins (3%). The 

states with the greatest amount of propamocarb hydrochloride applied were California, 

Michigan, Georgia, Florida, Texas, and Indiana. 

• Lawn care operators used approximately 4,000 lbs of propamocarb hydrochloride in 

2006, the only year for which data are available. Nurseries and greenhouses also used 

approximately 4,000 lbs that year. 

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• Although propamocarb hydrochloride is used on golf courses, use has been declining, 

from 85,000 lbs in 2002 to approximately 10,000 lbs in 2006. 

• For additional details, please refer to the following documents: BEAD Chemical Profile 

for Registration Review: Propamocarb-HCl, April 7, 2011; Propamocarb Screening 

Level Usage Analysis (SLUA), November 23, 2010; and Appendix A: Food/Feed & NonFood/Non-Feed Uses Considered in Registration Review Work Planning, March 3, 2011.

Recent and Ongoing Actions:

• The Agency received a petition to establish tolerances for propamocarb hydrochloride 

residues in/on lima beans from IR-4, Rutgers University in 2009. (See 74 FR16866.) To 

date, EPA has not established tolerances for propamocarb hydrochloride in/on lima 

beans. For more information on the lima bean petition, please see docket EPA-HQ-OPP2008-0887 on www.regulations.gov. 

• The 2009 risk assessment conducted in support of the petition to establish tolerances 

in/on lima beans identified occupational handler and post-application risks of concern for 

existing ornamental uses. In addition, potential drinking water risks of concern for the 

existing ornamental uses were identified. The Agency is currently working with the 

propamocarb hydrochloride registrants to mitigate these risk concerns.

Ecological Risk Assessment Status: 

The key findings of the most recent ecological risk assessments for propamocarb hydrochloride 

are summarized below. For a detailed discussion of the ecological risk assessment status, please 

refer to the September 20, 2011 memo, Registration Review – Preliminary Problem Formulation 

for Ecological Risk and Environmental Fate, Endangered Species, and Drinking Water 

Assessments for Propamocarb-HCl, in docket EPA-HQ-OPP-2011-0662. 

• The most recent comprehensive, national ecological risk assessment for propamocarb 

hydrochloride was completed in August 1995 in support of the propamocarb 

hydrochloride RED. This risk assessment was limited to registered uses at that time, 

including use on ornamental lawns and turf, ornamental sod farms (turf), and ornamental 

herbaceous plants, woody shrubs, and vines. Propamocarb hydrochloride was not 

registered for use on agricultural crops until 2000. In the 1995 ecological risk 

assessment, use of propamocarb hydrochloride on turf and ornamentals was associated 

with risk quotients that exceeded the Agency’s Level of Concern (LOC) for birds and 

mammals. No risk concerns were identified for fish, but acute risk concerns were 

identified for aquatic invertebrates. These risk concerns were mitigated in the 

propamocarb hydrochloride RED through required label changes. 

• Limited ecological risk assessments were conducted in 2000 and 2004 to support uses of 

propamocarb hydrochloride on potatoes, tomatoes, lettuce, peppers, and other fruiting 

vegetables. The June 2000 risk assessment for potatoes concluded that LOCs for avian 

endangered species were exceeded; however, no acute or chronic risk concerns for 

aquatic or non-endangered terrestrial organisms were identified. The 2004 risk 

13 
assessment for lettuce showed potential chronic risk concerns for birds only; there were 

no other acute or chronic risk concerns for terrestrial or aquatic organisms. 

• Chronic risk to aquatic invertebrates has not been characterized in previous risk 

assessments, because EPA did not have sufficient chronic toxicity data for aquatic 

invertebrates. However, a chronic daphnid study (MRID 45727801) has been submitted 

and is currently undergoing review. 

• Many of the ecological effects studies (both terrestrial and aquatic) submitted for 

propamocarb hydrochloride were conducted using formulated propamocarb 

hydrochloride pesticide products rather than the technical grade active ingredient (TGAI). 

Although all but one of these studies were scientifically sound, there is uncertainty 

because a higher percent active ingredient formulation may cause increased toxicity than 

what was seen in the submitted studies. Therefore, uncertainty exists regarding all taxa 

for which a formulated product was tested. 

Human Health Risk Assessment Status:

The key findings of the most recent human health risk assessment for propamocarb 

hydrochloride are summarized below. For a detailed discussion of the human health risk 

assessment status, please refer to the September 14, 2011 memo, Promamocarb Hydrochloride: 

Human-Health Assessment Scoping Document in Support of Registration Review, in docket 

EPA-HQ-OPP-2011-0662. 

• The most recent comprehensive human health risk assessment for propamocarb 

hydrochloride was completed in February 2004 in support of a FIFRA Section 3 petition 

for use of propamocarb hydrochloride on lettuce, fruiting vegetables, and cucurbits. An 

occupational and residential risk assessment was completed on November 5, 2009 to 

support a proposed use on lima beans (to date, this use has not been granted and this 

action is pending). 

Hazard Characterization: 

• Propamocarb hydrochloride has low acute toxicity via the oral, dermal, and inhalation 

routes of exposure. It is not a dermal irritant and does not cause skin sensitization; 

however, it is a slight eye irritant. 

• In animal studies, propamocarb hydrochloride is associated with neurotoxic effects. 

Subchronic and chronic rat studies showed decreased motor activity and brain lesions, 

and ocular effects. A dog study also showed ocular effects. In addition, subchronic and 

chronic dog studies showed toxicity to the gastrointestinal tract and lesions in the trachea 

and lungs following dietary exposure. 

• Developmental toxicity studies with propamocarb hydrochloride in the rat and rabbit did 

not show any increased evidence of susceptibility in offspring at doses associated with 

maternal toxicity. However, qualitative effects were seen in offspring, postimplantation 

losses, minor skeletal abnormalities, and minor lesions in the ears, heart, and upper 

gastrointestinal tract. 

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• In the 2004 human health risk assessment, EPA reduced the 10x FQPA safety factor to 1x 

because the toxicity database was adequate to characterize the potential for pre- and postnatal risk for infants and children, no developmental effects were observed in rats, and 

there was a lack of evidence of increased susceptibility. However, this FQPA safety 

factor decision preceded changes in EPA’s current science policy. 

• Propamocarb hydrochloride is not considered to be mutagenic, and it has been classified 

by EPA as “not likely to be carcinogenic in humans.” 

Dietary: 

• In support of the 2004 risk assessment, EPA conducted unrefined acute and 

chronic dietary (food) exposure assessments for the general U.S. population and 

various subgroups. Drinking water exposure was not incorporated directly in the 

dietary assessment. Acute and chronic dietary exposure estimates were below 

EPA’s levels of concern for all population subgroups. 

• In support of a petition for use of propamocarb hydrochloride in/on lima beans, a 2009 

preliminary (Tier I) drinking water assessment was conducted, which indicated risks of 

concern for drinking water based on the existing ornamental use (highest labeled 

application rate). The Agency is currently working with the registrants to mitigate the 

identified risk concerns. 

• For further details regarding the updated EDWC assessment, please see the August 7, 

2009 memo, Propamocarb Hydrochloride: Tier I Drinking Water Estimated 

Environmental Concentrations for Use in the Human Health Risk Assessment. This 

document may be found in docket EPA-HQ-OPP-2011-0662.

Residential: 

• As previously mentioned, EPA conducted an occupational and residential risk assessment 

in 2009 to support a proposed use on lima beans (this action is currently pending). The 

risk assessment considered exposure to residential handlers mixing, loading, and applying 

pesticide products containing propamocarb hydrochloride as well as post-application 

exposure to golfers. EPA’s risk estimates for residential handlers and post-application 

exposure to golfers did not exceed the Agency’s levels of concern.

• Post-application residential exposure from the treatment of ornamentals was considered 

to be negligible. 

Aggregate: 

• The Agency’s most recent aggregate risk assessment for propamocarb hydrochloride can 

be found in the February 2004 human health risk assessment supporting food uses on 

cucurbits and fruiting vegetables. Although exposure to drinking water was not 

incorporated directly in the dietary assessment, aggregate exposure to food and drinking 

water were estimated using EPA’s drinking water levels of comparison (DWLOCs) 

methodology. The 2004 risk assessment did not identify any aggregate risks of concern. 

15 
• However, the Agency’s preliminary 2009 evaluation of drinking water exposure indicates 

aggregate risks of concern due to drinking water residues from the ornamental use. The 

Agency is currently working with the registrants to mitigate the identified risk concerns. 

Occupational: 

• The Agency’s most recent occupational handler and post-application risk assessment was 

conducted in 2009 to support a petition for a new use of propamocarb hydrochloride on 

lima beans (this action is currently pending). 

• For most uses, handler risks were below the level of concern, provided that handlers wore 

gloves, as specified on propamocarb hydrochloride product labels. However, for the turf 

and ornamental use, EPA identified risk concerns for (1) handlers mixing/loading 

propamocarb hydrochloride for chemigation and groundboom application at the highest 

assumed application rate (218 lbs ai/A) and (2) handlers applying propamocarb 

hydrochloride by groundboom at the highest assumed application rate (218 lbs ai/A). 

EPA is working with registrants to mitigate identified risk concerns. 

• Post-application risks of concern were identified for workers handling ornamental plants 

treated with propamocarb hydrochloride via foliar drenching. The highest assumed 

application rate of 218 lbs ai/A results in risk concerns for re-entry workers for several 

days after treatment, resulting in recommended restricted entry intervals (REIs) ranging 

from 12 to 53 days. As previously mentioned, EPA has identified issues with label 

clarity for propamocarb hydrochloride products registered for use on turf and 

ornamentals. EPA is working with registrants to mitigate the identified risk concerns. 

Human Studies: 

• Past propamocarb hydrochloride risk assessments rely in part on data from studies in 

which adult human subjects were intentionally exposed to a pesticide to determine their 

dermal and inhalation exposure. Many such studies, involving exposure to many 

different pesticides, comprise generic pesticide exposure databases such as the Pesticide 

Handlers Exposure Database (PHED) and the Agricultural Reentry Task Force (ARTF) 

Database. EPA has reviewed all the studies supporting these multi-pesticide generic 

exposure databases, and has found no clear and convincing evidence that the conduct of 

any of them was either fundamentally unethical or significantly deficient relative to the 

ethical standards prevailing at the time the research was conducted. All applicable 

requirements of EPA’s Rule for the Protection of Human Subjects of Research (40 CPR 

Part 26) have been satisfied, and there is no regulatory barrier to continued reliance on 

these studies. 

Cumulative: 

• Although propamocarb hydrochloride is a carbamate pesticide, it is not a cholinesterase 

inhibitor and EPA has determined that it does not share a common mechanism of toxicity 

with the N-methyl carbamate pesticides. Therefore, it is not included in the N-methyl 

carbamate cumulative risk assessment. 

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• EPA has not yet determined whether or not propamocarb hydrochloride shares a common 

mechanism of toxicity with any other chemical substances. If the Agency determines that 

new information on propamocarb hydrochloride is available that could potentially affect 

a cumulative risk assessment and result in a risk of concern, the Agency will revisit the 

need for a cumulative assessment. 

Incidents:

• The Office of Pesticide Programs (OPP) Incident Data System (IDS) was consulted for 

reports of human health incidents associated with propamocarb hydrochloride, but no 

incident cases were reported. EPA will continue to monitor incident information for 

propamocarb hydrochloride and conduct additional analyses if needed. 

• The Agency has conducted a preliminary review of the Ecological Incident Information 

System (EIIS), which is maintained by OPP, and the Avian Monitoring Information 

System (AIMS), which is maintained by the American Bird Conservancy. In the EIIS, 

one ecological incident involving propamocarb hydrochloride was reported in Montana in 

July of 2002. In this incident, the product PREVICUR® FLEX was applied to 500 acres 

of sugar beets resulting in damage to 200 acres. An adjuvant was determined to be the 

probable cause of the incident. No incidents involving propamocarb were found in 

AIMS. 

Tolerances and International Harmonization: 

• Tolerances for residues of propamocarb hydrochloride in or on various food and feed 

crops are established under 40 CFR §180.499. 

• Where possible, the Agency will work to harmonize U.S. tolerances for propamocarb 

hydrochloride with Codex, Canadian, and Mexican Maximum Residue Levels (MRLs) 

for propamocarb hydrochloride. 

 

Data Call-In Status: 

• The most recent data call-in (DCI) for propamocarb hydrochloride was issued on October 

11, 1995, following completion of the propamocarb hydrochloride RED (GDCI-119302-

17708). All of the data requirements from this DCI have been fulfilled or waived, with 

the exception of GDLN 850.1300, Freshwater Invertebrate Life Cycle. A study has been 

submitted in support of this requirement and is currently undergoing Agency review. 

Although data have been submitted to EPA, this will be considered as a data gap until the 

data have been reviewed and found to be acceptable. 

• Certain data were required as a condition of registration for the first food use of 

propamocarb hydrochloride on potatoes. EPA has yet to receive data to fulfill Guideline 

860.1360, Storage Stability for Livestock Commodities (metabolites). During review of 

the livestock feeding study required as a condition of registration, EPA identified the 

need for Guideline 880.1380, Multiresidue testing (metabolites). These residue 

chemistry data are needed to establish livestock tolerances for propamocarb 

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hydrochloride because potatoes are a livestock feed commodity and will be listed as a 

data gap. 

Labels:

Propamocarb hydrochloride Section 3 product labels can be obtained from the Pesticide Product 

Label System (PPLS) website: http://oaspub.epa.gov/pestlabl/ppls.hom 

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III. SUMMARY OF DATA GAPS – Propamocarb hydrochloride 

The table below summarizes all anticipated data needs for propamocarb hydrochloride identified 

in Section I of this document (Preliminary Work Plan), the Registration Review – Preliminary 

Problem Formulation for Ecological Risk and Environmental Fate, Endangered Species, and 

Drinking Water Assessments for Propamocarb-HCl, dated September 20, 2011 and the 

Propamocarb Hydrochloride: Human-Health Assessment Scoping Document in Support of 

Registration Review, dated September 14, 2011. It also lists outstanding data requirements from 

the propamocarb RED and data required to establish livestock tolerances (associated with a 

conditional registration on potatoes). 

Table 1. Summary of Current Data Gaps for Propamocarb Hydrochloride 

Guideline 

Number Anticipated Data Requirement Test 

Material 

Study 

Duration 

Anticipated Data Needs for Propamocarb Registration Review

835.1230 Adsorption/Desorption TGAI 12 

835.4300 Aerobic Aquatic Metabolism (two additional soils) TGAI 24 

835.4400 Anaerobic Aquatic Metabolism (one additional soil) TGAI 24 

850.1350 Aquatic Invertebrate Life Cycle (estuarine/marine, mysid) TGAI 12 

850.1400 Fish Early Life Stage Estuarine/marine (sheepshead minnow) TGAI 12 

850.2100 Avian Oral Toxicity (passerine species)5 TGAI 12 

Avian Oral Toxicity (upland game bird) TGAI 12 

850.2200 Avian Dietary Toxicity (waterfowl and upland game bird) TGAI 12 

860.1360 Multiresidue Testing (2-hydroxy and glucuronide metabolites )6 Metab. 24 

860.1380 Storage Stability in Livestock Commodities (glucuronide 

metabolite)6 Metab. 24 

870.7800 Immunotoxicity TGAI 12 

870.3465 Inhalation Toxicity (28 day study)7 TGAI 12 

Outstanding Data Requirement from the Propamocarb RED (GDCI-119302-17708) 

850.1300 Invertebrate Life Cycle Toxicity (Daphnia magna) TGAI 12 

 

5

 The anticipated DCI will require the submission of a study protocol for review and approval by the Agency prior to 

study initiation. 

6

 This study is required to establish livestock tolerances. 

7

 EPA previously waived this study because minimal inhalation exposure is associated with outdoor agricultural 

uses and the study was not needed to evaluate worker risk. However, the study is now needed to evaluate worker 

risks for use of propamocarb hydrochloride in greenhouses.