Docket Number: EPA–HQ–OPP–2009–0639 

www.regulations.gov 

 

 

United States Prevention, Pesticides March 2010 

Environmental Protection and Toxic Substances 

Agency (7510P)

2-(Hydroxymethyl)-2-nitro-1,3-propanediol 

(Tris Nitro) Final Work Plan 

Registration Review 

March 2010 

Docket Number: EPA–HQ–OPP–2009–0336 

www.regulations.gov 

2-(Hydroxymethyl)-2 nitro-1,3-propanedil (Tris Nitro) Registration Review Team

Human Health & Environmental Effects 

Srinivas Gowda 

William Hazel 

Risk Management

K. Avivah Jakob 

Lance Wormell 

Office of General Counsel

Philip Ross 

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Introduction

This is the Environmental Protection Agency’s (EPA or “the Agency”) Final 

Work Plan (FWP) for the registration review of 2-(hydroxymethyl)-2-nitro-1,3-

propanediol (tris nitro) (Case 3149). The FWP includes the expected registration review 

time-line. The FWP also addresses public comments received concerning the 

Preliminary Work Plan (PWP) in the Summary Document which was posted in the tris 

nitro registration review docket (EPA-HQ-OPP-2009-0639), and any other comments 

concerning initial docket postings. The Summary Document provided information on 

what EPA knows about the pesticide and what additional risk analyses and data or 

information the Agency believes are needed to make a registration review decision. 

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. Changes in science, public policy and pesticide use 

practices will occur over time. 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 that statutory standard. The public phase of 

registration review begins when the initial docket is opened for each case. Information 

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

The tris nitro Preliminary Work Plan (PWP) was entered into the docket for this 

registration review on September 23, 2009. The 90-day comment period ended on 

December 22, 2009. The Preliminary Work Plan document is available on 

www.regulations.gov, docket number EPA-HQ-OPP-2009-0639. 

Comments Received on the Preliminary Work Plan

In the PWP, the EPA solicited comments on three specific topics: environmental 

justice, water body impairment and potential trade irritants. No comments or information 

were received during the public comment period concerning these issues. 

During the public comment period, the EPA received several comments, 

including a request from the technical registrant to delete all but two registered tris nitro 

uses. In correspondence dated November 19, 2009, the Dow Chemical Company 

submitted amendments requesting the deletion of all registered tris nitro end-uses with 

the exception of the following two uses: (1) oil field use and (2) recirculating water 

systems use. Table 1 lists the pending use deletions from tris nitro registrations/labels. 

The Agency is processing these use termination requests pursuant to FIFRA 

Section 6(f). The Agency will publish a notice in the Federal Register that it has received 

requests to terminate uses and, consistent with the registrant’s request that a longer 

comment period be waived, will allow a 30-day public comment period on the proposed 

use terminations. Unless the Agency receives comments which change its intention to 

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approve the use termination requests, the Agency will approve the use terminations and 

make them final and effective. 

Table 1. Pending Tris Nitro Use Deletions from Product Registrations and Labels

EPA 

Registration 

No. 

Product Name Pending Use Deletions 

464-657 Tris NitroTM Solid Industrial 

Bacteriostat 

Use in metalworking fluids; Latex paints; 

Resin/latex/polymer emulsions; Specialty industrial 

products; Livestock and poultry premises. 

464-658 Tris Nitro TM Brand of 50% 

(Aqueous) For Formulating 

Use 

Use in metalworking fluids; Latex paints; 

Resin/latex/polymer emulsions; Specialty industrial 

products; Livestock and poultry premises. 

464-663 Tris Nitro TM Brand of 50% 

Aqueous Tris 

(hydroxymethyl) nitromethane 

Use in paints, emulsions, and thickener solutions. Use 

in metalworking fluids. Use as a preservative for 

packaged emulsions, solutions, or suspensions, such 

as detergents and polishes containing water. 

464-668 Tris NitroTM Brand of 25% 

Aqueous Tris 

(hydroxymethyl) nitromethane

Use in metalworking fluids. Use as a preservative for 

packaged emulsions, solutions, or suspensions, such 

as detergents and polishes containing water. 

464-679 Tris NitroTM Brand Use in paints, emulsions, and thickener solutions. Use 

in metalworking fluids. Use as a preservative for 

packaged emulsion, solutions, or suspensions, such as 

detergents and polishes containing water. Use in pulp 

and paper-mill process water systems. 

Should these pending use terminations become final and effective, the Agency 

expects that the data needs, work plan and timeline described in the PWP will change as 

described in this document. The planned risk assessments and anticipated data needs for 

the tris nitro registration review case are discussed within this Final Work Plan (FWP). 

Further, this document makes final the work plan for the tris nitro registration review 

process. If the pending registration/label amendments involving the use terminations are 

withdrawn or otherwise not implemented, the Agency will conduct the exposure 

assessments outlined in the PWP and stated again in this FWP, and would expect to 

require the anticipated data needs also identified in both documents. 

 The following comments were submitted by the Dow Chemical Company in 

response to the tris nitro PWP. The Agency’s response to the particular comment follows 

the comment. 

Comment: The registration review documents identify the use of this active 

ingredient for metalworking applications and as a material preservative in 

detergents as trigger points necessitating the need for generation of 

chronic/carcinogenicity data. The Dow Chemical Company has submitted 

amendments for products containing tris nitro eliminating these end-uses. 

Consequently, the need for chronic/carcinogenicity data is no longer applicable. 

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Response: In response to the tris nitro PWP, the Dow Chemical Company 

submitted an amendment request, dated November 19, 2009, to terminate all but 

the oil field and recirculating water systems end-uses from registrations/labels. If 

these use terminations become effective, chronic and carcinogenicity data will not 

be required in support of the registration review of tris nitro because the two uses 

that would remain (oil field use and recirculating water systems use) are not 

expected to result in chronic exposure. 

Comment: Elimination of the end-use in detergents should also mitigate any 

Agency concerns about indirect food exposure, thus eliminating any need for a 

dietary food exposure risk assessment based on this use pattern. 

Response: The Agency agrees that if the termination of the detergent use becomes 

effective, an indirect dietary food exposure assessment would not be required in 

support of the registration review of tris nitro. The two tris nitro uses that would 

remain (oil field use and recirculating water systems use) do not trigger dietary 

food assessments. These uses are isolated, intermittent and very rarely in 

proximity to food crop or livestock production areas. Although the Agency does 

not expect drinking water exposure to occur, it is possible that discharges from 

industrial recirculating water systems could result in dietary drinking water 

exposure. However, the need for a dietary drinking water assessment will be 

revisited upon submission and review of the environmental fate data anticipated 

to be required. Oil field use would only result in groundwater contamination if a 

system failure occurs because other agencies and EPA offices protect against it. 

Therefore, a dietary food exposure assessment will not be needed to support the 

oil field and recirculating water tower systems uses of tris nitro; but the need for a 

dietary drinking water assessment will be revisited upon submission and review 

of the environmental fate data anticipated to be required. 

Comment: In determination of the need to conduct an aggregate assessment for 

tris nitro, it should be noted that the two end uses cited as potentially leading to 

this requirement (use in detergents and in paints) are being removed from the 

product labels. 

Response: Should the pending use terminations become final and effective a 

dietary food exposure assessment and residential exposure assessments will not be 

needed to support the two remaining uses. However, the need to conduct a 

dietary drinking water assessment and an aggregate assessment will be 

determined during the risk assessment development stage of this registration 

review. 

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Comment: The Water Quality section erroneously contains reference to another 

active ingredient and should be corrected. 

Response: On page 11 of the tris nitro PWP the Agency had erroneously made 

reference to two active ingredients (DTEA-HCl and DTEA) that are not a part of 

the tris nitro registration review case. The text should have referenced tris nitro 

instead of DTEA-HCl and DTEA. 

Comment: In the Introduction section (of the human health effects scoping 

document) it is noted correctly that tris nitro is non-irritating to the skin and not a 

dermal sensitizer. The document goes on further to express some concern about 

potential formaldehyde release in systems with pH > 8. It should be noted as the 

Agency further conducts its risk assessments, that the two remaining end uses 

(oilfield and industrial water systems) are maintained at pH < 8. 

Response: The Agency will consider this information as it conducts the 

registration review and makes its registration review decision for tris nitro. 

Comment: In view of the deletion of end-uses which have been interpreted as 

potentially leading to residential exposures (latex paints, resin/latex, polymer 

emulsion and detergent and polish suspensions), residential studies are not 

applicable for this active. 

Response: If the proposed use terminations presented in Table 1 become effective, 

residential exposure data will not be required in support of the registration review 

of tris nitro. 

Comment: A painting assessment will not be applicable for this active, due to the 

elimination of that end-use. An occupational handler dermal and inhalation 

exposure assessment resulting from use of preserved metalworking fluids will no 

longer be applicable for this active. Exposure and risk assessment for 

occupational bystanders working pulp and paper mills and metalworking facilities 

will no longer be applicable for this active. 

Response: The Agency agrees that if the proposed use terminations become 

effective, the following exposure risk assessments will no longer be needed: 

Painting exposure assessments; residential exposure assessments; an indirect 

dietary food exposure assessment; an occupational handler exposure assessment 

resulting from use of preserved metalworking fluids; occupational exposure from 

pet/livestock premise disinfection; and occupational exposure for bystanders 

working pulp and paper mills and metalworking facilities. 

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Comment: A clarification is needed concerning photodegradation in water data: 

this is listed as anticipated to be required for this active in this document (Product 

Chemistry, Environmental Fate and Ecotoxicity Scoping Document) but not so 

listed in the Summary Document. 

Response: The Agency inadvertently did not include (GLN 835.2240) 

photodegradation in water as an anticipated environmental fate data requirement 

in the tris nitro Summary Document Preliminary Work Plan. The Agency does 

anticipate that a photodegradation in water (GLN 835.2240) study will be needed 

in support of the tris nitro registration review. 

The following comment was submitted by the FIFRA Endangered Species Task 

Force in response to the tris nitro PWP. The Agency’s response to the particular 

comment follows the comment. 

Comment: The FIFRA Endangered Species Task Force (FESTF) submitted a 

comment which noted that the technical registrant of tris nitro, Dow Chemical 

Company, is a member of FESTF and is entitle to rely on FESTF data. In their 

comment, FESTF also noted that they are making every effort to inform 

registrants who are not currently eligible to rely on FESTF data the role of FESTF 

data and various options for reliance on that data. 

Response: The Agency thanks FESTF for its comment and will consider this 

information as it conducts the registration review and makes its registration 

review decisions. 

Risk Assessment & Data Needs

The tris nitro registration review case 3149 consists of one active ingredient. 

There are currently seven EPA registered products that contain tris nitro as an active 

ingredient (two manufacturing-use products and five end-use products). Tris nitro is 

registered as a bacteriostat, fungicide, slimicide and virucide for use as a materials 

preservative (in-can paints, emulsions, detergents, polishes, thickeners, etc.), an industrial 

preservative (metalworking fluids, pulp and paper mill process water systems, etc.), a 

disinfectant (livestock and pet premises), and in commercial and industrial water systems 

including oil fields. 

As previously mentioned, the technical registrant has submitted requests to 

terminate all but two of the registered tris nitro uses (see Table 1). In correspondence 

dated November 19, 2009, the Dow Chemical Company submitted amendments 

requesting the deletion of all registered tris nitro end-uses from affected registrations with 

the exception of the following two uses: (1) oil field use and (2) recirculating water 

systems use. The Agency is processing these use termination requests pursuant to FIFRA 

Section 6(f). The Agency will publish a notice in the Federal Register that it has received 

requests to terminate uses and, consistent with the registrant’s request that a longer 

comment period be waived, will allow a 30-day public comment period on the proposed 

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use terminations. Unless the Agency receives comments which change its intention to 

approve the use termination requests, the Agency will approve the use terminations and 

make them final and effective. 

The Agency anticipates that toxicity and exposure data will be needed to conduct 

residential (handler and post-application)1 and occupational (handler and postapplication/bystander) exposure risk assessments for the registered uses of tris nitro. 

However, should the pending use terminations become final and effective, the Agency 

expects that the human exposure assessment and anticipated human health data needs 

described in the tris nitro PWP and this FWP will change. Please refer to pages twelve 

and thirteen of this document for a complete list of the anticipated human health data 

needs. Refer to the footnotes in this document for further information regarding how the 

anticipated human health data needs and exposure assessment needs may change if the 

use terminations become final and effective. 

The Agency also anticipates that environmental fate and ecological exposure data 

will be needed to conduct an environmental risk assessment for the registered uses of tris 

nitro. Should the pending use terminations become final and effective an environmental 

exposure assessment will be needed for the recirculating water systems use only (and not 

the materials preservative uses because these uses will be terminated). The expected 

environmental fate and ecological exposure data needs in the PWP and this FWP will 

remain the same even if the pending use terminations become final and effective. 

Formaldehyde

Tris nitro is a formaldehyde (HCHO) releasing biocide. Therefore, this 

registration review case also addresses potential exposure to HCHO resulting from the 

use of tris nitro. However, this registration review case does not address possible 

aggregate risks from HCHO. When the HCHO registration review case is at the stage in 

which a risk assessment is conducted, aggregate risks from HCHO derived from the use 

of tris nitro will be considered at that time. The Agency issued a Reregistration 

Eligibility Decision (RED) document for formaldehyde in 2008 to address potential risks 

associated with formaldehyde. The formaldehyde RED did not include potential 

exposure to HCHO resulting from the use of products containing tris nitro as an active 

ingredient. Among other things, the Agency needs to determine how much HCHO is 

released from the tris nitro uses and if co-exposure is likely to occur.

The Office of Pesticide Programs (OPP) developed the formaldehyde inhalation 

non-cancer toxicological endpoint used in the 2008 formaldehyde RED through the 

established reregistration process, which includes stakeholder consultation and public 

comment. However, the result has not been subjected to an inter-agency review or 

external peer review. Because of time constraints imposed by statutory deadline, OPP 

could not consider all available peer reviewed science (for example, the intentional 

 

1 These assessments will not be needed if the registration/label amendments involving the use terminations 

become final and effective. However, if the use terminations do not become final and effective, these 

assessments will be needed for this registration review. 

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human dosing toxicity studies). Thus, this value (10 ppb residential, 100 ppb 

occupational) should be considered an interim value, developed solely for the purposes of 

the RED and subject to future revision and subsequent peer review and should not be 

used in other contexts as EPA's opinion of the best available science on the non-cancer 

effects of formaldehyde. 

The Agency has formed a work group that is charged with developing a 

harmonized non cancer hazard characterization document for formaldehyde. The Agency 

intends to use this non cancer information when assessing the risks associated with the 

antimicrobial uses of tris nitro and other formaldehyde releasers. In the near term, the 

antimicrobial uses will also be assessed for cancer risks in the same manner as presented 

in the formaldehyde RED (i.e., a range of cancer risks using the Chemical Industry 

Institute of Toxicology (CIIT) model and the existing Integrated Risk Information 

System [IRIS] unit risk). Once the IRIS update of the formaldehyde cancer unit risk is 

available, the Agency will adopt that value in our risk assessments. The formaldehyde 

risk assessments are available on EPA’s Pesticide Docket at: www.regulations.gov. The 

docket number is EPA-HQ-OPP-2008-0121. 

Human Health Risk Assessment Status 

Tris nitro was first registered in the United States in 1955. A Reregistration 

Eligibility Decision (RED) for tris nitro was issued in September 1993. The RED can be 

located at: http://www.epa.gov/pesticides/reregistration/status.htm. 

 The Agency has reviewed the hazard and exposure databases for tris nitro for this 

registration review case. Residential and occupational exposure assessments have not 

been conducted to assess possible risks resulting from the registered uses of tris nitro 

products. Also, toxicity endpoints for the parent compound (tris nitro) were not selected 

in support of the 1993 tris nitro RED. As a result of this review, EPA anticipates that 

residentiall and occupational handler risk assessments and additional toxicity data and 

exposure data will be needed to complete this registration review case. It is anticipated 

that toxicology data will be needed to address sub-chronic inhalation toxicity and chronic 

toxicity2 as well as potential carcinogenicity2. Exposure data including specific use 

pattern and physicochemical behavior data are expected to be needed to determine if 

residues of tris nitro and/or HCHO are likely to survive the material manufacturing and 

commercial processes. These data are also expected to be needed to determine if tris 

nitro and/or HCHO are released and at what rates they may be released. 

However, should the pending use terminations become final and effective, the 

Agency expects that the human exposure assessments and anticipated human health data 

needs described in the tris nitro PWP and this FWP will change. Please refer to pages 

twelve and thirteen of this document for a complete list of the anticipated human health 

data needs. Refer to the footnotes in this document for further information regarding how 

the anticipated human health data needs and exposure assessment needs may change if 

the use terminations become final and effective. 

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Further information and detailed justifications for the studies that are expected to 

be required are available in the document titled, “2-(Hydroxymethyl)-2-nitro-1,3-

propanediol. Human Health Effects Scoping Document for the Registration Review 

Decision,” dated March 23, 2010. 

Toxicity 

Tris nitro is of moderate acute toxicity (Toxicity Category III) via the oral and 

dermal routes of exposure and is of low acute toxicity (Toxicity Category IV) via the 

inhalation route. It is non-irritating (Toxicity Category IV) to the skin and somewhat 

irritating to the eyes (Toxicity Category III). As previously noted, tris nitro is a 

formaldehyde (HCHO) releasing chemical that slowly releases HCHO in alkaline 

environments and at temperatures above 49oC. However, tris nitro is unlike other HCHO 

releasing compounds because it is not a dermal sensitizing agent. 

No sub-chronic oral or inhalation toxicity studies are available for tris nitro. 

However, the Agency believes that oral exposure to tris nitro and HCHO will be minimal 

compared to dermal and inhalation exposures, respectively, because the registered uses 

are not likely to result in oral exposure. Instead these uses result primarily in dermal and 

inhalation exposure. The preserved paint, emulsions, detergent, polishes and thickener 

uses are not likely to result in inadvertent oral exposure of children and therefore oral 

toxicity data are not anticipated as being required. 

The Agency has an acceptable sub-chronic dermal toxicity study and therefore, 

further sub-chronic dermal toxicity data are not anticipated as being required. However, 

the Agency anticipates that a 90-day inhalation toxicity study will be needed to identify 

adverse effects that may result from short-term or intermediate-term exposures to tris 

nitro and its degradate (HCHO). 

The use of tris nitro as materials preservative in metalworking fluids may result in 

chronic worker exposure (e.g., machinists working with cutting oils) to tris nitro and/or 

HCHO.1 However, chronic toxicity data are not available for tris nitro. It is anticipated 

that chronic toxicity data2

 will be needed to conduct occupational handler risk 

assessments for the use of tris nitro as a metalworking fluid preservative.1

 The expected 

need for chronic toxicity data is also triggered by the use of tris nitro as a materials 

preservative in detergents.2 The current tris nitro labels do not prohibit the use of tris 

nitro as a materials preservative in dishwashing detergent. Therefore, the Agency 

believes that the use of tris nitro as a materials preservative in dishwashing detergent may 

result in chronic indirect dietary food exposure.1 Also, as a result of these uses, which 

may result in chronic exposure to tris nitro and/or HCHO, the Agency believes that 

carcinogenicity data will be needed to assess possible cancer risks.2 

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Dietary and Drinking Water Exposure and Risk

Dietary Food Exposure 

Tris nitro has no registered direct food uses and a dietary food exposure risk 

assessment has not been performed for tris nitro. However, an indirect dietary food 

exposure and risk assessment is needed to assess the use of tris nitro as a materials 

preservative in dishwashing detergents.1 The current labels state that tris nitro is used as 

an in-can preservative of “suspensions such as detergents.” This detergent use pattern 

includes dishwashing detergents and therefore, residue transfer to food and subsequent 

indirect food exposure may occur as a result of this use and a conservative indirect food 

exposure risk assessment will be needed to assess exposure from dishwashing detergent 

use.

1

 If the proposed dietary assessment results in an apparent risk of Agency concern, 

studies to determine the extent of residue transfer from the preserved detergent to eating 

implements and then to food may be necessary.1 and 2

 

 Tris nitro is also used as a slimicide in paper mill process water systems and as a 

disinfectant in livestock premises. Dietary food exposure resulting from these uses are 

mitigated by restrictive label language and specific product use instructions which are 

required on product labels (e.g., use is limited to the production of paper or paperboard 

that will not come in contact with food or feed; the livestock use is followed by a potable 

water rinse). Therefore, a dietary food risk assessment is not needed for the use of tris 

nitro as a slimicide in paper mill process water systems and as a disinfectant in livestock 

premises. 

Should the pending use termination of the detergent use become final and 

effective, an indirect dietary food exposure assessment would not be required in support 

of the registration review of tris nitro. The two tris nitro uses that would remain (oil 

field use and recirculating water systems use) do not trigger indirect dietary food 

assessments. These uses are isolated, intermittent and very rarely in proximity to food 

crop or livestock production areas. Although the Agency does not expect dietary food 

exposure to occur, it is possible that discharges from industrial recirculating water 

systems could result in dietary drinking water exposure. However, the need for a dietary 

drinking water exposure assessment will be revisited upon submission and review of the 

environmental fate data anticipated to be required. Oil field use would only result in 

groundwater contamination if a system failure occurs because other agencies and EPA 

offices protect against it. Therefore, a dietary food exposure assessment will not be 

needed to support the oil field and recirculating water tower systems uses of tris nitro; 

but the need for a dietary drinking water assessment will be revisited upon submission 

and review of the environmental fate data anticipated to be required. 

Dietary Drinking Water Exposure 

The need for a dietary drinking water exposure assessment for tris nitro will be 

determined upon review of environmental fate data which the Agency anticipates 

requiring. The Agency anticipates that environmental fate data will be useful to 

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determine if tris nitro can pass through waste-water treatment facilities into drinking 

water or migrate into residential groundwater wells as a result of its current use patterns. 

Therefore, the need for a dietary drinking water assessment will be revisited upon 

submission and review of the environmental fate data anticipated to be required.

Tolerances

Tris nitro has no registered direct food uses. The EPA has not established 

tolerances or exemptions from tolerances in raw agricultural commodities or processed 

food and feed products under the Federal Food, Drug and Cosmetic Act (FFDCA) for tris 

nitro. However, the current materials preservative use labels do not preclude tris nitro 

from use as a materials preservative for dishwashing detergent. Therefore, an indirect 

dietary food assessment is needed to assess exposure resulting from the use of tris nitro as 

a materials preservative in dishwashing detergent.1

 If the proposed dietary assessment 

results in an apparent risk of Agency concern, studies to determine the extent of residue 

transfer from the preserved detergent to eating implements and then to food may be 

necessary.2

However, should the pending use terminations become final and effective; an 

indirect dietary food exposure assessment and tolerances or exemptions from tolerances 

will not be needed to support the remaining two uses (oil field use and recirculating water 

tower systems use) because they are not likely to result in indirect dietary food exposure. 

Although the Agency does not expect dietary food exposure to occur (for the oil 

field and recirculating water tower systems uses), it is possible that discharges from 

industrial recirculating water systems could result in drinking water exposure. Therefore, 

the need for a dietary drinking water assessment will be revisited upon submission and 

review of the environmental fate data anticipated to be required. 

Aggregate and Cumulative Exposure and Risk

In examining aggregate exposure, EPA takes into account available and reliable 

information concerning exposures to pesticide residues in food and drinking water, as 

well as non-occupational pesticide exposures. Indirect food exposure is expected 

resulting from the dishwashing detergent preservative use.1

 Residential handler 

(painting) and post-application exposure of adults and children to tris nitro and/or HCHO 

are also likely to occur.1

 The need to conduct an aggregate assessment for tris nitro will 

be determined during the risk assessment development stage of this registration review 

case. 

Should the pending use terminations become final and effective a dietary food 

exposure assessment will not be needed to support the two remaining uses. However, the 

need to conduct a dietary drinking water assessment and an aggregate assessment will be 

determined during the risk assessment development stage of this registration review. 

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Section 408(b)(2)(D)(v) of FFDCA 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.” EPA has not yet determined 

whether tris nitro has a common mechanism with other compounds; consequently, a 

cumulative assessment will not be performed at this time. 

Occupational and Residential Exposure and Risk 

The Agency reviewed all available data associated with tris nitro and has 

determined that the currently registered uses of tris nitro may result in residential1 and 

occupational exposure to tris nitro and/or its degradate HCHO. Therefore, the Agency 

will complete the residential (handler and post-application)1 and occupational (handler 

and post-application/bystander) risk assessments presented below to assess possible 

dermal and inhalation exposure to tris nitro and/or HCHO: 

• Residential Handler Risk Assessment (adults) 1 - Exposure resulting from 

application/use of preserved materials (e.g., painting). The anticipated routes 

of exposure to residential handlers are dermal exposure to tris nitro and 

inhalation exposure to tris nitro and HCHO. 

• Residential Post-Application Assessment (adults and children) 1 - Exposure to 

materials treated with tris nitro. The anticipated post-application routes of 

exposure to residents are dermal exposure to tris nitro and inhalation exposure 

to HCHO. 

• Occupational Handler Assessment - Exposure resulting from activities such 

as pouring and mixing tris nitro in oil fields, cooling towers, materials 

preservation1

, metalworking fluid use1, use in pulp and paper mill water 

systems1

, application of spray in animal premises1 and use of preserved 

materials (painting)1. The anticipated routes of exposure to occupational 

handlers are dermal exposure to tris nitro and inhalation exposure to tris nitro 

and HCHO. 

• Occupational Post-Application/Bystander Assessment - Exposure of people 

working in oil fields and cooling towers, metalworking facilities1

 and pulp and 

paper mills1. The anticipated post-application/bystander routes of exposure to 

occupational workers are inhalation exposure to HCHO. 

However, if the registration/label amendments involving the use terminations 

become final and effective, the following exposure assessments will not be needed to 

support the then-remaining oil field and recirculating water tower systems uses because 

these two uses are not likely to result in the following exposure scenarios: residential 

exposure assessments; an indirect dietary food exposure assessment; an occupational 

handler exposure assessment resulting from use of preserved metalworking fluids; 

painting exposure assessments; occupational exposure from pet/livestock premise 

disinfection and occupational exposure for bystanders working pulp and paper mills and 

metalworking facilities.1

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Anticipated Human Health Data Needs 

The following data are currently anticipated as needed by the Agency for this 

registration review. However the footnotes should be consulted for information as to 

how these anticipated data needs could change should the pending use terminations 

become final and effective. 

Anticipated Toxicity Data Needs

• (GLN 870.3465) 90-day inhalation toxicity in rats 

• (GLN 870.4100) Chronic studies in rodents2

• (GLN 870.4200) Carcinogenicity studies (rat and mouse)2

Anticipated Occupational Handler Exposure Data Needs

• (GLN 875.1100) Dermal Exposure (outdoor) 

• (GLN 875.1300) Inhalation Exposure (outdoor) 

• (GLN 875.1600) Applicator Exposure Monitoring Data Reporting for Dermal 

and Inhalation Data 

• (GLN 875.1700) Product Use Information (outdoor) 

• (GLN 875.2800) Descriptions of Human Activity 

• (GLN 875.2900) Data Reporting and Calculations 

• (GLN 875.2700) Product Use Information (indoor)2 

• (GLN 875.1200) Dermal Exposure (indoor)2 

• (GLN 875.1400) Inhalation Exposure (indoor)2

As previously mentioned, should the pending use terminations become final and 

effective, the Agency expects that the human exposure assessment and anticipated human 

health data needs described in the tris nitro PWP and this FWP will change. Please refer 

to pages twelve and thirteen of this document for a complete list of the anticipated human 

health data needs. Also, the footnotes in this document should be consulted for 

information as to how these anticipated data needs could change should the pending use 

terminations become final and effective. 

Incidents

One incident related to the use of tris nitro has been reported in the OPP Incident 

Database System (IDS). Occupational handlers working in an aluminum rolling mill 

reported that they experienced tearing eyes, eye irritation, runny noses and sore throats 

when process water temperatures were raised. 

 

2

 These data would not be expected to be needed if the registration/label amendments involving the use 

terminations become final and effective. However, if the use terminations do not become final and 

effective, these data are expected to be needed for this registration review. 

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Environmental Fate and Ecological Risk Assessment Status 

The Agency reviewed the environmental fate and ecological hazard databases for 

tris nitro. Based on this review, risk assessments are needed (for the registered materials 

preservative1 and recirculating water tower systems uses) to ensure that the tris nitro 

registration review case meets the FIFRA standards. Should the pending use 

terminations become final and effective the environmental risk assessments listed below 

will be needed for the recirculating water systems use only (and not the materials 

preservative uses because these uses will be terminated). The Agency will complete the 

environmental fate and ecological hazard risk assessments presented below. Further 

information and detailed justifications for the exposure assessments and studies that are 

anticipated as being required are available in the document titled, “Summary of Product 

Chemistry, Environmental Fate, and Ecotoxicity Data for the 2-(Hydroxymethyl)-2-nitro1,3-propanediol Registration Review Decision Document,” dated March 23, 2010. 

• Environmental fate3

• Ecological hazard3

• Endangered species assessment3

Environmental fate and ecological risk assessments have not been conducted for 

tris nitro. The use of tris nitro as a materials preservative1

 and as an industrial slimicide 

in recirculating water towers could potentially result in environmental exposure. These 

uses may result in waste water treatment plant (WWTP) discharges into terrestrial and 

aquatic environments. Therefore, the Agency will conduct environmental fate and 

ecological risk assessments to assess environmental exposure resulting from possible 

discharges into terrestrial and aquatic environments. The Agency also anticipates that 

environmental fate and ecological data will be required to conduct these assessments. 

Should the pending use terminations become final and effective, the anticipated 

environmental fate and ecological exposure data needs in the PWP and this FWP will 

remain the same and it is anticipated that they will be required to support the recirculating 

water tower systems use. 

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

endangered species determination. The ecological risk assessment planned during 

registration review will allow the Agency to determine whether use of tris nitro 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. 

 

3 Should the pending use terminations become final and effective, these environmental exposure and risk 

assessments will still be needed to support the recirculating water systems use. 

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Docket Number: EPA–HQ–OPP–2009–0639 

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Anticipated Physical/Chemical Property Data Needs 

All product chemistry data requirements have been fulfilled for the active 

ingredient tris nitro. Therefore, additional product chemistry data are not expected to be 

needed for tris nitro. 

Anticipated Environmental Fate and Ecological Data Needs 

The Agency will conduct environmental fate and ecological risk assessments for 

tris nitro based on its use as a materials preservative1

 and as an industrial slimicide in 

recirculating water towers. These uses could potentially result in tris nitro passing 

through waste water treatment plants (WWTPs), which may then be discharged into 

terrestrial and/or aquatic environments. Therefore, environmental fate and ecological 

toxicity data for tris nitro (and/or any of its major degradation products that are of 

potential concern) are anticipated as being required. The environmental fate and 

ecological toxicity data listed below are anticipated as being required to conduct 

environmental fate and ecological risk assessments for tris nitro. Should the pending use 

terminations become final and effective, the anticipated environmental fate and 

ecological exposure data needs in the PWP and this FWP will remain the same and will 

be needed to support the recirculating water tower systems use. 

Anticipated Environmental Fate Data Needs

• (GLN 850.6800) Modified activated sludge respiration inhibition 

• (GLN 835.1110) Activated sludge sorption isotherm 

• (GLN 835.3110) Ready biodegradability 

• (GLN 835.2240) Photodegradation in water 

Anticipated Ecological Data Needs

• GLN 850.4400) Aquatic Plant Growth (aquatic vascular plant toxicity), Tier 

 II dose response study on floating macrophyte (Lemna gibba) 

• (GLN 850.5400) Aquatic Plant Growth (algal toxicity), Tier II dose response 

 studies on Anabaena flos-aquae (blue-green cyanobacteria), Navicula 

 pelliculosa (freshwater diatom), and Skeletonema costatum (marine diatom) 

Endocrine Disruptor Screening Program 

As required under FFDCA section 408(p), EPA has developed the Endocrine 

Disruptor Screening Program (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 

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Docket Number: EPA–HQ–OPP–2009–0639 

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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. 

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. This list of chemicals was selected based on the potential for human 

exposure through pathways such as food and water, residential activity, and certain postapplication agricultural scenarios. This list should not be construed as a list of known or 

likely endocrine disruptors. 

Tris nitro is not among the group of 58 pesticide active ingredients on the initial 

list to be screened under the EDSP. Under FFDCA sec. 408(p) the Agency must screen 

all pesticide chemicals. Accordingly, EPA anticipates issuing future EDSP test 

orders/data call-ins for all pesticide active ingredients. 

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

list of 67 chemicals, the test guidelines and the Tier 1 screening battery, please visit our 

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

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Timeline

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

tris nitro registration review case. 

Anticipated Schedule

Registration Review for Tris Nitro 

Projected Registration Review Timeline 

Activities 

Time 

Opening Docket 

Open Public Comment Period for Tris Nitro Docket 

Completed 

September 2009 

Close Public Comment Period 

Completed 

December 2009 

Case Development 

Develop Final Work Plan (FWP) 

Completed 

March 2010 

Issue Final DCI March 2011 

Data Submission March 2014 

Open Public Comment Period for Preliminary Risk Assessments July 2014 

Close Public Comment Period September 2014 

Registration Review Decision 

Open Public Comment Period for Proposed RR Decision December 2014 

Close Public Comment Period March 2015 

Final Decision June 2015 

Total (years) 6 years 

If the use terminations requested by the registrant do not become final and effective, this estimated timeline 

could change. 

Next Steps

A DCI will be developed for this registration review case regarding the data needs 

listed under the “Risk Assessment and Data Needs” section of this document. The 

Agency expects to issue the DCI in 2011. 

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