Docket Number: EPA–HQ–OPP–2009–0639 www.regulations.gov

United States Prevent ion, 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 2010Docket 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

1Docket Number: EPA–HQ–OPP–2009–0639 www.regulations.gov

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 nitr o) (Case 3149). The FWP includes th e 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 Rodentic ide Act (FIFRA) and w ill review each registered pesticide every 15 year s to determine whether it continues to meet the FIFRA standard for regist ration. Changes in science, public policy and pesticide use practices will occur over time. The registra tion review program is intended to make sure that, as the ability to assess risk evolve s and as policies and practices change, all registered pesticides continue to meet th at 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 trad e irritants. No comm ents or information were received during the public comme nt period concerning these issues.

During the public comment period, th e EPA received several comments, including a request from the tec hnical registrant to delete all but two registered tris nitro uses. In correspondence dated Novemb er 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 de letions from tris nitro registrations/labels.

The Agency is processing these use te rmination 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 wi th 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 Ag ency will approve the use terminations and

make them final and effective.

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

EPA Registration

No. Product Name Pending Use Deletions

464-657 Tris Nitro TM 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 Nitro TM 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 Nitro TM 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 beco me 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 anticip ated 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 nitr o registration review process. If the pending registration/label am endments involving the use terminations are withdrawn or otherwise not implemente d, 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 al so 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/carci nogenicity 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 system s end-uses from registrations/labels. If these use terminations become effective, chronic and carcinogenicity data will not be required in support of the registration re view of tris nitro because the two uses that would remain (oil field use and r ecirculating 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 expos ure, thus eliminating any need for a dietary food exposure risk assessm ent based on this use pattern.

Response : The Agency agrees that if the term ination of the detergent use becomes effective, an indirect dietary food exposur e assessment would not be required in support of the registration review of tris nitro. The two tris n itro uses that would remain (oil field use and recirculating wa ter systems use) do not trigger dietary

food assessments. These uses are isol ated, intermittent and very rarely in proximity to food crop or livestock pr oduction 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 th e environmental fate data anticipated to be required. Oil field use would onl y result in groundwater contamination if a system failure occurs because other agenci es 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 system s 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 tw o end uses cited as potentially leading to this requirement (use in detergents a nd 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 reside ntial 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 de velopment stage of this registration

review.

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Comment : The Water Quality section erroneous ly contains reference to another active ingredient and should be corrected.

Response : On page 11 of the tris nitro PW P the Agency had erroneously made reference to two active ingredients (DTEA-H Cl and DTEA) that are not a part of the tris nitro registration re view 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 ni tro 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 assessm ents, 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 regist ration review decision for tris nitro.

Comment : In view of the deletion of end-us es which have been interpreted as potentially leading to residential exposu res (latex paints, resin/latex, polymer emulsion and detergent and polish suspen sions), 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 requi red 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 o ccupational 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; residen tial exposure assessmen ts; an indirect dietary food exposure assessment; an occ upational handler exposure assessment resulting from use of preserved metalw orking fluids; occupational exposure from pet/livestock premise disi nfection; and occupational exposure for bystanders working pulp and paper mills and metalworking facilities.

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Comment : A clarification is needed concer ning photodegradation in water data: this is listed as anticipated to be requir ed for this active in this document (Product Chemistry, Environmental Fate and Ecot oxicity 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 anticipate d environmental fate data requirement in the tris nitro Summary Document Pr eliminary Work Plan. The Agency does anticipate that a photodegradation in water (GLN 835.2240) study will be needed in support of the tris n itro 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 re gistrant of tris nitro, Dow Chemical Company, is a member of FESTF and is en title to rely on FESTF data. In their comment, FESTF also noted that they are making every effort to inform registrants who are not curren tly eligible to rely on FESTF data the role of FESTF data and various options fo r reliance on that data.

Response : The Agency thanks FESTF for its comment and will consider this information as it conducts the registra tion 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 produ cts that contain tris nitro as an active ingredient (two manufacturing -use products and five end-us e products). Tris nitro is registered as a bacteriostat, fungicide, slim icide and virucide for use as a materials preservative (in-can paints, emulsions, detergen ts, polishes, thickeners , etc.), an industrial preservative (metalworking fluids, pulp and paper mill process water systems, etc.), a disinfectant (livestock and pe t 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 n itro end-uses from affect ed registrations with the exception of the following two uses: (1) oil field use and (2) recirculating water systems use. The Agency is processing thes e 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 wi th 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 Ag ency will approve the use terminations and

make them final and effective.

The Agency anticipates that toxicity a nd 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 docum ent for further information regarding how the anticipated human health data needs and e xposure assessment needs may change if the

use terminations become final and effective.

The Agency also anticipates that envir onmental 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 sy stems 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 te rminations become final and effective.

Formaldehyde

Tris nitro is a formaldehyde (HCHO) re leasing biocide. Therefore, this registration review case also addresses potential exposure to HCHO resulting from the use of tris nitro. However, this regist ration review case does not address possible aggregate risks from HCHO. When the HCHO re gistration 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 formal dehyde 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 a nd 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 c onstraints imposed by statutory deadline, OPP

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

1 These assessments will not be needed if the registra tion/label amendments involving the use terminations become final and effective. However, if the use te rminations 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 revi ew 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 wh en assessing the risks associated with the

antimicrobial uses of tris n itro and other formaldehyde releas ers. 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 th e existing Integrated Risk Information System [IRIS] unit risk). Once the IRIS upda te 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 Pe sticide 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 th e United States in 1955. A Reregistration Eligibility Decision (RED) for tris nitro wa s 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. Re sidential and occupational expo sure assessments have not been conducted to assess possibl e risks resulting from the regi stered uses of tris nitro products. Also, toxicity endpoints for the pare nt compound (tris nitro) were not selected in support of the 1993 tris nitro RED. As a re sult of this review, EPA anticipates that

residential l 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 toxicity 2 as well as potential carcinogenicity 2 . Exposure data including specific use pattern and physicochemical beha vior data are expected to be needed to determine if

residues of tris nitro and/or HCHO are likel y to survive the material manufacturing and commercial processes. These data are also e xpected 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 asse ssments and anticipated human health data

needs described in the tris nitro PWP and th is 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 justificati ons for the studies that are expected to be required are available in the doc ument titled, “2-(Hydroxymethyl)-2-nitro-1,3- propanediol. Human Health E ffects Scoping Document for the Registration Review Decision,” dated March 23, 2010.

Toxicity

Tris nitro is of moderate acute toxicity (Toxicity Category II I) via the oral and dermal routes of exposure and is of low acu te 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 II I). As previously noted, tris nitro is a formaldehyde (HCHO) releasing chemical that slowly releases HCHO in alkaline environments and at temperatur es above 49oC. However, tris nitro is unlike other HCHO releasing compounds because it is not a dermal sensitizing agent.

No sub-chronic oral or inha lation toxicity studies are available for tris nitro. However, the Agency believes that oral expos ure 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 us es 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 childre n and therefore oral toxicity data are not antici pated as being required.

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

further sub-chronic dermal toxi city data are not anticipated as being required. However, the Agency anticipates that a 90-day inhalati on toxicity study will be needed to identify adverse effects that may result from short-te rm or intermediate-term exposures to tris nitro and its degradate (HCHO).

The use of tris nitro as materials preserva tive 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 av ailable for tris nitro. It is anticipated that chronic toxicity data 2 will be needed to conduct occupational handler risk

assessments for the use of tris nitr o as a metalworking fluid preservative. 1 The expected need for chronic toxicity data is also trig gered by the use of tris nitro as a materials preservative in detergents. 2 The current tris nitro labels do not prohibit th e use of tris nitro as a materials preservative in dishwa shing detergent. Therefore, the Agency

believes that the use of tris nitro as a mate rials preservative in di shwashing 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 nitr o and/or HCHO, the Agency believes that carcinogenicity data will be need ed to assess possible cancer risks. 2

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Dietary and Drinking Wa ter Exposure and Risk

Dietary Food Exposure

Tris nitro has no registered direct f ood 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 tran sfer 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 tr ansfer from the preser ved 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. Dietar y 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 f eed; the livestock use is followed by a potable water rinse). Therefore, a diet ary 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. Th e two tris nitro uses that would remain (oil field use and recirculating water systems use) do not trigger i ndirect dietary food assessments. These uses are isolated, intermitte nt 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 po ssible 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 re visited upon submission and review of the environmental fate data anticipated to be re quired. 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 recirculati ng water tower systems us es of tris nitro; but the need for a dietary drinking water a ssessment 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 expos ure assessment for tris nitro will be determined upon review of environmental fate data which the Agency anticipates requiring. The Agency anticipates that envi ronmental fate data will be useful to

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determine if tris nitro can pass through wa ste-water treatment facilities into drinking water or migrate into residentia l groundwater wells as a result of its current use patterns. Therefore, the need for a dietary dri nking water assessment will be revisited upon

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

Tolerances

Tris nitro has no registered direct f ood uses. The EPA has not established tolerances or exemptions from tolerances in raw agricultural commodities or processed food and feed products under the Federal F ood, Drug and Cosmetic Act (FFDCA) for tris nitro. However, the current materials preserva tive 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 exposu re 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 dietar y 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 re sult in drinking water exposure. Therefore, the need for a dietary drinking water asse ssment 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 ta kes into account available and reliable information concerning exposures to pesticid e 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 beco me final and effective a dietary food exposure assessment will not be needed to s upport 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 devel opment stage of this registration review.

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Section 408(b)(2)(D)(v) of FFDCA require s that, when considering whether to establish, modify, or revoke a tolerance, th e Agency consider “available information” concerning the cumulative effects of a part icular pesticide's residues and “other

substances that have a common mechanism of toxicity.” EPA has not yet determined

whether tris nitro has a common mechanis m 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 residential 1 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 asse ssments 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 ar e 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 oi l fields, cooling towers, materials preservation 1 , metalworking fluid use 1 , use in pulp and paper mill water

systems 1 , application of spray in animal premises 1 and use of preserved materials (painting) 1 . The anticipated routes of exposure to occupational handlers are dermal exposure to tris nitr o and inhalation expos ure to tris nitro

and HCHO.

• Occupational Post-Application/Bystander Assessment - Exposure of people working in oil fields and cooli ng towers, metalworking facilities 1 and pulp and paper mills 1 . The anticipated post- application/bystander r outes of exposure to occupational workers are inha lation exposure to HCHO.

However, if the registration/label ame ndments involving the use terminations become final and effective, the following e xposure assessments will not be needed to support the then-remaining oil field and recirc ulating 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; occupationa l exposure from pet/livestock premise disinfection and occupational exposure for bys tanders 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 s hould be consulted for information as to how these anticipated data needs could ch ange should the pending use terminations

become final and effective.

Anticipated Toxicity Data Needs

• (GLN 870.3465) 90-day inhala tion toxicity in rats

• (GLN 870.4100) Chronic studies in rodents 2

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

Anticipated Occupational Ha ndler Exposure Data Needs

• (GLN 875.1100) Dermal Exposure (outdoor)

• (GLN 875.1300) Inhalation Exposure (outdoor)

• (GLN 875.1600) Applicator Exposure Moni toring 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 Reporti ng and Calculations

• (GLN 875.2700) Product Us e Information (indoor) 2

• (GLN 875.1200) Dermal Exposure (indoor) 2

• (GLN 875.1400) Inhalation Exposure (indoor) 2

As previously mentioned, should the pe nding 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 da ta needs could change should the pending use

terminations become final and effective.

Incidents

One incident related to the use of tris n itro has been reported in the OPP Incident Database System (IDS). Occupational handl ers working in an aluminum rolling mill reported that they experienced tearing eyes, eye irritation, runny nos es 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 Ecologi cal Risk Assessment Status

The Agency reviewed the environmental fate and ecological hazard databases for

tris nitro. Based on this revi ew, risk assessments are needed (for the registered materials preservative 1 and recirculating water tower systems us es) to ensure that the tris nitro registration review case meets the FI FRA standards. Should the pending use

terminations become final and effective the environmental risk assessments listed below will be needed for the recirculating wate r 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 th e exposure assessments and studies that are anticipated as being required are availabl e in the document titled, “Summary of Product Chemistry, Environmental Fate , and Ecotoxicity Data for the 2-(Hydroxymethyl)-2-nitro1,3-propanediol Registrati on Review Decision Docume nt,” dated March 23, 2010.

• Environmental fate 3

• Ecological hazard 3

• Endangered species assessment 3

Environmental fate and ecological risk assessments have not been conducted for

tris nitro. The use of tris n itro as a materials preservative 1 and as an industrial slimicide in recirculating water towers could potentia lly result in environmental exposure. These uses may result in waste water treatment plan t (WWTP) discharges into terrestrial and aquatic environments. Therefore, the Ag ency will conduct environmental fate and ecological risk assessments to assess environmental exposu re resulting from possible discharges into terrestrial and aquatic envir onments. 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 anticip ated that they will be requir ed to support the recirculating

water tower systems use.

The Agency has not conducted a risk assessment that supports a complete endangered species determination. The eco logical 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 threat ened or endangered sp ecies (listed species) or their designated critical ha bitats. When an assessment c oncludes that a pesticide’s use “may affect” a listed species or its designate d 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.

14Docket Number: EPA–HQ–OPP–2009–0639 www.regulations.gov

Anticipated Physical/Chemical Property Data Needs

All product chemistry data requirements have been fulfilled for the active ingredient tris nitro. Theref ore, 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 preservative 1 and as an industrial slimicide in recirculating water towers. These uses c ould potentially result in tris nitro passing through waste water treatment plants (WWTPs), which may then be discharged into terrestrial and/or aquatic e nvironments. Therefore, environmental fate and ecological toxicity data for tris nitro (and/or any of its major degr adation products that are of potential concern) are anticipated as bei ng required. The environmental fate and ecological toxicity data listed below are anticipated as being required to conduct environmental fate and ecological risk assessm ents for tris nitro. Should the pending use terminations become final and effective, the anticipated environmental fate and ecological exposure data needs in the PWP a nd this FWP will remain the same and will be needed to support the recircul ating water tower systems use.

Anticipated Environmental Fate Data Needs

• (GLN 850.6800) Modified activated sludge respiration inhibition

• (GLN 835.1110) Activated sl udge sorption isotherm

• (GLN 835.3110) Ready biodegradability

• (GLN 835.2240) Photodegradation in water

Anticipated Ecological Data Needs

• GLN 850.4400) Aquatic Plant Gr owth (aquatic vascular plant toxicity), Tier II dose response study on floating macrophyte ( Lemna gibba )

• (GLN 850.5400) Aquatic Plant Growth (alg al 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 dete rmine whether certain substances (including pesticide active and other ingred ients) may have an effect in humans or wildlife similar to an effect produced by a “natur ally occurring estrogen, or othe r such endocrine effects as the Administrator may designate.” The ED SP 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 substa nce 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 inte ract with E, A, or T hormonal systems will proceed to the next stage of the EDSP wher e EPA will determine which, if any, of the

15Docket Number: EPA–HQ–OPP–2009–0639 www.regulations.gov

Tier 2 tests are necessary based on the avai lable data. Tier 2 te sting is designed to identify any adverse endocrine related eff ects caused by the substance, and establish a dose-response relationship between th e 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 c ontains 58 pesticide ac tive ingredients and 9 inert ingredients. This list of chemicals was selected based on the potential for human exposure through pathways such as food and wa ter, residential activity, and certain postapplication agricultural s cenarios. This list should not be construed as a list of known or likely endocrine disruptors.

Tris nitro is not among the group of 58 pe sticide 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/

.

16Docket Number: EPA–HQ–OPP–2009–0639 www.regulations.gov

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 Pre liminary Risk Assessments July 2014

Close Public Comment Period September 2014

Registration Review Decision
Open Public Comment Period for Pr oposed 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 registra tion review case regarding the data needs

listed under the “Risk Assessment and Data N eeds” section of this document. The Agency expects to i ssue the DCI in 2011.

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