Docket Number: EPA-HQ-OPP-2010-0783 www.regulations.gov



## Summary Document for Sodium Asulam Registration Review: Initial Docket

March 20113 of 13 

### TABLE OF CONTENTS

I. Preliminary Work Plan (PWP) 4

II. Fact Sheet 11

______________________ __________________

Please Note

This Preliminary Work Plan and Fact Sheet su mmarize the Environmental Protection Agency's current position based on the following documents:

1. Registration Review: Preliminary Problem Formulation for Environmental Fate and Ecological Risk, Endangered Species, and Dr inking Water Assessments for Asulam and Sodium Asulam. December 22, 2010

2. Asulam: Human Health Risk Scoping Docu ment in Support of Registration Review. January 5, 2011

3. Asulam and Sodium Asulam: Review of Human Incidents. November 30, 2010

4. BEAD Chemical Profile for Re gistration Review on Asulam, Sodium Salt. December 2,

2010

5. Appendix A for Sodium Asulam. June 25, 2010

Supporting documents for sodium asulam ma y be found in the docket (EPA-HQ-OPP-2010- 0783) located on the internet at www.regulations.gov

.4 of 13 I. Preliminary Work Plan – Sodium Asulam

Introduction:

The Food Quality Protection Act (FQP A) of 1996 mandated a registration review program

. All pesticides sold or distributed in the Unite d States (U.S) generally must be registered by the Environmental Protection Agency (EPA or the Ag ency), based on scientific data showing that they will not cause unreasonable ri sks to human health or the environment when used as directed on product labeling. The registration review program is intended to ma ke 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 unreasonabl e 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 prog ram, the Agency periodically r eevaluates pesticides to make sure that as change occurs, products in the mark etplace can be used safely. Information on this program is provided at: http://www.epa.gov/oppsrr d1/registration_review/

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The Agency is implementing the registration revi ew program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), a nd will review each registered pesticide every 15 years to determine whether it continues to meet th e 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 belie ves are needed to make a registration review decision. After reviewing and responding to co mments and data received in the docket during this initial comment period, the Agency will de velop and commit to a final work plan and schedule for the registration review of sodium as ulam (“asulam” unless otherwise specified).

Asulam is a selective, systemic, postemergent, car bamate herbicide used to control a variety of annual grasses and broadleaf weeds on sugarcane, Christmas tree plantatio ns, ornamentals, turf (for sod only) and non-cropland areas (boundary fences, fencerows, hedgerows, lumberyards, storage areas and industrial plant sites, and ware house lots). In addition, asulam is used on spinach grown for seed in Washington and Ore gon under Special Local Need s Registrations that were issued in 2008. Asulam has no registered re sidential uses. The only end-use formulation of

asulam is a soluble/concentrate li quid (sodium salt of asulam). To lerances have been established for residues of asulam in/on sugarcane and livestock commodities (40 CFR §180.360). Asulam acts by inhibiting cell division in pl ants. Asulam was first register ed in 1975. The reregistration eligibility decision (RED ) was issued in 1995 and the toleranc e reassessment eligibility decision (TRED) was issued in 2002.

Anticipated Risk Assessment and Data Needs:

The Agency anticipates conducting a comprehe nsive ecological and human health risk assessment, including an endangered species asse ssment. Below is a summary of the issues relevant to the registra tion review of asulam.5 of 13 Ecological Risk:

• The most recent ecological risk assessment for asulam was completed in 1995 to support

the RED.

• The Agency has not conducted a risk asse ssment that supports a complete endangered species determination for asulam. The ecological risk assessment planned during registration review will allow the Agency to determine whether asulam’s use 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.

• Based upon the use pattern and asulam’s curre nt ecotoxicity and environmental fate database, the Agency anticipates requiri ng the following data in order to conduct a complete ecological risk assessment, including an endangered species assessment, for all

uses:

o GLN 850.2100 – Avian acute oral test (passerine species)

o GLN 850.4100, 4150 – Terrestrial plant toxi city tests (using TEP)(Tier II)

o GLN 850.2300 – Avian reproduction

o GLN 850.1350 – Aquatic invertebra te life cycle (freshwater)

o GLN 850.1400 – Fish early li fe stage (freshwater)

• Please refer to the document, Registration Review: Preliminary Problem Formulation for Environmental Fate and Ecological Ri sk, Endangered Species, and Drinking Water Assessments for Asulam and Sodium Asulam dated December 22, 2010, located in the

docket for a detailed discussion of the an ticipated risk assessm ent and data needs.

Human Health Risk:

• The most recent human health risk assessm ent for asulam was completed in 2002 to support the TRED.

• The most recent drinking water assessment for asulam was conducted in 2002 to support the TRED. A new drinking water assessment based on the submission of new or upgrade of existing ecological fate data and curre nt methodologies is anticipated to support registration review.

• The toxicity data base for asulam is subs tantially complete. Endpoints for oral (i.e., dietary, drinking water exposur e, incidental oral) exposur e are adequate. Dermal, inhalation and endpoints for the worker expos ure assessment need to be revised and updated consistent with the endpoints id entified in the TRED assessment.

• The Agency anticipates requiring the following data in order to support a human health

risk assessment for asulam:6 of 13 o GLN 870.6200 Neurotoxicity battery (acute and subchronic studies)

o GLN 870.7800 Immunotoxicity

• Following the submission of the toxicological da ta that are expected to be required, the Agency plans to update the human he alth toxicity profile as needed.

• To support the registration review of as ulam, dietary and drinking water exposure assessments will be updated to reflect current methodologies.

• Asulam is listed in 40 CFR §180.360 for residues in/on sugarcane and livestock commodities. The tolerance expressions for asulam will be reviewed during registration review to ensure that they appropriately covers the metabolites and degradates of asulam and that they specify the residues to be measured for each commodity.

• Since there are no registered residential uses and potential residentia l exposures were not anticipated as a result of a pplications of asulam, a resi dential exposure assessment was

not conducted for either the 1995 RED or the 2002 TRED. To support registration review, a residential exposure assessment th at accounts for possible residential exposures to asulam use on non-cropland areas may be conducted.

• To support registration review, the Agency intends to update the aggregate risk

assessment to reflect current standards.

• The most recent occupational exposure assessment for asulam was conducted to support the 1995 RED. An updated occupational risk assessment is anticipated for the registration review of asulam to update potential changes in the toxicity database and incorporate the most current methodologies.

• Please refer to the document, Asulam: Human Health Risk Scoping Document in Support of Registration Review dated January 5, 2011, located in the docket for a detailed discussion of the anticipated risk assessment and data needs for human health.

Endocrine Disruptor Screening Program:

As required by FIFRA and the Federal Food, Dr ug, and Cosmetic Act (FFDCA), EPA reviews numerous studies to assess pot ential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, subchr onic and chronic toxicity , including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be su sceptible to endocrine influence, including effects on endocrine target or gan histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductiv e loss, and sex ratios in offspring. For ecological hazard assessments, EP A evaluates acute tests and chr onic studies that assess growth, developmental and reproductive effects in diffe rent taxonomic groups. As part of asulam’s TRED decision, EPA reviewed these data and sele cted the most sensitive endpoints for relevant risk assessment scenarios from the existing haza rd database. However, as required by FFDCA7 of 13 section 408(p), asulam is subject to the endocri ne screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whet her 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 ot her such endocrine effect s as the Administrator may designate.” The EDSP employs a two-tiered approach to making th e 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 estrog en, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go th rough Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stag e of the EDSP where EPA will determine which, if any, of th e Tier 2 tests are necessary base d on the available data. Tier 2 testing is designed to identify a ny adverse endocrine-related eff ects 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 pest icide active ingredients and 9 inert ingredients. Asulam 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 issu e future EDSP orders/data callins, requiring the submission of EDSP screening assays for asulam. For further information on the status of the EDSP, the policie s and procedures, the lis t of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

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Timeline:

EPA has created the following estimated timeline for the completion of the asulam registration

review.

Registration Review for Asulam – Projected Regist ration Review Timeline

Activities Estimated Date Opening the Docket Open Docket and Public Co mment Period 2011 – March Close Public Comment 2011 – May Case Development Final Work Plan 2011 – August Issue DCI 2012 – April – June Data Submission 2014 – April – June Open Public Comment Period for Draft Risk Assessments 2015 – Oct. – Dec.

Close Public Comment Period 2016 – Jan. – March Registration Review Decision Open Public Comment Period for Proposed Registration Review

Decision 2016 – April – June

Close Public Comment Period 2016 – July – Sept. Registration Review Decision and Begin Post-Decision Follow-up 2017 Total (years) 68 of 13 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 asulam.

Trade Irritants:

Through the registration review process, the Ag ency intends to solicit information on trade irritants and, to the extent feas ible, take steps toward facilitating irritant resolution. Growers and other stakeholders are asked to comment on any tr ade irritant issues resulting from lack of Maximum Residue Limits (MRLs) or disparitie s between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the na ture of the concern.

Water Quality:

Asulam is not identified as a cause of impairme nt for any water bodies listed as impaired under section 303(d) of the Clean Water Act 1 . In addition, no Total Maximum Daily Loads (TMDL) have been developed for asulam 2 . More information on impaired water bodies and TMDLs can be found at the Agency’s website 3 . 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: Inclus ion of Impaired Water Body and Other Water Quality Data in OPP’s Registration Revi ew Risk Assessment and Management Process 4 in order to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

Environmental Justice:

EPA seeks to achieve environmenta l justice, the fair tr eatment and meaningful involvement of all people, regardless of race, color, national origi n, or income, in the deve lopment, implementation, and enforcement of environmental laws, regulati ons, 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 thei r location, cultural practices, or other factors, may have atypical, unusually high exposure to asulam, compared to the gene ral population. Please comment if you are aware of any sub-populatio ns that may have atypical, unusually high exposure compared to th e general population.

Other Information:

Stakeholders are also specifically asked to prov ide information and data that will assist the Agency in refining the ecological and human h ealth risk assessments, including any speciesspecific ecological effects determinations. The Ag ency is interested in receiving the following

information:

1 http://iaspub.epa.gov/tmdl_waters10/attains _nation_cy.cause_detail_30 3d?p_cause_group_id=885

2 http://iaspub.epa.gov/tmdl_waters10/attain s_nation.tmdl_pollutant_detail ?p_pollutant_group_id=885&p_ pollutant_group_name=PESTIC IDES

3 http://www.epa.gov/owow/tmdl/

4 http://www.epa.gov/oppsrrd1/regist ration_review/water_quality_sop.htm9 of 13 1. suggestions from stakeholders on ways to reduce non-target organism exposures to

asulam

2. confirmation on the following label information:

a. maximum application rates in units rela ted to mass per unit area of treatment

zone b. geographic limitations on use

3. use or potential use distri bution (e.g., acreage and geogr aphical distribution of relevant crop)

4. use history

5. median and 90 th percentile reported use rates (lbs. a.i./acre) from usage data – national, state, and county

6. application timing (date of first applica tion and application intervals) by crop – national, state, and county

7. sub-county crop location data

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

a. maximum reported use rate (lbs. a.i. /acre) from usage data – county

b. percent crop treated – county

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

d. total pounds per year – county

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

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

9. state or local use restrictions

10. ecological incidents (non-target plant dama ge and avian, fish, reptilian, amphibian, and mammalian mortalities) not already reported to the Agency

11. monitoring data

Next Steps:

After the 60-day comment period closes, the Ag ency will review and respond to any comments received in a timely manner, and then issue its Final Work Plan (FWP) for the asulam registration review.10 of 13 II. FACT SHEET

Background Information:

• Asulam sodium salt PC Code: 106902; CAS#: 2302-17-2

• Technical registrant: Unite d Phosphorus (EPA No. 70506)

• First registered in the U.S. in 1975.

• Reregistration Eligibility Decision issued in 1995 and the Tolerance Reassessment Eligibility Decision issued in 2002.

• There are nine FIFRA section 3 registrations and five FIFRA section 24 (c) (Special Local Needs) registrations.

• Pesticide Re-evaluation Divi sion Chemical Review Manager (CRM): Rusty Wasem, wasem.russell@epa.gov

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• Registration Division Product Mana ger (PM): Kathryn Montague, montague.kathryn@epa.gov

Use & Usage Information: For additional details, please refer to BEAD Appendix A dated April 21, 2010, and/or BEAD Chemical Profile for Registrati on Review on Asulam, Sodium Salt dated December 2, 2010,

located in the asulam docket.

• Asulam is a food/feed, and non-food/feed use herbicide registered for use on sugarcane, Christmas tree plantations, ornamentals, turf (for sod only) and non-cropland areas (boundary fences, fencerows, hedgerows, lumber yards, storage areas and industrial plant sites, and warehouse lots).

• Asulam is also registered for use on spinach grown for seed in Washington and Oregon under Special Local Needs Registrations that were issued in 2008.

• Registered asulam products are applied by foliar spray, broadcast, band treatment by sprayer, aircraft, low pressure ground e quipment and spot treatment by spreader.

• Asulam is only formulated as a soluble/concentrate liquid.

• Major usage of asulam is on sugarcane, with an approximate annual usage of 700,000

lbs./a.i.

Recent Actions:

• There are no recent Agency actions involving asulam.

Ecological Risk Assessment Status: The following are key findings of the most recent eco logical risk assessments for asulam. Please refer to the document, Registration Review: Preliminary Problem Formulation for Environmental Fate and Ecological Risk, Endan gered Species, and Drinki ng Water Assessments for Asulam and Sodium Asulam , dated December 22, 2010, located in the docket for a detailed discussion of the ecological risk assessment.11 of 13 • The most recent ecological risk assessment fo r asulam, conducted in support of the 1995 RED, concluded that the use of asulam exceeded the level of concern (LOC) for endangered and non-endangered te rrestrial and semi-aquatic pl ants for all uses. To address the identified risks of concern, the Ag ency specified mitigation measures in the

RED to reduce risk and additional environmen tal fate and ecological effects data to confirm its regulatory decision.

• Risks to terrestrial plants we re previously assessed using st udies conducted with technical asulam rather than typical end use product. Herbicidal active i ngredients are usually formulated with adjuvants or surfactants that are intended to enhance the activity of the pesticide. Therefore, the sensitivity of terrestri al plants to asulam as it is typically applied may have been underestimated.

Human Health Risk Assessment Status: The following are key findings of the most recent human health risk assessments for asulam. Please refer to the document, Asulam: Human Health Risk Scoping Document in Support of Registration Review , dated January 5, 2011, located in the docket for a detailed discussion of the

human health risk assessment.

Hazard Characterization:

• Asulam is of low acute toxicity by oral, dermal and inhalation routes of exposure. It is not an eye or skin irritant or a dermal sens itizer. Subchronic and ch ronic toxicity studies demonstrate that the thyroid gland is a target organ for asulam.

• Laboratory studies show no clear evidence of asulam being a developmental toxin. Developmental effects were seen in the ra t study but only at mate rnally toxic doses.

• Asulam has been classified as a possible human carcinogen.

Dietary (Food and Drinking Water):

• A dietary exposure analysis for food only wa s conducted for the 2002 TRED. An acute dietary risk assessment was not performed si nce there was no acute endpoint identified. A refined chronic dietary anal ysis was conducted that showed no risks of concern for the general U.S. population a nd all population subgroups ( ≤ 1% of cPAD).

Residential:

• Since there are no registered residential uses and potential residentia l exposures were not anticipated as a result of a pplications of asulam, a resi dential exposure assessment was

not conducted for either the 1995 RED or the 2002 TRED.

Aggregate:

• The most recent aggregate risk assessme nt was conducted to support the 2002 TRED. Short term aggregate risk from dietary/dr inking water and residential exposure was

assessed. This assessment concluded that sh ort-term aggregate exposure to asulam via food, water and incidental oral exposure was le ss than the Agency’s level of concern.

Occupational :12 of 13 • A qualitative worker exposure assessment was conducted for the 1995 RED based on potential handler and post-app lication exposures to asulam. At that time, the Agency determined that a quantit ative occupational exposure assessment was not required because the toxicology criteria for a quantitative assessment were not triggered and no endpoints of concern regarding dermal or inhalation toxicity were identified.

Cumulative:

• The Agency has not determined whether asul am shares a common mechanism of toxicity

with other chemical substances. While asulam is a carbamate pesticide, it does not share a common mode of action with the n-methyl carbamate pesticides and therefore has not been included in previous n-methyl carbamate cumulative assessments. If, in the future the Agency determines that new information on asulam is available that could potentially impact a cumulative risk assessment and resu lt in a risk of con cern, the Agency will

revisit the need for a cumulative risk assessment.

Incidents:

• The Office of Pesticide Programs Incident Data System (IDS) was reviewed for reports

of asulam human incidents. No human in cidents have been reported from 2002 to the present associated, with the use of asulam.

• No ecological incidents involving asulam were found in the Agency’s Ecological Incident Information System (EIIS) database or the American Bird Conservancy’s Avian Incident Monitoring System (AIMS). One plan t incident associated with sodium asulam has been reported to the Agency in an aggregated incident report from June 2003. Although only one incident associated with the use of asulam or sodium asulam has been reported to the EPA, the lack of incident re ports cannot be construed as the absence of incidents as there can be many reasons why th e Agency is not notified of adverse effects resulting from the use of a pesticide. Unless additional information on this 2003 aggregated incident report becomes available, it will be assumed to be due to a registered

use of asulam in the risk assessment.

Data Call-In (DCI) Status:

• Several data requirements issued as part of the RED and TRED DCIs remain outstanding. Data submitted to satisfy these data requirements were deemed insufficient, and subsequent attempts to upgrade the data by ne w technical registrant s were also deemed insufficient. The Agency intends to pursue th ese outstanding data requirements further. These following previously reque sted data requirements will need to be satisfied to support registration review:

o GLN 835.4100 – Aerobic soil metabolism

o GLN 835.4300 – Aerobic aquatic metabolism

o GLN 835.4400 – Anaerobic aquatic metabolism

o GLN 835.6100 – Terrestrial dissipation

o GLN 835.6100 – Frozen storage stability13 of 13 o GLN 870.2100 – Foliar (Dislodgeab le) Residue Dissipation

Tolerances and International Harmonization:

• 40 CFR §180.360 lists 18 tolerances for co mbined residues of asulam (methyl sulfanilylcarbamate) and its sulfanilamide containing metabolites in plant and livestock

commodities.

• There are currently no establ ished Canadian, Codex, or Mexican MRLs for asulam.

Labels:

• The labels for asulam can be obtained from the Pesticide Product Label System (PPLS)

website: http://oaspub.epa.gov/pestlabl/ppls.home

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