2 SODIUM ASULAM FINAL WORK PLAN

The Agency is implementing the new registration review program, and will re view each registered pesticide every 15 years to determine whether it continues to meet the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) standard for registration. Changes in science, public policy, and pesticide use practices will occur ove r 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: Introduction:

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for the registration review of asulam and sodium asulam (collectively referred to as asulam here after) . This FWP includes the expected registration review timeline. The work plan also addresses public comments received concerning the Preliminary Work Plan (PWP) in the Summary Document , dated March 15, 2011

, which was posted in the asulam registration review docket ( EPA

- HQ

- OPP

- 2010

- 0783 )

. The Summary Document provided information on what EPA knows about the pesticide and what additional risk analyses or information the Agency believes are needed to make a registration review decision.

http://www.epa.gov/oppsrrd1/registration_review/

.

Asulam is a selective

, systemic

, postem ergent

, carbamate herbicide used to control a variety of annual grasses and broadleaf weeds on sugarcane, Christmas tree plantations, ornamentals, turf (for sod only) and non

- cropland areas (fencerows, lumberyards, storage a reas, and industrial plant sites ). In addition, asulam is used on spinach grown for seed in Was hington and Oregon
under Special Local Needs Registration s that were issued in 2008. Asulam has no registered residential uses. The only end

- use formulation of asulam is a soluble/concentrat e liquid (sodium salt of asulam). Tolerance s have been established for residues of asulam in/on sugarcane and
livestock commodities (40 CFR §180.360)

. Asulam was first registered in 1975. The reregistration eligibility decision (RED) was issued in 1995 and the tolerance reassessment eligibility decision (TRED) was issued in 2002.

Comments Received on Preliminary Work Plan :

The Agency received two comments during the 60

- day public comment period for the asulam PWP, which began on March 30 , 2011 and ended on May 31 , 20 1 1 (EPA

- HQ

- OPP

- 2010

- 0783 ).
The comments covered data compensation issues and technical corrections

. These comment s did not change the work plan or timeline established in the PWP

. In the PWP, EPA also solicited comment on the spe cific topics of environmental justice, water body impairment, and trade irritants. No comments were received during the public comment period concerning these issues
either. T his document makes final the work plan for the registration review of asulam

. A summary of the submitted comments and the EPA ’s responses are presented in the “Summary of Comments and Agency Responses” section of this document.3 Risk Assessment and Data Needs:

**•** The most recent comprehensive ecological risk assessment was conducted for the Reregistration Eligibility Decision (RED) of A sulam in 1995

. The Agency anticipates conduct ing a comprehensive ecological risk assessment, including an endangered species assessment

, and an updated human health risk assessment for all uses of
asulam and it s degradates of concern

. Below is a summary of the issues relevant to the registration review of asulam

. Ecological Risk:

**•** The Agency will require the following data in order to conduct a comprehensive ecolog ical risk and endangered species assessment for asulam:

o GLN 850.1350

– Aquatic invertebrate life cycle (freshwater)

o GLN 850.1400

– Fish early life stage (freshwater)

o GLN 850.2100

– Avian acute oral toxicity (passerine species)

o GLN 850.2300

– Avian reproduction

o GLN 850.4100 , 4 150

– Terrestrial plant toxicity (using TEP, t ier II)

**•** The Agency has not conducted an ecological risk assessment that supports a complete endangered species determination for asulam . The ecological risk assessment planned during registration review will allow the Agency to determine whether the use of asulam 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 (FWS) and/or National Marine Fisheries Service (NMFS) (the Serv ices), as appropriate.

**•** Please refer to the document: Registration Review: Preliminary Problem For mulation for
Environmental Fate and Ecological Risk, Endangered Spec ies, and Drinking Water Assessments for Asulam and Sodium Asulam

, dated December 22 , 2010 located in the
docket for a more detailed discussion of the anticipated ecological risk assessment and
data needs.

Human Health Risk:

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

**•** An updated dietary assessment will reflect new toxicity data and incorporate the results from a new drinking water assessment.

**•** A residential exposure assessment that accounts for possible residential exposures to
asulam use on non

- cropland areas will be conducted to support registration review.

**•** An updated aggregate assessment will be conducted in order to capture any updates made to either the dietary or residential assessments.4 **•** The occupational risk assessment will also be upda ted to incorporate new toxicity data
and reflect current assessment methodologies

.

**•** The tolerance expressions for asulam in 40 CFR §180.360 will be reviewed during registration review to ensur e that they appropriately cover the metabolites and d egrad at es of asulam and that they specify the resi dues to be measure d for each commodity.

**•** The Agency will require the following studies, in accordance with the revised 40 CFR, Part 158, to conduct a comprehensive human health risk assessment for the registrati on review of asulam :

o GLN 870.6200 Neurotoxicity battery (acute and subchronic studies)

o GLN 870.7800 Immunotoxicity

**•** Please refer to the document: Asulam: Human Health Risk Scoping Document in Support of Registration Review dated March 2 , 201 1 in the docket for a more detailed discussion

o f the anticipated human health risk assessment and data needs

.

Under FFDCA section 408(p), the Agency must screen all pes ticide chemicals. Between October 2009 and February 2010, EPA issued test orders/data call

- ins for the first group of 67 chemicals, which contains 58 pesticide active ingredients and 9 inert ingredients. A sulam is not Endocrine Disruptor Screening Program:

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, these studies include acute, sub

- chronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endocrine influence , including effects on endocrine target organ histopathology, organ weights, estrus cyclist, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acute tests and ch ronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its most recent registration decision , EPA reviewed these data and selected the most sensitive endpoints for relevant risk assessment scenar ios from the existing hazard database. However, as required by FFDCA section 408(p), asulam is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP). EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administrator may designate.” The EDSP employs a two

- tier ed 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. Chemica ls that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine

- related effects caused by the substance, and
establish a dose

- response relationship between the d ose and the E, A, or T effect.5 among the group of 58 pesticide acti ve ingredients on the initial list to be screened under the EDSP. Accordingly, as part of registration review, EPA will issue future EDSP orders/data call

ins, requiring the submission of EDSP screening assays for asulam

. For further information on
the s tatus of the EDSP, the policies and procedures, the list of 67 chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website: http://www.epa.gov/endo/

.

Registration Review for Asulam

– Projected Registration Review Timeline Timeline:

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

.

Activities Estimated Date Opening the D ocket Open Docket and Public Comment 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

D ecision 2016

– April

– June

Close Public C omment P eriod 2016

– July

– Sept. Registration Review D ecision and Begin P ost

- D ecision F ollow

- up 2017 Total ( years ) 6

1. Comment Summary of Comments and Agency Responses :

The asulam registration review docket was open for a 60

- day comment period beginning on March 30, 2011 . During th e comment period

, the FIFRA Endangered Species Task Force (FESTF) provided comment on data compensation obligations and one of the registrant s , Aceto, made a usage correction

. The following is a summary of the comments and EPA’s responses:

The FIFRA Endangered Species Task Force (FESTF) submitted a comment that the Agency should ensure any company who is a registrant for asulam, but not a member of FESTF (or a company ha v ing met its data compensation obligations) provide a formal offer

- to

- pay to FESTF in conjunc tion w ith their support of the active ingredient.

EPA Response The Agency thanks FESTF for its comment and will consider this information as it conducts the registration review process and makes its registration review decision.6 2. Comment The registran t, Aceto, noted a n error in the Preliminary Problem Formulation for Asulam where the Agency indicated that it anticipates conducting a drinking water assessment from the use of asulam on potato storage facilities. Aceto notes that asulam has no current re gistered uses on potatoes or on/in potato storage facilities.

EPA Response The Agency notes the error ; Agency records indicate that asulam is not currently registered for use on potatoes or on/ in potato storage facilities . Therefore, potato or
potato storage facilities will not be part of the Agency’s assessments for the registration
review of asulam.

Summary of Data Gaps:

The table below summarizes all data needs for asulam as listed in the Asulam: Human Health Risk Scoping Document in Support of R egistration Review dated March 2, 2011 , and the Registration Review: Preliminary Problem For mulation for Environmental Fate and Ecological Risk, Endangered Spec ies, and Drinking Water Assessments for Asulam and Sodium Asulam

, dated December 22, 2010

.

Guideline

Number Data Requirement Study
Duration (Measured
in months
from receipt of

GDCI) Listed in

PWP Listed in

FWP

850.1350 Aquatic invertebrate life cycle (freshwater) 12 The Agency’s anticipated data needs did not change and the Agency will issue a DCI
for these studies 850.1400 Fish early life stage (freshwater) 12

850.2100 Avian acute oral toxicity (passerine species) 12

850.2300 Avian reproduction 24 850.4100,
850.4150 Terrestrial plant toxicity, tier II 12

870.6200 Neurotoxicity battery (acute and subchronic) 12

870.7800 Immunotoxicity 12

Next Steps:

The Agency plans to require the above referenced studies through a generic data call

- in, which is expected to be issued in late 2011. This new information will be used to conduct human health and ecological risk assessments for all registered uses of asulam

.