2 INTRODUCTION

This is the Environmental Protection Agency’s (E PA or the Agency) Final Work Plan (FWP) for the registration review of aldicarb. This wo rk plan addresses p ublic comments received concerning the Preliminary Work Plan (PWP), which was posted in aldicarb’s registration review docket (EPA-HQ-OPP-2012-0161). Aldicarb is an N -methyl carbamate insecticide that is marketed only as a granular product with a c oncentration of 15 percen t active ingredient. Aldicarb is registered for use to control soil bo rne pests including mites, various insects, and nematodes. There are no register ed residential uses of aldicarb. Aldicarb pr oducts are registered for use in agricultural areas on cotton, dry bean s, peanuts, soybeans, sugar beets, and sweet
potatoes.

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. Changes in scienc e, public policy, and pesticide us e practices occur over time. The registration review program is intended to make su re that, as the ability to assess risk evolves and as policies and practices change, al l registered pesticides continue to meet the statutory standard. The public phase of registration review begins wh en the initial docket is opened for each case. Information on this program is provided on the Agency’s website 1

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The FWP begins with any updates since the PWP wa s issued. Next is a summary of substantive comments received during the public comment peri od for the PWP concerning anticipated data needs, expected risk assessments, or the estimated timeline identified in the PWP, and a summary of the Agency’s responses to those comme nts. This section is followed by aldicarb’s registration review planned data needs, risk assessments expected to be conducted, and the projected registration review timeline. Las tly, there is a discu ssion of next steps.

UPDATES SINCE TH E PWP WAS ISSUED

There are no additional update s on aldicarb since the PWP.

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on the al dicarb Preliminary Work Plan, which opened on July 6, 2012 and closed on September 10, 2012, th e Agency received six public comments. Comments were submitted by registrants, sugar b eet industry representatives, a non-profit and an independent scientific research advocate. The comments do not a ddress the timeline described in the PWP, but they do address the planned ecological and human hea lth risk assessments and data requirements. In the PWP, EPA also solicited comments on the specific topics of environmental justice, water quality concerns, a nd trade irritants, but no comments or information were received

on those issues.

This section does not capture every comment made on the PWP nor all of the Agency’s responses. Summarized below ar e public comments that resulted in changes to the anticipated

1 http://www.epa.gov/oppsrrd1/registration_review/3 registration review data needs, risk assessments, or timeline, or are of a broader regulatory nature. Public comments and EPA responses in their entirety are locat ed in the docket, EPAHQ-OPP-2012-0161. Summarized public comments and Agency responses related to the anticipated ecological risk assessment or data needs are in the EFED Response to Comments Regarding the Registration Review Problem Formulation for Aldicarb while those relevant to the anticipated human health risk assessment or data needs ar e in the HED document entitled

Aldicarb . Response to Comments on Registration Review Docket (EPA-HQ-OPP-2012-0161) for Aldicarb (Case 0140)

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Comments submitted by Bayer Cr opScience in EPA-HQ-OPP-2012-0161-0010.

1. Comment: On August 16, 2010, the Agency and Bayer CropScience signed a Memorandum of Agreement setting forth the terms of the vol untary cancellation of a ll crop registrations of TEMIK® brand 15G Aldicarb Pesticide (EPA Reg. No. 264-330). Bayer’s request to terminate all uses of TEMIK® was published in the Fede ral Register on October 7, 2010 (Vol. 75, No. 194, Pages 62129-62131). Bayer CropScience reconfirms th e decision to voluntarily cancel all crop registrations of TEMIK® brand 15G Aldicarb Pe sticide and will not support the registration review for aldicarb.

Response: The Agency has finalized Bayer CropSci ence’s voluntary cancellation request. The final product cancellation order was announced in the Federal Register on December 19, 2012 (77 FR 75155) (FRL-9369-4).

Comments submitted by The Amalgamated Sugar Company LLC in EPA-HQ-OPP-2012- 0161-0009 and the Beet Sugar Developmen t Foundation in EPA-HQ-OPP-2012-0161-0014.

2. Comment: Support for usage on sugar beets.

Response: OPP appreciates the information provide d. Information pertaining to the use of aldicarb on sugar beets will be incorporated in the registration review decision anticipated in

2018.

Comments submitted by The Physicians Comm ittee for Responsible Medicine in EPA-HQOPP-2012-0161-0011 and Ag Logic LLC in EPA-HQ-OPP-2012-0161-0012.

3. Comment: Immunotoxicity studies already exist.

Response: Two referenced studies submitted to the Agency were reviewed previously and no concern for immunotoxicity was identified. Based on a reassessment of the immunotoxicity studies on aldicarb submitted to the Agency prior to the issuance of the PWP which identified anticipated data requirements for this registration review case, the studies are considered adequate to a ddress the question of aldicarb’s immunotoxicity potential. It is concluded that the anticipate d data requirement for imm unotoxicity testing (870.7800) for aldicarb is satisfied by these studies, and no a dditional immunotoxicity te sting is expected to be required for this registration review.4 4. Comment: Studies with passerine species already exi st. It would be highly unlikely that an additional avian acute oral toxicity study with a passerine species w ould yield any valuable new data. Also, technical aldicarb is more toxic than granular aldicarb to sparrows (0.8 mg/kg and 3.8 mg/kg, respectively).

Response: The Agency agrees that other data ar e available and will determine whether these data can be used quantitatively or qualitativel y for risk assessment purposes. If the data are submitted to the Agency and they are acceptable for risk assessment purposes, the passerine study will not be necessary. Schafer (1979) fou nd that acute oral testi ng with the grackle and the house sparrow resulted in LD50 values of 0.75 mg/kg (using technical aldicarb) for both these species; however, these data were not valid ated originally. Balcomb in the 1980s did test granular aldicarb 15G on the house sparrow and the red wing blackbird resulting in 40 to 100 percent mortality from inges tion of only 1-5 granules.

Comments submitted by Ag L ogic LLC in EPA-HQ-OPP-2012-0161-0012.

5. Comment: The mallard duck reproduction study submitted (MRID 48198801) that EFED deemed supplemental does fulfill the data requirement for an avian reproduction study.

Response: The Agency will use 3 ppm as the NOAE C if a new study is not submitted. As originally stated, even though MRID 48198801 was deemed scientifically sound, the study does not fulfill guideline requirements and will remain supplemental. The effects listed as occurring at 15 ppm were below 6 percent and thus were likely not biologically significant even though they were statistically significant. The subm itted bobwhite quail study resulted in more toxic values (NOAEC was 1.8 ppm).

The Agency has concluded that it will rely on th e most sensitive endpoint (bobwhite quail) for the development of the risk assessment and rely on MRID 48198801 as a supplemental study for information on the mallard duck. As such, the Agency removed the requirement for an avian reproduction study (850.2300) for the re gistration review of aldicarb.

PLANNED DATA NEEDS

Table 1 below summarizes the planned data needs for aldicarb based on the EFED Registration Review Problem Formulation for Aldicarb

, Aldicarb - Human Health Assessment Scoping Document in Support of Registration Review , EFED Response to Comments Regarding the Registration Review Proble m Formulation for Aldicarb and Aldicarb . Response to Comments on Registration Review Docket (EPA-HQ- OPP-2012-0161) for Aldicarb (Case 0140) . The table has been updated since the PWP to reflect public comments which resulted in changes to the data

needs. In addition to the ch anges described above in the Summary of Comments and Agency Responses section, guideline numbers 835.6100 and 835.6200 have been consolidated to guideline number 850.6100 since the PWP.5 Table 1: Planned Data Needs for Aldicarb’s Registration Review

Guideline

Number Study Title Test Material Estimated

Timeframe

(Months from receipt of DCI)

850.2100 Avian Acute Oral Toxicity Test (passerine species) TGAI 12

850.4100 Seedling Emergence and Seedling Growth 2 TEP 12
850.4150 Vegetative Vigor 2 TEP 12

850.6100 Environmental Chemistry Methods and Associated Independent Laboratory Validation

for soil and water 2 TGAI for parent,

aldicarb sulfoxide

and aldicarb sulfone 12

TGAI = technical grade active ingred ient; TEP = typical end-use product

RISK ASSESSMENTS FOR REGISTRATION REVIEW

During registration review, the Agency will conduct a comprehensive ecological risk assessment, including an endangered species assessment, for all uses of al dicarb. For human health, EPA anticipates the need to conduct revised diet ary and occupational risk assessments during registration review. If toxico logical endpoints or points of de parture are revised based on the data that are expected to be required for regist ration review, they will be considered in the new assessments, as well as any changes to the sta ndard operating procedures or default exposure assumptions.

Table 2 below summarizes the planned registrati on review risk assessments based on the EFED Problem Formulation and HED Scoping Document. The planned assessments have not changed

from what was included in the PWP.

2 On June 27, 2012, EPA announced certain revisions in harmonized guideline series 850 – Ecological Effects Tests

– including renumbering and other designations or changes for some guideline studies. See “Final Test Guidelines; OCSPP 850 Series; Notice of Av ailability” 77 FR 38282 , June 27, 2012. http://www.regulations.gov/#!documen tDetail;D=EPA-HQ-OPPT-2009-0154-0028

.6 Table 2: Planned Risk Assessments for Aldicarb’s Registration Review

Type of Risk Assessment Conduct? Notes

Ecological and Environmental Fate Comprehensive ecological (species to be assessed include terrestrial and aquatic organisms), including endangered species Y The Agency will evaluate ecological risk, environmental fate, and risks to Federally-listed threatened and/or endangered (listed) species from registered uses of

aldicarb.

Human Health Dietary

Food TBD 1 A revised dietary risk assessment may be required depending on the review of the cotton field trial studies (although the studies are not likely to substantially affect the dietary risk assessment), and drinking water modeling results. If the new drinking water model estimates are significantly higher than estimates in the current dietary risk assessment, the Agency will prepare a revised

assessment.

Drinking water Y A drinking water exposure assessment will be conducted to support future human health risk assessments for aldicarb to reflect label changes due reregistration, new percent crop area (PCA) estimates for surface water and new Tier 2 ground water modeling consistent with final guidance documents. The drinking water assessment will incorporate model estimates of aldicarb residues of concern in surface and ground waters. Currently, the residues of concern include aldicarb parent, aldicarb sulfoxide, and aldicarb sulfone. Occupational

Handlers (mixers, loaders, applicators) TBD The Agency may conduct a revised occupational exposure and risk assessment during registration review if toxicological endpoints change, based on the data expected to be required, or the Agency identifies significant changes in its interpretation and use of the Pesticide Handlers Exposur e Database (PHED)-based exposure data used in the previous assessment of aldicarb.

Post-application N The Agency does not believe that there is a significant potential for post-application exposures from aldicarb based on the manner in which it is applied and soil incorporated, the timing of application, the frequency of application, and the lack of known activities that would occur in the treated areas that might contribute to exposure. Also, the Agency does not believe that there is any significant potential fo r chemical trespass into adjoining areas such as residential neighborhoods.

Residential Handlers, post-application, incidental oral, and recreational N Aldicarb is not registered for use in residential settings. Therefore, a residential exposure assessment is not required.7 Other

Aggregate TBD An aggregate assessment typically evaluates the combined risk from dietary and residential exposures. Since there are no residential uses of aldicarb, only food and water are included in the aggregate risk assessment. If the new drinking water estimates exceed previous estimates and a new dietary risk assessment is conducted, then a new aggregate assessment would be conducted.

Cumulative TBD The Agency will determine if there is any new

information which would affect the cumulative risk assessment. Should the Agen cy determine that new information on aldicarb or another N-methyl carbamate is available that could potentially impact the cumulative risk assessment and result in a risk of concern, the Agency may revisit the cumulative risk assessment.

Tolerances Y The tolerance expression should be revised to ensure that it appropriately covers the metabolites and degradates of aldicarb and that it specifies the residues to be measured for each commodity. In addition, the Agency may need to establish a tolerance in/on cotton gin by-products once crop field trial studies submitted to the Agency have been

reviewed.

1 TBD = To be determined upon review of additional data. If the data do not significantly affect the exposure and risk estimates, the Agency will conti nue to rely upon existing assessments.

TIMELINE

EPA has created the following estimated timeline for the completion of aldicarb’s registration review in Table 3 below. The projected timelin e has been updated to re flect impacts of public comments received, changes to the planned data needs, and/or recent actions.

Table 3: Registration Review for Aldicarb – Projected Registra tion Review Timeline

Activities Estimated Date Opening the Docket Open Docket and 60-day Public Comment Period July 2012 - Completed Close Public Comment Sept 2012 - Completed Case Development Final Work Plan Dec 2012 - Completed Issue DCI 2013 - July – Sept. Data Submission 2014 - July – Sept. 30-day Public Comment Period for Draft Risk Assessments 2016 - Jan. – March Registration Review Decision 60-day Public Comment Period for Proposed Registration Review Decision 2016 - July – Sept. Registration Review Decision and Begin Post-Decision Follow-up 2017 Total (years) 3 5

3 The timeline could be affected by a cumulative group risk assessment for the N -methyl carbamates.8 NEXT STEPS

As noted previously, the Agency plans to requ ire several environmenta l fate and ecological effects studies for aldicarb through a data call-in, expected to be issued in the summer of 2013.