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INTRODUCTION

This is the Environmental Protection Agency’s (EPA or the Agency) Final Work Plan (FWP) for 

the registration review of aldicarb. This work plan addresses public 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 concentration of 15 percent active ingredient. 

Aldicarb is registered for use to control soil borne pests including mites, various insects, and 

nematodes. There are no registered residential uses of aldicarb. Aldicarb products are registered 

for use in agricultural areas on cotton, dry beans, peanuts, soybeans, sugar beets, and sweet 

potatoes. 

The Agency is implementing the registration review program pursuant to Section 3(g) of the 

Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and will review each registered 

pesticide every 15 years to determine whether it continues to meet the FIFRA standard for 

registration. Changes in science, public policy, and pesticide use practices occur over time. The 

registration review program is intended to make sure that, as the ability to assess risk evolves and 

as policies and practices change, all registered pesticides continue to meet the statutory standard. 

The public phase of registration review begins when the initial docket is opened for each case. 

Information on this program is provided on the Agency’s website1. 

The FWP begins with any updates since the PWP was issued. Next is a summary of substantive 

comments received during the public comment period 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 comments. This section is followed by aldicarb’s 

registration review planned data needs, risk assessments expected to be conducted, and the 

projected registration review timeline. Lastly, there is a discussion of next steps. 

UPDATES SINCE THE PWP WAS ISSUED

There are no additional updates on aldicarb since the PWP. 

SUMMARY OF COMMENTS AND AGENCY RESPONSES

During the 60-day public comment period on the aldicarb Preliminary Work Plan, which opened 

on July 6, 2012 and closed on September 10, 2012, the Agency received six public comments. 

Comments were submitted by registrants, sugar beet industry representatives, a non-profit and an 

independent scientific research advocate. The comments do not address the timeline described in 

the PWP, but they do address the planned ecological and human health risk assessments and data 

requirements. In the PWP, EPA also solicited comments on the specific topics of environmental 

justice, water quality concerns, and 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 are public comments that resulted in changes to the anticipated 

 

1

 http://www.epa.gov/oppsrrd1/registration_review/ 
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registration review data needs, risk assessments, or timeline, or are of a broader regulatory 

nature. Public comments and EPA responses in their entirety are located 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 are in the HED document entitled 

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

for Aldicarb (Case 0140). 

Comments submitted by Bayer CropScience 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 voluntary cancellation of all 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 Federal Register on October 7, 2010 (Vol. 75, No. 194, 

Pages 62129-62131). Bayer CropScience reconfirms the decision to voluntarily cancel all crop 

registrations of TEMIK® brand 15G Aldicarb Pesticide and will not support the registration 

review for aldicarb.

Response: The Agency has finalized Bayer CropScience’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 Development Foundation in EPA-HQ-OPP-2012-0161-0014. 

2. Comment: Support for usage on sugar beets.

Response: OPP appreciates the information provided. 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 Committee 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 address the question of aldicarb’s immunotoxicity potential. It is 

concluded that the anticipated data requirement for immunotoxicity testing (870.7800) for 

aldicarb is satisfied by these studies, and no additional immunotoxicity testing is expected to 

be required for this registration review. 
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4. Comment: Studies with passerine species already exist. It would be highly unlikely that an 

additional avian acute oral toxicity study with a passerine species would 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 are available and will determine whether these 

data can be used quantitatively or qualitatively 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) found that acute oral testing 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 validated 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 ingestion of only 1-5 granules.

Comments submitted by Ag Logic 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 NOAEC 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 submitted bobwhite quail study resulted in more toxic 

values (NOAEC was 1.8 ppm). 

The Agency has concluded that it will rely on the 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 registration 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 Problem 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 changes 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. 
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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 Growth2 TEP 12 

850.4150 Vegetative Vigor2 TEP 12 

850.6100 

Environmental Chemistry Methods and 

Associated Independent Laboratory Validation 

for soil and water2

TGAI for parent, 

aldicarb sulfoxide 

and aldicarb sulfone 

12 

TGAI = technical grade active ingredient; 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 aldicarb. For human health, EPA 

anticipates the need to conduct revised dietary and occupational risk assessments during 

registration review. If toxicological endpoints or points of departure are revised based on the 

data that are expected to be required for registration review, they will be considered in the new 

assessments, as well as any changes to the standard operating procedures or default exposure 

assumptions. 

Table 2 below summarizes the planned registration 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 Availability” 77 FR 38282, June 27, 2012. 

http://www.regulations.gov/#!documentDetail;D=EPA-HQ-OPPT-2009-0154-0028. 
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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 TBD1

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 Exposure 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 for 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. 
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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 Agency 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. 

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 TBD = To be determined upon review of additional data. If the data do not significantly affect the exposure and 

risk estimates, the Agency will continue 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 timeline has been updated to reflect impacts of public 

comments received, changes to the planned data needs, and/or recent actions. 

Table 3: Registration Review for Aldicarb – Projected Registration 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. 
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NEXT STEPS

As noted previously, the Agency plans to require several environmental fate and ecological 

effects studies for aldicarb through a data call-in, expected to be issued in the summer of 2013.