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A. PHYSICIANS COMMITTEE FOR RESPONSIBLE MEDICINE (PCRM)

COMMENTS:

1. PCRM Comment:

“The Summary Document indicates that the Agency may request testing for avian acute oral 

toxicity. We strongly support the use of the newly revised OECD Test Guideline 223 for the 

acute avian oral toxicity test...”

EFED Response:

To date the OECD has adopted the TG 223 guideline and has issued a validation report. At this 

time EFED is actively evaluating the results of the OECD validation report to determine if the 

TG 223 effects endpoints and dose/response information adequately address the purposes of the 

avian acute oral data requirement as described in 40 CFR Part 158. Until the Agency’s 

evaluation of that validation report is completed, EFED will not classify avian toxicity studies 

performed using the TG 223 protocol and the studies cannot be used to fulfill current data 

requirements. 

2. PCRM Comment:

“In response to past comments on the avian acute oral toxicity test... ‘EPA is not likely to accept 

studies conducted under the OECD guideline unless additional study validation is conducted for 

passerine species (from EFED Response to Comments on Preliminary Work Plan for Sodium 

Acifluorfen)’... If the Agency is interested in collecting all data in consideration of the use of the 

223 then it should not state that it will not accept information gathered according to this 

protocol.”

EFED Response:

EFED will consider all data submitted regarding the potential toxicity of pesticides. In reading 

through the previous Agency response, we understand how the sentence ‘EPA is not likely to 

accept studies conducted under the OECD guideline...” could be misunderstood. To clarify 

what was meant, the Agency will not be able to classify studies conducted using TG223 and 

passerines as ‘acceptable’ (and, thus, fulfilling guideline requirements) until it is verified that the 

OECD TG 223 using passerines adequately addresses the purposes of the passerine acute oral 

data requirement as described in 40 CFR Part 158.

B. AMERICAN BIRD CONSERVANCY (ABC) COMMENTS:

1. ABC Comment:

“The incident involving 18 pigeons was a deliberate poisoning incident, and strengthens the 

argument that methomyl should be labeled as Restricted Use, to prevent further abuse.”
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EFED Response:

EFED defers a specific response to this comment to OPP’s Pesticide Re-evaluation Division 

(PRD) since it relates directly to risk management, labeling, and product registrations. 

2. ABC Comment:

“Additionally, though relatively few incidents involving methomyl have formally been reported 

to ABC or EPA, the absence of incident reports cannot be construed as the absence of incidents.”

EFED Response:

EFED agrees that an absence of ecological incident reports cannot be used as evidence that 

incidents do not occur. Therefore, the incident data will be used accordingly in the ecological 

risk assessment conducted for methomyl.

3. ABC Comment:

“ABC request that EPA considers mitigation of the application of methomyl, such as plowing in 

the granules post application.”

EFED Response:

EFED defers a specific response to this comment to PRD since it relates directly to risk 

management, labeling, and product registrations. 

4. ABC Comment:

“Additionally, the Agency should evaluate whether the risk from puddles of standing water 

within 24 hours of irrigation. If the puddle model indicates a risk to birds, this method of 

application should be withdrawn, or specific monitoring requirements should be implemented...”

EFED Response:

EFED is actively working on tools that will address assessing risks to non-target animals 

(including birds) from exposure through drinking water, including puddles. If these tools are 

available, this potential exposure pathway will be considered quantitatively in the methomyl

ecological risk assessment conducted for Registration Review. Regarding withdrawing the 

registration of methomyl products or requiring monitoring data, EFED defers a specific response 

to these comments to PRD since they relate directly to risk management. 

5. ABC Comment:

“ 1) ABC requests an avian oral toxicity test using a passerine species.

 2) ABC requests an avian reproduction study with a mallard duck...”
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EFED Response:

EFED recommended that the Agency request both an acute oral passerine and an avian 

reproduction study with the mallard duck in the methomyl Problem Formulation.

6. ABC Comment:

“... ABC requests an avian reproductive and developmental study using a passerine species. 

ABC recognizes that EPA does not have an official Standard Operation Procedure (SOP) to 

recommend to registrants for passerine reproductive studies, however, we urge EPA to look 

beyond the lack of SOP and investigate the potential toxicity of this compound.”

EFED Response:

EFED is not aware of any data to show that methomyl is more toxic to passerine species than it 

is to bobwhite quail (Colinus virginianus) or mallard ducks (Anas platyrhynchos) on a chronic 

exposure basis as it relates to reproductive endpoints. Therefore, at this time, EFED believes that 

the data from the reproductive studies in the bobwhite quail and mallard duck studies will be 

adequate for assessing potential risks of methomyl to birds from chronic exposure. 

7. ABC Comment:

ABC requests a “...(m)itigation effort such as requiring users to plow in Methomyl 5G Granule.”

EFED Response:

EFED defers a specific response to this comment to PRD since it relates directly to risk 

management. 

8. ABC Comment:

ABC requests the “... (r)elease of formulation information of the Methomyl 5G Granule. The 

granule content information of Methomyl 5G Granule is Confidential Business Information 

(CBI). It is impossible to fully assess the risks of a granular formulation if we do not know if the 

granule is made from clay or silica...”

EFED Response:

EFED does have access to this type of information and it is considered in our ecological risk 

assessments. However, because specific formulation information is CBI, it must be protected as 

described in FIFRA. 

9. ABC Comment:

ABC requests that interim label changes be made to mitigate risks to birds from the use of 

methomyl since the registration review process is “so prolonged”.
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EFED Response:

EFED defers a specific response to this comment to PRD since it relates directly to risk 

management. 

C. DUPONT CROP PROTECTION (DCP) COMMENTS:

1. DCP Comment:

“GDLN 835.2240 – Aqueous Photolysis

GDLN 835.4100 – Aerobic Soil Metabolism

GDLN 835.4300 – Aerobic Aquatic Metabolism

GDLN 835.4400 – Anaerobic Aquatic Metabolism

Dupont believes existing data meets these data needs. Discussion with the Agency will 

determine if these data will fulfill the data requirements.”

EFED Response:

EFED’s problem formulation for methomyl, which may be found in the docket at 

www.regulations.gov (EPA-HQ-OPP-2010-0751), provides details on the environmental fate 

data deficiencies and information needed to conduct an exposure assessment for Registration 

Review. We look forward to receiving data that address these needs.

2. DCP Comment:

“GDLN 850.2300 – Avian reproduction study (mallard duck)

DuPont has conducted an avian reproduction study with the mallard (MRID 41898601) that 

satisfies this data requirement. This study was categorized as core and determined to fulfill the 

guideline requirement in the methomyl RED document.”

EFED Response:

The study cited (MRID 41898601) cannot be used to fulfill guideline requirements because there 

were effects noted at all treatment concentrations (the NOAEC from the mallard reproduction 

study is <50 mg a.i./kg-diet based on decreases in adult male body weight). This indicates that 

the mallard duck may be more sensitive to methomyl than the bobwhite quail on a chronic 

exposure basis. Therefore, EFED recommends requesting a reproduction study (850.2300) with 

the mallard duck to fulfill this data gap.

3. DCP Comment:

“On July 15, 2010, DuPont submitted comments on the NMFS Biological Opinion and EPA’s 

proposed measures. A response from the Agency is pending.”
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EFED Response:

The Agency has reviewed the comments DuPont submitted relative to the Endangered Species 

Protection Bulletins resulting from ESA consultation with the National Marine Fisheries Service. 

A letter is currently being prepared to explain how the Agency disposed of all comments it 

received on those bulletins.

4. DCP Comment:

“DuPont intends to provide information on multiple crop cycles to the Agency for use in risk 

assessments conducted for Registration Review.”

EFED Response:

EFED appreciates that DuPont will provide the Agency information on multiple crop cycles and 

looks forward to receiving the data and reviewing them for adequacy and suitability for use in 

risk assessment.

5. DCP Comment:

Regarding Table 3.2 in the Problem Formulation, “(t)he Lannate® SP formulation should have 

Chemigation listed under Methods of Application.”

EFED Response:

EFED appreciates the information provided by DuPont. EFED will review the Lannate® LV 

label and will make changes to the method of application as appropriate when conducting the 

ecological risk assessment for methomyl during the Registration Review process.

6. DCP Comment:

Regarding the environmental fate data requirements, “DuPont believes existing data meets these 

data needs. Discussion with the Agency will determine if these data will fulfill the data 

requirements.”

EFED Response:

See response #1.