A. PHYSICIANS COMMITTEE FOR RESPONSIBLE MEDICINE (PCRM)
COMMENTS :

1. PCRM Comment:

“As stated in the Summary Document the Ag ency may require the ‘(850.1075) Acute Fish Toxicity Study.’ We believe that the number of animals used can be reduced by following an acute threshold or ‘limit test’ approach”

EFED Response

The results from a limit test could be used to fulfill the data requireme nt for an Acute Fish Toxicity Study (850.1075) if it is conducted as described in the 850.1075 guidelines and is classified as acceptable.

2. PCRM Comment:

“We also encourage the use of (Q)SAR data either in place of, or addition to, the fish experimental data.”

EFED Response

The Agency is actively working with the Fe deral Drug Administration (FDA) and the Pest Management Regulatory Agency (PMRA) of Hea lth Canada, through the North American Free Trade Agreement (NAFTA) Technical Working Gr oup on Pesticides (Quant itative) Structure Activity Relationship [(Q)SAR] Guidance Document to develop guidance for the use of (Q)SAR to support pesticide risk assessment. We w ill consider the recommendations provided in the guidance document (once it is finalized) when conducting the ecological risk assessment for the Registration Review of methiocarb.

B. AMERICAN BIRD CO NSERVANCY (ABC) COMMENTS :

1. ABC Comment:

“We also ask that during regist ration review, and the data call-in period, all backyard uses of methiocarb be suspended to protect birds.”

EFED Response:

EFED defers the response to this comment to PRD since it relates directly to pesticide registration issues.

2. ABC Comment:

“We want EPA to require the registrant to conduct:

2... Reproductive toxicity te st with passerines...

EFED Response :

EFED is not aware of any data to show that meth iocarb 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 repr oductive endpoints. Therefore, at this time, EFED believes that the data from reproductive studies in the bobwh ite quail (see below) and mallard duck studies will be adequate for assessing potential risks of methiocarb to birds from chronic exposure. Furthermore, EFED does not have a validated protocol for a chronic reproduction study in passerines, and is not prepared at this time to make recommendations rega rding such a protocol. Any protocol developed would need to go thr ough a process of scien tific peer review. Therefore, EFED will not recommend requestin g a chronic reproductive study using passerines
for methiocarb at this time.

3. ABC Comment:

“We want EPA to require the registrant to conduct:

... Developmental toxicity test with a passerine model...”

EFED Response :

EFED is not aware of a validated protocol for a developmental toxicity study with a passerine, and is not prepared at this time to make r ecommendations regarding such a protocol. Any protocol developed would need to go through a process of scientific peer review. EFED, however, will check relevant Office of Pesticide Programs’ (OPP) databases for existing data on passerine developmental toxicity for methiocarb. If data are available, EFED will consider the potential for inclusion of such data in the risk assessment for methiocarb. However, the toxicity endpoints from available passerine de velopmental toxicity data will not be used quantitatively by EFED in risk assessment unless the endpoints are related directly to th e survival, growth, or reproduction.

4. ABC Comment:

“We want EPA to require the registrant to conduct:

... Reproductive toxicity test with bobw hite. There is no defined NOAEC for
methiocarb on bobwhites.”

EFED Response :

EFED did recommend requesting an Avian Repr oduction Test with bobwhite quail (850.2300) in
its Problem Formulation for methiocarb. Theref ore, we concur with ABC on this comment, but no changes need to be made to the Problem Fo rmulation for methiocarb (since EFED already recommended requesting these data).

35. ABC Comment:

“... ABC requests the following tests be required for regi stration review:

... Acute Oral Toxicity Tests on upland game species, waterf owl species and passerine species with:
a. MP
b. MSO
c. MSOP
d. MSO 2 e. MSO 2 P”

EFED Response :

As stated in the Problem Formulation for meth iocarb, the parent compound degrades in the environment to the major degradates methiocar b phenol (MP), methiocarb sulfoxide (MSO), and methiocarb sulfoxide phenol (MSOP); and to the minor degradates methiocarb sulfone (MSO 2 ) and methiocarb sulfone phenol (MSO 2 P). For the ecological risk assessment conducted as part of the Registration Review process, all of the degr adates listed above will be considered and the degradates of concern will be identified.

Some toxicity data for MSO 2 , MSO, MSO 2 P, and MSOP are available through the European Union’s Pesticide Properties Database (PPDB) ( http://sitem.herts.ac.uk/aer u/footprint/en/index.htm ). The studies from which these endpoints
are derived were not available fo r review at this time. Taken at face value, however, the data suggest that the degradates are no t more toxic than the parent fo r the taxa considered, with the exception of the acute toxicity values for earthworms (see Table 1 ).

The residues of concern for exposure and risk asse ssment will be reconsidered prior to analysis. In the absence of confirmatory da ta indicating low toxici ty concerns for the major degradates of methiocarb ( i.e ., MP, MSO, MSOP, MSO 2 , and MSO 2 P), they will be assumed of equal toxicity as the parent. Therefore, EF ED does not recommend calling-in acute avian toxicity data on methiocarb degradates at this time.

4Table 1. Toxicity Data for Methiocarb Degradates.

SOURCE METHIOCARB METHIOCARB
SULFONE

(MSO 2 ) METHIOCARB
SULFOXIDE (MSO) METHIOCARB
SULFONE
PHENOL (MSO 2 P) METHIOCARB
SULFOXIDE

PHENOL (MSOP) PPDB (EU) WEBSITE 1

Acute oral Rat (LD 50 ; mg/kg-bw) 19
-- -- -- >3160

Acute oral Avian (LD 50 ; mg/kg-bw) 5
-- -- -- --

Acute Fish (LC 50 ; mg/L) 0.65
-- 6.6 68.7 >106

Chronic Fish (NOAEC; mg/L) 0.05
-- -- -- --

Acute FW Invertebrate (EC 50 ; mg/L) 0.008
-- 0.056 54 157

Chronic FW Invertebrate (NOAEC) 0.0001
-- -- -- -- NV Aquatic Plant (EC 50 ; mg/L) 2.2
-- 2.75 120 >100

Acute Honeybees (LD 50 ; μg/bee) 0.23
-- -- -- --

Acute Earthworms (LC 50 ; mg/kg) 1322
-- 78 >1000 >1000

1 Pesticide Properties Database (PPDB) ( http://sitem.herts.ac.uk/aeru/footprint/en/index.htm )

6. ABC Comment:

“... ABC requests the following tests be required for regi stration review:

... Reproductive Toxicity Tests on upland game species, waterfowl species and passerine species with:
a. MP
b. MSO
c. MSOP
d. MSO 2 e. MSO 2 P”

EFED Response :

5As stated above and in the Problem Formulati on for methiocarb, the residues of concern for exposure and risk assessment will be reconsidered prior to analysis. In the absence of confirmatory data indicating low toxicity concerns for the major degradates of methiocarb ( i.e

., MP, MSO, MSOP, MSO 2 , and MSO 2 P), they will be assumed of equa l toxicity as the parent. Additionally, as stated above, EFED does not have a valida ted protocol for a chronic reproduction study in passerines, and is not prep ared at this time to make recommendations regarding such a protocol (see above). Th erefore, EFED will not recommend requesting a chronic reproductive study for methio carb degradates at this time.

7. ABC Comment:

“... ABC requests the EPA to suspend uses of meth iocarb for reduction of predation on the eggs of federally-listed birds.”

EFED Response :

EFED defers the response to this comment to PRD since it relates directly to pesticide registration issues.

8. ABC Comment:

“ABC recommends setting up a schedule for data cal l-ins for pesticides to go through the EDSP as soon as possible.”

EFED Response :

The Agency is currently and actively involved in the Tier I screening process for chemicals that have been identified for screening as potential endocrine disruptors. The second EDSP list of chemicals for Tier I screening was published in the Federal Register on November 17, 2010 (FR Vol. 75, No. 221; see page 70252).

B. FIFRA ENDANGERED SPECIES TASK FORCE (FESTF) COMMENTS :

1. FESTF Comment:

“ In June of 2004, March of 2005, and October 19, 2007, the FIFRA Endangered Species Task Force (FESTF) submitted its Information Management System ( FESTF Information Management System (IMS): Documentation of Structure and Function of IMS 1.1, MRID # 46325901) and documentation of the beta-tested IMS, NatureServe data ( FESTF Task Force Information Management System (IMS): BetaTested IMS 2.0 and Access to NatureServe Data - Final Report , MRID #46486301) and NatureServe
Data Evaluation and Review (MRID #47260101). These data fulfill the data requirements spelled out in Pesticide Registration Notice 2000-2 and provide the best available data necessary for the proximity analysis of Methiocarb use and listed species locations. ”

EFED Response:

6EFED will consider the data included in the FESTF Information Management System when conducting the endangered species assessment fo r methiocarb during the Registration Review

process.

2. FESTF Comment:

“ The leading registrant, as identified on the fact sheet included in the Registration Review Summary, is Gowan Company, an FESTF member. Gowan Compan y is entitled to rely on FESTF ... For those registrants who are not currently eligible to rely on FESTF data, FESTF is making every effort to inform them of the role of FESTF data in listed species asse ssments, while also affording them various options for reliance on that data, since these data are necessary not only to fulf ill EPA data requirements, but also to develop the assessments required to support the Regi stration Review process. It is imperative for EPA to assure that any company relyi ng upon FESTF data, but not listed in Attachment A, has filed with FESTF a proper offer to pay for data compensation. ”

EFED Response:

EFED defers the response to th is comment to PRD since it relate s directly to data compensation
issues.

7