UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

MEMORANDUM 

Date: March 26, 2014 

OFFICE OF 

CHEMICAL SAFETY AND 

POLLUTION PREVENTION 

SUBJECT: Methyl Bromide. HED's Response to the Methyl Bromide Preliminary Work 

Plan Comments Submitted by the Methyl Bromide Industry Panel (MBIP); 

D417431. 

PC Code: 05320 I DP Barcode: 0417431 

Decision No.: 486878 Registration No.: GDCI-053201-26629 

Petition No.: N/A Regulatory Action: PWP Response 

Risk Assessment Type: N/A Case No.: N/A 

TXRN~: NM CASN~: NM 

MRID No.: 4860270 I 40 CFR: N/A 

FROM: 

Risk 

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Assessment 

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Branch 

Assessor 

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Health Effects Division (7509P) 

THROUGH: Jeff Dawson, Chemist 

HED Immediate Office ~ 'J () ~~hael Metzger, Branch Chief 'J )( · 

Risk Assessment Branch VII (RA I) 

Health Effects Division (7509P) 

TO: Sue Bartow, Chemical Review Manager 

Cathryn Britton, Team Leader 

Pesticide Re-Evaluation Division (7508P) 

Attached is HED's response to the Methyl Bromide Industry Panel's comments submitted to the 

Agency on November 25, 2013 on the methyl bromide Preliminary Work Plan (PWP). 

There were two submissions to address the post-harvest commodity uses of methyl bromide as 

well as the pre-plant methyl bromide uses. 

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POST HARVEST: 

MBIP Summarized Comment: EPA's characterization that this data requirement ["875.2500-

Inhalation exposure (post-application)" from GDCI-05320 1-26629] is "outstanding" is incorrect. 

EPA Response: The Agency acknowledges the receipt of a study to address the data requirement 

(MRID 48602701), although that study does not fulfill the Agency data requirement. The MBIPsubmitted protocol included monitoring to be completed for California (Long Beach), the midAtlantic (PA, DE, NJ), and Florida (Miami). The Agency has only received data for the Long 

Beach location. Since the study has not been completed, the data requirement remains 

outstanding. 

MBIP Summarized Comment: If EPA conducts an updated risk assessment for methyl bromide 

as used in cold storage facilities, the Best Management Practices (BMPs) currently in place at 

facilities handling treated commodities should be taken into account. 

EPA Response: The Agency completes human health risk assessments based on a number of 

factors. In the case of methyl bromide, the product labels outline requirements for occupational 

handlers and bystanders who may be exposed to methyl bromide around ports, cold storage 

facilities, and for pre-plant soil fumigations. EPA completes an exposure and risk assessment for 

these workers/bystanders and available use and usage information to help characterize exposure 

and risk estimates for risk managers. EPA can consider how additional measures, like BMPs, 

can influence the risk picture. These practices can help risk managers in mitigating risks. 

PRE-PLANT: 

MBIP Summarized Comment: The ambient air monitoring data requirement (GDCI-053201-

836) applies to soil uses and the registrants are under no legal obligation to conduct the studies 

since the DCI references commodity fumigation sites. 

EPA Response: The PWP response from MBIP claims that the Human Health Scoping 

Document mischaracterized the outstanding GDCI as requiring ambient air monitoring near 

commodity fumigation sites in Miami, Florida and the Delaware River basin. The Human 

Health Scoping Document summarized the data gaps identified in order to complete a 

comprehensive risk assessment for methyl bromide. The Agency needs longitudinal ambient air 

monitoring data from areas of highest methyl bromide use - both for pre-plant and post-harvest 

commodity uses. 

HED believes that the appropriate choice for significant use areas includes: 

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1. Siskiyou County, CA 

o The Agency believes that monitoring data from Siskiyou County is important 

because of unique conditions that can not be translated from existing/on-going 

monitoring efforts (e.g.- due to weather, topographical, and use differences) 

2. Georgia forestry nurseries; and 

3. the Maritime Exchange Region for the Delaware River and Bay 

o The Agency believes that monitoring from this region is appropriate to reflect the 

post-harvest commodity fumigations that occur in mid-Atlantic ports 

(Pennsylvania, New Jersey, Delaware). 

Another suitable high use location may be appropriate. Criteria that must be considered in 

selecting the monitoring sites include: (1) areas of highest methyl bromide use, (2) duration of 

the use of methyl bromide for a candidate study area, (3) geographically unique features that 

could affect ambient air concentration levels (e.g., valleys, flat terrain), (4) weather 

considerations which may adversely impact ambient exposures (e.g., frequent inversions or air 

stagnation events), (5) proximity of methyl bromide use to bystander populations, (6) proximity 

of methyl bromide use to sensitive populations (e.g., school children), (7) proximity of methyl 

bromide use to minority populations to define potential environmental justice concerns such as 

disparate exposures to certain populations, and (8) logistical access. Because of the sampling 

design necessary to meet this DCI requirement, HED believes the registrants should be required 

to obtain a comprehensive Agency protocol review before study initiation. 

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