UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM Date: August 2, 2006 Subject: Agency Responses to Phase 5 Public Comments Related to Methyl Bromide's Commodity Risk Assessments and Risk Mitigation Options Proposal From: Steven Weiss, Chemical Review Manager Special Review Branch, Special Review and Reregistration Division To: Methyl Bromide Docket ( EPA HQ OPP 2005 0123)

The Environmental Protection Agency ( EPA) is developing a decision regarding the Food Quality Protection Act ( FQPA) tolerance reassessment for methyl bromide and reregistration eligibility of the commodity uses of the active ingredient methyl bromide through a 6 phase public participation process. During the public comment period of Phase 5, which closed on May 29, 2006, the Agency solicited comments on its risk assessments and risk mitigation options proposal. The Agency received comments from 18 sources: California Department of Pesticide Regulation; Value Recovery, Inc; Dow AgroSciences, LLC; The Royal Group; USA Rice Federation; Western Industries North, Inc; ASOEX; Natural Resources Defense Council; Fumigation Service & Supply, Inc.; Pet Food Institute; North American Millers' Association ( NAMA); Methyl Bromide Industry Panel ( MBIP); National Pest Management Association ( NPMA); Industrial Fumigant Company ( IFC); US Department of Agriculture/ Animal and Plant Health Inspection Service ( USDA/ APHIS); and a citizen. Most of the comments received were related to feasibility, cost, and impact of risk mitigation options document. The attached table contains the Agency's response to the Phase 5 public comments. 2 # ID Public Comment Agency Response 1 USA Rice In addition to other mitigation efforts, the agency is considering trying to apply the existing California regulatory regime for MeBr fumigations to the rest of the country through this Reregistration Eligibility Decision framework. Among the many possible problems with this approach, one stands out. The California system relies on the County Agricultural Commissioners to provide oversight, permitting and enforcement during structural fumigations. However this bureaucratic system is not duplicated in the other rice states. This fact presents an enormous flaw in the basic underpinnings of any California system, as it would be applied to other states. The Agency agrees. Agency's RED requires the responsible party ( i. e. the person supervising the fumigation) must certify in writing that he/ she has reviewed the FMP and that it addresses all elements required by product labels and the Agency methyl bromide commodity fumigation reference manual, and that all decisions on the treatment/ aeration processes, buffer zones, and PPE are appropriate and protective. States or local governments may opt to require third party certification ( e. g., county agricultural commissioners, state pesticide enforcement officials, certified industrial hygienists, or certified safety professionals). In that case, where fumigations are supervised by a federal authority such as APHIS, the federal agency may certify the FMP. The responsible party must contact the applicable State lead agency to determine the certification requirements for that state. 2 USA Rice California DPR requires very low concentrations in order to achieve a 100 fold safety margin for the areas surrounding a fumigation. During fumigations the structures and facilities are evacuated except for those necessary to the procedure. Air monitoring is maintained. USA Rice believes this should be sufficient for protection. DPR has estimated that a 100 fold margin of safety is achieved if air concentrations do not exceed 0.21 ppm measured as a 24 hour time weighted average. This exposure is equivalent to 0.63 ppm as an 8 hour time weighted average or 20 ppm as a 15 minute time weighted average. DPR's permit conditions apply only to California.

Current EPA labels are based on a 5 ppm exposure limit ( measured with direct read methods. EPA risk assessment is based on an UF of 30 and an 8 hour HEC of 30 ppm ( concentrations greater than 1 ppm are a risk concern). 3 NAMA We oppose the use of the California system as a template for national regulation. California has an entire infrastructure in place with people and processes for regulating pesticide usage. To merely duplicate that system and impose it on other states where that infrastructure does not exist would be cumbersome, unrealistic and would not add to the safe usage of methyl bromide. We do not think it is in the best interests of the public, the industry or EPA to put in place regulations for which the infrastructure, including a compliance and enforcement program, do not exist. Also, the California system was developed to address the pre existing use patterns and exposure issues unique to soil fumigation in that state. Those use patterns and exposure issues are not applicable to regulating structural fumigations such as grain mills. The Agency agrees that than California system can not be used as a drop in approach for the US. However, the Agency does believe that mitigation options for EPA labels can be developed based on many of the elements that are currently required by CDPR. Furthermore, CDPR does require permits for non soil fumigation including structural fumigations such as grain mills.

4 MBIP The MBIP takes issue with EPA's assertion that California's approach for managing risks from post harvest fumigation is " effective and feasible." California has developed a sophisticated system of regulations to manage risks from fumigation on a site by site basis. This system is complicated and expensive. It is unique to California because it relies on a regulatory infrastructure of local/ county agricultural commissioners who can apply controls to site specific conditions through a permitting system. EPA provides no evidence to support the claim of that this system is effective or that it would be feasible to implement it on a nation wide basis. The vast majority of post harvest/ food processing plant fumigations do not occur in California. Thus, the California system does not necessarily provide a model for a system that would be feasible for all areas. See response # 3.

5 Royal Although it is not mentioned as a risk mitigation proposal, Royal has heard in the industry of proposals by EPA to lower the 5 ppm requirement. Royal is not aware of data that support the need for any lower exposure requirement and believes such data should be made known. In addition, current technology permits us to measure for the 5 ppm level but not any level significantly lower than that. We have explored instrumentation and believe that the cost of equipment to measure lower The Agency appreciates the information provided by this commenter and has considered this information, along with other pertinent data, in its alternatives and user impact analysis for the proposed risk mitigations. 3 # ID Public Comment Agency Response levels of methyl bromide would probably be in the range of $ 15,000 to $ 20,000 per unit, as compared to the colorimetric tubes in use now ( costing less than $ 10 each) and even the most expensive infrared units ( such as the " MiniRae," which costs several thousand dollars). On a busy fumigation night, Royal can use more than 10 monitoring devices, plus infrared " spot" readers and countless colorimetric tubes. The cost associated with a change in the permissible levels of methyl bromide, then, is substantial. Finally, although Royal understands the desire to make methyl bromide use safer, a desire Royal certainly shares, the proposals appear to take the approach that the most logical way to attain the goal of safety is to set specific limits that would apply to all fumigations. In its two decades of fumigation Royal has learned that no two fumigations are alike because there are so many complex factors that can affect the fumigation. Royal's goal has always been control, not the application of absolute limits. For control, we need the years of experience of our fumigators, the input of the experience of APHIS, inquiring minds that examine and re examine our data, a full knowledge of many different types of equipment and the ability to design new equipment, a flexible infrastructure and flexibility in our operations and responses to conditions. We believe that the best course to a safer and more efficient use of methyl bromide consists of utilizing the knowledge in the industry and in APHIS, and rewarding companies that achieve demonstrable control. 6 APHIS Allowable Air Concentration: APHIS requests that EPA consider permitting the allowable ambient air concentration of methyl bromide to remain at 5 ppm, or 1/ 6 of the EPA's acceptable Human Equivalent Concentration ( HEC) of 30 ppm methyl bromide. EPA's suggested uncertainty factor of 30 has diminished the allowable air concentration to 1 ppm; this amount is below the level of detection of any portable air concentration detection devices currently available on the market. Although APHIS has identified a company which is interested in developing such technology, there is no guarantee as to when an adequate device might enter the market, or whether it would be as accurate as the company claims it will be. Today's portable detectors determine air concentrations down to 1 ppm with an accuracy of ± 1 ppm. This would indicate that 2 ppm ( 1/ 15 of EPA's HEC) would be the lowest air concentration that could be adequately measured. However, APHIS has been supervising fumigations for over 20 years using the current 5 ppm safety level with no record of detrimental human health effects. Since the current standard is already six times lower than the acceptable HEC, a reconsideration of the allowable air concentration is requested. The Agency is aware of the screening level issue related to real time monitoring devices. It is also investigating the feasibility of alternative sampling methods ( e. g., sampling pump with resin cartridges or vacuum canister) related to the types of monitoring protocols employed by APHIS.

It should be noted that 1 ppm 8 hour TWA pertains to air concentration that is of concern for human exposure and not the concentration that commodities must be aerated to.

7 APHIS A consequence of lowering the acceptable air concentration may be detrimental economic effects on a local, national, and global scale. It will take significantly longer, in some cases up to one day, to remove methyl bromide down to a lower level during the aeration process. Any increase aeration time will slow the flow of commerce at the ports. Vessels and cargo may back up, both at our country and at the exporting country; perishable commodities may become unmarketable due to spoilage, as they await fumigation without proper storage conditions. The income stream to the Port Authorities ( i. e., the States) may be reduced as fumigation business on their property slows. A long term effect may be a reduction in imports which will cause foreign governments to take more restrictive actions on our nation's exported products. The Agency acknowledges that the specific risk mitigation options that are being considered would likely have a different economic effect on each facility that conducts fumigations. Further, the Agency agrees that, depending on the particular risk mitigation option selected and the site specific conditions of the facility, some options could produce substantial adverse economic effects.

8 Private Citizen The use of this toxic chemical should not be allowed at all in any place. The Agency's has determined that MeBr can be used safely provided mitigation measures specified in the RED/ TRED are followed. 9 NRDC Mitigation methods ( other than use of alternatives) cannot effectively and adequately protect workers, nearby residents, or the broader U. S. and global population at risk due to these uses of MBr See response # 8.

10 NRDC Recognizing the unsafe uses of MBr and the impracticalities of achieving comprehensive exposure mitigation, coupled with the mandated phase out of this product, all uses of MBr should be considered ineligible for FIFRA reregistration and FQPA tolerance reassessment. The Agency believes that many uses can be re registered in compliance with FIFRA and FQPA. See response # 8, regarding risk mitigation. It should also be noted that pre shipment and quarantine uses are exempt from phase out under the Montreal Protocol. 11 CDPR To be considered safe for use in the State of California methyl bromide uses in structures and on food commodities within chambers requires a series of regulations and specific requirements to be followed. Questions and Answers These product use rules for methyl bromide in California are intended to protect both bystander and worker exposures, both of which have been determined to be This information provided was used by the Agency to develop a risk reduction mitigation strategy for MeBr's commodity uses. 4 # ID Public Comment Agency Response excessive by the USEPA in their risk assessment. These requirements ( attached to these comments), created by CDFA and California Department of Pesticide Registration have been determined to lead to safe use conditions. These use conditions, appropriate for California have been determined to be effective and would be appropriate for implementation in the rest of the United States. ( several files were sent with comment that contain CDPR requirements and guidelines) 12 NRDC Methyl bromide is a broad spectrum pesticide and extremely toxic vapor. In humans, is readily absorbed through the lungs, resulting in human poisoning incidents following inhalation exposure. This is of particular risk given that the toxicity effects occur at a much lower level than the odor threshold, so people may not even know that they are being exposed. Further effects can be delayed for days or even months after exposure, since it is a cumulative poison. Effects range from headaches and nausea to death in extreme cases. Inhalation of 1,600 ppm for 10 20 hours, or 7,900 ppm for 1.5 hours is lethal to humans. The lowest inhalation level found to cause toxicity in humans is 35 ppm in air. The Agency notes that all HECs used for risk assessment purposes are < 35 ppm cited by NRDC. For acute risk assessments the HECs used are 10 and 30 ppm for bystander ( non occupational) and occupational exposures, respectively. HECs for all other inhalation exposure scenarios are   4.4 ppm, well below the concentration cited by NRDC. 13 NRDC MBr is also a direct threat to the health of people who work with it. The National Cancer Institute has linked methyl bromide to increased prostate cancer risks in a study of 55,000 pesticide applicators, including farmers, nursery workers, and workers in warehouses and grain mills. Inexplicably, EPA nonetheless continues to classify MBr as not likely to be carcinogenic to humans ( OPP 2005 0123 0135, p. 21). As part of the Agricultural Health Study, additional analyses  including evaluation of a larger sample size  are being conducted to further elucidate the apparent link between methyl bromide exposure and prostate cancer. At the conclusion of these evaluations, the Agency will consider the results in conjunction with the previous study results as appropriate. 14 MBIP Uncertainty Factor Removed For Lack of DNT Study  Page 14 The MBIP supports EPA's decision to remove the 10x uncertainty factor previously applied for lack of a DNT study. The additional uncertainty factor was applied in previous iterations on the risk assessment. The MBIP submitted a DNT study, which the Agency has reviewed and found acceptable. This study eliminates the need for the uncertainty factor, and thus, in accordance with current HED policy, the Agency has properly removed it from the Post Harvest RA. No response needed.

15 MBIP Endpoints for Short and Intermediate Term Inhalation Exposures  Pages 11 and 15 EPA continues to use a sub chronic inhalation study in dogs   MRID 45722801 ( Schaefer Study)   to derive the endpoint for the short and intermediate term inhalation exposures. As noted in the MBIP's prior comments, the Schaefer Study establishes a NOAEL of 20 ppm. The Agency continues to utilize a different NOAEL   5.3 ppm for male dogs and 10 ppm for female dogs. Based on this study, the HEC equals 4.4 ppm for occupational and commodity bystander exposure. The MBIP incorporates its previous comments and submissions on this issue and reiterates its request that EPA reconsider its position on the NOAEL for this study. The Agency has evaluated two subchronic inhalation studies in dogs and has conducted a weight of evidence evaluation in establishing the point of departure for this risk assessment. While in MRID 43386802 unresponsiveness and/ or depressed appearance was reported for 2/ 8 females exposed to 5.3 ppm after 32 days of exposure, the Agency has concluded that these observations are spurious given that no effects were observed after 5 weeks of exposure at 11 ppm. Moreover, in a non guideline inhalation toxicity study in dogs ( MRID 45722801) no effects were seen at the 5.3 ppm exposure concentration after 6 weeks of exposure. Thus, the Agency reaffirms its conclusions that the NOAEL for these studies should be established at 5 ppm 16 MBIP Classification of Carcinogenic Potential   Page 13 EPA correctly states that methyl bromide is classified as a " not likely human carcinogen." However, the Post Harvest RA references the initial results of an Agricultural Health Study ( AHS). This is an epidemiology study conducted on workers exposed to a wide range of pesticides. The authors suggested a link between prostate cancer and methyl bromide use in agriculture. However, since its publication, this study has been evaluated by a blue ribbon panel of epidemiologists who concluded that the study is fundamentally flawed. The chief flaw of the study was that it did not adjust for potential confounders other than age. Among other findings, the blue ribbon panel concluded that despite sporadic positive results, the study did not show consistently increased risks to support a causal association between agricultural pesticide use and prostate cancer. The panel further concluded that it was not possible to attribute any particular pesticide as a putative cause of prostate cancer. The results of the panel's review are scheduled for publication in the near term. In addition, animal studies submitted and reviewed by EPA as part of the reregistration of methyl bromide do not show any evidence of carcinogenicity. In light of these data, and the questions of validity raised about the AHS, EPA should See response # 13. 5 # ID Public Comment Agency Response not use that study as a basis for regulating methyl bromide as a carcinogen. 17 NRDC Reregistration should not even be considered for uses not permitted under the Montreal Protocol and the Clean Air Act; The Montreal Protocol, as well as EPA regulations implementing the Clean Air Act, provide specific exemptions for critical uses and quarantine and preshipment uses. Additionally, use of pre phaseout ( pre 2005) inventory is not restricted under the Protocol, Clean Air Act, or EPA regulations. The Agency believes that all uses considered herein are authorized by, or exempted from, the Montreal Protocol and the Clean Air Act. 18 NRDC MBr is now banned except for uses that qualify under the Montreal Protocol and the Clean Air Act as either " quarantine and preshipment uses" or " critical uses." As a first principle, EPA's pesticide program should not even consider the reregistration of MBr for uses that are not authorized under the Montreal Protocol and the Clean Air Act. Thus, for the purposes of this proceeding, all uses other than the following should be ruled out from the outset: ( 1) Dry cure pork products; ( 2) California beans, California dried plums, California walnuts, California dates; ( 3) rice mills, bakeries, pet food facilities, grain mills; and ( 4) processed foods, spices/ herbs, cocoa, cheese processing plants. Except for other MBr uses conforming to QPS requirements, no other uses of MBr in the " enclosures, chambers and structural food processing facilities" use pattern should be considered eligible for FIFRA reregistration or tolerance reassessment under FQPA. See response # 17 19 ASOEX ASOEX also brings a unique perspective to the methyl bromide issue. The most dramatic evidence of ozone depletion occurs over the Southern polar ice cap, which includes Chilean territory. For this reason, ASOEX aggressively explored means to reduce methyl bromide emissions in its operations in Chile and, to the extent practicable, to comply with fumigation requirements by use of facilities in the U. S. ports of entry. If the commodity use of methyl bromide is further limited in the U. S., all Chilean fresh produce exports would necessarily be fumigated in Chile prior to export, with the possibility that ozone depleting emissions would occur at points much closer to the existing ozone hole. ASOEX doubts that the U. S. Congress, EPA or the USDA intended any law, its amendments and implementing regulations to increase the risk of ozone depletion. EPA agrees that there are minor latitudinal differences in impact according to the location of ODS emissions. The commenter has provided no specific information regarding changes in fumigation practices for quarantine commodities potentially affected by a U. S. phasedown in MeBr use.

20 NRDC In addition to its hazard to human health, MBr is the most powerful ozonedepleting chemical still in widespread use. After more than a decade's lead time, the deadline for phasing out MBr fell on December 31, 2004, with exceptions allowed only for " critical uses" and for " quarantine and pre shipment uses." One condition for a critical use exemption is the absence of technologically and economically feasible alternatives. The MBr exemptions allowed in 2005 and 2006 are estimated to cause more than 20 deaths from skin cancer, more than 4,000 other skin cancers cases, and more than 1,400 cataract cases, in the U. S. alone. The global health toll will be much larger. Although EPA has not specifically calculated the number of deaths that will arise as a result of both the 2005 and 2006 critical use exemptions, EPA experts concur that the commenter's estimate falls within the range projected by the Agency's AHEF model.

21 NRDC This exposure risk mitigation proposal, however, will not reduce the overall MBr usage, and thus the hazard to the ozone layer, in any significant way. Does EPA have data supporting its estimated impact? If so, what is the source of this data, and what are the costs associated with this proposal compared with the estimated impact on MBr total usage? Has EPA evaluated the impact of this restriction on the attractiveness of alternative pest control methods? The majority of options focus is on reducing direct exposure to MeBr. However, several of the options could be effective in reducing the overall amount of MeBr emitted and destruction of the ozone layer. These include: recovery destruction systems, alternatives, lower rates, and integrated pest management. These options used in combination with other options ( e. g. enclosure performance criteria) could also be effective in reducing MeBr emitted. The Agency has also included a qualitative impact of mitigation measures that is included in the docket. 22 MBIP EPA refers to the Office of Atmospheric Program's ( OAP's) estimate of the number of UV related skin cancer incidents based on commodity uses of methyl bromide. There are significant problems with the Atmospheric and Health Effects ( AHEF) model used in the OAP analysis, leading to an overestimate of the risk. Even if these problems were not present, the issue of increased UV exposure is not pertinent to the Office of Pesticide Program's current risk assessment of methyl bromide for reregistration purposes. The docket document referenced here  " The Role of Methyl Bromide in Stratospheric Ozone Depletion: Science and Health Considerations"   includes a detailed description of the peer review process the AHEF model has undergone. The AHEF model has been extensively peer reviewed, most recently in 1999, 2001, and 2003, and has been used to 6 # ID Public Comment Agency Response support EPA's regulatory impact analysis for the critical use program as well as the 2001 Report to Congress on the Benefits and Costs of the Clean Air Act. The Agency considers methyl bromide's health effects due to stratospheric ozone depletion appropriate for consideration in overall health effects assessment undertaken in the reregistration process 23 CDPR All of the mitigation options discussed are consistent or compatible with the current regulatory requirements in California. Complying with buffer zone requirements is the most difficult for most facilities. Impacts primarily depend on location of the facility within a community as well as the specific location of the chambers or other fumigation enclosures within the facility. Impacts are greatest where the facility or enclosure is situated near where people work or live. Food processing plants that use several hundred or several thousand pounds of methyl bromide to fumigate an entire facility are a particular concern. Some mitigation options have greater impact on certain types of facilities. For example, some fresh fruit facilities have problems complying with minimum aeration requirements. The Agency appreciates the information provided by this commenter and has considered this information, along with other pertinent data, in its analysis of the proposed risk mitigations.

24 CDPR While aeration though an elevated stack mitigates exposure in most situations, in a few cases exposure can be increased. Stacks rely on vertical distance to dilute ground level concentrations. Facilities where the top of the stack is at the same level as windows, doors, or air intakes of nearby buildings can be problematic. The mitigation options should address this situation. See response # 23 25 CDPR Unless included in the occupational mitigation options, U. S. EPA should consider controlling exposure from fumigated commodities in enclosed storage and processing areas. Some fumigated commodities continue to off gas methyl bromide after aeration is completed. The off gassing can lead to increasing concentrations in enclosed storage and processing areas, possibly causing unacceptable exposure to people working in these areas. In California, this issue is a concern for some nut facilities. See response # 23 26 CDPR Fumigation chambers that share common walls with another structure are also a concern. Few chambers are gas tight and some leakage occurs into the adjoining structure. Mitigating the exposure to people working in the adjoining structure is difficult unless the adjoining structure is vacated during fumigation. See response # 23 27 CDPR While implementation was difficult, the majority of California's facilities adapted to CDPR's requirements, and are still fumigating with methyl bromide. See response # 23 28 MBIP Implementing the requirements of the California permitting/ buffer zone system on a nationwide basis also raises issues regarding " unfunded federal mandates" under the Unfunded Mandates Reform Act of 1995, P. L. 104 4, 2 U. S. C. § 1501, et seq. (" the Act"). This Act was enacted " to end the imposition, in the absence of full consideration by Congress of Federal mandates on state, local and tribal governments without adequate funding . . . " See Section 2 of the Act, 2 U. S. C. § 1501. Moreover, imposing the California model on other states may affect an unconstitutional commandeering of governmental processes into federal service. See e. g., New York v. United States, 505 U. S. 144, 174 177 ( 1992) ( Federal government may not simply ` commandeer the processes of the States by directly compelling them to enact and enforce a federal regulatory program.) quoting Hodel v. Virginia Surface Mining & Reclamation Assn., Inc., 452 U. S. 264, 288 ( 1981). As noted above, many States do not have the regulatory systems and support necessary to implement a system like California's. If that system were imposed as part of the Agency's approach for risk mitigation, the States would necessarily be compelled to use their own funds to establish regulatory infrastructures necessary to implement those requirements. Such a result may constitute an unconstitutionally imposed burden on the States. The mitigation measures required by the Agency provide states or other federal agencies flexibility to decide to what extent they would like to oversee these requirements, including the option to self certify fumigation management plans.

29 APHIS While fumigation facilities do exist in California, the administrative burden and costs associated with complying with this state's permitting regulations have resulted in global, national, and local economic effects, all of which should be examined by EPA before a decision is made that California's approach for managing fumigation is effective and feasible on a national scale. Global ramifications include the choices made by importer/ exporters from various nations on the port of entry to ship their commodities. The costs associated with complying with the permitting regulations have driven up the costs of fumigating commodities in California to the point that many countries who export commodities requiring mandatory fumigation upon entry into this country choose to send their products to eastern ports. As examples, APHIS will address two major imported commodities which are known to carry actionable plant pests. The Agency also acknowledges that the specific risk mitigation options that are being considered would likely have a different economic effect on each facility that conducts fumigations. Further, the Agency agrees that, depending on the particular risk mitigation option selected and the site specific conditions of the facility, some options could produce substantial adverse economic effects. The Agency has also included a qualitative impact of mitigation measures that is 7 # ID Public Comment Agency Response Chilean fruit, particularly grapes, require mandatory fumigation upon entry into our ports due to known presence of quarantine mites. Quarantine pests are frequently intercepted on imported Italian tile; when that occurs, the tile may not enter the country without fumigation. Since fumigation costs are so high in California, Chilean fruit exporters as well as Italian tile exporters both ship a great majority of their products to eastern ports. The Italian embassy has complained to APHIS that the cost of fumigating Italian tiles in California is seven times higher than it is for fumigation at eastern ports. Regional fumigation costs are not controllable by APHIS regulation and cannot be addressed by APHIS. Fumigation costs are driven by the costs borne by the local fumigators which are passed on to the users. National ramifications include effects on the manner in which imported commodities are transported and distributed throughout the nation. APHIS has shown that, due to the higher costs associated with fumigation in California, products requiring mandatory fumigation are more often shipped to eastern ports, where it is cheaper to fumigate. From these eastern ports, these commodities are then moved westward by the trucking industry. Chilean grapes arriving at the port of Philadelphia are known to be transported to distribution centers located in Montana, Colorado, Idaho, and even Texas. From these western distribution centers, the grapes are trucked even further west to local retailers, sometimes as far as California, whose ports might have received the imported grapes directly had it not been for the costs associated with permitting regulations. Local effects are a result of the national ramifications just described, specifically, in the amount of business conducted in a region, as it appears that California ports, and with it the associated economic infrastructure, are loosing business to eastern ports. Another local ramification may include the effect the California regulations have had on local fumigation facilities. A fumigation facility consisting of five airtight chambers just off the pier in Oakland was unable to meet the city of Oakland's air permitting and zoning regulations; consequently, there has been a complete cessation of operations at this location. The fumigator subsequently was approved to operate at a nearby container fumigation station but was able to move only a single 240 cubic foot chamber to that location. The result: four airtight chambers remain unused while fumigation continues using the less tight direct container or tarpaulin fumigation methods. included in the docket.

30 NRDC EPA's own assessment reports that worker exposures exceed EPA tolerable levels in all scenarios associated with industrial fumigation activities for all exposure durations if no respiratory protection is used ( p. 61). Chronic exposures exceed EPA's level of concern for all durations regardless of whether or not respirators are used ( p. 61). Has EPA determined whether more air tight facilities would not increase unsafe worker exposure levels? The Agency concurs with NRDC's assessment of the risks which have been calculated. However, it is not likely that more " air tight" facilities would substantively increase unsafe worker exposure levels. Commodity applications are made using a regimented schedule that provides for a target methyl bromide concentration over a specific timeframe ( i. e., CxT schedule). As such, applicators would maintain methyl bromide levels over scheduled treatment durations at a specific target concentration. If facilities were more air tight it would mean less additional material would be added to maintain the target concentration but the target concentration would be the same, hence, worker exposure levels would also remain constant. 31 PFI As more fully explained below, members of PFI are concerned that the EPA's risk assessment is based on assumptions regarding use rates and applications that do not reflect actual methyl bromide use practices. These errors appear to have distorted the Agency's assessment. Given the importance of methyl bromide as a tool to eliminate pests from commercial pet food and other processed/ stored products, the accurate determination and portrayal of any risk is critical to the user community and the public in the perception about the safety of its continued use. The Agency cannot assess these comments in detail without specific examples. In general, it should be noted as described in Section <IP_ADDRESS> of the risk assessment ( see PERFUM model inputs) that 4 different application rates were considered along with 10 different loss rates from treated structures. Eleven different structure sizes were also considered in the ~ 300,000 model results that were generated ( see Table 6 of assessment). With these numbers of possible scenarios for consideration it is unlikely that a use situation similar to those of concern has not been addressed. 8 # ID Public Comment Agency Response 32 PFI We support the comments that the MBIP is submitting to EPA on the risk assessment at issue and urge EPA to refine its assessment before making any final decisions affecting the continued use of the product. Specifically, the Agency makes a number of assumptions on the rates of application, methods of use and other use practices for methyl bromide. These assumptions do not reflect typical use practices. In addition, a number of the Agency's proposed mitigation measures do not take into account the wide variation in the structures, facilities and sites application that are at issue here. These issues are more fully discussed below. See response # 31.

33 PFI Based on the EPA's assumptions about use practices, PFI is concerned that EPA has not adequately reviewed or incorporated the historical usage information previously provided by the user community. The Agency's assumptions, therefore, have resulted in a risk assessment that overestimates exposure and potential risks. Given the importance of methyl bromide as a critical commodity protection tool, and that no alternatives exist for pet food manufacturers in particular, EPA's risk determinations must be more accurate and mitigation measures, if any are adopted, must be appropriate to the level of risk. Thus, it is critical that EPA refine its risk assessment to reflect accurate data on use patterns, rates, and methods of application See response # 31.

34 NAMA On the subject of residues, it is worth noting that this association funded a methyl bromide residue study in 1993 to meet EPA requirements. Despite the earlier Comments of the North American Millers' Association comments about methyl bromide not being used to fumigate raw grain, in this study grain was fumigated with the compound in order to generate worst case scenario data. Also, the fumigant was applied at a highly exaggerated rate of 8.0 lb. per 1000 cubic feet. Still, there was no measurable methyl bromide in any of the processed fractions (< 0.25 parts per million) The Agency agrees that the residues for processed grain fractions would be very low.

35 NAMA We are concerned that EPA's risk assessment is based on assumptions regarding facility preparation, use rates, and application techniques that do not reflect actual use practices. Further, we believe those errors may have distorted the agency's assessment. Some of EPA's proposed mitigation measures would not be technically or economically feasible, or would not add measurably to the profile of safe usage for this fumigant. Since this comment does not specify what assumptions are errors, the Agency can not respond. Furthermore, the Agency has solicited comments of all stakeholders through the public process and has incorporated data on facility preparation, use rates, and application techniques in the revised risk assessment. 36 CDPR CDPR staff agrees with U. S. EPA's approach of using monitoring data, Industrial Source Complex Short Term 3 ( ISCST3) modeling, and Probabilistic Exposure and Risk model for Fumigants ( PERFUM) modeling to assess the bystander exposure from methyl bromide commodity fumigations. U. S. EPA appears to have used the appropriate data and model inputs to assess the exposure. However, input files for the PERFUM runs were not available for review. Therefore, this review will assume those inputs were appropriate. Given the described inputs, the PERFUM results generally appear reasonable. The range of model inputs covers the great majority, but not all of the commodity fumigation scenarios in California. The fumigation scenarios not included in U. S. EPA's assessment would not significantly impact the conclusions. The Agency concurs with the comment. If so desired PERFUM inputs and output files could be provided for review.

37 CDPR U. S. EPA should consider separate PERFUM simulations for day and night aeration for a few scenarios. Unlike emissions from field fumigations that occur for several hours or days, emissions during commodity aeration occur in a few minutes or hours. Due to the more stable atmospheric conditions at night, air concentrations and the resulting distribution of buffer zone distances during the day are very different from those at night. PERFUM outputs were calculated using different durations of exposure as appropriate for the various scenarios modeled as described in Section <IP_ADDRESS> ( see " Treatment Frequency & Emission Profiles"). The durations considered range from 1 to 24 hours depending upon the commodity treated. Most scenarios are based on either 1 or 4 hour exposures. PERFUM outputs were calculated for these short durations and presented over entire 24 hour intervals ( in the PERFUM output files which can be provided) so results could be reviewed for differing times of the day. When the results were summarized, the period which provided the longest calculated buffer distances were used in the Agency's risk summaries ( i. e., typically between 9PM and 3AM). If so desired, PERFUM outputs could be provided so that diurnal patterns could be further evaluated. Results can vary by as much as hundreds of meters at the upper percentiles of exposure with late 9 # ID Public Comment Agency Response afternoons tending to have the overall shortest predicted distances. 38 CDPR Page 21. Indirect Back Calculation   this section seems to give the impression that CDPR used the back calculation technique for forced air aeration ( stacks, building vents, etc.). This is not the case. CDPR used fumiscope readings taken during aeration to characterize the release of MeBr from commodity fumigations. Those measurements were used directly to model air concentrations at receptor locations that matched sampler locations in the monitoring studies. The Agency acknowledges this comment provided a correct description of how DPR used this information in a July 12, 2006 addendum document that is included in the docket.

39 CDPR Page 22. Figure 1. figure 1 does not seem to match the discussion. Page 22. "  unsettled conditions may reduce risk estimates but it is believed that even these conditions can result in conservative estimates because wind direction is constrained to a single vector over the period of concern." Although the text is unclear, unsettled conditions likely refer to stability classes A and B ( unstable) where significant vertical mixing can produce lower air concentrations due to dilution of pollutants in the air. For stack releases, in the absence of building effects, the highest maximum air concentrations are associated with unstable conditions because looping of the released plume can cause localized touchdown of the concentrated plume. Stable conditions produce maximum air concentrations the farthest from the stack but the magnitude of that maximum air concentration will be lower than for unstable conditions. The purpose of Figure 1 is to illustrate the basic premise of the Gaussian approach in ISCST3. The citation for Figure 1 would probably have been better on the previous page where there is a more general discussion of ISCST3 presented. The Agency also concurs with the characterization language provided. The intent of the original text was to indicate that a constrained wind direction could contribute significantly to the conservativeness that could be associated with ISCST3 results as it had been used in the Agency's earlier assessment. 40 CDPR Page 26. Scenario 3   Aeration with Stack. It appears that only stacks that are influenced by building effects were modeled in this scenario. This is equivalent to CDPR minimum stack analysis. The building effects parameters should be specified so the reader understands the dimensions of the generalized building used in these simulations. In addition to the minimum stack case, CDPR also has standard stack specification requirements ( height, exit velocity, mass of MeBr released, height differential with surrounding buildings) that result in no air concentrations at ground level exceeding the desired air concentration threshold. This means that the buffer zone would be 0 meters for all stacks meeting the standard stack requirements. In Section <IP_ADDRESS> of the risk assessment ( under PERFUM model inputs) the different treated structures that were considered in this assessment are described. Further information could be provided upon request along with the PERFUM input/ output files which would provide all necessary details pertaining to these factors. The Agency also concurs that only a minimum stack approach has been used. There are any number of model permutations that are possible in the standard stack height approach, as such, only a minimum stack approach was considered in the assessment. Possible use of the standard stack height approach for additional PERFUM analyses during the risk management phase of the Agency process may be considered if necessary and appropriate input factors can be determined. 41 CDPR Page 27. Scenario 5   Aeration with Mobile Ground Level Source not near Building. It is not clear how this release is made. If the tubing is pointing horizontally rather than vertically then the vertical exit velocity is zero. If the release is horizontal then that should be clearly stated. There is discussion on the SCRAM website on how to best model horizontal releases. See Model Clearinghouse Memo 93 II 09. The Agency evaluated possible implications of the suggested modeling approach. The July 12, 2006 addendum further addresses this issue.

42 CDPR Page 28. Stack Diameters. Was the assumption that the ` very large diameter stacks" produce reasonably realistic results tested? The interaction of the stack diameter with build effects should be at least discussed. This interaction could significantly affect the estimates. For stack releases the building effect algorithm adjusts the release height according to the ratio between the exit velocity of the plume and the wind speed. The exit velocity is a function of the exchange rate ( cubic ft/ min) and the diameter of the stack. So, the exit velocity resulting from the unrealistically large diameter combined with the required air exchange ( e. g., 1.0, 0.5. 0.05 air exchanges/ min) may not be appropriate. The Agency acknowledges this comment provided further characterization language in the July 12, 2006 addendum on this issue. It should also be noted that PERFUM constrains the Agency to completing the analysis using a single stack with varying diameter, where the value is proportional to the volume of the structure being aerated, exit velocities, and the air exchange rates. This is because PERFUM only provides outputs for a single stack and not multiple sources. 43 MBIP The MBIP's most significant comment relates to the no stack scenarios. In these scenarios, EPA used 3 feet as the release height for all of the building area sources, despite the fact that the larger buildings were considerably higher. Therefore, the release height does not match the building dimensions ( although CDPR found that lower heights worked better). When the stack is set at higher heights, there is greater dispersion in the plume before it reaches the ground, resulting in lower concentrations. According to CDPR ( CDPR 1994), using a release height of 3 feet overestimated The Agency acknowledges that there are many possible permutations and situations that could serve as a modeling context for methyl bromide including the one described in this comment. The Agency also acknowledges that there would be extreme difficulties in attempting to seal a facility during treatment and not have 10 # ID Public Comment Agency Response the concentrations when attempting to model a building fumigation. Therefore, a release height equal to half of the building height may be more appropriate, to account for the fact that not all of the fumigant will be released from the top of the building. The results below illustrate the impact of adjusting the release height to the full building height and half of the building height for a 100,000 ft3 building. This example assumes 100% of 4lbs/ 1000ft3 application rate released in one hour and a four hour exposure period. If a more reasonable release height is assumed, the buffer zones are reduced to zero. releases around windows and vents, etc. from larger buildings. However, it appears that the goal in the industry is to seal structures as tightly as possible during treatment which is represented in the scenario developed by the Agency. Such facilities also always have ground level entryways which are the basis for the 3 feet release height ( i. e., basically the middle of a standard doorframe). Based on the Agency's inquiries into the types of facilities used in commodity treatments there are many structures that would not appear to emit methyl bromide at heights greater than the size of a door such as solid concrete grain elevators or windowless large warehouses. It should also be noted that in the no stack aeration scenarios only passive aeration was modeled and in many real world cases active aeration would be used after treatments are complete for larger facilities where the height of the structure could significantly impact results. In these situations, the active aeration predicted buffer distances would be longer than what would be anticipated for the no stack aeration estimates because the total mass percentage loss would be greater during aeration ( where the intent is to emit methyl bromide) opposed to during treatment. 44 MBIP Another issue that should be investigated is the higher buffer zones obtained for the PPQ scenarios during the daytime hours. Typically, conditions are more conducive to dispersion during the daytime. Therefore, these results are counterintuitive and may reflect an error in EPA's assessment. See response # 37.

45 MBIP Whole Field v. Maximum Concentration Approach  Pages 29 30. The MBIP believes that exposure should be assessed on the basis of a population, not a single individual. Although specification of the exposed population is not entirely straightforward, the PERFUM model defines the population in the most constrained way possible. The population only includes the locations around the buffer zone perimeter. As one moves away from the perimeter, the concentrations fall and defining the population as alternatively being some distance from the site beyond the buffer zone would have resulted in smaller values. Going the other way, it is clearly inappropriate to include those locations inside the buffer zone, as these locations will be protected from exposures while the buffer zone is in place. For all of these reasons, the PERFUM model ( using the whole field rather than the maximum buffer approach) defines the population in the most conservative manner possible and is the approach that should be used. ( see MBIP's comments on page 8 for rest of text on this issue) The Agency appreciates the information provided by this commenter and has considered this information, along with other pertinent data, in its decision regarding the use of PERFUM modeling results.

46 MBIP   PERFUM Modeling Method  Page 32 Because of the conservative assumptions in other areas of the risk assessment, the 95th percentile is sufficiently protective. While we agree that the PERFUM Model is the best approach among the three modeling methods presented in the Post Harvest RA, PERFUM outputs should only be used to determine the relative effectiveness of various mitigation measures, and not to set prescriptive buffer zones. ( see MBIP's comments on page 9 for rest of text on this issue) see response # 45.

47 MBIP To provide more information about concentrations following fumigant applications, the MBIP has gathered downwind measurements of methyl bromide concentrations following recent commodity fumigations. Clearly, the comparison of the monitoring data and modeling results for the flour mill site warrant further evaluation and support the MBIP's view that the PERFUM Model should not be used to generate onerous buffer zones for all types of commodity fumigation The Agency is evaluating the possible implications of the monitoring data and modeling approach described in the comment. The July 12, 2006 addendum further addresses this issue.

48 APHIS The monitoring data supplied by the California Department of Food and Agriculture for evaluation by EPA are nearly 20 years old. Over the past 20 years there have been improvements in fumigation procedures and technology, including thicker and more durable tarpaulins, APHIS PPQ requirements for changing tarpaulins after a number of fumigations, more effective methods of sealing the The Agency acknowledges this comment with regard to the available monitoring data. In essence, the Agency used all of the monitoring data which were available along with modeling approaches to 11 # ID Public Comment Agency Response tarpaulins to the ground to prevent leakage, stricter requirements regarding the type of ground surface used for fumigation, and, monitoring to ensure that ambient air concentrations do not exceed 5 ppm beyond the 30 foot buffer during treatment or the 200 foot buffer during aeration. The California monitoring data are not accompanied by fumigation conditions and are therefore difficult to interpret. Specifically, was the commodity being treated under a tarp? What kind? How thick? Did it have holes or cracks? How was it sealed to the floor? What kind of flooring was under the tarp? ( Wood floors leak and are not permitted under APHIS supervision.) Was it a cement floor with cracks and gaps? Was a halide detector used after gas introduction to ensure that the tarp was holding the gas ( standard APHIS PPQ protocol)? In some cases, the ambient air concentrations from the California monitoring data are so high that, were it to occur under APHIS supervision, the operation would have to be ceased until the leaks were remedied. APHIS appreciates the difficulty of attempting to model ambient air concentrations; however, if EPA is going to change the buffers and consequently the manner in which all fumigators at our nation's ports of entry conduct their business, then the model should be supported by new monitoring data that reflect current fumigation technology and that indicate that ambient air concentrations exceed a safe level. produce an overall risk picture for methyl bromide commodity uses. The questions raised by APHIS regarding the specifics of the monitoring studies are pertinent and may or may not have resolution. With regard to modeling, the Agency has used a variety of treatment conditions ( e. g., retention & emission rates) as described in Section <IP_ADDRESS> of the risk assessment. The emission factors range from 1 to 100 percent of the material being emitted from a treated structure which, by definition, encompasses all manner of commodity treatments from those done with the latest technology ( e. g., thick tarps, good sealing methods, etc.) to those that are less than desirable.

The Agency has also described in its risk mitigation options a possible approach that would allow site specific monitoring to be used in conjunction with other factors to possibly seek relief from a buffer zone approach. This option it should be noted is still tentative. 49 Royal Application Site specific Fumigation Management Plans. In Royal's experience, a requirement of fumigation management plans for any type of fumigation is logical and feasible. Royal and its colleagues ( Royal is a founding member of the Food Protection Alliance, an association of fumigators that serves the U. S., Canada and Mexico1) already use fumigation management plans, and the manufacturers of fumigants offer model plans in their stewardship training and on their web sites. The associated cost of this proposal, therefore, would be the cost of the training necessary to the development, execution and documentation of the plans. The Agency appreciates the information provided by this commenter and has considered this information, along with other pertinent data, in its decision regarding the use of FMPs.

50 USA Rice EPA has suggested the use of Fumigation Management Plans ( FMPs) for methyl bromide fumigations. These plans were introduced with the re registration of phosphine. Good planning and monitoring are critical to any fumigation job. Although formal written plans may not have been a requirement on past product labeling, good planning and monitoring have always been part of a properly conducted fumigation. With proper planning and monitoring in place, human exposure concerns can be addressed before the treatment begins. FMP requirements now in place for phosphine were designed to ensure that facility management and the certified applicator were working together to ensure a safe, legal, and effective fumigation. USA Rice supports FMPs for use on MeBr. See response # 49 51 Western A Fumigation Management Plan is essential to a properly conducted fumigation operation. We endorse the Fumigation Management Plan outline that has been developed for phosphine based fumigants as well as Pro Fume fumigants. See response # 49 52 NRDC Application site specific fumigation management plans. EPA proposes to require comprehensive site specific plans to be submitted prior to application of MBr, to encourage fumigators to anticipate and evaluate factors that may lead to off site or unintended exposure to MBr. We are unconvinced that such a requirement will significantly reduce unsafe exposures. In addition, such a plan is unlikely to have a significant effect on mitigating environmental releases that are damaging to the ozone. Has EPA estimated the impact of this proposal on MBr use and release? Does EPA have data supporting its estimated impact? If so, what is the source of this data, and what are the costs associated with this proposal compared with the estimated impact on MBr total usage? Has EPA evaluated the impact of this restriction on the attractiveness of alternative pest control methods? See response # 49 53 FS& S Application Site specific Fumigation Plans: In review of methyl bromide [ 100%] product labels you will notice 10  19 pages of instruction, direction, product management and dosage tables. Please also notice that only 3 to 6 pages of this document actually address how to prepare and safely use this biocide. These few instructional pages cover diverse and wide ranging applications. It is important to realize that this product has no odor, is colorless and comes in a gaseous form. I believe the current labels for methyl bromide do not adequately protect operators and bystanders to the level of product management needed for continued safe use of For decades we have been provided with methyl bromide application labels / manuals with very gray areas of usage requirements. This has yielded unsafe and questionable usage habits by many fumigators. As an example   phosphine experienced similar but less dramatic labeling gray areas. See response # 49 12 # ID Public Comment Agency Response Phosphine is being managed much better with the implementation of a Fumigation Management Plan [ FMP]. This document has removed these gray areas by making each application site specific and situational recognition is forced. The methyl bromide alternative sulfuryl fluoride also mandates a FMP very similar to phosphine. I believe increased operator and bystander safety is the result. Additionally, current methyl bromide labels make space fumigation dosage rates unclear. These clarifications have been removed over the last several years. Clarification of dosage is needed along with recognition and control over additional gas needed after initial release. Many methyl bromide space fumigations require additional gas to be reintroduced after the initial application to achieve efficacy. This " add gas" can be abused by compromising difficult sealing and " just use more gas." This is another level of management needed and will more directly improve bystander safety. Education and enforcement of these new standards are needed in order to protect operators and bystanders. States need to be informed and trained regarding these changes. Educational materials must be updated in a timely manner so continuing education programs can bring licensed users up to date with new standards quickly. Changes have taken too long to transfer to the applicators in the past. The cost to implement these increased management standards would be minimal but this should have been mandated from the beginning. As a fumigator still using methyl bromide for quarantine and preshipment uses only  I can tell you that filling out an FMP for this product takes only a few minutes per application. such a dangerous compound. 54 NAMA Fumigation management plans The milling industry has an excellent record of safe pesticide usage. Still, we are committed to making incremental improvements wherever practical, and were closely involved in developing the concept for the fumigation management plan for aluminum and magnesium phosphide. Fumigation management plans have also been incorporated into the usage rules for sulfuryl fluoride, the most recently approved space fumigant. We believe consolidating all best practices into one easily usable document adds to safe usage, and support the development of a fumigation management plan for methyl bromide. See response # 49 55 MBIP In the Risk Mitigation Memo, EPA states that it sees comprehensive site specific fumigation management plans as a potentially valuable risk reduction option. The MBIP agrees. The requirement for a written fumigation plan, known as an FMP, is a requirement for other fumigants   particularly phosphine and aluminum and magnesium phosphide. The FMP requirement for phosphine was implemented in late 2003 as part of the reregistration process. Formal written plans are not required to be submitted to regulatory authorities. However, the FMP requirements require the fumigator and facility management to engage in good planning and monitoring to ensure safe and effective fumigation. Although formal written plans are not imposed as a requirement on methyl bromide product labeling, fumigators already use planning and monitoring to mitigate risk. FMP requirements now in place for phosphine were designed to ensure that facility management and the certified applicator were working together to ensure a safe, legal, and effective fumigation. The FMPs have resulted in documented safe and efficacious treatments. The MBIP generally supports the development of FMPs for methyl bromide. See response # 49 56 APHIS For the health and safety of all employees at the port, and to ensure that Federal phytosanitary regulations are appropriately met, APHIS PPQ already has a process in place to certify all fumigation sites where commodities are treated under APHIS regulation. APHIS PPQ considers this process to be safe and adequate. The fumigation site certification process, which can also be described as a site specific plan, may be found in Chapters 2 4 of the APHIS PPQ Treatment Manual at http:// www. aphis. usda. gov/ ppq/ manuals/ port/ Treatment_ Chapters. htm. To summarize, fumigation site certification is obtained by a thorough evaluation of the facility by a PPQ officer; this includes evaluating its location in relation to other port workers and nearby population centers. Two forms must be completed: A Compliance Agreement ( PPQ Form 519; Attachment 1), which is signed by the owner of the fumigation company, and, in the case of non tarped fumigations ( i. e. chambers), a detailed evaluation of the site specific facility, ( PPQ Form 480; Attachment 2) which is kept on file by APHIS PPQ. Tarped enclosures are evaluated each time a fumigation occurs using the back page of PPQ Form 429 ( see Treatment Manual, page A 1 12 at http:// www. aphis. usda. gov/ ppq/ manuals/ port/ pdf_ files/ Treatment_ Chapters/ A AAppendixA pdf). The Compliance Agreement contains specific and detailed Operational Procedures by which the fumigator is obligated to abide ( page 2 of 3 in Attachment 1). Failure to abide by the operational procedures specified in the Compliance Agreement could cause the fumigator to loose the right to fumigate APHISSee response # 49 13 # ID Public Comment Agency Response regulated commodities unless the failure is corrected; a fumigator whose major source of income is through import commodity fumigation has an incentive to comply. Non compliant fumigators may also be subjected to costly sanctions under the Plant Protection Act, APHIS PPQ's enabling legislation. For the health and safety of those in the immediate area, Part J ( page 2 of 3) of the Compliance Agreement, states, " The PPQ officer's decision is final and under no circumstances will it be revoked by others." APHIS is not in support of EPA regulations which may be inconsistent with this authority of APHIS PPQ. PPQ Form 480 is filled out for every non tarped enclosure ( i. e. chamber) used by the fumigation company, and is modified every time any feature of the site is changed. Since many fumigation companies work in different locations, there may be several facilities evaluated under a single compliance agreement using PPQ Form 480. For tarped enclosures, all APHIS PPQ employees supervising fumigation use a checklist located on the back page of PPQ Form 429. The checklist is reviewed for each fumigation. APHIS believes that the PPQ process for certifying fumigation facilities are more rigorous than the comprehensive site plans developed by California. It addresses all the safety features required by APHIS for safe and effective fumigation, including the ability to satisfy the APHIS imposed buffer requirements, which were developed by evaluating APHIS PPQ monitoring data on ambient air concentrations during actual fumigations. Since APHIS PPQ procedures are essentially site plans for facilities being used to fulfill Federal phytosanitary requirements, APHIS questions the value added if EPA were to impose the additional requirements of an EPA site plan on these particular facilities. 57 Royal Buffer Zones. Royal observes buffer zones in all of its operations; therefore, the degree to which buffer zones would affect its fumigations would be determined by the degree of change in any zone. In general, Royal believes that large fumigations would be affected far more than small ones by increases in buffer zones because of the difficulty of moving or expanding the area of large fumigations. Obviously, moving the fumigation is not an option in the case of structure fumigation, and in that case the customer, not Royal, would have the information on probable costs of obtaining additional land or other measures to establish a larger buffer zone. USDA APHIS approves all quarantine fumigation sites for tarpaulin fumigation, and it determines the buffer zone for each site. Royal has measured methyl bromide levels within the buffer zones approved by APHIS and has found the zones adequate to protect bystanders; in fact, Royal uses similar criteria to set its own buffer zones for non quarantine fumigations. The Risk Mitigation Proposal mentions the establishment of minimum buffer zones for all applications. Given the many factors that impact a determination of a buffer zone, Royal questions whether it is possible to establish minimum buffer zones that actually lower risk. Royal would urge that, in lieu of minimum buffer zones, efforts be made to create tools for individual analysis of each fumigation site. We note that USDA APHIS has inspectors with many years' experience in such analyses, and the fumigation industry also has experience in creating analytical tools, such as Dow Agro Science's Fumiguide for use of its sulfuryl fluoride product, ProFume. As noted by the revised risk assessment, factors pertinent to buffer zones include some that are within the control of the fumigator, such as loss/ emission rates and enclosure types. Royal believes that if fumigators are given the opportunity to prove that their equipment or methods lower risk, and if as a consequence they are able to obtain a marketable benefit such as having smaller buffer zones apply to their work, this will provide a significant incentive for improvement in the industry. This also mitigates against establishing minimum buffer zones in a " one size fits all" fashion. It should be noted that fumigators generally are not in a position to address the costs of moving fumigation sites or cargo, or storing cargo. Commodity fumigators go to the customer's location and generally do not have access to the type of financial information solicited by EPA such as land and construction costs. Royal can offer generally, however, that storage costs for dry commodities can run from $ 15 30 per container per day, and storage costs for refrigerated commodities are significant ( especially when energy costs are high), if such storage is even available. It is Royal's observation that cold storage facilities near the ports where Royal fumigates now operate at capacity and likely could not accommodate additional storage time for cargo that is delayed in fumigation. In addition, a delay in the fumigation of perishable commodities such as grapes reduces the value of the cargo. We have been told that each day's delay in fumigation lowers the value of a case of Chilean grapes by one dollar ( cases can be priced in the range of $ 7 to $ 28 depending upon market and fruit conditions). This is offered as anecdotal APHIS currently enforces the 5 ppm limit for all sites except California which is higher than MeBr levels required by CDPR and those that the Agency is now considering ( see response # 2).

Since the buffer zone concept is based on distance where concentrations are not a risk concern, it seems reasonable to assume it would lower risk for bystanders.

See response # 5.

The Agency also acknowledges that the specific risk mitigation options that are being considered would likely have a different economic effect on each facility that conducts fumigations. Further, the Agency agrees that, depending on the particular risk mitigation option selected and the site specific conditions of the facility, some options could produce substantial adverse economic effects. 14 # ID Public Comment Agency Response information only, as we are not aware of economic analysis to support it. Royal is not aware of any port that has space to increase its buffer zones, or that is in a position to acquire additional land for its use. East Coast quarantine fumigations take place at night, when other port personnel are not present, and existing buffer zones can be maintained without undue interruption of other port business. If buffer zones are materially increased, however, or if fumigations take place during the port's regular business hours, the flow of commerce will be interrupted and the risk of bystander exposure will increase. It may be that other risk mitigation measures, such as portable stacks or ventilation equipment that directs the aeration flow to specific areas, are more feasible in these circumstances. If fumigation with methyl bromide is not feasible at all, there are no alternative treatments approved for quarantine use on perishables such as the Southern Hemisphere fruit. 58 USA Rice The agency is considering the use of buffer zones. While some facilities may be able to handle excessively large buffer zones, other facilities suffer from encroaching industrial parks or suburbia. Current fumigation procedures require air monitoring around the site and this works well. Large buffer zones will be impracticable, and in some instances the zones may well replace air monitoring in workers' minds as the primary means to ensure safety. Air monitoring should remain in the fumigation plan. Compliance with buffer zones may also lead to reduced application rates, insufficient fumigation, and increased costs. The Agency agrees. To the extent possible, adding flexibility to the mitigation controls required is being considered by the Agency.

59 Western Buffer Zones, where needed, must be developed on a site by site basis. Not all fumigations are conducted under similar circumstances and a one size fits all buffer zone would unnecessarily eliminate certain fumigation sites, which have been selected out of operational necessity. A viable alternative to buffer zones is the active monitoring of gas concentration in a fumigation zone, which is our recommendation. The Agency believes that many sites will be able to comply with buffer zones with some modifications. However, to aid those sites that can not, the Agency has provided an option for site specific modeling and/ or collection of comprehensive air monitoring data. 60 ASOEX Buffer Zones: ASOEX strongly believes that the establishment of " buffer zones" is unnecessary for quarantine fumigations because APHIS already determines that the perimeter of 200 250 mm around methyl bromide fumigations is a buffer zone beyond which is considered to be safe. ASOEX is not aware of any U. S. port that has adequate and sufficient space available to increase buffer zones. If EPA imposes any increase in the existing buffer zones established and mandated by APHIS, such buffers could have adverse and serious effects not only on Chilean produce exports but also on the U. S. economy as APHIS argued precisely in its October 17, 2005 letter submitted to this EPA docket. ASOEX would like to call your attention to the following adverse effects listed by APHIS: ° Many ports would experience severe losses in commerce. A port like Philadelphia, which specializes in the importation of fresh fruit could lose most of their business; ° Fumigation businesses at those ports of entry would be closed, and port fumigators would lose their means of income; ° Commodity brokers and/ or importers which have built businesses based on bringing their imports into those ports would lose income from importing that commodity; ° Small importers may lose entire businesses; ° Local businesses which depend on certain imports would be affected, possibly to their detriment. HED's risk assessment indicated that the there is a risk concern for some scenarios at current perimeter that APHIS establishes.

See response # 5.

The Agency also acknowledges that the specific risk mitigation options that are being considered would likely have a different economic effect on each facility that conducts fumigations. Further, the Agency agrees that, depending on the particular risk mitigation option selected and the site specific conditions of the facility, some options could produce substantial adverse economic effects.

61 NRDC Buffer Zones. EPA proposes to establish buffer zones around an enclosure or structure during treatment and aeration to manage risks from inhalation exposure to workers and bystanders. We are unconvinced that this is a practical or effective proposal. EPA's own analysis of actual monitoring data establishes acute risks of concern to bystanders or nearby residents. Moreover, analyses conducted with the PERFUM model shows that concentrations are not reduced sufficiently even at the model's maximum limit of 1440 meters ( Fig 11, p. 41, p. 3). Further, it appears that the buffer zone modeling was conducted for a fumigation facility far smaller than numerous commercially operating facilities. As a result of the much larger internal volume of such facilities, the total amount of MBr required to achieve the intended fumigation purpose would have to be much larger than the amount EPA modeled for the smaller facility. This larger volume of MBr use would lead to the need for an even larger buffer zone. NRDC requests that EPA re model the bystander concentrations out to the PERFUM model's distance limit for the largest real world fumigation facilities that currently use MBr, and that EPA conduct whatever supplementary modeling is necessary to determine how large the buffer zones would have to be to guarantee that bystanders will not be exposed to unsafe exposure levels from facilities of real world size. Achieving these buffer zones   some as yet undetermined distance greater than 1440 meters  is extremely impractical. The result is that significant bystander In Section <IP_ADDRESS> of the risk assessment ( under PERFUM model inputs) the different treated structures that were considered in this assessment are described. These include volumes from 1000 to 1 million cubic feet which encompass the vast majority of methyl bromide treatments for commodity and industrial purposes conducted in the United States. The largest facilities that the Agency is aware of being treated are approximately 10 million cubic feet. NRDC indicates that larger structures lead to bigger amounts of methyl bromide being used for treatments which can lead to longer buffer distances. This is often the case, however, this does not necessarily always lead to longer predicted buffer zones because larger volume structures can sometimes have lower 15 # ID Public Comment Agency Response populations will remain at risk if these MBr uses are reregisted. The EPA reports on a system that is followed in California by the CDPR where buffer zones individually calculated according to site specific factors that are included in permit applications. While we are generally supportive of plans that allow flexibility and site specific considerations, in the case of MBr the result as been predictable; continued bystander poisoning events even with uses that comply with the label. buffer distances associated with them than smaller volume buildings because buffer distances are calculated based on distance from a source at ground level where the characteristics of a shorter building can lead to higher ground level air concentrations. Development of buffer distances longer than 1440 meters at this time is not possible with PERFUM and would require a modification to the code of the model. This model has been reviewed by the FIFRA SAP and it has been used in the Agency's assessments for fumigants; it is not an Agency model so modification to the code would depend on its developers. Site specific model analysis is an option that for defining appropriate buffer distances at larger facilities. It, along with other options, are currently under review and may or may not ultimately be selected as an option for managing the potential risks associated with methyl bromide use ( HED/ SRRD) 62 FS& S Risk Management Option 2  Buffer Zones: I believe an effective FMP will recognize spatial need. Fence line monitoring [ down wind] should be mandatory during application, maintenance and release / aeration of each fumigation. The Agency appreciates the information provided by this commenter and has considered this information, along with other pertinent data, in its decision regarding the use of buffer zones. 63 PFI On the question of buffer zones, PFI is concerned that if EPA applies a more restrictive requirement, facilities which currently depend on methyl bromide will be unable to use it. In addition, since pet food processing facilities are, in most cases, quite large, any restrictions on the amount of methyl bromide that may be used in a certain area will also be very problematic and could result in an increase in methyl bromide fumigations before new restrictions are in place. Although the Agency believes the mitigation approach outlined in the RED offers substantial flexibility for sitespecific solutions that are protective of workers and bystanders, it also recognizes that there will likely be some commodity fumigation sites where MeBr will no longer be practical to use. 64 NAMA Buffer zones We do not believe buffer zones add measurably to the safe usage of methyl bromide, and oppose the establishment of large buffer zones. During and after a fumigation air monitoring is conducted and security personnel are posted around the property to keep bystanders away. History shows this has been a very effective management practice. Grain milling is one of the US' oldest industries, and as a result there are many old, but still highly productive, mills in operation. Because of their age, increased urbanization and land development has resulted in encroachment toward the mills. Large buffer zones would unnecessarily preclude the use of MB in many of these locations. Relocating mills simply to accommodate large buffer zones is not economically practical. The milling industry is fully mature and profit margins are extremely small or nonexistent. The few new mills built in the last 10 years cost in excess of $ 30 million. Such capital expenditures will only be made where market conditions exist, not to simply allow the continued usage of a pesticide, no matter how useful it may be. During fumigant application and aeration, air monitoring around the facility perimeter and at fence lines, similar to the existing requirements for phosphine, remains the best practice for ensuring safety for the neighboring community. See response # 8.

65 MBIP The MBIP views actual air monitoring as a better risk mitigation tool for commodity fumigation than buffer zones. Excessively large buffer zones may mean that neighboring facilities would have to be notified and evacuated in order for the treatment to occur. These safety precautions would not add measurably to the safe usage of methyl bromide, but would cause unnecessary hardships and burdens on facilities and fumigators. The true focus should be on actual air monitoring around a treated site. In order to meet buffer zone requirements, facilities may be forced to reduce the volume treated or lower application rates. Reduced dosage decreases the ability of fumigant to penetrate into harborage areas and decreases effectiveness of the total treatment. Inability to treat all areas of a food handling establishment at the same time results in increased downtime for the facility when they have to treat areas that were cut The buffer zones estimated by the Agency are not arbitrary. See response # 61 regarding the range of scenarios that the Agency's modeling includes.

Air monitoring results alone may not be an adequate risk mitigation tool. The magnitude of samples needed to adequately measure plume/ maximum down wind concentration likely to be prohibitive. Even a modest number of non detects at fence line during aeration would not negate predicted buffers with 16 # ID Public Comment Agency Response out of the original fumigation. It also leads to unacceptably increased costs. As discussed above, administration of buffer zones would be a significant burden. Moreover, the variability among fumigation sites would lead to almost infinite possibilities for emission models upon which buffer zones are based. There are large variations from facility to facility in height, aeration rate, application rate, leakage during fumigation, and many other factors. It is unlikely that a manageable number of standard conditions could be established through labeling. However, the advent in recent years of sensitive, affordable, electronic analyzers for methyl bromide has increased the ability of fumigators to conduct real time monitoring around facilities under fumigation. Label language requiring monitoring during fumigation and aeration to demonstrate that methyl bromide concentrations do not exceed levels deemed to be acceptable would provide both a higher level of protection and greater flexibility than arbitrary buffer zones. modeling. Air monitoring would need to be accompanied with weather data, emission measurements, and revised model to be an effective mitigation tool.

66 APHIS APHIS is in agreement that buffers are necessary during methyl bromide treatment and aeration, and believes that the APHIS PPQ fumigation requirements that were established over 20 years ago using monitoring data, and which include different buffer zones for treatment ( 30 feet) and aeration ( 200 feet during the first 10 minutes), are safe and adequate ( see Chapters 2 3, 2 4, 2 5, 2 6, 2 7, and 2 8 of the APHIS PPQ Treatment Manual at http:// www. aphis. usda. gov/ ppq/ manuals/ port/ Treatment_ Chapters. htm). Only persons wearing a Self Contained Breathing Apparatus ( SCBA) may go within buffer zones during those times if the gas concentration is unknown. The policy further affirms, in accordance with the label, that no person may enter an area without SCBA gear if air concentrations exceed 5 ppm. This APHIS PPQ policy is enforced for any person near the fumigation site, including the private fumigators performing the fumigation and the APHIS employees supervising the fumigations. see response # 62.

67 APHIS APHIS is in full agreement that buffers are necessary for the safety of all port workers; buffers, based on air concentration monitoring data, are already required for all APHIS supervised fumigations. As already mentioned, PPQ requires a 30 foot buffer during treatment, and a 200 foot buffer during the first 10 minutes of aeration, when the majority of fumigant is expelled. These values were put in place after PPQ used monitoring data to determine that the ambient air concentrations never exceed 5 ppm, and in fact are often below the level of detection of air monitoring devices ( 1 ppm) at these distances. Increased buffer zones may make it impossible to fumigate in some ports which do not own property beyond the standard 200 foot buffer. Discontinued import/ export treatments would impact the local economies. APHIS believes that any changes in these buffer distances should be supported by valid monitoring data which indicate that the air concentrations exceed a safe level. APHIS notes that California regulations require buffers which permit passers by to move through a 1,000 foot buffer without SCBA gear. APHIS PPQ requires that the fumigators wear SCBA gear within the 30 foot buffer during treatment and the 200 foot buffer during aeration; furthermore, APHIS monitoring data have shown that the air concentration levels do not exceed 5 ppm ( and are often below the limit of detection of 1 ppm) outside of the APHIS PPQ buffer zones. see response # 62.

68 Royal Stacks and Fans. In Royal's quarantine fumigation operations, generally two types of stacks are used: permanent installations in buildings ( often referred to as " vent towers" or chimneys) and portable ductwork. Older warehouses may not have vent towers, but where they do exist, the towers tend to be the height of the building roof, which can be as low as 18 feet, or 30 feet or more. The Treatment Manual mandates Public Information and Records Integrity Branch rates of air flow turnover for aeration, as a result of which Royal has seen fan ratings of 40,000 cubic feet per minute in certain vent towers, but this is offered solely as an example and may not apply in other buildings or situations. Again, the owners of the facilities where fumigation takes place are better able to address specific requirements and associated costs. Royal is aware, however, of one estimate for retrofitting a 100,000 square foot dry warehouse to add vent towers at approximately $ 30,000 per tower. We do not know whether this cost includes the additional venting necessary to introduce outside air into a building when vent towers operate. In assessing the costs associated with the use of towers, it should be noted that once installed, the towers may limit the use of a building by limiting stowage patterns of the product to be fumigated. Where no stack or vent tower is available, Royal uses flexible ductwork and multiple exhaust fans ( generally rated at a minimum of 10,000 cfm each) to direct ground level aeration to areas that do not pose a risk of human exposure. In these cases, the ductwork may transport the methyl bromide several hundred feet before it is dissipated into the general atmosphere, and obviously the longer the ductwork, the more powerful the fans must be. This method can be used to channel aeration See response # 5. 17 # ID Public Comment Agency Response where natural conditions, such as prevailing winds, would otherwise create additional risk during aeration. Once again, the Treatment Manual may provide guidelines on ventilation requirements and calculations. Royal believes that EPA's estimate of $ 850 per 10,000 cfm fan is probably half of the real cost. We note that exhaust fans for aeration are engineered for that purpose and consequently are costly. It is possible to purchase a 10,000 cfm fan for $ 600 to $ 850, but it will not be adequate for aeration of fumigation chambers. On the subject of fumigation equipment in general Royal does not believe that it is possible or advisable to establish specific equipment standards, even for one particular type of fumigation such as tarpaulin fumigation. This is because equipment changes over time, each fumigation is unique and fumigators must tailor their equipment to the needs of the location. As just one example, Royal uses fans for introduction of methyl bromide gas, circulation of the gas, exhausting the gas and keeping a pattern of air flow in a warehouse where tarpaulin fumigation is taking place. Each use may dictate not just different cfm ratings but different fan engineering and design, and each fumigation will have it own configuration of fans for each purpose. Through years of experience, testing and assessment of equipment, fumigators develop the most effective and safest fumigation plans. Some fumigation equipment is highly specialized, and even " off the shelf" equipment may be employed in a specialized way. Royal believes that in any establishment of standards, care should be taken to preserve the fumigators' ability to use their experience and judgment through providing incentives to effective and safe fumigators who work to improve their industry and safeguard the public. 69 USA Rice Exhaust stacks are required to allow mills to aerate at night; otherwise all aeration must be during the day. This would require many mills to build roof mounted exhaust stacks, close sidewall exhaust vents and to reorient existing exhaust fans to push air upwards. Those mills with existing stacks may not have stacks that meet minimum height requirements for aeration which are 10 feet over the mill's highest point or obstruction within 200 ft. Another problem is that with the piecemeal construction of older mills, many have sectional roofs of differing heights requiring that individual stacks of varying lengths, some possibly significant, be constructed. The stack requirement also ignores a valid, proven and safe alternative of using existing, high, sidewall exhausts and/ or opening windows high up in the mills to allow aeration. Why build stacks when an existing tried and proven method exists? As to limiting aeration for any reason, rice mills assume huge losses when the mills are closed. Forcing them to stay closed another day so that aeration can occur in daylight is prohibitively costly and unnecessary. Consistent air monitoring will ensure the safety of those involved or nearby even with using sidewall exhausts on the upper levels of the mills. See response # 68.

70 NRDC Stacks. EPA believes that equipping enclosures or structures with vertical stacks will reduce the necessary size of buffer zones, and suggests that this method may be preferable in areas where a larger buffer zone is not feasible. NRDC does not consider the use of stacks to disperse MBr emissions to be a valid mitigation approach. Even if tall stacks would reduce risk to bystanders, it would not reduce the amount of MBr used, and therefore would not mitigate impacts to the ozone layer. Further, Congress long ago banned the use of tall stacks to disperse pollution in place of controlling it. See Sec. 122 of the Clean Air Act, 42 U. S. C. § 7423. Although this provision is specific to electric power plants, the policy of the law is clear that pollution dispersion is not an acceptable approach. The Agency agrees that where feasible safer alternatives are a preferred approached to using engineering controls such as stacks. However, the use of engineering controls is an effective mitigation option for reducing direct exposure to MeBr.

See response # 14 for additional comments regarding reducing the total MeBr emitted. 71 FS& S Risk Management Option 3   Stacks: When reviewing this issue it is important to understand that 50% to 80% [ Average] of the methyl bromide is commonly lost during the treatment period. The Agency considered this phenomenon through the retention and emission rate factors described in Section <IP_ADDRESS> in the risk assessment. Mass loss rates from 1 to 100 percent were considered in the analysis which encompass those described in the comment. 72 NAMA Exhaust stacks vented vertically to the outside air We oppose such a requirement. Grain mills may not have vertically vented exhaust stacks. Yet they can be aerated in a safe manner. Mills may be 8 or more stories high. Side venting exhaust and simply opening the windows on upper floors can be safe aeration points. Requiring the retrofitting of air handling systems coupled with the installation of exhaust stacks on the roof would not add measurably to safe aeration, and the costs would be substantial. In its assessment the Agency used vertical exhaust orientations for modeling purposes because that is the only output orientation that current models have the capability to address. The Agency acknowledges that side venting is a common practice given the appropriate situations or nature of the treated structures. It does not, however, have the modeling capability to better address this scenario. As such, it based its risk 18 # ID Public Comment Agency Response management decisions on the scenarios that best fit various cultural practices. 73 MBIP California regulations define a " standard height" exhaust stack as one which is: a) at least 10 feet above the enclosure's highest point; b) at least 10 feet above any major obstruction within 200 feet of the stack, and c) at a certain prescribed height ( above ground level) calculated from certain values set forth elsewhere in the regulations. Many food manufacturing sites have buildings designed with multiple stories, some up to 10 or 11 stories high, with exhausts exiting out the side of the facility. These exhausts may be over 100 feet in the air, but they would not meet the vertical venting requirements of the California regulations. Replacing exhaust systems would be extremely expensive and burdensome for these facilities. As noted above, potential exposure to bystanders can be more effectively controlled and regulated by imposing air monitoring requirements. If actual air monitoring demonstrates levels that are below levels of exposure concern, the stack height and position is irrelevant. In short, stack height requirements do not contribute to increased safety. Facilities should not be required to retrofit their stacks and incur additional costs to deal with potential concerns that are better addressed by more flexible and feasible monitoring requirements. See response # 40.

74 MBIP EPA has shown that the use of vertical stacks can significantly reduce the methyl bromide levels in areas surrounding fumigated facilities. For some facilities, particularly fixed fumigation locations, the use of stacks may offer a viable option to mitigate exposures. However, this option may not be feasible or necessary for certain types of facilities. See comments of North American Millers' Association regarding vertically vented stacks for grain mills. If anything, this option should be available to fumigators and facility operators to reduce methyl bromide levels if monitoring demonstrates concentrations in excess of targets. See response # 72.

75 APHIS Data from the Methyl Bromide Human Health Effects Document do not always support the above statement, and, in fact, indicate that some types of fumigation operations that aerate at ground level do not require a buffer. Nearly all fumigation conducted under APHIS supervision under normal atmospheric pressure are aerated at ground level ( small vacuum chambers, usually less than 1,000 cubic feet, are usually aerated through a stack.) Currently, only two warehouses that fumigate at normal atmospheric pressure contain permanent stacks for aeration; the stacks at one of those warehouses are currently inoperable and are not being used. The Agency agrees that in some cases ground level aeration results in smaller buffers compared to using certain stack scenarios. The Agency has modeled a wide range of scenarios that include ground level aeration ( e. g. PPQ method).

76 APHIS Fumigation warehouses, like the one the EPA visited with APHIS in Baltimore, are the property of the Port Authority, not of the fumigation company. Therefore, the costs of any regulations requiring changes to permanent structures are borne by the Port Authority. Buildings located on Port Authority property are expensive and exist at a premium. If the Port Authority decides not to put resources into building permanent stacks within their warehouses, fumigation at the warehouses ( and possibly that site) may cease; local, national and global economic effects may arise as a consequence. If the Port Authority complies and passes the costs along to the fumigator, it is possible that it may no longer be economical to fumigate if the fumigator cannot pass the costs on to the importers. The Port Authorities, along with the Department of Homeland Security's Custom and Border Protection, are increasingly taking over warehouses once used for fumigation and diverting their uses to other purposes; consequently, fumigations formerly conducted in warehouse buildings are progressively becoming redirected to temporary outdoor structures, often built right on the tarmac. These structures, which aerate at ground level and operate under APHIS PPQ certification, are not able to have permanent stacks; it is not known whether mobile stacks may be used at this point in time. It is APHIS's understanding that all fumigators in California operate using mobile stacks; however, these mobile units aerate from enclosures built within permanent warehouses or from containers directly, but not from temporary outdoor structures. It is not known whether these mobile units could be accommodated to fit nonpermanent structure situations used at other ports, where temporary enclosures are built outdoors and then sealed with a tarp. See response # 5.

The Agency also acknowledges that the specific risk mitigation options that are being considered would likely have a different economic effect on each facility that conducts fumigations. Further, the Agency agrees that, depending on the particular risk mitigation option selected and the site specific conditions of the facility, some options could produce substantial adverse economic effects.

77 Royal Enclosure Performance Criteria. Royal has always believed that it is possible to make most fumigation structures more air tight, and it has engaged in research and development throughout its existence to improve tarpaulin fumigation procedures and equipment. With respect to structure fumigation, careful sealing prior to fumigation is or should be an industry standard practice. The costs associated with sealing are primarily the sealing materials, training and the cost of the labor. Since each building is unique it is not possible to make general estimates of cost. With respect to tarpaulin fumigation, on just one improvement Royal invested at least three years' effort and many thousands of dollars to develop a fumigation seal for which it is seeking patent protection. ( Royal's seal replaces the sleeves filled See response # 5. 19 # ID Public Comment Agency Response with sand (" sand snakes") that are used to seal the tarp to the floor.) It should be noted that even the new seal is not applicable to all of Royal's tarpaulin fumigations. Each improvement entails costs for developing and testing, adapting the improvement to existing equipment or practices or changing equipment and practices to allow use of the improvement, and obtaining approval from regulators. Overall estimates of cost are very difficult but can range from tens to hundreds of thousands of dollars to take an idea to the point of being able to use it. The costs of installation, maintenance and use cannot be generalized, as they are determined by the particular aspects of the improvement, where it is used, on what type of fumigation, etc. 78 USA Rice Sealing procedures are constantly improving, however with rice mills, some of which started construction in the early 1900' s, and which are built using a variety of materials spanning that timeframe, appropriate sealing is not always practicable. As older construction materials are replaced with newer, tighter materials and gas escape routes are permanently sealed then fumigation sealing will achieve better results. Most mills and fumigators now spend considerable resources for the best sealing practices possible in order to reduce costs on the gas. See response # 5.

79 Western Sealing is an important part of any fumigation operation and for the preservation of required gas concentrations under an enclosure or within a structure. Currently, economics dictates the minimal use of methyl bromide, which will yield the proper results. Applicators are all moving towards improved sealing material and techniques that are less expensive than merely adding more fumigation to make up for losses. While sealing is a proper concern it should not be overly regulated adding unnecessary cost to an operation, particularly from a manpower perspective. See response # 5.

80 NRDC Enclosure performance criteria. EPA is soliciting information on whether the use fumigation structures that are more air tight would be effective in reducing the use and duration of aeration and buffer size ( 0133). There is no discussion in the EPA document of the estimated costs or quantitative mitigation impact of this measure on the overall reduction of volume of MBr used. Has EPA estimated the impact of this proposal on MBr use and release? Does EPA have data supporting its estimated impact? If so, what is the source of this data, and what are the costs associated with this proposal compared with the estimated impact on MBr total usage? Agency solicited and received comments for these the following questions as they relate to enclosure performance criteria: ° What is the feasibility of implementing this option on a national level? ° What are the costs associated with this option? ° How effectively does this option mitigate the risks resulting from methyl bromide use? 81 PFI As to sealing of structures, PFI members rely on the counsel provided by applicators on the appropriate sealing of structures. Before, during and after fumigations, PFI member facilities are constantly monitored to make sure they are as gas tight as practical. This reduces the amount of methyl bromide that is required is more cost effective. The Agency acknowledges receipt of this comment.

82 FS& S Risk Management Option 4   Enclosure Performance Criteria This will vary greatly. I believe a better way to manage this issue is to require continued gas tightness improvement. For space fumigations this could be a target of a 24 hour half loss. This would be a very good space fumigation if you are treating a mill, food plant or warehouse. For commodity storages and tarps which do not have windows, doors, vents and other structural challenges the half loss expectancy should be much higher. Responsible fumigators have always pushed to improve fumigation performance but many do not. Profume; a methyl bromide alternative does this very effectively with a computer program called Fumiguide. The Agency acknowledges this comment and applauds the use of more sophisticated treatment calculators ( e. g., Fumiguide).

83 NAMA Sealing structures prior to fumigation The proper sealing of structures is a critical step for an effective fumigation. Perhaps unforeseen technological advances in sealing materials may improve the effectiveness of sealing. Currently, however, we believe millers and fumigant applicators are doing an effective job of sealing structures. Spiraling fumigant costs are motivation to continue these efforts. See response # 81.

84 MBIP In the interest of greater safety and due to the high cost of fumigants, extensive efforts already have been implemented to improve sealing and reduce the amount of fumigant used. Many plants have permanently sealed areas of potential leakage. For example, exterior glass windows have been removed and permanently sealed shut. In addition, many fumigators are using Virtually Impermeable Film ( VIF) or high density poly to further reduce leakage. In general, permanently installed fumigation facilities have more options for improved sealing than food processing facilities. Label language could require the use of VIF for sealing and could require fumigators to demonstrate, by monitoring, the half loss rate during fumigation. See response # 5.

85 APHIS APHIS agrees that enclosure performance criteria are essential to protect the health and safety of all workers located at fumigation facilities; however, it does not seem likely that criteria specified by EPA for their current risk mitigation document See response # 5. 20 # ID Public Comment Agency Response would be adequate to reflect technological changes as they occur over time. APHIS PPQ modifies its fumigation policies by making frequent edits to the Treatment Manual to reflect improvements in fumigation technology. Since EPA modifications to such performance criteria may not be as timely, APHIS recommends that EPA consider ambient air concentrations as a sole performance criterion; that way, the fumigators are left to use their own creative devices to perform their duties in the most cost effective manner while conducting their operations under a safe air concentration limit. Currently, APHIS PPQ enclosure performance criteria including the tightness of the permanent and temporary enclosures, the size of the aeration fans, and the minimum required temperatures, are part of APHIS PPQ policy for fumigating imported commodities treated under APHIS supervision ( see Chapters 2 4 in the PPQ Treatment Manual at http:// www. aphis. usda. gov/ ppq/ manuals/ port/ Treatment_ Chapters. htm). While it is currently possible to require tighter structures, for example by requiring all fumigations to occur in a permanent chamber, the costs involved with doing this would make fumigation impractical from a cost/ benefit standpoint. If fumigation chambers became a regulatory requirement, some countries may consider the resultant higher costs of imported commodities to be a trade barrier; this may cause foreign governments to take more restrictive actions on our nation's exported products. Regarding tarps: Tarp technology, as well as the method by which tarps are held to the ground has improved over time. Requiring a minimum performance for tarps and sealing may encourage users to stay at that level instead of switching to more costly improved varieties as they are developed. APHIS PPQ handles leaks by inspecting the enclosure with a halide detector once the gas has been introduced to ensure that no gas is escaping ( self contained breathing apparatus must be used). If gas is detected, the leak is found and repaired immediately. If the leak cannot be repaired, the fumigation is aborted. Leaks may also be deduced and addressed if the concentration readings within the enclosure at the half hour point following gas introduction are not at the level specified in the Treatment Manual ( timed concentration readings within the enclosure are mandated by APHIS PPQ). APHIS PPQ also requires that the tarps be changed after a number of uses, that the tarp be examined for holes and cracks prior to use, that the flooring be scrutinized for fumigation appropriateness prior to the building of the enclosure. Regarding air tight enclosures: APHIS PPQ does own and operate air tight chambers to fumigate small lots of imported propagative plants ( 1,000 cubic feet or less). Currently, APHIS PPQ is planning to build a new chamber facility which would hold a mere four pallets of commodities ( less than a single container) in Miami. The cost for the chamber, including the necessary heating equipment, detectors, and sensors, is estimated to be around $ 400,000. Maintenance costs ( e. g., keeping the seals tight) will exceed $ 13,000 per year. Such chambers are not cost effective for fumigating large consignments of imported food commodities. Regarding minimum temperatures: It is APHIS's experience that it is difficult and expensive to raise the temperatures to the minimum required for fumigation in the major northern fumigation warehouses during winter months, when imported fruit arrive from the southern hemisphere. In addition, fumigation of perishable commodities at higher temperatures may cause more commodity damage than if the commodity is fumigated at lower temperatures. Requiring higher minimum temperatures may serve to create more of an economic effect, by moving fumigation businesses, and the associated regional economies that develop from them, out of the northern regions of this nation. APHIS also notes that many temperature/ treatment regimes are a result of international agreements; modifying internationally accepted temperature regimes without providing scientific justification ( on efficacy) may put our country in an awkward trade situation. 86 VR Presented is a comprehensive overview showing Value Recovery's approach to irreversibly destroying methyl bromide from fumigation ventilation streams for Q/ PS, and Structural fumigations. Methyl bromide belongs to a larger class of chemicals known as alkyl halides that readily undergo nucleophillic substitution reactions. Value Recovery exploited this fundamental feature in methyl bromide's structure to use it as a strategy to destroy it chemically. In order for this process to gain wide acceptance, removing methyl bromide from ventilation streams should have minimal influence on existing operations. Our solution to the emissions reduction problem has only one moving part, a blower fan, and all process other equipment is made of plastic, namely PVC, polyethylene and polypropylene. The blower fan has a Teflon coating. The cost of this process are estimated to be below 5% of the fumigation cost for quarantine and structural fumigations based on commercial trials and industry data. ( please note: additional cost analysis was provided by this commentor) See response # 5. 21 # ID Public Comment Agency Response 87 Royal Recovery/ Destruction Systems. Royal has been involved in development and/ or testing of three systems for the capture and destruction of methyl bromide: 1) its capture on charcoal and subsequent incineration of the charcoal ( the Incineration Method"); 2) capture on charcoal followed by washing the charcoal to release the bromine into a liquid and drying of the charcoal for reuse ( the " Washing Method"); and 3) bubbling the stream of air and methyl bromide through a solution that instantaneously destroys the methyl bromide ( the " Instantaneous Destruction Method"). All three systems successfully capture or destroy methyl bromide in a laboratory setting. None, at present, is capable of scaling up to the extent needed by Royal for use in its large tarpaulin fumigations of quarantine fruit that can total 3,000 lbs. of methyl bromide use in 24 hours. The Incineration Method was tested by several fumigation companies, including Royal. Royal successfully captured more than 90% of the methyl bromide in its test, but was not involved after that step in the process. It is Royal's understanding that incineration of the charcoal can be accomplished only at very high temperatures and that few incinerators exist in the U. S. for this purpose. Royal estimated that it would take railcars full of charcoal to capture the methyl bromide used in its quarantine fruit fumigations, and therefore a significant cost of the process could be in transportation of the spent charcoal. The Washing Method is used for container fumigations in other parts of the world. Its use involves purchase of an engineered door that is moved into the position of one of the container doors and through which the methyl bromide is extracted for capture on charcoal, plus washing equipment. Royal is working with the Australian manufacturer of the system, Nordiko, to adapt the door to the containers most commonly used in the U. S. Royal does not yet know the costs to purchase or use the Washing Method, but expects that the washing equipment could be set up to serve a number of doors ( and containers) so as to handle approximately 100 lbs. of methyl bromide per cycle. A significant cost of use may be that of disposal of the washing liquid, which may or may not be permitted in certain public water treatment facilities, or permitted only at a cost. Royal does not believe that this method can be scaled up for use in large quarantine fumigations of fruit. The Instantaneous Destruction Method has progressed beyond the laboratory setting but Royal is not aware of its regular use by any fumigator, and believes it may also have potential waste disposal problems. Royal has concluded that eventual use would probably also be for a group of containers and not for large scale fumigation. See response # 5.

88 NRDC Recovery/ Destruction System. EPA proposes that a system that recovered the excess gas or converted it into an inert material would reduce or eliminate the need for buffer zones and reduce skin cancer risks associated with ozone depletion ( 0133). There is no discussion in the EPA document of the quantitative mitigation impact of this measure on bystander exposures or the overall reduction of volume of MBr used. Has EPA estimated the impact of this proposal on MBr use and release? Does EPA have data supporting its estimated impact? If so, what is the source of this data, and what are the costs associated with this proposal, and how would those costs affect the attractiveness of alternative pest control methods? Agency solicited and received comments for these the following questions as they relate to Recovery/ Destruction Systems: ° What is the feasibility of implementing this option on a national level? ° What are the costs associated with this option? ° How effectively does this option mitigate the risks resulting from methyl bromide use? 89 FS& S Risk Management Option 5   Recovery / Destruction Systems We have seen and worked with a company who is currently destroying methyl bromide used on QPS containers treated with methyl bromide. These containers average 3,000 cubic feet and this system is currently 91% efficient. Costs range $ 50 per container to implement this process. There are no incentives to drive this technology. We believe we could improve this process and are currently evaluating new options. See response # 5.

90 MBIP The necessary technology for methyl bromide recovery and destruction using carbon based systems has been demonstrated at several small fumigation facilities. In general, for a facility with a fumigated volume of 10,000 ft3 or less, the system cost is $ 100,000  $ 250,000, depending on the specific installation. The main operational cost is regeneration of the carbon, which adds the equivalent of about $ 15/ lb to the cost of methyl bromide. While recovery systems for larger facilities are technically possible, the cost of the initial installation and the cost of the carbon regeneration may be prohibitive. For example, a system designed for a 250,000 ft3 fumigation facility would have an initial cost of up to $ 1,000,000. If the facility uses 30,000 pounds of methyl bromide per year, increased operating costs would be near $ 500,000. This could pose a significant economic burden. See response # 5.

91 APHIS Methyl bromide recovery systems are still in the infancy stage; only one fumigation facility which recovers methyl bromide has passed APHIS certification requirements. This unit can hold no more than a single container ( around 2700 cubic feet). This technology not cost effective for large scale fumigations needed See response # 5. 22 # ID Public Comment Agency Response for southern hemisphere perishable commodities such as Chilean grapes. The cost to build a recovery unit for these commodities, in terms of dollars per cubic foot of fumigation space, would be prohibitive. Even if cost were not a factor, the aeration technology is not sufficiently developed to appropriately treat the enormous quantity of imported food that enters our nation's borders. Perishable commodities requiring fumigation must be treated and moved into the channels of commerce quickly in order to maintain marketability. Current recovery systems, which force the air through charcoal to remove methyl bromide, can push air out of small enclosures at an adequate rate; however, they would not be able to push fumigant out of a 50,000 to 100,000 cubic foot enclosure fast enough to ensure that perishable commodities retain marketability. Even if the commodities were not damaged by from remaining under fumigation for too long, the delay in aeration would slow the movement of perishable commodities into the channels of commerce, thus causing additional marketability problems. Should the fumigation procedures slow down, traffic situations for both the shipping and trucking industries may arise at the ports; delays in treating perishable commodities may cause marketability problems before they reach the fumigation chamber. 92 Royal Limitation of Use by Amount and Time. Implicit in this proposal is an assumption that lower emissions of methyl bromide over a number of days are preferable to one emission event, at a higher level, during the same number of days. For Royal's large quarantine fumigations of fruit, however, a daily limit on the amount of methyl bromide used would result in greater risk and more methyl bromide used than in a single, large fumigation. For example, a large fumigation of Southern Hemisphere fruit can require 3,000 lbs. of methyl bromide. If the California limit of 1,000 lbs. is adopted, then three fumigations must be performed instead of one. Despite any measures to ensure safety, increasing the number of fumigations increases the chances for leaks, exposure, etc. In addition, a large quarantine fumigation uses less methyl bromide than several smaller ones. This is because the Treatment Manual requires the same clearance around the commodity and between it and the enclosure walls regardless of the size of the chamber ( for example, four to six inches between pallets, two feet from the top and sides of the stack of pallets). The area within the fumigation chamber that must be filled with methyl bromide, yet contains no commodity, is therefore a smaller percentage of the total area in a large enclosure than in a small one, resulting in a savings of methyl bromide in large fumigations. The costs associated with multiple fumigations are the extra labor, methyl bromide, storage and loss of value for perishable commodities. See response # 5.

93 USA Rice California also limits the total amount of methyl bromide per work site to 1000 pounds in a 24 hour period. In that state, if the total amount of methyl bromide used in any 24 hour period exceeds 1,000 pounds, or the treated volume exceeds 250,000 ft3, both the County Agricultural Commissioner and the California Department of Pesticide Regulations must evaluate the request in order to grant alternate conditions or mitigation measures. Some rice mills are in excess of 1,000,000 ft3 and alternate conditions, such as lowering the total amount of methyl bromide used in a 24 hour period, will not be workable because it would lower the amount of MeBr used to such low levels as to be ineffective and possibly harmful by contributing to insect resistance. It would also create the need for more treatments to cover large facilities thus creating more downtime and more risk for exposure due to the multiple jobs. See response # 5.

94 Western Limiting the amount of methyl bromide that can be used at a particular fumigation site during a given period would be a severe hardship on the movement of perishable commodities through many of the major ports in the United States. During the winter months and beyond, large shipments of perishables arrive and must move as quickly as possible to retailers or storage warehouses to preserve quality. The vessel arrivals are not precise due to the vagarious nature of shipping operations, often leading to the discharge of large volumes of perishables in any given period. Currently, volumes of perishables fumigated at any given site at many major ports are restricted by time limits established by USDA and time required to satisfy aeration prior to the release of the cargo. In other words, for imported commodities, the amount of fumigant used at a particular site in any given time period is already restricted by these constraints. See response # 5.

95 NRDC Limitation of use by amount and time. EPA proposes to limit the volume and time of fumigation to reduce overall use ( 0133). NRDC is supportive of any measures that severely and significantly limit or cancel MBr uses. However, there is no discussion in the EPA document of the limits that EPA proposes, for what uses, under what conditions, by how much. There is no discussion of estimated costs or quantitative mitigation impact of this measure on the overall reduction of volume of MBr used. Has EPA estimated the impact of this proposal on MBr use and Agency solicited and received comments for these the following questions as they relate to this option: ° What is the feasibility of implementing this option on a national level? ° What are the costs associated with this option? 23 # ID Public Comment Agency Response release? Does EPA have data supporting its estimated impact? If so, what is the source of this data, and what are the costs associated with this proposal and how would those costs affect the attractiveness of alternative pest control methods? ° How effectively does this option mitigate the risks resulting from methyl bromide use? 96 FS& S Risk Management Option 6   Limitations of Use by Amount and Time. For structures 1,000 pounds and 25,000 cubic feet would not be realistic. Average mill volume is 500,000 cubic feet and the average food processing plant is 1,500,000 cubic feet. I would direct my comments from RMO Option 4 as a more suitable limitation. See response # 5.

97 NAMA Restricting the quantities of methyl bromide used per fumigation We oppose the arbitrary restrictions on the quantities of methyl bromide used at each fumigation. As stated earlier, the most attractive trait of methyl bromide is its ability to achieve total control of pests in the food production facility. If complete, or as nearly complete as practical, control is not achieved, additional or more frequent applications of methyl bromide or other pesticides are required and total pesticide usage increases, not decreases as should be the goal. Simply put, the quantity of methyl bromide ( or any other pesticide) used should be the amount that will do the job correctly. Pest management experts, entomologists and others agree that further reductions in the pounds used per fumigation may cause other unintended effects. If the quantity used is too low to be lethal to all insects present, the low level fumigation will cause insects to evolve with resistance to the fumigant, increasing the demand for more pesticides. It is not practical, economically or technically, to divide the facility so as to fumigate only one portion of the mill at one time and thereby reduce the amount of compound used per fumigation. For example, consider a mill of 2.0 million cubic feet in volume. At a dosage of 1.25 pounds per 1,000 cubic feet, the fumigation would require 2,500 pounds of fumigant, not including so called ` add gas' or the additional fumigant that is added during the fumigation to keep the concentration at the target level lethal to insects. If an arbitrary restriction of, say, 1,000 pounds per fumigation were imposed, the mill would need to be fumigated in three separate events. This would triple the downtime and associated costs and lost revenue. Finally, the price of methyl bromide continues to spiral upward. It is highly unlikely that any user of the compound is using more than is necessary to achieve total control. See response # 5.

98 MBIP When fumigations occur in California the total amount of methyl bromide used in any 24 hour period may not exceed 1,000 pounds. If more methyl bromide is required or the treated volume exceeds 250,000 ft3, both the County Agricultural Commissioner and the California Department of Pesticide Regulations must evaluate the request in order to grant alternate conditions or mitigation measures. Typical food processing facilities are in excess of 1,000,000 ft3. Thus, the need to request alternate conditions would be necessary for many facilities. The alternate conditions typically imposed may not be feasible for a particular site and may make it impossible for that site to complete a fumigation. For example, one alternate condition utilized to allow for fumigation of larger facilities is to lower the total amount of methyl bromide used in a 24 hour period. Application rates as low as 5 oz/ 1,000 ft3 in combination with carbon dioxide ( CO2) would be necessary at some sites in order to meet this requirement. This does not allow for any amount of additional methyl bromide that may become necessary during the treatment to ensure a lethal dose against the targeted pest. A major concern with utilizing methyl bromide at such a low application rate is the future impact this would have on insect resistance. California also specifies the maximum concentration that can be present inside a facility before aeration can occur. An example of a final permit condition currently in place for a large food handling facility requires that not more than 50 pounds of methyl bromide may be present inside the structure before aeration is started. This results in unacceptable downtime for food handling establishments and could draw out aeration time into several days or up to a week. Downtime costs per day for a typical mill or food handling facility can easily exceed $ 100,000.00 per day See response # 5.