Page 1 U. S. A. CUN2003/ 049 CUCURBITS FIELD CUCURBITS GROWN OUTDOORS WITH PLASTIC TARPS COVERING THE ROWS CUCURBITS, INCLUDING SQUASH, CUCUMBER, MELONS OF MANY VARIETIES TABLE OF CONTENTS Introduction ................................................................................................................................ 2 Critical Need for Methyl Bromide................................................................................................ 2 Economic Impacts....................................................................................................................... 3 Response to Questions from MBTOC/ TEAP............................................................................... 4 Historical Emission Reductions & Methyl Bromide Dosage Rates ............................................. 12 Virtually Impermeable Film ( VIF) Tarps.................................................................................... 12 Market Window Information..................................................................................................... 13 Definitions................................................................................................................................. 15 References ................................................................................................................................ 16 LIST OF TABLES Table 1. Region, Key Pests, and Critical Need for MB................................................................. 2 Table 2. Measures of Economic Impact of Metam Sodium Use in Place of Methyl Bromide on Cucurbits in the U. S.............................................................................................................. 3 Table 3. Fumigant Alternatives to MB for Polyethylene Mulched Tomato ( Locascio et al., 1997). ............................................................................................................................................. 7 Table 4. Historical Use of MB in the Cucurbits Sector................................................................ 8 Table 5. Calculation of the Nominated Amount of Methyl Bromide in the Cucurbits Sector ........ 9 Table 6. Herbicides registered in the United States in Cucurbits................................................ 11 Page 2 INTRODUCTION The U. S. nomination for cucurbits is a critical need only for an amount of methyl bromide ( MB) associated with moderate to severe pest pressure ( primarily nutsedge in Southeastern United States and Georgia, and Phytophthora in Michigan), because there are no feasible alternatives and farmers face economic harm in using alternatives ( see Table 1). Alternatives for cucurbits fail to provide necessary pest control for moderate to severe pest pressure. The nomination also notes that applying alternatives is further complicated when plant back restrictions prevent farmers from meeting marketing windows ( e. g., winter for Georgia and the Southeast and spring for Michigan) when cucurbit sale prices are as much as 100% higher than during the rest of the year. The nomination notes progress in adopting emission reduction technologies, and in changing formulations and application rates to reduce MB dosage rates to some of the lowest in the world.

CRITICAL NEED FOR METHYL BROMIDE TABLE 1. REGION, KEY PESTS, AND CRITICAL NEED FOR METHYL BROMIDE Region Key Pests Critical Need for Methyl Bromide Georgia ( CUE 02 0048, 02 0051, 02 0052)

Southeastern US ( CUE 02 0042)  a consortium comprising Alabama, Arkansas, North Carolina, South Carolina, Tennessee, and Virginia Weeds: Yellow Nutsedge ( Cyperus esculentum), and Purple Nutsedge ( C. rotundus). At moderate to severe pest pressure, particularly where C. rotundus is dominant, only MB can currently provide effective and reliable control in these regions. The use of alternatives is limited due to a number of factors, such as susceptibility of the key pests to alternatives, and regulatory restrictions such as mandatory buffers around inhabited structures. MB applications in cucurbits are typically made using a 67: 33 mixture with chloropicrin under plastic. Resulting dosage rates are 150 kg/ ha   among the lowest in the world   making further reductions difficult to achieve without compromising pest control.

Michigan ( CUE 02 0005) Diseases: Soil inhabiting fungal pathogens   Phytophthora capsici and Fusarium oxysporum At moderate to severe pest pressure, particularly for P. capsici, which has shown resistance to other fungicides, only MB can provide effective and reliable control. Michigan's cool and cloudy climate, short growing season and narrow market window exacerbates the need for consistent control of fungal pests and a minimum plant back interval. MB applications in cucurbits are typically made using a 67: 33 mixture with chloropicrin under plastic. Resulting dosage rates are 150 kg/ ha   among the lowest in the world   making further reductions difficult to achieve without compromising pest control. Page 3 ECONOMIC IMPACTS In order to determine whether a proposed alternative to MB was considered to be ` economically feasible' for those situations where technically feasible alternatives exist, the U. S. took a ` weight of the evidence' or ` portfolio' approach. Rather than rely on a single indicator or even a series of indicators, each with a ` bright line', the situation of the applicant with respect to five measures was assessed. The five measures selected for consideration were: loss per hectare; loss per kilogram of MB; loss as a percent of gross revenue; loss as a percent of net cash returns; and change in profit margins. These measures were selected because the information was fairly readily available, they describe different aspects of potential loss and are independent of each other. In cases where information was not available for one or more of the measures, the remaining measures were used. In cases where a stream of benefits was derived from a MB application, net present value was used in the calculations.

When evaluating the case made by each application, expert economic judgment was used to determine whether each loss ( or change in profit margin) was significant, not significant, or borderline within the context of the applicant's market. Once decisions on individual measures were reached, an overall assessment was made which included the individual measures and any additional considerations such as social benefit.

The original U. S. nomination presented data showing that the next best alternative to MB, metam sodium, is not economically feasible in states/ regions where nutsedges are the key pests. In Michigan, the key pests are soil fungi, for which metam sodium has not shown technical feasibility. In Georgia and the other southeastern states, metam sodium might be effective against low to moderate nutsedge infestations, but not against moderate to severe pest pressure. Given this caveat, an economic analysis of metam sodium as an alternative control for nutsedge was conducted. Results are provided in Table 2.

TABLE 2. MEASURES OF ECONOMIC IMPACT OF METAM SODIUM USE IN PLACE OF METHYL BROMIDE ON CUCURBITS IN THE U. S.

Loss Measure Georgia ( CUE 02 0048, 02 0051, 02 0052) Southeast** ( CUE 02 0042) Michigan ( CUE 02 0005)

Yield Losses Up to 17% likely 10% loss Up to 26% loss Likely 15% loss No technically feasible option, therefore no economic analysis was conducted.

Loss Per Hectare US$ 391   $ 2,918 likely $ 1,862 loss US$ 1,210  $ 9,190 Likely $ 5,187 loss No technically feasible option, therefore no economic analysis was conducted. Loss Per Kilogram MB US$ 1.74   $ 13.00 likely $ 8.29 loss US$ 5.40  $ 41.10 Likely $ 23.10 loss No technically feasible option, therefore no economic analysis was conducted. Loss as a % of Gross Revenue Up to 11% likely 7% loss 4  30% loss likely 17% loss No technically feasible option, therefore no economic analysis was conducted. Loss as a % of Net Cash Returns 6   50% likely 28% loss 9  73% loss likely 41% loss No technically feasible option, therefore no economic analysis was conducted. Change in Profit Margins Not Available Not Available No technically feasible option, therefore no economic analysis was conducted. Notes. ** Loss measures were calculated based on the data from the USDA, National Agricultural Statistics Service Page 4 RESPONSE TO QUESTIONS FROM MBTOC/ TEAP 1. Provide details of the reasoning and assumptions used to calculate the nominated amount.

The details of the reasoning and assumptions used to calculate the nominated amount are shown in Tables 4 and 5.

The methodology used by the U. S. carefully scrutinized applications from the user community and took out ( 1) double counting; ( 2) any requested growth beyond historical acreage planted, and ( 3) requested amounts that fall under QPS. Furthermore, the United States adjusted the requests from the user community, when they had not already done so, to change the amount of MB nominated to account for ( 1) only the area where pest pressure cannot be controlled by alternatives, ( 2) the area where regulatory constraints limit adoption of alternatives, such as buffers near inhabited areas, and ( 3) the area where soil/ geological features limit use of alternatives, such as groundwater contamination in areas with karst topography. The nominated amount incorporates minimum efficacious use rates, mixtures of MB with chloropicrin, and the use of tarps to improve efficacy and reduce emissions.

2. List the registration status of herbicides for this crop and provide data on why these are not suitable for nutgrass control ( the main reason why MB is used in southeastern USA).

A list of herbicides, with activity against nutsedge species, which are currently registered for some or all U. S. cucurbit crops, is provided in Table 6. Herbicides not currently registered for cucurbits, but which have shown some activity against nutsedge in vegetables, are also listed.

3. As the CUN specifically request MB for areas where nutgrass exists in heavy infestations, the Party is requested to clarify the exact amount of MB required for this use and to validate the amount of MB required in those areas where 1,3 D is not available through local restrictions ( e. g., township caps, karst topography).

The details of the reasoning and assumptions used to calculate the nominated amount are shown in Tables 4 and 5. For cucurbits, MB is only requested for areas of moderate to severe nutsedge infestations.

4. The Party should consider recalculating the quantity nominated consistent with the use of emission control technologies applied in conjunction with chloropicrin where feasible.

The U. S. nomination considered the historical efforts by cucurbit growers to reduce emissions and to reduce MB dosages described in the section below titled, " Historical Emission Reductions & Methyl Bromide Dosage Rates." The section demonstrates notable success in the United States at efficiently using MB at low dosages with emission control technologies to control key pests. As the 2002 MBTOC report states, " in some countries ( e. g., the U. S.) the potential for reducing MB dosages for soil fumigation Page 5 compared to many other countries will be less because dosages are already low." Growers requesting this exemption have routinely used plastic tarpaulins since the 1980s to reduce MB emissions and maximize MB effectiveness. Recent efforts have continued to try to maximize each quantity of MB, using formulations of MB/ Pic with lower MB proportions and continued testing of virtually impermeable film ( VIF) tarps. The difficulties and impediments in adopting VIF tarps are being investigated in the U. S. and are described in the section below titled, " Virtually Impermeable Film ( VIF) Tarps." The U. S. nomination is calculated based on growers continuing to use a 67: 33 mixture of MB with chloropicrin. Because the U. S. nomination already accounts for the use of emission control technologies and lower methyl bromide content mixtures, no recalculation was performed.

5. The Party is asked to provide detail on why key alternatives reported by MBTOC, e. g., 1,3 D/ Pic and grafting are not effective alternatives.

1,3 dichloropropene + chloropicrin The United States has found no evidence that these chemicals adequately control the soil fungi cited as critical pests by Michigan. For other regions, the 1,3 D + chloropicrin combination has shown activity suppressing weeds, but control of nutsedge has not been as consistent or as effective as MB, particularly when weed populations are high ( Locasio et al 1997). Data presented in Table 3 show the results in tomatoes where nutsedge is not adequately controlled by 1,3 D + chloropicrin. The U. S. nominations have attempted to differentiate between low and moderate to severe pest infestations. Yield loss estimates show a 5% reduction in cucumber yield can occur with approximately 15 yellow nutsedge plants/ m ² ( Johnson and Mullinix 1999). Williams and Warren ( 1975) showed that purple nutsedge also could reduce cucumber yield by as much as 43% when nutsedge densities reached 400 plants/ m2 or more. Considering that both nutsedge species can reach densities in the thousands of plants/ m2, these results indicate that relatively low levels of nutsedge infestations are enough to reduce cucurbit yield significantly. For watermelon, over 40% yield loss can occur with 12 yellow nutsedge plants/ m ² , for both direct seeded and transplant watermelons. A 10% yield loss was predicted to occur at only two yellow nutsedge plants/ m ² . ( Buker et al., 2003)

Additionally, there are practical constraints to using 1 3 dichloropropene in the United States, which include: i) Prohibitions of use in certain soil types: 1,3 dichloropropene is restricted from use in soils underlain by karst topography and sandy ( porous) sub soils, because these geological features  common in the southeastern United States  could lead to ground water contamination ( see the Reregistration Eligibility Decision ( RED) for this chemical; available on the internet at: http:// www. epa. gov/ REDs/ 0328red. pdf). ii) Set back restrictions (~ 100 meters from occupied structures; ~ 30 meters for emulsified formulations applied via chemigation), which are often imposed by local jurisdictions, further limit the proportion of the field that can be treated. iii) Highly restrictive personal protective equipment ( PPE) requirements for 1,3 dichloropropene applications, which limit feasibility of use in the very warm and Page 6 humid climate of the southeastern United States during the typical cucurbitgrowing season. For example, these PPE restrictions require applicators to wear fully sealed suits, with respirators. Such suits usually do not have refrigeration components, and under conditions of high heat and humidity rapidly become unbearable for a typical applicator. Although these requirements have recently been eased somewhat so that fewer people are subject to use the full complement of PPE, workers who come in close contact with the liquid formulation must still wear heavy layers of protective equipment, as described above. iv) A 3 week time interval before planting that is recommended to avoid phytotoxic levels after 1,3 dichloropropene applications. This interval can cause delays in production schedules for the cucurbits in question, because they are doublecropped with other commodities and so season long production of both crops would be affected. This can lead to growers missing specific market windows, such as end of year premiums for the winter markets, thus reducing profits on cucurbit crops.

Grafting Grafting is not currently a viable MB alternative for commercial production of cucurbits in the United States because it does not address nutsedge or Phytophthora pest pressure. Grafting has shown some potential for Fusarium ( but not Phytophthora) management ( Fritsch 2002, Miguel 2002). The United States is not aware of grafting being a viable alternative for the suppression of nutsedges in any cucurbit producing region in the world. In addition, a review by Porter et al. ( 2002) describes resistant rootstocks " to protect susceptible annual and perennial crops against soil borne pathogens", but not to control weeds.

6. The Party is requested to verify that MB used for other crops in rotation [ with cucurbits] is not double counted with that requested for cucurbits.

The U. S. Government has verified that there is no double counting of the amount requested for cucurbits in the nomination. Details are provided in Table 5.

7. The nomination did not give comparative data, except some yields, to determine the technical feasibility of many alternatives and their comparative performance compared to MB under the circumstances of the nomination.

See response above to MBTOC/ TEAP comment # 5. Additional data on yield losses due to nutsedges are also provided below in Table 3 and the text following it. Page 7 TABLE 3. FUMIGANT ALTERNATIVES TO METHYL BROMIDE FOR POLYETHYLENE MULCHED TOMATO ( LOCASCIO ET AL., 1997)

Chemicals Rate (/ ha) Average Nutsedge Density (#/ m2) Average Yield ( ton/ ha) % Yield Loss ( compared to MB)

Nontreated  300 a c 20.1 f 59.1%

MeBr + Pic 67 33 390 kg 90 e 49.1 a

Telone + Pic ( C 17) 327 L 340 a 34.6 bc 29.5%

Telone + Pic ( C 17) + Peb* 327 L + 4.5 kg 150 de 42.5 ab 13.4%

Note: Numbers followed by the same letter ( within a column) are not significantly different at a 0.05 level of probability. For details please original citation listed in references. Note that pebulate is not registered in the U. S. at this time.

In other studies of cucurbit crops, a regression analysis showed a 5% reduction in cucumber yield with a density of approximately 15 yellow nutsedge plants/ m ² . ( Johnson and Mullinix, 1999). For watermelon, over 40% yield loss with 12 yellow nutsedge plants/ m ² for both direct seeded and transplant watermelons. A 10% yield loss was predicted to occur with only two yellow nutsedge plants/ m ² ( Buker et al., 2003, in press).

8. The nomination states that metam sodium is a technical alternative for southern US States with low to moderate nutgrass pressure and requests MB be given a CUE for 25% of production of the total US crop.

The amount nominated for the southeastern U. S. comprises only the 25% of production acreage that is affected by moderate to heavy nutsedge pressure. Additional details on the specific amounts nominated, summarized from the nomination, may be found in Table 5 of this document. Note that in the key pest pressure row of Table 5 includes a value of 100% for the southeast sector because the applicant in this case only requested methyl bromide in those areas of moderate to severe pest pressure where methyl bromide is needed.

9. Although there has been a change from 98% to 67% MB in formulations to date, no further plan has been presented to reduce emissions.

U. S. growers continue to test formulations with lower MB concentrations, as well as testing VIF tarping. Other emission reducing strategies, such as the use of LDPE and HDPE plastic tarps, are in routine use. In past trials, when MB and chloropicrin are used in a 50: 50 combination, they tend to increase plant vegetative growth at the expense of fruit/ vegetable production. This characteristic is desirable for orchard replant but highly undesirable for annual crops where the fruit is the harvested product ( personal communication with Sally Schneider, Agricultural Research Service, US Department of Agriculture, and Michael V. McKenry, University of California Riverside, Parlier, California). Although many sectors continue to test the 50: 50 combination, this formulation has not given good results in tested cropping conditions because it provides less weed control and there is increased vegetative growth by the weeds that survive. Page 8 Please also see the section on " Historical Emission Reductions & Methyl Bromide Dosage Rates" for additional discussion.

TABLE 4. HISTORICAL USE OF METHYL BROMIDE IN THE CUCURBITS SECTOR*

Historical Use Rates ( kg/ ha) Total Amount ( kg) Area Treated ( ha)

1997 216 1,074,867 4,818 1998 216 1,265,303 5,617 1999 169 1,042,645 6,373 2000 146 1,019,770 6,791 2001 144 1,189,840 7,972 Acres planted in U. S.: 415,530 ( 168,159 ha). Percent of U. S. cucurbit acreage requested: 5% Sources: Rates, amounts, and area treated are from applicants' information. Percent of U. S. acreage is from USDA, 2001. National Agricultural Statistics Service, Agricultural Statistics 2001 Page 9 TABLE 5. CALCULATION OF THE NOMINATED AMOUNT OF METHYL BROMIDE IN THE CUCURBITS SECTOR.

Calculation of Nominated Amount 0005   Michigan Cucurbits 0042   SE Cucurbit Consortium 0048   GA Fruit and Veg. Growers Association   Squash 0051   GA Fruit and Veg. Growers Association   Cucumber 0052   GA Fruit and Veg. Growers Association   Melon Applicant request for 2005 Hectares ( ha) 185 5,018 618 448 1,637 % of Regional hectares ( ha)( A) 3 25 17 7 12 Kilograms ( kg) of MB 28,187 753,688 92,874 67,224 245,800 Adjustments to Request Double counted hectares ( ha)( B)           Growth / increasing production ( ha)( C) ( 66.4)       0.4 Quarantine and preshipment hectares ( ha)( D)           Adjusted Hectares Requested ( ha)( E) 185 5,018 618 448 1,636 Impacts to Adjusted Hectares Key Pest Impacts (%)( F) 100 100 100 100 100 Regulatory Impacts (%)( G) 0 0 0 0 0 Soil Impacts (%)( H) 0 0 0 0 0 Total Combined Impacts (%)( I) 100 100 100 100 100 Qualifying Area ( ha)( J) 185 5,018 618 448 1,636 Use Rate ( kg/ ha)( K) 152 150 150 150 150 CUE Amount Nominated ( kg)( L) 28,187 753,688 92,874 67,224 245,800 % Reduction from Initial Request ( M) 0 0 0 0 0 Sum of all CUE Nominations in Sector ( kg)( M) 1,187,773 Multiplier for Margin of Error ( N) 1.0000 Total U. S. Sector Nomination ( kg)( O) 1,187,773 Page 10 Footnotes for Table 5:

Values may not sum exactly due to rounding.

A. Percent of regional hectares is the area in the applicant's request divided by the total area planted in that crop in the region covered by the request as found in the USDA National Agricultural Statistics Service ( NASS). Note, however, that the NASS categories do not always correspond one to one with the sector nominations in the U. S. CUE nomination ( e. g., roma and cherry tomatoes were included in the applicant's request, but were not included in NASS surveys). Values greater than 100 percent are due to the inclusion of these varieties in the U. S. CUE request that were not included in the USDA NASS: nevertheless, these numbers are often instructive in assessing the requested coverage of applications received from growers. B. Double counted hectares is the area counted in more than one application or rotated within one year of an application to a crop that also uses MB. There was no double counting in this sector. C. Growth / increasing production hectares is the amount of area requested by the applicant that is greater than that historically treated or treated at a higher use rate. Values in parentheses indicate negative values. There was 0.4 hectares of growth removed. D. Quarantine and pre shipment ( QPS) hectares is the area in the applicant's request subject to QPS treatments. No part of these applications was for a quarantine or pre shipment use. E. Adjusted hectares requested is the hectares in the applicant's request minus the acreage affected by double counting, growth / increasing production, and quarantine and pre shipment. F. Key pest impacts are the percent (%) of the requested area with moderate to severe pest problems. Key pests are those that are not adequately controlled by MB alternatives. In the case of the Michigan application only those acres in the state where Phytophthora is endemic were included in the nomination. In the case of Georgia and the Southeastern U. S. applications only those acres in the state where Nutsedge is endemic were included in the nomination. G. Regulatory impacts are the percent (%) of the requested area where alternatives cannot be legally used pursuant to state and local limits on the use of alternatives intended for the protection of human health or the environment ( e. g., township caps). H. Soil impacts are the percent (%) of the requested area where alternatives cannot be used due to soil type ( e. g., heavy clay soils may not show adequate performance). I. Total combined impacts is the percent (%) of the requested area where alternatives cannot be used due to key pest, regulatory, or soil impacts. In each case the total area impacted is the area, which is impacted by one or more of the individual impacts. For each application the assessment was made by biologists familiar with the specific situation and able to make judgments about the extent of overlap of the impacts. For example, in some situations the impacts are mutually exclusive   in heavy clay soils 1,3 D will not be effective because it does not penetrate these soils evenly, but none of the heavy soil areas will be impacted by township ( regulatory) caps because no one will use 1,3 D in this situation, so this soils impact must be added to the township cap regulatory impact in a California application. In other words there is no overlap. In other situations one area of impact might be a subset of another impact. In these cases, the combined impact is equal to the largest individual impact. J. Qualifying area is calculated by multiplying the adjusted hectares requested by the total combined impacts. K. Use rate is the requested use rate for 2005. This rate was adjusted downward from the applicants' requested use rate based on historical use patterns. L. CUE amount nominated is calculated by multiplying the qualifying area by the use rate. M. Percent reduction from initial request is the percentage of the initial request that did not qualify for the CUE nomination. N. Sum of all CUE nominations in sector. Self explanatory. O. Multiplier for margin of error. This factor is applied to increase the total US Nomination by 1 %. This factor is intended to compensate for the compounding influence of using the low end of the range for all input parameters in the calculation of the US nomination ( i. e., using the lowest percent impact on the lowest number of acres at the lowest dosage is likely to result in values that are unrealistically too small). Cucurbits was nominated for the entire requested amount so the multiplier is 1.0 Page 11 P. Total U. S. sector nomination is calculated by multiplying the sum of all sector nominations by the margin of error multiplier.

TABLE 6. HERBICIDES REGISTERED IN THE UNITED STATES IN CUCURBITS Herbicide U. S. Registration Status * Major Comments Halosulfuron methyl Yes Potential crop injury; plant back restrictions ( see notes below)

Pebulate No Was registered for use in tomatoes but registration lapsed December 31, 2002 ( registrant corporation went out of business)

S metolachlor No Registered ONLY in tomatoes; does not control purple nutsedge Glyphosate Yes Non selective; will not control nutsedge in the plant rows; does not provide residual control Paraquat Yes Non selective; will not control nutsedge in the plant rows; does not provide residual control Terbacil No Registered ONLY in strawberries; rotation restrictions Rimsulfuron No Registered ONLY in tomatoes; rotational restrictions Trifloxysulfuron No Registration pending ONLY in tomatoes * Y = Registered for use; N = Not registered for use Additional notes on specific herbicides listed: Halosulfuron methyl In December 2002, halosulfuron methyl ( Sandea ® ) was registered to control nutsedge in tomatoes, peppers, eggplant, and cucurbits. This recent registration was not on the list of alternatives from MBTOC and several years are needed to see if it will be adopted. The many limitations to halosulfuron, when combined, limit its technical feasibility and adoption by cucurbit growers in the United States in the areas for the nominated MB amount. Limitations include:

Excessive amounts of water ( greater than 2.5 cm) soon after a pre emergent application may cause crop injury. Rainfall within four hours after a post emergence application may also reduce effectiveness. Sudden storms with greater than 2.5 cm of rainfall are not uncommon, especially in the southeastern United States.

Not all hybrids/ varieties have been tested for sensitivity to halosulfuron methyl. Halosulfuron may also delay maturity of treated crops.

This herbicide has plant back restrictions from 0 to 36 months. Many of the vegetable crops fall within the 4 to 12 month range, although some are longer. The economic impacts from plant back restrictions can be significant, both from the prospect of reduced yields as well as by missed ` high value' market windows.

Halosulfuron should not be applied if the crop or target weeds are under stress due to drought, water saturated soils, low fertility, or other poor growing conditions.

This herbicide cannot be applied to crops treated with soil applied organophosphate insecticides. Foliar applications of organophosphate insecticides may not be made within 21 days before or 7 days after halosulfuron application. Note: All the limitations above are listed in the US registration label for halosulfuron, which in turn is based on proprietary data submitted to EPA by the registrant company.

Glyphosate Glyphosate is a non selective herbicide that usually only suppresses but does not control nutsedge development. Additionally, glyphosate provides no residual weed control. Glyphosate may be applied prior to planting or Page 12 ONLY between vegetable rows. Contact of glyphosate with the crop will likely cause severe injury. Row middle application use is limited because of the potential of glyphosate drift to the crop causing severe injury.

Paraquat Paraquat is a non selective herbicide that provides poor control of nutsedge. Additionally, paraquat does not provide residual weed control. Paraquat may be applied prior to planting or ONLY between vegetable rows. Contact of paraquat with the crop can cause severe injury.

HISTORICAL EMISSION REDUCTIONS & METHYL BROMIDE DOSAGE RATES All states/ regions are continuing to test formulations with lower proportions of MB, as well as methods for using higher barrier tarps ( see VIF discussion below).

In the Southeastern U. S., the MB dosage rate under tarped beds in 1997 was 216 kg/ ha. By 2002, the MB dosage rate under tarped beds had dropped to 150 kg/ ha. All areas growing cucurbits in the southeastern USA inject MB+ Pic formulation 31   46 cm below the soil surface and beds are built above the soil surface and tarped, so the formulation is injected 46   61 cm below the surface of the tarped bed. The success in lowering the dosage rate is due principally to a switch from a 98: 2 formulation to a 67: 33 formulation.

In Georgia, data was gathered on the MB dosage rate under tarped beds since 1992. In 1992, the MB dosage rate below tarped beds was 340 kg/ ha. By 2002, the MB dosage rate under tarped beds had dropped to 150 kg/ ha. All areas growing cucurbits in the Georgia inject MB+ Pic formulation approximately 30 cm below the surface of the tarped bed. The success in lowering the dosage rate is due principally to a switch from a 98: 2 to a 67: 33 formulation, but also was accomplished through a reduction in application rates since 1992.

In Michigan, 95% of vegetable growers nominated were already using a 67: 33 formulation of MB+ Pic in 1997 and the remaining were using a 98: 2 formulation. By 2000, 5% of growers were using the 50: 50 formulation with the remaining 95% using the 67: 33 formulation. Although there was a shift to formulations with lower MB, growers found they needed to increase application rates due to the increasing problems with Phytophthora capsici. In Michigan, the MB dosage rate for all fresh vegetables has been between 120  152 kg/ ha in the period since 1997, when P. capsici populations expanded. The MB+ Pic formulations are injected approximately 31 cm below the tarped beds that are used to grow all fresh vegetables in Michigan.

VIRTUALLY IMPERMEABLE FILM ( VIF) TARps Although many sectors are continuing to test VIF tarps in trials throughout the country, at this time VIF tarps are generally not technically and economically feasible for the following reasons:

Disposal Issues

Landfill disposal of VIF and VIF burning have come under increasing restrictions in some jurisdictions; both are labor intensive and costly.

Ingredients in VIF limit recycling into end use products. Page 13 Cost

Average cost of VIF tarps is $ 580/ acre, whereas average cost of low density polyethylene ( LDPE) tarps is $ 275/ acre, and high density polyethylene ( HDPE) tarps is $ 393/ acre.

Farmers in some regions report VIF tarp removal and disposal costs of more than $ 240 per acre compared to removal and disposal costs of approximately $ 60 per acre for tarps used in flat fumigation.

Environmental Consequences

Inorganic bromide residues in soil are higher when VIF tarps are used; further, the hydrolysis of MB in water may result in the accumulation of bromide ions, thus increasing the chances for groundwater contamination.

Evidence suggests that VIF tarping could actually lead to increased levels of emissions when the tarps are removed, thus increasing exposure to workers and nearby structures.

VIF Supply & Demand Logistics

VIF tarps are currently manufactured only in Europe, and current VIF tarp production capacity in Europe is not high enough to meet U. S. demands.

VIF tarps manufactured in Europe do not meet U. S. application size and criteria.

European firms are unlikely to make the investment necessary to ensure a viable supply of adequate VIF tarps to U. S. farmers before the 2005 phase out date.

VIF Challenges to Agricultural Practices

A glue to join sheets of VIF is still not available.

Increasing cover times with VIF to between 10 20 days can disrupt double cropping schedules and cause growers to miss optimum marketing windows.

Photo degradation of VIF makes it brittle and ineffective at controlling weeds over months of double cropping systems ( current non VIF tarps remain on beds for 12 15 months after one MB fumigation).

MARKET WINDOW INFORMATION The series below indicate the importance of considering market windows, and the concomitant large difference in prices that accompany them, when deciding if alternatives to MB are economically feasible. Although such detailed series are not available for all crops, both tomatoes and strawberries demonstrate large fluctuations in prices over three week intervals from peak price to the midseason price. This pattern is also observable for other fresh fruit and vegetable crops, including cucurbit crops.

Prices received by strawberry growers rapidly decline from their early season peak. The average price received by Florida Strawberry growers dropped 30% between February and March in 1999, 37% in 2000, and 40% in 2001. In California strawberry prices declined in this time period 19% in 1999, 29% in 2000, and 23% in 2001.

The existence of these sharp declines in prices which occur after a short period of high prices ( a period know as ` the market window') ensure that revenue losses caused by the longer plant back periods required when using certain alternatives will not be proportional to the lost production Page 14 time but will, rather, be amplified by the lower commodity price of the post` market window'. The result is a decline in crop revenue, which in the case of Florida strawberries would be approximately 40% of gross revenue apart from any losses due to reduced production.

Fresh strawberries ( winter and spring), prices received per cwt, monthly, 2001 Source, NASS Annual Price Report 2002 $ 0.00 $ 20.00 $ 40.00 $ 60.00 $ 80.00 $ 100.00 $ 120.00 $ 140.00 $ 160.00 $ 180.00 $ 200.00 Jan 01 Feb 01 Mar 01 Apr 01 May 01 Jun 01 Jul 01 Aug 01 Sep 01 Oct 01 Nov 01 Dec 01 FL CA Fresh strawberries ( winter and spring), prices received per cwt, monthly, 1999  2001 Source, NASS Annual Price Report 2002 $ 0.00 $ 20.00 $ 40.00 $ 60.00 $ 80.00 $ 100.00 $ 120.00 $ 140.00 $ 160.00 $ 180.00 $ 200.00 Jan 99 Mar 99 May 99 Jul 99 Sep 99 Nov 99 Jan 00 Mar 00 May 00 Jul 00 Sep 00 Nov 00 Jan 01 Mar 01 May 01 Jul 01 Sep 01 Nov 01 FL CA Though the pattern is not as well defined, prices for tomatoes follow a similar cycle. Three weeks is the added plant back time required when using 1,3 D or chloropicrin. When using MITC generators, recommended plant back can increase to six weeks.

Fresh tomatoes, prices received per cwt, monthly, 2001 Source, NASS Annual Price Report 2002 $ 0.00 $ 10.00 $ 20.00 $ 30.00 $ 40.00 $ 50.00 $ 60.00 Jan 01 Feb 01 Mar 01 Apr 01 May 01 Jun 01 Jul 01 Aug 01 Sep 01 Oct 01 Nov 01 Dec 01 FL CA Page 15 FRESH TOMATOES, PRICES RECEIVED PER CWT, MONTHLY, 1999  2001 Source, NASS Annual Price Report 2002 $ 0.00 $ 10.00 $ 20.00 $ 30.00 $ 40.00 $ 50.00 $ 60.00 Jan  99 Mar 99 May 99 Jul 99 Sep 99 Nov 99 Jan 00 Mar 00 May 00 Jul 00 Sep  00 Nov 00 Jan  01 Mar 01 May 01 Jul 01 Sep 01 Nov 01 FL CA DEFINITIONS THAT MAY BE RELEVANT TO THIS CUN Source of yield loss estimates Where published studies of yield losses under conditions of moderate to severe key pest pressure were not available ( the situation for which the U. S. is requesting continued use of MB), the U. S. developed such estimates by contacting university professors conducting experiments using MB alternatives in the appropriate land grant institutions. The experts were asked to develop such an estimate based on their experience with MB and with alternatives. The results of this process were used when better data were not available.

Source of buffer restriction implications for methyl bromide use Estimates of the impact of buffers required when using some MB alternatives on the proportion of acreage where such alternatives could be used were developed from confidential information submitted to EPA in support of a registration application for a MB alternative. Because at the time of the analysis, a request to reduce the size of the required buffer for some alternatives was under consideration, a smaller buffer was selected for the analysis. Since that time the size of the regulatory buffer has been reduced so that it now conforms to the buffer selected for the analysis.

Source of area impacted by key pests estimates One of the important determinants of the amount of MB requested has been the extent of area infested with ` key pests', that is, pests which cannot be controlled by alternatives to MB when such pests are present at moderate to severe levels. Because there are few surveys that cover substantial portions of the areas for which MB is requested, we have relied on a variety of sources in addition to the surveys. These sources include websites of land grant universities; discussions with researchers, both those employed by USDA in the Agricultural Research Service ( ARS) and those at land grant universities; discussions with growers whose operations cover widely different locations encompassing different incidences of key pests; information from pesticide applicators; and, information taken from the applications themselves.

Source of area impacted by regulations estimates There are two main sources used to develop the estimate of area impacted by regulations. First, Page 16 for the impact of Township caps in California we have used a series of papers by Carpenter, Lynch, and Trout, supplemented by discussions with Dr. Trout to ensure that any recent regulatory changes have been properly accounted for. Second, the estimate of the area impacted by buffers, is described above.

Source of area impacted by soil type estimates First, for the area impacted by karst topography, estimates were developed and mapped by he Florida Department of Environmental Protection. The area of California used for agriculture and which is made of clay soils unsuitable for pest control with a MB alternative has been determined by discussions with agricultural researchers and agricultural extension agents in California, and discussion with other knowledgeable individuals such as pesticide applicators. The estimates for California understate the areas in which alternatives to MB are not suitable because no effort was made to estimate the extent of hilly terrain where currently available substitutes cannot be applied at uniform dosages.

Source of area impacted by combined impacts estimate Combined impacts were determined on a case by case basis for each specific crop/ location combination after consultation with individuals knowledgeable with the specific circumstances. The nature of the individual impacts is such that in some situations they are independent of each other, in some they are mutually exclusive, and in some cover identical areas. It was not, therefore, possible to have a formula that would arrive at an appropriate estimate of combined impacts. A more complete description is found in the footnotes to the ` calculation' table.

REFERENCES Buker, R. S., III, W. M. Stall, S. M. Olson, and D. G. Schilling. 2003. Season Long Interference of Yellow Nutsedge ( Cyperus esculentus) with Direct Seeded and Transplanted Watermelon ( Citrullus lanatus). ( Unpublished; in press for Weed Technology).

Environmental Protection Agency, 1998. Reregistration Eligibility Decision ( RED) 1,3 Dichloropropene. Available at http:// www. epa. gov/ REDs/ 0328red. pdf Fritsch. J. 2002. The current status of alternatives to methyl bromide in vegetable crops in France. In: Proceedings of International Conference on Alternatives to Methyl Bromide. T. A. Batchelor and J. M. Bolivar ( eds). Available on the Web at: http:// europa. eu. int/ comm/ environment/ ozone/ conference/

Johnson, W. C., III, B. G. Mullinix, Jr. 1999. Cyperus esculentus interference in Cucumis sativus. Weed Sci. 47: 327 331.

Locascio, S. J., J. P. Gilreath, D. W. Dickson, T. A. Kucharek, J. P. Jones, and J. W. Noling. 1997. Fumigant alternatives to methyl bromide for polyethylene mulched tomato. HortScience 32 ( 7): 1208 1211. Page 17 Miguel. A. 2002. Grafting as a non chemical alternative to methyl bromide for tomatoes in Spain. In: Proceedings of International Conference on Alternatives to Methyl Bromide. T. A. Batchelor and J. M. Bolivar ( eds). Available on the Web at: http:// europa. eu. int/ comm/ environment/ ozone/ conference Porter et al ( 2002). 2002 Report of the Methyl Bromide Technical Options Committee, 2002 Assessment. Ed. Banks, H. J. Pg 54.

Williams, R. D. and G. F. Warren. 1975. Competition between purple nutsedge and vegetables. Weed Sci. 23: 317 323.


[Federal Register Volume 85, Number 50 (Friday, March 13, 2020)]
[Notices]
[Pages 14684-14686]
[FR Doc No: 2020-05131]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-4711]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Nonbinding Feedback
After Certain Food and Drug Administration Inspections of Device
Establishments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (PRA).

DATES: Fax written comments on the collection of information by April
13, 2020.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Nonbinding Feedback After Certain FDA Inspections of Device
Establishments.'' Also include the FDA docket number found in brackets
in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,

Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Requests for Nonbinding Feedback After Certain FDA Inspections of
Device Establishments

OMB Control Number 0910-NEW

    The guidance document entitled ``Nonbinding Feedback After Certain
FDA Inspections of Device Establishments'' explains how the owner,
operator, or agent in charge of a device establishment may submit a
request for nonbinding feedback to FDA regarding actions the firm has
proposed to take to address certain kinds of inspectional observations
that have been documented on an FDA Inspectional Observations Form
(Form FDA 483) and issued to the firm upon completion of an inspection
of the firm's establishment. The guidance also identifies a
standardized method for communicating and submitting requests for
nonbinding feedback and describes how FDA evaluates and responds to
such requests.
    In the Federal Register of February 19, 2019 (84 FR 4823), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received comments on the following PRA
related topics:
    FDA received several comments regarding whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility.
    (Comment 1) One commenter requested that FDA clarify the benefits
of requesting nonbinding feedback (e.g., whether nonbinding feedback,
and a subsequent reaction to that feedback) could prevent a Warning
Letter from being issued.
    (Response) FDA believes that the benefits of requesting nonbinding
feedback are clear. Specifically, timely nonbinding feedback could help
firms determine whether proposed actions to address inspectional
observations are adequate, possibly avoiding unnecessary investment in
potential solutions not likely to satisfactorily address an
inspectional observation. FDA's considerations and procedures for
determining whether a Warning Letter should be issued are identified in
other documents (e.g., FDA's Regulatory Procedures Manual).
    (Comment 2) Multiple commenters felt that the guidance applies
narrow criteria that forecloses meaningful access to Agency feedback.
For example, some commenters felt that FDA should provide feedback on
any emerging safety issue, not just those that are likely to cause
death or serious injury.
    (Response) Section 704(h)(2) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C. 374(h)(2)) sets forth eligibility
criteria for a request for nonbinding feedback. FDA's guidance
describes situations involving significant observations that the Agency
believes meet the statutory criteria. In addition, we note that firms
have other options to engage with FDA.
    FDA received several comments related to ways to enhance the
quality, utility, and clarity of the information to be collected.
    (Comment 3) Multiple commenters asked whether findings from Medical
Device Single Audit Program (MDSAP) audits are eligible to receive
nonbinding feedback.
    (Response) The Medical Device Single Audit Program is a voluntary
program that allows an MDSAP-recognized Auditing Organization to
conduct a single regulatory audit of a medical device manufacturer that
satisfies the relevant requirements of the regulatory authorities
participating in the program. MDSAP audits do not meet the definition
of an inspection set forth in section 704 of the FD&C Act; therefore,
findings from MDSAP audits are not eligible to receive nonbinding
feedback.
    (Comment 4) One commenter stated that the guidance contradicts
least burdensome principles.
    (Response) FDA disagrees with the comment. As stated in FDA's
guidance, ``The Least Burdensome Provisions: Concepts and Principles,''
\1\ FDA defines ``least burdensome'' to be ``the minimum amount of
information necessary to adequately address a relevant regulatory
question or issue through the most efficient manner at the right
time.'' FDA believes that the nonbinding feedback program is
fundamentally ``least burdensome,'' because it strives to help firms
avoid unnecessary investment in potential solutions not likely to
satisfactorily address an inspectional observation. By providing a
mechanism in which firms can, voluntarily, seek nonbinding feedback on
proposed actions to address certain inspectional observations, the
program seeks to help firms resolve regulatory issues through the most
efficient manner at the right time, using the minimum amount of
information necessary.
---------------------------------------------------------------------------

    \1\ The guidance is available at: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/least-burdensome-provisions-concept-and-principles.
---------------------------------------------------------------------------

    (Comment 5) One commenter asked whether outputs of the draft
guidance, such as requests for nonbinding feedback or FDA's responses
to requests for nonbinding feedback, will be placed in a public
database.
    (Response) The FD&C Act does not require requests for nonbinding
feedback or FDA's responses to requests for nonbinding feedback to be
placed in a public database. However, FDA may take additional actions
(e.g., issue Warning Letters or safety communications) in response to
significant inspectional observations, some of which may be posted
publicly.
    (Comment 6) Multiple commenters requested that FDA extend the
``deadline'' for requesting nonbinding feedback beyond 15 days after
issuance of a Form FDA 483. For example, some commenters felt that
imposing a 15 day ``deadline'' for requesting nonbinding feedback would
result in rushed remediations without a sufficient understanding of the
root-cause of the underlying quality system deviations.
    (Response) Firms are not required to submit requests for nonbinding
feedback. To be eligible for nonbinding feedback, a request for
nonbinding feedback must involve a public health priority, implicate
systemic or major actions, or relate to emerging safety issues. FDA
believes that a corrective action should be taken as expeditiously as
possible in response to an observation that meets one or more of the
statutory criteria. In situations where a firm is unable to submit a
timely request for nonbinding feedback, the firm has other options to
engage with FDA.
    (Comment 7) Multiple commenters requested that FDA allow multiple
chances to seek nonbinding feedback. For example, some commenters
stated that a firm's initial corrective action plan may change over
time and that remediation may take months; therefore, firms may need
feedback more than once and more than 15 days after issuance of a Form
FDA 483.
    (Response) FDA believes that inspectional observations that involve
a public health priority, implicate systemic or major actions, or
relate to emerging safety issues should be corrected as expeditiously
as possible. FDA acknowledges that in some situations, firms may desire
feedback more than once. If multiple requests for nonbinding feedback
are timely and

meet the other statutory requirements, FDA is required to respond to
each request within 45 days. If multiple requests for nonbinding
feedback are not timely, then these requests will not be subject to a
response from FDA within 45 days.
    Finally, FDA acknowledges that when the inspectional observations
involve a public health priority, implicate a systemic or major action,
or relate to an emerging safety issue, continued communication between
FDA and the firm may be needed after issuance of the nonbinding
feedback to ensure adequate protection of public health. In such cases,
FDA may continue communication with the firm and/or take any action
necessary to ensure adequate protection of public health.
    FDA received one comment regarding ways to minimize the burden of
the collection of information on respondents, including through the use
of automated collection techniques, when appropriate, and other forms
of information technology.
    (Comment 8) One commenter requested that FDA develop templates for
manufacturers to submit when requesting nonbinding feedback.
    (Response) At this time, FDA does not believe that providing a
template would be appropriate since the content of the request for
nonbinding feedback is expected to be situationally dependent and
different firms may have different preferred formats for requesting
nonbinding feedback. FDA believes that use of a template may be too
restrictive and could result in pertinent information not being
included in the request for nonbinding feedback. Nonetheless, FDA may
choose to utilize a template at a later date if it determines it would
be beneficial to firms to do so.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for nonbinding feedback after certain FDA inspections of               220                1              220              500          110,000
 device establishments.............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Our estimate that 220 respondents per year will request nonbinding
feedback is based on recent inspectional data. Based on the
recommendations in the guidance and our experience with similar
information collections, we believe it will take approximately 500
hours to complete a request for nonbinding feedback. Therefore, we
estimate the burden of this information collection to be 110,000 hours.

    Dated: March 9, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-05131 Filed 3-12-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 218 (Thursday, November 10, 2016)]
[Notices]
[Page 79019]
[FR Doc No: 2016-27186]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9030-1]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/nepa.
Weekly receipt of Environmental Impact Statements (EISs) Filed 10/31/
2016 Through 11/04/2016.
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

EIS No. 20160261, Draft, USFS, ID, Coeur d Alene Basin Natural Resource
Restoration Plan, Comment Period Ends: 01/13/2017, Contact: Jo
Christensen<PHONE_NUMBER>
EIS No. 20160262, Draft Supplement, Caltrans, CA, State Route 241-91
Tolled Express Lanes Connector Project, Comment Period Ends: 01/09/
2017, Contact: Bahar Heydari<PHONE_NUMBER>
EIS No. 20160263, Draft, USN, WA, EA-18G ``Growler'' Airfield
Operations at the NAS Whidbey Island Complex, Comment Period Ends: 01/
25/2017, Contact: Sarah Stallings<PHONE_NUMBER>
EIS No. 20160264, Final, USFWS, PRO, Programmatic--Eagle Rule Revision,
Review Period Ends: 12/09/2016, Contact: Eliza Savage<PHONE_NUMBER>
EIS No. 20160265, Draft Supplement, USFS, MT, Beaverhead-Deerlodge
National Forest Land and Resource Management Plan to Comply with the
District Court Order (Bighorn Sheep) 2009 Revised Forest Plan, Comment
Period Ends: 02/09/2017, Contact: Jan Bowey<PHONE_NUMBER>
EIS No. 20160266, Draft, NRC, MO, Construction Permit for the Northwest
Medical Isotopes Radioisotope Production Facility, Comment Period Ends:
12/29/2016, Contact: David Drucker<PHONE_NUMBER>
EIS No. 20160267, Final, VA, SD, National Historic Preservation Act
Section 106 Consultation: Reconfiguration of VA Black Hills Health Care
System, Review Period Ends: 12/09/2016, Contact: Billie J. Beal 605-
720-7243

    Dated: November 7, 2016.
Dawn Roberts,
Management Analyst, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2016-27186 Filed 11-9-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 127 (Monday, July 2, 2018)]
[Rules and Regulations]
[Pages 30865-30866]
[FR Doc No: 2018-14139]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2018-0633]
RIN 1625-AA00

Safety Zone; Columbia River, Kennewick, WA

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

-----------------------------------------------------------------------

SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of the Columbia River near Columbia Park in Kennewick,
WA. This action is necessary to provide for the safety of life on these
navigable waters during a fireworks display on July 4, 2018. This
regulation prohibits persons and vessels from being in the safety zone
unless authorized by the Captain of the Port Columbia River or a
designated representative.

DATES: This rule is effective from 9 p.m. to 11:30 p.m. on July 4,
2018.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to http://www.regulations.gov, type USCG-
2018-0633 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LCDR Laura Springer, Waterways Management Division,
Marine Safety Unit Portland, Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    Tri City Water Follies will be conducting a fireworks display from
10 p.m. to 10:30 p.m. on July 4, 2018, to commemorate Independence Day.
The fireworks are to be launched from Columbia Park in Kennewick, WA,
over the Columbia River. Hazards from firework displays include
accidental discharge of fireworks, dangerous projectiles, and falling
hot embers or other debris. The Captain of the Port Columbia River
(COTP) has determined that potential hazards associated with the
fireworks to be used in this display will be a safety concern for
anyone within a 450-yard radius of the launch site.
    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it would be impracticable to complete
a notice-and-comment rulemaking by the date of the fireworks display,
July 4, 2018.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable because the Coast Guard needs to have
a safety zone regulation in place by July 4, 2018, to respond to the
potential safety hazards associated with the fireworks display on that
date.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The Captain of the Port Columbia River (COTP) has determined that
potential hazards associated with the fireworks display on July 4,
2018, will be a safety concern for anyone within a 450-yard radius of
the launch site. This rule is needed to protect personnel, vessels, and
the marine environment in the navigable waters within the safety zone
before, during, and after the scheduled event.

IV. Discussion of the Rule

    This rule establishes a safety zone from 9 p.m. to 11:30 p.m. on
July 4, 2018. The safety zone will cover all navigable waters of the
Columbia River within 450 yards of a launch site located at
46[deg]13'22'' N, 119[deg]08'30'' W, in vicinity of Columbia Park in
Kennewick, WA. The duration of the zone is intended to ensure the
safety of vessels and these navigable waters an hour before, during,
and an hour after the scheduled 10 p.m. to 10:30 p.m. fireworks
display. No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the size,
location, duration, and time-of-day of the safety zone. Vessel traffic
will be able to safely transit around this safety zone which will
impact a small designated area of the Columbia River for approximately
two and a half hours when vessel traffic is normally low. Moreover, the
Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM marine
channel 16 about the zone, and the rule allows vessels to seek
permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety

zone may be small entities, for the reasons stated in section V.A
above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the national government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section above.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01 and Commandant Instruction M16475.1D, which guide the
Coast Guard in complying with the National Environmental Policy Act of
1969 (42 U.S.C. 4321-4370f), and have determined that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This rule involves
a safety zone lasting approximately two and a half hours that will
prohibit entry within 450 yards of a fireworks launch site. It is
categorically excluded from further review under paragraph L60(a) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 01. A
Record of Environmental Consideration supporting this determination is
available in the docket where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows

    Authority:  33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-
1, and 160.5; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  165.T13-0633 to read as follows:

Sec.  165.T13-0633   Safety Zone; Columbia River, Kennewick, WA.

    (a) Safety zone. The following area is designated a safety zone:
Waters of the Columbia River, within a 450-yard radius of the fireworks
launch site located at 46[deg]13'22'' N, 119[deg]08'30'' W in vicinity
of Columbia Park in Kennewick, WA.
    (b) Regulations. In accordance with Sec.  165.23, no person may
enter or remain in this safety zone unless authorized by the Captain of
the Port Columbia River or his designated representative. Also in
accordance with Sec.  165.23, no person may bring into, or allow to
remain in this safety zone any vehicle, vessel, or object unless
authorized by the Captain of the Port Columbia River or his designated
representative.
    (c) Enforcement period. This section will be enforced from 9 p.m.
to 11:30 p.m. on July 4, 2018.

    Dated: June 25, 2018.
D.F. Berliner,
Captain, U.S. Coast Guard, Acting Captain of the Port, Sector Columbia
River.
[FR Doc. 2018-14139 Filed 6-29-18; 8:45 am]
 BILLING CODE 9110-04-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

WASHINGTON, DC 20460

			OFFICE OF  PREVENTION, PESTICIDES,  AND TOXIC SUBSTANCES

January 2, 2008

MEMORANDUM:

Subject:	Revised Dietary and Drinking Water Exposure Chapter for
Diiodomethy p-tolyl sulfone for the Reregistration Eligibility Decision
(RED) Document (Case 4009)

To:		K. Avivah Jacob, Chemical Review Manager,

		Regulatory Management Branch II

Antimicrobials Division (7510P)

From: 		Cassi Walls, Ph.D., Chemist

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

Thru:		Norm Cook, Branch Chief

Risk Assessment and Science Support Branch (RASSB)

Antimicrobials Division (7510P)

DP Barcode: 		344855

Chemical Name:	Diiodomethyl p-tolyl sulfone

PC Code:		101002

CAS Registry No. 	20018-09-1

Attached is a review of the dietary and drinking water exposures and
risks for the antimicrobial uses of diiodomethyl p-tolyl sulfone to
support the Reregistration Eligibility Decision (RED) document.  The
text of this assessment was revised to correct errors identified during
the error only comment period.

I.	Executive Summary

The Antimicrobials Division (AD) assessed the potential dietary and
drinking water exposures and risks for the antimicrobial uses of
diiodomethyl p-tolyl sulfone.  The potential dietary exposures include
the following: indirect food additive from paper products when used as a
preservative in adhesives, can end and side-seam cements, and sealants
and caulking materials for repeated use food contact surfaces.   None of
the dietary risks exceeded the Agency’s level of concern.  However, it
is recommended that the diiodomethy p-tolyl sulfone labels be revised to
clearly state which set of use directions is intended for the indirect
food uses cleared by FDA.  Furthermore in order to accept non-food
contact paper language, examples of non-food contact paper (i.e.,
newsprint, Kraft paper, brown paper mills, sheets for corrugated board)
must also be listed on the labels.

Based on the use patterns, the potential for diiodomethy p-tolyl sulfone
to impact drinking water sources is negligible and therefore a
quantitative drinking water assessment was not conducted.

II.  SEQ CHAPTER \h \r 1  	Dietary Exposures and Risks to Diiodomethy
p-tolyl sulfone as an Indirect Food Additive

AD assessed the potential dietary exposure to the active ingredient,
diiodomethy p-tolyl sulfone, from its use as an indirect food additive.
The US Food and Drug Administration (US FDA) has granted diiodomethy
p-tolyl sulfone indirect food clearances for the following uses:

175.105 Substances for Use Only as Components of Adhesives

175.300 Substances for Use as Components of Coatings – Resinous and
Polymeric Coatings (Can End and Side Seam Cements) with a limitation of
not to exceed 0.3% by wt in can-sealing cements;

176.300  Substances for Use as Basic Components of Paper and Paperboard
Components – Slimicides with a limitation of not to exceed 0.2 pounds
per ton of dry weight of fiber; and

177.2600 Substances for Use as Basic Components of Repeated Use Food
contact Surfaces – Rubber Articles Intended for Repeated Use with a
limitation of not to exceed 0.3% by wt of sealants and caulking
materials.

It should be noted that in 21CFR176.300, US FDA has cleared the use of
diiodomethy p-tolyl sulfone as an indirect food additive for its use as
a pulp and paper slimicide at a maximum level of 0.20 pound per ton of
dry weight fiber.  However, this use was not assessed in this document
because all of the current diiodomethy p-tolyl sulfone labels for the
pulp and paper slimicide use state for non-food contact paper only.
Although EPA accepts this language on the labels, examples of non-food
contact paper (i.e., newsprint, Kraft paper, brown paper mills, sheets
for corrugated board) must also be listed.  Most of the diiodomethy
p-tolyl sulfone labels will need to be updated to include non-food
contact paper examples.

No residue data have been submitted in support of the diiodomethy
p-tolyl sulfone antimicrobial dietary uses.  Therefore, a
screening-level assessment has been conducted using the US FDA’s
Center for Food Safety & Applied Nutrition’s (CFSAN) approach as
presented in “Preparation of Food Contact Notifications and Food
Additive Petitions for Food Contact Substances: Chemistry
Recommendations” dated December 2007 and memos obtained from FDA
granting the diiodomethy p-tolyl sulfone clearances.  Using the maximum
application rates and US FDA’s default assumptions, “worst-case”
dietary concentration values were calculated by AD and are summarized in
Table 1.

Table 1. Diiodomethy p-tolyl sulfone Dietary Exposures from Indirect
Food Uses

FDA Clearance

(21 CFR §)	Use	Dietary Conc (ppb)	EDI

(µg/person/day)	Dose

 (mg/kg/day)

	Adult	Child	Adult	Child

175.105	Preservative in Adhesives	6.7	20.0	10.0	0.00029	0.00067

177.2600

	Preservative in Repeat-use Rubber Sealants and Caulking Materials	1	3
1.5	0.000043	0.00010

175.300	Preservative in Can Side-Seam Cements	2.7	8.1	4.1	0.00012
0.00027

Preservative of Paper Adhesives

As regulated under 21CFR 175.105, diiodomethy p-tolyl sulfone can be
used to preserve adhesive formulations used in food packaging.  Dietary
exposures to diiodomethy p-tolyl sulfone from this type of use were
estimated using the following assumptions:

Based on FDA’s guidance document, it was assumed that “If the
adhesive is either separated from food by a functional barrier, or the
quantity of adhesive that contacts aqueous and fatty food is limited to
the trace amount at seams and edges, then migration levels for the
substances generally will be assumed to be no greater than 50 ppb.
Applying a CF (consumption factor) of 0.14 for adhesives gives a dietary
concentration of 7 ppb” (US FDA, 2007).  It should be noted that for
components of adhesives, FDA assumes that the food concentration of 50
ppb is for the finished additive, not adhesive (US FDA, 1999).  Note: CF
is the percentage of daily diet expected to contact paper adhesives.

The finished additive, AMICAL 48 (EPA Reg. No. 464-670), contains 95%
active ingredient

Adult food consumption is 3000 g/day; child food consumption is 1500
g/day.

Adult body weight is 70 kg; child body weight is 15 kg.

Calculations:

Determination of the Dietary Concentration (DC):

Food conc. x CF x %ai

	(50 ng adhesive/g food) (0.14) x (95% ai) = 6.7 ng ai/g food

Determination of the Estimated Daily Intake (EDI):

Dietary conc. x Daily food consumption

 μg ai/g food) (3000 g food /day) = 20.0 μg ai/person/day

Child: (0.0067 μg ai/g food) (1500 g food /day) = 10.0 μg
ai/person/day

Determination of the Daily Dietary Dose:

EDI / Body Weight

Adult: (20.0 μg ai /day) (mg/1000 μg) / (70 kg) = 0.00029 mg ai/kg
bw/day

      Child: (10.0 μg ai/day) (mg/1000 μg) / (15 kg) = 0.00067 mg
ai/kg bw/day

Preservative of Can End and Sid- Seam Cements

As regulated under 21CFR 175.300 (Substances for Use as Components of
Coatings – Resinous and Polymeric Coatings), diiodomethy p-tolyl
sulfone also can be used to preserve can end and side seam cement
formulations with the limitation of not to exceed 0.3% by weight.  Based
on FDA’s 1999 memo clearing diiodomethy p-tolyl sulfone indirect food
uses, dietary exposures were estimated using the following assumptions:

Diiodomethy p-tolyl sulfone migrates to all types of food in contact
with side seam cements at a rate of 14 ng ai/g food per day (FAP 6B3961
memorandum dated 10/10/86 and 2/9/87)

Maximum diiodomethy p-tolyl sulfone concentration in cement is 0.3%

Cement quantity per can is 80 mg

Can volume is 177 ml (or 0.177 L)

1% of  cement surface contacts food

Diiodomethy p-tolyl sulfone migration from cement to food is 100%

The consumption factors (CF) is 0.20

Polymer coated can CF = 0.17

Uncoated can CF = 0.03

Adult food consumption is 3000 g/day; child food consumption is 1500
g/day.

Adult body weight is 70 kg; child body weight is 15 kg.

Calculations:

Determination of the food concentration:

(Cement Quantity x %ai) / Can Volume x Cement Surface Contact with Food

((80 mg) (0.3%ai) / (0.177 ml)) (1%) = 0.014 mg ai/L (or 14 ng ai/g
food)

Determination of the Dietary Concentration (DC):

Food conc. x CF

	(14 ng ai/g food) (0.20) = 2.7 ng ai/g food

Determination of the Estimated Daily Intake (EDI):

Dietary conc. x Daily food consumption

 μg ai/g food) (3000 g food /day) = 8.1 μg ai/person/day

Child: (0.0027 μg ai/g food) (1500 g food /day) = 4.1 μg ai/person/day

Determination of the Daily Dietary Dose:

EDI / Body Weight

Adult: (8.1 μg ai /day) (mg/1000 μg) / (70 kg) = 0.00012 mg ai/kg
bw/day

Child: (4.1 μg ai/day) (mg/1000 μg) / (15 kg) = 0.00027 mg ai/kg
bw/day

It should be noted that the FDA clearance for the can side seam cement
preservative use provides a limitation of not to exceed 0.3% diiodomethy
p-tolyl sulfone by weight.  The AMICAL 48 label (EPA Reg. No. 464-670)
provides use instructions for “use in adhesives, caulks and
sealants” as well as “use in rubber and plastic products”.  The
“use in adhesives, caulks and sealants” provides a use rate of
0.0098 – 0.29% ai for “adhesives, binders, e.g. joint compounds,
tile mastics, wallpaper pastes, carpet backing, air filer and foil scrim
Kraft laminate; and sealants and caulks.”  The “use in rubber and
plastic products” provides a use rate of 0.095 – 0.76% ai for
“PVC, polyurethane, rubber, thermoplastic rubber and other polymeric
based products, coating, adhesives, foams, and sealants.”  Neither one
of these use descriptions gives a clear indication of where the can end
and side seam cements would fall under.  Based on discussions during the
SMART meeting, the registrant stated that the can end and side seam
cements would fall under the “use in adhesives, caulks and
sealants”, therefore the maximum application rate of 0.3% ai was used
in this assessment.  It is recommended that the labels be revised to
clearly state which set of use directions is intended for the indirect
food uses cleared by FDA.

Preservative of Repeat-Use Rubber Sealants and Caulking Materials

As regulated under 21CFR 177.2600 (Substances for Use as Basic
Components of Repeated Use Food contact Surfaces – Rubber Articles
Intended for Repeated Use), diiodomethy p-tolyl sulfone also can be used
to preserve can end and side seam cement formulations with the
limitation of not to exceed 0.3% by weight.  Based on FDA’s 1999 memo
clearing diiodomethy p-tolyl sulfone indirect food uses, dietary
exposures were estimated using the following assumptions:

Diiodomethy p-tolyl sulfone migrates to all types of food in incidental
contact with caulk containing 1000 mg/kg diiodomethy p-tolyl sulfone at
a rate of 20 ng ai/g food per day (FAP 7B3321 memorandum dated 10/21/77
and 2/17/78)

The consumption factors (CF) is 0.05 for repeat-use rubber articles

Adult food consumption is 3000 g/day; child food consumption is 1500
g/day.

Adult body weight is 70 kg; child body weight is 15 kg.

Calculations:

Determination of the Dietary Concentration (DC):

Food conc. x CF

	(20 ng ai/g food) (0.05) = 1.0 ng ai/g food

Determination of the Estimated Daily Intake (EDI):

Dietary conc. x Daily food consumption

 μg ai/g food) (3000 g food /day) = 3.0 μg ai/person/day

Child: (0.001 μg ai/g food) (1500 g food /day) = 1.5 μg ai/person/day

Determination of the Daily Dietary Dose:

EDI / Body Weight

Adult: (3.0 μg ai /day) (mg/1000 μg) / (70 kg) = 0.000043 mg ai/kg
bw/day

Child: (1.5 μg ai/day) (mg/1000 μg) / (15 kg) = 0.00010 mg ai/kg
bw/day

It should be noted that the FDA clearance for the repeat use rubber
sealant preservative use provides a limitation of not to exceed 0.3%
diiodomethy p-tolyl sulfone by weight.  The AMICAL 48 label (EPA Reg.
No. 464-670) provides use instructions for “use in adhesives, caulks
and sealants” as well as “use in rubber and plastic products”.
The “use in adhesives, caulks and sealants” provides a use rate of
0.0098 – 0.29% ai for “adhesives, binders, e.g. joint compounds,
tile mastics, wallpaper pastes, carpet backing, air filer and foil scrim
Kraft laminate; and sealants and caulks.”  The “use in rubber and
plastic products” provides a use rate of 0.095 – 0.76% ai for
“PVC, polyurethane, rubber, thermoplastic rubber and other polymeric
based products, coating, adhesives, foams, and sealants.”  Neither one
of these use descriptions gives a clear indication of where the repeat
use rubber sealant would fall under.  Based on discussions during the
SMART meeting, the registrant stated that the repeat use rubber sealant
would fall under the “use in adhesives, caulks and sealants”,
therefore the maximum application rate of 0.3% ai (rather than 0.76% ai)
was used in this assessment.  It is recommended that the labels be
revised to clearly state which set of use directions is intended for the
indirect food uses cleared by FDA.

Cumulative Dietary Exposure

The cumulative estimated dietary intakes (CEDI) of diiodomethy p-tolyl
sulfone from its use as a preservative in adhesives, can end cements,
and repeat-use rubber sealants are presented in Table 2.

Table 2. Diiodomethy p-tolyl sulfone Cumulative Exposures

FDA Clearance

(21 CFR §)	Use	Conc in Food (ng/g)	Dietary Conc (ppb)	EDI
(µg/person/day)	Dose

(mg/kg/day)

Adult	Child	Adult	Child

175.105	Preservative in Adhesives	47.5	6.7	20.0	10.0	0.00029	0.00067

177.2600

	Preservative in Repeat-use Rubber Sealants and Caulking Materials	20	1
3	1.5	0.000043	0.00010

175.300	Preservative in Can Side-Seam Cements	14	2.7	8.1	4.1	0.00012
0.00027

	Cumulative

10.4	31.1	15.5	0.00044	0.0010

Dietary Risks from diiodomethy p-tolyl sulfone as an Indirect Food
Additive

The dietary risks from diiodomethy p-tolyl sulfone used as an indirect
food additive in preservative of adhesives, can side-seam cements, and
repeat-use rubber sealants were calculated using the toxicological data
provided from ADTC (DP Barcode D314321).  There was no appropriate
endpoint selected attributable to an acute exposure, therefore the acute
dietary risks were not necessary to assess.  Utilizing the chronic PAD
of 0.002 mg/kg/day, the dietary risks were estimated and summarized in
Table 3.  None of the uses exceed the Agency’s level of concern for
the chronic exposure durations.

Table 3. Dietary Risks of Diiodomethy p-tolyl sulfone Indirect Food Uses

FDA Clearance

(21 CFR §)	Use	Dose

(mg/kg/day)	%cPAD

Adult	Child	Adult	Child

175.105	Preservative in Adhesives	0.00029	0.00067	14%	33%

177.2600 	Preservative in Repeat-use
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IV.  References:

US Food and Drug Administration (US FDA) Center for Food Safety &
Applied Nutrition’s (CFSAN). 2007.  “Preparation of Food Contact
Notifications and Food Additive Petitions for Food Contact Substances:
Chemistry Recommendations.”
http://www.cfsan.fda.gov/~dms/opa3pmnc.html. December.

US Food and Drug Administration (US FDA) 1999. Memorandum from the
Division of Product Manufacture and Use, Chemistry Review Team HFS-246.
to the Division of Petition Control, HFS-215 Attn: M. Hepp, Ph.D.
“FAP 9B4668 (MATS #1055 M2.0 and 2.1): Angus Chemical Co,; submission
of 5/5/99. 4-(Diiodomethylsulfonyl) toluene as a slimicide in the
manufacture of paper and paperboard.”  August 12.

US Food and Drug Administration (US FDA) 1987. Memorandum from the
Regulatory Food Chemistry Branch, HFF-458.  to the Indirect Additives
Branch, HFF-335 Attn: M. Stephens.  “FAP 6B3961-Abbott Laboratories.
Submission dated 11/4/86. 4-(Diiodomethylsulfonyl) toluene (DIMST) for
use as a component of side seam cements.”  February 9.

US Food and Drug Administration (US FDA) 1986. Memorandum from the
Regulatory Food Chemistry Branch, HFF-458.  to the Indirect Additives
Branch, HFF-335.  “FAP 6B3961-Abbott Laboratories.
4-(Diiodomethylsulfonyl) toluene (DIMST) for use as a component of side
seam cements. Submission dated 8/8/86.”  October 10.

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