UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES February 22, 2002 MEMORANDUM Subject: Reregistration of Methyl Bromide: Product and Residue Chemistry Chapters to the Reregistration Eligibility Document; Chemical No. 53201; DP Barcode D271583 From: Christine L. Olinger, Chemist Reregistration Branch I Health Effects Division ( 7509C)

Through: Whang Phang Ph. D., Branch Senior Scientist Reregistration Branch I Health Effects Division ( 7509C)

and Christina Swartz, Chemist William Hazel, Chemist Reregistration Branch I Health Effects Division ( 7509C)

To: Joseph Nevola Special Review and Reregistration Division ( 7508W)

Attached are the Product and Residue Chemistry Chapters to the Reregistration Eligibility Document for the fumigant methyl bromide. These chapters have been prepared by Dynamac Corporation under supervision of HED, and the review has been revised to reflect Division policies.

Summary of Product Chemistry Chapter Most product chemistry requirements have been satisfied for the technical and manufacturing use products. Confirmatory data are required for the Albemarle 98% FI ( formulation intermediate) and the Great Lakes MPs ( manufacturing use products). 2 Summary of Residue Chemistry Chapter Sufficient residue chemistry data are available to conduct a reasonably reliable dietary exposure assessment. No additional residue chemistry studies are required, but the registrants must modify product labels so they are consistent with the residue studies.

cc: COlinger, Reg. Std. File, 7509C: RRB1: CLOlinger: clo: CM# 2: Rm 722J: 305 5406: 2/ 06/ 02 RDI: CSwartz: 12/ 05/ 01; WPhang: 01/ 30/ 02 H H H Br METHYL BROMIDE REREGISTRATION ELIGIBILITY DECISION:

PRODUCT CHEMISTRY CONSIDERATIONS PC Code 053201; Case No. 0335 DP Barcode D271583 DESCRIPTION OF CHEMICAL Methyl bromide [ bromomethane ( IUPAC)] is an insecticide/ rodenticide registered for use as a pre plant soil fumigant and post harvest crop storage fumigant.

Empirical Formula: CH 3 Br Molecular Weight: 94.94 CAS Registry No.: 74 83 9 PC Code: 053201 IDENTIFICATION OF ACTIVE INGREDIENT Methyl bromide is a colorless, odorless gas at normal temperatures and pressures, and a liquified gas under moderate pressure. Methyl bromide has a specific gravity ( liquid) of 1.732 at 0 C and 760 mm Hg, vapor density ( gas) of 3.27, boiling point of 3.6 C, octanol/ water partition coefficient ( log P ow ) of 1.19, and vapor pressure of 1400 mm Hg at 20 C. Methyl bromide is soluble in water at 1.75 g/ 100 mL at 20 C, and is readily soluble in lower alcohols, ethers, esters, ketones, halogenated hydrocarbons, aromatic hydrocarbons, and carbon disulfide. Methyl bromide degrades by hydrolysis.

MANUFACTURING USE PRODUCTS According to a search of the Reference Files System ( REFS) conducted 2/ 6/ 02, there are seven registered manufacturing use products ( MPs) under PC Code 053201. The registered MPs listed in Table 1 are subject to a reregistration eligibility decision. 2 Table 1. Registered methyl bromide manufacturing use products.

Formulation EPA Reg. No. Registrant 100% T 15298 4 Ameribrom, Incorporated 99.8% T 3377 9 Albemarle Corporation 1 98% FI 2 3377 27 100% T 5785 51 Great Lakes Chemical Corporation 99.5% FI 5785 109 98% FI 5785 56 67% FI 5785 52 1 Previously Ethyl Corporation. 2 Although REFS identifies this product as a technical, the Methyl Bromide Update determined that this product is actually an FI.

REGULATORY BACKGROUND The Methyl Bromide Reregistration Standard issued 3/ 28/ 86 required additional product chemistry data concerning methyl bromide. The Methyl Bromide Guidance Document dated 8/ 86 required that all new product chemistry data be submitted for the reregistration of methyl bromide because new requirements had been introduced and previously submitted data needed to be updated. Data submitted in response to the Guidance Document for the MPs were evaluated in Agency reviews and in the Methyl Bromide Reregistration Standard Update dated 6/ 21/ 91 with regard to adequacy in fulfilling product chemistry requirements. Data in support of registration/ reregistration have been submitted by the Methyl Bromide Industry Panel ( MBIP) which consists of the following members: Albemarle Corporation, Great Lakes Chemicals Corporation, Ameribrom, Inc., and Trical, Inc. The Methyl Bromide Update summarized the available product chemistry database and required additional data for the Ameribrom, Albemarle, and Great Lakes Chemical T/ TGAIs and formulation intermediates ( FIs).

As a safety measure, the Guidance Document required that end use products with methyl bromide as the active ingredient, which will be used for any purpose other than the fumigation of RACs in enclosed chambers, contain 0.25 2.0% chloropicrin as an odor warning agent. Chloropicrin at this concentration is considered/ listed as an inert ingredient.

The current status of the product chemistry data requirements for the methyl bromide T/ TGAIs and FIs is presented in the attached data summary tables. Refer to these tables for a listing of the outstanding product chemistry data requirements. 3 CONCLUSIONS Most pertinent product chemistry requirements data have been satisfied for the Ameribrom 100% and Albemarle 99.8% T/ TGAIs, and for the Albemarle 98% FI; however, additional data are required for the T/ TGAIs concerning oxidation/ reduction and UV/ vis absorption ( OPPTS 830.6314 and 7050) and for the Albemarle 98% FI concerning oxidation/ reduction ( OPPTS 830.6314). All pertinent product chemistry data requirements have been satisfied for the Great Lakes 99.5% FI. Additional data are required for the remaining Great Lakes MPs as follow: ( i) for the 100% T/ TGAI, data concerning certified limits, oxidation/ reduction, and UV/ vis absorption ( OPPTS 830.1750, 6314, and 7050); ( ii) for the 98% FI, discussions/ data concerning formation of impurities, certified limits, enforcement methods, and oxidation/ reduction ( OPPTS 830.1600, 1670, 1800, and 6314); and ( iii) for the 67% FI, discussions/ data concerning formation of impurities, enforcement methods, and oxidation/ reduction ( OPPTS 830.1670, 1800, and 6314). Provided that the registrants submit the data required in the attached data summary tables for the methyl bromide MPs, and either certify that the suppliers of beginning materials and the manufacturing processes have not changed since the last comprehensive product chemistry reviews or submit complete updated product chemistry data packages, the Branch has no objections to the reregistration of methyl bromide with respect to product chemistry data requirements. 4 Case No. 0335 PC Code: 053201 Case Name: Methyl bromide Registrant: Ameribrom, Incorporated Product( s): 100% T ( EPA Reg. No. 15298 4)

PRODUCT CHEMISTRY DATA SUMMARY Guideline Number Requirement Are Data Requirements Fulfilled? 1 MRID Number 2 830.1550 Product identity and composition Y 40138201, CSF 7/ 2/ 96 3 830.1600 Description of materials used to produce the product Y 40138201, 42500801 4 830.1620 Description of production process Y 40138201, 42500801 4 830.1670 Discussion of formation of impurities Y 40138201 830.1700 Preliminary analysis Y 42500802 4 830.1750 Certified limits Y 40138201, 42500802 4, CSF 7/ 2/ 96 3 830.1800 Enforcement analytical method Y 42500802 4 830.6302 Color Y 40138201 830.6303 Physical state Y 40138201 830.6304 Odor N/ A 5 40138201 830.6313 Stability to normal and elevated temperatures, metals, and metal ions N/ A 6 830.6314 Oxidation/ reduction: chemical incompatability N 830.6315 Flammability N/ A 7 830.6316 Explodability N/ A 6 830.6317 Storage stability Y 40832501 8 830.6319 Miscibility N/ A 7 830.6320 Corrosion characteristics Y 42933201 9 830.7000 pH N/ A 6 40138201 830.7050 UV/ visible absorption N 10 830.7100 Viscosity N/ A 7 830.7200 Melting point/ melting range N/ A 7 40138201 830.7220 Boiling point/ boiling range N/ A 7 40138201 830.7300 Density/ relative density/ bulk density N/ A 7 40138201 830.7370 Dissociation constants in water N/ A 6 830.7550 Partition coefficient ( n octanol/ water), shake flask method Y 42541301 11 830.7840 Water solubility: column elution method; shake flask method Y 40138201, 42537801 11, 43257101 12 830.7950 Vapor pressure N/ A 7 40138201 1 Y = Yes; N = No; N/ A = Not Applicable.

2 Bolded references were reviewed in the Methyl Bromide Reregistration Standard Update dated 6/ 21/ 91; all other references were reviewed as noted.

3 RD Memorandum, D228391, 8/ 5/ 96, A. Skapars.

4 DP Barcode D183771, 2/ 12/ 93, D. McNeilly. 5 5 Data are not required because methyl bromide is a hazardous gas.

6 Data requirements were waived under DP Barcode D173004, 2/ 7/ 92, R. Perfetti.

7 Data are not required because the TGAI/ MP is a gas at room temperature and standard pressure.

8 MBIP data; DP Barcode D208064, 11/ 15/ 96, K. Dockter.

9 DP Barcode D202501, 5/ 3/ 94, F. Toghrol.

10 The OPPTS Series 830, Product Properties Test Guidelines require data pertaining to UV/ visible absorption for the PAI.

11 MBIP data; DP Barcodes D184917 and D184926, 3/ 2/ 93, D. McNeilly.

12 MBIP data; DP Barcodes D204592 and D204938, 9/ 8/ 94, F. Toghrol. 6 Case No. 0335 PC Code: 053201 Case Name: Methyl bromide Registrant: Albemarle Corporation Product( s): 99.8% T ( EPA Reg. No. 3377 9)

PRODUCT CHEMISTRY DATA SUMMARY Guideline Number Requirement Are Data Requirements Fulfilled? 1 MRID Number 2 830.1550 Product identity and composition Y 40254204, 43588301 3 CSF 6/ 2/ 97 4, CSF 3/ 16/ 00 5 830.1600 Description of materials used to produce the product Y 40254204, 43588301 3, 45080201 5 830.1620 Description of production process Y 40254204, 43588301 3, 45080201 5 830.1670 Discussion of formation of impurities Y 40254204, 43588301 3, 45080201 5 830.1700 Preliminary analysis Y 40254205, 42500701 6, 43588301 3, 45080201 5 830.1750 Certified limits Y 40254205, 43588301 3 CSF 6/ 2/ 97 4, CSF 3/ 16/ 00 5 830.1800 Enforcement analytical method Y 42500701 6 830.6302 Color Y 43588302 3 830.6303 Physical state Y 43588302 3 830.6304 Odor N/ A 7 830.6313 Stability to normal and elevated temperatures, metals, and metal ions N/ A 8 830.6314 Oxidation/ reduction: chemical incompatability N 9 40254206 830.6315 Flammability N/ A 10 830.6316 Explodability N/ A 8 40254206 830.6317 Storage stability Y 40832501 11 830.6319 Miscibility N/ A 10 830.6320 Corrosion characteristics Y 42933201 12 830.7000 pH N/ A 8 830.7050 UV/ visible absorption N 13 830.7100 Viscosity N/ A 10 40254206 830.7200 Melting point/ melting range N/ A 10 830.7220 Boiling point/ boiling range N/ A 10 830.7300 Density/ relative density/ bulk density N/ A 10 830.7370 Dissociation constants in water N/ A 8 830.7550 Partition coefficient ( n octanol/ water), shake flask method Y 42541301 14 830.7840 Water solubility: column elution method; shake flask method Y 42537801 14, 43257101 15 830.7950 Vapor pressure N/ A 10 1 Y = Yes; N = No; N/ A = Not Applicable. Data for the basic and alternate formulation have been reviewed.

2 Bolded references were reviewed in the Methyl Bromide Reregistration Standard Update dated 6/ 21/ 91; all other 7 references were reviewed as noted.

3 DP Barcodes D213604 and D228086, 11/ 14/ 96, K. Dockter.

4 RD Memorandum, D237440, 12/ 30/ 97, B. Kitchens.

5 RD Memorandum, D265672, 6/ 5/ 00, B. Kitchens.

6 DP Barcode D183769, 2/ 11/ 93, D. McNeilly.

7 Data are not required because methyl bromide is a hazardous gas.

8 Data requirements were waived under DP Barcode D173004, 2/ 7/ 92, R. Perfetti.

9 Additional data are required concerning the procedure, raw data, and calculations used in the determination.

10 Data are not required because the TGAI/ MP is a gas at room temperature and standard pressure.

11 MBIP data; DP Barcode D208064, 11/ 15/ 96, K. Dockter.

12 DP Barcode D202501, 5/ 3/ 94, F. Toghrol.

13 The OPPTS Series 830, Product Properties Test Guidelines require data pertaining to UV/ visible absorption for the PAI.

14 MBIP data; DP Barcodes D184917 and D184926, 3/ 2/ 93, D. McNeilly.

15 MBIP data; DP Barcodes D204592 and D204938, 9/ 8/ 94, F. Toghrol. 8 Case No. 0335 PC Code: 053201 Case Name: Methyl bromide Registrant: Albemarle Corporation Product( s): 98% FI ( EPA Reg. No. 3377 27)

PRODUCT CHEMISTRY DATA SUMMARY Guideline Number Requirement Are Data Requirements Fulfilled? 1 MRID Number 2 830.1550 Product identity and composition Y 40315901, 44004101 3, 44004102 3, CSF 6/ 2/ 97 4 830.1600 Description of materials used to produce the product Y 40315901, 44004101 3 830.1650 Description of formulation process Y 40315901, 44004101 3 830.1670 Discussion of formation of impurities Y 40315901, 44004101 3 830.1700 Preliminary analysis Y 44004102 3 830.1750 Certified limits Y 44004101 3, 44004102 3, CSF 6/ 2/ 97 4 830.1800 Enforcement analytical method Y 44004102 3 830.6302 Color Y 44043101 3 830.6303 Physical state Y 44043101 3 830.6304 Odor N/ A 5 830.6313 Stability to normal and elevated temperatures, metals, and metal ions N/ A 6 830.6314 Oxidation/ reduction: chemical incompatability N 7 40315903 830.6315 Flammability N/ A 8 830.6316 Explodability N/ A 9 40315903 830.6317 Storage stability Y 40832501 10 830.6319 Miscibility N/ A 8 830.6320 Corrosion characteristics Y 42933201 11 830.7000 pH N/ A 9 830.7050 UV/ visible absorption N/ A 6 830.7100 Viscosity N/ A 9 40315903 830.7200 Melting point/ melting range N/ A 6 830.7220 Boiling point/ boiling range N/ A 6 830.7300 Density/ relative density/ bulk density N/ A 8 830.7370 Dissociation constants in water N/ A 6 830.7550 Partition coefficient ( n octanol/ water), shake flask method N/ A 6 830.7840 Water solubility: column elution method; shake flask method N/ A 6 830.7950 Vapor pressure N/ A 6 1 Y = Yes; N = No; N/ A = Not Applicable. Although REFS identifies this product as a technical, the Methyl Bromide Update determined that its is actually an FI manufactured from an EPA registered product; therefore, all TGAI data requirements will be fulfilled by data for the technical source product.

2 Bolded references were reviewed in the Methyl Bromide Reregistration Standard Update dated 6/ 21/ 91; all other references were reviewed as noted. 9 3 DP Barcodes D213604 and D228086, 11/ 14/ 96, K. Dockter.

4 RD Memorandum, D237441, 12/ 30/ 97, B. Kitchens.

5 Data are not required because methyl bromide is a hazardous gas.

6 Data requirements for the TGAI will be fulfilled by data for the technical source product.

7 Additional data are required concerning the procedure, raw data, and calculations used in the determination.

8 Data are not required because the TGAI/ MP is a gas at room temperature and standard pressure.

9 Data requirements were waived under DP Barcode D173004, 2/ 7/ 92, R. Perfetti.

10 MBIP data; DP Barcode D208064, 11/ 15/ 96, K. Dockter.

11 DP Barcode D202501, 5/ 3/ 94, F. Toghrol. 10 Case No. 0335 PC Code: 053201 Case Name: Methyl bromide Registrant: Great Lakes Chemical Corporation Product( s): 100% T ( EPA Reg. No. 5785 51)

PRODUCT CHEMISTRY DATA SUMMARY Guideline Number Requirement Are Data Requirements Fulfilled? 1 MRID Number 2 830.1550 Product identity and composition Y 40253201, 42569603 3, 42571801 3 830.1600 Description of materials used to produce the product Y 40253201, 42571801 3 830.1620 Description of production process Y 40253201, 42571801 3 830.1670 Discussion of formation of impurities Y 40253201 830.1700 Preliminary analysis Y 40253202, 42569601 3 830.1750 Certified limits N 4 40253202, 42569603 3, 42571801 3 830.1800 Enforcement analytical method Y 40253203,42569601 3 830.6302 Color Y 40253203 830.6303 Physical state Y 40253203 830.6304 Odor N/ A 5 40253203 830.6313 Stability to normal and elevated temperatures, metals, and metal ions N/ A 6 42053203 830.6314 Oxidation/ reduction: chemical incompatability N 7 40253203 830.6315 Flammability N/ A 8 830.6316 Explodability N/ A 6 40253203 830.6317 Storage stability Y 40253203, 40832501 9 830.6319 Miscibility N/ A 8 830.6320 Corrosion characteristics Y 40253203, 42933201 10 830.7000 pH N/ A 6 830.7050 UV/ visible absorption N 11 830.7100 Viscosity N/ A 8 830.7200 Melting point/ melting range N/ A 8 830.7220 Boiling point/ boiling range N/ A 8 40253203 830.7300 Density/ relative density/ bulk density N/ A 8 40253203 830.7370 Dissociation constants in water N/ A 6 830.7550 Partition coefficient ( n octanol/ water), shake flask method Y 40253203, 42541301 12 830.7840 Water solubility: column elution method; shake flask method Y 40253203, 42537801 12, 43257101 13 830.7950 Vapor pressure N/ A 8 40253203 1 Y = Yes; N = No; N/ A = Not Applicable.

2 Bolded references were reviewed in the Methyl Bromide Reregistration Standard Update dated 6/ 21/ 91; all other references were reviewed as noted.

3 D275390, C. Olinger 7/ 17/ 01. 11 4 The CSF must be revised to adjust the proposed upper certified limit for methyl bromide.

5 Data are not required because methyl bromide is a hazardous gas.

6 Data requirements were waived under DP Barcode D173004, 2/ 7/ 92, R. Perfetti.

7 Additional data are required concerning the procedure, raw data, and calculations used in the determination.

8 Data are not required because the TGAI/ MP is a gas at room temperature and standard pressure.

9 MBIP data; DP Barcode D208064, 11/ 15/ 96, K. Dockter.

10 DP Barcode D196315, 1/ 13/ 94, F. Toghrol.

11 The OPPTS Series 830, Product Properties Test Guidelines require data pertaining to UV/ visible absorption for the PAI.

12 MBIP data; DP Barcodes D184917 and D184926, 3/ 2/ 93, D. McNeilly.

13 MBIP data; DP Barcodes D204592 and D204938, 9/ 8/ 94, F. Toghrol. 12 Case No. 0335 PC Code: 053201 Case Name: Methyl bromide Registrant: Great Lakes Chemical Corporation Product( s): 99.5% FI ( EPA Reg. No. 5785 109)

PRODUCT CHEMISTRY DATA SUMMARY Guideline Number Requirement Are Data Requirements Fulfilled? 1 MRID Number 2 830.1550 Product identity and composition Y CSF 12/ 18/ 99 3 830.1600 Description of materials used to produce the product N/ A 4 830.1650 Description of formulation process N/ A 4 830.1670 Discussion of formation of impurities N/ A 4 830.1700 Preliminary analysis N/ A 5 830.1750 Certified limits Y CSF 12/ 18/ 99 3 830.1800 Enforcement analytical method N/ A 4 830.6302 Color N/ A 4 830.6303 Physical state N/ A 4 830.6304 Odor N/ A 6 830.6313 Stability to normal and elevated temperatures, metals, and metal ions N/ A 5 830.6314 Oxidation/ reduction: chemical incompatability N/ A 4 830.6315 Flammability N/ A 7 830.6316 Explodability N/ A 8 830.6317 Storage stability Y 40832501 9 830.6319 Miscibility N/ A 7 830.6320 Corrosion characteristics Y 42933201 10 830.7000 pH N/ A 8 830.7050 UV/ visible absorption N/ A 5 830.7100 Viscosity N/ A 7 830.7200 Melting point/ melting range N/ A 5 830.7220 Boiling point/ boiling range N/ A 5 830.7300 Density/ relative density/ bulk density N/ A 7 830.7370 Dissociation constants in water N/ A 5 830.7550 Partition coefficient ( n octanol/ water), shake flask method N/ A 5 830.7840 Water solubility: column elution method; shake flask method N/ A 5 830.7950 Vapor pressure N/ A 5 1 Y = Yes; N = No; N/ A = Not Applicable. This product was registered under a " Me Too" application. The Technical Review Branch approved bridging data for an identical end use product ( EPA Reg. No. 5785 8) as well as data for the 100% T ( EPA Reg. No. 5785 51) and the 98% FI ( EPA Reg. No. 5785 56) to fulfill data requirements ( DP Barcode D253973, 3/ 25/ 99, E. McAndrew). Because the product is manufactured from an EPAregistered product, TGAI data requirements will be fulfilled by data for the technical source product.

2 All references were reviewed as noted. 13 3 RD Memorandum, D253971, 4/ 19/ 99, S. Mathur.

4 Data requirements will be fulfilled by bridging data for EPA Reg. Nos. 5785 8, 5785 51, and/ or 5785 56.

5 Data requirements for the TGAI will be fulfilled by data for the technical source product.

6 Data are not required because methyl bromide is a hazardous gas.

7 Data are not required because the TGAI/ MP is a gas at room temperature and standard pressure.

8 Data requirements were waived under DP Barcode D173004, 2/ 7/ 92, R. Perfetti.

9 MBIP data; DP Barcode D208064, 11/ 15/ 96, K. Dockter.

10 DP Barcode D196315, 1/ 13/ 94, F. Toghrol. 14 Case No. 0335 PC Code: 053201 Case Name: Methyl bromide Registrant: Great Lakes Chemical Corporation Product( s): 98% FI ( EPA Reg. No. 5785 56)

PRODUCT CHEMISTRY DATA SUMMARY Guideline Number Requirement Are Data Requirements Fulfilled? 1 MRID Number 2 830.1550 Product identity and composition Y 42571803 3, CSF 8/ 6/ 96 3 830.1600 Description of materials used to produce the product Y 42571803 3 830.1650 Description of formulation process Y 42571803 3 830.1670 Discussion of formation of impurities N 830.1700 Preliminary analysis N/ A 5 830.1750 Certified limits N 4 42571803 3, CSF 8/ 6/ 96 3 830.1800 Enforcement analytical method N 830.6302 Color Y 42571803 3 830.6303 Physical state Y 42571803 3 830.6304 Odor N/ A 6 830.6313 Stability to normal and elevated temperatures, metals, and metal ions N/ A 5 830.6314 Oxidation/ reduction: chemical incompatability N 830.6315 Flammability N/ A 7 830.6316 Explodability N/ A 8 830.6317 Storage stability Y 40832501 9 830.6319 Miscibility N/ A 7 830.6320 Corrosion characteristics Y 42933201 10 830.7000 pH N/ A 8 830.7050 UV/ visible absorption N/ A 5 830.7100 Viscosity N/ A 7 830.7200 Melting point/ melting range N/ A 5 830.7220 Boiling point/ boiling range N/ A 5 830.7300 Density/ relative density/ bulk density N/ A 7 830.7370 Dissociation constants in water N/ A 5 830.7550 Partition coefficient ( n octanol/ water), shake flask method N/ A 5 830.7840 Water solubility: column elution method; shake flask method N/ A 5 830.7950 Vapor pressure N/ A 5 1 Y = Yes; N = No; N/ A = Not Applicable. The 98% FI is manufactured from an EPA registered product; therefore, all TGAI data requirements will be fulfilled by data for the technical source product.

2 Bolded references were reviewed in the Methyl Bromide Reregistration Standard Update dated 6/ 21/ 91; all other references were reviewed as noted.

3 D275390, C. Olinger 7/ 17/ 01.

4 The CSF must be revised to list the current sources of the warning agent and the respective EPA Reg. Nos. 15 5 Data requirements for the TGAI will be fulfilled by data for the technical source product.

6 Data are not required because methyl bromide is a hazardous gas.

7 Data are not required because the TGAI/ MP is a gas at room temperature and standard pressure.

8 Data requirements were waived under DP Barcode D173004, 2/ 7/ 92, R. Perfetti.

9 MBIP data; DP Barcode D208064, 11/ 15/ 96, K. Dockter.

10 DP Barcode D196315, 1/ 13/ 94, F. Toghrol. 16 Case No. 0335 PC Code: 053201 Case Name: Methyl bromide Registrant: Great Lakes Chemical Corporation Product( s): 67% FI ( EPA Reg. No. 5785 52)

PRODUCT CHEMISTRY DATA SUMMARY Guideline Number Requirement Are Data Requirements Fulfilled? 1 MRID Number 2 830.1550 Product identity and composition Y CSF 8/ 19/ 97 3 830.1600 Description of materials used to produce the product Y 42571802 4 830.1650 Description of formulation process Y 42571802 4, 44230001 5 830.1670 Discussion of formation of impurities N 830.1700 Preliminary analysis N/ A 6 830.1750 Certified limits Y 42571802 4, CSF 8/ 19/ 97 3 830.1800 Enforcement analytical method N 830.6302 Color Y 42571802 4 830.6303 Physical state Y 42571802 4 830.6304 Odor N/ A 7 830.6313 Stability to normal and elevated temperatures, metals, and metal ions N/ A 6 830.6314 Oxidation/ reduction: chemical incompatability N 830.6315 Flammability N/ A 8 830.6316 Explodability N/ A 9 830.6317 Storage stability Y 40832501 10 830.6319 Miscibility N/ A 8 830.6320 Corrosion characteristics Y 42933201 11 830.7000 pH N/ A 9 830.7050 UV/ visible absorption N/ A 6 830.7100 Viscosity N/ A 8 830.7200 Melting point/ melting range N/ A 6 830.7220 Boiling point/ boiling range N/ A 6 830.7300 Density/ relative density/ bulk density N/ A 8 830.7370 Dissociation constants in water N/ A 6 830.7550 Partition coefficient ( n octanol/ water), shake flask method N/ A 6 830.7840 Water solubility: column elution method; shake flask method N/ A 6 830.7950 Vapor pressure N/ A 6 1 Y = Yes; N = No; N/ A = Not Applicable. The 67% FI is manufactured from an EPA registered product; therefore, all TGAI data requirements will be fulfilled by data for the technical source product.

2 All references were reviewed as noted.

3 RD Letter, 11/ 10/ 97, M. Waller 4 D275390, C. Olinger 7/ 17/ 01. 17 5 RD Memorandum, D234151, 7/ 1/ 97, A. Smith.

6 Data requirements for the TGAI will be fulfilled by data for the technical source product.

7 Data are not required because methyl bromide is a hazardous gas.

8 Data are not required because the TGAI/ MP is a gas at room temperature and standard pressure.

9 Data requirements were waived under DP Barcode D173004, 2/ 7/ 92, R. Perfetti.

10 MBIP data; DP Barcode D208064, 11/ 15/ 96, K. Dockter.

11 DP Barcode D196315, 1/ 13/ 94, F. Toghrol. 18 AGENCY MEMORANDA CITED IN THIS DOCUMENT CBRS No( s).: 9225 and 9269 DP Barcode( s): D173004 Subject: Great Lakes Chemical Corp.: Response to the Methyl Bromide Reregistration Standard: Product and Residue Chemistry Data Waiver Requests. From: R. Perfetti To: W. Burnam and L. Rossi Dated: 2/ 7/ 92 MRID( s): None CBRS No( s).: 10752 DP Barcode( s): D183769 Subject: Methyl Bromide: Product Chemistry Data, GDLN 62 3. From: D. McNeilly To: D. Mackey Dated: 2/ 11/ 93 MRID( s): 42500701 CBRS No( s).: 10757 DP Barcode( s): D183771 Subject: Methyl Bromide: Product Chemistry Data, Ameribrom Corp. Subdivision D, GDLNs: 61 2, 62 1, 62 2, and 62 3. From: D. McNeilly To: D. Mackey Dated: 2/ 12/ 93 MRID( s): 42500801 and 42500802 CBRS No( s).: 10922 and 10923 DP Barcode( s): D184917 and 184926 Subject: Methyl Bromide: Product Chem Data, GDLNs 63 8, 63 11. From: D. McNeilly To: D. Mackey Dated: 3/ 2/ 93 MRID( s): 42537801 and 42541301 19 CBRS No( s).: 12752 DP Barcode( s): D196315 Subject: Methyl Bromide Reregistration: List A Chemical No. 053201; Case No. 0335. Great Lakes Response to Methyl Bromide Product Chemistry Data Requirements Regarding Corrosion Characteristics ( GLN No. 63 20). From: F. Toghrol To: L. Rossi/ L. Schnaubelt Dated: 1/ 13/ 94 MRID( s): 42933201 CBRS No( s).: 13577 DP Barcode( s): D202501 Subject: Methyl Bromide Reregistration: List A Chemical No. 053201; Case No. 0335. Methyl Bromide Industry Panel ( MBIP) Response ( letter dated 4/ 25/ 94) to Methyl Bromide Product Chemistry Data Requirements Regarding Corrosion Characteristics ( GLN No. 63 20). From: F. Toghrol To: L. Rossi/ L. Schnaubelt Dated: 5/ 3/ 94 MRID( s): 42933201 CBRS No( s).: 13922 and 13941 DP Barcode( s): D204592 and D204938 Subject: Methyl Bromide Reregistration: List A Chemical No. 053201; Case No. 0335. MBIP: Response to Methyl Bromide Product Chemistry Data Requirements Regarding Methyl Bromide Solubility ( GLN No. 63 8). From: F. Toghrol To: L. Schnaubelt Dated: 9/ 8/ 94 MRID( s): 43257101 CBRS No( s).: 13101 DP Barcode( s): D198382 Subject: Methyl Bromide Reregistration: List A Chemical No. 053201; Case No. 0335. Ameribrom, Inc.: Response to Methyl Bromide Product Chemistry Data Requirements Regarding Methyl Bromide Product Identity and Disclosure of Ingredients and Certification of Ingredient Limits ( GLN No. 61 1 and 62 2). From: F. Toghrol To: L. Schnaubelt Dated: 9/ 27/ 94 MRID( s): None 20 DP Barcode( s): RD Memorandum D228391 Subject: Product Chemistry Review; Reg. No. or File Symbol No. 15298 4. From: A. Skapars To: W. Francis/ L. Dobbins Dated: 8/ 5/ 96 MRID( s): None CBRS No( s).: 15331 and 17499 DP Barcode( s): D213604 and D228086 Subject: Methyl Bromide Reregistration. Albemarle 3/ 13 & 15/ 95 and 2/ 1 & 6/ 14/ 96 Responses [ Series 830 Data & CSF for the 99% T; 3377 9 and Series 830 Data for the 98% T; [ 3377 27] to the Agency 3/ 22/ 94 Letter, RE: the 6/ 21/ 91 Reregistration Standard Update, and " as a Follow up to the Albemarle 2/ 22/ 95 Letter". From: K. Dockter To: P. Deschamp Dated: 11/ 14/ 96 MRID( s): 43588301, 43588302, 44004101, 44004102, and 44043101 CBRS No( s).: 14482 DP Barcode( s): D208064 Subject: Methyl Bromide Reregistration. CMA 9/ 29/ 94 Response [ 830.6317 Data for EPA Reg. No. 5785 51 AA] to R. Perfetti 2/ 7/ 92 Review; CBRS 9225. Chemical 053201, Case 0335. From: K. Dockter To: P. Deschamp Dated: 11/ 15/ 96 MRID( s): 40832501 DP Barcode( s): RD Memorandum D234151 Subject: Product Chemistry Review; Reg./ File Symbol No. 5785 52; Product Name: 67 33; Company: Great Lakes Chem Corp. From: A. Smith To: K. Swift Dated: 7/ 1/ 97 MRID( s): 44230001 21 DP Barcode( s): RD Letter Subject: Review of Basic Formula Dated August 19, 1997; 67 33; EPA Reg. No. 5785 52; Your Letter Dated August 19, 1997. From: M. Waller To: P. Bricker, Great Lakes Chemical Corporation Dated: 11/ 10/ 97 MRID( s): None DP Barcode( s): RD Memorandum D237440 Subject: Product Chemistry Review; Reg./ File Symbol No. 3377 9; Product Name: Methyl Bromide Technical; Company: Albemarle Corporation. From: B. Kitchens To: M. Waller/ T. Stowe Dated: 12/ 30/ 97 MRID( s): None DP Barcode( s): RD Memorandum D237441 Subject: Product Chemistry Review; Reg./ File Symbol No. 3377 27; Product Name: MB R 98 Technical; Company: Albemarle Corporation. From: B. Kitchens To: M. Waller/ T. Stowe Dated: 12/ 30/ 97 MRID( s): None DP Barcode( s): TRB Memorandum D253973 Subject: Technical Review Branch Similarity Clinic Determination. EPA Reg. No. 5785 RNO. Methyl Bromide 99.5. Case No. 064296. From: E. McAndrew To: T. Stowe Dated: 3/ 25/ 99 MRID( s): None DP Barcode( s): RD Memorandum D253971 Subject: Product Chemistry Review; Reg./ File Symbol No. 5785 RNO; Product Name: Methyl Bromide 99.5; Company: Great Lakes Chemical Corporation. From: S. Mathur To: M. Waller Dated: 4/ 19/ 99 MRID( s): None 22 DP Barcode( s): RD Memorandum D265672 Subject: Product Chemistry Review; Reg./ File Symbol No. 3377 9; Product Name: Methyl Bromide Technical; Company: Albemarle Corporation. From: B. Kitchens To: M. Waller/ T. Stowe Dated: 6/ 5/ 00 MRID( s): 45080201 DP Barcode( s): D275390 Subject: Reregistration of Methyl Bromide: Product Chemistry Data From: C. Olinger To: J. Nevola Dated: 7/ 17/ 01 MRID( s): 42569601, 42569603, 42571801 42571803 PRODUCT CHEMISTRY CITATIONS Bibliographic citations include only MRIDs containing data which fulfill data requirements.

References ( cited):

40138201 Ameribrom, Inc. ( 1987) Product Chemistry: Methyl Bromide. Unpublished compilation. 13 p.

40253201 McAllister, D. ( 1986) Methyl Bromide  Product Identity: Laboratory Project ID: 921 157. Unpublished compilation prepared by Great Lakes Chemical Corp. 13 p.

40253202 McAllister, D. ( 1986) Methyl Bromide  Analysis and Certification of Product Ingredients: Laboratory Project ID: 921 163. Unpublished compilation prepared by Great Lakes Chemical Corp. 28 p.

40253203 McAllister, D. ( 1986) Methyl Bromide  Physical and Chemical Characteristics: Laboratory Project ID: 921 150. Unpublished compilation prepared by Great Lakes Chemical Corp. 4 p.

40254204 Ethyl Corp. ( 1987) Methyl Bromide Technical  Product Chemistry. Unpublished compilation. 19 p.

40254205 Ethyl Corp. ( 1987) Methyl Bromide Technical  Product Chemistry. Unpublished study. 6 p.

40254206 Ethyl Corp. ( 1987) Methyl Bromide Technical  Product Chemistry. Unpublished study. 3 p. 23 40315901 Ethyl Corp. ( 1987) M B R 98 Technical  Product Chemistry Data. Unpublished compilation. 14 p.

40315903 Ethyl Corp. ( 1987) M B R 98 Technical  Product Chemistry: Physical and Chemical Properties. Unpublished study. 3 p.

40832501 Ivancovich, A. ( 1988) Methyl Bromide Storage Stability Study Longterm Storage: Project ID: B. R. No. 12.87. Unpublished study prepared by Bolsa Research Associates. 16 p.

42500701 Ethyl Corp. ( 1992) Methyl Bromide Technical: Product Chemistry. Unpublished study. 8 p.

42500801 Cohen, T. ( 1992) Methyl Bromide: Product Chemistry: Lab Project Number: 8326/ DCI/ 92 61. Unpublished study prepared by Bromine Compounds Ltd. 25 p.

42500802 Cohen, T. ( 1992) Methyl Bromide: Product Chemistry: Lab Project Number: 8326/ DCI/ 92 62. Unpublished study prepared by Bromine Compounds Ltd. 19 p.

42537801 Chemical Manufacturers Association ( 1992) Determination of Water Solubility of Methyl Bromide: Unpublished study prepared by Great Lakes Corp. 16 p.

42541301 Secara, S. ( 1990) Methyl Bromide  Octanol/ Water Partition Coefficient: Lab Project Number: BR 172: 90. Unpublished study prepared by BOLSA Research Associates, Inc. 11 p.

42569601 Severs, L. ( 1992) Method Validation and Preliminary Analysis for Methyl Bromide Formulations: Final Report: Lab Project Number: WILL 12294. Unpublished study prepared by EIL Research Labs., Inc. 84 p.

42569603 Kelley, J. ( 1992) Certification of Limits for Methyl Bromide, " 98 2" and " 67 33": Lab Project Number. Unpublished study prepared by Great Lakes chemical Corp. 8 p.

42571801 McAllister, D. ( 1992) Product Chemistry Data: Methyl Bromide. Unpublished study prepared by Great Lakes Chemical Corp. 74 p.

42571802 McAllister, D. ( 1992) Product Chemistry Data: Methyl Bromide. Unpublished study prepared by Great Lakes Chemical Corp. 25 p.

42571803 McAllister, D. ( 1992) Product Chemistry Data: Methyl Bromide. Unpublished study prepared by Great Lakes Chemical Corp. 25 p.

42933201 Spires, P.; Coffey, R. ( 1993) Methyl Bromide Formulation Corrosion Studies: Final Report: Lab Project Number: MBIP 19.0 CORROS GLC. Unpublished study prepared by Great Lakes Chemical Corporation. 56 p. 24 43257101 Severs, L. ( 1994) Determination of Methyl Bromide Solubility in Petroleum Based Solvents: Final Report: Lab Project Number: WILL 49012. Unpublished study prepared by WILL Research Labs., Inc. 49 p.

43588301 Daigle, C. ( 1995) Methyl Bromide Technical  Product Chemistry. Unpublished study prepared by Albemarle Corp. 33 p.

43588302 Daigle, C. ( 1995) Methyl Bromide Technical  Product Chemistry. Unpublished study prepared by Albemarle Corp. 3 p.

44004101 Albemarle Corp. ( 1996) M B R 98 Technical  Product Chemistry: ( Product Identity and Composition). Unpublished study. 35 p.

44004102 Albemarle Corp. ( 1996) M B R 98 Technical  Product Chemistry: ( Analysis and Certification of Ingredients): Lab Project Number: BR726: 95. Unpublished study. 60 p.

44043101 Ter Haar, G. ( 1996) M B R 98 Technical  Product Chemistry: ( Physical and Chemical Characteristics): Lab Project Number: 36MS001.187.01. Unpublished study prepared by Albemarle Corp. 4 p.

44230001 Howland, M. ( 1997) Product Chemistry Data. for 67 33: Update ( to the Manufacturing Process). Unpublished study prepared by Great Lakes Chemical Corp. 8 p.

45080201 Card, S. ( 2000) Product Chemistry Beginning Materials, Preliminary Analysis of Methyl Bromide Technical. Unpublished study prepared by Albemarle Corp. 18 p. { OPPTS 830.1550, 830.1600, 830.1670, 830.1700, 830.1750} METHYL BROMIDE REREGISTRATION ELIGIBILITY DECISION RESIDUE CHEMISTRY CONSIDERATIONS PC Code 053201; Case No. 0335 DP Barcode D271583 TABLE OF CONTENTS page INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 REGULATORY BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 SUMMARY OF SCIENCE FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 OPPTS GLN 860.1200: Directions for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 OPPTS GLN 860.1300: Nature of the Residue in Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 OPPTS GLN 860.1300: Nature of the Residue in Livestock . . . . . . . . . . . . . . . . . . . . . . . . 3 OPPTS GLN 860.1340: Residue Analytical Methods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 OPPTS GLN 860.1360: Multiresidue Method Testing . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 OPPTS GLN 860.1380: Storage Stability Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 OPPTS GLN 860.1500: Magnitude of the Residue in Crop Plants . . . . . . . . . . . . . . . . . . . . 4 OPPTS GLN 860.1520: Magnitude of the Residue in Processed Food/ Feed . . . . . . . . . . . . 4 OPPTS GLN 860.1480: Magnitude of the Residue in Meat, Milk, Poultry, and Eggs . . . . . 4 OPPTS GLN 860.1400: Magnitude of the Residue in Water, Fish, Irrigated Crops . . . . . . . 4 OPPTS GLN 860.1460: Magnitude of the Residue in Food handling Establishments . . . . . . 4 OPPTS GLN 860.1850 and 1900: Rotational Crops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 TOLERANCE REASSESSMENT SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 DIETARY EXPOSURE ASSESSMENT SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 CODEX HARMONIZATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 AGENCY MEMORANDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 RESIDUE CHEMISTRY CITATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 H H H Br METHYL BROMIDE REREGISTRATION ELIGIBILITY DOCUMENT RESIDUE CHEMISTRY CONSIDERATIONS PC Code 053201; Case 0335 DP Barcode D271583 INTRODUCTION Methyl bromide is an insecticide and antimicrobial pesticide registered for pre plant soil fumigation and post harvest fumigation of numerous raw agricultural commodities and processed foods and feeds. Methyl bromide is registered by members of the Methyl Bromide Industry Panel ( MBIP), which includes Ameribrom, Inc., Albemarle Corp., Great Lakes Chemical Co., and Tri Cal, Inc. Pressurized gas ( PrG) formulations for commodity fumigation are marketed under the trade names Meth O Gas and Metabrom.

REGULATORY BACKGROUND Methyl bromide is a List A reregistration chemical. It was the subject of a Registration Standard issued 3/ 28/ 86, a Guidance Document issued 8/ 86, and a Registration Standard Update issued 6/ 21/ 91. These documents summarized the regulatory conclusions on the available residue chemistry data and specified that additional data were required for reregistration purposes. Several submissions of data have been received since the Registration Standard Update was issued. The information contained in this document outlines the current Residue Chemistry Science Assessments with respect to the reregistration of methyl bromide.

Tolerances for residues of inorganic bromides in/ on plant raw agricultural commodities ( RACs) and processed foods and feeds that have been fumigated with methyl bromide have been established under 40 CFR § 180.123. Tolerances for residues of inorganic bromides in/ on plant RACs grown in soil fumigated with combinations of chloropicrin, methyl bromide, and propargyl bromide have been established under 40 CFR § 180.199.

The EPA has determined that soil fumigation uses of methyl bromide are classified as non food uses ( S. Irene, 1/ 31/ 97). The Agency has also approved the replacement of inorganic bromide tolerances with tolerances for methyl bromide per se, as supported by residue chemistry data ( Letter to MBIP, A. Lindsay, 7/ 7/ 89). Subsequently, in conjunction with acceptance of plant metabolism data, HED recommended that methyl bromide per se is the residue to be regulated ( DP Barcode D168913, R. Perfetti, 9/ 24/ 91). 2 The Food Quality Protection Act ( FQPA) of 1996 has amended and strengthened the standard for establishing tolerances under the Federal Food, Drug, and Cosmetic Act ( FFDCA). All future tolerance petitions as well as reassessment of established tolerances must meet the requirements of the FFDCA as amended by the FQPA. OPP may require additional data to determine if the terms of the amended statute are met.

SUMMARY OF SCIENCE FINDINGS OPPTS GLN 860.1200: Directions for Use A search of the Agency's Reference Files System ( REFS) on 2/ 1/ 01 indicated that there are five methyl bromide end use products ( EPs) with post harvest uses on food/ feed commodities registered to members of the MBIP. These EPs are presented below.

Methyl bromide End Use Products with Food/ Feed Uses Registered to Members of the MBIP.

EPA Reg No. Label Acceptance Date Formulation Class Product Name 5785 11 6/ 6/ 97 100% PrG Meth O Gas 100 5785 41 11/ 4/ 94 100% PrG Meth O Gas Q 8622 5 8/ 96 99.7% PrG Ameribrom Methyl Bromide Grain Fumigant 8622 16 8/ 19/ 99 100% PrG Metabrom 100 8622 55 8/ 19/ 99 100% PrG Metabrom Q A comprehensive summary of the registered food/ feed use patterns of methyl bromide, based on the product labels currently registered to the MBIP, is presented in Tables A1 and A2. These tables also indicate any recommended label changes, such removing use directions for commodities that are no longer being supported, and revising exposure rates and times to be consistent with the exposures reflected in the supporting residue data. A tabular summary of the residue chemistry science assessments for reregistration of methyl bromide is presented in Table B. The conclusions listed in Table B regarding the reregistration eligibility of methyl bromide food/ feed uses are based on the use patterns registered by members of the MBIP. When end use product DCIs are developed ( e. g., at issuance of the RED), RD should require that all end use product labels ( e. g., MAI labels, SLNs, and products subject to the generic data exemption) be amended such that they are consistent with the basic producers' labels.

OPPTS GLN 860.1300: Nature of the Residue in Plants The qualitative nature of the residue in plants is adequately understood, based on studies in which the commodities maize, potato, alfalfa, peanuts, almonds, oatmeal, apples, oranges, and wheat were fumigated with radioactive methyl bromide at a rate equivalent to ~ 2x the registered rate. Residues consisted of methyl bromide and naturally occurring compounds such as methylated amino acids and nucleotides. The residue of concern is methyl bromide per se.

HED has determined that the pre plant soil fumigation use is a non food use. Treated soil must 3 be fumigated for a minimum of two weeks to allow sufficient dissipation of residues; excessive residues of methyl bromide per se would be phytotoxic. Minimal methyl bromide residues are available for uptake by the plant at the end of the soil aeration period. Considering the highly reactive nature of methyl bromide, any residues taken up by the plant would be converted to natural constituents by the time of plant harvest. Therefore, tolerances are not needed to support the pre plant fumigation use of methyl bromide.

OPPTS GLN 860.1300: Nature of the Residue in Livestock Animal metabolism data are not required for methyl bromide. Potential feed items with registered post harvest or storage fumigation uses include stored grain, soybeans, and processed animal feeds. The maximum tolerance for residues in any of these is 10 ppm, based on residues 24 hours after the aeration period that follows fumigation. The transfer of detectable residues from feed items to meat, milk or eggs, is not expected, and is a Category ( 3) situation under 40 CFR § 180.6( a).

OPPTS GLN 860.1340: Residue Analytical Methods The head space procedure of King et al. for determining methyl bromide has been forwarded to FDA for inclusion in PAM Vol. II. This method is adequate for data collection and would be suitable for tolerance enforcement on plant and processed food commodities. Analytical methods for secondary residues of methyl bromide in livestock commodities are not required.

OPPTS GLN 860.1360: Multiresidue Method Testing FDA multiresidue test methods are not applicable to methyl bromide. Protocols A and B are not applicable to monohalogenated alkanes. Although methyl bromide would be detectable in protocol C, residues would like not be recovered through any of the extraction techniques.

OPPTS GLN 860.1380: Storage Stability Data Methyl bromide residues decline rapidly, e. g., 30% in rice stored in dry ice for 40 hours. For the commodity fumigation residue trials, the registrants agreed to place residue samples in impermeable containers at < 3.7 C as soon as possible. HED has determined that storage stability data are not required unless samples are or have been stored for longer than 12 hours. Most of the residue data used to reassess tolerances were generated from samples stored for 12 hours or less. For some samples stored for longer intervals, results were compared with initial analyses obtained after shorter periods; the results were comparable. Therefore, there are no unresolved storage stability issues related to samples used for tolerance reassessment. 4 OPPTS GLN 860.1500: Magnitude of the Residue in Crop Plants Provided that the specified amendments are made in label use directions, the requirements for magnitude of the residue data in/ on plants are fulfilled for the crop groups covering commodities labeled for methyl bromide post harvest fumigation. Adequate data are available for carrots, potatoes, radishes, sugar beets, turnips, garlic, onions ( bulb and green), celery, lettuce ( head and leaf), spinach, broccoli, cabbage, cauliflower, beans ( dried and succulent), peas ( dried and succulent), soybeans, peppers, tomatoes ( field and greenhouse), cantaloupes, cucumbers, summer squash, grapefruit, lemons, oranges, apples, pears, cherries, peaches, plums, blackberries, almonds, pecans, pistachios, walnuts, corn ( field and sweet), rice, sorghum, wheat, asparagus, blueberries, grapes, kiwi fruit, pineapple, and strawberries.

The MBIP does not intend to support post harvest fumigation uses of methyl bromide on alfalfa, avocados, coffee, copra, cottonseed, mangoes, okra, papayas, peanuts, pomegranates, or timothy ( DP Barcode D197531, R. Perfetti, 1/ 10/ 94).

OPPTS GLN 860.1520: Magnitude of the Residue in Processed Food/ Feed The reregistration requirements for magnitude of the residue in processed food/ feed commodities are fulfilled for apples, grapes, tomatoes, citrus, corn, wheat, and rice. The available processing studies indicate that methyl bromide residues do not concentrate in any processed commodity.

OPPTS GLN 860.1480: Magnitude of the Residue in Meat, Milk, Poultry, and Eggs Residues of for methyl bromide are not expected in meat, milk, poultry, and eggs when livestock are fed raw agricultural commodities treated with methyl bromide. Therefore, tolerances for residues in livestock commodities are not needed. Reisudes in some processed foods derived from animal products ( e. g. dried eggs, cheeses, and cured meats) are regulated by the tolerance for processed foods.

OPPTS GLN 860.1400: Magnitude of the Residue in Water, Fish, Irrigated Crops As there are no aquatic uses of methyl bromide, this guideline is not applicable.

OPPTS GLN 860.1460: Magnitude of the Residue in Food handling Establishments Data requirements are fulfilled for processed foods that are fumigated with methyl bromide. Adequate data are available on dried herbs and spices, flour, corn meal, rolled oats, cake mix, Parmesan cheese, dried eggs, chocolate chips, cocoa butter, chocolate liquor, instant white rice, shelled roasted peanuts, unpopped popcorn, and country ham. These data are also sufficient to cover residues in stored animal feeds. 5 OPPTS GLN 860.1850 and 1900: Rotational Crops These guidelines are not applicable to methyl bromide. The agricultural uses of methyl bromide are non food uses; therefore, residues in rotational crops are also not of concern. 6 continued, footnotes follow Table A1. Post harvest uses of methyl bromide on raw agricultural commodities registered to members of the Methyl Bromide Industry Panel ( MBIP). a Commodity Maximum Dosage ( lb ai/ 1000 ft3) Maximum Exposure time ( hours) Recommended label revisions b Alfalfa, hay 3 24 Remove from labels; the MBIP is not supporting this use.

Almonds 3.5 24 Apples 5 2 Apricots 5 2 Artichokes, Jerusalem 3.5 4 Asparagus 4 2 The available data support a maximum rate of 3.5 lb ai/ 1000 ft3 for 2 hours Barley 9 24 The available data support a maximum dose of 3 lb ai/ 1000 ft3 for 24 hours.

Beans ( all) 4 24 The available data support a maximum rate of 4 lb ai/ 1000 ft3 for 2 hours for succulent beans and for 24 hours for dried beans. Beans ( dried) 4 24 Beets ( roots) 3 4 Blackberries None None The available data would support a maximum dose of 3 lb ai/ 1000 ft3 for 4 hours.

Blueberries 2 4 Brazil nuts 3.5 24 Broccoli None None The available data would support a maximum dose of 4 lb ai/ 1000 ft3 for 2 hours.

Bushnuts 3.5 24 Butternuts 3.5 24 Cabbage 4 4 Cantaloupes 4 2 The available data support a maximum dose of 2.5 lb ai/ 1000 ft3 for 2 hours.

Carrots 4 4 Cashews 3.5 24 Cauliflower None None The available data would support a maximum rate of 4 lb ai/ 10000 ft3 for 2 hours Cherries 5 2 Chestnuts 3.5 24 Chestnuts ( vacuum) 6 6 Table A1. Continued.

Commodity Maximum Dosage ( lb ai/ 1000 ft3) Maximum Exposure time ( hours) Recommended label revisions b 7 continued, footnotes follow Cippolini bulbs 4 4 The available data support a maximum dose of 3 lb ai/ 1000 ft3 for 6 hours.

Citron c 3 2 Directions should be clarified to indicate the use is on the citrus fruit, citron.

Cocoa beans 2 24 The available data support a maximum of two applications at 1.5 lb ai/ 1000 ft3 each for 24 hours with a minimum retreatment interval of 12 days.

Cocoa beans ( vacuum) 1.5 12 Coffee beans 3 24 Remove from labels; the MBIP is not supporting uses on coffee beans or copra. Copra 3.5 24 Corn 9 24 The available data support a maximum dose of 4 lb ai/ 1000 ft3 for 24 hours. Corn, pop ( vacuum) 9 3 Corn, sweet 3 4 Cottonseed 8 24 Remove from labels; MBIP is not supporting this use.

Cucumbers 4 4 The available data support a maximum rate of 2 lb ai/ 1000 ft3 for 4 hours Eggplant 3 4 Filberts 3.5 24 Garlic 3 4 The available data support a maximum rate of 2.5 lb ai/ 1000 ft3 for 4 hours Grapefruit 3 2 Grapes 4 4 The available data support a maximum dose of 4 lb ai/ 1000 ft3 for 2 hours.

Hickory nuts 3.5 24 Honeydew melons 4 2 The available data support a maximum dose of 2.5 lb ai/ 1000 ft3 for 2 hours.

Horseradish 3 4 Kiwi fruit None None The available data would support a maximum dose of 4 lb ai/ 1000 ft3 for 3 hours.

Kumquats 3 2 Leafy vegetables None None The available data would support a maximum rate of 4 lb ai/ 1000 ft3 for 2 hours Lemons 3 2 Table A1. Continued.

Commodity Maximum Dosage ( lb ai/ 1000 ft3) Maximum Exposure time ( hours) Recommended label revisions b 8 continued, footnotes follow Limes 3 2 Macadamia nuts 3.5 24 Muskmelons 4 2 The available data support a maximum dose of 2.5 lb ai/ 1000 ft3 for 2 hours.

Nectarines 5 2 Oats 3 24 Okra 3.5 2 Remove from labels; MBIP is not supporting this use.

Onions 3 6 Oranges 3 2 Parsnips 3 4 Peaches 5 2 Peanuts 3.5 24 Remove from labels; MBIP is not supporting this use.

Pears 5 2 Peas ( with pods) 3 2 Peas ( dried) 4 24 Pecans 3.5 24 Peppers 4 2 Pimentos 2.5 3 Pineapples 6 6 The available residue data support a maximum dose of 4 lb ai/ 1000 ft3 for 2 hours Pistachios 3.5 24 Plums 5 2 Potatoes 3 6 Pumpkins 2.5 2 Quinces 5 2 Radishes 3 4 The available data support a maximum dose of 3 lb ai/ 1000 ft3 for 4 hours.

Rice 9 24 The available data support a maximum rate of 3 lb ai/ 1000 ft3 for 24 hours.

Rutabagas 3 6 Rye 9 24 The available data support a maximum rate of 3 lb ai/ 1000 ft3 for 24 hours.

Salsify roots 3 3 Table A1. Continued.

Commodity Maximum Dosage ( lb ai/ 1000 ft3) Maximum Exposure time ( hours) Recommended label revisions b 9 Sorghum ( grain) 9 24 The available data support a maximum rate of 4 lb ai/ 1000 ft3 for 24 hours.

Squash ( summer) 4 2 The available data support a maximum rate of 3 lb ai/ 1000 ft3 for 2 hours.

Squash ( winter) 4 2 The available cantaloupe data support a maximum rate of 2.5 lb ai/ 1000 ft3 for 2 hours.

Squash, zucchini 2.5 3 The available data support a maximum rate of 3 lb ai/ 1000 ft3 for 2 hours.

Strawberries 3 4 Sugar beets ( roots) 3 4 The available data support a maximum rate of 3 lb ai/ 1000 ft3 for 2 hours.

Sweet potatoes 4 4.5 The available data support a maximum rate of 4 lb ai/ 1000 ft3 for 4 hours.

Tangelos 3 2 Tangerines 3 2 Tomatoes 3 4 Turnips ( roots) 3 4 Walnuts 3.5 24 Watermelons 4 2 The available data support a maximum dose of 2.5 lb ai/ 1000 ft3 for 2 hours.

Wheat 3 24 Yams 4 4.5 The available data support a maximum dose of 4 lb ai/ 1000 ft3 for 4 hours.

a The maximum rate and duration of exposure are based on use directions on one or more of the following labels, registered to members of the MBIP for post harvest applications: EPA Reg. Nos. 5785 11 ( dated 6/ 97), 5785 41 ( dated 11/ 94), 8622 5 ( dated 1/ 92), 8622 16 ( dated 8/ 99), and 8622 55 ( dated 8/ 99). The labels do not specify a maximum number of applications and the minimum intervals between applications. Treated areas must be aerated until methyl bromide concentration is # 5 ppm. b Post harvest fumigation uses that the MBIP is not supporting are listed in DP Barcode D197531, R. Perfetti, 1/ 10/ 94. c Based upon the use rate, the use on citron is assumed to be on the citrus fruit and not on citron melons. 10 Table A2. Food/ feed uses of methyl bromide registered to members of the MBIP on processed commodities.

Commodity/ structure Maximum Dosage ( lb ai/ 1000 ft3) Max. Exposure time ( hours) Recommended label rate changes, supported by residue data Chocolate products ( e. g. cocoa butter, chocolate chips, and chocolate liquor) None None The available data support a maximum rate of 1.5 lb ai/ 1000 ft3 for 24 hours Dried fruits ( e. g., apples, apricots, cherries, dates, peaches, prunes, raisins) 2 24 The available data support a maximum rate of 1.5 lb ai/ 1000 ft3 for 24 hours.

Figs ( dried) 2 24 Cheese ( e. g., Parmesan and Roquefort) 2 24 The available data support a maximum rate of 3 lb ai/ 1000 ft3 for 24 hours. Eggs ( dried) 2 24 Hams and cured meats 2 24 Processed foods 2 48 Processed grain 2 24 Prunes 5 2 The available data support a maximum rate of 1.5 lb ai/ 1000 ft3 for 24 hours.

Spices and herbs ( dried) 3 24 The available data support a maximum of two applications each at 3.5 lb ai/ 1000 ft3 for 12 hours with a minimum retreatment interval of 24 hours.

Animal feed ( e. g., pet food) 2 24 Premise treatment Warehouses, grain elevators, grain bins, poultry houses, restaurants, food processing plants 9 72 a The maximum rate and duration of exposure are based on use directions on one or more of the following labels, registered to members of the MBIP for post harvest applications: EPA Reg. Nos. 5785 11 ( dated 6/ 97), 5785 41 ( dated 11/ 94), 8622 5 ( dated 1/ 92), 8622 16 ( dated 8/ 99), and 8622 55 ( dated 8/ 99). The labels do not specify a maximum number of applications and the minimum intervals between applications. Treated areas must be aerated until methyl bromide concentration is # 5 ppm. ( continued; footnotes follow) 11 Table B. Residue Chemistry Science Assessments for Reregistration of Methyl Bromide.

GLN: Data Requirements Current Tolerances, ppm [ 40 CFR] Must Additional Data Be Submitted? References 1 860.1200: Directions for Use N/ A Yes2 See Table A.

860.1300: Plant Metabolism N/ A No 00065237 00079550 416277013 421377014 860.1300: Animal Metabolism N/ A No 860.1340: Residue Analytical Methods  Plant commodities N/ A No 00026180 00043601 00079041 00112926 00118768 00118838 00149535 00152907 00153317 00160629 40579501 40607801  Animal commodities N/ A No 860.1360: Multiresidue Methods N/ A N/ A 860.1380: Storage Stability Data N/ A No 00153317 40618501 860.1500: Crop Field Trials Root and Tuber Vegetables Group 00088683 00089457 00090408 00119550 00152907 00153317  Carrots 30.0 [ § 180.123( a)( 1)] No 429496015  Jerusalem artichokes 30.0 [ § 180.123( a)( 1)] No  Ginger roots 100 [ § 180.123( c)( 1)] 100 [ § 180.199( c)] No 00090408 00119550 409264016 409265016  Horseradish 30.0 [ § 180.123( a)( 1)] No  Parsnip roots 30.0 [ § 180.123( a)( 1)] No  Potatoes 30.0 [ § 180.123( a)( 1)] No 429496015  Radishes 30.0 [ § 180.123( a)( 1)] No 429496015  Rutabagas 30.0 [ § 180.123( a)( 1)] No Table B. ( continued).

GLN: Data Requirements Current Tolerances, ppm [ 40 CFR] Must Additional Data Be Submitted? References 1 ( continued; footnotes follow) 12  Salsify roots 30.0 [ § 180.123( a)( 1)] No  Sugar beet roots No 429496015  Sweet potatoes 30.0 [ § 180.123( a)( 1)] No  Turnips, roots 30.0 [ § 180.123( a)( 1)] No 429496015 Leaves of Root and Tuber Vegetables Group  Sugar beet tops No Bulb Vegetables Group 00079043 00088683 00089457 00152907 00153317  Cippolini 50.0 [ § 180.123( a)( 1)] No  Garlic 50.0 [ § 180.123( a)( 1)] No 429496015  Onions 20.0 [ § 180.123( a)( 1)] 300 ( dry bulb) [ § 180.199( b)] No 429496015 Leafy Vegetables ( Except Brassica) Group 00079048 00152907 00157445  Celery None No 429496015  Lettuce 300 [ § 180.199( b)] No 429496015  Spinach None No 429496015 Brassica Leafy Vegetables Group 00013057 00140445 00152907 00153317 00157445  Broccoli 25 [ § 180.199( a)] No 429496015  Cauliflower 25 [ § 180.199( a)] No 429496015  Cabbage 50.0 [ § 180.123( a)( 1)] No 429496015 Table B. ( continued).

GLN: Data Requirements Current Tolerances, ppm [ 40 CFR] Must Additional Data Be Submitted? References 1 ( continued; footnotes follow) 13 Legume Vegetables Group 00088683 00089457 00118817 00127221 00152907 00153317  Beans 50.0 [ § 180.123( a)( 1)] No 429496015  Beans, green 50.0 [ § 180.123( a)( 1)] No 429496015  Beans, lima 50.0 [ § 180.123( a)( 1)] No 429496015  Beans, snap 50.0 [ § 180.123( a)( 1)] No 429496015  Peas 50.0 [ § 180.123( a)( 1)] No 429496015  Peas, black eyed 50.0 [ § 180.123( a)( 1)] No  Soybeans 200.0 [ § 180.123( a)( 1)] No 429496015 Fruiting Vegetables ( Except Cucurbits) Group 00013000 00013057 00088683 00089457 00118837 00135683 00152907 00153317  Eggplant 20.0 [ § 180.123( a)( 1)] 60 [ § 180.199( a)] No  Peppers 30.0 [ § 180.123( a)( 1)] 25 [ § 180.199( a)] No 429496015  Pimentos 30.0 [ § 180.123( a)( 1)] No  Tomatoes 20.0 [ § 180.123( a)( 1)] 40 [ § 180.199( a)] No 429496015 Cucurbit Vegetables Group 00013057 00089457 00152907 00153317  Cantaloupes 20.0 [ § 180.123( a)( 1)] No 429496015 Table B. ( continued).

GLN: Data Requirements Current Tolerances, ppm [ 40 CFR] Must Additional Data Be Submitted? References 1 ( continued; footnotes follow) 14  Cucumbers 30.0 [ § 180.123( a)( 1)] No 429496015  Honeydew melons 20.0 [ § 180.123( a)( 1)] No  Muskmelon 20.0 [ § 180.123( a)( 1)] 40 [ § 180.199( a)] No  Pumpkins 20.0 [ § 180.123( a)( 1)] No  Squash, summer 30.0 [ § 180.123( a)( 1)] No 429496015  Squash, winter 20.0 [ § 180.123( a)( 1)] No  Squash, zucchini 20.0 [ § 180.123( a)( 1)] No  Watermelon 20.0 [ § 180.123( a)( 1)] No Citrus Fruits Group 10.0 [ § 180.242( a)] No 00066267 00089457 00153317  Citrus citron 30.0 [ § 180.123( a)( 1)] No  Grapefruit 30.0 [ § 180.123( a)( 1)] No 429496015  Kumquats 30.0 [ § 180.123( a)( 1)] No  Lemons 30.0 [ § 180.123( a)( 1)] No 430258017  Limes 30.0 [ § 180.123( a)( 1)] No  Oranges 30.0 [ § 180.123( a)( 1)] No 429496015  Tangerines 30.0 [ § 180.123( a)( 1)] No Pome Fruits Group 00088683 00118837 00153317 00160628  Apples 5.0 [ § 180.123( a)( 1)] No 429496015 Table B. ( continued).

GLN: Data Requirements Current Tolerances, ppm [ 40 CFR] Must Additional Data Be Submitted? References 1 ( continued; footnotes follow) 15  Pears 5.0 [ § 180.123( a)( 1)] No 429496015  Quinces 5.0 [ § 180.123( a)( 1)] No Stone Fruits Group 00089457 00149535 00153317 00160628  Apricots 20.0 [ § 180.123( a)( 1)] No  Cherries 20.0 [ § 180.123( a)( 1)] No 429496015  Nectarines 20.0 [ § 180.123( a)( 1)] No 430258017  Peaches 20.0 [ § 180.123( a)( 1)] No 429496015 430258017  Plums 20.0 [ § 180.123( a)( 1)] No 429496015 430258017 Small Fruits and Berries Group 429496015  Blueberries 20.0 [ § 180.123( a)( 1)] No 00089457 00127767 00149535 00152907 00153317 429496015 Tree Nuts Group 00088683 00118821 00119256 00149535 00153317  Almonds 200.0 [ § 180.123( a)( 1)] No 438850018  Brazil nuts 200.0 [ § 180.123( a)( 1)] No  Bush nuts 200.0 [ § 180.123( a)( 1)] No  Butternuts 200.0 [ § 180.123( a)( 1)] No  Cashews 200.0 [ § 180.123( a)( 1)] No  Chestnuts 200.0 [ § 180.123( a)( 1)] No  Filberts 200.0 [ § 180.123( a)( 1)] No Table B. ( continued).

GLN: Data Requirements Current Tolerances, ppm [ 40 CFR] Must Additional Data Be Submitted? References 1 ( continued; footnotes follow) 16  Hickory nuts 200.0 [ § 180.123( a)( 1)] No  Pecans 200.0 [ § 180.123( a)( 1)] No 438850018  Pistachio nuts 200.0 [ § 180.123( a)( 1)] No 438850018  Walnuts 200.0 [ § 180.123( a)( 1)] No 438850018 Cereal Grains Group 00088683 00089457 00090269 00109713 00118817 00118820 00118838 00149535 00153317  Barley 50.0 [ § 180.123( a)( 1)] No  Corn 50.0 [ § 180.123( a)( 1)] No 429496015  Corn, pop 240.0 [ § 180.123( a)( 1)] No  Corn, sweet 50.0 [ § 180.123( a)( 1)] No 429496015  Oats 50.0 [ § 180.123( a)( 1)] No  Rice 50.0 [ § 180.123( a)( 1)] No 429496015  Rye 50.0 [ § 180.123( a)( 1)] No  Sorghum 50.0 [ § 180.123( a)( 1)] No 429496015  Wheat 50.0 [ § 180.123( a)( 1)] No 429496015 Grass Forage and Hay Group  Timothy, hay 50.0 [ § 180.123( a)( 1)] No Non grass Animal Feeds Group 00088683 00118830  Alfalfa, hay 50.0 [ § 180.123( a)( 1)] No Table B. ( continued).

GLN: Data Requirements Current Tolerances, ppm [ 40 CFR] Must Additional Data Be Submitted? References 1 ( continued; footnotes follow) 17 Herbs and Spices Group 400 [ § 180.123( a)( 2)( i)( A)] No 00090408 00118838 00119550 00152907 00153317 00160627 430298017 Miscellaneous Commodities  Artichokes 20.0 [ § 180.123( a)( 1)] No  Asparagus 100.0 [ § 180.123( a)( 1)] 300 [ § 180.199( b)] No 00079048 00090147 429496015  Avocados 75.0 [ § 180.123( a)( 1)] No 00135683  Cocoa 50.0 [ § 180.123( a)( 1)] No 00088683 00153317 430257017  Coffee 75.0 [ § 180.123( a)( 1)] No 00090408 00119550 00153317  Copra 100.0 [ § 180.123( a)( 1)] No 00089457 00118838  Cottonseed 200.0 [ § 180.123( a)( 1)] No 00088638  Grapes 20.0 [ § 180.123( a)( 1)] No 00089457 00118829 00149535 00152907 00153317 429496015 430258017  Kiwi fruit None No 429496015  Mangoes 20.0 [ § 180.123( a)( 1)] No  Okra 30.0 [ § 180.123( a)( 1)] 00152907  Papayas 20.0 [ § 180.123( a)( 1)] No  Peanuts 200 [ § 180.123( a)( 1)] No 00088683 00089066  Pineapples 20.0 [ § 180.123( a)( 1)] 300 [ § 180.199( a)] No 00012908 429496015 Table B. ( continued).

GLN: Data Requirements Current Tolerances, ppm [ 40 CFR] Must Additional Data Be Submitted? References 1 18  Pomegranates 100.0 [ § 180.123( a)( 1)] No  Strawberries 60.0 [ § 180.123( a)( 1)] 300 [ § 180.199( a)] No 00012999 00013057 00089457 00096432 00118845 00149535 00152907 00153317 429496015  Tobacco NA 00153317 860.1520: Processed Food/ Feed 125 [ § 180.123( a)( 2)( i)( D)] 00088683 00109713 00118817 00118837 00118838 00153317  Apple wet pomace, juice None No 432787019 433434019  Citrus pulp, juice, oil No 432787019  Corn grain milled fractions No 429638015  Corn, sweet, cannery waste No 432870019  Grape wet pomace, juice No 432787019 433434019  Potato No  Raisins No 438850028  Rice, hulls No 430236017  Soybean, meal, oil No  Tomato, wet pomace, juice No 432474019  Wheat, milled fractions ( exc. flour) No 430253017 860.1480: Meat, Milk, Poultry, and Eggs None No 860.1400: Water, Fish, and Irrigated Crops None N/ A 860.1460: Food Handling  Dog Food 400 [ § 180.123( a)( 3)( i)] No  Dried eggs 400 [ § 180.123( a)( 2)( i)( A)] No 430251017 430252017 Table B. ( continued).

GLN: Data Requirements Current Tolerances, ppm [ 40 CFR] Must Additional Data Be Submitted? References 1 19 1. References were reviewed in the Methyl Bromide Guidance Document dated 8/ 86. Bolded references were reviewed in the Methyl Bromide Reregistration Standard Update ( 6/ 21/ 91). Other references were reviewed as noted.

2. Based upon the available residue data and/ or changes in data requirements, the Agency is recommending changes to use directions. The recommended label amendments are listed in Tables A1 and A2.

3. CBRS No. 7101, no DP Barcode, R. Perfetti, 3/ 8/ 91.

4. DP Barcode D168913, R. Perfetti, 9/ 24/ 91.  Dried figs 250 [ § 180.123( a)( 2)( i)( C)] No 438850028  Fermented malt beverages 25 [ § 180.123( a)( 2)( ii)] 25 [ § 180.123( a)( 4)] No  Grain Milled Fractions 125 [ § 180.123( a)( 3)( ii)] 125 [ § 180.521( a)( 3)] No  Parmesan cheese and Roquefort cheese 325 [ § 180.123( a)( 2)( i)( B)] No 430251017 430252017  Processed grain 125 180.522( a)( 1) No  Processed herbs and spices 400 [ § 180.123( a)( 2)( i)( A)] No 430298017  Tomato products, concentrated 250 [ § 180.123( a)( 2)( i)( C)] No  Processed foods 125 [ § 180.123( a)( 2)( i)( D)] No 430251017 430252017 4362970110 860.1850: Confined Rotational Crops N/ A NA 860.1900: Field Rotational Crops None NA Table B ( continued).

20 5. DP Barcodes D196312 and D196317, R. Perfetti, 4/ 7/ 94. 6. CBTS Nos. 4764 and 4766, S. Malak, 8/ 22/ 89.

7. DP Barcodes D197515, D197516, D197517, D197518, D197519, D197520, D197528; R. Perfetti; 5/ 6/ 94.

8. DP Barcode D275389, C. Olinger, 7/ 17/ 01.

9. DP Barcodes D204238, D205160, D205462, D206950; R. Perfetti; 11/ 16/ 94.

10. DP Barcode D215044, B. Cropp Kohlligian, 8/ 15/ 95. 21 TOLERANCE REASSESSMENT SUMMARY Tolerances are currently established for residues of inorganic bromides ( calculated as Br) in/ on raw and processed commodities that have been fumigated with the antimicrobial agent and insecticide methyl bromide [ 40 CFR § 180.123]. The Agency has approved the replacement of inorganic bromide tolerances with tolerances for methyl bromide per se as supported by residue chemistry data ( Letter to MBIP, A. Lindsay, 7/ 7/ 89). In conjunction with acceptance of plant metabolism data, HED subsequently recommended that methyl bromide per se is the residue to be regulated ( DP Barcode D168913, R. Perfetti, 9/ 24/ 91).

The reassessed tolerances under 40 CFR § 180.123( a) should be defined in terms of residues of methyl bromide per se resulting from the post harvest, stored commodity fumigation use of products containing methyl bromide. The post harvest designation ( POST H) following each commodity listing can be deleted.

Tolerances have also been established for residues of inorganic bromides ( calculated as Br) in/ on ginger root grown in soil fumigated with methyl bromide [ 40 CFR § 180.123( c)] and in raw agricultural commodities grown in soil fumigated with chloropicrin, methyl bromide, and propargyl bromide [ 40 CFR § 180.199( a c)]. The Agency has determined that soil fumigation uses are classified as non food uses and do not require the establishment of a tolerance or exemption from a tolerance ( memorandum to S. Johnson, S. Irene, 1/ 31/ 97). Therefore, the tolerances in 40 CFR § 180.123( c) and § 180.199( a c) should be revoked.

A summary of the methyl bromide tolerance reassessment for the above commodities, with recommended modifications to commodity definitions, is presented in Table C.

Tolerances Listed Under 40 CFR § 180.123( a)( 1):

Provided that the requested label amendments are made, sufficient data are available to reassess tolerances for residues in/ on all commodities with uses being supported by the MBIP. The available commodity fumigation data support lowering all tolerance levels, with the exception of those on apples, pears, and quinces. The available data indicate that the 5.0 ppm tolerances for residues in/ on apples, pears, and quinces are inadequate and should be increased to 8.0 ppm and reassigned to the pome fruits crop group.

Tolerances for residues in/ on individual commodities should be reassigned to the appropriate crop group tolerances. However, individual tolerances should remain for residues in/ on asparagus, cocoa beans, grapes, pineapples, and strawberries.

Tolerances for residues in/ on the following commodities should be revoked, as there is no registered use or the MBIP is not supporting the tolerance: alfalfa hay, avocados, coffee beans, copra, cottonseed, mangoes, okra, papayas, peanuts, pomegranates, and timothy ( DP Barcode D197531, R. Perfetti, 1/ 10/ 94). 22 Tolerances Listed Under 40 CFR § 180.123( a)( 2):

Based upon the available methyl bromide residue data on various processed foods ( DP Barcodes D197515 20 and D197228, R. Perfetti, 5/ 6/ 94; and DP Barcode D215044, R. Perfetti, 8/ 15/ 95), tolerances for residues in individual food items, except for dried herbs and spices, should be reassigned to the single category " processed foods, excluding chocolate", under 40 CFR § 180.123 ( a)( 2). The available residue data on processed foods support a separate tolerance for " chocolate, products" at 55.0 ppm. Separate tolerances for dried herbs and spices should be reassessed to 35.0 ppm.

In addition, the tolerance for residues in fermented malt beverages should be revoked, as there is no registered fumigation use of methyl bromide on this product.

Tolerances Listed Under 40 CFR § 180.123( a)( 3):

The available residue data for processed foods ( DP Barcode D215044, R. Perfetti, 8/ 15/ 95) will also support separate tolerances for residues in " processed feeds" under 40 CFR § 180.123 ( a)( 3).

Tolerances Needed Under 40 CFR § 180.123( a):

Tolerances should be established for residues of methyl bromide per se in on the following crop groups: root and tuber vegetables, bulb vegetables, leafy vegetables, brassica leafy vegetables, legume vegetables, fruiting vegetables, cucurbit vegetables, citrus fruits, pome fruits, stone fruits, berries, tree nuts, and cereal grains. A separate tolerance should also be proposed for kiwifruit if the MBIP intends on including a use on this crop on their labels.

Tolerance Listed Under 40 CFR § 180.123( c):

The tolerance for a regional registration for residues in/ on ginger root should be revoked, as soil fumigation treatments are now considered non food uses. The post harvest use on ginger root will be covered by the crop group tolerance for methyl bromide per se in/ on root and tuber vegetables.

Restriction for Peanut Hulls Under 40 CFR § 180.123a:

EPA has determined that soil fumigation use of methyl bromide is considered a non food use. Furthermore, the MBIP is not supporting a post harvest fumigation use on peanuts as a raw agricultural commodity. Therefore, this section should be deleted.

Tolerances Listed Under 40 CFR § 180.199( a):

The tolerances for residues in/ on broccoli, cauliflower, eggplants, muskmeons, peppers, pineapples, strawberries, and tomatoes should be revoked, as soil fumigation treatments are now considered non food uses. 23 Tolerances Listed Under 40 CFR § 180.199( b):

The tolerances for regional registration for residues in/ on asparagus, lettuce, and onions should be revoked, as soil fumigation treatments are now considered non food uses.

Tolerance Listed Under 40 CFR § 180.199( c):

The tolerance for a regional registration for residues in/ on ginger root should be revoked, as soil fumigation treatments are now considered non food uses.

Tolerance Listed Under 40 CFR § 180.521( a)( 3):

The tolerance of 125 ppm for residues of inorganic bromides in milled fractions from cereal grain should be revoked. Tolerances for the milled fractions would be no higher than that of the raw agricultural commodity and are therefore not needed.

Tolerances Listed Under 40 CFR § 180.522( a):

The tolerances for residues in/ on cereal grains and fermented malt beverages should be revoked, as there are no registered fumigation uses of methyl bromide on these products. 24 ( continued) Table C. Tolerance Reassessment Summary for Methyl bromide.

Commodity Current Tolerance ( ppm) Tolerance Reassessment ( ppm) Comment/ Correct Commodity Definition Tolerances listed under 40 CFR § 180.123 ( a)( 1):

Alfalfa, hay ( POST H) 50.0 Revoke The MBIP is not supporting this use.

Almonds ( POST H) 200.0 150.0 a Reassign to crop group tolerance for residues in/ on the Tree Nuts Group. Commodity fumigation trials support a decreased tolerance level for methyl bromide.

Apples ( POST H) 5.0 8.0 a Reassign to crop group tolerance for residues in/ on the Pome Fruits Group. Commodity fumigation trials support an increased tolerance level for methyl bromide.

Apricots ( POST H) 20.0 5.0 a Reassign to crop group tolerance for residues in/ on the Stone Fruits Group. Commodity fumigation trials support a decreased tolerance level for methyl bromide.

Artichokes, Jerusalem ( POST H) 30.0 3.0 a Reassign to crop group tolerance for residues in/ on the Root and Tuber Vegetables Group. Commodity fumigation trials support a decreased tolerance level for methyl bromide.

Asparagus ( POST H) 100.0 0.05 Commodity fumigation trials support a decreased tolerance level for methyl bromide.

Avocados ( POST H) 75.0 Revoke No registered use or MBIP is not supporting Barley ( POST H) 50.0 8.0 a Reassign to crop group tolerance for residues in/ on the Cereal Grains Group. Commodity fumigation trials support a decreased tolerance level for methyl bromide.

Beans ( POST H) 50.0 3.0 a Reassign to crop group tolerance for residues in/ on the Legume Vegetables Group. Commodity fumigation trials support a decreased tolerance level for methyl bromide. Beans, green ( POST H) 50.0 Beans, lima ( POST H) 50.0 Beans, snap ( POST H) 50.0 Beets, garden, roots ( POST H) 30.0 3.0 a See comments under artichokes, Jerusalem.

Beets, sugar, roots ( POST H) 30.0 Blueberries ( POST H) 20.0 0.5 a Reassign to crop group tolerance for residues in/ on Berries Crop Group. Commodity fumigation trials support a decreased tolerance level for methyl bromide. Table C ( continued).

Commodity Current Tolerance ( ppm) Tolerance Reassessment ( ppm) Comment/ Correct Commodity Definition 25 ( continued) Brazil nuts ( POST H) 200.0 150.0 a See comment under almonds.

Bush nuts ( POST H) 200.0 Butternuts ( POST H) 200.0 Cabbage ( POST H) 50.0 1.0 a Reassign to crop group tolerance for residues in/ on the Brassica Leafy Vegetables Group. Commodity fumigation trials support a decreased tolerance level.

Cantaloupes ( POST H) 20.0 5.0 a Reassign to crop group tolerance for residues in/ on the Cucurbit Vegetables Group. Commodity fumigation trials support a decreased tolerance level.

Carrots ( POST H) 30.0 3.0 a See comments under artichokes, Jerusalem.

Cashews ( POST H) 200.0 150.0 a See comments under almonds.

Cherries ( POST H) 20.0 5.0 a See comments under apricots.

Chestnuts ( POST H) 200.0 150.0 a See comments under almonds.

Cippolini, bulbs ( POST H) 50.0 2.0 a Reassign to crop group tolerance for residues in/ on the Bulb Vegetables Group. Commodity fumigation trials support a decreased tolerance level.

Citrus citron ( POST H) 30.0 2.0 a Reassign to crop tolerance for residues in/ on Citrus Fruits Group. Commodity fumigation trials support a decreased tolerance level.

Cocoa beans ( POST H) 50.0 8.0 Commodity fumigation trials support a decreased tolerance level.

Coffee beans ( POST H) 75.0 Revoke The MBIP is not supporting these uses.

Copra ( POST H) 100.0 Revoke Corn ( POST H) 50.0 8.0 a See comments under barley.

Corn, pop ( POST H) 240.0 Corn, sweet ( K+ CWHR)( POST H) 50.0 Cottonseed ( POST H) 200.0 Revoke The MBIP is not supporting this use.

Cucumbers ( POST H) 30.0 5.0 a See comments under cantaloupe.

Cumin, seed ( POST H) 100.0 Revoke Covered by tolerance for residues in herbs and spices.

Eggplant ( POST H) 20.0 7.0 a Reassign to crop group tolerance for residues in/ on the Fruiting Vegetables Group. Commodity fumigation trials support a decreased tolerance level.

Filberts ( Hazelnuts) ( POST H) 200.0 150.0 a See comments under almonds.

Garlic ( POST H) 50.0 2.0 a See comments under Cippolini bulbs. Table C ( continued).

Commodity Current Tolerance ( ppm) Tolerance Reassessment ( ppm) Comment/ Correct Commodity Definition 26 ( continued) Ginger, roots ( POST H) 100.0 3.0 a See comments under artichoke, Jerusalem.

Grapefruit ( POST H) 30.0 2.0 a See comments under citron.

Grape ( POST H) 20.0 4.0 Commodity fumigation trials support a decreased tolerance level.

Hickory nuts ( POST H) 200.0 150.0 a See comments under almond.

Honeydew melons ( POST H) 20.0 5.0 a See comments under cantaloupe.

Horseradish ( POST H) 30.0 3.0 a See comments under artichokes, Jerusalem.

Kumquats ( POST H) 30.0 2.0 a See comments under citron.

Lemons ( POST H) 30.0 Limes ( POST H) 30.0 Macadamia nuts ( POST H) 200.0 150.0 a See comment under almonds.

Mangoes ( POST H) 20.0 Revoke No registered use or MBIP is not supporting.

Muskmelons ( POST H) 20.0 5.0 a See comments under cantaloupe.

Nectarines ( POST H) 20.0 5.0 a See comments under apricot.

Oats ( POST H) 50.0 8.0 a See comments under barley.

Okra ( POST H) 30.0 Revoke The MBIP is not supporting this use.

Onions ( POST H) 20.0 2.0 a See comments under Cippolini bulbs.

Oranges ( POST H) 30.0 2.0 a See comments under citron.

Papayas ( POST H) 20.0 Revoke No registered use or MBIP is not supporting.

Parsnips ( POST H) 30.0 3.0 a See comments under artichoke, Jerusalem.

Peaches ( POST H) 20.0 5.0 a See comments under apricot.

Peanuts ( POST H) 200.0 Revoke No registered use or MBIP is not supporting.

Pears ( POST H) 5.0 8.0 a See comment under apples.

Peas ( POST H) 50.0 3.0 a See comments under beans.

Peas, black eyed ( POST H) 50.0 Pecans ( POST H) 200.0 150.0 a See comment under almonds.

Peppers ( POST H) 30.0 7.0 a See comment under eggplants.

Pimentos ( POST H) 30.0 Pineapples ( POST H) 20.0 5.0 Commodity fumigation trials support a decreased tolerance level.

Pistachio nuts ( POST H) 200.0 150.0 a See comment under almonds.

Plums ( POST H) 20.0 5.0 a See comment under apricots.

Pomegranates 100.0 Revoke No registered use or MBIP is not supporting Potatoes ( POST H) 75.0 3.0 a See comments under artichokes, Jerusalem.

Pumpkins ( POST H) 20.0 5.0 a See comments under cantaloupes. Table C ( continued).

Commodity Current Tolerance ( ppm) Tolerance Reassessment ( ppm) Comment/ Correct Commodity Definition 27 ( continued) Quinces ( POST H) 5.0 8.0 a See comments under apples.

Radishes ( POST H) 30.0 3.0 a See comments under artichokes, Jerusalem.

Rice ( POST H) 50.0 8.0 a See comments under barley.

Rutabagas ( POST H) 30.0 3.0 a See comments under artichokes, Jerusalem.

Rye ( POST H) 50.0 8.0 a See comments under barley.

Salsify, roots ( POST H) 30.0 3.0 a See comments under artichokes, Jerusalem.

Sorghum, grain ( POST H) 50.0 8.0 a See comments under barley.

Soybeans ( POST H) 200.0 3.0 a See comments under beans.

Squash, summer ( POST H) 20.0 5.0 a See comments under cantaloupes.

Squash, winter ( POST H) 20.0 Squash, zucchini ( POST H) 20.0 Strawberries ( PRE and POST H) 60.0 0.05 Commodity fumigation trials support a decreased tolerance level.

Sweet potatoes ( POST H) 75.0 3.0 a See comments under artichokes, Jerusalem.

Tangerines ( POST H) 30.0 2.0 a See comments under citron.

Timothy, hay ( POST H) 50.0 Revoke No registered use or MBIP is not supporting Tomatoes ( POST H) 20.0 7.0 a See comments under eggplants.

Turnips, roots ( POST H) 30.0 3.0 a See comments under artichokes, Jerusalem.

Walnuts ( POST H) 200.0 150.0 a See comments under almonds.

Watermelons ( POST H) 20.0 5.0 a See comments under cantaloupes.

Wheat ( POST H) 50.0 8.0 a See comments under barley.

Tolerances listed under 40 CFR § 185.123 ( a)( 2):

Dried eggs 400 Reassign Reassign to " processed foods, excluding chocolate" under § 180.123 ( a)( 2). Parmesan cheese 325 Roquefort cheese 325 Tomatoes, concentrated products 250 Figs, dried 250 Processed foods other than those listed above 125 10.0 Processed foods, excluding chocolate Tolerance level can be lowered to cover levels of methyl bromide detected in processed food fumigation trials.

Herbs, processed 400 35.0 This tolerance can be lowered to cover levels of methyl bromide detected in processed herb and spice fumigation trials. Spices, processed 400 35.0 Fermented malt beverages 25 Revoke No registered use Tolerances listed under 40 CFR § 185.123 ( a)( 3): Table C ( continued).

Commodity Current Tolerance ( ppm) Tolerance Reassessment ( ppm) Comment/ Correct Commodity Definition 28 Dog food 400 Reassign Reassign to " processed feeds" under § 180.123 ( a)( 3). Barley, milled fractions 125 Corn, milled fractions 125 Sorghum ( milo), grain, milled fractions 125 Oats, milled fractions 125 Rice, milled fractions 125 Rye, milled fractions 125 Wheat, milled fractions 125 Tolerance listed under 40 CFR § 180.123 ( c):

Ginger, roots ( PRE and POST H) 100 Revoke Use will be covered by tolerance for residues in/ on the Root and Tuber Vegetables Group.

Tolerances listed under 40 CFR § 180.199 ( a, b and c):

Broccoli 25 Revoke Soil fumigation treatments are considered non food uses. Cauliflower 25 Eggplants 60 Muskmelons 40 Peppers 25 Pineapples 25 Strawberries 25 Tomatoes 40 Asparagus 300 Lettuce 300 Onions, dry bulb 300 Ginger, roots ( PRE and POST H) 100 Revoke See comment under ginger [ § 180.123 ( b)]

Tolerances needed under 40 CFR § 180.123 ( a)( 1):

Vegetable, root and tuber, group None 3.0 Crop group tolerance recommendations are based on maximum methyl bromide residues in/ on representative commodities of each group in commodity fumigation trials. Vegetable, bulb, group None 2.0 Vegetable, leafy, group None 0.5 Vegetable, Brassica leafy, group None 1.0 Vegetable, legume, group None 3.0 Vegetable, fruiting, group None 7.0 Vegetable, cucurbit, group None 5.0 Fruit, citrus, group None 2.0 Fruit, pome, group None 8.0 Fruit, stone, group None 5.0 Table C ( continued).

Commodity Current Tolerance ( ppm) Tolerance Reassessment ( ppm) Comment/ Correct Commodity Definition 29 Berry group None 0.5 Grain, cereal, group None 8.0 Kiwifruit None 5.0 The available data would support a tolerance of 5.0 ppm if the MBIP intends to include a use on kiwifruit on their labels.

Tolerances needed under 40 CFR § 180.123 ( a)( 2):

Chocolate products None 55.0 The available residue data on processed foods support a separate tolerance for " chocolate, products" at 55.0 ppm.

Tolerances needed under 40 CFR § 180.123 ( a)( 3):

Processed feeds None 10.0 The available residue data on processed foods also supports at 10 ppm tolerance for " processed feeds".

a Reassessed tolerance for the associated crop group. 30 DIETARY EXPOSURE ASSESSMENT SUMMARY For reregistration and risk assessment purposes, adequate plant metabolism data are available. Adequate magnitude of the residue data for methyl bromide residues are also available for all the registered uses the MBIP is supporting. Adequate residue data are also available for all processed commodities. Data on animal metabolism and residues in animal commodities are not required. A reasonably reliable risk assessment for the uses of methyl bromide can be conducted at this time using existing and reassessed tolerances.

CODEX HARMONIZATION There are no established or proposed Codex maximum residue limits for methyl bromide; therefore, harmonization of U. S. tolerances with Codex is not required.

AGENCY MEMORANDA CITED IN THIS DOCUMENT DP Barcode: None Subject: Methyl Bromide Registration Standard Administrative Review of Inorganic Bromide Tolerances From: Anne Lindsay, RD To: L. V. White, Methyl bromide Industry Panel Dated: 7/ 7/ 89 MRID( s): None DP Barcode: None Subject: Methyl Bromide Industry Panel: Response to the Methyl Bromide Registration Standard: Metabolism Studies From: R. B. Perfetti, HED To: R. Engler Dated: 3/ 8/ 91 MRID( s): 41627701 DP Barcode: D168913 Subject: Methyl Bromide Industry Panel: Response to the Methyl Bromide Registration Standard: Metabolism Study From: R. B. Perfetti, HED To: W. Burnam Dated: 9/ 24/ 91 MRID( s): 42137701 31 DP Barcode: D197531 Subject: Methyl Bromide Industry Panel: Response to the Methyl Bromide Registration Standard: Magnitude of the Residue Data Discussions and Waiver Requests From: R. B. Perfetti, HED To: L. Rossi, SRRD Dated: 1/ 10/ 94 MRID( s): None DP Barcodes: D196317 and D196312 Subject: Response to the Methyl Bromide Registration Standard: Residue Data From: R. B. Perfetti, HED To: L. Rossi, SRRD Dated: 4/ 7/ 94 MRID( s): 42949601, 42963801 DP Barcodes: D197515, D197516, D197517, D197518, D197519, D197520, and D197228 Subject: Response to the Methyl Bromide Registration Standard: Residue Data. From: R. B. Perfetti, HED To: L. Rossi, SRRD Dated: 5/ 6/ 94 MRID( s): 43025301, 43025701, 43025801, 43025101, 43029801, 43025202, 43023601 DP Barcodes: D204238, D205160, D205462, and D206950 Subject: Response to the Methyl Bromide Registration Standard: Processing Studies. From: R. B. Perfetti, HED To: E. Saito, SRRD Dated: 11/ 16/ 94 MRID( s): 43287001, 43247401, 43278701, 43343401 DP Barcode: D215044 Subject: Methyl Bromide. Magnitude of the Residue in processed Commodities: Instant White Rice, Shelled Roasted peanuts, Unpopped Corn, and Country Ham. From: B. Cropp Kohlligian, HED To: L. Schnaubelt/ B. O'Keefe, SRRD Dated: 8/ 15/ 95 MRID( s): 43628701 32 DP Barcode: None Subject: Methyl Bromide. Food vs. Non Food Use Status for Soil Fumigation Uses. From: S. Irene, HED To: S. Johnson, RD Dated: 1/ 31/ 97 MRID( s): None DP Barcode: D275389 Subject: Methyl Bromide. Magnitude of the Residue in/ on Tree Nuts and Dried Fruit. From: C. Olinger, HED To: J. Nevola, SRRD Dated: 7/ 17/ 01 MRID( s): 43885001, 43885002 33 RESIDUE CHEMISTRY CITATIONS Bibliographic citations include only MRIDs containing data which fulfill data requirements.

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43629701 Ussary, J.; Moseman, R.; Tracey, S. ( 1995) Fumigation of Processed Foods with Methyl Bromide: Magnitude of the Residues: Final Report: Lab Project Number: P8. Unpublished study prepared by Webb Technical Group, Inc. 145 p.

43885001 Hartsell, P.; Hurley, J. ( 1995) Magnitude of Organic Bromide Residues on Tree Nut Meats ( Shelled Almonds, Pecans, Pistachios, and Walnuts) Following Post Harvest Fumigation: Amended Report: Lab Project Number: 2B. Unpublished study prepared by DFA of California. 90 p.

43885002 Hartsell, P.; Hurley, J. ( 1995) Magnitude of Organic Bromide Residues on Dried Raisins, Raisin Waste, Prunes, Figs & Dates Following Post Harvest Fumigation: Amended Report: Lab Project Number: 2A. Unpublished study prepared by DFA of California.. 97 p.