Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 1 of 14 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM Date: 6/ 19/ 06 Subject: Azoxystrobin. Uses on Foliage of Legume Vegetables, Group 7; Fruiting Vegetables, Group 8 ( Except Tomato); Pea and Bean, Succulent and Dried Shelled ( Except Soybeans), Subroups 6B and 6C; and Nongrass Animal Feeds, Group 18. Summary of Analytical Chemistry and Residue Data. Petition Number 4E6823.

DP Num: 328984 Decision Number: 355347 PC Code: 128810 MRID Numbers: NA 40 CFR 180.507 Chemical Class: Strobilurin Fungicide From: W. Cutchin, Chemist ARIA/ TRB Registration Division ( 7509P)

Through: L. Cheng, Chemist RAB3 Health Effects Division ( 7509P)

And Chemistry Science Advisory Council Health Effects Division ( 7509P)

To: S. Jackson/ D. Rosenblatt RM05 RIMUERB Registration Division ( 7509P)

Executive Summary The Interregional Research Project # 4 ( IR 4) is requesting the following tolerances for the residues of azoxystrobin ( methyl( E) 2( 2( 6( 2 cyanophenoxy) pyrimidin 4 yloxy) phenyl) 3 methoxyacrylate) and the Z isomer of azoxystrobin, [ methyl( Z) 2( 2( 6 ( 2 cyanophenoxy) pyrimidin 4 yloxy) phenyl) 3 methoxyacrylate] ( R230310): Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 2 of 14 Commodity Proposed Tolerance ( ppm)

vegetables, foliage of legume, Group 7 30.0 vegetables, fruit, Group 8 ( except tomato) 2.0 pea and bean, succulent shelled, Group 6B 0.5 pea and bean, dried shelled, except soybean, Group 6C 0.5 animal feed, nongrass, Group 18 forage 30.0 animal feed, nongrass, Group 18 hay 55.0 Azoxystrobin is a broad spectrum fungicide for control of many plant diseases. It has the same biochemical mode of action as the naturally occurring strobilurins and is structurally related to them. It is in the same chemical class as trifloxystrobin.

Permanent tolerances are currently established ( 40 CFR § 180.507) for the combined residues of azoxystrobin and the Z isomer in/ on various raw and processed plant commodities ranging from 0.01 ppm in/ on pecans to 260 ppm in/ on the Herb Subgroup 19A, dried, except chive, vegetable, leafy, except brassica, group 4 at 30.0 ppm, and including soybean, forage at 25.0 ppm, soybean, hay at 55.0 ppm, soybean, hulls at 1.0 ppm, and soybean, seed at 0.5 ppm. Tolerances are also established [ 40 CFR § 180.507( a)( 2)] for residues of azoxystrobin per se in milk at 0.006 ppm and the fat, meat, and meat byproducts of cattle, goats, hogs, horses, and sheep at levels ranging from 0.01  0.07 ppm.

Azoxystrobin is formulated as Abound ® Flowable Fungicide ( EPA Reg. No.: 100 1098), a flowable suspension concentrate ( SC) with 22.9% active ingredient ( ai). The product is to be applied to vegetables, fruiting, Group 8 ( except tomato); pea and bean, succulent and dried, except soybean, Subgroups 6B and 6C; and nongrass animal feeds, Group 18. The product will be applied prior to disease development, by ground, air, or chemigation four times with 7 14 day intervals at 0.10 0.25 lb ai/ A ( 1.0 lb ai/ A/ season) and a 0 day PHI.

Adequate plant metabolism studies on azoxystrobin have been previously conducted using grapes, peanuts, and wheat. Adequate livestock metabolism studies for azoxystrobin have also been submitted. The HED Metabolism Assessment Review Committee ( MARC) has determined that the residues of concern in/ on plants for the tolerance expression and risk assessment are azoxystrobin and its Z isomer. The MARC determined that the residue of concern in/ on livestock for the tolerance expression and risk assessment is azoxystrobin only.

Previously submitted storage stability data indicate that residues of azoxystrobin and the Z isomer are stable in oil seed rape, soybean meal, corn grits, carrot root, leaf lettuce, wheat forage, orange oil, orange juice, and orange pulp for at least two years under frozen storage. The information is adequate for the purpose of supporting the proposed tolerances. Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 3 of 14 Adequate methodology is available for enforcement of the established tolerances on plants. The gas chromatography with nitrogen phosphorus detector ( GC/ NPD) method, RAM 243/ 04, has undergone a method validation by the EPA analytical laboratory. EPA comments have been incorporated and the revised method, designated RAM 243, has been submitted to FDA for inclusion in the Pesticide Analytical Manual ( PAM), Volume II as an enforcement method. Adequate methodology is available for enforcement of the established tolerances on livestock. The GC method 255/ 01 has been validated by the EPA analytical laboratory for the analysis of milk and livestock tissues. The EPA laboratory's written report with an EPA addendum to accompany the method, and the method, will be submitted to FDA for inclusion in PAM, Vol. II. Data pertaining to the multiresidue methods testing of azoxystrobin in conjunction with the grape tolerance petition have previously been submitted. The data indicate that azoxystrobin could not be recovered through application of the multiresidue protocols.

No new residue field trial data were submitted for the foliage of legume vegetables, Crop Group 7, pea and bean, succulent and dried, except soybean, Subgroups 6B and 6C, or nongrass animal feeds, Group 18. The representative commodities for Group 7 are foliar portions of any cultivar of bean, field pea, and soybean. RAB2 previously stated that as long as the use pattern is similar and the proposed field trial residue data supporting a tolerance for Group 4 are submitted and deemed adequate, it will be appropriate to request a tolerance for Group 7 at the same level as Group 4. The requirements set forth by RAB2 for the establishment of an azoxystrobin tolerance on the foliage of legume vegetables, Group 7 have been satisfied. TRB recommends for the establishment of a tolerance at 30.0 ppm for the residues of azoxystrobin on vegetables, foliage of legume, Group 7. Since the proposed tolerance on Group 7 will include soybean hay and forage, the existing tolerances on those commodities should be removed ( minutes, ChemSAC, 5/ 10/ 06).

There are tolerances established for members of Group 8: peppers, okra, and eggplant at 2.0 ppm, and tomato at 0.2 ppm ( CFR § 180.507). Although all the existing residue data on the Group 8 representative commodities were determined to be sufficient to establish a crop group tolerance, risk cup issues at the time precluded increasing the tomato tolerance and separate tolerances were requested on okra and eggplant. Since the existing data were determined to be adequate for a crop group tolerance, there is sufficient data to support the petition for the requested subgroup. However, the commodity definition presented by the petitioner is incorrect. A new Section F should be submitted requesting a tolerance for the residues of azoxystrobin at 2.0 ppm on vegetables, fruiting, Group 8 ( except tomato). The existing separate tolerances on pepper, okra, and eggplant should be removed.

The existing tolerance commodity definitions are: pea and bean, dried shelled, except soybean, subgroup, except cowpea, and field pea; and pea and bean, succulent shelled, subgroup, except cowpea. The subgroup tolerances excluded cowpea and field pea because there was no residue field data for forage, hay, and/ or silage as livestock feeds. In order to satisfy the data requirements, RAB3 previously indicated that residue data on the representative crops of Group 7 were required. However, as stated above, the requirements set forth by RAB2 for the establishment of an azoxystrobin tolerance on vegetables, foliage of legume, Group 7 have been Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 4 of 14 satisfied. Therefore, no further residue field trial data is required. TRB recommends for the establishment of tolerances at 0.5 ppm for the residues of azoxystrobin on pea and bean, succulent shelled, Subgroup 6B; and pea and bean, dried shelled, except soybean, Subgroup 6C.

IR 4 requested that the Agency use data supporting the tolerances for vegetable, leafy, except Brassica, Group 4 at 30.0 ppm, Brassica, leafy greens, Subgroup 5B at 25 ppm, and soybean, hay at 55.0 ppm to support the establishment of tolerances for animal feed, nongrass, Group 18, forage at 30.0 ppm and animal feed, nongrass, Group 18, hay at 55.0 ppm. ChemSAC has determined that the existing data cited by the petitioner is not sufficient to support the requested tolerance. TRB recommends against the proposed tolerances on animal feed, nongrass, Group 18, forage and hay. However, based on the existing use on soybeans, which has the same use pattern as that proposed for animal feed, nongrass, Group 18, a reduced number of residue field trials would be appropriate. Six residue field trials each with the appropriate geographic distribution on the two representative crops for animal feed, nongrass, Group 18 ( alfalfa and clover) are required to support a proposed azoxystrobin tolerance.

There are no processed commodities associated with the uses of azoxystrobin on foliage of legume vegetables, Group 7; vegetables, fruiting, Group 8 ( except tomato); and pea and bean, succulent and dried shelled, except soybean, Subgroups 6B and 6C. The livestock feed items of regulatory interest for the current action are cowpea seed at 0.05 ppm, cowpea hay and forage at 30.0 ppm; and soybean, forage and hay, for which the tolerance will be raised to 30 ppm. Since the worst case cattle and swine diets using existing and proposed tolerances will not exceed the level of the ruminant feeding study used to establish the current tolerances, no increase in tolerances for ruminant and swine commodities are required. None of the commodities for which tolerances are proposed have poultry feed items of regulatory interest; therefore, no change in azoxystrobin poultry tolerances is required.

The label indicates that only crops with registered uses may be planted within 12 months of application. This plantback interval is adequate.

Regulatory Recommendations and Residue Chemistry Deficiencies Provided a revised Section F is received and pending the results of the forthcoming human health risk assessment, TRB recommends for the following tolerances for the residues of azoxystrobin:

Commodity Tolerance ( ppm)

vegetables, foliage of legume, Group 7 30.0 vegetables, fruiting, Group 8 ( except tomato) 2.0 pea and bean, succulent shelled, Subgroup 6B 0.5 pea and bean, dried shelled, except soybean, Subgroup 6C 0.5 Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 5 of 14 TRB recommends against the requested tolerance on animal feed, nongrass, Group 18. The residue chemistry data base is not adequate to support the requested use, additional residue field trial data is required.

Note to PM: The existing tolerances on soybean hay and forage, pepper, okra, and eggplant should be removed.

Background Azoxystrobin is a broad spectrum fungicide for control of many plant diseases. It has the same biochemical mode of action as the naturally occurring strobilurins and is structurally related to them. Azoxystrobin is a   methoxyacrylate. It is in the same chemical class as trifloxystrobin. Azoxystrobin acts by inhibiting electron transport.

TABLE 1. Test Compound Nomenclature Compound Chemical Structure Common name azoxystrobin Company experimental name ICIA5504 IUPAC name methyl ( E) 2{ 2[ 6( 2 cyanophenoxy) pyrimidin 4 yloxy] phenyl} 3 methoxyacrylate CAS name methyl ( E) 2[[ 6( 2 cyanophenoxy) 4 pyrimidinyl] oxy] ( methoxymethylene) benzeneacetate CAS # 131860 33 8 End use product/ EP Amistar   ( EPA Reg. No.: 100 1164), Quadris ® Flowable ( EPA Reg. No.: 100 1098), Abound ® Fungicide ( EPA Reg. No.: 100 1098)

TABLE 2. Physicochemical Properties Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 6 of 14 Parameter Value Melting point/ range 114 116 ° C pH 6.4 Density 1.25 g/ cm3 Water solubility ( mg/ L at 20 ° C) solvent solubility ( mg/ L) water, pH 5.2 6.7 water, pH 7 6.7 water, pH 9.2 5.9 Solvent solubility ( mg/ L at 20 ° C) solvent solubility ( mg/ mL) n hexane 0.057 methanol 20 ethyl acetate 130 toluene 55 acetone 86 dichloromethane 400 Vapor pressure at 25 ° C 1.1 x 10 13 kPa = 8.2 x 10 13 mg Hg Dissociation constant ( pKa) Not dissociable Octanol/ water partition coefficient Log( KOW) log POW = 2.5 UV/ visible absorption spectrum Not available 860.1200 Directions for Use TABLE 3. Summary of Directions for Use of Azoxystrobin.

Applic. Timing, Type, and Equip. Formulation [ EPA Reg. No.] Applic. Rate ( lb ai/ A) Max. No. Applic. per Season Max. Seasonal Applic. Rate ( lb ai/ A) PHI ( days) Use Directions and Limitations Peppers and Other Fruiting Vegetables ( Except Cucurbits)

Apply by ground, air, or chemigation prior to disease development. Abound ® Fungicide [ 100 1098] 0.10 0.25 4 1.0 0 Apply on a 7 14 day schedule. Adjuvant may be added.

Foliage of Legume Vegetables Apply by ground, air, or chemigation prior to disease development. Abound ® Fungicide [ 100 1098] 0.10 0.25 4 1.5 0 Apply on a 7 14 day schedule. Adjuvant may be added.

Dry and Succulent Legume Vegetables Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 7 of 14 Apply by ground, air, or chemigation prior to disease development. Abound ® Fungicide [ 100 1098] 0.10 0.25 4 1.5 0 Apply on a 7 14 day schedule. Adjuvant may be added.

Forage, Fodder, Straw and Hay Grass and Nongrass Apply by ground, air, or chemigation prior to disease development. Abound ® Fungicide [ 100 1098] 0.10 0.25 4 Nongrass: 1.5 Mixed Grass and Nongrass: 0.75 0 Apply on a 7 14 day schedule. Adjuvant may be added.

Conclusions. The label is adequate to allow evaluation of the residue data relative to the proposed use.

860.1300 Nature of the Residue  Plants PP# 5F4541, DP Num: 218318 and 218448, J. Garbus, 3/ 19/ 96 PP# 6F4762, DP Num: 230634, 230635, 230636, and 230637, L. Kutney, 4/ 25/ 97 DP Num: 251683, W. Wassell, 2/ 30/ 98 Adequate metabolism studies on grapes, peanuts, and wheat were submitted in conjunction with earlier petitions ( PP# 5F4541, DP Num: 218318 and 218448, J. Garbus, 3/ 19/ 96; and PP# 6F4762, DP Num: 230634, 230635, 230636, and 230637, L. Kutney, 4/ 25/ 97). Azoxystrobin undergoes photochemical isomerization to produce the Z isomer and is extensively metabolized in plants. The parent compound undergoes cleavage of the ether linkages between the phenylacrylate and pyrimidinyl rings and the cyanophenyl and pyrimidinyl rings, with subsequent oxidation, hydrolysis, and/ or reduction of the primary metabolites to form numerous secondary metabolites. Azoxystrobin is systemic. The HED MARC has determined that the residues of concern in/ on plants for the tolerance expression and risk assessment purposes are azoxystrobin and its Z isomer ( DP Num: 251683, W. Wassell, 2/ 30/ 98).

860.1300 Nature of the Residue  Livestock PP# 5F4541, DP Num: 218318 and 218448, J. Garbus, 3/ 19/ 96 PP# 6F4762, DP Num: 230634, 230635, 230636, and 230637, L. Kutney, 4/ 25/ 97 DP Num: 251683, W. Wassell, 2/ 30/ 98 Adequate ruminant and poultry metabolism studies were submitted in conjunction with earlier petitions ( PP# 5F4541, DP Num: 218318 and 218448, 3/ 19/ 96, J. Garbus; and PP# 6F4762, DP Num: 230634, 230635, 230636, and 230637, 4/ 25/ 97, L. Kutney). The HED MARC has determined that the residue of concern in livestock is parent azoxystrobin only ( DP Num: 251683, 12/ 30/ 98, W. Wassell).

860.1340 Residue Analytical Methods PP# 5F4541 and PP# 6F4762, DP Num: 235342, C. Stafford, 5/ 30/ 97 Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 8 of 14 DP Num: 249657 and 249668, D. Dotson, 1/ 25/ 99 For plant commodities, method RAM 243/ 04 has undergone method validation by the Analytical Chemistry Branch ( ACB), BEAD ( PP# 5F4541 and PP# 6F4762, DP Num: 235342, C. Stafford, 5/ 30/ 97). BEAD comments have been incorporated and the revised method ( designated RAM 243, dated 5/ 15/ 98; MRID 44595105) has been submitted to FDA for inclusion in PAM II.

For analysis of livestock commodities, the petitioner had previously proposed GC method 255/ 01 for the enforcement of tolerances for residues of azoxystrobin in livestock commodities. This method has been validated by the EPA analytical laboratory for the analysis of milk and livestock tissues ( DP Num: 249657 and 249668, D. Dotson, 1/ 25/ 99). The EPA laboratory's written report with an EPA addendum to accompany the method, and the method, will be submitted to FDA for inclusion in PAM, Vol. II. In the interim, copies are available from PIRIB/ IRSD ( 7502P) and ACB/ BEAD ( 7503P).

860.1360 Multiresidue Methods PP# 5F4541, DP Num: 218318 and 218448, J. Garbus, 3/ 19/ 96 Data have previously been submitted pertaining to the multiresidue methods testing of azoxystrobin in conjunction with the grape tolerance petition ( PP# 5F4541; DP Num: 218318 and 218448, J. Garbus, 3/ 19/ 96). The data indicate that azoxystrobin could not be recovered through application of the multiresidue protocols. These data have been forwarded to FDA.

860.1380 Storage Stability PP# 9F06058 and ID# s 000100 01098 and 000100 01093, DP Num: 283588 & 287062, MRID 45738101, N. Dodd, 2/ 6/ 03 Previously submitted storage stability data indicates that residues of azoxystrobin and the Z isomer ( R230310) are stable in soybean meal, corn grits, carrot root, leaf lettuce, wheat forage, orange oil, orange juice, and orange pulp for at least two years under frozen storage ( PP# 9F06058 and ID# s 000100 01098 and 000100 01093, DP Num: 283588 & 287062, MRID 45738101, N. Dodd, 2/ 6/ 03).

860.1400 Water, Fish, and Irrigated Crops As no water, fish, or irrigated crop issues are associated with the uses of azoxystrobin on foliage of legume vegetables, Crop Group 7; fruiting vegetables, Crop Group 8 ( except tomato); pea and bean, succulent and dried shelled, Crop Groups 6B and 6C, this guideline requirement is not relevant to the current petition.

860.1460 Food Handling Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 9 of 14 As there are no food handling uses for azoxystrobin, this guideline requirement is not relevant to the current petition.

860.1480 Meat, Milk, Poultry, and Eggs PP# 9F06058, DP Num: 260134, M. Nelson, 9/ 6/ 00 The livestock feed items of regulatory interest for the current action are cowpea seed at 0.05 ppm, cowpea hay and forage at 30.0 ppm; and soybean, forage and hay, for which the tolerance will be raised to 30 ppm. The tolerances for beef livestock commodities were established based on the feed items: rice grain at 5.0 ppm, turnip tops at 50.0 ppm and soybean forage at 25 ppm. These tolerance levels resulted in MTDBs for beef cattle of 105.6 ppm and dairy cattle of 73.7 ppm ( PP# 9F06058, DP Num: 260134, M. Nelson, 9/ 6/ 00). Changing the commodities used in the original MTDB calculation to cowpea seed at 0.05 ppm would not result in an increase in the MTDBs for cattle. However, using the worst case for the pending tolerances, the tolerance level for cowpea, forage at 30.0 ppm with the feeding information in OPPTS Test Guidelines, 860.1000, result in increases in the MTDB for beef and dairy cattle to 123.9 and 110.6 ppm, respectively. The current tolerances on ruminant commodities were established based on a feeding study at 5, 25, 75, and 250 ppm. Since the worst case cattle diets using existing and proposed tolerances ( Table 4) will not exceed the level of the ruminant feeding study used to establish the current tolerances ( 250 ppm), no increase in tolerances for ruminant commodities are required.

The tolerances for swine commodities were established based on the feed items: rice grain at 5.0 ppm, canola, meal at 1.0 ppm, and aspirated grain fractions at 30.0 ppm, which resulted in a MTDB on swine of 9.5 ppm ( PP# 9F06058, DP Num: 260134, M. Nelson, 9/ 6/ 00). The tolerances for swine commodities were established using the same feeding study as that used for ruminants. Changing the commodities used in the MTDB calculation to include cowpea, forage at 30.0 ppm with the feeding information in OPPTS Test Guidelines, 860.1000, result in an increase in the MTDB for swine to 15.1 ppm. Since the worst case swine diet using existing and proposed tolerances ( Table 4) will not exceed the level of the ruminant feeding study used to establish the current tolerances ( 25 ppm), no increase in tolerances for swine commodities are required.

The tolerances for poultry commodities were established based on the rice feed items: grain and bran at 5.0 ppm, and hulls at 20.0 ppm which results in a MTDB on poultry of 7.3 ppm. None of the commodities for which tolerances are proposed have poultry feed items of regulatory interest; therefore, no change in azoxystrobin poultry tolerances is required.

TABLE 4. Azoxystrobin Maximum Theoretical Daily Dietary Burdens for Livestock Feed Commodity Tolerance, ppm % Dry Matter % of Diet Burden ( ppm)*

Beef cattle Rice, grain 5.0 88 10 0.6 Cowpea, forage 30.0 30 40 40 Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 10 of 14 Turnip, tops 50.0 30 50 83.3 TOTAL 100 123.9 Dairy cattle Rice, grain 5.0 88 10 0.6 Cowpea, forage 30.0 30 60 60 Turnip, tops 50.0 30 30 50 TOTAL 100 110.6 Swine Rice, grain 5.0 NA** 60 3 Cowpea, forage 30.0 NA 15 4.5 Canola, meal 1.0 NA 10 0.1 Aspirated grain fractions 50 NA 15 7.5 TOTAL 100 15.1 * Burden = Tolerance x (% Diet/% Dry Matter) ** NA = Not applicable to swine and poultry dietary calculations, per OPPTS Test Guidelines, 860.1000, Table 1, Footnote 2.

860.1500 Crop Field Trials DP Num: 254140, G. Herndon, 3/ 17/ 99 PP# 9F06058, DP Num: 260134, M. Nelson, 9/ 6/ 00 PP# 9F06058 and ID# s 000100 01098 and 000100 01093, DP Num: 283588 & 287062, MRID 45738101, N. Dodd, 2/ 6/ 03 PP# 1E6264, MRID 45332502 DP Num: 274312, G. Herndon, 4/ 30/ 01 PP# 0F6218, DP Num: 278801, N. Dodd, 7/ 31/ 02 Vegetables, Foliage of Legume, Group 7 No new residue field trial data were submitted for the foliage of legume vegetables, Crop Group 7. The representative commodities for Crop Group 7 are foliar portions of any cultivar of bean, field pea, and soybean. RAB2 stated in their 3/ 17/ 99 memo: " As long as the use pattern is similar, RAB2 would expect residues to be similar for Crop Group 4 and Crop Group 7. Provided that the proposed field trial residue data supporting a tolerance for Crop Group 4 are submitted and deemed adequate, RAB2 concludes that it will be appropriate for IR 4 to request a tolerance for Crop Group 7 at the same level as Crop Group 4" ( DP Num: 254140, G. Herndon, 3/ 17/ 99). The use patterns for Crop Group 4 and Crop Group 7 are the same: 0.10 0.25 lb ai/ A per application, with a seasonal maximum of 1.5 lb/ A and 0 day PHI. A tolerance for vegetable, leafy, except Brassica, Group 4 at 30.0 ppm was conditionally recommended upon the receipt and acceptance of additional spinach field trials ( PP# 9F06058, DP Num: 260134, M. Nelson, 9/ 6/ 00). The additional trials were submitted and found to be adequate to satisfy the conditional registration ( PP# 9F06058 and ID# s 000100 01098 and 000100 01093, DP Num: 283588 & 287062, MRID 45738101, N. Dodd, 2/ 6/ 03). Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 11 of 14 The requirements set forth by RAB2 for the establishment of an azoxystrobin tolerance on the foliage of legume vegetables, Crop Group 7 have been satisfied. TRB recommends for the establishment of a tolerance at 30.0 ppm for the residues of azoxystrobin on vegetables, foliage of legume, Group 7. The proposed tolerance on Group 7 will include a soybean hay and forage.

Note to PM: The existing tolerances on soybean hay and forage should be removed.

Vegetables, Fruiting, Group 8 ( Except Tomato)

No new residue field trial data were submitted for vegetables, Fruiting, Group 8 ( except tomato). There are tolerances established for members of Crop Group 8: peppers, okra, and eggplant at 2.0 ppm; and tomato at 0.2 ppm ( CFR § 180.507). Bell and non bell pepper data ( PP# 1E6264, MRID 45332502) were used to establish the okra and eggplant tolerances as a result of a previous request from IR 4 ( DP Num: 274312, G. Herndon, 4/ 30/ 01). Although all the existing data on the Crop Group 8 representative commodities were determined to be sufficient to establish a crop group tolerance, risk cup issues at the time precluded increasing the tomato tolerance and separate tolerances were requested on okra and eggplant. Since the existing data were determined to be adequate for a crop group tolerance, there is sufficient data to support the petition for the requested subgroup. The commodity definition presented by the petitioner is incorrect. A new Section F should be submitted requesting a tolerance for the residues of azoxystrobin at 2.0 ppm on vegetables, fruiting, Group 8 ( except tomato).

Note to PM: The existing separate tolerances on pepper, okra, and eggplant should be removed.

Pea and Bean, Succulent and Dried Shelled ( except Soybean), Subgroups 6B and 6C No new residue field trial data were submitted for pea and bean, succulent and dried, except soybean, Subgroups 6B and 6C. The existing tolerance commodity definitions are: pea and bean, dried shelled, except soybean, subgroup, except cowpea, and field pea; and pea and bean, succulent shelled, subgroup, except cowpea. The subgroup tolerances excluded cowpea and field pea because there was no residue field data for forage, hay, and/ or silage as livestock feeds. In order to satisfy the data requirements, RAB3 indicated that " the petitioner must provide residue data on the representative crops of Crop Group 7" ( PP# 0F6218, DP Num: 278801, N. Dodd, 7/ 31/ 02). However, as stated above, the requirements set forth by RAB2 for the establishment of an azoxystrobin tolerance on vegetables, foliage of legume, Group 7 have been satisfied. Therefore, no further residue field trial data is required. TRB recommends for the establishment of tolerances at 0.5 ppm for the residues of azoxystrobin on pea and bean, succulent shelled, Subgroup 6B; and pea and bean, dried shelled, except soybean, Subgroup 6C.

Animal Feed, Nongrass, Group 18 ChemSAC, 5/ 10/ 06 No new residue field trial data were submitted for animal feed, nongrass, Group 18. IR 4 requests that the Agency use data supporting the tolerances for vegetable, leafy, except Brassica, Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 12 of 14 Group 4 at 30.0 ppm, Brassica, leafy greens, Subgroup 5B at 25 ppm, and soybean, hay at 55.0 ppm as adequate support for the establishment of tolerances for animal feed, nongrass, Group 18, forage at 30.0 ppm and animal feed, nongrass, Group 18, hay at 55.0 ppm. ChemSAC has determined that the existing data cited by the petitioner is not sufficient to support the requested tolerance ( ChemSAC, 5/ 10/ 06). TRB recommends against the proposed tolerances on animal feed, nongrass, Group 18, forage and hay.

However, based on the existing use on soybeans, which has the same use pattern as that proposed for animal feed, nongrass, Group 18, a reduced number of residue field trials would be appropriate. Six residue field trials with the appropriate geographic distribution on the two representative crops for animal feed, nongrass, Group 18, alfalfa and clover are required to support a proposed azoxystrobin tolerance.

860.1520 Processed Food and Feed There are no processed commodities associated with the uses of azoxystrobin on foliage of legume vegetables, Group 7; fruiting vegetables, Group 8 ( except tomato); and pea and bean, succulent and dried shelled, Subgroups 6B and 6C; therefore, a discussion of processed food and feed is not germane to this action.

860.1650 Submittal of Analytical Reference Standards The analytical reference standards for both azoxystrobin ( 7/ 2000) and its Z isomer ( 5/ 2001) have been submitted to the EPA National Pesticide Standards Repository.

860.1850 Confined Accumulation in Rotational Crops DP Num: 230634, 230635, 230636, and 230637, L. Kutney, 4/ 25/ 97 DP Num: 260134, M. Nelson, 9/ 6/ 00 Adequate confined studies have previously been reviewed ( DP Num: 230634, 230635, 230636, and 230637, L. Kutney, 4/ 25/ 97) and summarized ( DP Num: 260134, M. J. Nelson, 9/ 6/ 00). Azoxystrobin was identified in all RACs at the 30 DAT interval. In 30 DAT samples, the Z isomer was only identified in wheat forage and straw. Compound 42 was the major metabolite identified in 30 DAT lettuce and wheat forage and straw. In 30 DAT radish roots, azoxystrobin was the major metabolite and in 30 DAT radish tops, metabolites G2, N1, and N2 were the major metabolites. In 30 DAT wheat grain, 14C starch was found to account for the largest portion of radioactivity. Several conjugated metabolites ( compound 42 and the M, N, and O metabolites) of primary crop metabolites were identified, indicating that azoxystrobin is more extensively metabolized in rotational crops than in primary crops. The residues of concern in rotational crops are parent and the Z isomer.

860.1900 Field Accumulation in Rotational Crops DP Num: 230634, 230635, 230636, and 230637, L. Kutney, 4/ 25/ 97 Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 13 of 14 DP Num: 260134, M. Nelson, 9/ 6/ 00 Limited field rotational crop studies were previously reviewed ( DP Num: 230634, 230635, 230636, and 230637, 4/ 25/ 97, L. Kutney) and summarized ( DP Num: 260134, 9/ 6/ 00, M. J. Nelson). The limited field accumulation study ( MRID 45640307) is adequate to indicate that residues of azoxystrobin and Z isomer ( R230310) will not occur in mustard greens, turnip roots, turnip tops, and wheat grain planted 36 days after application of azoxystrobin, as an 80% water dispersible granular formulation, to a primary crop at a rate of 1.6 lb ai/ A/ season. This study also indicates that small residues of azoxystrobin per se may occur in wheat matrices other than grain at a plantback interval of approximately 60 days after treatment ( DAT) ( i. e., 0.02 ppm in wheat forage at 61 DAT; 0.01 ppm in wheat hay at 45 DAT; 0.04 ppm in wheat straw at 59 DAT). No residues of Z isomer ( R230310) were found in any matrix at any plantback interval.

The label indicates that only crops with registered uses may be planted within 12 months of application. This plantback interval is adequate.

860.1550 Proposed Tolerances The HED MARC has determined that the residues of concern in/ on plants for the tolerance expression and risk assessment purposes are azoxystrobin and its Z isomer. The HED MARC has determined that the residue of concern in livestock is parent azoxystrobin only. The existing azoxystrobin tolerances are listed in 40 CFR § 180.507. There are no Codex MRLs for azoxystrobin. Canada and Mexico have an MRL for tomato at 0.2. Mexico also has an MRL for chili pepper at 2.0 ppm. These existing MRLs match those proposed by the petitioner. There are no other Canadian or Mexican MRLs for commodities of concern in this action. Therefore, there are no international harmonization issues associated with this action.

TABLE 5. Tolerance Summary for Azoxystrobin Commodity Established/ Proposed Tolerance ( ppm) Recommended Tolerance ( ppm) Comments ( correct commodity definition)

vegetables, foliage of legume, Group 7 30.0 30.0 vegetables, fruiting, Group 8 ( except tomato) 2.0 2.0 pea and bean, succulent shelled, Subgroup 6B 0.5 0.5 pea and bean, dried shelled, except soybean, Subgroup 6C 0.5 0.5 Azoxystrobin Summary of Analytical Chemistry and Residue Data DP Num: 328984 14 of 14 INTERNATIONAL RESIDUE LIMIT STATUS Chemical Name: Common Name: Azoxystrobin Proposed tolerance Reevaluated tolerance Other Date: 5/ 2/ 06 Codex Status ( Maximum Residue Limits) U . S. Tolerances X No Codex proposal step 6 or above No Codex proposal step 6 or above for the crops requested Petition Numbers: 4E68237 DP Barcodes: D312953 Other Identifier: 128810 Reviewer/ Branch: W. Cutchin Residue definition ( step 8/ CXL): N/ A Proposed Residue definition: Combined residues of azoxystrobin and its Z isomer Crop ( s) MRL ( mg/ kg) Crop( s) Tolerance ( ppm)

foliage of legume vegetables, Crop Group 7 30.0 fruiting vegetables, Crop Group 8 ( except tomato) 2.0 pea and bean, succulent shelled, Crop Group 6B 0.5 pea and bean, dried shelled, Crop Group 6C 0.5 nongrass animal feed, forage, Crop Group 18 30.0 nongrass animal feed, hay Crop Group 18 55.0 Limits for Canada Limits for Mexico No Limits No Limits for the crops requested No Limits No Limits for the crops requested Residue definition: (  E) methyl 2[[ 6( 2 cyanophenoxy) 4 pyrimidinyl] oxy]    methoxymethylene) benzeneacetate, including the isomer ( Z) methyl 2[[ 6( 2 cyanophenoxy) 4 pyrimidinyl] oxy] ( methoxymethylene) benzeneacetate Residue definition: Azoxistrobin Crop( s) MRL ( mg/ kg) Crop( s) MRL ( mg/ kg)

Tomato 0.2 Tomato 0.2 Chile pepper 2.

Notes/ Special Instructions: S. Funk, 05/ 07/ 2006


[Federal Register Volume 86, Number 219 (Wednesday, November 17, 2021)]
[Proposed Rules]
[Pages 64129-64132]
[FR Doc No: 2021-25027]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Chapter I

[EPA-HQ-OPPT-2021-0622; FRL-9100-01-OCSPP]

TSCA Section 21 Petition for Rulemaking Under TSCA Section 6;
Reasons for Agency Response; Denial of Requested Rulemaking

AGENCY: Environmental Protection Agency (EPA).

ACTION: Petition; reasons for Agency response.

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SUMMARY: This action announces the availability of EPA's response to a
petition received on August 16, 2021, from William D. Bush. The
petition requests that EPA determine that the ``chemical mixtures
contained within cosmetics present an unreasonable risk of injury to
health and the environment,'' and issue a rule or order under the Toxic
Substances Control Act (TSCA) to ``eliminate the hazardous chemicals
used in mixtures [in cosmetics].'' After careful consideration, EPA has
denied the petition for the reasons set forth in this document.

DATES: EPA's response to this TSCA section 21 petition was signed
November 10, 2021.

ADDRESSES: The docket for this petition, identified by docket
identification (ID) number EPA-HQ-OPPT-2021-0622, is available at
https://www.regulations.gov or at the Office of Pollution Prevention
and Toxics Docket (OPPT Docket), Environmental Protection Agency Docket
Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334, 1301
Constitution Ave. NW, Washington, DC. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPPT Docket is (202) 566-
0280.
    Due to the public health concerns related to COVID-19, the EPA
Docket Center (EPA/DC) and Public Reading Room is by appointment only.
For the latest status information on EPA/DC services and docket access,
visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Amy Shuman, Existing Chemicals
Risk Management Division (7404T), Office of Pollution Prevention and
Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; email
address: [email protected].gov.
    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address: [email protected].

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to those persons who manufacture (including
import), distribute in commerce, process, use, or dispose of cosmetics.
Since other entities may also be interested, the Agency has not
attempted to describe all the specific entities that may be affected by
this action.

B. What is EPA's authority for taking this action?

    Under TSCA section 21 (15 U.S.C. 2620), any person can petition EPA
to initiate a proceeding for the issuance, amendment, or repeal of a
rule under TSCA sections 4, 6, or 8, or to issue an order under TSCA
sections 4, 5(e), or 5(f). A TSCA section 21 petition must set forth
the facts which it is claimed establish that it is necessary to
initiate the action requested. EPA is required to grant or deny the
petition within 90 days of its filing. If EPA grants the petition, the
Agency must promptly commence an appropriate proceeding. If EPA denies
the petition, the Agency must publish its reasons for the denial in the
Federal Register. A petitioner may commence a civil action in a U.S.
district court seeking to compel initiation of the requested proceeding
within 60 days of a denial or, if EPA does not issue a decision, within
60 days of the expiration of the 90-day period.

C. What criteria apply to a decision on this TSCA section 21 petition?

1. Legal Standard Regarding TSCA Section 21 Petitions
    TSCA section 21(b)(1) requires that the petition ``set forth the
facts which it is claimed establish that it is necessary'' to initiate
the proceeding requested. 15 U.S.C. 2620(b)(1). Thus, TSCA section 21
implicitly incorporates the statutory standards that apply to the
requested actions. Accordingly, EPA has relied on the standards in TSCA
section 21 and in

the provisions under which actions have been requested in evaluating
this TSCA section 21 petition.
2. Legal Standard Regarding TSCA Section 6(a)
    In general, to promulgate a rule under TSCA section 6(a), EPA must
first determine ``in accordance with section 6(b)(4)(A) that the
manufacture, processing, distribution in commerce, use, or disposal of
a chemical substance or mixture . . . presents an unreasonable risk.''
15 U.S.C. 2605(a). TSCA section (b)(4)(A) is part of the risk
evaluation process whereby EPA must determine ``whether a chemical
substance presents an unreasonable risk of injury to health or the
environment,'' and thus, whether a rule under TSCA section 6(a) is
necessary. 15 U.S.C. 2605(b)(4)(A). In particular, EPA must conduct
this evaluation ``without consideration of costs or other non-risk
factors, including an unreasonable risk to a potentially exposed or
susceptible subpopulation identified as relevant to the risk evaluation
by the Administrator, under the conditions of use.'' Id. Unless EPA
establishes an exemption under TSCA section 6(g) (whereby certain
unreasonable risks may be allowed to persist for a limited period) or
EPA is addressing a persistent, bioaccumulative, and toxic substance as
set forth in TSCA section 6(h), the standard for an adequate rule under
TSCA section 6(a) is that it regulates ``so that the chemical substance
or mixture no longer presents'' unreasonable risks under the conditions
of use. 15 U.S.C. 2605(a). EPA may eliminate the unreasonable risk of a
chemical substance or mixture by regulating manufacture, processing,
distribution in commerce, commercial use, or disposal of the chemical
substance in one or more of the manners described in TSCA section 6(a).
3. Legal Standard Regarding TSCA Sections 3(2) and (10)
    TSCA section 3(2) excludes from the definition of a ``chemical
substance'' ``any food, food additive, drug, cosmetic, or device (as
such terms are defined in Section 201 of the Federal Food, Drug, and
Cosmetic Act [21 U.S.C. 321]) when manufactured, processed, or
distributed in commerce for use as a food, food additive, drug,
cosmetic, or device.'' 15 U.S.C. 2602(2) (emphases added). In addition,
TSCA section 3(10) defines ``mixture'' as ``any combination of two or
more chemical substances if the combination does not occur in nature
and is not, in whole or in part, the result of a chemical reaction;
except that such term does include any combination which occurs, in
whole or in part, as a result of a chemical reaction if none of the
chemical substances comprising the combination is a new chemical
substance and if the combination could have been manufactured for
commercial purposes without a chemical reaction at the time the
chemical substances comprising the combination were combined.'' 15
U.S.C. 2602(10).
4. Legal Standard Regarding TSCA Section 26
    TSCA section 26(h) requires EPA, in carrying out TSCA sections 4,
5, and 6, to make science-based decisions using ``scientific
information, technical procedures, measures, methods, protocols,
methodologies, or models, employed in a manner consistent with the best
available science,'' while also taking into account other
considerations, including the relevance of information and any
uncertainties. 15 U.S.C. 2625(h). TSCA section 26(i) requires that
decisions under TSCA sections 4, 5, and 6 be ``based on the weight of
scientific evidence.'' 15 U.S.C. 2625(i). TSCA section 26(k) requires
that EPA consider information that is reasonably available in carrying
out TSCA sections 4, 5, and 6. 15 U.S.C. 2625(k).

II. Summary of the TSCA Section 21 Petition

A. What action was requested?

    On August 16, 2021, EPA received a TSCA section 21 petition (Ref.
1) from William D. Bush (the petitioner) that requests EPA take several
actions under TSCA section 6. The petition asks EPA to determine that
the ``chemical mixtures contained within cosmetics present an
unreasonable risk of injury to health and the environment'' and seeks
the issuance of a rule or order to ``eliminate the hazardous chemicals
used in mixtures [in cosmetics].'' The petition also requests ``any
other prudent [methods] of toxic mixture substance control [EPA] may
see due and fit.''
1. Request for Determination That the Chemical Mixtures Contained
Within Cosmetics Present an Unreasonable Risk of Injury to Health and
the Environment
    The petition requests that EPA determine that the ``chemical
mixtures contained within cosmetics present an unreasonable risk of
injury to health and the environment.'' With respect to actions under
TSCA section 6, TSCA section 21 provides only for the submission of a
petition seeking the initiation of a proceeding for the issuance,
amendment, or repeal of a rule under TSCA section 6(a). In general,
before promulgating a TSCA section 6(a) rule, EPA must first determine
``in accordance with section 6(b)(4)(A)''--that is, through a TSCA risk
evaluation--whether a chemical substance presents an unreasonable risk
to health or the environment under the conditions of use. To initiate a
TSCA section 6(b) risk evaluation, however, EPA generally must
designate the chemical substance a high priority for risk evaluation.
Prioritization of high priority substances for risk evaluation under
TSCA section 6(b) and risk evaluation under TSCA section 6(b) are
activities distinct from rulemaking under TSCA section 6(a). Because
TSCA section 21 does not provide an avenue for petitioners to request
the initiation of the prioritization process or the risk evaluation
process through which EPA would determine whether ``chemical mixtures
contained within cosmetics'' present an unreasonable risk, this Federal
Register document does not address this specific request.
2. Request for Order by Rule That the Manufacturing Producers of
Cosmetics Eliminate the Hazardous Chemicals Used in Mixtures in
Cosmetics
    The petition requests that EPA ``[o]rder by [r]ule that the
manufacturing producers of cosmetics eliminate the hazardous chemicals
used in mixtures [in cosmetics].'' TSCA section 21 provides for the
submission of a petition to initiate a proceeding for the issuance,
amendment, or repeal of a rule under TSCA sections 4, 6, or 8, or to
issue an order under TSCA sections 4, 5(e), or 5(f). As the petitioner
is seeking issuance of a rule under TSCA section 6, this Federal
Register document addresses this request.
3. Request for Other Methods of Toxic Mixture Substance Control the
Agency Determines To Be Required
    The petition requests that EPA exercise ``any other prudent
[methods] of toxic mixture substance control'' that the Agency deems
``due and fit.'' As a regulatory body, EPA cannot deviate from the
statutory remedies established under TSCA section 21. Therefore, a
solicitation for EPA to exercise ``any other prudent [methods]'' that
the Agency deems ``due and fit'' does not adequately identify an
objective that is executable within TSCA section 21. Therefore, this
Federal Register document does not address this specific request.

B. What support did the petitioner offer?

    To support the request for an order by rule that the manufacturing
producers of cosmetics eliminate the hazardous chemicals used in
mixtures in cosmetics, the petitioner offers information relating to
human health impacts as a result of cosmetic application, human health
and environmental impacts affected by cosmetic manufacture and import
volume, and lack of cosmetic regulatory policy (Ref. 1, pp. 1-4). Of 13
points included in that discussion, seven are excerpts from an article
on the toxicity of chemicals and contaminants of cosmetics (Ref. 2);
these points are discussed in detail below. For the remaining six
points, the petitioner paraphrases information from the article (Ref.
2), and references the authority of the U.S. Food and Drug
Administration and regulatory actions taken worldwide as each relates
to human health and environmental impacts from cosmetic chemicals.
    Regarding the seven points attributed to the article on the
toxicity of chemicals and contaminants in cosmetics, the petitioner
cites various metrics associated with the manufacture and use of
cosmetic products (Ref. 1, points 5, 10, 11, and 12) and the alleged
environmental and human health effects resulting from exposure thereto
(Ref. 1, points 1, 5, and 10).
    Regarding manufacturing metrics, the petitioner highlights
references from the article by stating, ``[s]ince 2009, 595 cosmetic
manufacturers reported using 88 chemicals, in more than 73,000
[cosmetic] products'' (Ref. 1, point 5). The petitioner further states
that ``American women use an average of 12 personal care products that
contain 168 different chemicals'' and that the United States cosmetic
industry since 2010 ``has grown an average of 4.1 percent annually''
with sales from 2016 totaling over $169 billion (Ref. 1, points 10 and
11). Lastly, the petitioner points to increased import of cosmetics
from 181 different countries by highlighting ``[c]osmetic imports from
China increased 79 percent between FY 2011 and FY 2016'' (Ref. 1, point
12).
    The associated health affects statements mentioned by the
petitioner include that cosmetic chemicals ``have been linked to
cancer, birth defects, and reproductive harm'' and that ``[m]any of
these products are applied directly to the skin, the body's largest
organ, where ingredients can be absorbed directly into the
bloodstream'' (Ref. 1, points 5 and 10). To expand on this point, the
petitioner states ``[n]ot only are these toxic chemicals entering our
bodies through direct application, but excess product that is washed
down the drain pollutes our waterways and drinking water, and compounds
doses of hazardous chemicals in air, water, food, and other consumer
products'' (Ref. 1, point 1).
    In addition, the petitioner includes a summary of the findings and
policy section of the Pollution Prevention Act (42 U.S.C. 13101) (Ref.
1, points 14 and 15), though TSCA section 21 does not provide an avenue
for recourse under such Act. The petitioner cites language from the
Pollution Prevention Act which states that ``pollution should be
prevented or reduced at the source whenever feasible; pollution that
cannot be prevented should be recycled in an environmentally safe
manner, whenever feasible; pollution that cannot be prevented or
recycled should be treated in an environmentally safe manner whenever
feasible; and disposal or other release into the environment should be
employed only as a last resort and should be conducted in an
environmentally safe manner'' and that ``source reduction is
fundamentally different and more desirable than waste management and
pollution control.''
    The petitioner also provides two claims: (1) ``[t]oxic [c]hemicals
added to and included in [c]osmetics are unreasonable;'' and (2)
``[c]osmetic [d]isposal presents a clear unreasonable risk to the
[e]nvironment.'' (Ref. 1, pp. 5-6). To support the former claim, the
petitioner argues that the chemical mixtures contained in cosmetics
provide no benefit to consumers considering said chemicals can ``harm
public welfare and the environment through their use consumption and
disposal,'' but does not cite or provide reference. To support the
latter claim, the petitioner states that ``research studies of toxic
waste entering the environment are clear in identifying cosmetics as a
major hazardous waste emission,'' but does not cite or provide any
reference to such studies.

III. Disposition of TSCA Section 21 Petition

A. What is EPA's response?

    After careful consideration, EPA has denied this TSCA section 21
petition. A copy of the Agency's response, which consists of the letter
to the petitioner and this document, is posted on the EPA petition
website at https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-21#cosmetics. The response, the petition (Ref. 1),
and other information is available in the docket for this TSCA section
21 petition.

B. What was EPA's reason for this response?

    TSCA section 21 does provide for the submission of a petition
seeking the initiation of a proceeding for the issuance of a rule under
TSCA section 6(a). The petition must ``set forth the facts which it is
claimed establish that it is necessary to issue'' the requested rule.
15 U.S.C. 2620(b)(1). When determining whether the petition meets that
burden, EPA will consider whether the manufacture, distribution in
commerce, processing, use, or disposal of a chemical substance or
mixture, or any combination of such activities, may present an
unreasonable risk of injury to health or the environment.
    EPA evaluated the information presented in the petition and
considered that information in the context of the applicable
authorities and requirements of TSCA sections 3(2), 6, 21, and 26.
Notwithstanding that the burden is on the petitioner to present ``the
facts which it is claimed establish that it is necessary'' for EPA to
initiate the rule or issue the order sought, EPA nonetheless also
considered relevant information that was reasonably available to the
Agency during the 90-day petition review period. As detailed further in
this Unit, EPA finds that the petitioner has not met its burden to
support the requested actions.
    Under TSCA section 6(a), EPA must, by rule, issue regulations
applying one or more of the listed requirements to the extent necessary
so that a chemical substance or mixture found to present unreasonable
risk no longer presents such risk.-TSCA section 3(2)(B), which defines
``chemical substance,'' excludes ``any food, food additive, drug,
cosmetic, or device (as such terms are defined in Section 201 of the
Federal Food, Drug, and Cosmetic Act [21 U.S.C. 321]) when
manufactured, processed, or distributed in commerce for use as a food,
food additive, drug, cosmetic, or device'' (emphases added). According
to section 201(i) of the Federal Food, Drug, and Cosmetic Act (FFDCA),
``cosmetic'' means ``articles intended to be rubbed, poured, sprinkled,
or sprayed on, introduced into, or otherwise applied to the human body
or any part thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance, and articles intended for
use as a component of any such articles; except that such term shall
not include soap.'' 21 U.S.C. 321(i). Under TSCA, ``cosmetics'' are not
a ``chemical substance'' when manufactured, processed, or distributed
in commerce for use as a cosmetic. Therefore, EPA cannot issue a rule
pursuant to TSCA

section 6(a) to apply requirements to such cosmetics. In addition,
while a ``mixture'' can be subject to TSCA section 6(a), because the
requested action is for ``hazardous chemicals used in mixtures [in
cosmetics],'' EPA cannot issue a rule pursuant to TSCA section 6(a) to
apply requirements to cosmetics when manufactured, processed, or
distributed in commerce for use as a cosmetic. To the extent the
petition seeks action on ``cosmetics'' when manufactured, processed, or
distributed in commerce as cosmetics--including direct regulation of
cosmetics through an order by rule that cosmetic manufacturers
eliminate hazardous chemicals used in mixtures in cosmetics or through
an action to address the first claim that ``[t]oxic [c]hemicals added
to and included in [c]osmetics are unreasonable''--the petition does
not request actions that are within EPA's jurisdiction under TSCA.
    To the extent the petition seeks action on ``chemical substances''
within the TSCA section 3(2) definition of that term--including action
to address the petitioner's second claim that ``[c]osmetic [d]isposal
presents a clear unreasonable risk to the [e]nvironment''--EPA finds
that the petitioner did not set forth facts establishing that it is
necessary to initiate an appropriate proceeding pursuant to TSCA
section 21. In particular, with respect to the second claim, EPA finds
that the petition did not demonstrate facts that could support an EPA
determination of unreasonable risk to the environment. Rather, the
specific chemical substances identified by the petition as examples are
discussed by reference to their potential human health effects when
used in manufactured cosmetic products. In addition, while the petition
cites TSCA and Pollution Prevention Act authorities applicable to
disposal, there are no data or references offered to support the
assertion that ``research studies of toxic waste entering the
environment are clear in identifying cosmetics as a major hazardous
waste emission'' (Ref. 1, p. 6). As explained above, TSCA section
21(b)(1) requires that the petition ``set forth the facts which it is
claimed establish that it is necessary'' to initiate the proceeding
requested. 15 U.S.C. 2620(b)(1). TSCA section 21(b)(4)(B) also provides
the standard for judicial review should EPA deny a request for
rulemaking under TSCA section 6(a): ``If the petitioner demonstrates to
the satisfaction of the court by a preponderance of the evidence that .
. . the chemical substance or mixture to be subject to such rule . . .
presents an unreasonable risk of injury to health or the environment,
without consideration of costs or other non-risk factors, including an
unreasonable risk to a potentially exposed or susceptible
subpopulation, under the conditions of use,'' the court shall order the
EPA Administrator to initiate the requested action. 15 U.S.C.
2620(b)(4)(B). Consistent with these provisions, a petition for a TSCA
section 6(a) rulemaking must set forth facts which would enable EPA to
conclude that there is an unreasonable risk for which a TSCA section
6(a) risk management rule is warranted. EPA does not find that the
petition in this case sets forth facts which would enable EPA to
conclude that the disposal of particular chemical substance(s) or
mixture(s) in cosmetics presents unreasonable risk and that an
appropriate proceeding should be initiated. To the extent the petition
seeks other action cognizable under TSCA section 21 to address
``chemical substances'' in cosmetics outside of cosmetic disposal, EPA
similarly finds that the petition does not set forth sufficient facts
to establish the necessity of initiating an appropriate proceeding
under TSCA section 21.
    Finally, to the extent that the petition referenced the Pollution
Prevention Act (42 U.S.C. 13101), the Agency reiterates that TSCA
section 21 does not provide an avenue for recourse under such Act.

B. What were EPA's conclusions?

    EPA denied the request to issue a rule under TSCA section 6(a).
TSCA section 3(2)(B) excludes ``cosmetic'' from the definition of
``chemical substance'' when manufactured, processed, or distributed in
commerce for use as a cosmetic. Therefore, cosmetics, and any
combination of chemicals contained therein, are not chemical substances
under TSCA when manufactured, processed, or distributed in commerce for
use as a cosmetic. To the extent the petition seeks TSCA section 6
action on ``cosmetics'' when manufactured, processed, or distributed in
commerce as cosmetics, the requested actions are not within EPA's
jurisdiction under TSCA. In addition, to the extent the petition seeks
action on ``chemical substances'' within the TSCA section 3(2)
definition of that term, EPA finds that the petition did not set forth
facts establishing that it is necessary to initiate an appropriate
proceeding pursuant to TSCA section 21. In particular, the petition did
not identify the disposal of any particular chemical substance(s) or
mixture(s) that could support an EPA determination of unreasonable risk
to the environment and, therefore, did not set forth sufficient facts
establishing that it is necessary to issue a TSCA section 6(a) rule
addressing cosmetic disposal.

IV. References

    The following is a listing of the documents that are specifically
referenced in this document. The docket includes these documents and
other information considered by EPA, including documents that are
referenced within the documents that are included in the docket, even
if the referenced document is not physically located in the docket. For
assistance in locating these other documents, please consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

1. Bush, William D. Petition for Issuance of New Rules under Section
15 U.S.C. 2605 re: [COSMETICS]. Received August 16, 2021.
2. Faber, S. (2020). The Toxic Twelve Chemicals and Contaminants in
Cosmetics. Available at https://www.ewg.org/the-toxic-twelve-chemicals-and-contaminants-in-cosmetics.

    Authority: 15 U.S.C. 2601 et seq.

    Dated: November 10, 2021.
Michal Freedhoff,
Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2021-25027 Filed 11-16-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: November 29, 2010 (Volume 75, Number 228)]
[Notices]
[Page 73116]
[DOCID:fr29no10-116]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2008-0333]

Delaware River and Bay Oil Spill Advisory Committee; Meetings

AGENCY: Coast Guard, DHS.

ACTION: Notice of advisory committee meetings.

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SUMMARY: The Delaware River and Bay Oil Spill Advisory Committee
(DRBOSAC) will meet in Philadelphia, Pennsylvania, to discuss and
approve DRBOSAC's report on oil spill prevention and response
strategies for the Delaware River and Bay. These meetings will be open
to the public.

DATES: The Committee will meet on Thursday December 16, 2010 and
possibly Friday December 17th, 2010 from 10 a.m. to 4 p.m. These
meetings may close early if all business is finished. Written material,
requests to make oral presentations, and requests to have a copy of
your material distributed to each member of the committee should reach
the Coast Guard on or before Friday December 10, 2010.

ADDRESSES: The Committee will meet at Coast Guard Sector Delaware Bay,
1 Washington Ave., Philadelphia, Pennsylvania 19147. Send written
material and requests to make oral presentations to Gerald Conrad,
Liaison to the Designated Federal Officer (DFO) of the DRBOSAC, at the
address above. This notice and any documents identified in the
SUPPLEMENTARY INFORMATION section as being available in the docket may
be viewed online, at http://www.regulations.gov, using docket number
USCG-2008-0333.

FOR FURTHER INFORMATION CONTACT: Gerald Conrad, Liaison to the DFO of
the DRBOSAC, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. App. 2 (Pub. L. 92-463). The
Coast Guard Authorization Act of 2010 (Pub. L. 111-281) extended the
statutory authorization for the Committee until Dec 31, 2010.

Agenda of the Meetings

    The agenda for the December 16 & 17, 2010 Committee meetings are as
follows:
    (1) Opening comments.
    (2) Administrative announcements.
    (3) Introductions and roll call.
    (4) Presentations from the public.
    (5) Debriefs from: Response, Prevention, Recovery/Mitigation
subcommittees.
    (6) Public comments.
    (7) Committee's report recommendation(s), discussion and votes.
    (8) Closing.
    More information and details on the meetings will be available at
the committee Web site, located at https://home&port.uscg.mil/drbosac,
or on the Federal Docket Management System (FDMS) at http://
www.Regulations.gov. To locate documents related to this Committee on
FDMS, search http://www.Regulations.gov for the docket number USCG-
2008-0333. Additional details may be added to the agenda up to December
10, 2010.

Procedural

    These meetings are open to the public. All persons entering the
building will have to present identification and may be subject to
screening. Please note that the meetings may close early if all
business is finished.
    The public will be able to make oral presentations, for a length of
time as decided by the Chair, when given the opportunity, as noted in
the agenda. Members of the public wishing to make an oral presentation
to the committee are encouraged to contact the Coast Guard at the
contacts listed above no later than December 10, 2010. The public may
file written statements with the committee; written material should
reach the Coast Guard no later than December 10, 2010. If you would
like a copy of your material distributed to each member of the
committee, please submit 35 copies to the Liaison to the DFO no later
than December 10, 2010, and indicate that the material is to be
distributed to committee members at the December 16 and 17, 2010
meetings.
    Please register your attendance with the Liaison to the DFO no
later than December 10, 2010.

Information on Services for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the meetings, contact
the Liaison to the DFO as soon as possible.

    Dated: November 23, 2010.
Joseph M. Re,
Captain, U.S. Coast Guard, Office of Performance Management (CG-0954).
[FR Doc. 2010-29938 Filed 11-26-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 79, Number 235 (Monday, December 8, 2014)]
[Proposed Rules]
[Pages 72754-72756]
[FR Doc No: 2014-28689]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0296]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 33 individuals from the
vision requirement in the Federal Motor Carrier Safety Regulations
(FMCSRs). They are unable to meet the vision requirement in one eye for
various reasons. The exemptions will enable these individuals to
operate commercial motor vehicles (CMVs) in interstate commerce without
meeting the prescribed vision requirement in one eye. The Agency has
concluded that granting these exemptions will provide a level of safety
that is equivalent to or greater than the level of safety maintained
without the exemptions for these CMV drivers.

DATES: The exemptions were granted October 31, 2014. The exemptions
expire on October 31, 2016.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, R.N., Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays. If you have questions
on viewing or submitting material to the docket, contact Docket
Services, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

II. Background

    On September 30, 2014, FMCSA published a notice of receipt of
exemption applications from certain individuals, and requested comments
from the public (79 FR 58856). That notice listed 33 applicants' case
histories. The 33 individuals applied for exemptions from the vision
requirement in 49 CFR 391.41(b)(10), for drivers who operate CMVs in
interstate commerce.
    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
for a 2-year period if it finds ``such exemption would likely achieve a
level of safety that is equivalent to or greater than the level that
would be achieved absent such exemption.'' The statute also allows the
Agency to renew exemptions at the end of the 2-year period.
Accordingly, FMCSA has evaluated the 33 applications on their merits
and made a determination to grant exemptions to each of them.

III. Vision and Driving Experience of the Applicants

    The vision requirement in the FMCSRs provides:
    A person is physically qualified to drive a commercial motor
vehicle if that person has distant visual acuity of at least 20/40
(Snellen) in each eye without corrective lenses or visual acuity
separately corrected to 20/40 (Snellen) or better with corrective
lenses, distant binocular acuity of a least 20/40 (Snellen) in both
eyes with or without corrective lenses, field of vision of at least
70[deg] in the horizontal meridian in each eye, and the ability to
recognize the colors of traffic signals and devices showing red, green,
and amber (49 CFR 391.41(b)(10)).
    FMCSA recognizes that some drivers do not meet the vision
requirement but have adapted their driving to accommodate their vision
limitation and demonstrated their ability to drive safely. The 33
exemption applicants listed in this notice are in this category. They
are unable to meet the vision requirement in one eye for various
reasons, including amblyopia, macular scar, histoplasmosis, retinal
detachment, glaucoma, complete loss of vision, refractive amblyopia,
central serous retinopathy, enucleation, macular scar, central
suppression consistent with amblyopia, strabismic amblyopia, end stage
maculopathy from toxoplasmosis, central retinal artery occlusion,
exotropia, prosthetic eye, and a cataract. In most cases, their eye
conditions were not recently developed. Twenty-three of the applicants
were either born with their vision impairments or have had them since
childhood.
    The 10 individuals that sustained their vision conditions as adults
have had it for a range of two to 42 years.
    Although each applicant has one eye which does not meet the vision
requirement in 49 CFR 391.41(b)(10), each has at least 20/40 corrected
vision in the other eye, and in a doctor's opinion, has sufficient
vision to perform all the tasks necessary to operate a CMV. Doctors'
opinions are supported by the applicants' possession of valid
commercial driver's licenses (CDLs) or non-CDLs to operate CMVs. Before
issuing CDLs, States subject drivers to knowledge and skills tests
designed to evaluate their qualifications to operate a CMV.
    All of these applicants satisfied the testing requirements for
their State of residence. By meeting State licensing requirements, the
applicants demonstrated their ability to operate a CMV, with their
limited vision, to the satisfaction of the State.
    While possessing a valid CDL or non-CDL, these 33 drivers have been
authorized to drive a CMV in intrastate commerce, even though their
vision disqualified them from driving in interstate commerce. They have
driven CMVs with their limited vision in careers ranging from 2.5 to 50
years. In the past three years, two of the drivers were involved in
crashes and one was convicted of a moving violation in a CMV.
    The qualifications, experience, and medical condition of each
applicant were stated and discussed in detail in

the September 30, 2014 notice (79 FR 58856).

IV. Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the vision requirement in 49 CFR 391.41(b)(10) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. Without the exemption, applicants
will continue to be restricted to intrastate driving. With the
exemption, applicants can drive in interstate commerce. Thus, our
analysis focuses on whether an equal or greater level of safety is
likely to be achieved by permitting each of these drivers to drive in
interstate commerce as opposed to restricting him or her to driving in
intrastate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered the medical reports about the applicants' vision as well as
their driving records and experience with the vision deficiency.
    To qualify for an exemption from the vision requirement, FMCSA
requires a person to present verifiable evidence that he/she has driven
a commercial vehicle safely with the vision deficiency for the past 3
years. Recent driving performance is especially important in evaluating
future safety, according to several research studies designed to
correlate past and future driving performance. Results of these studies
support the principle that the best predictor of future performance by
a driver is his/her past record of crashes and traffic violations.
Copies of the studies may be found at Docket Number FMCSA-1998-3637.
    FMCSA believes it can properly apply the principle to monocular
drivers, because data from the Federal Highway Administration's (FHWA)
former waiver study program clearly demonstrate the driving performance
of experienced monocular drivers in the program is better than that of
all CMV drivers collectively (See 61 FR 13338, 13345, March 26, 1996).
The fact that experienced monocular drivers demonstrated safe driving
records in the waiver program supports a conclusion that other
monocular drivers, meeting the same qualifying conditions as those
required by the waiver program, are also likely to have adapted to
their vision deficiency and will continue to operate safely.
    The first major research correlating past and future performance
was done in England by Greenwood and Yule in 1920. Subsequent studies,
building on that model, concluded that crash rates for the same
individual exposed to certain risks for two different time periods vary
only slightly (See Bates and Neyman, University of California
Publications in Statistics, April 1952). Other studies demonstrated
theories of predicting crash proneness from crash history coupled with
other factors. These factors--such as age, sex, geographic location,
mileage driven and conviction history--are used every day by insurance
companies and motor vehicle bureaus to predict the probability of an
individual experiencing future crashes (See Weber, Donald C.,
``Accident Rate Potential: An Application of Multiple Regression
Analysis of a Poisson Process,'' Journal of American Statistical
Association, June 1971). A 1964 California Driver Record Study prepared
by the California Department of Motor Vehicles concluded that the best
overall crash predictor for both concurrent and nonconcurrent events is
the number of single convictions. This study used 3 consecutive years
of data, comparing the experiences of drivers in the first 2 years with
their experiences in the final year.
    Applying principles from these studies to the past 3-year record of
the 33 applicants, two of the drivers were involved in crashes and one
was convicted of a moving violation in a CMV. All the applicants
achieved a record of safety while driving with their vision impairment,
demonstrating the likelihood that they have adapted their driving
skills to accommodate their condition. As the applicants' ample driving
histories with their vision deficiencies are good predictors of future
performance, FMCSA concludes their ability to drive safely can be
projected into the future.
    We believe that the applicants' intrastate driving experience and
history provide an adequate basis for predicting their ability to drive
safely in interstate commerce. Intrastate driving, like interstate
operations, involves substantial driving on highways on the interstate
system and on other roads built to interstate standards. Moreover,
driving in congested urban areas exposes the driver to more pedestrian
and vehicular traffic than exists on interstate highways. Faster
reaction to traffic and traffic signals is generally required because
distances between them are more compact. These conditions tax visual
capacity and driver response just as intensely as interstate driving
conditions. The veteran drivers in this proceeding have operated CMVs
safely under those conditions for at least 3 years, most for much
longer. Their experience and driving records lead us to believe that
each applicant is capable of operating in interstate commerce as safely
as he/she has been performing in intrastate commerce. Consequently,
FMCSA finds that exempting these applicants from the vision requirement
in 49 CFR 391.41(b)(10) is likely to achieve a level of safety equal to
that existing without the exemption. For this reason, the Agency is
granting the exemptions for the 2-year period allowed by 49 U.S.C.
31136(e) and 31315 to the 33 applicants listed in the notice of
September 30, 2014 (79 FR 58856).
    We recognize that the vision of an applicant may change and affect
his/her ability to operate a CMV as safely as in the past. As a
condition of the exemption, therefore, FMCSA will impose requirements
on the 33 individuals consistent with the grandfathering provisions
applied to drivers who participated in the Agency's vision waiver
program.
    Those requirements are found at 49 CFR 391.64(b) and include the
following: (1) That each individual be physically examined every year
(a) by an ophthalmologist or optometrist who attests that the vision in
the better eye continues to meet the requirement in 49 CFR
391.41(b)(10) and (b) by a medical examiner who attests that the
individual is otherwise physically qualified under 49 CFR 391.41; (2)
that each individual provide a copy of the ophthalmologist's or
optometrist's report to the medical examiner at the time of the annual
medical examination; and (3) that each individual provide a copy of the
annual medical certification to the employer for retention in the
driver's qualification file, or keep a copy in his/her driver's
qualification file if he/she is self-employed. The driver must have a
copy of the certification when driving, for presentation to a duly
authorized Federal, State, or local enforcement official.

V. Discussion of Comments

    FMCSA received two comments in this proceeding. The comments are
discussed below.
    Rachel King is in favor of granting the drivers listed below an
exemption from the vision standard.
    Miller Keely does not believe anyone who has failed a vision test,
regardless of whether they have been approved by an optometrist or
ophthalmologist, should be granted an exemption from the vision
standard.

IV. Conclusion

    Based upon its evaluation of the 33 exemption applications, FMCSA
exempts the following drivers from the vision requirement in 49 CFR
391.41(b)(10), subject to the

requirements cited above (49 CFR 391.64(b)):

Terry A. Adler (SD)
Richard J. Beck (IL)
Avis C. Bell (IN)
Jeffrey L. Bendix (SD)
Edward L. Bon (LA)
William L. Brady (KS)
Marty R. Brewster (OK)
John M. Brown (KY)
Robert M. Cassell, Jr. (NC)
Henry L. Chrestensen, Sr. (IA)
Charles D. Cohoon (FL)
Jack M. Conklin (NE)
Michael E. Cummins (IL)
Dave J. Eckert (CA)
Sanford L. Goodwin (TX)
Tonia L. Graves (AZ)
Gregory S. Hatten (LA)
Jason P. Jones (IN)
Jason R. King (MO)
Theodore J. Laycock (MA)
Thomas J. Long III (MD)
Marcus E. Manson (TX)
Thomas J. McClure (IA)
Steven W. Miller (PA)
Aaron F. Naylor (PA)
Billy R. O'Guynn (AL)
Walter B. Peltier (AZ)
Gregory S. Rasnic (OH)
Jimmy D. Renfroe (AR)
Sabahudin Sabic (IA)
Klifford N. Siemens (KS)
Aaron H. Walser (ID)
John A. Workman (IL)

    In accordance with 49 U.S.C. 31136(e) and 31315, each exemption
will be valid for 2 years unless revoked earlier by FMCSA. The
exemption will be revoked if: (1) The person fails to comply with the
terms and conditions of the exemption; (2) the exemption has resulted
in a lower level of safety than was maintained before it was granted;
or (3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136 and 31315.
    If the exemption is still effective at the end of the 2-year
period, the person may apply to FMCSA for a renewal under procedures in
effect at that time.

    Dated: December 1, 2014.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-28689 Filed 12-5-14; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Notices]
[Page 38857]
[FR Doc No: 2023-12734]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PL03-3-013]

Energy Intelligence Group, Inc.; Notice of Filing

    Take notice that on June 7, 2023, Energy Intelligence Group, Inc.
filed a formal application to the Federal Energy Regulatory Commission
(Commission) for re-approval as a price index developer fully or
substantially in compliance with the Commission's April 2022 Actions
Regarding the Commission's Policy on Price Index Formation and
Transparency, and Indices Referenced in Natural Gas and Electric
Tariffs (Revised Policy Statement).\1\
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    \1\ 179 FERC ] 61,036 (2022).
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at [email protected] or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFiling'' link
at http://www.ferc.gov. Persons unable to file electronically may mail
similar pleadings to the Federal Energy Regulatory Commission, 888
First Street NE, Washington, DC 20426. Hand delivered submissions in
docketed proceedings should be delivered to Health and Human Services,
12225 Wilkins Avenue, Rockville, Maryland 20852.
    The Commission's Office of Public Participation (OPP) supports
meaningful public engagement and participation in Commission
proceedings. OPP can help members of the public, including landowners,
environmental justice communities, Tribal members and others, access
publicly available information and navigate Commission processes. For
public inquiries and assistance with making filings such as
interventions, comments, or requests for rehearing, the public is
encouraged to contact OPP at<PHONE_NUMBER> or [email protected].
    Comment Date: 5:00 p.m. Eastern Time on June 20, 2023.

    Dated: June 8, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-12734 Filed 6-13-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 27 (Tuesday, February 10, 2015)]
[Notices]
[Page 7511]
[FR Doc No: 2015-02797]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold a Closed Meeting on Thursday,
February 12, 2015 at 2:00 p.m.
    Commissioners, Counsel to the Commissioners, the Secretary to the
Commission, and recording secretaries will attend the Closed Meeting.
Certain staff members who have an interest in the matters also may be
present.
    The General Counsel of the Commission, or her designee, has
certified that, in her opinion, one or more of the exemptions set forth
in 5 U.S.C. 552b(c)(3), (5), (7), 9(B) and (10) and 17 CFR
200.402(a)(3), (5), (7), 9(ii) and (10), permit consideration of the
scheduled matter at the Closed Meeting.
    Commissioner Gallagher, as duty officer, voted to consider the
items listed for the Closed Meeting in closed session.
    The subject matter of the Closed Meeting will be:
Institution and settlement of injunctive actions;
Institution and settlement of administrative proceedings;
Opinion; and
Other matters relating to enforcement proceedings.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact the Office of the
Secretary at<PHONE_NUMBER>.

    Dated: February 5, 2015.
Brent J. Fields,
Secretary.
[FR Doc. 2015-02797 Filed 2-6-15; 11:15 am]
BILLING CODE 8011-01-P