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Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities
AGENCY:
Environmental Protection Agency (EPA).
ACTION:
Notice of filing of petitions and request for comment.
SUMMARY:
This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
DATES:
Comments must be received on or before July 10, 2017.
ADDRESSES:
Submit your comments, identified by the docket identification (ID) number and the pesticide petition number (PP) of interest as shown in the body of this document, by one of the following methods:
- Federal eRulemaking Portal:http://www.regulations.gov. Follow the online instructions for submitting comments. Do not submit electronically any information you consider to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute.
- Mail: OPP Docket, Environmental Protection Agency Docket Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001.
- Hand Delivery: To make special arrangements for hand delivery or delivery of boxed information, please follow the instructions athttp://www.epa.gov/dockets/contacts.html.
Additional instructions on commenting or visiting the docket, along with more information about dockets generally, is available athttp://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT:
Michael Goodis, Registration Division (RD) (7505P), main telephone number: (703) 305-7090; email address:RDFRNotices@epa.gov. The mailing address for each contact person is: Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-0001. As part of the mailing address, include the contact person's name, division, and mail code.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. The following list of North American Industrial Classification System (NAICS) codes is not intended to be exhaustive, but rather provides a guide to help readers determine whether this document applies to them. Potentially affected entities may include:
- Crop production (NAICS code 111).
- Animal production (NAICS code 112).
- Food manufacturing (NAICS code 311).
- Pesticide manufacturing (NAICS code 32532).
If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT for the division listed at the end of the pesticide petition summary of interest.
B. What should I consider as I prepare my comments for EPA?
1. Submitting CBI. Do not submit this information to EPA through regulations.gov or email. Clearly mark the part or all of the information that you claim to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the outside of the disk or CD-ROM as CBI and then identify electronically within the disk or CD-ROM the specific information that is claimed as CBI. In addition to one complete version of the comment that includes information claimed as CBI, a copy of the comment that does not contain the information claimed as CBI must be submitted for inclusion in the public docket. Information so marked will not be disclosed except in accordance with procedures set forth in40 CFR part 2.
2. Tips for preparing your comments. When preparing and submitting your comments, see the commenting tips athttp://www.epa.gov/dockets/comments.html.
3. Environmental justice. EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of any group, including minority and/or low-income populations, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the Agency seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have atypical or disproportionately high and adverse human health impacts or environmental effects from exposure to the pesticides discussed in this document, compared to the general population.
II. What action is the Agency taking?
EPA is requesting the establishment or modification of regulations in40 CFR part 180for residues of pesticide chemicals in or on various food commodities.
The Agency is taking public comment on the requests before responding to the petitioners. EPA is not proposing any particular action at this time. EPA has determined that the pesticide petitions described in this document contain the data or information prescribed in FFDCA section 408(d)(2),21 U.S.C. 346a(d)(2); however, EPA has not fully evaluated the sufficiency of the submitted data at this time or whether the data support granting of the pesticide petitions. After considering the public comments, EPA intends to evaluate whether and what action may be warranted. Additional data may be needed before EPA can make a final determination on these pesticide petitions.
Pursuant to40 CFR 180.7(f), a summary of each of the petitions that are the subject of this document, prepared by the petitioner, is included in a docket EPA has created for each rulemaking. The docket for each of the petitions is available athttp://www.regulations.gov.
As specified in FFDCA section 408(d)(3),21 U.S.C. 346a(d)(3), EPA is publishing notice of the petitions so that the public has an opportunity to comment on these requests for the establishment or modification of regulations for residues of pesticides in or on food commodities. Further information on the petitions may be obtained through the petition summaries referenced in this unit.
Amended Tolerance Exemptions for Inerts (Except PIPS)
1. PP IN-11012. (EPA-HQ-OPP-2017-0046). Dow AgroSciences, 9330 Zionsville Road, Indianapolis, IN 46268, requests to amend an exemption from the requirement of a tolerance for residues of nicotinamide (CAS Reg. No. 98-92-0) when used as a pesticide inert ingredient in pesticide formulations under40 CFR 180.920to increase the limitation of concentration of nicotinamide in pesticide formulations from 0.5% to 5.0%. The petitioner believes no analytical method is needed because it is not required for an Start Printed Page 26642exemption from the requirement of a tolerance. Contact: RD.
2. PP IN-10990. (EPA-HQ-OPP-2016-0755). Spring Trading Company, 203 Dogwood Trail, Magnolia, TX 77354 on behalf of Sasol Chemicals (USA), 12120 Wickchester Lane, Houston, TX 77079, requests to amend an exemption from the requirement of a tolerance under40 CFR 180.960for residues of -alkyl-- hydroxypoly (oxypropylene) and/or poly (oxyethylene) polymers where the alkyl chain contains a minimum of six carbons and a minimum number-average molecular weight of 1,000 when used as an inert ingredient in pesticide formulations to include poly(oxy-1,2-ethanediyl), -isooctyl--hydroxy (CAS Reg. No. 61723-78-2). The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD.
Amended Tolerances for Non-Inerts
1. PP 6E8528. EPA-HQ-OPP-2017-0035. IR-4 Project Headquarters, 500 College Road East, Suite 201W, Princeton, New Jersey 08540, requests to amend tolerances in40 CFR part 180.431for residues of the herbicide clopyralid by removing the established tolerances for residues of the herbicide clopyralid (3,6-dichloro-2-pyridinecarboxylic acid), including its metabolites and degradates, from its application in the acid form or in the form of its salts, to be determined by measuring only clopyralid in or on raw agricultural commodities: Apple at 0.05 ppm, Asparagus at 1.0 ppm, Beet, garden tops at 3.0 ppm, Beet, sugar, tops at 3.0 ppm, Brassica, head and stem, subgroup 5A at 2.0 ppm, Brassica, leafy greens, subgroup 5B at 5.0 ppm, Cranberry at 4.0 ppm, Fruit, stone, group 12 at 0.5 ppm, Strawberry at 4.0 ppm, Turnip, greens at 4.0 ppm and Canola, seed at 3.0 ppm, upon establishment of New Tolerances petition-for under PP 6E8528 mentioned above. Gas chromatography/electron-capture detection (GC/ECD) method is available in The Pesticide Analytical Manual Vol. II to enforce the tolerance expression for clopyralid in plant commodities. Contact RD.
2. PP 6E8532. (EPA-HQ-OPP-2017-0072). Interregional Research Project No. 4, IR-4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201-W, Princeton, NJ 08540, requests to amend the tolerances in40 CFR 180.498for residues of sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) and its metabolites HMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide) and DMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide, calculated as the stoichiometric equivalent of sulfentrazone by removing the tolerances for Asparagus at 0.15 ppm; Brassica, head and stem, subgroup 5A at 0.20 ppm; Brassica, leafy greens, subgroup 5B at 0.40 ppm; Nut, tree, group 14 at 0.15 ppm; Pistachio at 0.15 ppm; and Turnip, tops at 0.60 ppm. The analytical enforcement method for sulfentrazone was used with minor modification that eliminated several clean-up and derivatization steps that was required for GC/MSD but not for LC/MS/MS. The analytical method for sulfentrazone involves separate analyses for parent and its metabolites. The parent is analyzed by evaporation and reconstitution of the sample prior to analysis by LC/MS/MS GC/ECD. The metabolites samples were refluxed in the presence of acid and cleaned up with solid phase extraction prior to analysis by LC/MS/MS. Contact: RD.
3. PP 7F8543. EPA-HQ-OPP-2017-0156. Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808-2951, requests to amend the existing citrus fruits (crop group 10-10) tolerances in40 CFR part 180.675for residues of the insecticide tolfenpyrad as follows: (1) Reduce the established tolerance for the citrus fruit RAC from 1.5 to 0.9 parts per million (ppm); (2) reduce the established tolerance for dried citrus pulp from 8.0 to 3.0 ppm; (3) reduce the established tolerance for citrus oil from 70 to 27 ppm; and (4) reduce the PHI of 14 days to a PHI of 3 days. An acceptable high performance liquid chromatography method with tandem mass spectrometry detection (LC/MS/MS) for enforcement of tolfenpyrad residue tolerances in/on plant commodities exists. The method limit of quantification is 0.01 ppm. The method for plant commodities has been adequately validated and has undergone acceptable independent laboratory validation (ILV). An acceptable LC/MS/MS method also exists for determining residues of tolfenpyrad and its metabolites, PT-CA, OH-PT-CA, and PCA in milk, bovine meat, kidney, liver and fat. The method for livestock commodities has been adequately validated and has undergone acceptable ILV. Acceptable multiresidue methods test data have been submitted for tolfenpyrad per se. The data indicate that the PAM multiresidue methods are not suitable for determination of tolfenpyrad. Metabolite PT-CA is the major residue in livestock matrices and has been identified as a residue of concern for tolerance enforcement in livestock commodities. This metabolite was not tested through the appropriate FDA multiresidue PAM I method; however, based on the structural similarity between tolfenpyrad and PT-CA, it is anticipated that the multiresidue method protocols would not be suitable for analysis of PT-CA. Contact: RD.
New Tolerance Exemptions for Inerts (Except PIPS)
1. PP IN-11003. (EPA-HQ-OPP-2017-0108) Seppic, Inc., 302 Bridges Rd #210, Fairfield, NJ 07004, requests to establish an exemption from the requirement of a tolerance for residues of fatty acids, rape-oil, triesters with polyethylene glycol either with glycerol (3:1) (CAS Reg. No. 688045-21-8) as an inert ingredient in pesticide formulations under40 CFR 180.960. The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD.
2. PP IN-11014. (EPA-HQ-OPP-2017-0084). SciReg, Inc., 12733 Director's Loop, Woodbridge, VA 22192 on behalf of Solvay USA Inc, 504 Carnegie Center, Princeton, NJ 08540, requests to establish an exemption from the requirement of a tolerance in40 CFR 180.920for residues of acetic acid, 2-ethylhexyl ester (CAS Reg. No. 103-09-3) when used as an inert ingredient (solvent/cosolvent) at a concentration of not more than 50% by weight in pesticide formulations applied to growing crops only under40 CFR 180.920. The petitioner believes no analytical method is needed because it is not required for an exemption from the requirement of a tolerance. Contact: RD.
3. PP IN-11024. (EPA-HQ-OPP-2017-0103). SciReg. Inc., 12733 Director's Loop, Woodbridge, VA 22192, on behalf of Solvay USA Inc., 504 Carnegie Center, Princeton, NJ 08540, requests to establish an exemption from the requirement of a tolerance for residues of 2,2-dimethyl-1,3-dioxolane-4-methanol (CAS Reg. No. 100-79-8) when used as an inert ingredient (solvent/cosolvent) in pesticide formulations applied to growing crops, raw agricultural commodities after harvest, and for use in antimicrobial food contact surface sanitizing solutions under40 CFR 180.910and40 CFR 180.940, respectively. The petitioner believes no analytical method is needed because it is not required for an Start Printed Page 26643exemption from the requirement of a tolerance. Contact: RD
New Tolerances for Non-Inerts
1. PP 6E8524. (EPA-HQ-OPP-2016-0681). Gowan Company, P.O. Box 5569, Yuma, AZ 85366-5569, requests to establish a tolerance in40 CFR part 180for residues of the fungicide, zoxamide, in or on banana at 0.3 parts per million (ppm). The gas chromatography with mass selective detection is used to measure and evaluate the chemical Zoxamide, 3,5-dichloro-N-(3-chloro-1-ethyl-1-methyl-2-oxopropyl)-4-methylbenzamide. Contact: RD.
2. PP 6E8528. EPA-HQ-OPP-2017-0035. Interregional Research Project Number 4 (IR-4), IR-4 Project Headquarters, 500 College Road East, Suite 201W, Princeton, New Jersey 08540, requests to establish tolerances in40 CFR part 180for residues of the herbicide clopyralid (3,6-dichloro-2-pyridinecarboxylic acid), including its metabolites and degradates, from its application in the acid form or in the form of its salts, to be determined by measuring only clopyralid in or on the raw agricultural commodities: Berry, low growing, subgroup 13-07G at 4.0 parts per million (ppm), Berry, low growing, except strawberry, subgroup 13-07H at 4.0 ppm, Brassica, leafy greens, subgroup 4-16B at 5.0 ppm, Fruit, pome, group 11-10 at 0.05 ppm, Fruit, stone, group 12-12 at 0.5 ppm, Radish, roots at 0.3 ppm, Stalk and stem vegetable subgroup 22A at 1.0 ppm, Vegetable, brassica, head and stem, group 5-16 at 2.0 ppm, and Vegetable, leaves of root and tuber, group 2 at 5.0 ppm. Gas chromatography/electron-capture detection (GC/ECD) method is available in The Pesticide Analytical Manual Vol. II to enforce the tolerance expression for clopyralid in plant commodities. Contact RD.
3. PP 6E8532. (EPA-HQ-OPP-2017-0072). Interregional Research Project No. 4, IR-4, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201-W, Princeton, NJ 08540, requests to establish tolerances in40 CFR part 180for residues of sulfentrazone (N-[2,4-dichloro-5-[4-(difluoromethyl)-4,5-dihydro-3-methyl-5-oxo-1H-1,2,4-triazol-1-yl]phenyl]methanesulfonamide) and its metabolites HMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-3-hydroxymethyl-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide) and DMS (N-(2,4-dichloro-5-(4-(difluoromethyl)-4,5-dihydro-5-oxo-1H-1,2,4-triazol-1-yl)phenyl)methanesulfonamide, calculated as the stoichiometric equivalent of sulfentrazone in or on the raw agricultural commodities Chia, dry seed at 0.15 parts per million (ppm); Teff, forage at 0.50 ppm; Teff, grain at 0.15 ppm; Teff, hay at 0.30 ppm; Teff, straw at 1.5 ppm; Stalk and stem vegetable subgroup 22A at 0.15 ppm; Vegetable, brassica, head and stem, group 5-16 at 0.20 ppm; Brassica, leafy greens, subgroup 4-16B at 0.60 ppm; and Nut, tree, group 14-12 at 0.15 ppm). The analytical enforcement method for sulfentrazone was used with minor modification that eliminated several clean-up and derivatization steps that was required for GC/MSD but not for LC/MS/MS. The analytical method for sulfentrazone involves separate analyses for parent and its metabolites. The parent is analyzed by evaporation and reconstitution of the sample prior to analysis by LC/MS/MS GC/ECD. The metabolites samples were refluxed in the presence of acid and cleaned up with solid phase extraction prior to analysis by LC/MS/MS. Contact: RD.
4. PP 6E8539. (EPA-HQ-OPP-2017-0089). Interregional Research Project Number 4 (IR-4), Rutgers, The State University of New Jersey, 500 College Road East, Suite 201 W, Princeton, NJ 08540, requests to establish tolerances in40 CFR part 180. 337 for residues of the fungicide/bactericide Oxytetracycline (4S,4aR,5S,5aR,6S,12aS)-4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,6,10,12,12a-hexahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide in or on Cherry, sweet at 0.1 parts per million (ppm) and Cherry, tart at 0.1 ppm. The Liquid Chromatography/Mass Spectrometry (LC/MS/MS) is used to measure and evaluate the chemical residues. Contact: RD.
5. PP 7E8545. (EPA-HQ-OPP-2017-0109). Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box 18300, Greensboro, NC 27419-8300, requests on behalf of Winfield Solutions, LLC, to establish an import tolerance in40 CFR part 180for residues of the insecticide, pirimiphos-methyl in or on wheat gluten at 0.1 parts per million (ppm). Gas chromatography method with flame photometric detection (GC-FPD) is used to measure and evaluate the chemical pirimiphos-methyl. Contact: RD.
6. PP 6F8489. EPA-HQ-OPP-2017-0155. Gowan Company, P.O. Box 5569, Yuma, AZ 85366-5569, requests to establish tolerances in40 CFR part 180.448for residues of the insecticide hexythiazox, in or on hops at 20 parts per million (ppm). The basic analytical method was previously reviewed by the Agency in association with the establishment of the current tolerances with registrations of multiple commodities. The methods used in a new hops raw agricultural commodities study are described fully in the study report, which is submitted concurrently with this petition. Contact: RD.
7. PP 6F8536. (EPA-HQ-OPP-2017-0095). E.I. du Pont de Nemours and Company, 974 Centre Road, Wilmington, Delaware 19805, requests to establish a tolerance in40 CFR part 180for residues of the insecticide indoxacarb in or on corn, field, forage at 10 parts per million (ppm); corn, field, grain at 0.02 ppm; corn, field, stover at 15 ppm; corn, field, aspirated grain fractions at 45 ppm; corn, field, flour at 0.07 ppm; corn, field, meal at 0.03 ppm; corn, field, oil at 0.05 ppm. The LC-MS/MS analytical method is used to measure and evaluate the chemical on the various corn commodities. Contact: RD.
8. PP 7F8544. EPA-HQ-OPP-2017-0156. Nichino America, Inc., 4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808-2951, requests to establish tolerances in40 CFR part 180.675for residues of the insecticide tolfenpyrad, in or on Brassica, head and stem vegetables, crop group 5-16 at 5 parts per million (ppm); Brassica, leafy greens, subgroup 4-16B at 40 ppm; Vegetables, cucurbit, crop group 9 at 0.7 ppm; Vegetables, fruiting, crop group 8-10 at 0.7 ppm; Fruit, pome, crop group 11-10 at 0.7 ppm; Apple, wet pomace, at 2.5 ppm; Fruit, citrus, crop group 10-10 at 0.9 ppm; Citrus, dried pulp at 3.0 ppm; and Citrus, oil at 28 ppm. An acceptable high performance liquid chromatography method with tandem mass spectrometry detection (LC/MS/MS) for enforcement of tolfenpyrad residue tolerances in/on plant commodities exists. The method limit of quantification is 0.01 ppm. The method for plant commodities has been adequately validated and has undergone acceptable independent laboratory validation (ILV). An acceptable LC/MS/MS method also exists for determining residues of tolfenpyrad and its metabolites, PT-CA, OH-PT-CA, and PCA in milk, bovine meat, kidney, liver and fat. The method for livestock commodities has been adequately validated and has undergone acceptable ILV. Acceptable multiresidue methods test data have been submitted for tolfenpyrad per se. The data indicate that the PAM multiresidue methods are not suitable for determination of tolfenpyrad. Metabolite PT-CA is the major residue in livestock matrices and has been identified as a residue of concern for tolerance enforcement in livestock commodities. This metabolite was not tested through the appropriate FDA multiresidue PAM I method; Start Printed Page 26644however, based on the structural similarity between tolfenpyrad and PT-CA, it is anticipated that the multiresidue method protocols would not be suitable for analysis of PT-CA. Contact: RD.
9. PP 6E8450. (EPA-HQ-OPP-2016-0519). Interregional Research Project No. 4 (IR-4) Project Headquarters, Rutgers, The State University of New Jersey, 500 College Road East, Suite 201W, Princeton, NJ 08540, requests to establish tolerances in40 CFR part 180.614for residues of the bactericide, Kasugamycin, (3-O-[2-amino-4-[(carboxyimino-methyl)amino]-2,3,4,6-tetradeoxy--D-arabino-hexopyranosyl]-D-chiro-inositol) in or on Fruit, stone, subgroup 12-12A at 0.6 parts per million (ppm) and Walnut at 0.04 ppm. The Analytical Method, Meth-146, Revision #4 is used to measure and evaluate the chemical kasugamycin. Contact: RD.
New Tolerance Exemptions for Non-Inerts (Except PIPS)
PP 6F8520. (EPA-HQ-OPP-2017-0080). Monsanto Company, 1300 I (Eye) St. NW., Suite 450 East, Washington, DC 20005, requests to establish an exemption from the requirement of a tolerance in40 CFR part 180for residues of the plant growth regulator LCO SP104: D-Glucose,O-2-deoxy-2-[[(11Z)-1-oxo-11-octadecen-1-yl]amino]--D-glucopyranosyl-(14)-O-2-(acetylamino)-2-deoxy--D-glucopyranosyl-(14)-O-2-(acetylamino)-2-deoxy--D-glucopyranosyl-(14)-O-2-(acetylamino)- 2-deoxy--D-glucopyranosyl-(14)-2-(acetylamino)-2-deoxy- in or on raw agricultural commodities and processed foods. The petitioner believes no analytical method is needed because analytical methods normally utilized for detection of compounds in crop plants are incapable of quantifying the negligible levels of LCO SP104 that are predicted to be presented in raw or processed agricultural commodities. Even in the unlikely event that dietary exposure does occur associated with the requested uses, the demonstrated favorable toxicological profile for LCO SP104 does not present a potential hazard for humans or the environment. Contact: BPPD.
New Tolerance Exemptions for PIPS
1. PP 6F8541. (EPA-HQ-OPP-2017-0113). Bayer CropScience LP, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709, requests to establish an exemption from the requirement of a tolerance in40 CFR part 174for residues of the plant-incorporated protectant (PIP) Bacillus thuringiensis Cry14Ab-1 protein in or on soybean. The petitioner believes no analytical method is needed because this petition is for a temporary exemption from the requirement of a tolerance without numerical limitation; thus, an analytical method should not be required. Contact: BPPD.
2. PP IN-11022 (EPA-HQ-OPP-2017-0115). Bayer CropScience LP, 2 T.W. Alexander Dr., Research Triangle Park, NC 27709, requests to establish an exemption from the requirement of a tolerance in40 CFR part 174for residues of the plant-incorporated protectant (PIP) inert ingredient 4-hydroxyphenyl pyruvate deoxygenase (HPPD-4) in or on all food commodities. The petitioner believes no analytical method is needed because this petition is for a temporary exemption from the requirement of a tolerance without numerical limitation; thus, an analytical method should not be required. Contact: BPPD.
Authority:21 U.S.C. 346a.
Dated: April 27, 2017.
Delores Barber,
Director, Information Technology and Resources Management Division, Office of Pesticide Programs.
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