Pesticides; tolerances in food, animal feeds, and raw agricultural commodities: etc.,
[Federal Register: October 16, 1998 (Volume 63, Number 200)]
[Proposed Rules]
[Page 55565-55571]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr16oc98-33]
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Parts 180 and 185
[OPP-300734; FRL-6035-7]
RIN 2070-AB78
Pesticides Tolerance Reassessment Actions; 4-Amino-6-(1,1- dimethylethyl)-3-(methylthio)-1,2,4-triazin-5(4H)-one [Metribuzin], Dichlobenil, Diphenylamine, O-Ethyl O-[4-(methylthio) phenyl] S-propyl phosphorodithioate [Sulprofos], Pendimethalin, and Terbacil
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule.
SUMMARY: This document announces the proposed revocation of tolerances for the herbicides 4-amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4- triazin-5(4H)-one [Metribuzin], dichlobenil, pendimethalin, and terbacil; and the insecticide O-ethyl O-[4-(methylthio) phenyl] S- propyl phosphorodithioate [Sulprofos]. EPA expects to determine whether any individuals or groups want to support these tolerances. Also, this document is proposing the establishment and revision of tolerances for 4-amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4-triazin-5(4H)-one (metribuzin), dichlobenil, pendimethalin, terbacil, and the plant growth regulator diphenylamine. In addition, EPA is also proposing to revise commodity terminology for 4-amino-6-(1,1-dimethylethyl)-3- (methylthio)-1,2,4-triazin-5(4H)-one [Metribuzin], diphenylamine, and pendimethalin to conform to current practice. The regulatory actions in this notice are part of the Agency's reregistration program under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), and the tolerance reassessment requirements of the Federal Food, Drug, and Cosmetic Act (FFDCA). By law, EPA is required to reassess 33% of the tolerances in existence on August 2, 1996, by August 1999, or about 3,200 tolerances.
DATES: Comments must be received on or before December 15, 1998.
ADDRESSES: Comments may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit IV of the ``SUPPLEMENTARY INFORMATION'' section of this document. Be sure to identify the appropriate docket number [OPP- 300734].
FOR FURTHER INFORMATION CONTACT: For technical information contact: Joseph Nevola, Special Review Branch, (7508C), Special Review and Reregistration Division, Office of Pesticide Programs, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460. Office location: Special Review Branch, Crystal Mall #2, 6th floor, 1921 Jefferson Davis Hwy., Arlington, VA. Telephone: (703) 308-8037; e- mail: nevola.joseph@epa.gov.
SUPPLEMENTARY INFORMATION:
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What is the progress of tolerance reassessment?
By law, EPA is required to reassess 33% of the tolerances in existence on August 2, 1996, by August 1999, or about 3,200 tolerances. The regulatory actions proposed in this document pertain to the provosed revocation of 29 tolerances and/or exemptions, which count toward the August, 1999 review deadline of FIFRA, as amended by the Food Quality Protection Act (FQPA) of 1996.
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Does this notice apply to me?
You may be affected by this notice if you sell, distribute, manufacture, or use pesticides for agricultural applications, process food, distribute or sell food, or implement governmental pesticide regulations. Pesticide reregistration and other actions [see FIFRA section 4(g)(2)] include tolerance and exemption reassessment under FFDCA section 408. In this notice, the tolerance actions are proposed in coordination with the cancellation of associated registrations. Potentially affected categories and entities may include, but are not limited to:
Examples of Potentially Category
Affected Entities
Agricultural Stakeholders................. Growers/Agricultural Workers Contractors [Certified/ Commercial Applicators, Handlers, Advisors, etc.] Commercial Processors Pesticide Manufacturers User Groups Food Consumers Food Distributors......................... Wholesale Contractors Retail Vendors Commercial Traders/Importers Intergovernmental Stakeholders............ State, Local, and/or Tribal Government Agencies Foreign Entities.......................... Governments, Growers, Trade Groups
This table is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this table could also be affected. If you have any questions regarding the applicability of this action to a particular entity, you can consult with the technical person listed in the ``FOR FURTHER INFORMATION CONTACT'' section.
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How can I get additional information or copies of this or other support documents?
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Electronically
You may obtain electronic copies of this document and various support documents from the EPA Internet Home Page at http:// www.epa.gov/. On the Home Page select ``Laws and Regulations'' and then look up the entry for this document under ``Federal Register - Environmental Documents.'' You can also go directly to the ``Federal Register'' listings at http://www.epa.gov/homepage/fedrgstr/.
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In Person or by Phone
If you have any questions or need additional information about this action, please contact the technical person identified in the ``FOR FURTHER INFORMATION CONTACT'' section. In addition, the official record for this notice, including the public version, has been established under docket control number [OPP-300734], (including comments and data submitted electronically as described below). A public version of this record, including printed, paper versions of any electronic comments, which does not include any information claimed as Confidential Business Information (CBI), is available for inspection in Room 119, Crystal Mall
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How can I respond to this notice?
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How and to whom do I submit comments to?
You may submit comments through the mail, in person, or electronically. Be sure to identify the appropriate docket control number (i.e., [OPP-300734]) in your correspondence.
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By mail. Submit written comments, identified by the docket control number [OPP-300734], to: Public Information and Records Integrity Branch, Information Resources and Services Division (7502C), Office of Pesticide Programs, U.S. Environmental Protection Agency, 401 M St., S.W., Washington, DC 20460.
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In person or by courier. Deliver written comments, identified by the docket control number [OPP-300734], to: Public Information and Records Integrity Branch, Office of Pesticide Programs, U.S. Environmental Protection Agency, Rm. 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA.
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Electronically. Submit your comments and/or data electronically by E-mail to: oppt.ncic@epa.gov. Do not submit any information electronically that you consider to be CBI. Submit electronic comments in ASCII file format avoiding the use of special characters and any form of encryption. Comment and data will also be accepted on standard computer disks in WordPerfect 5.1/6.1 or ASCII file format. All comments and data in electronic form must be identified by the appropriate docket control number [OPP-300734]. You may also file electronic comments and data online at many Federal Depository Libraries.
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How should I handle CBI information in my comments?
You may claim information that you submit in response to this document as CBI by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the comment that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential will be included in the public docket by EPA without prior notice. If you have any questions about CBI or the procedures for claiming CBI, please consult with the technical person identified in the ``FOR FURTHER INFORMATION CONTACT'' section.
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What is a `tolerance''?
A ``tolerance'' represents the maximum level for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. Section 408 of FFDCA, 21 U.S.C. 301 et seq., as amended by the FQPA of 1996, Pub.L. 104-170, authorizes the establishment of tolerances (maximum residue levels), exemptions from the requirement of a tolerance, modifications in tolerances, and revocation of tolerances for residues of pesticide chemicals in or on raw agricultural commodities and processed foods. 21 U.S.C. 346(a). Without a tolerance or exemption, food containing pesticide residues is considered to be unsafe and therefore ``adulterated'' under section 402(a) of the FFDCA. If food containing pesticide residues is considered to be ``adulterated,'' you can not distribute the product in interstate commerce (21 U.S.C. 331(a) and 342(a)). For a food-use pesticide to be sold and distributed, the pesticide must not only have appropriate tolerances under the FFDCA, but also must be registered under section 3 of FIFRA (7 U.S.C. et seq.).
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Why is EPA proposing the tolerance actions discussed below?
EPA has issued a Reregistration Eligibility Decision (RED) for each of the pesticides subject to this notice, except for sulprofos, which during the RED process was voluntarily canceled by the registrant. The RED contains the Agency's evaluation of the database for a pesticide, including requirements for additional data on the active ingredients to confirm the potential human health and environmental risk assessments associated with current product uses, and the Agency's decisions and conditions under which these uses and products will be eligible for reregistration. The safety findings for pesticide tolerances can be found in those RED documents. Printed copies of the RED may be obtained from EPA's National Center for Environmental Publications and Information (EPA/NCEPI), PO Box 42419, Cincinnati, OH 45242-2419, telephone 1-800-490-9198; fax 513-489-8695 and from the National Technical Information Service (NTIS), 5285 Port Royal Road, Springfield, VA 22161, telephone 703-487-4650. Electronic copies of the RED are available on the internet at http://www.epa.gov/REDs.
It is EPA's general practice to propose revocation of tolerances for residues of pesticide active ingredients for which FIFRA registrations no longer exist. EPA has historically expressed a concern that retention of tolerances that are not necessary to cover residues in or on legally treated foods has the potential to encourage misuse of pesticides within the United States. However, in accordance with FFDCA section 408, EPA will not revoke any tolerance or exemption proposed for revocation if any person demonstrates a need for the retention of the tolerance, and if retention of the tolerance will meet the tolerance standard established under FQPA. Generally, interested parties support the retention of such tolerances in order to permit treated commodities to be legally imported into the United States, since raw agricultural commodities or processed food or feed commodities containing pesticide residues not covered by a tolerance or exemption are considered to be adulterated.
Tolerances and exemptions established for pesticide chemicals with FIFRA registrations cover residues in or on both domestic and imported commodities. To retain these tolerances and exemptions, EPA must make a finding that the tolerances and exemptions are safe. To make this safety finding, EPA needs data and information indicating that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide residues covered by the tolerances and exemptions.
For tolerances without U.S. registrations, EPA has the same toxicology and residue chemistry data requirements as are needed to support U.S. food-use registrations. For import tolerances, EPA applies these data requirements on a case-by-case basis to account for specific growing conditions in foreign countries. (See 40 CFR part 158 for EPA's data requirements to support domestic use of a pesticide and the establishment and maintenance of a tolerance. EPA is developing a guidance concerning submissions for import tolerance support. This guidance will be made available to interested stakeholders.) In most cases, EPA also requires residue chemistry data (crop field trials) that are representative of growing conditions in exporting countries in the same manner that EPA requires representative residue chemistry data from different U.S. regions to support domestic use of a pesticide and any resulting tolerance(s) or exemption(s). Good Laboratory Practice (GLP) requirements for studies submitted in support of tolerances and exemptions for import purposes only are the same as for domestic purposes; i.e., the studies are required to either
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fully meet GLP standards, or have sufficient justification presented to show that deviations from GLP requirements do not significantly affect the results of the studies.
Monitoring and enforcement of pesticide tolerances and exemptions are carried out by the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). This includes monitoring for pesticide residues in or on commodities imported into the United States.
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Which pesticides are covered by this action?
4-Amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4-triazin-5(4H)- one [Metribuzin, trade name Sencor] is an herbicide used on a wide range of crop and non-crop sites, including alfalfa, asparagus, barley, carrots, field corn, garbanzo beans, lentils, peas, potatoes, soybean, sugarcane, tomatoes, wheat, fallow land and turfgrasses, to selectively control broadleaf and grassy weed species. It is manufactured by Bayer Corporation.
Dichlobenil (trade names Casoron, Norosac) is a selective herbicide registered for use on cranberry bogs, dichondra, ornamentals; blackberry, raspberry, and blueberry fields; apple, pear, filbert, and cherry orchards; vineyards, and hybrid poplar-cottonwood plantations. It is manufactured by Uniroyal Chemical.
Diphenylamine is a plant growth regulator used post-harvest on apples to control storage scald. Elf Atochem and Pace International are the manufacturers of the chemical.
O-Ethyl O-[4-(methylthio) phenyl] S-propyl phosphorodithioate
[Sulprofos] is an insecticide once used on cotton. It was manufactured by Bayer Corporation.
Pendimethalin (trade names Prowl, Squadron) is a selective herbicide used to control broadleaf weeds and grassy weed species on a number of crop and noncrop areas and on residential lawns and ornamentals. It is manufactured by American Cyanamid Corporation.
Terbacil (3-tert-butyl-5-chloro-6-methyluracil, trade name Sinbar) is an herbicide used to control barnyardgrass, broadleaf weeds, chickweed, clover, crabgrass, dandelion, foxtail, peppergrass, pigweed, quackgrass, ragweed, and ryegrass. It is manufactured by E. I. Du Pont de Nemours and Co., Incorporated.
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What action is being taken?
This notice proposes revocation of FFDCA tolerances for residues of the herbicides 4-amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4- triazin-5(4H)-one [Metribuzin], dichlobenil, pendimethalin, and terbacil; and the insecticide O-Ethyl O-[4-(methylthio) phenyl] S- propyl phosphorodithioate [Sulprofos] in or on commodities listed in the regulatory text because these pesticides are not registered under FIFRA for uses on the commodities. The registrations for these pesticide chemicals were canceled because the registrant failed to pay the required maintenance fee and/or the registrant voluntarily canceled one or more registered uses of the pesticide. It is EPA's general practice to propose revocation of those tolerances for residues of pesticide chemicals for which there are no active registrations under FIFRA, unless any person in comments on the proposal demonstrates a need for the tolerance to cover residues in or on imported commodities or domestic commodities legally treated.
Changes in the commodity terminology and definitions are proposed in accordance with the revised Crop Group Regulation (40 CFR 180.41) and the updated Table I ``Raw Agricultural and Processed Commodities and Feedstuffs Derived from Crops' (August, 1996) in the Residue Chemistry Test Guidelines: OPPTS 860.1000 (EPA 721-C-96-169). Table I contains data on both crops and livestock diets, and lists feed commodities considered significant in livestock diets. Significant feedstuffs account for more than 99% of the available annual tonnage (on-a dry-matter basis) of feedstuffs used in the domestic production of more than 95 percent of beef and dairy cattle, poultry, swine, milk, and eggs. EPA has devised criteria to include or exclude feedstuffs from Table I and sets tolerances for significant feedstuffs. Tolerances are not set for feedstuffs which are neither significant nor a human food. Pesticide residues on such feedstuffs are governed by tolerances on the commodity from which they are derived (December 17, 1997, 62 FR 66020) (FRL-5753-1). These changes are technical in nature and have no effect on the scope of the tolerance.
This notice also proposes to establish and revise tolerances as given in the regulatory text. A determination of safety by EPA includes consideration of (a) potential cumulative effects with pesticides that have a common mode of toxicity, (b) aggregate risks resulting from exposure to residues in food and drinking water and exposure occuring due to pesticide application in residential settings, and (c) special sensitivity to children. FFDCA section 408(b)(2)(C) requires that when determining appropriate tolerances EPA apply an additional ten-fold safety factor for infants and children to take into account potential pre- and post-natal toxicity and the completeness of data on toxicity and exposure unless a different margin of safety, on the basis of reliable data, will be safe for infants and children. Retention, reduction, or removal of the ten-fold safety factor is based on a weight-of-evidence evaluation of all applicable data. Through the Reregistration Eligibility Decision (RED) process, EPA has determined that each of the amended tolerances meet the safety standards under FQPA for each of the following active ingredients. This safety finding determination is found in detail in the RED for the active ingredient. Each RED concerning an active ingredient is publically available as described in Unit VI of this proposed rule and by contacting the Pesticide Docket, Public Information and Records Integrity Branch, Information Resources and Services (7502C), Office of Pesticide Programs (OPP), U.S. EPA, Washington, DC 20460, telephone 703-305-5805.
4-Amino-6(1,1-dimethylethyl)-3-(methylthio)-1,2,4-triazin-5(4H)-one
[Metribuzin]
The tolerance for lentils, vine hay in 40 CFR 180.332 is being proposed for revocation. Lentils, vine hay is no longer considered a significant livestock feed commodity. Contrary to the RED, a registered use now exists for sweet corn, as conveyed by EPA in a letter to the Bayer Corporation as of August, 1997. Therefore, the tolerance for corn, fresh (inc. sweet K + CWHR) will not be revoked. Tolerances for both barley, hay and wheat, hay are proposed to be established at 7 ppm. Tolerances for both asparagus and soybeans should be increased from 0.05 to 0.1 and from 0.1 to 0.3 ppm, respectively. The tolerance for peas, vine hay is proposed to be increased from 0.05 to 4 ppm (along with a proposed terminology revision to peas, field, hay); and the tolerance for sugarcane molasses was listed incorrectly as 0.3 ppm, it should be revised to reflect the correct tolerance of 2 ppm (August 24, 1978, 43 FR 35915), along with a proposed terminology revision to sugarcane, molasses. Other terminology changes are given in the regulatory text.
Dichlobenil
The tolerances listed under 40 CFR 180.231 are for the combined negligible residues of the herbicide dichlobenil (2,6- dichlorobenzonitrile) and its metabolite 2,6-dichlorobenzoic acid (2,6- DCBA). The Agency has determined that the metabolite 2,6-
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Dichlorobenzamide (BAM) should be added to the tolerance expression and the metabolite 2,6-DCBA should be deleted from the tolerance expression. Tolerances for almond hulls; avocados; citrus; figs; and mangoes in 40 CFR 180.231 are being proposed for revocation because no registered uses exist. The tolerance for nuts in 40 CFR 180.231 is proposed for revocation and a tolerance for filberts is being proposed to be established at 0.1 parts per million, since the use of dichlobenil on all other nuts has been canceled. Based upon the available residue data and to reflect the combined residues of dichlobenil and BAM, tolerances for apples and pears should be increased from 0.15 to 0.5 ppm, and tolerances for blackberries, cranberries, and raspberries should be decreased from 0.15 to 0.10 ppm.
Diphenylamine
This notice proposes to establish tolerances of 0.01 ppm for residues in milk and meat, fat, and mbyp (excluding liver) of cattle, goats, horses, and sheep. Separate tolerances are proposed to be established at 0.1 ppm for residues of diphenylamine in liver of cattle, goats, horses, and sheep. A tolerance of 30 ppm is proposed to be established for diphenylamine residues in wet apple pomace. Also, this notice proposes to increase milk and meat tolerances for diphenylamine residues from 0 to 0.01 ppm based on adequate ruminant data. Terminology changes are given in the regulatory text.
O-Ethyl O-[4-(methylthio) phenyl] S-propyl phosphorodithioate
[Sulprofos]
The tolerance for cottonseed oil in 40 CFR 185.3000 is being proposed for revocation because the registrant voluntarily canceled its registered use.
Pendimethalin
The tolerance for peanut, forage in 40 CFR 180.361(a) is being proposed for revocation because it is no longer considered a significant livestock feed commodity; therefore, a tolerance is not necessary. This notice proposes to establish a tolerance of 0.1 ppm for residues in or on rice, straw; and to raise the tolerance on rice grain from 0.05 to 0.1 ppm based on available field trial data and to reflect the analytical method's limit of quantitation for the combined residues of pendimethalin and its regulated metabolite. EPA also proposes to combine the tolerance for garlic, listed under 180.361(c) Tolerances with regional registrations, with tolerances 180.361(a), which lists tolerances for registrations without regional restriction, since EPA has data that supports a national registration and tolerance for garlic at the same level (0.1 ppm). Terminology changes are given in the regulatory text.
Terbacil
Tolerances for pears; pecans; sainfoin, forage; and sainfoin hay in 40 CFR 180.209(a) are being proposed for revocation because no registered uses exist. Tolerances for cattle, fat; cattle, mybp; cattle, meat; goats, fat; goats, mbyp; goats, meat; hogs, fat; hogs, mbyp; hogs, meat; horses, fat; horses, mbyp; horses, meat; milk, fat; sheep, fat; sheep, mbyp; and sheep, meat in 40 CFR 180.209(a) are being proposed for revocation because there is no reasonable expectation of finite terbacil residues in animal commodities since available data support the establishment of lower alfalfa tolerances [40 CFR 180.6(a)(3)]. For further information, consult the RED for Terbacil. EPA is proposing that the tolerance expressions be unified to include terbacil (3-tert-butyl-5-chloro-6-methyluracil) and its metabolites [3- tert-butyl-5-chloro-6-hydroxymethyl-uracil], [6-chloro-2,3-dihydro-7- hydroxymethyl 3,3-dimethyl-5H-oxazolo (3,2-a) pyrimidin-5-one], and [6- chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo (3,2-a) pyrimidin-5-one], calculated as terbacil. In accordance, 40 CFR 180.209 sections (a)(1) and (a)(2) should be combined. To reflect the combined limit of detection for terbacil and its three regulated metabolites, this document proposes to raise the tolerances for terbacil residues in or on peaches from 0.1 to 0.2 ppm, blueberries from 0.1 to 0.2 ppm, and caneberries from 0.1 to 0.2 ppm. Based upon available residue data, tolerances should be increased for apples from 0.1 to 0.3 ppm, asparagus from 0.2 to 0.4 ppm, and sugarcane from 0.1 to 0.4 ppm; however, tolerances should be decreased for alfalfa, forage; from 5.0 to 1.0 ppm, and alfalfa, hay; from 5.0 to 2.0 ppm.
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When do these actions become effective?
EPA proposes that these actions become effective 90 days following publication of a final rule in the Federal Register. EPA has delayed the effectiveness of these revocations for 90 days following publication of a final rule to ensure that all affected parties receive notice of EPA's action. For this particular proposed rule, the actions will affect uses which have been canceled for more than a year. This should ensure that commodities have cleared the channels of trade. If you have comments regarding existing stocks, please submit comments as described in Unit IV of this preamble.
Any commodities listed in the regulatory text of this notice that are treated with the pesticides subject to this notice, and that are in the channels of trade following the tolerance revocations, shall be subject to FFDCA section 408(1)(5), as established by FQPA. Under this section, any residue of these pesticides in or on such food shall not render the food adulterated so long as it is shown to the satisfaction of FDA that, (1) the residue is present as the result of an application or use of the pesticide at a time and in a manner that was lawful under FIFRA, and (2) the residue does not exceed the level that was authorized at the time of the application or use to be present on the food under a tolerance or exemption from tolerance. Evidence to show that food was lawfully treated may include records that verify the dates that the pesticide was applied to such food.
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What can I do if I wish the Agency to maintain a tolerance that the Agency proposes to revoke?
In addition to submitting comments in response to this notice, you may also submit an objection. EPA subsequently issues a final rule after considering the comments that are submitted in response to this notice. If you fail to file an objection to the final rule within the time period specified, you will have waived the right to raise any issues resolved in the final rule. After the specified time, the issues resolved in the final rule cannot be raised again in any subsequent proceedings.
This proposal provides 60 days for any interested person to demonstrate a need for retaining a tolerance, if retention of the tolerance will meet the tolerance standard established under FQPA. If EPA receives a comment to that effect, EPA will not proceed to revoke the tolerance immediately. However, EPA will take steps to ensure the submission of any needed supporting data and will issue an order in the Federal Register under FFDCA section 408(f) if needed. The order would specify the data needed, the time frames for its submission, and would require that within 90 days some person or persons notify EPA that they will submit the data. If the data are not submitted as required in the order, EPA will take appropriate action under FIFRA or FFDCA.
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How do the regulatory assessment requirements apply to this action?
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Is this a ``significant regulatory action''?
No. Under Executive Order 12866, entitled Regulatory Planning and Review (58 FR 51735, October 4, 1993), this action is not a ``significant regulatory action.'' The Office of Management and Budget (OMB) has determined that tolerance actions, in general, are not ``significant'' unless the action involves the revocation of a tolerance that may result in a substantial adverse and material affect on the economy. In addition, this action is not subject to Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), because this action is not an economically significant regulatory action as defined by Executive Order 12866. Nonetheless, environmental health and safety risks to children are considered by the Agency when determining appropriate tolerances. Under FQPA, EPA is required to apply an additional 10-fold safety factor to risk assessments in order to ensure the protection of infants and children unless reliable data supports a different safety factor.
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Does this action contain any reporting or recordkeeping requirements?
No. This action does not impose any information collection requirements subject to OMB review or approval pursuant to the Paperwork Reduction Act (44 U.S.C. 3501 et seq.).
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Does this action involve any ``unfunded mandates''?
No. This action does not impose any enforceable duty, or contain any ``unfunded mandates'' as described in Title II of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4).
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Do Executive Orders 12875 and 13084 require EPA to consult with States and Indian Tribal Governments prior to taking the action in this notice?
No. Under Executive Order 12875, entitled Enhancing the Intergovernmental Partnership (58 FR 58093, October 28, 1993), EPA may not issue a regulation that is not required by statute and that creates a mandate upon a State, local or tribal government, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by those governments. If the mandate is unfunded, EPA must provide to the Office of Management and Budget (OMB) a description of the extent of EPA's prior consultation with representatives of affected State, local and tribal governments, the nature of their concerns, copies of any written communications from the governments, and a statement supporting the need to issue the regulation. In addition, Executive Order 12875 requires EPA to develop an effective process permitting elected officials and other representatives of State, local and tribal governments ``to provide meaningful and timely input in the development of regulatory proposals containing significant unfunded mandates.''
Today's proposed rule does not create an unfunded federal mandate on State, local or tribal governments. The rule does not impose any enforceable duties on these entities. Accordingly, the requirements of section 1(a) of Executive Order 12875 do not apply to this proposed rule.
Under Executive Order 13084, entitled Consultation and Coordination with Indian Tribal Governmen (63 FR 27655, May 19,1998), EPA may not issue a regulation that is not required by statute, that significantly or uniquely affects the communities of Indian tribal governments, and that imposes substantial direct compliance costs on those communities, unless the Federal government provides the funds necessary to pay the direct compliance costs incurred by the tribal governments. If the mandate is unfunded, EPA must provide OMB, in a separately identified section of the preamble to the rule, a description of the extent of EPA's prior consultation with representatives of affected tribal governments, a summary of the nature of their concerns, and a statement supporting the need to issue the regulation. In addition, Executive Order 13084 requires EPA to develop an effective process permitting elected and other representatives of Indian tribal governments ``to provide meaningful and timely input in the development of regulatory policies on matters that significantly or uniquely affect their communities.''
Today's proposed rule does not significantly or uniquely affect the communities of Indian tribal governments. This action does not involve or impose any requirements that affect Indian Tribes. Accordingly, the requirements of section 3(b) of Executive Order 13084 do not apply to this proposed rule.
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Does this action involve any environmental justice issues?
No. This action is not expected to have any potential impacts on minorities and low income communities. Special consideration of environmental justice issues is not required under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations (59 FR 7629, February 16, 1994).
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Does this action have a potentially significant impact on a substantial number of small entities?
No. Pursuant to section 605(b) of the Regulatory Flexibility Act (5 U.S.C. 601 et seq.), the Agency hereby certifies that tolerance actions, including these specific tolerance actions, will not result in a significant economic impact on a substantial number of small entities. Because similar tolerance actions are expected to have the same general impact from chemical to chemical, this certification is applicable to all tolerance actions. Unless a particular tolerance action is expected to have impacts different than those used for the analysis, this determination will also serve as a ``generic'' certification for the promulgation of any pesticide tolerance action, and EPA will incorporate it by reference in future individual tolerance actions. This ``generic'' certification (46 FR 24950, May 4, 1981) and the rationale presented below has been provided to the Chief Counsel for Advocacy of the Small Business Administration. Technical changes such as changing the individual commodity name or crop group definition will have no impact on the crop itself or residue requirements. Therefore, I certify that these types of administrative changes will not have an economic impact or cause significant adverse effects on a substantial number of small entities.
EPA has determined that the revocation of a tolerance after the use of the pesticide becomes illegal in this country, will not have a significant impact on a substantial number of small entities, because such revocations do not have a significant impact on affected entities in general, regardless of the size of the entity. Since small entities are not disproportionally impacted, EPA considered the impacts on domestic growers and domestic importers of food products that could be affected by the revocation of the tolerance.
In the case of domestically grown food, the tolerances revoked by this notice will have no economic impact. Since the uses are no longer registered, uses have already been deleted from the pesticide product labels. U.S. growers may no longer purchase the pesticides in question for use on such crops and EPA believes that no existing stocks
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remain of the pesticides in question labeled for the deleted uses. In these circumstances, revoking the tolerances after deletion of the uses should have no impact on food grown in the United States. However, food legally treated under FIFRA before the use deletions occurred will not be considered adulterated if the residue level complies with the tolerance in effect at the time of treatment [see FFDCA section 408(l)(5)].
Revocation may have an effect on domestic importers of foreign- grown food to the extent their foreign suppliers use pesticides in ways that result in residues no longer allowed in the United States. If foreign growers use a pesticide on crops for which there is no tolerance or exemption from the requirement of a tolerance, the food they grow will be considered adulterated and subject to detention and regulatory action if residues of the pesticide are found in or on the food when offered for import or imported into the United States. Nevertheless, the effect on U.S. importers is expected to be minimal regardless of their size.
In the absence of extraordinary circumstances, the revocation of a particular tolerance is unlikely to have a significant impact on the price of a commodity on the international market. Transaction costs may occur as a result of having to find alternative suppliers of food untreated with pesticides for which tolerances were revoked. Affected importers, however, would have the options of finding other suppliers in the same country or in other countries, or inducing the same supplier to switch to alternative pest controls. Given the existence of these options, EPA expects any price increases or transaction costs resulting from revocations to be minor. Given the overall minimal impact anticipated, revocations are not expected to have a significant impact on those affected, including small entities.
As to the pesticide uses involved in this action, EPA has reviewed its available data on imported food and foreign pesticide usage and concludes that there is a reasonable international supply of food not treated with the pesticides having tolerances that are proposed for revocation, generally within the same countries from which the relevant commodities are currently imported.
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Does this action involve technical standards?
No. This tolerance action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Pub. L. 104-113, Section 12(d) (15 U.S.C. 272 note). Section 12(d) directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (e.g., materials specifications, test methods, sampling procedures, business practices, etc.) that are developed or adopted by voluntary consensus standards bodies. The NTTAA requires EPA to provide Congress, through OMB, explanations when the Agency decides not to use available and applicable voluntary consensus standards. EPA invites public comment on this conclusion.
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Are there any international trade issues raised by this action?
EPA is working to ensure that the U.S. tolerance reassessment program under FQPA does not disrupt international trade. EPA considers Codex Maximum Residue Limits (MRLs) in setting U.S. tolerances and in reassessing them. MRLs are established by the Codex Committee on Pesticide Residues, a committee within the Codex Alimentarius Commission, an international organization formed to promote the coordination of international food standards. When possible, EPA seeks to harmonize U.S. tolerances with Codex MRLs. EPA may establish a tolerance that is different from a Codex MRL, however FFDCA section 408(b)(4) requires that EPA explain in a Federal Register notice the reasons for departing from the Codex level. EPA's effort to harmonize with Codex MRLs is summarized in the tolerance reassessment section of individual REDs. The U.S. EPA is developing a guidance concerning submissions for import tolerance support. This guidance will be made available to interested stakeholders.
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Is this action subject to review under the Congressional Review Act?
No. This action is not a final rule. Under 5 U.S.C. 801(a)(1)(A) of the Administrative Procedure Act (APA) as amended by the Small Business Regulatory Enforcement Fairness Act of 1996 (Title II of Pub. L. 104- 121, 110 Stat. 847), only final rules must be submitted to the U.S. Senate, the U.S. House of Representatives, and the Comptroller General of the United States prior to publication in the Federal Register.
List of Subjects
40 CFR Part 180
Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and record keeping requirements.
40 CFR Part 185
Environmental protection, Food additives, Pesticides and pests.
Dated: September 28, 1998.
Marcia E. Mulkey, Director, Office of Pesticide Programs.
Therefore, it is proposed that 40 CFR parts 180 and 185 be amended to read as follows:
PART 180--[AMENDED]
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In part 180:
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The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 346a and 371.
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Section 180.190 is revised to read as follows:
Sec. 180.190 Diphenylamine; tolerances for residues.
(a) General. Tolerances for residues of the plant regulator diphenylamine are established in or on the following commodities:
Commodity
Parts per million
Apple, pomace, wet........................ 30 Apples from preharvest or postharvest use 10 (including use of impregnated wraps). Cattle, fat............................... 0.01 Cattle, liver............................. 0.1 Cattle, mbyp (excluding liver)............ 0.01 Cattle, meat.............................. 0.01 Goat, fat................................. 0.01 Goat, liver............................... 0.1 Goat, mbyp (excluding liver).............. 0.01 Goat, meat................................ 0.01 Horse, fat................................ 0.01 Horse, liver.............................. 0.1 Horse, mbyp (excluding liver)............. 0.01 Horse, meat............................... 0.01 Milk...................................... 0.01 Sheep, fat................................ 0.01 Sheep, liver.............................. 0.1 Sheep, mbyp (excluding liver)............. 0.01 Sheep, meat............................... 0.01
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registrations. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
[[Page 55571]]
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In Sec. 180.209, by alphabeticaly adding the entries in the table in paragraph (a)(1) to the table in paragraph (a)(2), by removing paragraph (a)(1), by redesignating paragraph (a)(2) as paragraph (a), and revising newly designated paragraph (a) to read as follows:
Sec. 180.209 Terbacil; tolerances for residues.
(a) General. Tolerances are established for combined residues of the herbicide terbacil (3-tert-butyl-5-chloro-6-methyluracil) and its metabolites [3-tert-butyl-5-chloro-6-hydroxymethyluracil], [6-chloro- 2,3-dihydro-7-hydroxymethyl 3,3-dimethyl-5H-oxazolo (3,2-a) pyrimidin- 5-one], and [6-chloro-2,3-dihydro-3,3,7-trimethyl-5H-oxazolo (3,2-a) pyrimidin-5-one], calculated as terbacil, in or on raw agricultural commodities as follows:
Commodity
Parts per million
Alfalfa, forage........................... 1.0 Alfalfa, hay.............................. 2.0 Apple..................................... 0.3 Asparagus................................. 0.4 Blueberry................................. 0.2 Caneberry (blackberry, boysenberry,
0.2 dewberry, loganberry, raspberry, and youngberry, and varieties and/or hybrids of these). Citrus fruits............................. 0.1 Mint hay (peppermint and spearmint)....... 2.0 Peach..................................... 0.2 Strawberry................................ 0.1 Sugarcane................................. 0.4
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Section 180.231 is revised to read as follows:
Sec. 180.231 Dichlobenil; tolerances for residues.
(a) General. Tolerances are established for the combined residues of the herbicide dichlobenil (2,6-dichlorobenzonitrile) and its metabolite 2,6-dichlorobenzamide in or on the following raw agricultural commodities:
Commodity
Parts per million
Apple..................................... 0.5 Blackberry................................ 0.1 Blueberry................................. 0.15 Cranberry................................. 0.1 Filbert................................... 0.1 Grape..................................... 0.15 Pear...................................... 0.5 Raspberry................................. 0.1 Stone fruits group........................ 0.15
(b) Section 18 emergency exemptions. [Reserved]
(c) Tolerances with regional registration. [Reserved]
(d) Indirect or inadvertent residues. [Reserved]
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In Sec. 180.332, paragraph (a) the table is revised to read as follows:
Sec. 180.332 4-Amino-6-(1,1-dimethylethyl)-3-(methylthio)-1,2,4- triazin-5(4H)-one; tolerances for residues.
(a) * * *
Commodity
Parts per million
Alfalfa, green............................ 2 Alfalfa, hay.............................. 7 Asparagus................................. 0.1 Barley, grain............................. 0.75 Barley, hay............................... 7 Barley, milled fractions (exceept flour).. 3 Barley, straw............................. 1 Carrots................................... 0.3 Cattle, fat............................... 0.7 Cattle, mbyp.............................. 0.7 Cattle, meat.............................. 0.7 Corn, field, stover....................... 0.1 Corn, field, forage....................... 0.1 Corn, fresh (inc. sweet K+CWHR)........... 0.05 Corn, grain (inc. popcorn)................ 0.05 Eggs...................................... 0.01 Goats, fat................................ 0.7 Goats, mbyp............................... 0.7 Goats, meat............................... 0.7 Grass, forage............................. 2 Grass, hay................................ 7 Hogs, fat................................. 0.7 Hogs, mbyp................................ 0.7 Hogs, meat................................ 0.7 Horses, fat............................... 0.7 Horses, mbyp.............................. 0.7 Horses, meat.............................. 0.7 Lentil.................................... 0.5 Milk...................................... 0.05 Peas, field, hay.......................... 4 Pea, field, vine.......................... 0.5 Pea, seed................................. 0.05 Pea, succulent............................ 0.1 Potato, processed potato waste............ 3 Potatoes.................................. 0.6 Poultry, fat.............................. 0.7 Poultry, mbyp............................. 0.7 Poultry, meat............................. 0.7 Sainfoin, forage.......................... 2 Sainfoin, hay............................. 7 Sheep, fat................................ 0.7 Sheep, mbyp............................... 0.7 Sheep, meat............................... 0.7 Soybean, seed............................. 0.3 Soybeans, forage.......................... 4 Soybeans, hay............................. 4 Sugarcane................................. 0.1 Sugarcane, molasses....................... 2 Tomatoes.................................. 0.1 Wheat, forage............................. 2 Wheat, hay................................ 7 Wheat, grain.............................. 0.75 Wheat, milled fractions (except flour).... 3 Wheat, straw.............................. 1
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In Sec. 180.361, paragraph (a), the table is revised to read as follows:
Sec. 180.361 Pendimethalin; tolerances for residues.
(a) * * *
Commodity
Parts per million
Bean, succulent and bean, seed............ 0.1 Beans, forage............................. 0.1 Beans, hay................................ 0.1 Corn, field, stover....................... 0.1 Corn, forage.............................. 0.1 Corn, sweet (K+CWHR)...................... 0.1 Corn, field, grain........................ 0.1 Corn, pop, grain.......................... 0.1 Cotton, undelinted seed................... 0.1 Onions, dry bulb.......................... 0.1 Peanuts................................... 0.1 Peanut, hay............................... 0.1 Peas (except field peas).................. 0.1 Potatoes.................................. 0.1 Rice, grain............................... 0.1 Rice, straw............................... 0.1 Sorghum, stover........................... 0.1 Sorghum, forage........................... 0.1 Sorghum, grain............................ 0.1 Soybeans.................................. 0.1 Soybeans, forage.......................... 0.1 Soybeans, hay............................. 0.1 Sugarcane................................. 0.1 Sunflower, seeds.......................... 0.1
* * * * *
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In Sec. 180.361, paragraph (c), the entry for ``garlic'' is alphabetically added to the table in paragraph (a).
PART 185-- [AMENDED]
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In part 185:
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The authority citation for part 185 continues to read as follows:
Authority: 21 U.S.C. 348.
Sec. 185.3000 [Removed]
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By removing Sec. 185.3000.
[FR Doc. 98-27707Filed10-15-98; 8:45 am]
BILLING CODE 6560-50-F
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