5839 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under section 408( d) of the FFDCA, such as the exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

XII. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule '' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: January 16, 2003. Janet L. Andersen, Director, Biopesticides and Pollution Prevention Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

1. The authority citation for part 180 continues to read as follows:

Authority: 21 U. S. C. 321( q), 346( a) and 374.

2. Section 180.1150 of subpart D is revised to read as follows:

§ 180.1150 6 Benzyladenine; exemption from the requirement of a tolerance.

( a) The plant growth regulator 6 benzyladenine is exempt from the requirement of a tolerance when used as a fruit thinning agent at an application rate not to exceed 30 grams of active ingredient per acre in or on apples. ( b) 6 Benzyladenine is temporarily exempt from the requirement of a tolerance in or on apples at   182 grams of active ingredient per acre per season, and in or on pistachio at   60 grams of active ingredient per acre per season when used in accordance with the Experimental Use Permit 73049   EUP   2. The temporary exemption from a tolerance will expire on January 31, 2005. [ FR Doc. 03   2431 Filed 2   4   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2002   0344; FRL   7289   7]

Cyprodinil; Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes tolerances for residues of cyprodinil in or on the bushberry subgroup, caneberry subgroup, juneberry, lingonberry, pistachio, salal and watercress. The Interregional Research Project Number 4 ( IR 4) requested these tolerances under the Federal Food, Drug, and Cosmetic Act ( FFDCA) , as amended by the Food Quality Protection Act of 1996 ( FQPA). DATES: This regulation is effective February 5, 2003. Objections and requests for hearings, identified by docket ID number OPP   2002   0344, must be received on or before April 7, 2003. ADDRESSES: Written objections and hearing requests may besubmitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Hoyt Jamerson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   9368; e mail address: jamerson. hoyt@ epa. gov.

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. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS Code 111)   Animal production ( NAICS Code 112)   Food manufacturing ( NAICS Code 311)   Pesticide manufacturing ( NAICS Code 32532) This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00047 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1 5840 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2002   0344. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. To access the OPPTS Harmonized Guidelines referenced in this document, go directly to the guidelines at http:// www. epa. gov/ opptsfrs/ home/ guidelin. htm. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of May 1, 2002 ( 67 FR 21671)( FRL   6833   4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104   170), announcing the filing of pesticide petitions ( PP 2E6359, 2E6365, 2E6377 and 2E6393) by IR 4, 681 U. S. Highway # 1 South, North Brunswick, NJ 08902   3390. That notice included a summary of the petitions prepared by Syngenta Crop Protection, Inc., the registrant. There were no comments received in response to the notice of filing. The petitions requested that 40 CFR 180.532 be amended by establishing tolerances for residues of the fungicide cyprodinil, 4 cyclopropyl 6 methyl Nphenyl 2 pyrimidinamine, in or on the caneberry subgroup at 10.0 parts per million ( ppm) ( 2E6393), watercress at 20 ppm ( 2E6365), pistachio at 0.07 ppm ( 2E6377) and the bushberry subgroup, lingonberry, juneberry, and salal, at 3.0 ppm ( 2E6359). IR 4 subsequently revised the petition to propose the following tolerances for cyprodinil residues in or on the caneberry subgroup at 10.0 parts per million ( ppm), watercress at 20 ppm, pistachio at 0.10 ppm and the bushberry subgroup, lingonberry, juneberry, and salal, at 3.0 ppm. Section 408( b)( 2)( A)( i) of the FFDCA allows EPA to establish a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( b)( 2)( A)( ii) of the FFDCA defines `` safe'' to mean that`` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of the FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....'' EPA performs a number of analyses to determine the risks from aggregate exposure to pesticide residues. For further discussion of the regulatory requirements of section 408 of the FFDCA and a complete description of the risk assessment process, see the final rule on Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997) ( FRL   5754   7).

III. Aggregate Risk Assessment and Determination of Safety Consistent with section 408( b)( 2)( D) of the FFDCA, EPA has reviewed the available scientific data and other relevant information in support of this action. EPA has sufficient data to assess the hazards of and to make a determination on aggregate exposure, consistent with section 408( b)( 2) of the FFDCA, for a tolerance for residues of cyprodinil on the caneberry subgroup at 10.0 parts per million ( ppm), watercress at 20 ppm, pistachio at 0.10 ppm and the bushberry subgroup, lingonberry, juneberry, and salal, at 3.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by cyprodinil are discussed in Table 1 of this unit as well as the no observed adverse effect level ( NOAEL) and the lowest observed adverse effectlevel ( LOAEL) from the toxicity studies reviewed.

VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00048 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1 5841 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline No. Study Type Results 870.3100 90   Day oral toxicity mouse NOAEL = 73.3/ 103 ( male/ female ( m/ f)) milligram/ kilogram/ day ( mg/ kg/ day) LOAEL = 257/ 349 ( m/ f) mg/ kg/ day based on histopathological changes in the liver ( m/ f)

870.3100 90   Day oral toxicity rat NOAEL = 3.14 ( mg/ kg/ day) LOAEL = 19 mg/ kg/ day based on increasedtubular kidney lesions in males 870.3150 90   Day oral toxicity  dog NOAEL = 210/ 232 ( m/ f) mg/ kg/ day LOAEL = 560/ 581 mg/ kg/ day based on lowerbody weight gains and decreased food consumption inboth sexes 870.3200 Carcinogenicity  mice NOAEL = 16.1 mg/ kg/ day LOAEL = 212.4 mg/ kg/ day based on a dose related increase in the incidence of focal and multifocal hyperplasia of the exocrine pancreas in males No evidence of carcinogenicity 870.3700 Prenatal developmental  rat Maternal NOAEL = 200 mg/ kg/ day LOAEL = 1,000 mg/ kg/ day based on lower body weight/ body weight gain and reduced food consumption Developmental NOAEL = 200 mg/ kg/ day LOAEL = 1,000 mg/ kg/ day based on lowermean fetal weights and increased incidence of delayedossification 870.3700 Prenatal developmental  rabbit Maternal NOAEL = 150 mg/ kg/ day LOAEL = 400 mg/ kg/ day based on decreasedbody weight gain Developmental NOAEL = 150 mg/ kg/ day LOAEL = 400 mg/ kg/ day based on slight increase of litters showing extra ( 13th) ribs 870.3800 Reproduction and fertility effects  rat Parental/ Systemic NOAEL = 81 mg/ kg/ day LOAEL = 326 mg/ kg/ day based on lowerbody weights in the F0 females during the pre matingperiod. Reproductive/ Developmental NOAEL = 81mg/ kg/ day LOAEL = 326 mg/ kg/ day based on decreasedpup weights ( F1 and F2)

870.4100 Chronic toxicity dogs NOAEL = 65.63/ 67.99 ( m/ f) mg/ kg/ day LOAEL = 449.25/ 446.3 ( m/ f) mg/ kg/ day based on lower body weight gains and decreased food consumption and food efficiency 870.4300 Chronic toxicity/ Carcinogenicity( feeding)  rat NOAEL = 2.7 mg/ kg/ day LOAEL = 35.6 mg/ kg/ day based on degenerative liver lesions ( spongiosis hepatis) in males No evidence of carcinogenicity 870.5265 and 870.5100 Gene Mutation In a reverse gene mutation assay withSalmonella typhimurium/ Escherichia coli, cyprodinil was negative up to concentrations (  1,250 µ g/ plate +/ S9) that produced reproducible cytotoxicity for the majority of strains. Compound insolubility was reported at   313 µ g/ plate.

870.5300 Gene Mutation In a Chinese hamster V79 cell HGPRT forward gene mutation assay, cyprodinil was negative up to cytotoxic concentrations (  96.0 µ g/ mL with S9) (  24 µ g/ mL without S9).

870.5375 Cytogenetics/ In vitro Chromosomal Aberration In an in vitro assay for chromosome aberrations in Chinese hamster ovary ( CHO) cells, cyprodinil gave negative results up tocytotoxic concentrations (  50 µ g/ mL without S9, 18   or 42   hour cell harvest or   25 µ g/ mL with S9, 18   hour cell harvest) or to the highest subcytotoxic concentration ( 50 µ g/ mL with S9, 42   hour cell harvest).

VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1 5842 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY   Continued Guideline No. Study Type Results 870.5395 Cytogenetics/ In vivo bone marrow micronucleus In an in vivo bone marrow micronucleus assay, cyprodinil was negative when administered orally ( gavage) at 5,000 mg/ kg( HDT) to both sexes of Tif: MAGF mice. No signs of overt toxicity or clear evidence of cytotoxicity for the target organ were noted at any dose or sacrifice time.

870.5550 Unscheduled DNA Synthesis In an Unscheduled DNA Synthesis( UDS) assay in primary rat hepatocytes, cyprodinil was negative up to a cytotoxic concentration ( 80 µ g/ mL).

870.7485 Metabolism and pharmacokinetics Single oral doses ( 0.5 or 100 mg/ kg bw) of phenyl or pyrimidyl radiolabelled cyprodinil ( purity   98%) were administered toTif: RAIf( SPF) rats, with one low dose group receiving unlabelled cyprodinil ( purity   99%) for 2 weeks prior to treatment with radiolabelled compound. Absorption was very rapid ( tcmax= 0.3 hours) with rapid clearance ( tcmax/ 2= 1.2 hours). A minimum of 75% of the administered dose was absorbed. Excretion was rapid and almost complete, with urine as the principle route of excretion ( 48   68%), and > 90% of the administered dose detected in the urine and feces within 48 hours. Excretion, distribution and metabolite profiles were essentially independent of dose level, pretreatment, and type of label, although there were some quantitative differences sex dependent qualitative differences in two urinary metabolite fractions.

870.7485 Metabolism and pharmacokinetics Excreta ( Group D1 and D2) and bile ( Group G1) from radiolabelled cyprodinil treated Tif: RAIf( SPF) rats were used to characterize, isolateand identify cyprodinil metabolites Eleven metabolites were isolated from urine, feces and bile, and the metabolic pathways in the rat were proposed. All urinary and biliary metabolites ( with the exception of 7U) were conjugated with glucuronic acid or sulfonated, and excreted. Cyprodinil was almostcompletely metabolized by hydroxylation of the phenyl ring ( position 4) or pyrimidine ring ( position 5), followed by conjugation. An alternative pathwayinvolved oxidation of the phenyl ring followed by glucuronic acid conjugation. A quantitative sex difference was observed with respect to sulfonation ofthe major metabolite that formed 6U. The monosulfate metabolite ( 1U) was predominant in females, whereas equal amounts of mono and disulfate ( 6U) conjugates were noted in males. Most of the significant metabolites in feces were exocons of biliary metabolites ( 2U, 3U, 1G). These were assumed to be deconjugated in the intestines, partially reabsorbed into the generalcirculation, conjugated again, and eliminated renally. The major metabolic pathways of cyprodinil were not significantly influenced by the dose, treatment regimen, or sex of the animal.

B. Toxicological Endpoints The dose at which no adverse effects are observed ( the NOAEL) from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern ( LOC). However, the lowest dose at which adverse effects of concern are identified ( the LOAEL) is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor ( UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF ( RfD = NOAEL/ UF). Where an additional safety factor ( SF) is retained due to concerns unique to the FQPA, this additional factor is applied to the RfD by dividing the RfD by such additional factor. The acute or chronic Population Adjusted Dose ( aPAD or cPAD) is a modification of the RfD to accommodate this type of FQPA SF. For non dietary risk assessments ( other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF ( 10X to account for interspecies differences and 10X for intraspecies differences) the VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1 5843 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations LOC is 100. To estimate risk, a ratio of the NOAEL to exposures ( margin of exposure ( MOE) = NOAEL/ exposure) is calculated and compared to the LOC. The linear default risk methodology ( Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases ( e. g., risk is expressed as 1 x 10 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non linear approach, a `` point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure ( MOEcancer = point of departure/ exposures) is calculated. A summary of the toxicological endpoints for cyprodinil used for human risk assessment is shown in Table 2 of this unit:

TABLE 2.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CYPRODINIL FOR USE IN HUMAN RISK ASSESSMENT Exposure Scenario Dose Used in Risk Assessment UF FQPA SF and Endpoint for Risk Assessment Study and Toxicological Effects Acute Dietary females 13   50years of age Developmental NOAEL = 150 mg/ kg/ day UF = 100 Acute RfD = 1.5 mg/ kg/ day FQPA SF = 1X aPAD = acute RfD ÷ FQPA SF = 1.5 mg/ kg/ day Developmental Toxicity  rabbit Developmental LOAEL = 400 mg/ kg/ day based on slight increase of litters showing extra ribs ( 13th).

Chronic Dietary all populations NOAEL= 2.7 UF = 100 Chronic RfD = 0.03 mg/ kg/ day FQPA SF = 1X cPAD = chronic RfD ÷ FQPA SF = 0.03 mg/ kg/ day 2   Year Chronic Toxicity/ Carcinogenicity rat LOAEL = 35.6 mg/ kg/ day based on degenerative liver lesions ( spongiosis hepatis) in males.

Cancer ( oral, dermal, inhalation Classification: `` not likely to be carcinogenic tohumans''

* The reference to the FQPA SF refers to any additional SF retained due to concerns unique tothe FQPA.

C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.352) for the residues of cyprodinil, in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from cyprodinil in food as follows: i. Acute exposure. Acute dietary risk assessments are performed for a fooduse pesticide if a toxicological study has indicated the possibility of an effect of concern occurring as a result of a one day or single exposure. The Dietary Exposure Evaluation Model ( DEEM   ) analysis evaluated the individual food consumption as reported by respondents in the USDA insert 1989   1992 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the acute exposure assessments: 100% crop treated ( PCT) and tolerance level residues for cyprodinil on all treated crops. This assessment was a Tier I analysis. However, the only acute endpoint identified was for the population subgroup females 13   50 years old based on a slight increase of litters showing extra ribs ( 13th). No effects that could be attributed to a single exposure were observed ( no end point was chosen) for any other population subgroup, including the general U. S. population; therefore, an acute dietary assessment for the general U. S. population or other subgroups was not conducted. ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model ( DEEM   ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1989   1992 nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: 100% crop treated ( PCT) and tolerancelevel residues for cyprodinil on all treated crops. This assessment was a Tier I analysis. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for cyprodinil in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of cyprodinil. The Agency uses the Generic Estimated Environmental Concentration ( GENEEC) or the Pesticide Root Zone/ Exposure Analysis Modeling System ( PRZM/ EXAMS) to estimate pesticide concentrations in surface water and SCIGROW which predicts pesticide concentrations in groundwater. In general, EPA will use GENEEC ( a tier 1 model) before using PRZM/ EXAMS ( a tier 2 model) for a screening level assessment for surface water. The GENEEC model is a subset of the PRZM/ EXAMS model that uses a specific highend runoff scenario for pesticides. GENEEC incorporates a farm pond scenario, while PRZM/ EXAMS incorporate an index reservoir environment in place of the previous pond scenario. The PRZM/ EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health levels of concern.

VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1 5844 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations ( EECs) from these models to quantify drinking water exposure and risk as a percent of reference dose or percent of population adjusted dose. Instead, drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to cyprodinil they are further discussed in the aggregate risk sections below. Based on the PRZM/ EXAMS and SCIGROW models the estimated environmental concentrations ( EECs) of cyprodinil for acute exposures are estimated to be 32 parts per billion ( ppb) for surface water and 0.04 ppb for ground water. The EECs for chronic exposures are estimated to be 6 ppb for surface water and 0.04 ppb for ground water. 3. From non dietary exposure. The term `` residential exposure'' is used in this document to refer to nonoccupational non dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Cyprodinil is not registered for use on any sites that would result in residential exposure. 4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408( b)( 2)( D)( v) of the FFDCA requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider `` available information'' concerning the cumulative effects of a particular pesticide's residues and `` other substances that have a common mechanism of toxicity.'' EPA does not have, at this time, available data to determine whether cyprodinil has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, cyprodinil does not appear to produce a toxic metabolite produced by other substances. For the purposes of this tolerance action, therefore, EPA has not assumed that cyprodinil has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children 1. In general. Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty ( safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. Prenatal and postnatal sensitivity. There is no evidence of increased susceptibility of rat or rabbit fetuses followingin utero exposure in the developmental studies with cyprodinil. There is no evidence of increased susceptibility of young rats in the reproduction study with cyprodinil. 3. Conclusion. With the exception of missing 21/ 28   day dermal toxicity and 28   day inhalation toxicity studies in rats, there is a complete toxicity data base for cyprodinil and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Since there are no residential uses for cyprodinil the only exposure route to infants and children is the oral route, for which the toxicity and exposure data base is complete. Therefore dermal and inhalationtoxicity studies, are not needed to assess risk to infants and children and EPA determined that the 10X safety factor to protect infants and children should be reduced to 1X. The FQPA 10X safety factor is removed because:   i. There are currently no registered or proposed residential( nonoccupational uses of cyprodinil.   ii. There was no evidence ( qualitative or quantitative) of increased susceptibility in the developmental rat or rabbit study following in utero exposure or in the two generation reproduction study following pre or post natal exposure.   iii. There was also no evidence of a neurodevelopmental effect in the rat or rabbit developmental toxicity studies or in the rat two generation reproductivetoxicity study.   iv. There are no data deficiencies for pre and/ or post natal exposure and hence there are no residual uncertainties.   v. Food and drinking water exposure assessments will notunderestimate the potential exposure for all populations, including infants and children.

E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water, and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water ( EECs). DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water [ e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD  ( average food + residential exposure)]. This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the USEPA are used to calculate DWLOCs: 2 liter ( L)/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg ( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short term, intermediate term, chronic, and cancer. When EECs for surface water and groundwater are less than the calculated DWLOCs, EPA concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which EPA has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because EPA considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, EPA will reassess the potential impacts of residues of the pesticide in VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1 5845 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations drinking water as a part of the aggregate risk assessment process. 1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to cyprodinil will occupy < 1% of the aPAD for the subpopulation females 13   50 years old, the only population for whom an effect attributable to an acute exposure could be observed. In addition, there is potential for acute dietary exposure to cyprodinil in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the aPAD, as shown in Table 3 of this unit:

TABLE 3.   AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO CYPRODINIL Population Subgroup aPAD ( mg/ kg) % aPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Acute DWLOC ( ppb)

Females 13   50 years old 1.5 < 1.0 32 0.04 44,000 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to cyprodinil from food will utilize 7.4% of the cPAD for the U. S. population, 24% of the cPAD for all infants (< 1 year old) and 22% of the cPAD for children 1   6 years old. There are no residential uses for cyprodinil that result in chronic residential exposure to cyprodinil. Based the use pattern, chronic residential exposure to residues of cyprodinil is not expected. In addition, there is potential for chronic dietary exposure to cyprodinil in drinking water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 4 of this unit:

TABLE 4.   AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON CANCER) EXPOSURE TO CYPRODINIL Population Subgroup cPAD mg/ kg/ day % cPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Chronic DWLOC ( ppb)

U. S. Population 0.03 7.4 6 0.04 970 All Infants (< 1 year old) 0.03 24 6 0.04 230 Children 1   6 years old 0.03 22 6 0.04 230 Children 7   12 years old 0.03 9.1 6 0.04 270 Females 13   50years old 0.03 5.3 6 0.04 1,000 3. Short and intermediate term risk. Short and intermediate term aggregate exposure take into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Cyprodinil is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's level of concern. 5. Aggregate cancer risk for U. S. population. Cyprodinil has been classified as `` not likely to be carcinogenic in humans'' based on the results of a carcinogenicity study in mice and the combined chronic toxicity and carcinogenicity study in rats. Therefore, cyprodinil is not expected to pose a cancer risk to humans. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to cyprodinil residues. IV. Other Considerations A. Analytical Enforcement Methodology The results of Multiresidue Method testing of cyprodinil and its metabolite CGA   232449 have been forwarded to the Food and Drug Administration ( FDA). Cyprodinil was tested according to the FDA Multiresidue protocols ( Protocols C, D, and E), and acceptable recoveries were obtained for cyprodinil fortified in apples at 0.50 ppm using Protocol D. The petitioner is proposing the Method AG   631A as a tolerance enforcement method for residues of cyprodinil in/ on the subject crops. This method, entitled `` Analytical Method for the Determination of Residues of CGA   219417 in Crops by High Performance Liquid Chromatography With Column Switching,'' is a reissue of Methods AG   631 and REM 141.01. The method includes confirmatory procedures using gas chromatography/ nitrogen/ phosphorus detector ( GC/ NPD). The method has successfully undergone radiovalidation using 14C labeled tomato samples and independent laboratory validation. In addition, the method has been the subject of acceptable Agency petition method validations on stone fruits and almond nutmeat and hulls.

B. International Residue Limits There are no Mexican, Canadian or Codex maximum residue limits established for cyprodinil in/ on caneberries, bushberries, pistachios and watercress, and thus no compatibility issues to be reconciled.

C. Conditions The Agency is requiring as conditions for registration the following: An acceptable 21/ 28   day dermal toxicity study in rats ( GLN 870.3200). A 28   day inhalation toxicity study in rats ( GLN 870.3465)

V. Conclusion Therefore, the tolerance is established for residues of cyprodinil on the caneberry subgroup at 10.0 ppm, watercress at 20 ppm, pistachio at 0.10 ppm and the bushberry subgroup, lingonberry, juneberry, and salal, at 3.0 ppm.

VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1 5846 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations VI. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing?

You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number   OPP   2002   0344 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 7, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential 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 information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP   2002   0344, to: Public Information and Records Integrity Branch, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 1. You may also send an electronic copy of your request via e mail to: oppdocket epa. gov. Please use an ASCII file format and avoid the use of special characters and any form of encryption. Copies of electronic objections and hearing requests will also be accepted on disks in WordPerfect 6.1/ 8.0 or ASCII file format. Do not include any CBI in your electronic copy. You may also submit an electronic copy of your request at many Federal Depository Libraries.

B. When Will the Agency Grant a Request for a Hearing? A request for a hearing will be granted if the Administrator determines that the material submitted shows the following: There is a genuine and substantial issue of fact; there is a reasonable possibility that available evidence identified by the requestor would, if established resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary; and resolution of the factual issues( s) in the manner sought by the requestor would be adequate to justify the action requested ( 40 CFR 178.32).

VII. Statutory and Executive Order Reviews This final rule establishes a tolerance under section 408( d) of the FFDCA in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This 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), Public Law 104   113, section 12( d) ( 15 U. S. C. 272 note). Since VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1 5847 Federal Register / Vol. 68, No. 24 / Wednesday, February 5, 2003 / Rules and Regulations tolerances and exemptions that are established on the basis of a petition under section 408( d) of the FFDCA, such as the tolerance in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408( n)( 4) of the FFDCA. For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule.

VIII. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2).

List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: January 24, 2003. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

1. The authority citation for part 180 continues to read as follows:

Authority: 21 U. S. C. 321( q), 346( a) and 371.

2. Section 180.532 is amended by adding alphabetically the following commodities to the table in paragraph ( a)( 1) to read as follows:

§ 180.532 Cyprodinil; tolerances forresidues.

( a) * * * ( 1) * * *

Commodity Parts per million * * * * * Bushberry subgroup 13B 3.0 Caneberry subgroup 13A 10 * * * * * Juneberry ........................ 3.0 Lingonberry ..................... 3.0 Pistachio ......................... 0.10 * * * * * Salal ................................ 3.0 Watercress ...................... 20 * * * * * [ FR Doc. 03   2771 Filed 2   4   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2002   0355; FRL   7285   9]

Thiophanate Methyl; Pesticide Tolerance for Emergency Exemptions AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a time limited tolerance for residues of thiophanate methyl and its metabolite ( methyl 2 benzimidazoyl carbamate ( MBC)) in or on mushrooms. This action is in response to EPA's granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act ( FIFRA) authorizing use of the pesticide on mushroom spawn. This regulation establishes a maximum permissible level for residues of thiophanate methyl in this food commodity. The tolerance will expire and is revoked on December 31, 2004. DATES: This regulation is effective February 5, 2003. Objections and requests for hearings, identified by docket ID number OPP   2002   0355, must be received on or before April 7, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit VII. of the SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   9356; e mail address: conrath. andrea@ epa. gov.

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. Potentially affected entities may include, but are not limited to:   Crop producers ( NAICS 111)   Animal producers ( NAICS 112)   Food manufacturing ( NAICS 311)

VerDate Dec< 13> 2002 20: 53 Feb 04, 2003 Jkt 200001 PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 05FER1. SGM 05FER1


[Federal Register Volume 80, Number 208 (Wednesday, October 28, 2015)]
[Rules and Regulations]
[Pages 65964-65968]
[FR Doc No: 2015-27461]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2014-0591; FRL-9934-14]

Methoxyfenozide; Pesticide Tolerances

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes tolerances for residues of
methoxyfenozide in or on multiple commodities which are identified and
discussed later in this document. Interregional Research Project Number
4 (IR-4) requested these tolerances under the Federal Food, Drug, and
Cosmetic Act (FFDCA).

DATES: This regulation is effective October 28, 2015. Objections and
requests for hearings must be received on or before December 28, 2015,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2014-0591, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), West William Jefferson Clinton Bldg., Rm. 3334,
1301 Constitution Ave. NW., Washington, DC 20460-0001. 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<PHONE_NUMBER>, and the telephone number for the OPP
Docket is<PHONE_NUMBER>. Please review the visitor instructions and
additional information about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Susan Lewis, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; main telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
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).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of EPA's
tolerance regulations at 40 CFR part 180 through the Government
Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2014-0591 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
December 28, 2015. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2014-0591, 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 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 at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Summary of Petitioned-For Tolerance

    In the Federal Register of March 4, 2015 (80 FR 11611) (FRL-9922-
68), EPA issued a document pursuant to FFDCA section 408(d)(3), 21
U.S.C. 346a(d)(3), announcing the filing of a pesticide petition (PP
4E8298) by IR-4, 500 College Road East, Suite 201W, Princeton, NJ
08540. The petition requested that 40 CFR part 180 be amended by
establishing tolerances for residues of the insecticide
methoxyfenozide, (3-methoxy-2-methylbenzoic acid 2-(3,5-
dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide), under paragraph (a)
in or on: Chive, fresh leaves at 30.0 parts per million (ppm); fruit,
stone, group 12-12, except plum, prune, fresh at 3.0 ppm; and nut,
tree, group 14-12 at 0.10 ppm. The petition also proposed the following
tolerances under paragraph (a) be removed upon approval of the proposed
tolerances listed above: Fruit, stone, group 12, except plum, prune,
fresh at 3.0 ppm; nut, tree, group 14 at 0.10 ppm; pistachio at 0.10
ppm; and in paragraph (d), chive at 4.5 ppm be removed. The petition
additionally

requested to amend the tolerances in 40 CFR 180.544 for residues of
methoxyfenozide in or on onion, green, subgroup 3-07B at 5.0 ppm to
onion, green, subgroup 3-07B, except chive at 5.0 ppm; and herb
subgroup 19A, except chive at 400 ppm to herb subgroup 19A, except
chive, fresh leaves at 400 ppm. That document referenced a summary of
the petition prepared on behalf of IR-4 by Dow AgroSciences LLC, the
registrant, which is available in the docket, http://www.regulations.gov. No FFDCA-related comments were received on the
notice of filing.
    Based upon review of the data supporting the petition, EPA has
determined that the amended tolerance on onion, green, subgroup 3-07B,
except chive should be established in or on onion, green, subgroup 3-
07B, except chive, fresh leaves. The reasons for these changes are
explained in Unit IV.C.

III. Aggregate Risk Assessment and Determination of Safety

    Section 408(b)(2)(A)(i) of FFDCA allows EPA to establish a
tolerance (the legal limit for a pesticide chemical residue in or on a
food) only if EPA determines that the tolerance is ``safe.'' Section
408(b)(2)(A)(ii) of FFDCA defines ``safe'' to mean that ``there is a
reasonable certainty that no harm will result from aggregate exposure
to the pesticide chemical residue, including all anticipated dietary
exposures and all other exposures for which there is reliable
information.'' This includes exposure through drinking water and in
residential settings, but does not include occupational exposure.
Section 408(b)(2)(C) of FFDCA requires EPA to give special
consideration to exposure of infants and children to the pesticide
chemical residue in establishing a tolerance and to ``ensure that there
is a reasonable certainty that no harm will result to infants and
children from aggregate exposure to the pesticide chemical residue . .
. .''
    Consistent with FFDCA section 408(b)(2)(D), and the factors
specified in FFDCA section 408(b)(2)(D), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for methoxyfenozide including
exposure resulting from the tolerances established by this action.
EPA's assessment of exposures and risks associated with methoxyfenozide
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered its
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children.
    Many of the available short-term or subchronic toxicity studies on
methoxyfenozide showed little or no toxicity. The main target organs
identified from the toxicity studies in the rat and dog were the liver,
thyroid, and red blood cells (RBCs). The most consistent findings
across species and studies were transiently decreased RBC parameters
and increased liver, thyroid, adrenal, and spleen weights. Increases in
thyroid and adrenal weights were observed in the rat chronic oral
study. Thyroid weights were also increased in the dog following chronic
exposure. However, no accompanying histopathology was observed.
    Acute and subchronic oral neurotoxicity studies in the rat did not
show evidence of potential neurotoxicity. In the acute study, decreased
hindlimb grip strength on day 0 was reported in males. This finding was
only observed at the limit dose in males and was not observed in the
subchronic neurotoxicity study and was therefore not considered
evidence of neurotoxicity. No clinical signs of neurotoxicity or
neurohistopathology were observed in other guideline studies.
    No maternal or developmental effects were observed in either the
rat or rabbit oral developmental toxicity studies. In the rat 2-
generation reproductive toxicity study, parental effects were limited
to increased liver weight and microscopic periportal hypertrophy. No
offspring or reproductive toxicity was observed. In a 28-day dietary
immunotoxicity study in the rat, no immunotoxicity was observed, and
the only observed effect was increased liver weights.
    There was no evidence of carcinogenicity in the rat dietary 24-
month chronic toxicity/carcinogenicity study or the mouse dietary 18-
month carcinogenicity study. No mutagenic or clastogenic potential was
observed in the battery of genotoxicity studies on methoxyfenozide.
Based on these findings, methoxyfenozide is classified as not likely to
be carcinogenic to humans.
    Specific information on the studies received and the nature of the
adverse effects caused by methoxyfenozide as well as the no-observed-
adverse-effect-level (NOAEL) and the lowest-observed-adverse-effect-
level (LOAEL) from the toxicity studies can be found at http://www.regulations.gov in document, ``Methoxyfenozide. Human Health Draft
Risk Assessment for Registration Review and New Use Risk Assessment to
Support the Registration of Proposed Use on Chives, and Crop Group
Expansions for Stone Fruit and Tree Nuts'' in pp. 42-47 in docket ID
number EPA-HQ-OPP-2014-0591.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA
identifies toxicological points of departure (POD) and levels of
concern to use in evaluating the risk posed by human exposure to the
pesticide. For hazards that have a threshold below which there is no
appreciable risk, the toxicological POD is used as the basis for
derivation of reference values for risk assessment. PODs are developed
based on a careful analysis of the doses in each toxicological study to
determine the dose at which the NOAEL and the LOAEL are identified.
Uncertainty/safety factors are used in conjunction with the POD to
calculate a safe exposure level--generally referred to as a population-
adjusted dose (PAD) or a reference dose (RfD)--and a safe margin of
exposure (MOE). For non-threshold risks, the Agency assumes that any
amount of exposure will lead to some degree of risk. Thus, the Agency
estimates risk in terms of the probability of an occurrence of the
adverse effect expected in a lifetime. For more information on the
general principles EPA uses in risk characterization and a complete
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm. A summary of the toxicological
endpoints for methoxyfenozide used for human risk assessment is
discussed in Table 1 of Unit III.B. of the final rule published in the
Federal Register of August 27, 2014 (79 FR 51103) (FRL-9913-99).

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to methoxyfenozide, EPA considered exposure under the
petitioned-for tolerances as well as all existing methoxyfenozide
tolerances in 40 CFR 180.544. EPA assessed dietary exposures from
methoxyfenozide in food as follows:
    i. Acute exposure. Quantitative acute dietary exposure and risk
assessments

are performed for a food-use pesticide, if a toxicological study has
indicated the possibility of an effect of concern occurring as a result
of a 1-day or single exposure. No such effects were identified in the
toxicological studies for methoxyfenozide; therefore, a quantitative
acute dietary exposure assessment is unnecessary.
    ii. Chronic exposure. In conducting the chronic dietary exposure
assessment EPA used the food consumption data from the USDA under the
National Health and Nutrition Examination Survey, What We Eat in
America (NHANES/WWEIA), 2003 to 2008. As to residue levels in food, EPA
used tolerance-level residues and the assumption of 100 percent crop
treated (PCT) for all existing and proposed commodities.
    iii. Cancer. Based on the data summarized in Unit III.A., EPA has
concluded that methoxyfenozide does not pose a cancer risk to humans.
Therefore, a dietary exposure assessment for the purpose of assessing
cancer risk is unnecessary.
    iv. Anticipated residue and PCT information. EPA did not use
anticipated residue and/or PCT information in the dietary assessment
for methoxyfenozide. Tolerance level residues and/or 100 PCT were
assumed for all food commodities.
    2. Dietary exposure from drinking water. The residues of concern in
drinking water are methoxyfenozide and the degradates RH-117,236 and
RH-131,154, which are only present at low concentrations. The Agency
used screening-level water exposure models in the dietary exposure
analysis and risk assessment for methoxyfenozide and its degradates in
drinking water. These simulation models take into account data on the
physical, chemical, and fate/transport characteristics of
methoxyfenozide and its degradates. Further information regarding EPA
drinking water models used in pesticide exposure assessment can be
found at http://www.epa.gov/oppefed1/models/water/index.htm.
    Based on the FQPA Index Reservoir Screening Tool (FIRST), Screening
Concentration in Ground Water (SCI-GROW), and the Pesticide Root Zone
Model Ground Water (PRZM GW) models, the estimated drinking water
concentrations (EDWCs) of methoxyfenozide and its degradates for
chronic exposures for non-cancer assessments are estimated to be 7.57
parts per billion (ppb) for surface water and 214 ppb for ground water.
    Modeled estimates of drinking water concentrations were directly
entered into the dietary exposure model. For chronic dietary risk
assessment, the water concentration of value 214 ppb was used to assess
the contribution to drinking water.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., for lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). Methoxyfenozide is
currently registered for use on ornamentals in and around home gardens,
which could result in residential exposures. EPA assessed residential
exposure using the following assumptions: Residential handlers were
assessed for potential short-term inhalation exposures from mixing,
loading, and applying methoxyfenozide. A quantitative dermal assessment
for residential handlers was not conducted since there is no systemic
toxicity associated with dermal exposures to methoxyfenozide. Adult
post-application exposures were not quantitatively assessed since no
dermal hazard was identified for methoxyfenozide and inhalation
exposures are typically negligible in outdoor settings. Furthermore,
the inhalation exposure assessment performed for residential handlers
is representative of worse case inhalation exposures and is considered
protective for post-application inhalation exposure scenarios.
    Post-application oral exposure to children is not expected since
the extent to which young children engage in activities associated with
areas where treated ornamentals are grown (or utilize these areas for
prolonged periods of play) is low. Therefore, an incidental oral post-
application exposure assessment was not conducted. Further information
regarding EPA standard assumptions and generic inputs for residential
exposures may be found at http://www.epa.gov/pesticides/trac/science/trac6a05.pdf.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found methoxyfenozide to share a common mechanism of
toxicity with any other substances, and methoxyfenozide does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that
methoxyfenozide does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    1. In general. Section 408(b)(2)(C) of FFDCA provides that EPA
shall apply an additional tenfold (10X) margin of safety for infants
and children in the case of threshold effects to account for prenatal
and postnatal toxicity and the completeness of the database on toxicity
and exposure unless EPA determines based on reliable data that a
different margin of safety will be safe for infants and children. This
additional margin of safety is commonly referred to as the Food Quality
Protection Act Safety Factor (FQPA SF). In applying this provision, EPA
either retains the default value of 10X, or uses a different additional
safety factor when reliable data available to EPA support the choice of
a different factor.
    2. Prenatal and postnatal sensitivity. There is no evidence of
qualitative or quantitative susceptibility of the developing fetus or
offspring, based on the developmental and reproductive toxicity study
results for methoxyfenozide. No developmental toxicity was observed in
either the rat or rabbit developmental toxicity studies, and there was
no evidence of offspring or reproductive toxicity in the rat 2-
generation reproductive toxicity study.
    3. Conclusion. EPA has determined that reliable data show the
safety of infants and children would be adequately protected if the
FQPA SF were reduced to 1X. That decision is based on the following
findings:
    i. The toxicity database for methoxyfenozide is complete.
    ii. There is no indication that methoxyfenozide is a neurotoxic
chemical and there is no need for a developmental neurotoxicity study
or additional uncertainty factors (UFs) to account for neurotoxicity.
    iii. There is no evidence that methoxyfenozide results in increased
susceptibility in in utero rats or rabbits in the prenatal
developmental studies or in young rats in the 2-generation reproduction
study.
    iv. There are no residual uncertainties identified in the exposure
databases. The chronic dietary food exposure assessment was performed
based on 100 PCT and tolerance-level residues. EPA

made conservative (protective) assumptions in the ground and surface
water modeling used to assess exposure to methoxyfenozide in drinking
water. Based on the discussion Unit III.C.3., regarding residential use
patterns, EPA does not expect residential uses of methoxyfenozide to
result in postapplication exposure of children or incidental oral
exposures of toddlers. These assessments will not underestimate the
exposure and risks posed by methoxyfenozide.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide
exposures are safe by comparing aggregate exposure estimates to the
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA
calculates the lifetime probability of acquiring cancer given the
estimated aggregate exposure. Short-, intermediate-, and chronic-term
risks are evaluated by comparing the estimated aggregate food, water,
and residential exposure to the appropriate PODs to ensure that an
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into
account acute exposure estimates from dietary consumption of food and
drinking water. No adverse effect resulting from a single oral exposure
was identified and no acute dietary endpoint was selected. Therefore,
methoxyfenozide is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this
unit for chronic exposure, EPA has concluded that chronic exposure to
methoxyfenozide from food and water will utilize 84% of the cPAD for
children 1 to 2 years old, the population group receiving the greatest
exposure. Based on the explanation in Unit III.C.3., regarding
residential use patterns, chronic residential exposure to residues of
methoxyfenozide is not expected.
    3. Short-term risk. Short-term aggregate exposure takes into
account short-term residential exposure plus chronic exposure to food
and water (considered to be a background exposure level).
Methoxyfenozide is currently registered for uses that could result in
short-term residential exposure, and the Agency has determined that it
is appropriate to aggregate chronic exposure through food and water
with short-term residential exposures to methoxyfenozide.
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water,
and residential exposures result in an aggregate MOE of 540. Because
EPA's level of concern for methoxyfenozide is a MOE of 100 or below,
these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure
takes into account intermediate-term residential exposure plus chronic
exposure to food and water (considered to be a background exposure
level). An intermediate-term adverse effect was identified; however,
methoxyfenozide is not registered for any use patterns that would
result in intermediate-term residential exposure. Intermediate-term
risk is assessed based on intermediate-term residential exposure plus
chronic dietary exposure. Because there is no intermediate-term
residential exposure and chronic dietary exposure has already been
assessed under the appropriately protective cPAD (which is at least as
protective as the POD used to assess intermediate-term risk), no
further assessment of intermediate-term risk is necessary, and EPA
relies on the chronic dietary risk assessment for evaluating
intermediate-term risk for methoxyfenozide.
    5. Aggregate cancer risk for U.S. population. Based on the lack of
evidence of carcinogenicity in two adequate rodent carcinogenicity
studies, methoxyfenozide is not expected to pose a cancer risk to
humans.
    6. Determination of safety. Based on these risk assessments, EPA
concludes that there is a reasonable certainty that no harm will result
to the general population, or to infants and children from aggregate
exposure to methoxyfenozide residues.

IV. Other Considerations

A. Analytical Enforcement Methodology

    Adequate enforcement methodology using high performance liquid
chromatography (HPLC), with either tandem mass spectrometric detection
(LC-MS/MS), or ultraviolet detection (UV) is available to enforce the
tolerance expression.
    The method may be requested from: Chief, Analytical Chemistry
Branch, Environmental Science Center, 701 Mapes Rd., Ft. Meade, MD
20755-5350; telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>
B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for methoxyfenozide in or on
chive or the commodities associated with herb subgroup 19A or green
onion subgroup 3-07B. Codex has established an MRL in or on tree nuts
at 0.1 milligram/kilogram (mg/kg), which is harmonized with the
recommended tolerance of 0.10 ppm in or on tree nut crop group 14-12.
However, Codex has established a tolerance in or on stone fruit at 2
mg/kg that cannot be harmonized with the EPA tolerance in or on stone
fruit group 12-12, except plum, prune, fresh at 3.0 ppm because the
Organization for Economic Cooperation and Development (OECD) tolerance
calculations that EPA uses to calculate U.S. tolerance levels result in
a tolerance that is higher than the Codex MRL, and reduction of the
tolerance would result in the risk of violative residues resulting from
proper use according to label directions.

C. Revisions to Petitioned-For Tolerances

    Based on the data supporting the petition, the Agency determined
that the petitioned-for tolerance on chive, fresh leaves at 30.0 ppm
should be established in or on chive, fresh leaves at 30 ppm because
EPA establishes tolerances using whole numbers for tolerances of 10 ppm
or more, per the OECD tolerance calculation procedures. The Agency also
determined that the petitioned-for-amended tolerance in or on onion,
green, subgroup 3-07B, except chive should be established in or on
onion, green, subgroup 3-07B, except chive, fresh leaves. This is due
to the fact that only chive, fresh leaves are included in subgroup 3-
07B, and the Agency is establishing a separate tolerance for chive,
fresh leaves at 30 ppm.

V. Conclusion

    Therefore, tolerances are established for residues of
methoxyfenozide, (3-methoxy-2-methylbenzoic acid 2-(3,5-

dimethylbenzoyl)-2-(1,1-dimethylethyl) hydrazide), in or on chive,
fresh leaves at 30 ppm; fruit, stone, group 12-12, except plum, prune,
fresh at 3.0 ppm; herb subgroup 19A, except chive, fresh leaves at 400
ppm; onion, green, subgroup 3-07B, except chive, fresh leaves at 5.0
ppm; and nut, tree, group 14-12 at 0.10 ppm. This rule additionally
removes the established tolerances in or on fruit, stone, group 12,
except plum, prune, fresh at 3.0 ppm; herb subgroup 19A, except chive
at 400 ppm; nut, tree, group 14 at 0.10 ppm; onion, green, subgroup 3-
07B at 5.0 ppm; pistachio at 0.10 ppm; and in paragraph (d)(2), chive
at 4.5 ppm.

VI. Statutory and Executive Order Reviews

    This action establishes tolerances under FFDCA section 408(d) in
response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this action has been
exempted from review under Executive Order 12866, this action is not
subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This action does not contain any
information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This action directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this action. In addition, this
action does not impose any enforceable duty or contain any unfunded
mandate as described under Title II of the Unfunded Mandates Reform Act
(UMRA) (2 U.S.C. 1501 et seq.).
    This 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 (NTTAA) (15 U.S.C. 272 note).

VII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: October 20, 2015.
Susan Lewis,
Director, Registration Division, Office of Pesticide Programs.
    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority: 21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.544:
0
a. Remove the following commodities from the table in paragraph (a):
``Fruit, stone, group 12, except plum, prune, fresh''; ``Herb subgroup
19A, except chive''; ``Nut, tree, group 14''; ``Onion, green, subgroup
3-07B''; and ``Pistachio''.
0
b. Remove the commodity ``Chive'' from the table in paragraph (d)(2).
0
c. Add alphabetically add the following commodities to the table in
paragraph (a).
    The additions and revisions read as follows:

Sec.  180.544  Methoxyfenozide; tolerances for residues.

    (a) * * *

------------------------------------------------------------------------
                                                             Parts per
                        Commodity                             million
------------------------------------------------------------------------

                                * * * * *
Chive, fresh leaves.....................................              30
------------------------------------------------------------------------

                                * * * * *
Fruit, stone, group 12-12, except plum, prune, fresh....             3.0
------------------------------------------------------------------------

                                * * * * *
Herb subgroup 19A, except chive, fresh leaves...........             400
------------------------------------------------------------------------

                                * * * * *
Nut, tree, group 14-12..................................            0.10
Onion, green, subgroup 3-07B, except chive, fresh leaves             5.0

                                * * * * *
------------------------------------------------------------------------

* * * * *
[FR Doc. 2015-27461 Filed 10-27-15; 8:45 am]
 BILLING CODE 6560-50-P


Facility Contact with Mack Molding in Arlington, VT - Surface Coating of Plastic Parts for Business Machines (NSPS Subpart TTT)
Date
October 19, 2021
Subject
Data collection
Stakeholder
Brian Sullivan, facilities manager
802-375-2511
<EMAIL_ADDRESS>EPA in attendance
-
ERG in attendance
Liz Hubbard

No answer when we initially called this Mack Molding location, but received a call back from Brian Sullivan. He did not feel comfortable sharing information over the phone and asked if we could send him an email instead as he wanted to confirm our contractor credentials.
Mr. Sullivan responded to our email request saying that he would verify our contractor designation letter and spoke with Keith Barnett on the phone. Mr. Sullivan stated that he might make a CBI claim on some of the information that was requested.
Mr. Sullivan later followed up with an email which said that he had spoken with the plant manager and that they do not currently manufacture business machines. The most recent contract involving business machines that they know of was a contract with Xerox 20 years ago.
Facilities
The Clean Air Act requires the EPA to periodically review and revise its federal rules. We are asking for your help with this requirement for the NSPS Subpart TTT (Surface Coating of Plastic Parts for Business Machines). Your facility was identified in an EPA database as subject to Subpart TTT. We collected your air permit from the Vermont Department of Environmental Conservation and have confirmed this.
We have prepared a short telephone survey for facilities that are subject to this rule. We hope to learn more about the impact of the 1988 rule, ways it might be improved for future facilities, and to look for innovation in the control of air pollution (e.g., new add-on control technologies, new work practices or operational procedure).  After the call we can share with you a copy of the minutes and discuss any necessary changes.
 Describe your business and surface coating process and approximately what fraction of your operation is used to coat plastic parts for business machines?
 When did the facility open and how has production changed over time?
 Today, how many different products are coated (what fraction are plastic parts for business machines)?
 How many spray booths do you have (what fraction are used for coating plastic parts for business machines)?
 Because of COVID we are unable to visit facilities. Do you have a promotional video that might take the place of a plant tour? Is there a possibility of scheduling a virtual plant tour?

 Can you share with us an approximate annual surface coating throughput (approximately what fraction is used to coat plastic parts for business machines)?
 Can you provide a range of the amount of coating used on a single product?

 We found your facility in a database indicating it is subject to NSPS subpart TTT (i.e., Surface Coating of Plastic Parts for Business Machines). Have you implemented any procedures or VOC control technologies to comply with that rule?

 Have you made other accommodations to comply with Subpart TTT requirements and standards (e.g., VOC reporting requirements)? Are there business reasons for using paints with more than minimum VOC (e.g., because higher solvent contents are necessary for effective paint transfer for your product, or because the solvents preventing your coating from spoiling)?

 Do you track either spray booths' transfer efficiency or VOC concentrations in booth exhaust?

 If you were building a new plant in a different location to address a growing demand applying surface coating to plastic parts for business machines, how would it be different?

 Do you have plans to expand your coating operation for plastic parts for business machines?

 Do you have other industry contacts that are knowledgeable about the rule and might have useful input in our review?