27729 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Rules and Regulations Reduction Act of 1995 ( 44 U. S. C. 3501   3520).

Federalism A rule has implications for federalism under Executive Order 13132, Federalism, if it has a substantial direct effect on State or local governments and would either preempt State law or impose a substantial direct cost of compliance on them. We have analyzed this rule under that Order and have determined that it does not have implications for federalism.

Unfunded Mandates Reform Act The Unfunded Mandates Reform Act of 1995 ( 2 U. S. C. 1531   1538) requires Federal agencies to assess the effects of their discretionary regulatory actions. In particular, the Act addresses actions that may result in the expenditure by a State, local, or tribal government, in the aggregate, or by the private sector of $ 100,000,000 or more in any one year. Though this rule will not result in such an expenditure, we do discuss the effects of this rule elsewhere in this preamble.

Taking of Private Property This rule will not effect a taking of private property or otherwise have taking implications under Executive Order 12630, Governmental Actions and Interference with Constitutionally Protected Property Rights.

Civil Justice Reform This rule meets applicable standards in sections 3( a) and 3( b)( 2) of Executive Order 12988, Civil Justice Reform, to minimize litigation, eliminate ambiguity, and reduce burden.

Protection of Children We have analyzed this rule under Executive Order 13045, Protection of Children from Environmental Health Risks and Safety Risks. This rule is not an economically significant rule and does not create an environmental risk to health or risk to safety that may disproportionately affect children.

Indian Tribal Governments This rule does not have tribal implications under Executive Order 13175, Consultation and Coordination with Indian Tribal Governments, because it does not have a substantial direct effect on one or more Indian tribes, 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. Energy Effects We have analyzed this rule under Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use. We have determined that it is not a `` significant energy action'' under that order because it is not a `` significant regulatory action'' under Executive Order 12866 and is not likely to have a significant adverse effect on the supply, distribution, or use of energy. The Administrator of the Office of Information and Regulatory Affairs has not designated it as a significant energy action. Therefore, it does not require a Statement of Energy Effects under Executive Order 13211.

Environment We have analyzed this rule under Commandant Instruction M16475.1D, which guides the Coast Guard in complying with the National Environmental Policy Act of 1969 ( NEPA) ( 42 U. S. C. 4321   4370f), and have concluded that there are no factors in this case that would limit the use of categorical exclusion under section 2. B. 2 of the Instruction. Therefore, this rule is categorically excluded, under figure 2   1 paragraph ( 34)( g), of the instruction, from further environmental documentation because this rule is not expected to result in any significant environmental impact as described in NEPA. A final `` Environmental Analysis Check List'' and a final `` Categorical Exclusion Determination'' are available in the docket where indicated under ADDRESSES.

List of Subjects in 33 CFR Part 165 Harbors, Marine safety, Navigation ( water), Reporting and recordkeeping requirements, Security measures, Vessels, Waterways.

 For the reasons discussed in the preamble, the Coast Guard amends 33 CFR part 165 as follows:

PART 165   REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS  1. The authority citation for part 165 continues to read as follows:

Authority: 33 U. S. C. 1231; 50 U. S. C. 191, 33 CFR 1.05   1( g), 6.04   1, 6.04   6, and 160.5; Department of Homeland Security Delegation No. 0170.

 2. From 8 a. m. on May 11, 2003 through 8 p. m. on November 15, 2003 add temporary § 165. T09   214 to read as follows:

§ 165. T09   214 Regulated Navigation Area; Des Plaines River, Joliet, Illinois ( a) Regulated navigation area. The following waters are a Regulated Navigation Area ( RNA): All portions of the Des Plaines River between mile 287.3 ( McDonough St. Bridge) and mile 288.7 ( Ruby Street Bridge). ( b) Applicability. This section applies to operators of all southbound tows transiting beneath the Jefferson Street Bridge ( mile 287.9), Joliet, Illinois with barge configurations of over 89 feet in overall width and more than 800 feet in length. ( c) Regulations. ( 1) All southbound tows to which this section applies must use an assist tug when transiting through the RNA. ( 2) The general regulations contained in 33 CFR 165.13 apply to this section. ( 3) Deviation from this section is prohibited unless specifically authorized by the Commander, Ninth Coast Guard District or his designated representatives. Designated representatives include the Captain of the Port Chicago.

Dated: May 9, 2003. Ronald F. Silva, Rear Admiral, Coast Guard, Commander, Ninth Coast Guard District. [ FR Doc. 03   12687 Filed 5   20   03; 8: 45 am]

BILLING CODE 4910   15   P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0163; FRL   7306   1]

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

SUMMARY: This regulation establishes a tolerance for combined residues of pyraflufen ethyl in or on cotton. Nichino America Incorporated requested this tolerance 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 May 21, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0163, must be received on or before July 21, 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 VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Joanne I. Miller, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington,

VerDate Jan< 31> 2003 14: 22 May 20, 2003 Jkt 200001 PO 00000 Frm 00003 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 21MYR1. SGM 21MYR1 27730 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Rules and Regulations DC 20460   0001; telephone number: ( 703) 305   6224; e mail address: miller. joanne@ epa. gov.

SUPPLEMENTARY INFORMATION:

I. General Information A. Does this Action Apply to Me?

You may be potentially affected by this action if you an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS 111)   Animal production ( NAICS 112)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532) This listing 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 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   2003   0163. 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 November 20, 2002 ( 67 FR 70073) ( FRL   7184   7), 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 a pesticide petition ( 1F6428) by Nichino America Incorporated, 4550 New Linden Hill Road, Suite 501, Wilmington, DE 19808. That notice included a summary of the petition prepared by Nichino America Incorporated, the registrant. There were no comments received in response to the notice of filing. The petition requested that 40 CFR 180.585 be amended by establishing tolerances for combined residues of the herbicide pyraflufen ethyl ( ethyl 2 chloro 5( 4 chloro 5 difluoromethoxy 1 methyl 1H pyrazol 3 yl) 4 fluorophenoxyacetate) and its acid metabolite, E 1 ( 2 chloro 5( 4 chloro 5 difluoromethoxy 1 methyl 1H pyrazol 3 yl) 4 fluorophenoxyacetic acid), expressed as the ester equivalent in or on cotton undelinted seed at 0.05 parts per million ( ppm) and cotton gin byproduct at 1.5 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 November 26, 1997) ( 62 FR 62961) ( 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 tolerances for residues of pyraflufen ethyl on cotton undelinted seed at 0.04 ppm and cotton gin byproduct at 1.5 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 pyraflufen ethyl are discussed in Table 1 of this unit as well as the no observed adverse effect level ( NOAEL) and the lowest observed adverse effect level ( LOAEL) from the toxicity studies reviewed.

VerDate Jan< 31> 2003 14: 22 May 20, 2003 Jkt 200001 PO 00000 Frm 00004 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 21MYR1. SGM 21MYR1 27731 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Rules and Regulations TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline No. Study Type Results 870.3100 90   day oral toxicity in rats NOAEL = 5,000 parts per million ( ppm) ( 456   499 milligrams kilograms/ day ( mg/ kg/ day)). LOAEL = 15,000 ppm ( 1,489   1,503 mg/ kg/ day) based on clinical signs, death, effects on erythrocytes, changes in clinical chemicals for liver function and splenomegaly.

870.3150 90   day oral toxicity in dogs NOAEL = 1,000 mg/ kg/ day. LOAEL not established, no effects observed.

870.3200 28   Day dermal toxicity in rats NOAEL = 1,000 mg/ kg/ day. LOAEL not established; no effects observed.

870.3700 Prenatal developmental in rats Maternal NOAEL   1,000 mg/ kg/ day Maternal LOAEL not determined; no effects observed. Developmental NOAEL   1,000 mg/ kg/ day. Developmental LOAEL not determined; no effects observed.

870.3700 Prenatal developmental in rabbits Maternal NOAEL = 20 mg/ kg/ day. Maternal LOAEL= 60 mg/ kg/ day based on mortality. Developmental = 60 mg/ kg/ day. Developmental LOAEL = 150 mg/ kg/ day based on increased incidence of abortion.

870.3800 Reproduction and fertility effects Parental NOAEL = 1,000 ppm ( 70.8   82.3 mg/ kg/ day ( M); 80.1   91.2 ( F). Parental LOAEL = 10,000 ppm ( 721   844 and 813   901 mg/ kg/ day) based on decreased body weight ( bwt) and bwt gains of F0 and F1( M) and F1( F), gross and microscopic liver lesions of ( M) and ( F) both generations. Reproductive NOAEL   10,000 ppm ( 721   844 and 813   901 mg/ kg/ day). Reproductive LOAEL not determined; no effects observed. Offspring NOAEL = 1,000 ppm ( 70.8   82.3 mg/ kg/ day ( M); 80.1   91.2 ( F). Offspring LOAEL = 10,000 ppm ( 721   844 and 813   901 mg/ kg/ day) based on decreased bwt and bwt gains of the F1 and F2 pups.

870.4100 Chronic toxicity in dogs NOAEL   1,000 mg/ kg/ day. LOAEL not determined; no effects observed.

870.4200 Carcinogenicity in mice NOAEL = 200 ppm ( 20.99 mg/ kg/ day ( M); 19.58 mg/ kg/ day ( F). LOAEL = 1,000 ppm ( 109.7 mg/ kg/ day ( M); 98.3 mg/ kg/ day ( F) based on liver toxicity, hepatocellular tumors at 5,000 ppm; possibly hemangioma/ hemangioasarcomas.

870.4300 Chronic toxicity in rodents/ carcinogenicity in rats NOAEL = 2,000 ppm ( 86.7 mg/ kg/ day ( M); 111.5 mg/ kg/ day ( F). LOAEL = 10,000 ppm ( 468.1 mg/ kg/ day ( M); 578.5 mg/ kg/ day ( F) based on decreased bwt and bwt gain in males and microcytic anemia, liver lesions and kidney toxicity ( both sexes); possible increase pheochromocytomas in females

870.5100 Gene nutation Non mutagenic when tested up to 5,000 µ g/ plate, in presence and absence of metabolic activation ( S9 mix), in S. typhimurium strains TA98, TA100, TA1535, TA1537 and TA1538 and E. coli strain WP2( uvrA). There was no evidence of induced mutant colonies over background.

VerDate Jan< 31> 2003 14: 22 May 20, 2003 Jkt 200001 PO 00000 Frm 00005 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 21MYR1. SGM 21MYR1 27732 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Rules and Regulations TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY   Continued Guideline No. Study Type Results 870.5300 Gene mutation In mammalian cell gene mutation assays at the TK locus, L5178Y mouse lymphoma cells cultured in vitro were exposed to pyraflufen ethyl in dimethylsulfoxide ( DMOS) in the absence of mammalian metabolic activation ( S9 mix) and with S9 mix. Concentrations 160 µ g/ mL were insoluble cytotoxicity was seen at 80 µ g/ mL  S9 and 160 µ g/ mL + S9. There was no increase in the number of mutant colonies over background in the absence of S9 mix but a non reproducible dose related increase in the number of mutant colonies was seen in the presence of S9 mix. In mammalian cell gene mutation assays at the TK locus, L5178Y mouse lymphoma cells cultured in vitro were exposed to pyraflufen ethyl in DMSO in the absence of mammalian metabolic activation ( S9 mix) and with S9 mix. There was no evidence of induced mutant colonies over background up to cytotoxic concentrations ( 50 µ g/ mL S9; and 350 µ g/ mL + S9.

870.5375 Chromosomal aberration In a mammalian cell cytogenetics assay, human primary lymphocyte cultures were exposed to pyraflufen ethyl in DMSO without metabolic activation ( S9 mix) or with S9 mix. Compound precipitation occurred at 2,600 µ g/ mL +/ S9. There was no evidence of chromosomal aberration induction over background.

870.5395 Cytogenetics In a CD 1 mouse bone marrow micronucleus assay, five mice/ sex/ dose/ harvest time were treated via oral gavage with pyraflufen ethyl in corn oil. ET 751 was tested to the limit ( LTD) dose of 5,000 mg/ kg bwt. Signs of compound toxicity were limited to piloerection, hunched posture in one female, and piloerection and hunched posture in one male receiving 5,000 mg/ kg. No bone marrow cytotoxicity was seen at any dose. There was no statistically significant increase in the frequency of micronucleated polychromatic erythrocytes in bone marrow after any dose or treatment time.

870.5500 Bacillus subtilis In a differential killing/ growth inhibition assay in bacteria, strains H17 ( rec+) and M45 ( rec) of B. subtilis were exposed to pyraflufen ethyl in DMSO in the presence and absence of metabolic activation ( S9 mix). There was no evidence of greater growth inhibition or cell killing in repair defective strains compared to repair competent strains up to the limit of test material solubility.

870.5550 Unscheduled DNA synthesis ( UDS) In an in vivo/ in vitro UDS assay in rat hepatocytes, pyraflufen ethyl was administered to five SPF outbred albino Hsd/ Ola Sprague Dawley male rats per test group by oral gavage ( four of the five rats were used for hepatocyte culture). No signs of overt toxicity to the test animals or cytotoxic effects to the target cells were seen up to the LTD ( 2,000 mg/ kg). The mean net nuclear grain count was below zero for both doses at both treatment times indicating no induction of UDS as tested in this study.

VerDate Jan< 31> 2003 14: 22 May 20, 2003 Jkt 200001 PO 00000 Frm 00006 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 21MYR1. SGM 21MYR1 27733 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Rules and Regulations TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY   Continued Guideline No. Study Type Results 870.7485 Metabolism and pharmacokinetics Pyraflufen ethyl was readily absorbed and excreted within 96 hours following a single or repeated oral dose of 5 mg/ kg ( plasma t1/ 2 of 3   3.5 hours). However, at a dose of 500 mg/ kg, absorption was saturated as indicated by Cmax values which did not reflect the 100 fold dose differential ( 2.7   2.8 Fg eq/ g for the low dose group and 100   107 Fg eq hr/ g for the high dose group). Following single or multiple oral low doses ( 5 mg/ kg) of pyraflufen ethyl, urinary excretion accounted for 27   33% of the administered radioactivity suggesting that a multiple exposure regimen did not affect the absorption/ excretion processes Urinary excretion was reduced to only 5   7% following a single 500 mg/ kg dose. Excretion via the feces accounted for the remainder of the administered radioactivity in all treatment groups. Analysis of biliary excretion following a single 5 mg/ kg dose showed that 36% of the administered dose appeared in the bile. Based upon the excretion data, total bioavailability of a low dose was approximately 56%. Biliary excretion data were not available for a high dose group which prevented a definitive assessment of bioavailability. Excretory patterns did not exhibit gender related variability. However, plasma and blood clearance was more rapid in females than in males as shown by plasma/ blood radioactivity time course and the greater AUC values for males ( 32.3 vs 18.4 Fg eq hr/ g for the low dose group and 2,738 vs 1,401 Fg eq hr/ g for the high dose group). Radioactivity concentrations indicated tissue concentrations at or near detection limits ( generally < 0.01 Fg eq/ g and never exceeding 0.02 Fg eq/ g) at 96 hrs postdose for any tissues. Therefore, neither pyraflufen ethyl nor its metabolites appear to undergo significant sequestration. Tissue burden data following compound administration did not suggest a specific target beyond those tissues, namely liver and kidney, which are associated with absorption and elimination of orally administered xenobiotics.

B. Toxicological Endpoints The dose at which no observed adverse effects levels are ( 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 observed adverse effects of levels 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 ( aRfD or cRfD) 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 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 pyraflufen ethyl used for human risk assessment is shown in Table 2:

VerDate Jan< 31> 2003 14: 22 May 20, 2003 Jkt 200001 PO 00000 Frm 00007 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 21MYR1. SGM 21MYR1 27734 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Rules and Regulations TABLE 2.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR PYRAFLUFEN ETHYL FOR USE IN HUMAN RISK ASSESSMENT Exposure Scenario Dose ( mg/ kg/ day) UF/ MOE Hazard Based Special FQPA Safety Factor Endpoint for Risk Assessment Dietary Risk Assessments Acute dietary Not applicable Not applicable No adverse effect attributable to a single exposure ( dose) was observed in oral toxicity studies, including the developmental toxicity studies in rats and rabbits.

Chronic dietary NOAEL= 20 UF = 100 Chronic RfD = 0.20 mg/ kg/ day 1X Mouse carcinogenicity. LOAEL = 98 mg/ kg/ day based on liver toxicity.

Incidental oral short term ( 1   30 days) residential only NOAEL= 20 UF = 100 MOE= 100 1X Developmental toxicity rabbit. LOAEL = 60 mg/ kg/ day based on decreases in body weight and food consumption, GI observations and abortions.

Incidental oral intermediate term ( 1   6 months) residential only NOAEL= 20 UF = 100 MOE= 100 1X Mouse carcinogenicity. LOAEL = 98 mg/ kg/ day based on liver toxicity at interim sacrifice.

Non Dietary Risk Assessments Dermal short term and intermediate term Not applicable Not applicable In a 28 dermal toxicity study in rats, no dermal or systemic toxicity was seen at the LTD ( 1,000 mg/ kg/ day). The physical and chemical characteristics ( e. g., Kow is low) indicate that dermal absorption is not expected to occur to any appreciable extent. There is no concern for prenatal and/ or postnatal toxicity. Therefore, no hazard was identified and quantification of dermal risk is not required.

Residential MOE = not applicable Not applicable Occupational MOE = not applicable Not applicable Inhalation1 short term ( 1   30 days) Oral NOAEL= 20 1X Developmental toxicity rabbit. LOAEL = 60 mg/ kg/ day based on decreases in bwt and food consumption, GI observations, and abortions.

Residential MOE = 100 Occupational MOE= 100 Inhalation1 intermediate term ( 1   6 months) Oral NOAEL= 20 1X Mouse carcinogenicity. LOAEL = 98 mg/ kg/ day based on liver toxicity at interim sacrifice.

Residential MOE = 100 Occupational MOE= 100 Inhalation1 long term (< 6 months) Oral NOAEL= 20 1X Mouse carcinogenicity. LOAEL = 98 mg/ kg/ day based on liver toxicity.

Residential MOE = 100 Occupational MOE= 100 Cancer Classification: `` Likely to be Carcinogenic to Humans'' by the oral route Q1* = 3.32 x 10 2 ( mg/ kg/ day) 1 1 Oral endpoints were selected because inhalation studies were unavailable. Absorption via the inhalation route is presumed to be equivalent to oral absorption. * The reference to the FQPA SF refers to any additional SF retained due to concerns unique to the FQPA.

VerDate Jan< 31> 2003 14: 22 May 20, 2003 Jkt 200001 PO 00000 Frm 00008 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 21MYR1. SGM 21MYR1 27735 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Rules and Regulations C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.585) for the combined residues of pyraflufen ethyl ( ethyl 2 chloro 5( 4 chloro 5 difluoromethoxy 1 methyl 1H pyrazol 3 yl) 4 fluorophenoxyacetate) and its acid metabolite, E 1 ( 2 chloro 5( 4 chloro 5 difluoromethoxy 1 methyl 1Hpyrazol 3 yl) 4 fluorophenoxyacetic acid), expressed as the ester equivalent in or on a variety of raw agricultural commodities. Risk assessments were conducted by EPA to assess dietary exposures from pyraflufen ethyl 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 1   day or single exposure. No adverse effect attributable to a single exposure ( dose) of pyraflufen ethyl was observed in the oral toxicity studies, including the developmental toxicity studies in rats and rabbits. Therefore, EPA did not identify an acute dietary endpoint and an acute dietary assessment was not performed because no acute risk is expected. ii. Chronic exposure. In conducting this chronic dietary risk assessment the Dietary Exposure Evaluation Model ( DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the United State Department of Agriculture ( USDA) nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) 1989   1992 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 pyraflufen ethyl on all treated crops. This assessment was Tier I analysis. The exposure from pyraflufen ethyl residues in food occupies less than 1% of the chronic population adjusted dose ( cPAD) for all population subgroups and is not a concern. iii. Cancer. The cancer dietary exposure assessment was conducted using the DEEM analysis evaluated the individual food consumption as reported by respondents in the USDA nationwide CSFII 1989   1992 and accumulated exposure to the chemical for each commodity. The following assumptions were made for the cancer assessments: 100% PCT and tolerancelevel residues for pyraflufen ethyl on all treated crops. The estimated exposure to the U. S. population ( total) to pyraflufenethyl is 2 x 10 5 mg/ kg/ day. Applying the Q1* of 0.0332 ( mg/ kg/ day) 1 to the exposure value results in a cancer risk estimate of 6.6 x 10 7. Therefore, the lifetime cancer risk to the U. S. population is below EPA's level of concern. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for pyraflufen ethyl 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 chemical and physical characteristics of pyraflufen ethyl. The Agency uses the First Index Reservoir Screening Tool ( FIRST) or the Pesticide Root Zone/ Exposure Analysis Modeling System ( PRZM/ EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The Screening Concentration in Ground Water ( SCI GROW) model is used to predict pesticide concentrations in shallow ground water. For a screeninglevel assessment for surface water EPA will use FIRST ( a tier 1 model) before using PRZM/ EXAMS ( a tier 2 model). The FIRST model is a subset of the PRZM/ EXAMS model that uses a specific high end runoff scenario for pesticides. While both FIRST and PRZM/ EXAMS incorporate an index reservoir environment, the PRZM/ EXAMS model includes a PCT crop area factor as an adjustment to account for the maximum PCT 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. 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 referance dose (% RfD) or percent population adjusted dose (% PAD). 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 pyraflufen ethyl they are further discussed in the aggregate risk sections below. Based on the FIRST and SCI GROW models the EECs of pyraflufen ethyl for acute exposures are estimated to be 1.25 parts per billion ( ppb) for surface water and 0.002 ppb for ground water. The EECs for chronic exposures are estimated to be 0.28 ppb for surface water and 0.002 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). Pyraflufen ethyl is currently registered for use on the following residential non dietary sites: Airports, nurseries, ornamental turf, golf courses, roadsides, and railroads. The risk assessment was conducted using the following residential exposure assumptions: adults and children may be exposed to residues of pyraflufenethyl through postapplication contact with treated areas which may include residential/ recreational areas. 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 pyraflufen ethyl 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, pyraflufen ethyl 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 pyraflufen ethyl 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 VerDate Jan< 31> 2003 14: 22 May 20, 2003 Jkt 200001 PO 00000 Frm 00009 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 21MYR1. SGM 21MYR1 27736 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Rules and Regulations 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 ( MOS) 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 that a different MOS will be safe for infants and children. MOS 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 following in utero exposure in the developmental studies with pyraflufenethyl There is no evidence of increased susceptibility of young rats in the reproduction study with pyraflufenethyl EPA concluded there are no residual uncertainties for prenatal and/ or postnatal exposure. 3. Conclusion. There is a complete toxicity database for pyraflufen ethyl and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The field trial data on cotton, while some of which may be limited in geographic representation or lack of early season application, indicate that residues of pyraflufen ethyl are expected to be finite. EPA determined that the 10X SF to protect infants and children should be removed and instead, a different additional safety factor of 1X should be used. The FQPA factor is removed because: There is no evidence of increased susceptibility of rat or rabbit fetuses following in utero exposure in the developmental studies with pyraflufen ethyl; there is no evidence of increased susceptibility of young rats in the reproduction study with pyraflufenethyl there are no residual uncertainties identified in the exposure databases; the dietary food exposure assessment is expected to be conservative, tolerancelevel residues and 100% crop treated information were used; and dietary drinking water exposure is based on conservative modeling estimates.

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 bwts. Default bwts and consumption values as used by the United States Environmental Protection Agency Office of Water are used to calculate DWLOCs: 2 liter ( L)/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg ( child). Default bwts 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 ground water 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 drinking water as a part of the aggregate risk assessment process. 1. Acute risk. No adverse effect attributable to a single exposure ( dose) of pyraflufen ethyl was observed in the oral toxicity studies, including the developmental toxicity studies in rats and rabbits. Therefore, an acute RfD was not established and no acute risk is expected. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to pyraflufen ethyl from food will utilize < 1% of the cPAD for the U. S. population and < 1% of the cPAD for children ( 1   6 years). Based on the use pattern, chronic residential exposure to residues of pyraflufen ethyl is not expected. In addition, there is potential for chronic dietary exposure to pyraflufen ethyl 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 the following Table 3:

TABLE 3.   AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON CANCER) EXPOSURE TO PYRAFLUFEN ETHYL Population Subgroup1 cPAD mg/ kg/ day % cPAD ( Food) Surface Water EEC ( ppb) 2 Ground Water EEC ( ppb) 2 Chronic DWLOC ( ppb) 3 U. S population 0.20 < 1 0.28 0.002 7,000 Males ( 20+ years old) 0.20 < 1 0.28 0.002 7,000 Females ( 13   50 years old) 0.20 < 1 0.28 0.002 6,000 Children ( 1   6 years old) 0.20 < 1 0.28 0.002 2,000 Males ( 13   19 years old) 0.20 < 1 0.28 0.002 7,000 1 Subgroups with the highest food source dietary exposure were selected for adult males, adult females and children. The following bwts were used ( 70 kg adult male; 60 kg adult females; 10 kg child). 2 The crop producing the highest level was used ( potatoes, 0.009 lb active ingredient/ acre). 3 Chronic DWLOC ( ppb) = [ maximum chronic water exposure ( mg/ kg/ day) x bwt ( kg)] ÷ [ water consumption ( L) x 10 3 mg/ kg]).

VerDate Jan< 31> 2003 14: 22 May 20, 2003 Jkt 200001 PO 00000 Frm 00010 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 21MYR1. SGM 21MYR1 27737 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Rules and Regulations 3. Short term risk. The short term aggregate risk assessment estimates risks likely to result from 1   30 days exposure to pyraflufen ethyl residues from food, drinking water, and residential pesticide uses. High end estimates of residential exposure are used in the short term aggregate assessment, while average ( chronic) values are used to account for dietary ( food only) exposure. The shortterm aggregate risk assessment is considered conservative because foodsource dietary exposure is based on a Tier 1 DEEM assessment ( tolerance level residues and 100% crop treated information were used). A short term aggregate risk assessment is not performed for adults because no handler exposure is expected and postapplication inhalation exposure is expected to be negligible. A short term aggregate risk assessment is required for infants and children because there is a potential for oral postapplication exposure resulting from residential uses. Pyraflufen ethyl is currently registered for use that could result in short term residential exposure and the Agency has determined that it is appropriate to aggregate chronic food and water and short term exposures for pyraflufen ethyl. Using the exposure assumptions described in this unit for short term exposures, EPA has concluded that food and residential exposures aggregated result in aggregate MOEs of 170,000 for children ( 1   6 years old). These aggregate MOEs do not exceed the Agency's level of concern for aggregate exposure to food and residential uses. In addition, short term DWLOCs were calculated and compared to the EECs for chronic exposure of pyraflufen ethyl in ground and surface water. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect short term aggregate exposure to exceed the Agency's level of concern, as shown in Table 4:

TABLE 4.   AGGREGATE RISK ASSESSMENT FOR SHORT TERM EXPOSURE TO PYRAFLUFEN ETHYL Population Subgroup Aggregate MOE ( Food + Residential) 1 Aggregate Level of Concern ( LOC) Surface Water EEC ( ppb) 2 Ground Water EEC ( ppb) 2 Short Term DWLOC ( ppb) 3 Children ( 1   6 years old) 170,000 100 0.28 0.002 2,000 1 Aggregate MOE = NOAEL ( Avg Food Exposure + Residential Exposure). 2 The crop producing the highest level was used ( potatoes, 0.009 lb ai/ acre). 3DWLOC( ppb) = [ maximum water exposure ( mg/ kg/ day) x bwt ( kg)] ÷ [ water consumption ( L) x 10 3 mg/ kg] *( bwt: Children 10 kg).

4. Intermediate term risk. The intermediate term aggregate risk assessment estimates risks likely to result from 1   6 months of exposure to pyraflufen ethyl residues from food, drinking water, and residential pesticide uses. High end estimates of residential exposure are used in the intermediateterm assessment, while average values are used for food and drinking water exposure. An intermediate term aggregate risk assessment is not preformed for adults because no handler exposure is expected and postapplication inhalation exposure is expected to be negligible. Also, an intermediate term aggregate risk assessment is not preformed for infants and children because postapplication exposure over the intermediate term duration is not likely based on the use pattern. 5. Aggregate cancer risk for U. S. population. Pyraflufen ethyl has been classified as a `` Likely to be Carcinogenic to Humans'' by the oral route of exposure ( Q1* of 3.32 x 10 2 ( mg/ kg/ day) 1). Using the exposure assumptions discussed in this unit for cancer, the cancinogenic risk is determined for the U. S. population ( total) only. The aggregate cancer DWLOC ( 2.3 ppb) is greater than EPA's estimates of pyraflufen ethyl residues in drinking water. Therefore, the aggregate cancer risk from residues of pyraflufenethyl in food and drinking water does not exceed EPA's level of concern as shown in the following Table 5:

TABLE 5.   CANCER DWLOC CALCULATIONS FOR THE U. S. POPULATION Q1* mg/ kg/ day) 1 Negligible Risk Level1 Aggregate cancer risk ( food and residential Ground Water EEC2 ( ppb) Surface Water EEC2 ( ppb) Cancer DWLOC3 ( ppb)

0.0332 3.0E 6 8.3E 7 0.002 0.28 2.3 1 Negligible risk is that below 10 6. 3.0E 6 is statistically within the range that EPA generally accepts as `` negligible risk''. 2 The crop producing the highest level was used ( potatoes). 3Cancer DWLOC ( ppb) = [ maximum water exposure ( mg/ kg/ day) x bwt ( kg)] ÷ [ water consumption ( L) x 10 3 mg/ kg]

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 pyraflufenethyl residues. IV. Other Considerations A. Analytical Enforcement Methodology Nichino America, Inc. has submitted a petition method validation ( PMV) and an independent laboratory validation for a Gas Chromatography/ Mass Spectometry ( GC/ MS) method proposed for the enforcement of tolerances for residues of pyraflufen ethyl and its acid metabolite, E 1. The proposed plant method is adequate for enforcement of tolerances in/ on cotton. Adequate enforcement methodology ( example   GC) 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: ( 410) 305   2905; email address: residuemethods@ epa. gov.

VerDate Jan< 31> 2003 14: 22 May 20, 2003 Jkt 200001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 21MYR1. SGM 21MYR1 27738 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Rules and Regulations B. International Residue Limits There is neither a Codex proposal, nor Canadian or Mexican limits, for residues of pyraflufen ethyl in/ on cotton. Harmonization is not an issue for this petition.

C. Conditions A risk assessment for human health has been conducted for this proposed use. Using the proposed or recommended tolerances, the chronic estimates are well below the Agency's level of concern and the cancer risk estimate is also within Agency's level of concern. The following data are being required by the Agency to complete the database requirements prior to approval of an unconditional registration of pyraflufen ethyl on cotton:   Product label contain a statement limiting use to commercial applicators only so that possible use by homeowners on residential turf would be minimized and/ or include a restriction prohibiting use by homeowners for the turf and ornamental use sites.   Proposed uses in farmyards, farm buildings, fence lines, dry ditches and ditch banks be removed from the label due to the potential for residues to contact food sources in these use sites.   The label for pyraflufen ethyl should clearly state the allowable number of applications per season.

V. Conclusion Therefore, tolerances are established for combined residues of pyraflufenethyl ( ethyl 2 chloro 5( 4 chloro 5 difluoromethoxy 1 methyl 1H pyrazol 3 yl) 4 fluorophenoxyacetate) and its acid metabolite, E 1 ( 2 chloro 5( 4 chloro 5 difluoromethoxy 1 methyl 1Hpyrazol 3 yl) 4 fluorophenoxyacetic acid), expressed pyraflufen ethyl in or on cotton undelinted seed at 0.04 ppm and cotton gin byproduct at 1.5 ppm.

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   2003   0163 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 July 21, 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   2003   0163, 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 VerDate Jan< 31> 2003 14: 22 May 20, 2003 Jkt 200001 PO 00000 Frm 00012 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 21MYR1. SGM 21MYR1 27739 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Rules and Regulations 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 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. Congressional Review Act 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: May 7, 2003. Debra Edwards, 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 180.585 is amended by alphabetically adding commodities in the table in paragraph ( a) to read as follows:

§ 180.585 Pyraflufen ethyl; tolerances for residues.

( a) * * *

Commodity Parts per million Cotton, gin byproduct .................................................................................................................. 1.5 Cotton, undelinted seed ............................................................................................................... 0.04 VerDate Jan< 31> 2003 14: 22 May 20, 2003 Jkt 200001 PO 00000 Frm 00013 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 21MYR1. SGM 21MYR1 27740 Federal Register / Vol. 68, No. 98 / Wednesday, May 21, 2003 / Rules and Regulations * * * * * [ FR Doc. 03   12359 Filed 5   20   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0151; FRL   7305   2]

Indoxacarb; Pesticide Tolerances for Emergency Exemptions AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a time limited tolerance for combined residues of indoxacarb and its Renantimomer in or on collards. 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 collards. This regulation establishes a maximum permissible level for residues of indoxacarb in this food commodity. The tolerance will expire and is revoked on June 30, 2006. DATES: This regulation is effective May 21, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0151, must be received on or before July 21, 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: Barbara Madden, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   6463; e mail address: Madden. Barbara@ 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 a federal or state government agency ( NAICS 9241) involved in administration of environmental quality programs ( i. e., Departments of Agriculture, Environment, etc). This listing 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 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   2003   0151. 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. 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 EPA, on its own initiative, in accordance with sections 408( e) and 408( l)( 6) of the Federal Food, Drug, and Cosmetic Act ( FFDCA), 21 U. S. C. 346a, is establishing a tolerance for combined residues of the insecticide indoxacarb [( S) methyl 7 chloro 2,5 dihydro 2 [[( methoxycarbonyl)[ 4 ( trifluoromethoxy) phenyl] amino] carbonyl] indeno [ 1,2 e][ 1,3,4] oxadiazine 4a( 3H) carboxylate] and its R enantimomer [( R) methyl 7 chloro 2,5 dihydro 2 [[( methoxycarbonyl)[ 4 ( trifluoromethoxy) phenyl] amino] carbonyl] indeno [ 1,2 e][ 1,3,4] oxadiazine 4a( 3H) carboxylate in or on collards at 3.0 parts per million ( ppm). This tolerance will expire and is revoked on June 30, 2006. EPA will publish a document in the Federal Register to remove the revoked tolerance from the Code of Federal Regulations. Section 408( l)( 6) of the FFDCA requires EPA to establish a time limited tolerance or exemption from the requirement for a tolerance for pesticide chemical residues in food that will result from the use of a pesticide under an emergency exemption granted by EPA under section 18 of FIFRA. Such tolerances can be established without providing notice or period for public comment. EPA does not intend for its actions on section 18 related tolerances to set binding precedents for the application of section 408 of the FFDCA and the new safety standard to other tolerances and exemptions. Section 408( e) of the FFDCA allows EPA to establish a tolerance or an exemption from the requirement of a tolerance on its own initiative, i. e., without having received any petition from an outside party. 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. . . .'' Section 18 of the FIFRA authorizes EPA to exempt any Federal or State VerDate Jan< 31> 2003 14: 22 May 20, 2003 Jkt 200001 PO 00000 Frm 00014 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 21MYR1. SGM 21MYR1


[Federal Register: August 6, 2009 (Volume 74, Number 150)]
[Notices]
[Page 39310-39311]
[DOCID:fr06au09-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2594-013]

Northern Lights, Inc.; Notice of Application Accepted for Filing,
Soliciting Motions To Intervene and Protests, Ready for Environmental
Analysis, and Soliciting Comments, Recommendations, Preliminary Terms
and Conditions, and Preliminary Fishway Prescriptions

July 30, 2009.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Major License.
    b. Project No.: 2594-013.
    c. Date filed: July 17, 2009.
    d. Applicant: Northern Lights, Inc. (NLI).
    e. Name of Project: Lake Creek Hydroelectric Project.
    f. Location: The existing project is located on Lake Creek in
Lincoln County, Montana, near the City of Troy. The project does not
affect federal lands.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mark Contor, Operations Manager, Northern
Lights Inc., P.O. Box 269, 421 Chevy Street, Sagle, ID 83860; Telephone
(800) 326-9594 ext. 134.
    i. FERC Contact: Shana Murray, Telephone<PHONE_NUMBER>, and e-mail
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests, comments,
recommendations, preliminary terms and conditions, and preliminary
fishway prescriptions is 60 days from the issuance of this notice;
reply comments are due 105 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    Motions to intervene, protests, comments, recommendations,
preliminary terms and conditions, and preliminary fishway prescriptions
may be filed electronically via the Internet in lieu of paper. The
Commission strongly encourages electronic filings. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
(http://www.ferc.gov/docs-filing/ferconline.asp) under the ``e-filing''
link. For a simpler method of submitting text only comments, click on
``Quick Comment.''
    k. This application has been accepted for filing and is now is
ready for environmental analysis.
    l. The Project consists of: (1) A 268-foot-long, 44-foot-high
concrete gravity dam; (2) a 30-acre reservoir with a storage capacity
of 150 acre-feet (af); (3) a reinforced concrete intake structure; (4)
a 1,694-foot-long, 10-foot diameter flowline, leading to a forebay
created by a reinforced concrete structure with wood superstructure;
(5) a 297-foot-long, 5-foot diameter penstock, leading to Powerhouse
No. 1 containing a Francis-type, turbine-generating unit with a rated
capacity of 1 megawatt (MW); (6) a 441-foot-long penstock with a
diameter of 8.5 feet, leading to Powerhouse No. 2 containing a Francis-
type, turbine-generating unit with a rated capacity of 3.5 MW; (7) a
2.4-7.97/13.8 kilovolt step-up transformer at

Powerhouse No. 2; and (8) appurtenant facilities. The project is
estimated to generate an average of 23,400,000 kilowatthours annually.
The dam and existing project facilities are owned and operated by the
applicant. The applicant is not proposing to add capacity or to make
any modifications to the Project or its operation under the new
license.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''
link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is also available for
inspection and reproduction at the address in item h above.
    Register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Anyone may submit comments, a protest, or a motion to intervene
in accordance with the requirements of Rules of Practice and Procedure,
18 CFR 385.210, .211, .214. In determining the appropriate action to
take, the Commission will consider all protests or other comments
filed, but only those who file a motion to intervene in accordance with
the Commission's Rules may become a party to the proceeding. Any
comments, protests, or motions to intervene must be received on or
before the specified comment date for the particular application.
    All filings must (1) Bear in all capital letters the title
``PROTEST'', ``MOTION TO INTERVENE'', ``COMMENTS,'' ``REPLY COMMENTS,''
``RECOMMENDATIONS,'' ``PRELIMINARY TERMS AND CONDITIONS,'' or
``PRELIMINARY FISHWAY PRESCRIPTIONS''; (2) set forth in the heading the
name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, recommendations, terms and conditions or prescriptions must
set forth their evidentiary basis and otherwise comply with the
requirements of 18 CFR 4.34(b). Agencies may obtain copies of the
application directly from the applicant. A copy of any protest or
motion to intervene must be served upon each representative of the
applicant specified in the particular application. A copy of all other
filings in reference to this application must be accompanied by proof
of service on all persons listed in the service list prepared by the
Commission in this proceeding, in accordance with 18 CFR 4.34(b) and
385.2010.
    o. Procedural Schedule: The application will be processed according
to the following revised Hydro Licensing Schedule. Revisions to the
schedule may be made as appropriate.

------------------------------------------------------------------------
              Milestone                           Target date
------------------------------------------------------------------------
Filing of recommendations,             November 28, 2009.
 preliminary terms and conditions,
 and preliminary fishway
 prescriptions.
Commission issues Draft EA or EIS....  May 27, 2010.
Comments on Draft EA or EIS..........  July 26, 2010.
Modified Terms and Conditions........  September 24, 2010.
Commission Issues Final EA or EIS....  December 23, 2010.
------------------------------------------------------------------------

    p. Final amendments to the application must be filed with the
Commission no later than 30 days from the issuance date of this notice.
    q. A license applicant must file no later than 60 days following
the date of issuance of the notice of acceptance and ready for
environmental analysis provided for in Sec.  5.22: (1) A copy of the
water quality certification; (2) a copy of the request for
certification, including proof of the date on which the certifying
agency received the request; or (3) evidence of waiver of water quality
certification.

Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. E9-18797 Filed 8-5-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 59 (Tuesday, March 30, 2021)]
[Notices]
[Page 16596]
[FR Doc No: 2021-06502]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-1502-000]

Maverick Solar 6, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced Maverick
Solar 6, LLC's application for market-based rate authority, with an
accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is April 13, 2021.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TYY,<PHONE_NUMBER>.

    Dated: March 24, 2021.
Kimberly D. Bose,
Secretary.
[FR Doc. 2021-06502 Filed 3-29-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 47 (Monday, March 11, 2019)]
[Notices]
[Pages 8700-8701]
[FR Doc No: 2019-04321]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-97-000]

Guthrie Natural Gas Utility; Notice of Application

    Take notice that on February 21, 2019, Guthrie Natural Gas Utility
(Guthrie), P.O. Box 632, Guthrie, Kentucky 42234, filed in Docket No.
CP19-97-000 an application pursuant to section 7(f) of the Natural Gas
Act (NGA) requesting a service area determination so that it may expand
or enlarge its facilities with or without further Commission
authorization. Guthrie is a public utility providing natural gas
service to customers in Kentucky that is regulated by the Kentucky
Public Service Commission. Guthrie is seeking a service area
determination to operate approximately 25 feet of pipeline across the
Kentucky/Tennessee border in order to interconnect with the City of
Clarksville, Tennessee's Gas and Water Department pipeline facilities,
through which Guthrie receives its natural gas supply. Guthrie states
this interconnect is required to serve a new customer in Guthrie,
Kentucky, and that Guthrie does not now or in the future intend to
serve customers in Tennessee. Guthrie also requests that the Commission
determine that Guthrie qualifies as a local distribution company for
the purposes of transportation under section 311 of the Natural Gas
Policy Act of 1978 and that it be granted waiver of all reporting and
accounting requirements, as well as other rules and regulations that
are normally applicable to natural gas companies subject to the
Commission's jurisdiction, all as more fully set forth in the
application which is on file with the Commission and open to public
inspection.
    The filing is available for review at the Commission in the Public
Reference Room or may be viewed on the Commission's website web at
http://www.ferc.gov using the eLibrary link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions concerning this application may be directed to Dwight
Luton, Kentucky Energy Systems, LLC, P.O. Box 632, Guthrie, Kentucky
42234, by telephone at<PHONE_NUMBER>, or by email
<EMAIL_ADDRESS>or James Covington, Mayor of the City of
Guthrie, Kentucky, 110 Kendall Street, Guthrie,

Kentucky 42234, by telephone at<PHONE_NUMBER>.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 3 copies of filings made in the proceeding with the Commission
and must provide a copy to the applicant and to every other party. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commenters will not be required to serve
copies of filed documents on all other parties. However, the non-party
commenters will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    As of the February 27, 2018 date of the Commission's order in
Docket No. CP16-4-001, the Commission will apply its revised practice
concerning out-of-time motions to intervene in any new Natural Gas Act
section 3 or section 7 proceeding.\1\ Persons desiring to become a
party to a certificate proceeding are to intervene in a timely manner.
If seeking to intervene out-of-time, the movant is required to show
good cause why the time limitation should be waived, and should provide
justification by reference to factors set forth in Rule 214(d)(1) of
the Commission's Rules and Regulations.\2\
---------------------------------------------------------------------------

    \1\ Tennessee Gas Pipeline Company, L.L.C., 162 FERC 61,167 at
50 (2018).
    \2\ 18 CFR 385.214(d)(1).
---------------------------------------------------------------------------

    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically should
submit an original and 3 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on March 20, 2019.

    Dated: February 27, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-04321 Filed 3-8-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 79, Number 133 (Friday, July 11, 2014)]
[Notices]
[Page 40100]
[FR Doc No: 2014-16245]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9015-8]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/compliance/nepa/.
Weekly receipt of Environmental Impact Statements
Filed 06/30/2014 through 07/03/2014
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

EIS No. 20140186, Final EIS, USFS, NM, Valles Caldera National
Preserve--Landscape Restoration and Stewardship Plan, Review Period
Ends: 08/11/2014, Contact: Marie Rodriguez<PHONE_NUMBER>.
EIS No. 20140187, Second Final Supplement, USACE, WA, Grays Harbor
Navigation Improvement Project, Review Period Ends: 08/11/2014,
Contact: Leah Wickstrom<PHONE_NUMBER>.
EIS No. 20140188, Final EIS, NPS, FL, Canaveral National Seashore Final
General Management Plan, Review Period Ends: 08/11/2014, Contact: Chris
Church<PHONE_NUMBER>.
EIS No. 20140189, Draft EIS, USFS, CO, Middle Bald Mountain Area
Communication Site, Comment Period Ends: 08/25/2014, Contact: Carol
Kruse<PHONE_NUMBER>.
EIS No. 20140190, Revised Draft EIS, USFS, 00, Greater Sage Grouse Bi-
State Distinct Population Segment Forest Plan Amendment, Comment Period
Ends: 10/09/2014, Contact: James Winfrey<PHONE_NUMBER>.

    Dated: July 8, 2014.
Dawn Roberts,
Management Analyst, NEPA Compliance Division, Office of Federal
Activities.
[FR Doc. 2014-16245 Filed 7-10-14; 8:45 am]
BILLING CODE 6560-50-P