48302 Federal Register / Vol. 68, No. 156 / Wednesday, August 13, 2003 / Rules and Regulations 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. 801et 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: July 31, 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 180.548 is amended by revising the table to paragraph ( a) to read as follows:

§ 180.548 Tralkoxydim; tolerances for residues.

( a) * * *

Commodity Parts per million Expiration/ revocation date Barley, grain ..... 0.02 5/ 1/ 05 Barley, hay ........ 0.02 5/ 1/ 05 Barley, straw ..... 0.05 5/ 1/ 05 Wheat, forage 0.05 5/ 1/ 05 Wheat, grain ..... 0.02 5/ 1/ 05 Wheat, hay ....... 0.02 5/ 1/ 05 Wheat, straw ..... 0.05 5/ 1/ 05 * * * * *

[ FR Doc. 03   20433 Filed 8   12   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0251; FRL   7319   5]

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

SUMMARY: This regulation establishes a tolerance for residues of hydramethylnon in or on pineapple. BASF 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 August 13, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0251, must be received on or before October 14, 2003.

VerDate jul< 14> 2003 15: 39 Aug 12, 2003 Jkt 200001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 13AUR1. SGM 13AUR1 48303 Federal Register / Vol. 68, No. 156 / Wednesday, August 13, 2003 / Rules and Regulations 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: Richard J. Gebken, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   6701; e mail address: gebken. richard@ 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 111)   Food manufacturing ( NAICS 311)   Pesticide manufacturing ( NAICS 32532)   Animal production ( NAICS 112) 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   0251 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 October 6, 1999 ( 64 FR Page 54300   54303) ( FRL   6029   9), 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 ( PP 2F02609) by BASF Corporation, 26 Davis Drive, P. O. Box 13528, Research Triangle Park, NC 27709   3528. That notice included a summary of the petition prepared by BASF Corporation, the registrant. There were no comments received in response to the notice of filing. The petition requested that 40 CFR 180.395 be amended by establishing a tolerance for residues of the insecticide Hydramethylnon in or on pineapple at 0.05 parts per million ( 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 hydramethylnon on pineapple at 0.05 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 hydramethylnon are discussed in Table 1 of this unit as well as the no observed adverse effectlevel ( NOAEL) and the lowest observedadverse effect level ( LOAEL) from the toxicity studies reviewed.

VerDate jul< 14> 2003 15: 39 Aug 12, 2003 Jkt 200001 PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 13AUR1. SGM 13AUR1 48304 Federal Register / Vol. 68, No. 156 / Wednesday, August 13, 2003 / Rules and Regulations TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline No. Study Type Results 870.3100 Subchronic Feeding  Rat NOAEL = 2.5 mg/ kg/ day LOAEL = 5.0 mg/ kg/ day  decreased testicular weights ( 34%), and testicular atrophy.

870.3150 Subchronic Gavage  Dog NOAEL = 3 mg/ kg/ day  LDT; decreased food consumption ( 11%/ 20%, males/ females) and body weight gain ( 11%/ 9%, males/ females). LOAEL = not defined Lethal Dose = 6 mg/ kg/ day  decreased food consumption and body weight gain,   SGPT, cachexia, wasting of muscle and subcutaneous fat, testicular atrophy, and death.

870.3150 Subchronic Gavage  Dog NOAEL = 1.0 mg/ kg/ day LOAEL = 3.0 mg/ kg/ day  increased incidence of soft stools, mucoid stools, and diarrhea.

870.3200 21   Day Dermal  Rabbit NOAEL = 250 mg/ kg/ day ( HDT) Food consumption was depressed as much as 38% and 45% in the high dose males and females, compared to controls. The high dose males and females weighed as much as 8% and 9% less than the controls The platelet count in the high dose females at termination was 54% less than controls, but was not considered adverse because it is a common finding following skin abrasion.

870.3700 Developmental Toxicity  Rat Maternal NOEL = 3 mg/ kg/ day Maternal NOAEL = 10 mg/ kg/ day  8% decrease in body weight and yellowish discoloration of the fat. Maternal LOAEL = 30 mg/ kg/ day  16% decrease in body weight; increased incidence of nasal mucus, alopecia soft stools, staining of the anogenital fur, yellowish discoloration of the fat, and small thymus. Developmental NOEL = 10 mg/ kg/ day Developmental LOAEL = 30 mg/ kg/ day  decreased mean fetal weights and increased incidence of rudimentary structures and incompletely ossified supraoccipitals. At 30 mg/ kg/ day, a 16% decrease in maternal body weight, increased incidence of clinical signs ( nasal mucus, alopecia, soft stool, staining of anogenital fur), yellowish discoloration of the fat, and small thymus were observed.

870.3700 Developmental Toxicity  Rabbit Maternal NOAEL = 5 mg/ kg/ day  soft stools, and reduced amount of stools. Maternal LOAEL = 10 mg/ kg/ day  abortions, soft stools, reduced amount of stools, and anogenital matting and discharge. Developmental NOAEL = 5 mg/ kg/ day  decreased fetal weight ( 8%). Developmental LOAEL = 10 mg/ kg/ day  abortions, decreased fetal weight ( 16%).

870.3800 2 Generation Reproductive Toxicity  Rat Reproductive/ Systemic NOAEL = 25 ppm ( 1.66/ 2.01 mg/ kg/ day, male/ female) Reproductive/ Systemic LOAEL = 50 ppm ( 3.32 / 4.13 mg/ kg/ day, male/ female) ( degeneration of the germinal epithelium ( 1/ 29) and aspermia ( 1/ 29)

870.4100 Chronic Feeding Toxicity  Dog See 870.3150 870.4200 Carcinogenicity Feeding  Mouse ( 18 months) NOAEL = 25 ppm ( 3.57 mg/ kg/ day) in males NOAEL = not defined in females. LOAEL = 50 ppm ( 6.93 mg/ kg/ day) in males ( testicular lesions) LOAEL = 25 ppm ( 4.45 mg/ kg/ day) in females ( LDT; combined lung adenomas and carcinomas) The high dose females were sacrificed after 5 weeks due to high mortality.

VerDate jul< 14> 2003 15: 39 Aug 12, 2003 Jkt 200001 PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 13AUR1. SGM 13AUR1 48305 Federal Register / Vol. 68, No. 156 / Wednesday, August 13, 2003 / Rules and Regulations TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY   Continued Guideline No. Study Type Results 870.4300 Chronic Feeding Toxicity/ Carcinogenicity Rat NOAEL = 50 ppm ( 2.4 mg/ kg/ day in males, 3.0 mg/ kg/ day in females) LOAEL = 100 ppm ( 4.9 mg/ kg/ day in males, 6.2 mg/ kg/ day in females) ( small, soft testes, decreased testicular weights, and testicular atrophy in males; decreased body weight gain in females)

870.5100 Bacterial Reverse Mutation Test ( Ames Assay) Negative 870.5375 In Vitro Chromosomal Aberration in Chinese Hamster Ovary ( CHO) Cells Negative 870.5450 Rodent Dominant Lethal Assay  Rat Negative 870.5575 D4 Mitotic Gene Conversion Assay Negative P1 Forward Gene Mutation Assay Negative 870.7485 Metabolism  Rat The majority of the administered dose of phenyl or pyrimidinyl 14C Cl 217,300 was recovered in the feces ( 85   98%). Recovery in the urine was minimal ( 1 to 2% of the administered dose). There were no sex or dose related differences in urinary or fecal elimination.

870.7600 Dermal Penetration  Rat Sprague Dawley rats were dermally dosed with a gel formulation containing 2% a. i. ( Maxforce Gel   ) . Total dose absorbed after 10 hours was 0.414%

870.7600 Dermal Penetration  Rat Sprague Dawley rats were dermally dosed with a gel formulation containing 2.16% a. i. ( Siege   ) . Total dose absorbed after 10 hours was 0.97%

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 intra species 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 factors ( 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 hydramethylnon used for human risk assessment is shown in the following Table 2:

VerDate jul< 14> 2003 15: 39 Aug 12, 2003 Jkt 200001 PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 13AUR1. SGM 13AUR1 48306 Federal Register / Vol. 68, No. 156 / Wednesday, August 13, 2003 / Rules and Regulations TABLE 2.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR HYDRAMETHYLNON FOR USE IN HUMAN RISK ASSESSMENT Exposure Scenario Dose Used in Risk Assessment, UF FQPA SF* and Level of Concern for Risk Assessment Study and Toxicological Effects Acute Dietary ( Females 13   50 years of age) NOAEL = 5 mg/ kg/ day UF = 100 Acute RfD = 0.05 mg/ kg/ day FQPA SF = 1 aPAD = acute RfD ÷ FQPA SF = 0.05 mg/ kg/ day Developmental toxicity in rabbits LOAEL = 10 mg/ kg/ day based on abortions.

Acute Dietary ( General population including infants and children)   There is no appropriate single dose endpoint for the general population.

Chronic Dietary ( All populations NOAEL= 1.66 mg/ kg/ day UF = 100 Chronic RfD = 0.017 mg/ kg/ day FQPA SF = 1 cPAD = chronic RfD ÷ FQPA SF = 0.017 mg/ kg/ day 2 Generation reproductive toxicity in rats LOAEL = 3.32 mg/ kg/ day based on testicular effects.

Short Term Incidental Oral ( 1   30 days) Oral NOAEL= 1.66 mg/ kg/ day LOC for MOE = 100 ( Residential) 2 Generation reproductive toxicity in rats LOAEL = 3.32 mg/ kg/ day based on testicular effects.

Intermediate Term Incidental Oral ( 1   6 months) Oral NOAEL= 1.66 mg/ kg/ day LOC for MOE = 100 ( Residential) 2 Generation reproductive toxicity in rats LOAEL = 3.32 mg/ kg/ day based on testicular effects.

Short Term Dermal ( 1 to 30 days)( Residential) Oral NOAEL= 1.66 mg/ kg/ day ( dermal absorption rate = 1%) LOC for MOE = 100 ( Residential) 2 Generation reproductive toxicity in rats LOAEL = 3.32 mg/ kg/ day based on testicular effects.

Intermediate Term Dermal ( 1 week to 6 months) ( Residential Oral NOAEL = 1.66 mg/ kg/ day( dermal absorption rate = 1%) LOC for MOE = 100 ( Residential) 2 Generation reproductive toxicity in rats LOAEL = 3.32 mg/ kg/ day based on testicular effects.

Long Term Dermal ( several months to lifetime) ( Residential Oral NOAEL= 1.66 mg/ kg/ day ( dermal absorption rate = 1%) LOC for MOE = 100 ( Residential) 2 Generation reproductive toxicity in rats LOAEL = 3.32 mg/ kg/ day based on testicular effects.

Short Term Inhalation ( 1 to 7 days) ( Residential) inhalation ( or oral) study NOAEL= 1.66 mg/ kg/ day( inhalation absorption rate = 100%) LOC for MOE = 100 ( Residential) 2 Generation reproductive toxicity in rats LOAEL = 3.32 mg/ kg/ day based on testicular effects.

Intermediate Term Inhalation ( 1 week to several months) ( Residential) inhalation ( or oral) study NOAEL = 1.66 mg/ kg/ day( inhalation absorption rate = 100%) LOC for MOE = 100 ( Residential) 2 Generation reproductive toxicity in rats LOAEL = 3.32 mg/ kg/ day based on testicular effects.

Long Term Inhalation ( several months to lifetime) ( Residential inhalation ( or oral) study NOAEL= 1.66 mg/ kg/ day( inhalation absorption rate = 100%) LOC for MOE = 100 ( Residential) 2 Generation reproductive toxicity in rats LOAEL = 3.32 mg/ kg/ day based on testicular effects.

Cancer ( oral, dermal, inhalation The Agency's Cancer Peer Review Committee determined that hydramethylnon should be classified as a Group C possible human carcinogen, and recommended that, for the purpose of risk characterization, the Reference Dose approach should be used for quantification of human risk. The Cancer Peer Review report was issued on March 28, 1991. The Agency's HIARC committee concurred with the cancer classification on March 4, 2003.

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

C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.395) for the residues of hydramethylnon, on grass and grass hay for pasture and rangeland at 0.05 ppm established in terms of parent only, tetrahydro 5,5 dimethyl 2( 1H) pyrimidinone ( 3( 4 ( trifluoromethyl) phenyl) 1( 2( 4 ( trifluoromethyl) phenyl) ethenyl) 2 propenylidene) hydrazone. The Agency determined that the residue of concern in grasses and the milk, meat, and meat byproducts of ruminants is hydramethylnon per se, and that there is no reasonable expectation of finite hydramethylnon residues of concern in VerDate jul< 14> 2003 15: 39 Aug 12, 2003 Jkt 200001 PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 13AUR1. SGM 13AUR1 48307 Federal Register / Vol. 68, No. 156 / Wednesday, August 13, 2003 / Rules and Regulations the milk, meat, and meat byproducts of ruminants 40 CFR 180.6( a)( 3) as a result of hydramethylnon use on grasses. The Agency has also previously recommended that the grass forage tolerance be increased to 2.0 ppm and the grass hay tolerance be increased to 0.1 ppm. The residue chemistry and toxicological databases support the requested tolerance of 0.05 ppm for hydramethylnon on pineapple. Since there are no detectable hydramethylnon residues in the pineapple feed item, process residues, tolerances for hydramethylnon residues in animal commodities need not be established. Risk assessments were conducted by EPA to assess dietary exposures from hydramethylnon 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. An unrefined, Tier 1 acute dietary exposure assessment was conducted using tolerance level residues and assuming 100% crop treated ( CT) for all registered and proposed commodities. The acute analysis was conducted for females 13   49 years old only as no appropriate single dose endpoint was established for the general U. S. population and infants and children. The acute dietary exposure estimates are well below the Agency's level of concern (< 100% aPAD) at the 95th exposure percentile for females 13   49 years old (< 1% of the aPAD). 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 1994   1996/ 1998 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: A Tier 1 ( conservative, deterministic assessment using tolerance level residues, and 100% crop treated ( CT) for the proposed commodity; and DEEMFCID   ver. 1.30, processing factors set to ( 1) a chronic dietary exposure assessment was conducted for the general U. S. population and various population subgroups. The chronic dietary exposure estimates are well below the Agency's level of concern (< 100% cPAD) for the general U. S. population (< 1% of the cPAD) and all population subgroups. iii. Cancer. In a chronic feeding/ carcinogenicity study in Charles River CD rats, no compound related clinical signs were observed and survival was not affected by treatment. The LOAEL was based on small, soft testes, decreased testicular weights ( 27%), and testicular atrophy in males; and decreased body weight gain in females ( 22%). Statistically significant findings of neoplasia were found in the uterus ( adenomatous polyps) and adrenals ( medullary adenomas), but these were not considered toxicologically significant because they were seen at doses above the MTD. In an 18 month carcinogenicity feeding study in Charles River CD 1 mice, survival decreased as the dose increased, but not enough to jeopardize the study. The LOAEL was based on testicular degeneration ( hypospermia, interstitial cell hyperplasia of Leydig cells, and germinal cell degeneration) in males, and combined lung adenomas and carcinomas in females. Findings of hyperplasia and neoplasia in the lungs of males were not considered toxicologically significant because they were seen at doses above the MTD. Findings in females of statistically significant increases in lung adenomas and combined lung adenomas/ carcinomas were, however, considered toxicologically significant. The Agency's Cancer Peer Review Committee classified hydramethylnon as a Group C possible human carcinogen, and recommended that, for the purpose of risk characterization, the Reference Dose approach should be used for quantification of human risk. This classification was based upon statistically significant increases in lung adenomas and combined lung adenomas/ carcinomas in female mice. Dietary risk concerns due to long term consumption of hydramethylnon residues are adequately addressed by the chronic exposure analysis using the RfD. iv. Anticipated residue and percent crop treated ( PCT) information. Section 408( b)( 2)( F) of the FFDCA states that the Agency may use data on the actual percent of food treated for assessing chronic dietary risk only if the Agency can make the following findings: Condition 1, that the data used are reliable and provide a valid basis to show what percentage of the food derived from such crop is likely to contain such pesticide residue; Condition 2, that the exposure estimate does not underestimate exposure for any significant subpopulation group; and Condition 3, if data are available on pesticide use and food consumption in a particular area, the exposure estimate does not understate exposure for the population in such area. In addition, the Agency must provide for periodic evaluation of any estimates used. To provide for the periodic evaluation of the estimate of PCT as required by section 408( b)( 2)( F) of the FFDCA, EPA may require registrants to submit data on PCT. A routine chronic dietary exposure analysis for pineapple was based on 100% of pineapple crop treated, and 100% of grasses, forage ( pasture and rangeland) treated with hydramethylnon. The Agency believes that the three conditions previously discussed have been met. With respect to Condition 1, EPA used a conservative, model assessment as outlined in Unit III. C. 1. ii. above, using tolerance level residues and 100% CT for the proposed commodity pineapple, and existing commodities. As to Conditions 2 and 3, regional consumption information and consumption information for significant subpopulations is taken into account through EPA's computer based model for evaluating the exposure of significant subpopulations including several regional groups. Use of this consumption information in EPA's risk assessment process ensures that EPA's exposure estimate does not understate exposure for any significant subpopulation group and allows the Agency to be reasonably certain that no regional population is exposed to residue levels higher than those estimated by the Agency. Other than the data available through national food consumption surveys, EPA does not have available information on the regional consumption of food to which hydramethylnon may be applied in a particular area. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for hydramethylnon 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 use pattern, physical characteristics and environmental fate of hydramethylnon. The Agency uses the FQPA Index Reservoir Screening Tool ( FIRST) or the Pesticide Root Zone Model/ Exposure Analysis Modeling System ( PRZM/ EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The screening concentation in ground water ( SCI GROW) model is used to predict pesticide concentrations in shallow groundwater. For a screening level assessment for surface water EPA will use FIRST ( a tier 1 VerDate jul< 14> 2003 15: 39 Aug 12, 2003 Jkt 200001 PO 00000 Frm 00057 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 13AUR1. SGM 13AUR1 48308 Federal Register / Vol. 68, No. 156 / Wednesday, August 13, 2003 / Rules and Regulations 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 and an index reservoir with the percent crop area adjustment. 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 and transformation of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide an initial 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 of reference dose or percent of population adusted dose (% RfD or % 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 hydramethylnon they are further discussed in the aggregate risk sections in Unit III. E. Based on the FIRST and SCI GROW models the EECs of hydramethylnon for acute exposures are estimated to be 76.09 parts per billion ( ppb) for surface water and 0.035 ppb for ground water. The EECs for chronic exposures are estimated to be 1.45 ppb for surface water and 0.035 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). Hydramethylnon is currently registered for use on the following residential non dietary sites: Hydramethylnon is used as a bait in child resistant packaging ( CRP) and as a gel bait to control ants and roaches indoors, and as a granular formulation to control ants in yards and on lawns. It is also applied by pest control operators ( PCOs) in the same forms for indoor and outdoor pest control. The risk assessment was conducted using the following residential exposure assumptions: The Agency has completed a non dietary exposure and risk assessment for hydramethylnon including the following uses: residential consumers applying granular and gel formulations; children and adults contacting recreational turf or residential lawns treated with hydramethylnon; and toddlers' incidental nondietary ingestion of products applied around the home. Non occupational handler exposures from the granular formulations applied to outdoor residential sites are assumed to be short term in duration, based on rapid dissipation and insect foraging. No chemical specific data were submitted for the registration of hydramethylnon uses. Per an Agency policy, non occupational handler assessments are based on surrogate unit exposures from the draft Standard Operating Procedures ( SOPs) for Residential Exposure Assessments ( 12/ 18/ 97) and recommended approaches by the Agency's Exposure Science Advisory Committee ( ExpoSAC). Updates to the Residential SOPs ( 02/ 01) alter the residential postapplication scenario assumptions. These updated assumptions are expected to better represent residential exposure and are still considered to be high end, screening level assumptions. The nonoccupational handler assessments for push type granular spreaders were based on surrogate unit exposures from two Outdoor Residential Exposure Task Force ( ORETF) studies. The ant bait stations containing hydramethylnon are in child resistant packaging ( CRP). The bait stations are supposed to be placed in less accessible locations such as in or under kitchen counters. However, handling or mouthing of the bait stations is the most commonly reported incidental `` exposure'' to hydramethylnon. Such exposures involve, at most, children mouthing the bait container with little or no contact with the actual bait. In the absence of an applicable acute dietary endpoint, and with the vast majority of incident data resulting in little or no health effects, no quantitative assessment of accidental exposure to the internal contents of bait stations was conducted. The gel product containing hydramethylnon is supposed to be applied in dime sized portions in locations inaccessible to children. Accidental ingestion of gel from such application is considered unlikely and was therefore not assessed. Adult consumer exposures when installing and removing bait stations are expected to be minimal. Consumer exposure when applying the gel compound from a syringe is considered negligible. Limited accessibility ( i. e., crack, crevice, behind appliances, in crawl spaces) of the gel and granular formulations when used by professional applicators in the home make it unlikely that residents would be exposed to these formulations indoors. For the proposed application of granules to outdoor residential sites, dermal MOEs calculated for non occupational handlers were 10,000 or greater. Dermal postapplication exposure from lawns treated with hydramethylnon granules at the maximum application rate of 2.2 lb product per acre ( 0.022 lb ai/ A) were estimated using standard assumptions, as no chemical specific residue data were available. For adults and children playing actively for two hours on a just treated lawn, the estimated MOEs were 41,000 and 24,000, respectively. The aggregate ( dermal, hand mouth and object mouth) MOE for a 15 kg child playing on a lawn was 4,000. The MOE for incidental ingestion of 3 mg of 1% hydramethylnon granules found on the surface of the lawn was 850. The hydramethylnon granules are formulated as small granules to allow for ant removal, and are therefore not easily noticed by a child, and ingestion is unlikely. 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 hydramethylnon 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, hydramethylnon 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 hydramethylnon 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).

VerDate jul< 14> 2003 15: 39 Aug 12, 2003 Jkt 200001 PO 00000 Frm 00058 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 13AUR1. SGM 13AUR1 48309 Federal Register / Vol. 68, No. 156 / Wednesday, August 13, 2003 / Rules and Regulations 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. The Agency has concluded that there is no concern for pre and/ or postnatal toxicity resulting from exposure to hydramethylnon. 3. Conclusion. There is a complete toxicity data base for hydramethylnon and exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. The Agency determined that no special FQPA Safety Factor is needed ( 1x) for hydramethylnon. The exposure databases ( dietary food, drinking water, and residential) are complete and the risk assessment for each potential exposure scenario includes all metabolites and/ or degradates of concern and does not underestimate the potential risk for 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 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 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 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 hydramethylnon will occupy < 1% of the aPAD for females 13 years and older. In addition, there is potential for acute dietary exposure to hydramethylnon 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 the following Table 3:

TABLE 3.   AGGREGATE RISK ASSESSMENT FOR ACUTE EXPOSURE TO HYDRAMETHYLNON.

Population Subgroup aPAD ( mg/ kg) % aPAD ( Food) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Acute DWLOC ( ppb)

Females ( 13   49 years old) 0.05 < 1 76.09 0.035 1,500 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to hydramethylnon from food will utilize < 1% of the cPAD for the U. S. population, and < 1% ( 0.02%) of the cPAD for children 1   2 years old. Based on the use pattern, chronic residential exposure to residues of hydramethylnon is not expected. In addition, there is potential for chronic dietary exposure to hydramethylnon 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 4:

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

U. S. Population 0.017 0.000005 1.45 0.035 600 All infants (< 1 year old) 0.017 0.000012 1.45 0.035 170 Children ( 1   2 years old) 0.017 0.000026 1.45 0.035 170 Children ( 3   5 years old) 0.017 0.000016 1.45 0.035 170 VerDate jul< 14> 2003 15: 39 Aug 12, 2003 Jkt 200001 PO 00000 Frm 00059 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 13AUR1. SGM 13AUR1 48310 Federal Register / Vol. 68, No. 156 / Wednesday, August 13, 2003 / Rules and Regulations TABLE 4.   AGGREGATE RISK ASSESSMENT FOR CHRONIC ( NON CANCER) EXPOSURE TO HYDRAMETHYLNON   Continued Population Subgroup cPAD mg/ kg/ day Chronic Food Exposure ( mg/ kg/ day) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Chronic DWLOC ( ppb)

Children ( 6   12 years old) 0.017 0.000008 1.45 0.035 170 Youth ( 13   19 years old) 0.017 0.000002 1.45 0.035 170 Adults ( 20   49 years old) 0.017 0.000003 1.45 0.035 600 Females ( 13   49 years old) 0.017 0.000004 1.45 0.035 510 Adults ( 50+ years old) 0.017 0.000002 1.45 0.035 600 3. Short term risk. Short term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Hydramethylnon 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 hydramethylnon. 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 exposures for both adults ( MOE = 8,000; handler and post application) and children ( MOE = 680; post application). Therefore, the turf treatment exposure estimates were aggregated with the chronic dietary ( food) to provide a worst case estimate of short term aggregate risk for the U. S. population and children 1   2 years old ( the child population subgroup with the highest estimated average ( chronic) dietary food exposure). 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 hydramethylnon 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 the following Table 5:

TABLE 5.   AGGREGATE RISK ASSESSMENT FOR SHORT TERM EXPOSURE TO HYDRAMETHYLNON Population Subgroup Aggregate MOE ( Food + Residential Aggregate Level of Concern ( LOC) Surface Water EEC ( ppb) Ground Water EEC ( ppb) Short Term DWLOC ( ppb)

US Population 7,700 100 76.09 0.035 580 Children 1   2 years old 3,300 100 76.09 0.035 165 4. Intermediate term risk. Intermediate term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Though residential exposure could occur with the use of hydramethylnon, an intermediate term aggregate risk assessment was not performed because it is based on the same toxic endpoint and dose as the short term, and the higher exposure used in the short term assessment represents a worse case. 5. Aggregate cancer risk for U. S. population. A separate cancer aggregate risk assessment was not performed because the Reference Dose approach was recommended for quantification of human risk. Cancer risks are adequately addressed by the chronic aggregate and assessment which used the chronic reference dose ( cRfD). 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 hydramethylnon residues.

IV. Other Considerations A. Analytical Enforcement Methodology The method presented by BASF Corporation and designated M 2458, is the predecessor to method M 2458.01 for which BASF Corporation has submitted as an independent method validation. The updated method corrects some typographical errors and clarifies some of the fractionation steps. Adequate enforcement methodology ( example   gas chromatography) 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; e mail address: residuemethods@ epa. gov. B. International Residue Limits No maximum residue limits for hydramethylnon in/ on pineapple have been established or proposed by Codex, Canada, or Mexico for any agricultural commodity; therefore, no compatibility concerns exist with respect to U. S. tolerances.

C. Conditions The following studies are required to further characterize the environmental effects of hydramethylnon: Estuarine/ marine fish LC50 ( 72   1), Estuarine/ marine invertebrate EC50 ( 72   2), and Sediment Toxicity Testing ( Harmonized guidelines 850.1735 and 850.1740). In addition, the following studies are required for any future expansion of hydramethylnon uses: Aquatic Photodegradation ( 161   2), Aerobic Aquatic Metabolism ( 162   4), and Terrestrial Field Dissipation ( 164   1).

VerDate jul< 14> 2003 15: 39 Aug 12, 2003 Jkt 200001 PO 00000 Frm 00060 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 13AUR1. SGM 13AUR1 48311 Federal Register / Vol. 68, No. 156 / Wednesday, August 13, 2003 / Rules and Regulations D. Recommendation for Tolerances The residue chemistry and toxicological databases support the requested tolerance of 0.05 ppm for hydramethylnon on pineapple. The Agency has also previously recommended that the grass ( pasture and rangeland) tolerance be increased to 2.0 ppm and the grass hay ( pasture and rangeland) tolerance be increased to 0.1 ppm ( Hydramethylnon RED, EPA 738   R   98   023, 12/ 98).

V. Conclusion Therefore, the tolerance is established for residues of hydramethylnon, in or on pineapple at 0.05 ppm., and revised for grass ( pasture and rangeland) at 2.0 ppm, and grass hay ( pasture and rangeland) at 0.1 ppm respectively.

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   0251 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 October 14, 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   0251, 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 VerDate jul< 14> 2003 15: 39 Aug 12, 2003 Jkt 200001 PO 00000 Frm 00061 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 13AUR1. SGM 13AUR1 48312 Federal Register / Vol. 68, No. 156 / Wednesday, August 13, 2003 / Rules and Regulations 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: July 31, 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 180.395 is amended by adding alphabetically the commodity `` pineapple'' to the table in paragraph ( a) to read as follows: § 180.395 Hydramethylnon; tolerances for residues.

( a) * * *

Commodity Parts per million * * * * * Pineapple .............................. 0.05 * * * * *

[ FR Doc. 03   20432 Filed 8   12   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0134; FRL   7320   5]

Diallyl Sulfides; Exemption from the Requirement of a Tolerance; Correction AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule; correction.

SUMMARY: EPA issued a final rule in the Federal Register of July 9, 2003, establishing an exemption from the requirement of a tolerance for residues of diallyl sulfides ( DADs) in/ or garlic, leeks, onions, and shallots. This document corrects a typographical error in the preamble that appeared in that document.

DATES: This document is effective on August 13, 2003.

FOR FURTHER INFORMATION CONTACT: Driss Benmhend, Biopesticides and Pollution Prevention Division ( 7511C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   9525; e mail address: benmhend@ epa. gov.

SUPPLEMENTARY INFORMATION:

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

The Agency included in the final rule a list of those who may be potentially affected by this action. If you have 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   0134. The official public VerDate jul< 14> 2003 15: 39 Aug 12, 2003 Jkt 200001 PO 00000 Frm 00062 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 13AUR1. SGM 13AUR1


[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33851-33852]
[FR Doc No: 2013-13243]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0596]

Lung Cancer Patient-Focused Drug Development; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting and an opportunity for public comment on Patient-Focused Drug
Development for lung cancer. Patient-Focused Drug Development is part
of FDA's performance commitments made as part of the fifth
authorization of the Prescription Drug User Fee Act (PDUFA V). The
public meeting is intended to allow FDA to obtain patients'
perspectives on the impact of lung cancer on daily life as well as the
available therapies for lung cancer.

DATES: The public meeting will be held on June 28, 2013, from 8:30 a.m.
to 12:30 p.m. Registration to attend the meeting must be received by
June 19, 2013 (see SUPPLEMENTARY INFORMATION for instructions). Submit
electronic or written comments by July 29, 2013.

ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting
participants is through Building 1, where routine security checks will
be performed. For parking and security information, please refer to
http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    Submit electronic comments to www.regulations.gov. Submit written
comments to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All
comments should be identified with the docket number found in brackets
in the heading of this document.
    FDA will post the complete agenda and additional meeting background
material approximately 5 days before the meeting at http://www.fda.gov/Forindustry/UserFees/PrescriptionDrugUserFee/ucm353273.htm.

FOR FURTHER INFORMATION CONTACT: Graham Thompson, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1199, Silver Spring, MD 20993, 301-796-
0684, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected lung cancer to be the focus of a public meeting
under Patient-Focused Drug Development, an initiative that involves
obtaining a better understanding of patients' perspectives on the
severity of the disease and the available therapies for the condition.
Patient-Focused Drug Development is being conducted to fulfill FDA
performance commitments made as part of the reauthorization of PDUFA V
under Title I of the Food and Drug Safety and Innovation Act (FDASIA)
(Pub. L. 112-144). The full set of performance commitments is available
on the FDA Web site at http://www.fda.gov/downloads/ForIndustry/UserFees/PrescriptionDrugUserFee/UCM270412.pdf.
    FDA has committed to obtaining the patient perspective in 20
disease areas during the course of PDUFA V. For each disease area, the
Agency will conduct a public meeting to discuss the disease and its
impact on patients' daily lives, the types of treatment benefit that
matter most to patients, and patients' perspectives on the adequacy of
the available therapies. These meetings will include participation of
FDA review divisions, the relevant patient community, and other
interested stakeholders.
    On April 11, 2013, FDA published a document (78 FR 21613) in the
Federal Register that announced the disease areas for meetings in
fiscal years (FY) 2013 to 2015, the first 3 years of the 5-year PDUFA V
timeframe. The Agency used several criteria outlined in the April 11,
2013, document to develop the list of disease areas. Public comment on
the Agency's proposed criteria and potential disease areas was gathered
through a Federal Register document for public comment that was
published on September 24, 2012 (77 FR 58849), and a public meeting
that was convened on October 25, 2012. In selecting the set of disease
areas, FDA carefully considered the public comments received and the
perspectives of review divisions at FDA. By the end of FY 2015, FDA
will initiate a public process for determining the disease areas for FY
2016 and 2017. More information, including the list of disease areas
and a general schedule of meetings, is posted on FDA's Web site at
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Public Meeting Information

A. Purpose and Scope of the Meeting

    As part of Patient-Focused Drug Development, FDA will gather
patient and patient stakeholder input on symptoms of lung cancer that
matter most to patients and on current approaches to treating lung
cancer. Lung cancer is a disease caused by uncontrolled growth of
abnormal cells in the tissues of the lung, usually in the cells lining
air passages. Lung cancer cells can spread (metastasize) to almost

any other part of the body, such as to the brain or to bones. Available
therapies for management of lung cancer falls into two main categories:
therapies to reduce or control the spread of disease (including
surgery, radiation therapy, conventional chemotherapy, and targeted
therapies), and supportive care therapies to improve or manage symptoms
of the underlying condition (lung cancer) or the side effects of cancer
treatments. FDA is interested in patients' perspectives for the two
main types of lung cancer (small-cell and non-small cell lung cancer)
on the importance of disease symptoms, benefits of treatment
approaches, and possible cancer treatment side effects.
    The draft questions that will be asked of patients and patient
stakeholders at the meeting are provided in the paragraphs that follow.
For each of these topics, a brief initial patient panel discussion will
begin the dialogue and will be followed by a facilitated discussion
inviting comments from other patient and patient stakeholder
participants. In addition to input generated through this public
meeting, FDA is interested in receiving patient input addressing these
questions through the public docket (see ADDRESSES).
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
    1. For context, how long ago was your diagnosis of lung cancer? Is
your cancer currently in only one area of the lung or has it spread to
other parts of the lung or outside of the lungs?
    2. Of all the symptoms that you experience because of your lung
cancer, which one to three symptoms have the most significant impact on
your daily life? (Examples may include pain, cough, shortness of
breath, fatigue, voice hoarseness.)
    3. Are there specific activities that are important to you but that
you cannot do at all, or as fully as you would like, because of lung
cancer? (Examples may include sleeping through the night, climbing
stairs, household activities.)
Topic 2: Patients' Perspectives on Current Approaches To Treating Lung
Cancer
    1. Are you currently undergoing any cancer treatments to help
reduce or control the spread of your lung cancer? Please describe.
    1.1 What do you consider to be the most significant downsides of
these treatments? (Examples of downsides may include side effects,
going to the hospital for treatment, frequent blood tests, etc.)
    1.2 How do these downsides affect your daily life?
    2. What supportive care treatments, if any, are you taking to help
improve or manage the symptoms you experience because of your lung
cancer? Please include any prescription medicines, over-the-counter
products, and other therapies including non-drug therapies (such as
breathing techniques).
    2.1 What specific symptoms do your treatments address?
    2.2 How well do these treatments manage these symptoms?
    2.3 Are there symptoms that your current treatment regimen does not
address at all, or does not treat as well as you would like?
    3. When thinking about your overall goals for treatment, how do you
weigh the importance of prolonging your life versus improving the
symptoms you experience because of your lung cancer?
    4. What factors do you take into account when making decisions
about using treatments to help reduce or control the spread of your
lung cancer? In particular:
    4.1 What information on the potential benefits of these treatments
factors most into your decision? (Examples of potential benefits from
treatments may include shrinking the tumor, delaying the growth of the
tumor, prolonging life, etc.)
    4.2 How do you weigh the potential benefits of these treatments
versus the common side effects of the treatments? (Common side effects
could include nausea, loss of appetite fatigue, diarrhea, rash.)
    4.3 How do you weigh potential benefits of these treatments versus
the less common but serious risks associated with the treatments?
(Examples of less common but serious risks are developing a hole in the
stomach or intestine, liver failure, kidney failure, lung inflammation,
blood clot, stroke, heart attack, serious infections, etc.)

B. Attendance and/or Participation in the Meeting

    If you wish to attend this meeting, visit http://patientfocusedlungcancer.eventbrite.com. Please register by June 19,
2013. Those who are unable to attend the meeting in person can register
to view a live Web cast of the meeting. You will be asked to indicate
in your registration if you plan to attend in person or via the Web
cast. Your registration will also contain your complete contact
information, including name, title, affiliation, address, email
address, and phone number. Seating will be limited, so early
registration is recommended. Registration is free and will be on a
first-come, first-served basis. However, FDA may limit the number of
participants from each organization based on space limitations.
Registrants will receive confirmation once they have been accepted.
Onsite registration on the day of the meeting will be based on space
availability. If you need special accommodations because of disability,
please contact Graham Thompson (see FOR FURTHER INFORMATION CONTACT) at
least 7 days before the meeting. More information will be posted on the
meeting Web site at least 5 days before the meeting date.
    Patients who are interested in presenting comments as part of the
initial panel discussions should indicate in their registration which
topic(s) they wish to address. They will be asked to send a brief
summary of responses to the topic(s) questions via email to
<EMAIL_ADDRESS>Panelists will be notified of their
selection soon after the close of registration on June 19, 2013. FDA
will try to accommodate all patients and patient advocate participants
who wish to speak, either through the panel discussion or audience
participation; however, the duration of comments may be limited by time
constraints.
    Interested members of the public, including those who attend the
meeting in person or through the Web cast, are invited to provide
electronic or written responses to any or all of the questions
pertaining to Topics 1 and 2 to the Division of Dockets Management (see
ADDRESSES). Comments may be submitted until July 29, 2013.

    Dated: May 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13243 Filed 6-4-13; 8:45 am]
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[Federal Register Volume 79, Number 179 (Tuesday, September 16, 2014)]
[Proposed Rules]
[Page 55412]
[FR Doc No: 2014-21973]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 51 and 52

[EPA-HQ-OAR-2006-0605; FRL-9916-63-OAR]
RIN 2060-AO24

Prevention of Significant Deterioration (PSD) for Particulate
Matter Less Than 2.5 Micrometers (PM2.5)--Increments, Significant
Impact Levels (SILs) and Significant Monitoring Concentration (SMC)--
Notice of Action Denying Petition for Reconsideration and Amended
Rulemaking

AGENCY: Environmental Protection Agency (EPA).

ACTION: Action denying petition for reconsideration and amended
rulemaking.

-----------------------------------------------------------------------

SUMMARY: The Environmental Protection Agency (EPA) is providing notice
that it has responded to a petition for reconsideration and amended
rulemaking of certain provisions of the final rule, ``Prevention of
Significant Deterioration (PSD) for Particulate Matter Less Than 2.5
Micrometers (PM2.5)--Increments, Significant Impact Levels
(SILs) and Significant Monitoring Concentration (SMC),'' published on
October 20, 2010. The final rule set forth provisions identifying the
maximum allowable increases in ambient pollutant concentrations
(``increments'') for PM2.5, modifying the definitions for
the baseline dates and the baseline area, and adding two screening
tools known as SILs and an SMC for PM2.5. On December 23,
2013, the EPA received a petition for reconsideration pursuant to the
Clean Air Act (CAA) and for an amended rulemaking pursuant to the
Administrative Procedures Act, from the state of North Carolina. The
EPA considered the petition for reconsideration and amended rulemaking,
along with information contained in the rulemaking docket, in reaching
a decision on the petition. The EPA Administrator Gina McCarthy denied
the petition for reconsideration and amended rulemaking in a letter to
the Attorney General of North Carolina dated August 28, 2014. The
letter documents the EPA's reasons for the denial and can be found in
the rulemaking docket.

DATES: The EPA's response to this petition was signed on August. 28,
2014. Any petitions for review of the final letter denying the petition
for reconsideration and amended rulemaking of certain provisions of the
final rule published in the Federal Register on October 20, 2010 (75 FR
64864) must be filed in the Court of Appeal for the District of
Columbia Circuit on or before November 17, 2014.

FOR FURTHER INFORMATION CONTACT: Mr. Dan deRoeck, Air Quality Policy
Division (C504-03), U.S. Environmental Protection Agency, Research
Triangle Park, NC, 27711; telephone number:<PHONE_NUMBER>; or email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. How can I get copies of this document and other related information?

    This Federal Register document, the petition for reconsideration
and amended rulemaking, and the letter denying the petition are
available in the docket that the EPA has established for the
``Prevention of Significant Deterioration (PSD) for Particulate Matter
Less Than 2.5 Micrometers (PM2.5)--Increments, Significant
Impact Levels (SILs) and Significant Monitoring Concentration (SMC)''
rulemaking under Docket ID No. EPA-HQ-OAR-2006-0605. The table below
identifies the petitioner, the date of the petition, the document
identification number for the petition, the date of the EPA's response,
and the document identification number for the EPA's response.

----------------------------------------------------------------------------------------------------------------
                                                         Petition:
             Petitioner                  Date of        Document No.     Date of EPA     EPA response: Document
                                     petition to EPA     in docket         response           No. in docket
----------------------------------------------------------------------------------------------------------------
State of North Carolina............      12/23/2013            -0065        8/28/2014       -0066, -0067, -0068
----------------------------------------------------------------------------------------------------------------

    Note that all document numbers listed in the table are in the form
of ``EPA-HQ-OAR-2006-0605-xxxx.
    All documents in the docket are listed on the http://www.regulations.gov Web site. Although listed in the index, some
information may not be publicly available, i.e., confidential business
information or other information whose disclosure is restricted by
statute. Certain other material, such as copyrighted material, is not
placed on the Internet and will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically through http://www.regulations.gov or in hard copy at
the EPA Docket Center, Docket ID No. EPA-HQ-OAR-2006-0605, EPA William
Jefferson Clinton West Building, Room 3334, 1301 Constitution Ave. NW.,
Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number for the Public Reading Room is<PHONE_NUMBER>, and the telephone
number for the EPA Docket Center is<PHONE_NUMBER>.
    In addition to being available in the docket, an electronic copy of
this notice of the EPA's decision denying the petition for
reconsideration and amended rulemaking and of the EPA's response letter
outlining reasons for the denial will also be available on the World
Wide Web. Following signature of this document by the Acting Assistant
Administrator, Office of Air and Radiation, a copy of this document
will be posted on EPA's New Source Review Web site, under Regulations &
Standards, at http://www.epa.gov/nsr.

II. Judicial Review

    Under CAA section 307(b), judicial review of this final action is
available only by filing a petition for review in the U.S. Court of
Appeals for the District of Columbia Circuit on or before November 17,
2014.

    Dated: September 5, 2014.
Janet G. McCabe,
Acting Assistant Administrator for Air and Radiation.
[FR Doc. 2014-21973 Filed 9-15-14; 8:45 am]
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