55519 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations 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: September 10, 2003. Debra Edwards, Director, Registration Division, Office of Pesticide Programs.

 Therefore, 40 CFR part 180 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 180.553 is amended as follows: a. By revising the commodities plum, prune, dried and plum, prune, fresh in the table in paragraph ( a). b. By removing the commodity fruit, stone, except plum, prune, fresh in the table in paragraph ( a). c. By alphabetically adding commodities in the table in paragraph ( a).

§ 180.553 Fenhexamid; tolerances for residues.

( a) * * *

Commodity Parts per million * * * * *

Cucumber 2.0 Fruit, stone, group 12, except plum, prune, fresh, postharvest 10.0 * * * * *

Kiwifruit, postharvest 15.0 * * * * *

Leafy greens, subgroup 4A, except spinach 30.0 * * * * *

Plum, prune, dried 2.5 Plum, prune, fresh 1.5 * * * * *

Vegetable, fruiting, group 8, except nonbell pepper 2.0 * * * * *

[ FR Doc. 03   24013 Filed 9   25   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2003   0146; FRL   7320   8]

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

SUMMARY: This regulation establishes a tolerance for residues of chlorfenapyr [ 4 bromo 2( 4 chlorophenyl) 1 ( ethoxymethyl) 5( trifluoromethyl) 1Hpyrrole 3 carbonitrile] in or on vegetables, fruiting, group 8. BASF Agro Research, now BASF Corporation 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 September 26, 2003. Objections and requests for hearings, identified by docket ID number OPP   2003   0146, must be received on or before November 25, 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: Ann Sibold, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 305   6502; e mail address: sibold. ann@ epa. gov.

SUPPLEMENTARY INFORMATION:

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

You may be potentially affected by this action if you grow fruiting vegetables in commercial greenhouses, consume vegetables that were raised in commercial greenhouses, or provide pest control services to commercial greenhouses. Potentially affected entities may include, but are not limited to:   Crop production ( NAICS 111)   Pesticide manufacturing ( NAICS 32532)   Other food crops grown under cover ( NAICS 111419)   Entomological services, agricultural; insect control for crops ( NAICS 115112)   Agricultural production or harvesting crews ( NAICS 115115) This listing is not intended to be exhaustive, but rather provides a guide VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00087 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55520 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations 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   0146. 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 September 13, 2000 ( 65 FR 55236) ( FRL   6742   3), 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 an amended pesticide petition ( PP 6F4716) by BASF Agro Research, now BASF Corporation, P. O. Box 400, Princeton, NJ 08543   0400, now P. O. Box 13528, Research Triangle Park, NC 27709   3528. ( The original pesticide petition PP 6F4716 was filed by American Cyanamid ( now BASF Agro Research) in 1996). The 2000 notice included a summary of the petition prepared by BASF Agro Research, the registrant. There were no comments received in response to the notice of filing. The petition requested that 40 CFR 180.513 be amended by establishing a tolerance for residues of the insecticide chlorfenapyr, [ 4 bromo 2( 4 chlorophenyl) 1( ethoxymethyl) 5 ( trifluoromethyl) 1H pyrrole 3 carbonitrile], in or on vegetables, fruiting, group 8 at 1.0 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 chlorfenapyr on vegetables, fruiting, group 8 at 1.0 ppm. EPA's assessment of exposures and risks associated with establishing the tolerance follows.

A. Toxicological Profile EPA has evaluated the available toxicity data and considered its validity, completeness, and reliability as well as the relationship of the results of the studies to human risk. EPA has also considered available information concerning the variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by chlorfenapyr 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 jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00088 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55521 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline No. Study Type MRID No. ( year)/ Classification Doses Results 870.3100 90   Day oral toxicity rats 42770219 ( 1993) Acceptable/ guideline 0, 150, 300, 600, 900, 1,200 ppm 0, 11.7, 24.1, 48.4, 72.5, 94.5 mg/ kg/ day NOAEL = 24.1 mg/ kg/ day LOAEL = 48.4, based on spongiform myelopathy in the brain and spinal cord of male rats, decreased body weight gain and increased relative liver weight in males and females, increased absolute liver weight in females, and decreased hemoglobin in females 870.3100 90   Day oral toxicity mouse 43492830 ( 1994) Acceptable/ guideline 0, 40, 80, 160, 320 M: 0, 7.1, 14.8, 27.6, 62.6 mg/ kg/ day F: 0, 9.2, 19.3, 40, 78 mg/ kg/ day NOAEL = 27.6/ 40, M/ F LOAEL = 62.6/ 78, M/ F, based on reduced body weights/ body weight gains, and spongiform encephalopathy in both sexes 870.3150 90   Day oral toxicity dog 42770220 ( 1993) Acceptable/ guideline 0, 60, 120,  247* ppm M: 0, 2.1, 3.9, 6.7 mg/ kg/ day F: 0, 2.2, 4.5, 6.8 mg/ kg/ day * High dose animals received 300 ppm during days 1   15, 240 ppm during days 15   25, and 200 ppm during days 25   93 NOAEL = 3.9/ 4.5 mg/ kg/ day, M/ F LOAEL = 6.7/ 6.8 mg/ kg/ day, M/ F, based on emaciation, decreased body weight gains, and decreased food efficiency 870.3200 21/ 28   Day dermal toxicity rabbit 43492831 ( 1993) Unacceptable/ guideline due to incomplete histopathological examination 0, 100, 400, 1,000 mg/ kg/ day NOAEL = 100 mg/ kg/ day LOAEL = 400 mg/ kg/ day, for both sexes, based on changes in liver chemistry and morphology 870.3700 Prenatal developmental rat 42884202 ( 1993) Acceptable/ guideline 0, 25, 75, 225 mg/ kg/ day Maternal NOAEL = 25 mg/ kg/ day Maternal LOAEL = 75 mg/ kg/ day, based on decreased body weight gain and relative food consumption during treatment Developmental NOAEL   225 mg/ kg/ day Developmental LOAEL = not identified 870.3700 Prenatal developmental rabbit 42770222 ( 1993) Acceptable/ guideline 0, 5, 15, 30 mg/ kg/ day Maternal NOAEL = 5 mg/ kg/ day Maternal LOAEL = 15 mg/ kg/ day, based on decreased body weight gain during treatment Developmental NOAEL = 15 mg/ kg/ day Developmental LOAEL = 30 mg/ kg/ day, based on increased post implantation loss 870.3800 2   Generation reproduction and fertility effects rat 43492836 ( 1994) Acceptable/ guideline 0, 60, 300, 600 ppm Premating doses for P1 males/ females: 0/ 0, 4.5/ 5.0, 22.2/ 24.5, 44/ 44.6 mg/ kg/ day Premating doses for F1 males/ females: 0/ 0, 4.4/ 5.1, 22.5/ 25.6, 44.6/ 50.7 mg/ kg/ day Parental systemic NOAEL = 4.4   4.5 mg/ kg/ day, M Parental systemic LOAEL = 22.2   22.5 mg/ kg/ day, M, based on decreased absolute body weight/ body weight gains of P1 males during premating Offspring systemic NOAEL = 4.4   5.1 mg/ kg/ day Offspring systemic LOAEL = 22.2   25.6 mg/ kg/ day, based on decreased pup weights at weaning Reproductive NOAEL   44   50.7 mg/ kg/ day Reproductive LOAEL: not identified VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00089 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55522 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY   Continued Guideline No. Study Type MRID No. ( year)/ Classification Doses Results 870.4100 Chronic toxicity dog 43492834 ( 1994) Acceptable/ guideline 0, 60, 120, 240 ppm M: 0, 2.1, 4.0, 8.7 mg/ kg/ day F: 0, 2.3, 4.5, 10.1 mg/ kg/ day NOAEL = 4.0/ 4.5 mg/ kg/ day, M/ F LOAEL = 8.7/ 10.1 mg/ kg/ day, M/ F, based on decreased body weight/ body weight gains 870.4200 Carcinogenicity mouse 43492838 ( 1994) Acceptable/ guideline 0, 20, 120, 240 ppm M: 0, 2.8, 16.6, 34.5 mg/ kg/ day F: 0, 3.7, 21.9, 44.5 mg/ kg/ day NOAEL = 2.8/ 3.7 mg/ kg/ day, M/ F LOAEL = 16.6/ 21.9 mg/ kg/ day, M/ F, based on decreased body weight gains, brain vacuolation, and scabbing of the skin ( males) No evidence of carcinogenicity 870.4300 Combined chronic/ carcinogenicity in rat 43492837 ( 1994) Acceptable/ guideline 0, 60, 300, 600 ppm M: 0, 2.9, 15.0, 30.8 mg/ kg/ day F: 0, 3.6, 18.6, 37 mg/ kg/ day NOAEL = 15 mg/ kg/ day, males LOAEL = 30.8 mg/ kg/ day, males, based on anemia NOAEL = 3.6 mg/ kg/ day, females LOAEL = 18.6 mg/ kg/ day, females, based on decreased body weight/ body weight gain Classification: `` Suggestive Evidence of Carcinogenicity, but Not Sufficient to Assess Human Carcinogenic Potential based on significant trends in liver tumors ( adenomas and combined adenomas/ carcinomas), malignant histiocytic sarcomas, and testicular cell tumors in male rats and uterine polyps in female rats seen at the highest dose 870.5100 Bacterial reverse mutation 42770223 ( 1993) Acceptable/ Guideline Negative for reverse mutation in S. typhimurium strains TA 98, TA 100, TA 1535, TA 1537, TA 1538 and E. coli strain WP2 uvrA exposed up to cytotoxicity ( 50 µ g/ plate, +/ S9)

870.5300 In vitro mammalian cell gene mutation in Chinese hamster ovary cells ( CHO/ HGPRT) 42770224, 43187601 ( 1993) Acceptable/ Guideline Independently performed tests were negative up to a cytotoxic and precipitating concentration ( 500 µ g/ ml) in the presence of S9 activation or the solubility limit ( 250 µ g/ ml) without S9 activation 870.5375 In vitro mammalian chromosome aberration ( CHO) 43492843 ( 1994) Acceptable The test was negative up to 100 µ g/ ml  S9 or 25 µ g/ ml + S9; higher doses with or without S9 activation were cytotoxic 870.5385 In vitro chromosome aberration assay in Chinese hamster lung ( CHL) cells 43492839 ( 1994) Acceptable/ Guideline The test was negative up to a precipitating level without S9 activation ( 225 µ g/ ml) or a concentration range of 3.5   14.1 µ g/ ml + S9. Higher S9 activated doses (  28 µ g/ ml) were cytotoxic 870.5395 Mammalian micronucleus ( mouse) 42770225, 43187602 ( 1993, 1994) Acceptable/ Guideline The test was negative in mice administered single oral gavage doses of 7.5   30 mg/ kg ( males) or 5   20 mg/ kg ( females Clinical toxicity ( deaths in males and diarrhea in females) was seen at the HDT. There was, however, no evidence of cytotoxicity for the target organ 870.5550 Unscheduled DNA synthesis 42770226 ( 1993) Acceptable/ Guideline Negative for inducing unscheduled DNA synthesis in primary rat hepatocyte cultures exposed up to severely toxic concentrations (  30 µ g/ ml)

870.6200 Acute neurotoxicity screening battery rat 43492829 ( 1994) Acceptable/ guideline 0, 45, 90, 180 mg/ kg NOAEL = 45 mg/ kg/ day LOAEL = 90 mg/ kg/ day, based on lethargy in male rats on the day of treatment 870.6200 Chronic neurotoxicity rat 43492833 ( 1994) Acceptable/ Guideline 0, 60, 300, 600 ppm M: 0, 2.6, 13.6, 28.2 mg/ kg/ day F: 0, 3.4, 18, 37.4 mg/ kg/ day NOAEL = 2.6/ 3.4 mg/ kg/ day, M/ F LOAEL = 13.6/ 18 mg/ kg/ day, M/ F, based on the presence of myelinopathic alterations in the central nervous system ( CNS) in male rats and decreased average body weights/ body weight gains, food efficiency, absolute food consumption ( females) and water consumption ( males)

VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00090 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55523 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations TABLE 1.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY   Continued Guideline No. Study Type MRID No. ( year)/ Classification Doses Results 870.7485 Metabolism and pharmacokinetics rat 43492844 ( 1994) Acceptable/ guideline 20, 200 mg/ kg/ day Low recoveries of the radioactive dose in urine and tissues indicate limited absorption of CL 303,630 ( chlorfenapyr) by rats. The radioactivity in urine, as a percent of administered dose, from the high dosed rats was about half that from the single and multiple low dosed rats. More than 80% of the doses were eliminated in the feces. Most of the radioactivity was eliminated in the feces and urine within 48 hours of dosing. After 7 days, 89   121% of the dosed radioactivity was recovered. At sacrifice, female rats had greater ( about twice) recovery of radioactivity in the carcass, blood, and fat at all doses than did males. The highest recovery of radioactivity from a single organ was from the liver ( 0.15   0.48% of dose) Metabolite and parent compound accounted for 72   91% of the radioactive doses. Parent compound was the major radioactive component found in excreta, accounting for approximately 40   70% of the administered doses. Minor amounts of eight primary and conjugated metabolites and four unidentified isolated components were detected each at less than 10% of the dosed radioactivity. Liver and kidney contained several primary and conjugated metabolites and only minor levels of the parent compound (  8.3% of the radioactivity in the sample). Based on the metabolites identified, the major deposition route of orally administered chlorfenapyr is fecal excretion of unaltered parent compound. Other pathways include cleavage of the ethoxymethyl side chain, followed by de alkylation and ring hydroxylation, and some degree of conjugation of the de alkylated, ring hydroxylated metabolite. The two rings of the molecule are not cleaved. Metabolites are excreted primarily in urine; accumulation in tissues is minimal B. Toxicological Endpoints The dose at which 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 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. An additional safety factor ( SF) may be required if the data base is incomplete. For chlorfenapyr EPA concluded that a developmental neurotoxicity ( DNT) study is required based on the presence of neuropathology ( CNS lesions) and neurotoxic signs seen in adult rats ( males) and mice ( both sexes). EPA further concluded that a UF of 10X is required until the data are received and evaluated. EPA does not have sufficient reliable data justifying the selection of a factor lower than the default 10X value for the additional SF for the protection or infants and children for this data gap. 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 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. A summary of the toxicological endpoints for chlorfenapyr used for human risk assessment is shown in Table 2 of this unit:

TABLE 2.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CHLORFENAPYR FOR USE IN HUMAN RISK ASSESSMENT.

Exposure Scenario Dose Used in Risk Assessment UF Special FQPA SF* and LOC for Risk Assessment Study and Toxicological Effects Acute Dietary ( Females 13   50 years of age) NOAEL = 15 mg/ kg UF = 1,000 aRfD = 0.015 mg/ kg Special FQPA SF = 1X aPAD = aRfD ÷ FQPA SF = 0.015 mg/ kg Developmental toxicity study  rabbit LOAEL = 30 mg/ kg/ day based on increased post implantation loss VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00091 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55524 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations TABLE 2.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR CHLORFENAPYR FOR USE IN HUMAN RISK ASSESSMENT.   Continued Exposure Scenario Dose Used in Risk Assessment UF Special FQPA SF* and LOC for Risk Assessment Study and Toxicological Effects Acute Dietary ( General population including infants and children) NOAEL = 45 mg/ kg UF = 1,000 aRfD = 0.045 mg/ kg Special FQPA SF = 1X aPAD = aRfD ÷ FQPA SF = 0.045 mg/ kg Acute neurotoxicity study  rat LOAEL = 90 mg/ kg/ day based on lethargy in male rats Chronic Dietary ( All populations NOAEL= 2.6 mg/ kg/ day UF = 1,000 cRfD = 0.003 mg/ kg/ day Special FQPA SF = 1X cPAD = cRfD ÷ FQPA SF = 0.003 mg/ kg/ day Chronic neurotoxicity study  rat LOAEL = 13.6/ 18 mg/ kg/ day, M/ F, based on the presence of myelinopathic alterations in the CNS in male rats and decreased average body weights, body weigh gains, food efficiency, absolute food consumption ( F), and water consumption ( M) Supporting this endpoint are similar CNS lesions and skin lesions observed in the mouse carcinogenicity study ( NOAEL = 2.8)

* The reference to the special 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. Risk assessments were conducted by EPA to assess dietary exposures from chlorfenapyr 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. The Dietary Exposure Evaluation Model ( DEEM   ) analysis evaluated the individual food consumption as reported by respondents in the USDA 1994   1996 and 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 acute exposure assessments: Tolerance level residues ( not anticipated residues); 100% crop treated for all registered and proposed commodities; and default DEEM   Version 7.76 processing factors for all commodities. EPA selected separate acute dietary endpoints for females 13   50 years old and the general U. S. population ( including infants and children). Therefore, two separate acute dietary exposure assessments were performed for females 13   49 years old and for the general U. S. population and various population subgroups. These assessments conclude that the acute dietary exposure estimates are below EPA's LOC (< 100% aPAD) at the 95th exposure percentile for females 13   49 years old ( 15% aPAD), and the general U. S. population ( 6% of the aPAD) and all other population subgroups. The most highly exposed population subgroup ( other than females 13   49 years old) is children 1   2 years old, at 12% of the aPAD. ii. Chronic exposure. In conducting this chronic dietary risk assessment the DEEM   analysis evaluated the individual food consumption as reported by respondents in the USDA 1994   1996, and 1998 nationwide CSFII and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance level residues ( not anticipated residues); 100% crop treated for all registered and proposed commodities; and default DEEM   Version 7.76 processing factors for all commodities. An assessment of the general U. S. population and various population subgroups was conducted. This assessment concludes that the chronic dietary exposure estimates are below EPA's LOC (< 100% cPAD) for the general U. S. population ( 24% of the cPAD) and all population subgroups. The most highly exposed population subgroup is children 1   2 years old, at 47% of the cPAD. 2. Dietary exposure from drinking water. The registered uses of chlorfenapyr include: Termiticide use, crack and crevice use, and use on ornamental plants grown in greenhouses. The proposed use is for vegetable crops grown in greenhouses. When used according to label directions, these uses are not expected to result in contamination of drinking 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). Chlorfenapyr is registered for residential crack and crevice use and in ground termite use. EPA has addressed the issues of possible residential exposures to chlorfenapyr when used according to label directions, either as a termiticide or as a crack and crevice treatment. EPA concluded that there is essentially no incidental oral or dermal exposures. Further, the low vapor pressure of chlorfenapyr makes inhalation exposure negligible. 4. Cumulative effects from 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 chlorfenapyr has a common mechanism of toxicity with other substances. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to chlorfenapyr and any other substances and chlorfenapyr 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 chlorfenapyr has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00092 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55525 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the policy statements released by EPA's Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA's website at http:// www. epa. gov/ pesticides/ cumulative/.

D. Safety Factor for Infants and Children 1. In general. Section 408 of the FFDCA provides that EPA shall apply an additional tenfold margin of safety for infants and children in the case of threshold effects to account for prenatal and postnatal toxicity and the completeness of the data base on toxicity and exposure unless EPA determines that a different margin of safety will be safe for infants and children. Margins of safety are incorporated into EPA risk assessments either directly through use of a MOE analysis or through using uncertainty ( safety) factors in calculating a dose level that poses no appreciable risk to humans. 2. Prenatal and postnatal sensitivity. There is no evidence ( qualitative or quantitative) for increased susceptibility following in utero exposure in the developmental toxicity studies in rats and rabbits or prenatal/ postnatal exposure in the 2   generation reproduction study in rats. In both the rat and rabbit developmental toxicity studies maternal toxicity included decreased body weight gain. No developmental toxicity was noted in rats up to the highest dose tested of 225 mg/ kg/ day). Developmental toxicity in rabbits ( increased post implantation loss) occurred at a higher dose than maternal toxicity. In the 2   generation reproduction study in rats, parental and offspring toxicity included body weight decrements at similar doses. No reproductive effects were noted up to the highest dose tested. 3. Conclusion. EPA evaluated the potential for increased susceptibility of infants and children from exposure to chlorfenapyr. EPA concluded that the toxicology data base was incomplete for FQPA purposes because a required DNT has not been submitted. The DNT was required due to the presence of neuropathology ( central nervous system lesions) and neurotoxic signs seen in adult rats ( males) and mice ( both sexes). Other than lacking the DNT study, EPA identified no residual uncertainties for prenatal/ postnatal toxicity. This decision is based on the following:   There is no evidence ( qualitative or quantitative) of increased susceptibility of rat or rabbit fetuses to in utero exposure in developmental toxicity studies. There is no evidence ( qualitative or quantitative) of increased susceptibility of rat offspring in the multi generation reproduction toxicity study.   There are no concerns or residual uncertainties for prenatal and postnatal toxicity in the available developmental and 2   generation reproduction toxicity studies.   The conservative residue assumptions used in the dietary exposure risk assessments, and the completeness of the residue chemistry database. EPA concluded that a FQPA SF in the form of UFDB of 10X is required until the data from the DNT study are received and evaluated. EPA does not have sufficient reliable data justifying the selection of a factor lower than the default 10X value for this data gap.

E. Aggregate Risks and Determination of Safety.

1. Acute risk. Using the exposure assumptions discussed in this unit for acute exposure, the acute dietary exposure from food to chlorfenapyr will occupy 6% of the aPAD for the U. S. population, 15% of the aPAD for females 13 years and older, 12% of the aPAD for children 1   2 years old and 3% of the aPAD for infants < 1 year old. As explained in Unit III. C. 2., there is no potential for acute dietary exposure to chlorfenapyr in drinking water. EPA does not expect the aggregate exposure to exceed 100% of the aPAD. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to chlorfenapyr from food will utilize 24% of the cPAD for the U. S. population, 10% of the cPAD for infants < 1 year old and 47% of the cPAD for children 1   2 years old. Based on the use pattern, chronic residential exposure to residues of chlorfenapyr is not expected. There is no potential for chronic dietary exposure to chlorfenapyr in drinking water. EPA does not expect the aggregate exposure to exceed 100% of the cPAD. 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). Chlorfenapyr is registered for use on sites that would result in negligible residential exposure and no exposure from drinking water. Therefore, the aggregate risk is equal to the risk from food, and does not exceed the Agency's LOC.

IV. Other Considerations A. Analytical Enforcement Methodology 1. Residue analytical methods. The proposed enforcement method is M2427, a gas chromatography/ electron capture detection ( GC/ ECD) method with an limit of quantitation ( LOQ) of 0.05 ppm. Method M2427 has been subjected to a successful independent laboratory validation ( ILV) as well as an acceptable radiovalidation using samples obtained from lettuce and tomato metabolism studies. A version of this method, M2284 was sent to EPA's Analytical Chemistry Branch ( ACB) in Beltsville, MD for a petition method validation ( PMV) on oranges and citrus oil. Although the PMV was successful, minor revisions were required. A new version of analytical method M2284 with the recommended revisions has not been submitted. The Agency's review of PP 6F4716 concluded that method M2427 is adequate for data collection and tolerance enforcement purposes pending submission of the rewritten method M2284. Since M2427 is similar to M2284, the petitioner was directed to rewrite Method M2427 following the ACB comments regarding M2284. The petitioner has submitted Method 2427.02, which contains the requested revisions. 2. Multiresidue method ( MRM). The data requirement for MRM is satisfied pending U. S. Food and Drug Administration ( FDA) review and acceptance of the MRM results. The petitioner previously submitted MRM recovery data for chlorfenapyr through FDA Protocols A through E. Protocols A and B were not applicable to chlorfenapyr. In Protocol C, chlorfenapyr gave a good response with the electron capture detector on three different GC columns. In Protocol D, using pears as a non fatty food representative, the 5% OV 101 column gave the greatest sensitivity at 0.05 and 0.50 ppm. In Protocol E, chlorfenapyr eluted well on Florisil in both the ethyl ether/ petroleum ether system and the alternate hexane/ acetonitrile/ methylene chloride system and gave acceptable recovery. Adequate enforcement methodology 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.

VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00093 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55526 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations B. International Residue Limits There are no established Codex, Canadian, or Mexican maximum residue levels ( MRLs) for chlorfenapyr on fruiting vegetables; therefore, harmonization of MRLs and U. S. tolerances is not an issue at this time.

C. Conditions The following data are required as a condition of registration: A developmental neurotoxicity study to determine the cause/ relationship of potential central nervous system/ myelinopathic alterations to neurotoxicity in the developing young.

V. Conclusion Therefore, the tolerance is established for residues of chlorfenapyr, 4 bromo 2 ( 4 chlorophenyl) 1( ethoxymethyl) 5 ( trifluoromethyl) 1H pyrrole 3 carbonitrile, in or on vegetables, fruiting, group 8 at 1.0 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   0146 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 November 25, 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   0146, 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 VerDate jul< 14> 2003 14: 38 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00094 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1 55527 Federal Register / Vol. 68, No. 187 / Friday, September 26, 2003 / Rules and Regulations 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: September 22, 2003. James Jones, Director, 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. A new section heading and text are added to § 180.513 to read as follows:

§ 180.513 Chlorfenapyr; tolerances for residues.

( a) General. Tolerances are established for residues of the insecticide chlorfenapyr [ 4 bromo 2( 4 chlorophenyl) 1( ethoxymethyl) 5 ( trifluoromethyl) 1H pyrrole 3 carbonitrile] in or on the following raw agricultural commodities:

Commodity Parts per million Vegetables, fruiting, group 8 .... 1.0 ( b) Section 18 emergency exemptions. [ Reserved] ( c) Tolerances with regional registrations. [ Reserved] ( d) Indirect or inadvertent residues. [ Reserved]

[ FR Doc. 03   24405 Filed 9   25   03; 8: 45 am]

BILLING CODE 6560   50   S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services 42 CFR Part 447 [ CMS   2175   CN]

RIN 0938   AM20 Medicaid Program; Time Limitation on Price Recalculations and Recordkeeping Requirements Under the Drug Rebate Program; Correction AGENCY: Centers for Medicare & Medicaid Services ( CMS), HHS. ACTION: Final rule; correction.

SUMMARY: This document corrects the effective date of a final rule with comment period published in the Federal Register on August 29, 2003 ( 68 FR 51912). That rule finalizes separately, in an accelerated timeframe, two specific provisions of the September 19, 1995 proposed rule. It establishes new recordkeeping requirements for drug manufacturers under the Medicaid drug rebate program. It also sets forth a 3 year time limitation during which manufacturers must report changes to average manufacturer price and best price for purposes of reporting data to us. In addition, it announces the pressing need for codification of fundamental recordkeeping requirements. It also announces our intention to continue to work on finalizing the complete drug VerDate jul< 14> 2003 15: 34 Sep 25, 2003 Jkt 200001 PO 00000 Frm 00095 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 26SER1. SGM 26SER1


                                 EPA SCIENTIFIC ADVISORY COMMITTEE ON CHEMICALS
                       CHARGE TO THE PANEL  -  ASBESTOS

As amended by the Frank R. Lautenberg Chemical Safety for the 21st Century Act on June 22, 2016, the Toxic Substances Control Act (TSCA), requires the U.S. Environmental Protection Agency (EPA) to conduct risk evaluations on existing chemicals. In December of 2016, EPA published a list of the initial ten chemical substances that are the subject of the Agency's chemical risk evaluation process (81 FR 91927), as required by TSCA. Asbestos is one of the first ten chemical substances and the ninth of the ten to undergo a peer review by the Science Advisory Committee on Chemicals (SACC). In response to this requirement, EPA has prepared and published a draft risk evaluation for Asbestos. The EPA has solicited comments from the public on the draft and will incorporate them as appropriate, along with comments from peer reviewers, into the final risk evaluation.

The focus of this meeting is to conduct the peer review of the Agency's draft risk evaluation of asbestos and associated supplemental materials. At the end of the peer review process, EPA will use the reviewers' comments/recommendations, as well as public comment, to finalize the risk evaluation.

This draft risk evaluation contains the following components:
      :: Discussion of chemistry and physical-chemical properties
      :: Characterization of uses/sources
      :: Detailed description of the systematic review process developed by the Office of Pollution Prevention and Toxics to search, screen, and evaluate scientific literature for use in the risk evaluation process.
      :: Environmental fate and transport assessment
      :: Environmental exposure assessment
      :: Human health hazard assessment
      :: Environmental hazard assessment
      :: Risk characterization
      :: Risk determination

CHARGE QUESTIONS:
Systematic Review (Section 1.5 of the Draft Risk Evaluation):
The Toxic Substances Control Act (TSCA) requires that EPA use data and/or information in a manner consistent with the "best available science" and that EPA base decisions on the "weight of the scientific evidence". The EPA's Final Rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726), defines ``best available science'' as science that is reliable and unbiased. This involves the use of supporting studies conducted in accordance with sound and objective science practices, including, when available, peer reviewed science and supporting studies and data collected by accepted methods or best available methods (if the reliability of the method and the nature of the decision justifies use of the data). The Final Rule also defines the "weight of the scientific evidence" as a systematic review method, applied in a manner suited to the nature of the evidence or decision, that uses a pre-established protocol to comprehensively, objectively, transparently, and consistently identify and evaluate each stream of evidence, including the strengths, limitations, and relevance of each study and to integrate evidence as necessary and appropriate based upon strengths, limitations, and relevance.

To meet these scientific standards, EPA applied systematic review approaches and methods to support the asbestos draft risk evaluation. Information on the approaches and/or methods is described in the draft risk evaluation as well as the following documents:

 :: Strategy for Conducting Literature Searches for Asbestos: Supplemental File for the TSCA Scope Document, (EPA-HQ-OPPT-2016-0736-0083)

:: Asbestos (CASRN 1332-31-4) Bibliography: Supplemental File for the TSCA Scope Document, (EPA-HQ-OPPT-2016-0736-0084)

 :: Asbestos Problem Formulation (EPA-HQ-OPPT-2016-0736-0131)

:: Application of Systematic Review in TSCA Risk Evaluations (EPA-HQ-OPPT-2016-0736-0132)

EPA has solicited peer review and public feedback on systematic review approaches and methods for prior evaluations. A general question on these approaches is not included in this charge; however, EPA will accept comment on the systematic review approaches used for this evaluation if provided.

1.  Environmental Exposure and Release
Based on the reasonably available information in the published literature, provided by industries using asbestos, and reported in EPA databases, there is minimal or no releases of asbestos associated with the conditions of use (COUs) that EPA is evaluating in this risk evaluation.

1.1. Please comment on whether the information presented supports the analysis and conclusion in the draft environmental exposure section (Section 2.2 and Appendix D).

1.2. Please comment on whether EPA adequately, clearly and appropriately presented the physical-chemical properties/characteristics of chrysotile asbestos.

2.  Occupational Exposure (Section 2.3.1)
Workers and occupational non-users may be exposed to commercial chrysotile asbestos when workers perform activities associated with several COUs:
 Asbestos diaphragms used in the chlor-alkali industry
 Asbestos-containing sheet gaskets (both stamping and use)
 Oil field brake blocks
 Aftermarket automotive brakes and linings
 Other vehicle friction products
 Other gaskets (Utility vehicles)

EPA evaluated what is known about chronic exposures to workers and occupational nonusers (ONUs) for the COUs listed above via the inhalation pathway only. The principle approach EPA used to estimate occupational exposures  -  for both workers and ONUs - was reviewing and interpreting monitoring data, whether provided by industry or documented in the peer-reviewed literature. EPA assumed that workers and occupational non-users would be adolescents and adults of both sexes (>=16 and older).

   2.1. Please comment on the estimation methods and assumptions used for occupational exposure assessment (including ONUs) in terms of concentration, frequency and duration of exposures; and their use in the risk evaluation. Below are two specific issues in which EPA is particularly interested in feedback from the SACC

       Incorporation of Short-Term Occupational Monitoring Results
       EPA received from industry (or obtained from the published literature short-term (i.e., less than a full 8-hour work shift) monitoring data for several of the COUs (chlor-alkali, sheet gaskets/stamping, aftermarket automotive parts, and other vehicle friction products).  For these COUs, EPA calculated a separate "full-shift" asbestos exposure estimates as well as a short-term exposure estimate to account for these occasional, short, high-exposure scenarios. Please comment on the method used.

       ONU Exposure Estimates
       Based on the readily available information, EPA used different methods to estimate ONU exposures. ONU estimates were made for each COU; however, the limited information did not allow the development of ONU exposures for short-term exposure scenarios for chlor-alkali, sheet gasket use, oil field brake blocks, or other gaskets/UTVs. Please comment on the method(s) used (identified below).

 Chlor-alkali (Section <IP_ADDRESS>.5): For ONU exposure estimates area samples were used. Two chlor-alkali facilities provided a total of 15 area samples which were all below the limit of detection (LOD). There were two different detection limits in the two submissions. Although true exposure values below any limit of detection may be unevenly distributed from zero to the limit of detection, we assumed that the central tendency exposure concentration estimate is based on one-half of the detection limit for individual samples and the high-end concentration is based on the highest detection limit across the samples.
 Sheet Gasket Stamping and use (Sections <IP_ADDRESS>.5 and <IP_ADDRESS>.5): EPA did not identify any ONU exposure measurements for these COUs. However, the literature includes "bystander" exposure studies. Specifically, one publication (Mangold, 2006) measured "bystander" exposure during asbestos-containing gasket removal. The "bystander" locations in this study were between 5 and 10 feet from the gasket removal activity, and asbestos concentrations were between 2.5 and 9 times lower than those measured for the worker. Based on these observations, EPA assumes that ONU exposures for these COUs are a factor of 5.75 (i.e., the midpoint between 2.5 and 9) lower than the directly exposed workers.
 Oilfield brake blocks (Section <IP_ADDRESS>.5): EPA has not identified specific data on potential ONU inhalation exposures from brake block use. It is assumed that ONUs do not directly handle brake block and drawworks machineries and that this equipment is always used and serviced outdoors close to oil wells. Given the limited information identified in Section <IP_ADDRESS>.4 (i.e., worker monitored values), the lower of the two reported values was used to represent ONU exposures for this COU.
 Aftermarket automotive brakes (Section <IP_ADDRESS>.5): EPA has not identified data on potential ONU inhalation exposures from after-market auto brake scenarios. ONUs do not directly handle brakes and the ONU exposure estimates in Table 2-15 were generated by assuming that asbestos concentrations decreased by a factor of 8.4 between the worker location and the ONU location. EPA derived this reduction factor from a publication (Madl, 2008) that had concurrent worker and bystander exposure measurements where the bystander was approximately 5 feet from the worker. The value of 8.4 is the average concentration reduction across four concurrent sampling events.
 Other gaskets/UTVs (Section <IP_ADDRESS>.4): Paustenbach (2006) includes area sampling results that EPA thought appropriate for ONU exposures. These samples were collected at breathing zone height at locations near the ends of the muffler shop bays where the exhaust system work was performed. The area sample durations ranged from 25 to 80 minutes, and these samples were collected during exhaust system work. Overall, 21 area samples from these locations were analyzed by PCM; and 16 of these samples were non-detects for asbestos. Among the PCM data from this subset of area samples, the authors report that the average asbestos concentration was 0.005 fibers/cc and the maximum asbestos concentration was 0.015 fibers/cc. The study authors did not report 8-hour TWA concentrations for the area sample locations. EPA used these average and maximum asbestos concentrations to estimate potential ONU exposures.

   2.2. Please comment on EPA's reasonableness of these assumptions, the uncertainties they introduce, and the resulting confidence in the occupational exposure estimates (Section 4.3.3).

   2.3. Please provide specific suggestions or recommendations for alternative approaches, estimation methods, or information sources that EPA should consider for improving the occupational exposure assessment.

3.  Consumer Exposure (Section 2.3.2)
Consumers (Do-it-Yourselfers, or DIY, or DIY mechanics) and bystanders may be exposed to commercial chrysotile asbestos when consumers perform activities associated with several COUs:

 Aftermarket automotive brakes and linings
 Other Gaskets (Utility vehicles - UTVs)

   3.1. Please comment on the estimation methods and assumptions used for consumer/DIY exposure assessment (including bystanders) in terms of concentration, frequency and duration of exposures; and their use in the risk evaluation. Please include your thoughts on the reasonableness of the estimated age at start of exposure and duration and frequency of exposure for the consumer (DIY and bystander) (Section 4.2.3).

   3.2. Please comment on EPA's approach to developing consumer/DIY exposure estimates for aftermarket automotive brakes/linings (Section <IP_ADDRESS>). Please include your thoughts on the reasonableness of the estimated age at start of exposure and duration and frequency of exposure for the consumer (DIY and bystander) (Section 4.2.3).

   3.3. Please comment on EPA's approach to developing bystander exposure estimates (specifically the use of reduction factors [RFs] (Sections <IP_ADDRESS> and <IP_ADDRESS>).

   3.4. Please comment on EPA's approach to develop consumer/DIY exposure estimates for other gaskets (UTVs) (Section <IP_ADDRESS>).

   3.5. Please comment on EPA's reasonableness of the assumptions used, the uncertainties they introduce, and the resulting confidence in the consumer exposure estimates (Section 4.3.4).

   3.6. Please comment on the methods and assumptions used in approaches for the sensitivity analysis for the consumer (DIY and bystander) risk estimates for both aftermarket automotive brakes and UTV gaskets (Appendix L).

   3.7. Please provide any specific suggestions or recommendations for alternative approaches, estimation methods, assumptions, or information that should be considered by the Agency for improving the consumer exposure assessment.

4.  Human Health Hazard/Derivation of the Inhalation Unit Risk (IUR)
EPA derived the chrysotile-based inhalation unit risk (IUR) based on a review of the epidemiology literature describing occupational cohorts exposed to commercial chrysotile that provided adequate data for assessment of lung cancer and mesothelioma risks. Cancer potency values were either extracted from published epidemiology studies or derived from the data within those studies. Once the cancer potency values were obtained, they were adjusted for differences in air volumes between workers and other populations so that those values can be applied to the U.S. population as a whole in the standard EPA life-table analyses. The life-table methodology allows the estimation of an exposure concentration association associated with a specific extra risk of cancer mortality caused by commercial chrysotile asbestos. According to standard practice, the lifetime unit risks for lung cancer and mesothelioma were estimated separately and then statistically combined to yield the cancer inhalation unit risk.

Less-than-lifetime or partial lifetime unit risks were also derived for a range of exposure scenarios based on different ages of first exposure and durations of exposure.

   4.1. Please comment on EPA's choice of focusing on only lung cancer and mesothelioma.

   4.2. Please comment on the appropriateness of the approach to derive the commercial chrysotile-based IURs, including the underlying assumptions, strengths and weaknesses of the choice of study cohorts used, the key calculation decisions and the modelling used to derive the IUR (Section 3.2.4).

   4.3. Please comment on EPA's approach to characterizing the implications of the assumptions and uncertainties for the confidence associated with the derivation of the IURs (Section 4.3.5).

   4.4. Please provide any specific suggestions or recommendations for alternative approaches that should be considered by the Agency in deriving the commercial chrysotile-based IUR.

5. Human Health Risk Characterization
EPA posited that there were minimal or no releases of asbestos to surface water associated with the conditions of use (COUs) evaluated in this risk evaluation and thus concluded there is no risk to aquatic or sediment-dwelling organisms (Section 4.1).
As discussed above, EPA calculated the potential for extra cancer risk via inhalation exposures for occupational (workers and ONUs) and consumers (DIYers and bystanders) for cancer effects. The risk characterization provides a discussion of the uncertainties surrounding the risk calculations.

On the basis of the estimated exposure and risks, EPA concluded that inhalation of chrysotile asbestos presents an unreasonable risk of injury to workers (and ONUs) and consumers (and bystanders) (See Section 4.2.). EPA also concludes that asbestos does not present an unreasonable risk to environmental receptors exposed via surface water (see Section 4.1). EPA makes this determination considering risk to potentially exposed and susceptible subpopulations identified as relevant, under the conditions of use without considering costs or other non-risk factors.

   5.1. EPA presented overall human health risk conclusions (Sections 4.5.2 and 4.5.3) based on risk estimates for cancer. Please comment on EPA's approach including any alternative considerations for assessing and presenting risk conclusions including the risk summary tables (Table 4-55 and 4-56).

   5.2. Please comment on the clarity and validity of specific confidence summaries presented in Section 4.3.

   5.3. Throughout this charge we have asked reviewers to comment on the uncertainties and data limitations associated with the methodologies used to assess the environmental and human health risks. Please comment on whether that information has been carried forward to the characterization of the risk evaluation such that the strength of the unreasonable risk conclusions is characterized in a clear and transparent manner (Section 4.3).

   5.4. Please comment on whether the analysis presented in Section 4 supports the conclusions for both the environment (Section 4.5.1) and human health (Section 4.5.2 and 4.5.3) in the draft risk characterization section concerning asbestos. If not, please explain the limitations of these conclusions, and whether there are alternative approaches or information that could be used to further develop the risk estimates within the context of the requirements stated in EPA's Final Rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726) (Section 4).

   5.5. Please comment on any other aspect of the environmental or human health risk characterization that has not been mentioned above (Section 4).

6.  Additional Questions:
The Frank R. Lautenberg Chemical Safety for the 21st Century Act (2016) (amended TSCA) states that "potentially exposed or susceptible subpopulations" (PESS) be considered in the risk evaluation process. PESS is defined in the Lautenberg Act to include populations with greater exposure or greater response, including due to lifestyle, dietary, and biological susceptibility factors, than the general population.

   6.1. Has a thorough and transparent review of the available information been conducted that has led to the identification and characterization of all PESS (Sections 2.3.3, 3.2.5., and 4.4.1)? Do you know of additional information about PESS that EPA needs to consider? Additionally, has the uncertainty around PESS been adequately characterized?

The EPA risk characterization of human health risk from inhalation exposure to workers includes estimates of risk for respirator use. EPA was supplied information on respirator use from some industry representatives. EPA estimated cancer risks based on no use of respirators and with respirators by the respirator assigned protection factors (APFs) of 10 and 25. EPA did not assume occupational non users (ONUs) or consumers used personal protective equipment in the risk estimation process.

   6.2. Please comment on whether EPA has adequately, clearly, and appropriately presented the reasoning, approach, assumptions, and uncertainties for characterizing risk to workers using PPE (exposure - Sections <IP_ADDRESS>.; risk Section 4.2.1 and Tables 4-3 and 4-38).

   6.3 Please comment on whether EPA has adequately, clearly, and appropriately presented the reasoning, approach, assumptions, and uncertainties for characterizing risk to ONUs who would not be expected to use PPE (Sections 4.2.1 and 4.3.7).

    7.  Overall Content and Organization
EPA's Final Rule, Procedures for Chemical Risk Evaluation Under the Amended Toxic Substances Control Act (82 FR 33726) stipulates the process by which EPA is to complete risk evaluations under the Frank R. Lautenberg Chemical Safety for the 21st Century Act.

As part of this draft risk evaluation for asbestos, EPA evaluated potential environmental, occupational and consumer exposures. The evaluation considered reasonably available information, including manufacture, use, and release information, and physical-chemical characteristics. It is important that the information presented in the risk evaluation and accompanying documents is clear and concise and describes the process in a scientifically credible manner.

To increase the quality and credibility of scientific information disseminated by EPA, EPA uses the peer review process specifically as a tool for determining fitness of scientific information for the intended purpose. The questions below are intended to guide the peer reviewers toward determining if EPA collected, used and disseminated information that is `fit for purpose' based on utility (the data's utility for its intended users and for its intended purpose), integrity (the data's security), and objectivity (whether the disseminated information is accurate, reliable, and unbiased as a matter of presentation and substance). The peer reviewers' critical focus should pertain to recommendations of the technical information's usefulness for intended users and the public.

   7.1. Please comment on the overall content, organization, and presentation of the asbestos draft risk evaluation. Please provide suggestions for improving the clarity of the information presented.

   7.2. Please comment on the objectivity of the information used to support the risk characterization and the sensitivity of the agency's conclusions to analytic decisions made.


[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Page 53929]
[FR Doc No: 2011-22039]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2007-0008]

National Advisory Council

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Committee management; notice of federal advisory committee
meeting.

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

SUMMARY: The National Advisory Council (NAC) will meet by
teleconference on September 14, 2011 for the purpose of discussing the
Presidential Policy Directive 8 on National Preparedness. The meeting
will be open to the public.

DATES: The teleconference will take place Wednesday, September 14,
2011, from 3 p.m. E.D.T. to 5 p.m. E.D.T. Please note that the meeting
may close early if the National Advisory Council has completed its
business. Written comments must be received by September 2, 2011.

ADDRESSES: The meeting will be held by teleconference only. Members of
the public who wish to obtain the listen-only call-in number, access
code, and other information for the public teleconference may contact
Patricia A. Kalla as listed in the FOR FURTHER INFORMATION CONTACT
section by close of business on September 13, 2011. For information on
services for individuals with disabilities or to request special
assistance, contact Patricia A. Kalla as soon as possible.
    To facilitate public participation, we are inviting public comment
on the issues to be considered by the committee as listed in the
SUPPLEMENTARY INFORMATION section. Comments must be submitted in
writing no later than September 2, 2011 and must be identified by
Docket ID FEMA-2007-0008 and may be submitted by one of the following
methods:
    Federal Rulemaking Portal: http://www.regulations.gov. Follow the
instructions for submitting comments.
    E-mail<EMAIL_ADDRESS>Include Docket ID FEMA-2007-0008 in the
subject line of the message.
    Fax:<PHONE_NUMBER>.
    Mail: FEMA, Office of Chief Counsel, 500 C Street, SW., Room 840,
Washington, DC 20472-3100.
    Instructions: All submissions received must include the words
``Federal Emergency Management Agency'' and the Docket ID FEMA-2007-
0008 for this action. Comments received will be posted without
alteration at http://www.regulations.gov, including any personal
information provided.
    Docket: For access to the docket to read documents or comments
received by the National Advisory Council, go to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Patricia A. Kalla, Designated Federal
Officer, FEMA, 500 C Street, SW., Room 832, Washington, DC 20472-3100,
telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, and e-mail<EMAIL_ADDRESS>The NAC website is located at: http://www.fema.gov/about/nac/.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act, 5 U.S.C. App. (Pub. L. 92-463).
    The National Advisory Council (NAC) was established to ensure
effective and ongoing coordination of Federal preparedness, protection,
response, recovery, and mitigation for natural disasters, acts of
terrorism, and other man-made disasters. The NAC advises the
Administrator of the Federal Emergency Management Agency on all aspects
of emergency management. The NAC incorporates State, local and tribal
government and private sector input in the development and revision of
the national preparedness goal, the national preparedness system, the
National Incident Management System, the National Response Plan and
other related plans and strategies.
    Agenda: The NAC plans to discuss the March 30, 2011 Presidential
Policy Directive 8 (PPD-8) on National Preparedness. PPD-8 directs the
Secretary of Homeland Security to develop a national preparedness goal
that identifies the core capabilities necessary for preparedness and a
national preparedness system to guide activities that will enable the
Nation to achieve the goal. The NAC plans to finalize recommendations
on the development of the preparedness goal and incorporation of these
recommendations into the preparedness goal. The draft national
preparedness goal has been posted to Docket ID FEMA-2007-0008.

W. Craig Fugate,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2011-22039 Filed 8-29-11; 8:45 am]
BILLING CODE 9111-48-P


[Federal Register: September 22, 2010 (Volume 75, Number 183)]
[Notices]
[Page 57768]
[DOCID:fr22se10-63]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13700-000]

Hydrodynamics, Inc.; Notice of Preliminary Permit Application
Accepted for Filing and Soliciting Comments, Motions To Intervene, and
Competing Applications

September 16, 2010.
    On April 5, 2010, Hydrodynamics, Inc. filed an application for a
preliminary permit, pursuant to section 4(f) of the Federal Power Act
(FPA), proposing to study the feasibility of the Mill Coulee
Hydroelectric Project to be located in Cascade County, Montana near
Fairfield, Montana on the Mill Coulee canal, a water distribution
facility of the U.S. Bureau of Reclamation's Sun River Project. The
sole purpose of a preliminary permit, if issued, is to grant the permit
holder priority to file a license application during the permit term. A
preliminary permit does not authorize the permit holder to perform any
land-disturbing activities or otherwise enter upon lands or waters
owned by others without the owners' express permission.
    The proposed project will consist of the following: (1) A new 3-
foot-high, 20-foot-wide, one-foot-thick diversion structure with a
flood gate and trash rack; (2) a 2,020-foot-long, 48-inch-diameter
polyethylene penstock; (3) a 60-foot-long, 60-foot-wide powerhouse; (4)
a turbine/generator unit with a capacity rating of 900 kilowatts; (5) a
3,750-foot-long clay-lined tailrace canal returning flows to the Mill
Coulee canal; and (6) a 69-kilovolt, 3,400-foot-long transmission line.
    Annual energy production is estimated to be 2.25 gigawatt-hours.
    Applicant Contact: Roger Kirk, Hydrodynamics, Inc., 521 E. Peach,
Suite 2B, Bozeman, MT 59715; phone:<PHONE_NUMBER>.
    FERC Contact: Dianne Rodman; phone:<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36. Comments, motions to intervene, notices of intent, and
competing applications may be filed electronically via the Internet.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site http://www.ferc.gov/docs-filing/efiling.asp. Commenters can
submit brief comments up to 6,000 characters, without prior
registration, using the eComment system at http://www.ferc.gov/docs-
filing/ecomment.asp. You must include your name and contact information
at the end of your comments. For assistance, please contact FERC Online
Support. Although the Commission strongly encourages electronic filing,
documents may also be paper-filed. To paper-file, mail an original and
seven copies to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's Web site at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-13700-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-23682 Filed 9-21-10; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 197 (Friday, October 15, 2021)]
[Notices]
[Page 57418]
[FR Doc No: 2021-22495]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER21-2755-000.
    Applicants: Effingham County Power, LLC.
    Description: Amendment to August 24, 2021 Effingham County Power,
LLC tariff filing.
    Filed Date: 10/8/21.
    Accession Number: 20211008-5235.
    Comment Date: 5 p.m. ET 10/15/21.

    Docket Numbers: ER21-2774-001.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Amendment: Amendment to Revisions to Sch. 12-
Appx A: July 2021 RTEP to be effective 11/24/2021.
    Filed Date: 10/8/21.
    Accession Number: 20211008-5268.
    Comment Date: 5 p.m. ET 10/29/21.

    Docket Numbers: ER22-70-000.
    Applicants: Tucson Electric Power Company.
    Description: Sec.  205(d) Rate Filing: Rate Schedule No. 348,
Concurrence to CAISO RS No. 6889 to be effective 12/1/2021.
    Filed Date: 10/8/21.
    Accession Number: 20211008-5095.
    Comment Date: 5 p.m. ET 10/29/21.

    Docket Numbers: ER22-71-000.
    Applicants: Golden Spread Electric Cooperative, Inc.
    Description: Sec.  205(d) Rate Filing: WPC TCEC Ex A and C Filing
to be effective 10/1/2021.
    Filed Date: 10/8/21.
    Accession Number: 20211008-5101.
    Comment Date: 5 p.m. ET 10/29/21.

    Docket Numbers: ER22-72-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Original ISA and ICSA,
Service Agreement Nos. 6198 and 6199; Queue No. AE1-104 to be effective
9/9/2021.
    Filed Date: 10/8/21.
    Accession Number: 20211008-5109.
    Comment Date: 5 p.m. ET 10/29/21.

    Docket Numbers: ER22-73-000.
    Applicants: Northern States Power Company, a Minnesota corporation.
    Description: Tariff Amendment: 2021-10-08 NSP-GFLS-A&R TSA-436-NOC-
0.1.0 to be effective 12/31/2021.
    Filed Date: 10/8/21.
    Accession Number: 20211008-5194.
    Comment Date: 5 p.m. ET 10/29/21.

    Docket Numbers: ER22-74-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Compliance filing: 2021-10-08_STR Tariff Waiver
Request to be effective N/A.
    Filed Date: 10/8/21.
    Accession Number: 20211008-5224.
    Comment Date: 5 p.m. ET 10/29/21.

    Docket Numbers: ER22-75-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2021-10-08_STR Regulating
Reserve Tariff filing to be effective 5/1/2022.
    Filed Date: 10/8/21.
    Accession Number: 20211008-5225.
    Comment Date: 5 p.m. ET 10/29/21.

    Docket Numbers: ER22-76-000.
    Applicants: Florida Power & Light Company.
    Description: Sec.  205(d) Rate Filing: FPL and Seminole Pseudo-Tie
Agreement for Seminole's Delivery Points to be effective 10/9/2021.
    Filed Date: 10/8/21.
    Accession Number: 20211008-5227.
    Comment Date: 5 p.m. ET 10/29/21.

    Docket Numbers: ER22-77-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: DSA Homestead Energy Storage
SA No. 1158 WDT1710 to be effective 12/8/2021.
    Filed Date: 10/8/21.
    Accession Number: 20211008-5230.
    Comment Date: 5 p.m. ET 10/29/21.

    Docket Numbers: ER22-78-000.
    Applicants: Idaho Power Company.
    Description: Sec.  205(d) Rate Filing: SA 424--PowerEx--Jeff to
Bora to be effective 4/1/2022.
    Filed Date: 10/8/21.
    Accession Number: 20211008-5243.
    Comment Date: 5 p.m. ET 10/29/21.

    Docket Numbers: ER22-79-000.
    Applicants: Duke Energy Progress, LLC.
    Description: Sec.  205(d) Rate Filing: DEP-Powells Creek ASOA SA
No. 365 to be effective 12/8/2021.
    Filed Date: 10/8/21.
    Accession Number: 20211008-5253.
    Comment Date: 5 p.m. ET 10/29/21.

    Docket Numbers: ER22-80-000.
    Applicants: Coyote Ridge Wind, LLC.
    Description: Baseline eTariff Filing: Filing of Reactive Supply
Service Rate Schedule FERC No. 1 to be effective 10/12/2021.
    Filed Date: 10/8/21.
    Accession Number: 20211008-5266.
    Comment Date: 5 p.m. ET 10/29/21.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 8, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-22495 Filed 10-14-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: January 22, 2007 (Volume 72, Number 13)]
[Notices]
[Page 2677]
[DOCID:fr22ja07-53]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Termination of License by Implied Surrender and
Soliciting Comments, Protests, and Motions To Intervene

January 16, 2007.

    Take notice that the following hydroelectric proceeding has been
initiated by the Commission:
    a. Type of Proceeding: Termination of license by implied surrender.
    b. Project No.: 7931-021.
    c. Date Initiated: January 12, 2007.
    d. Licensee/Transferor/Transferee: The license was involved in an
uncompleted transfer proceeding. The licensee/transferor is Larry
Hensley and the transferee is Eugene Mark Souza.
    e. Name and Location of Project: The partially constructed 30-
kilowatt 29 Mile Creek Project is located on the South Fork of the
American River in El Dorado County, California and occupies lands of
the United States within the El Dorado National Forest.
    f. Filed Pursuant to: 18 CFR 6.4.
    g. Licensee/Transferor/Transferee Contact Information: Larry
Hensley, 5701 Hollyberry Lane, Placerville, CA 95667 and Eugene Mark
Souza, 4595 Pacheco Boulevard, Martinez, CA 94553 or 108 Dawn Lane,
Placerville, CA 95667.
    h. FERC Contact: Tom Papsidero,<PHONE_NUMBER>.
    i. Deadline for filing comments, protests, and motions to
intervene: February 16, 2007.
    All documents (original and eight copies) should be filed with
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-7931-021) on any documents or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in 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.
    j. Description of Existing Facilities: The partially constructed
project consists of the following existing facilities: (1) A concrete
diversion dam, 2-foot-high by 15-foot-long, and (2) a 1,800-foot-long,
6-inch steel pipe.
    k. Description of Proceeding: 18 CFR 6.4 of the Commission's
regulations provides, among other things, that it is deemed to be the
intent of a licensee to surrender a license, if the licensee abandons a
project for a period of three years.
    By order issued August 10, 2000 (92 FERC ] 62,124), the Commission
approved the transfer of the minor license, issued in 1986 (36 FERC ]
62,235), for the 29 Mile Creek Project No. 7931 from Mr. Larry Hensley
to Mr. Eugene Mark Souza, and granted an extension of the previously-
extended deadline in Article 301 of the license for completing
construction of the project. Ordering paragraph (F) of the Order
Approving Transfer of License and Granting Extension of Time issued
August 10, 2000, stated that: ``Approval of the transfer is contingent
upon: (1) Transfer of title of the properties under license and
delivery of all license instruments to Eugene Mark Souza, who shall be
subject to the terms and conditions of the license as though he were
the original licensee; and (2) Eugene Mark Souza acknowledging
acceptance of this order and its terms and conditions by signing and
returning the attached acceptance sheet. Within 60 days from the date
of this order, Eugene Mark Souza shall submit certified copies of all
instruments of conveyance and the signed acceptance sheet.''
    To date the transferee has not filed the conveyance documents and
acceptance sheets showing that the transfer has been completed, and
neither the transferor/transferee has filed the required quarterly
progress reports showing work done to complete construction of the
project, nor any requests to extend the deadlines for filing the
documents and reports.
    l. Location of the Orders: A copy of each order is available for
inspection and reproduction 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, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>.

    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: 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 proceeding.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper; see 18 CFR 385.2001 (a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    o. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``PROTEST'', or
``MOTION TO INTERVENE'', and ``RECOMMENDATIONS FOR TERMS AND
CONDITIONS'', as applicable, and the Project Number of the proceeding.
Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address.
    p. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described proceeding. If an agency does not
file comments within the time specified for filing comments, it will be
presumed to have no comments.

Magalie R. Salas,
Secretary.
[FR Doc. E7-783 Filed 1-19-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: August 25, 2006 (Volume 71, Number 165)]
[CORRECTIONS]
[Page 50506]
[DOCID:fr25au06-152]

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

DEPARTMENT OF LABOR

Occupational Safety and Health Administration

Maritime Advisory Committee on Safety and Health (MACOSH)

Correction

    In notice document 06-6746 beginning on page 45075 in the issue of
Tuesday, August 8, 2006, make the following correction:
    On page 45076, in the first column, in the sixth paragraph, in the
first line, ``Leon'' should read ``Lemon''.

[FR Doc. C6-6746 Filed 8-24-06; 8:45 am]

BILLING CODE 1505-01-D


[Federal Register Volume 76, Number 164 (Wednesday, August 24, 2011)]
[Notices]
[Page 53025]
[FR Doc No: 2011-21658]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: FAA Airport
Master Record

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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

SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Airport Safety Data Program involves the collection and
dissemination of civil aeronautics information.

DATES: Written comments should be submitted by October 24, 2011.

FOR FURTHER INFORMATION CONTACT: Carla Scott on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0015.
    Title: FAA Airport Master Record.
    Form Numbers: FAA Forms 5010-1, 5010-2, 5010-3, 5010-5.
    Type of Review: Renewal of an information collection.
    Background: 49 U.S.C. 329(b) empowers and directs the Secretary of
Transportation to collect and disseminate information on civil
aeronautics. Aeronautical information is required to be collected by
the FAA in order to carry out agency missions such as those related to
aviation flying safety, flight planning, airport engineering and
federal grants analysis, aeronautical chart and flight information
publications, and the promotion of air commerce as required by statute.
    Respondents: Approximately 19,800 airport owners/managers and state
inspectors.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 1 hour.
    Estimated Total Annual Burden: 8,870 hours.
    ADDRESSES: Send comments to the FAA at the following address: Ms.
Carla Scott, Room 336, Federal Aviation Administration, AES-300, 950
L'Enfant Plaza, SW., Washington, DC 20024.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Dated: August 18, 2011.
Carla Scott,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
[FR Doc. 2011-21658 Filed 8-23-11; 8:45 am]
BILLING CODE 4910-13-P