[Federal Register Volume 82, Number 142 (Wednesday, July 26, 2017)]
[Notices]
[Page 34728]
[FR Doc No: 2017-15635]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-81180; File No. SR-GEMX-2017-24]

Self-Regulatory Organizations; Nasdaq GEMX, LLC; Notice of
Designation of a Longer Period for Commission Action on a Proposed Rule
Change To Adopt Rule 912

July 20, 2017.
    On June 9, 2017, Nasdaq GEMX, LLC (``GEMX'' or the ``Exchange'')
filed with the Securities and Exchange Commission (``Commission''),
pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'' or ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to adopt Rule 912 (Consolidated Audit Trail--Fee
Dispute Resolution). The proposed rule change was published for comment
in the Federal Register on June 23, 2017.\3\ The Commission received no
comment letters on the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 80970 (June 19, 2017),
82 FR 28708 (``Notice'').
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    Section 19(b)(2) of the Act \4\ provides that, within 45 days of
the publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
Commission is extending this 45-day time period.
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    \4\ 15 U.S.C. 78s(b)(2).
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    The Commission finds that it is appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the proposed rule change. The
proposed rule change would establish the procedures for resolving
potential disputes related to CAT Fees charged to Industry Members.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\5\ designates September 21, 2017, as the date by which the
Commission should either approve or disapprove or institute proceedings
to determine whether to disapprove the proposed rule change (File
Number SR-GEMX-2017-24).
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    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(31).
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Eduardo A. Aleman,
Assistant Secretary.
[FR Doc. 2017-15635 Filed 7-25-17; 8:45 am]
 BILLING CODE 8011-01-P


40189 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations List of Subjects in 40 CFR Part 180 Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: May 20, 2002. Marcia E. Mulkey, 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. Section 180.[ 380] is amended by removing from the table in paragraph ( a) the entries for `` cucumbres'', `` peppers ( bell)'', `` stonefruits, except plums/ fresh prunes'' and `` strawberries'', and by adding paragraph ( e) to read as follows:

§ 180.380 Vinclozolin; tolerances for residues.

* * * * * ( e) Revoked tolerances subject to the channel of trade provisions. The following table lists commodities with residues of vinclozolin resulting from lawful use are subject to the channels of trade provisions of section 408( l)( 5) of the FFDCA:

Commodity Parts per million Cucumbers 1.0 Peppers ( bell) 3.0 Stonefruits, except plums/ fresh prunes 25.0 Strawberries 10.0 [ FR Doc. 02   13520 Filed 6   11   02; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2002   0082; FRL   7180   8]

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

SUMMARY: This regulation establishes tolerances for residues of triflusulfuron methyl in or on beet, sugar, roots; beet, sugar, tops; and chicory, roots. Interregional Research Project # 4 ( IR 4) and E. I. Dupont de Nemours & Company requested these tolerances under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA).

DATES: This regulation is effective June 12, 2002. Objections and requests for hearings, identified by docket ID number OPP   2002   0082, must be received on or before August 12, 2002.

ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP   2002   0082 in the subject line on the first page of your response.

FOR FURTHER INFORMATION CONTACT: By mail: James A. Tompkins or Hoyt Jamerson, Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: ( 703) 305   5697 or ( 703) 308   9368; e mail address: tompkins. jim@ epa. gov or jamerson. hoyt@ epa. gov.

SUPPLEMENTARY INFORMATION:

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

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected categories and entities may include, but are not limited to:

TABLE 1.   EXAMPLES OF POTENTIALLY AFFECTED ENTITIES Categories NAICS codes Examples of potentially affected entities Industry 111 112 311 32532 Crop production Animal production Food manufacturing Pesticide manufacturing This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in the table could also be affected. The North American Industrial Classification System ( NAICS) codes have been provided to assist you and others in determining whether or not this action might apply to certain entities. If you have questions regarding the applicability of this action to a particular entity, consult the persons listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Additional Information, Including Copies of this Document and Other Related Documents?

1. Electronically. You may obtain electronic copies of this document, and certain other related documents that might be available electronically, from the EPA Internet Home Page at http:// www. epa. gov/. To access this document, on the Home Page select `` Laws and Regulations,'' `` Regulations and Proposed Rules,'' and then look up the entry for this document under the `` Federal Register   Environmental Documents.'' You can also go directly to 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. 2. In person. The Agency has established an official record for this action under docket ID number OPP   2002   0082. The official record consists of the documents specifically referenced in this action, and other information related to this action, including any information claimed as Confidential Business Information ( CBI). This official record includes the documents that are physically located in the docket, as well as the documents that are referenced in those documents. The public version of the official record does not include any information claimed as CBI. The public version of the official record, which includes printed, paper versions of any electronic comments submitted during an applicable comment period is available for inspection in the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA, from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The PIRIB telephone number is ( 703) 305   5805.

II. Background and Statutory Findings In the Federal Register of December 22, 1999 ( 64 FR 71760) ( FRL   6391   1) and August 8, 2001 ( 66 FR 41593) ( FRL   6795   4), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104   170), announcing the filing of a pesticide petition ( PP) by IR 4 and E. I. Dupont de Nemours & Company, 681 US Highway # 1 South North Brunswick, NJ 08902   3390, and E. I. DuPont de VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00049 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40190 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations Nemours & Company, DuPont Agricultural Products, Barley Mill Plaza, Wilmington, DE 19880   0038. This notice included a summary of the petition prepared by E. I. DuPont de Nemours, the registrant. There were no comments received in response to the notice of filing. The petition requested that 40 CFR 180.492 be amended by establishing a tolerance for residues of the herbicide, triflusulfuron methyl, methyl 2[[[[[ 4 ( dimethylamino) 6( 2,2,2 trifluoroethoxy) 1,3,5 triazin 2 yl] amino] carbonyl] amino] sulfonyl] 3 methylbenzoate, in or on chicory, root at 0.05 parts per million ( ppm) ( PP 0E6214). PP 4F4278 proposed that the currently established time limited tolerances for sugar beet, root at 0.05 ppm and sugar beet, top at 0.05 ppm be converted to permanent tolerances and to revise the commodities to read beet, sugar, roots at 0.05 ppm and beet, sugar, tops at 0.05 ppm. Section 408( b)( 2)( A)( i) of FFDCA allows EPA to establish a tolerance ( the legal limit for a pesticide chemical residue in or on a food) only if EPA determines that the tolerance is `` safe.'' Section 408( b)( 2)( A)( ii) of FFDCA defines `` safe'' to mean that `` there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.'' This includes exposure through drinking water and in residential settings, but does not include occupational exposure. Section 408( b)( 2)( C) of FFDCA requires EPA to give special consideration to exposure of infants and children to the pesticide chemical residue in establishing a tolerance and to `` ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposure to the pesticide chemical residue....'' 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 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 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 FFDCA, for tolerances for residues of triflusulfuron methyl on chicory, root at 0.05 ppm; and to convert the timelimited tolerances for beet, sugar, root at 0.05 ppm and beet, sugar, top at 0.05 to permanent tolerances. EPA's assessment of exposures and risks associated with establishing the tolerances 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 triflusulfuron methyl are discussed in Table 2 of this unit, as well as the no observed adverseeffect level ( NOAEL) and the lowestobserved adverse effect level ( LOAEL) from the toxicity studies reviewed.

TABLE 2.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY Guideline No. Study type Results 870.3100 90   Day oral toxicity rodents ( two studies submitted) NOAEL = 6.56/ 7.71 ( m/ f) mg/ kg/ day ( milligram/ kilogram/ day) LOAEL = 133/ 153 ( m/ f) mg/ kg/ day based on decreased body weight gain and food efficiency in males; increased incidence of histopathological changes ( kidney and spleen) in females. NOAEL = 6.20/ 7.54 ( m/ f) mg/ kg/ day LOAEL = 127/ 150 ( m/ f) mg/ kg/ day; based on decreased mean body weight gain, decreased mean food consumption ( f), decreased mean food efficiency, alterations in hematology parameters ( m); hemosiderin in kidneys ( f)

870.3150 90   Day oral toxicity in nonrodents NOAEL = 3.9/ 3.7 ( m/ f) mg/ kg/ day LOAEL = 146.9/ 159.9 ( m/ f) mg/ kg/ day based on decreased mean body weight and body weight gain, decreased hematocrit, hemoglobin, RBC` s, SGOT, SGPT, ALP, absolute and relative liver and testes weight; microscopic abnormalities of the liver and testes.

870.3200 21/ 28   Day dermal toxicity NOAEL = 1,000 mg/ kg/ day LOAEL = 1,000 mg/ kg/ day based on limit dose.

870.3700a Pre natal developmental in rodents Maternal NOAEL = 120 mg/ kg/ day LOAEL = 350 mg/ kg/ day based on decreased body weight gain, decreased food consumption and lower food efficiency. Developmental NOAEL = > 1,000 mg/ kg/ day limit dose LOAEL = > 1,000 mg/ kg/ day.

870.3700b Pre natal developmental in nonrodents Maternal NOAEL = 90 mg/ kg/ day LOAEL = 270 mg/ kg/ day based on clinical signs including absent/ reduced stool and stained fur, maternal death, increased abortions, decreased body weight gain, and lower food efficiency. Developmental NOAEL = 90 mg/ kg/ day LOAEL = 270 mg/ kg/ day based on increased abortions.

VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00050 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40191 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations TABLE 2.   SUBCHRONIC, CHRONIC, AND OTHER TOXICITY   Continued Guideline No. Study type Results 870.3800 Reproduction and fertility effects Parental/ Systemic NOAEL = 5.81/ 7.75 ( m/ f) mg/ kg/ day LOAEL = 44/ 58 mg/ kg/ day based on decreased body weight, decreased body weight gain, decreased food consumption, and decreased food efficiency. Reproductive NOAEL = 89.5/ 115 ( m/ f) mg/ kg/ day based on the absence of reproductive effects at the highest dose tested ( HDT). LOAEL = > 115 mg/ kg/ day. Offspring NOAEL = 5.81/ 7.75 ( m/ f) mg/ kg/ day LOAEL = 44/ 58 ( m/ f) mg/ kg/ day based on decreased F1 pup body weight on days 14 and 21 due to exposure via milk and in the diet.

870.4100a Chronic toxicity rodents NOAEL = 2.44 mg/ kg/ day LOAEL = 30.6 mg/ kg/ day based on decreased body weight and body weight gain, alteration in hematology ( mainly males) and increased incidences of interstitial cell hyperplasia in testes.

870.4100b Chronic toxicity dogs NOAEL = 26.9 mg/ kg/ day LOAEL = 116.6 mg/ kg/ day based on increased liver weight, alkaline phosphatase, and hepatocellular hypertrophy.

870.4200 Carcino genicity rats NOAEL = 2.44 mg/ kg/ day LOAEL = 30.6 mg/ kg/ day based on decreased body weight and body weight gain, alteration in hematology ( mainly males) and increased incidences of interstitial cell hyperplasia in the testes. ( Possible) evidence of carcinogenicity 870.4300 Carcino genicity mice NOAEL = 14.6 mg/ kg/ day LOAEL = 349 mg/ kg/ day based on increased liver weight and increased hepatic cell tumors ( adenomas and/ or carcinomas combined. ( Possible) evidence of carcinogenicity 870.5100 Gene Mutation No genotoxic effect in Ames assay using S. typhimurium. ( two studies)

870.5375 Cytogenetics No genotoxic effect in Chinese hampster ovary ( CHO) gene mutation assay 870.5375 870.5395 Other Effects Positive effects in the presence of metabolic activation, but inconclusive in the absence of metabolic activation in a chromosomal aberration/ human lymphocyte study. Mouse micronucleus assay negative for genotoxic effects.

870.6200a Acute neurotoxicity screening battery NOAEL = > 2,000 mg/ kg/ day HDT LOAEL = Not established 870.6200b Subchronic neurotoxicity screening battery NOAEL = 92.7/ 7.1 ( m/ f) mg/ kg/ day LOAEL = 186.2/ 51.6 ( m/ f) mg/ kg/ day based on decreased body weight and body weight gain.

870.7485 Metabolism and pharmacokinetics Urine major route of excretion at low doses and the feces at high doses. Ndesmethyl triflusulfuron methyl, the upper urinary metabolite composed between 25   44% of the dose at the low dose level ( single and repeated). Parent was the major component in the high dose feces and liver.

870.7600 Dermal penetration No dermal absorption studies were available. A 27% absorption was calculated from a ratio of the LOAEL from a developmental and 21   day dermal toxicity studies in rabbits.

Special studies: In vivo and in vitro mechanic studies The purpose of these studies was to investigate the mechanism of Leydig cell tumor induction in the testes of male rats. A dose dependent decrease in aromatase enzyme activity was seen in vitro, but was inconclusive in vivo.

B. Toxicological Endpoints The dose at which no adverse effects are observed, the NOAEL, from the toxicology study identified as appropriate for use in risk assessment is used to estimate the toxicological level of concern ( LOC). However, the lowest dose at which adverse effects of concern are identified, the LOAEL, is sometimes used for risk assessment if no NOAEL was achieved in the toxicology study selected. An uncertainty factor ( UF) is applied to reflect uncertainties inherent in the extrapolation from laboratory animal data to humans and in the variations in sensitivity among members of the human population as well as other unknowns. An UF of 100 is routinely used, 10X to account for interspecies differences and 10X for intraspecies differences. For dietary risk assessment ( other than cancer) the Agency uses the UF to calculate an acute or chronic reference dose ( acute RfD or chronic RfD) where the RfD is equal to the NOAEL divided by the appropriate UF ( RfD = NOAEL/

VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00051 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40192 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations UF). Where an additional safety factor 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 safety factor. For non dietary risk assessments ( other than cancer) the UF is used to determine the LOC. For example, when 100 is the appropriate UF ( 10X to account for interspecies differences and 10X for intraspecies differences) the LOC is 100. To estimate risk, a ratio of the NOAEL to exposures ( margin of exposure ( MOE) = NOAEL/ exposure) is calculated and compared to the LOC. The linear default risk methodology ( Q*) is the primary method currently used by the Agency to quantify carcinogenic risk. The Q* approach assumes that any amount of exposure will lead to some degree of cancer risk. A Q* is calculated and used to estimate risk which represents a probability of occurrence of additional cancer cases ( e. g., risk is expressed as 1 x 10 6 or one in a million). Under certain specific circumstances, MOE calculations will be used for the carcinogenic risk assessment. In this non linear approach, a `` point of departure'' is identified below which carcinogenic effects are not expected. The point of departure is typically a NOAEL based on an endpoint related to cancer effects though it may be a different value derived from the dose response curve. To estimate risk, a ratio of the point of departure to exposure ( MOEcancer= point of departure/ exposures) is calculated. A summary of the toxicological endpoints for triflusulfuron methyl used for human risk assessment is shown in Table 3 of this unit:

TABLE 3.   SUMMARY OF TOXICOLOGICAL DOSE AND ENDPOINTS FOR TRIFLUSULFURON METHYL FOR USE IN HUMAN RISK ASSESSMENT Exposure scenario Dose used in risk assessment UF FQPA SF* and LOC for risk assessment Study and toxicological effects Acute Dietary ( all population subgroups) N/ A No toxicological effects attributable to a single exposure ( dose) were observed in oral toxicity studies. Therefore, an acute RfD can not be established and an acute dietary risk assessment will not be conducted for the general population.

Chronic Dietary ( all populations) NOAEL = 2.44 mg/ kg/ day UF = 100 Chronic RfD = 0.024 mg/ kg/ day FQPA SF = 1x cPAD = chronic RfD ÷ FQPA SF = 0.024 mg/ kg/ day Chronic Toxicity in Rats LOAEL = 30.6 mg/ kg/ day based on decreased body weight and body weight gain, alter. In hematology ( mainly males), increased incidence of interstitial cell hyperplasia in testes.

Cancer ( oral, dermal, inhalation) Triflusulfuron methyl is classified as a Group C   possible human carcinogen chemical.

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

C. Exposure Assessment 1. Dietary exposure from food and feed uses. Tolerances have been established ( 40 CFR 180.492) for the residues of triflusulfuron methyl in or on sugar beet, root and sugar beet, top. Risk assessments were conducted by EPA to assess dietary exposures from triflusulfuron methyl 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. There are no effects attributable to a single, oral dose of triflusulfuron methyl. Therefore, an acute dietary risk assessment was not conducted. ii. Chronic exposure. In conducting this chronic dietary risk assessment, the Dietary Exposure Evaluation Model ( DEEMTM) analysis evaluated the individual food consumption as reported by respondents in the United States Department of Agriculture 1989   1992 Nationwide Continuing Surveys of Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. The following assumptions were made for the chronic exposure assessments: Tolerance level residues and that 100% of the crop is treated. Because suitable data depicting residues of triflusulfuron methyl in drinking were not available for incorporation into the dietary exposure model, the dietary exposure estimates do not include potential exposure from drinking water. The dietary exposure is based on sugar beets, because chicory was not reported as being consumed in the 1989   1992 CSFII. Therefore, inclusion of chicory in the dietary analysis would not alter the exposure or risk estimates from those obtained from sugar beets. The cRfD or 0.024 mg/ kg/ day was determined where the NOAEL of 2.44 mg/ kg/ day is based on decreased body weight gain, alterations in hematology ( mainly in males) and increases in the incidence of interstitial hyperplasia in the testes at the LOAEL of 30.6 mg/ kg/ day. A 100   fold UF for interspecies extrapolation and intraspecies variability was applied. iii. Cancer. Triflusulfuron methyl is classified as a Group C   possible human carcinogen chemical and for the purpose of risk characterization the RfD approach should be used for quantification of human risk. This decision was based on evidence of statistically significant, dose related increases in the incidence of interstitial cell adenomas of the testes at two doses, as well as statistically significant positive trend for these tumors in male rats. The testicular interstitial cell adenomas observed in the rat were benign. There was no reported increased tumor incidences of any type in the female rat and the dosing was adequate for assessing the carcinogenic potential of triflusulfuron methyl. Evidence of a hormonal mechanism for development of these benign tumors in rats does exist, however, the data were suggestive but not conclusive. Although there was some evidence of clastogenic activity for triflusulfuron methyl, positive results were only seen with activation in human lymphocytes/ chromosomal aberration assay. Triflusulfuron methyl is a member of a class of chemicals known as sulfonylureas. Of the 12 VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00052 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40193 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations analogs structurally related to triflusulfuron methyl, three sulfonylureas have been associated with carcinogenicity in rodents. Primisulfuron methyl and prosulfuron are classified as Group D carcinogens ( not classifiable as to human carcinogenicity). Only tribenuron methyl is classified as a Group C carcinogen ( possible human carcinogen), however, a Q* for cancer risk assessment is not required because there is no evidence of genotoxicity and the increased incidence of mammary gland tumors is observed at doses which exceed the maximum tolerated dose. Therefore the RfD approach is appropriate for quantification of human cancer risk. 2. Dietary exposure from drinking water. The Agency lacks sufficient monitoring exposure data to complete a comprehensive dietary exposure analysis and risk assessment for triflusulfuron methyl in drinking water. Because the Agency does not have comprehensive monitoring data, drinking water concentration estimates are made by reliance on simulation or modeling taking into account data on the physical characteristics of triflusulfuron methyl. The Agency uses the First Index Reservoir Screening Tool ( FIRST) or the Pesticide Root Zone/ Exposure Analysis Modeling System ( PRZM/ EXAMS), to produce estimates of pesticide concentrations in an index reservoir. The SCI GROW model is used to predict pesticide concentrations in shallow ground water. For a screening level assessment for surface water EPA will use FIRST ( a tier 1 model) before using PRZM/ EXAMS ( a tier 2 model). The FIRST model is a subset of the PRZM/ EXAMS model that uses a specific highend runoff scenario for pesticides. While both FIRST and PRZM/ EXAMS incorporate an index reservoir environment, the PRZM/ EXAMS model includes a percent crop area factor as an adjustment to account for the maximum percent crop coverage within a watershed or drainage basin. None of these models include consideration of the impact, processing ( mixing, dilution, or treatment) of raw water for distribution as drinking water would likely have on the removal of pesticides from the source water. The primary use of these models by the Agency at this stage is to provide a coarse screen for sorting out pesticides for which it is highly unlikely that drinking water concentrations would ever exceed human health LOCs. Since the models used are considered to be screening tools in the risk assessment process, the Agency does not use estimated environmental concentrations ( EECs) from these models to quantify drinking water exposure and risk as a % RfD or % PAD. Instead drinking water levels of comparison ( DWLOCs) are calculated and used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food, and from residential uses. Since DWLOCs address total aggregate exposure to triflusulfuron methyl they are further discussed in the aggregate risk sections in Unit III. E. Based on the PRZM/ EXAMS and SCIGROW models the EECs of triflusulfuron methyl for acute exposures are estimated to be 0.42 parts per billion ( ppb) for surface water and 0.5 ppb for ground water. The EECs for chronic exposures are estimated to be 0.005 ppb for surface water and 0.5 ug/ L ( micrograms/ Liter) for ground water. 3. From non dietary exposure. The term `` residential exposure'' is used in this document to refer to nonoccupational non dietary exposure ( e. g., for lawn and garden pest control, indoor pest control, termiticides, and flea and tick control on pets). Triflusulfuron methyl is not registered for use on any sites that would result in residential exposure. 4. Cumulative exposure to substances with a common mechanism of toxicity. Section 408( b)( 2)( D)( v) of 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 triflusulfuron methyl has a common mechanism of toxicity with other substances or how to include this pesticide in a cumulative risk assessment. Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, triflusulfuron methyl 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 triflusulfuron methyl has a common mechanism of toxicity with other substances. For information regarding EPA's efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see the final rule for Bifenthrin Pesticide Tolerances ( 62 FR 62961, November 26, 1997).

D. Safety Factor for Infants and Children 1. In general. Section 408 of FFDCA provides that EPA shall apply an additional 10   fold margin of safety for infants and children in the case of threshold effects to account for pre natal and post natal 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. Pre natal and post natal sensitivity. There is no quantitative or qualitative evidence of increased susceptibility of rat or rabbit fetuses to in utero exposure in the developmental studies. No developmental toxicity was seen at the limit dose ( 1,000 mg/ kg/ day) in rats. In rabbits, developmental toxicity manifested as abortions in the presence of severe maternal toxicity ( mortality, abortions, clinical signs, decreased body weight, and food efficiency). In the 2   generation reproductive toxicity study, the effects in the offspring ( decreased pup body weight in F1 on days 14 and 21; late lactation) can be attributed to the decreases in body weights seen in the parental animals. In addition, this decrease was seen only in the F1 generation but not in the second generation. There is no indication for a developmental neurotoxicity study since no neuropathological or neurobehavioral effects in the acute or subchronic neurotoxicity studies were observed; no alteration of the fetal nervous system was observed; and no evidence of neurotoxicity was found in other studies in the data base. 3. Conclusion. The toxicity data base for triflusulfuron methyl is complete except for a 28   day inhalation ( nose only) toxicity study. This study is of marginal value for the FFDCA determination because there are no residential uses of triflusulfuron methyl. Exposure data are complete or are estimated based on data that reasonably accounts for potential exposures. Based on these reasons, the FQPA Safety Factor for the protection of children has been removed ( i. e. reduced to 1x.)

E. Aggregate Risks and Determination of Safety To estimate total aggregate exposure to a pesticide from food, drinking water,

VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00053 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40194 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations and residential uses, the Agency calculates DWLOCs which are used as a point of comparison against the model estimates of a pesticide's concentration in water. DWLOC values are not regulatory standards for drinking water. DWLOCs are theoretical upper limits on a pesticide's concentration in drinking water in light of total aggregate exposure to a pesticide in food and residential uses. In calculating a DWLOC, the Agency determines how much of the acceptable exposure ( i. e., the PAD) is available for exposure through drinking water ( e. g., allowable chronic water exposure ( mg/ kg/ day) = cPAD ¥ ( average food + residential exposure)). This allowable exposure through drinking water is used to calculate a DWLOC. A DWLOC will vary depending on the toxic endpoint, drinking water consumption, and body weights. Default body weights and consumption values as used by the EPA Office of Water are used to calculate DWLOCs: 2L/ 70 kg ( adult male), 2L/ 60 kg ( adult female), and 1L/ 10 kg ( child). Default body weights and drinking water consumption values vary on an individual basis. This variation will be taken into account in more refined screening level and quantitative drinking water exposure assessments. Different populations will have different DWLOCs. Generally, a DWLOC is calculated for each type of risk assessment used: Acute, short term, intermediate term, chronic, and cancer. When EECs for surface water and ground water are less than the calculated DWLOCs, OPP concludes with reasonable certainty that exposures to the pesticide in drinking water ( when considered along with other sources of exposure for which OPP has reliable data) would not result in unacceptable levels of aggregate human health risk at this time. Because OPP considers the aggregate risk resulting from multiple exposure pathways associated with a pesticide's uses, levels of comparison in drinking water may vary as those uses change. If new uses are added in the future, OPP will reassess the potential impacts of residues of the pesticide in drinking water as a part of the aggregate risk assessment process. 1. Acute risk. Because there are no effects attributable to a single, oral dose of triflusulfuron methyl is not expected to pose an acute risk. 2. Chronic risk. Using the exposure assumptions described in this unit for chronic exposure, EPA has concluded that exposure to triflusulfuron methyl from food will utilize < 1% of the cPAD for the U. S. population, < 1% of the cPAD for infants < 1 year, and < 1% of the cPAD for children aged 1   6 years and children aged 7   12 years. There are no residential uses for triflusulfuron methyl that result in chronic residential exposure to triflusulfuron methyl. After calculating DWLOCs and comparing them to the EECs for surface and ground water, EPA does not expect the aggregate exposure to exceed 100% of the cPAD, as shown in Table 4 of this unit:

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

U. S. Population 0.000011 < 1 0.005 0.50 840 Female ( 13   50 years) 0.000009 < 1 0.005 0.50 720 All infants (< 1 year) 0.000040 < 1 0.005 0.50 240 Children ( 1   6 years) 0.000025 < 1 0.005 0.50 240 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). Triflusulfuron methyl is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC. 4. Intermediate term risk. Intermediate term aggregate exposure takes into account residential exposure plus chronic exposure to food and water ( considered to be a background exposure level). Triflusulfuron methyl is not registered for use on any sites that would result in residential exposure. Therefore, the aggregate risk is the sum of the risk from food and water, which do not exceed the Agency's LOC. 5. Aggregate cancer risk for U. S. population. Triflusulfuron methyl has been designated a Category C `` possible human carcinogen'' and does not require a separate cancer risk assessment. Because the RfD approach was determined appropriate for quanification of human cancer risk, the chronic aggregate risk assessment is sufficiently protective of human health. 6. Determination of safety. Based on these risk assessments, EPA concludes that there is a reasonable certainty that no harm will result to the general population, and to infants and children from aggregate exposure to triflusulfuron methyl residues.

IV. Other Considerations A. Analytical Enforcement Methodology An adequate tolerance enforcement method is available in PAM II. The method extracts residues of triflusulfuron methyl in a buffered acetonitrile solution, cleans the extract on a phenyl solid phase extraction cartridge, and quantitates residues on a HPLC/ UV system. B. International Residue Limits There are no Canadian or Codex MRLs established for triflusulfuron methyl.

C. Conditions Submission of a 28   day inhalation ( nose only) toxicity study is required as condition of registration.

V. Conclusion Therefore, the tolerances are established for residues of triflusulfuron methyl, methyl 2[[[[[ 4 ( dimethylamino) 6( 2,2,2 trifluoroethoxy) 1,3,5 triazin 2 yl] amino] carbonyl] amino] sulfonyl] 3 methylbenzoate, in or on chicory, roots at 0.05 ppm; and time limited tolerances for sugar beet, root at 0.05 ppm and sugar beet, top at 0.05 ppm are converted to permanent tolerances and redefined as beet, sugar, roots and beet, sugar, tops.

VI. Objections and Hearing Requests Under section 408( g) of FFDCA, as amended by the FQPA, any person may VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00054 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40195 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations 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 of 1996, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of 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 FFDCA sections 408 and 409. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2002   0082 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 August 12, 2002. 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 ( 1900), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. You may also deliver your request to the Office of the Hearing Clerk in Rm. C400, Waterside Mall, 401 M St., SW., Washington, DC 20460. 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 ( 202) 260   4865. 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. 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. 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. 2. Mail your copies, identified by docket ID number OPP   2002   0082, 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. In person or by courier, bring a copy to the location of the PIRIB described in Unit I. B. 2. 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. Regulatory Assessment Requirements This final rule establishes a tolerance under FFDCA section 408( d) in response to a petition submitted to the Agency. The Office of Management and Budget ( OMB) has exempted these types of actions from review under Executive Order 12866, entitled Regulatory Planning and Review ( 58 FR 51735, October 4, 1993). Because this rule has been exempted from review under Executive Order 12866 due to its lack of significance, this rule is not subject to Executive Order 13211, Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use ( 66 FR 28355, May 22, 2001). This final rule does not contain any information collections subject to OMB approval under the Paperwork Reduction Act ( PRA), 44 U. S. C. 3501 et seq., or impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act of 1995 ( UMRA) ( Public Law 104   4). Nor does it require any special considerations under Executive Order 12898, entitled Federal Actions to Address Environmental Justice in Minority Populations and Low Income Populations ( 59 FR 7629, February 16, 1994); or OMB review or any Agency action under Executive Order 13045, entitled Protection of Children from Environmental Health Risks and Safety Risks ( 62 FR 19885, April 23, 1997). This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12( d) of the National Technology Transfer and Advancement Act of 1995 ( NTTAA), Public Law 104   113, section 12( d) ( 15 U. S. C. 272 note). Since tolerances and exemptions that are established on the basis of a petition under FFDCA section 408( d), such as the tolerance in this final rule, do not VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00055 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1 40196 Federal Register / Vol. 67, No. 113 / Wednesday, June 12, 2002 / Rules and Regulations 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 FFDCA section 408( n)( 4). For these same reasons, the Agency has determined that this rule does not have any `` tribal implications'' as described in Executive Order 13175, entitled Consultation and Coordination with Indian Tribal Governments ( 65 FR 67249, November 6, 2000). Executive Order 13175, requires EPA to develop an accountable process to ensure `` meaningful and timely input by tribal officials in the development of regulatory policies that have tribal implications.'' `` Policies that have tribal implications'' is defined in the Executive order to include regulations that have `` substantial direct effects on one or more Indian tribes, on the relationship between the Federal Government and the Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes.'' This rule will not have substantial direct effects on tribal governments, on the relationship between the Federal Government and Indian tribes, or on the distribution of power and responsibilities between the Federal Government and Indian tribes, as specified in Executive Order 13175. Thus, Executive Order 13175 does not apply to this rule. VIII. Submission to Congress and the Comptroller General The Congressional Review Act, 5 U. S. C. 801 et seq., as added by the Small Business Regulatory Enforcement Fairness Act of 1996, generally provides that before a rule may take effect, the agency promulgating the rule must submit a rule report, which includes a copy of the rule, to each House of the Congress and to the Comptroller General of the United States. EPA will submit a report containing this rule and other required information to the U. S. Senate, the U. S. House of Representatives, and the Comptroller General of the United States prior to publication of this final rule in the Federal Register. This final rule is not a `` major rule'' as defined by 5 U. S. C. 804( 2).

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

Dated: May 31, 2002. Peter Caulkins, Acting Director, Registration Division, Office of Pesticide Programs.

Therefore, 40 CFR chapter I is amended as follows:

PART 180   [ AMENDED]

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

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

2. Section 180.492 is revised to read as follows:

§ 180.492 Triflusulfuron methyl; tolerances for residues.

( a) General. Tolerances are established for residues of the herbicide, triflusulfuron methyl 2[[[[[ 4 ( dimethylamino) 6( 2,2,2 trifluoroethoxy) 1,3,5 triazin 2 yl] amino] carbonyl] amino] sulfonyl] 3 methylbenzoate in or on the raw agricultural commodities:

Commodity Parts per million Beet, sugar, roots ..... 0.05 Beet, sugar, tops ....... 0.05 Chicory, roots ............ 0.05 ( b) Section 18 emergency exemptions. [ Reserved] ( c) Tolerances with regional registrations. [ Reserved] ( d) Indirect or inadvertent residues. [ Reserved]

[ FR Doc. 02   14501 Filed 6   11   02; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2002   0099; FRL   7182   1]

RIN 2070   AB78 Spinosad; Time Limited Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a time limited tolerance for residues/ combined residues of spinosad in or on stored grains ( barley, corn, oats, rice, sorghum/ milo, and wheat). Dow AgroSciences LLC requested this tolerance under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act ( FQPA) of 1996. The tolerance will expire on May 31, 2004. This timelimited tolerance is to permit the marketing of stored grains in accordance with the Experimental Use Permit ( EUP) 62719 EUP 50 which is being issued concurrently. DATES: This regulation is effective June 12, 2002. Objections and requests for hearings, identified by docket ID number OPP   2002   0099, must be received on or before August 12, 2002. ADDRESSES: Written objections and hearing requests may be submitted by mail, in person, or by courier. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. To ensure proper receipt by EPA, your objections and hearing requests must identify docket ID number OPP   2002   0099 in the subject line on the first page of your response. FOR FURTHER INFORMATION CONTACT: By mail: William G. Sproat, Jr., Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460; telephone number: 703   308   8587; e mail address: sproat. william@ epa. gov. SUPPLEMENTARY INFORMATION:

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

You may be affected by this action if you are an agricultural producer, food manufacturer, or pesticide VerDate May< 23> 2002 00: 52 Jun 12, 2002 Jkt 197001 PO 00000 Frm 00056 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 12JNR1. SGM pfrm17 PsN: 12JNR1


                      Information Collection Request for
             Diesel Emissions Reduction Act (DERA) Rebate Program

                 OMB Control No. 2060-NEW, EPA ICR No. 2461.01

                               February 2, 2012

                 United States Environmental Protection Agency
                          Office of Air and Radiation
                         1200 Pennsylvania Avenue, NW
                             Washington, DC 20460

Contents

1. Identification of the Information Collection	4
1(a) Title of the Information Collection	4
1(b) Short Characterization/Abstract	4
2. Need For and Use of the Collection	4
2(a) Need/Authority for the Collection	4
2(b) Practical Utility/Users of the Data	5
3. Non-duplication, Consultations, and Other Collection Criteria	6
3(a) Non-duplication	6
3(b) Public Notice Required Prior to ICR Submissions to OMB	6
3(c) Consultations	6
3(d) Effects of Less Frequent Collection	7
3(e) General Guidelines	8
3(f) Confidentiality	8
3(g) Sensitive Questions	8
4. The Respondents and the Information Requested	8
4(a) Respondents/Standard Industrial Classification (SIC) Codes	8
4(b) Information Requested	9
4(b)(i) Data Items	9
4(b)(ii) Respondent Activities	9
5(a) Agency Activities	10
5(b) Collection Methodology and Management	10
5(c) Small Entity Flexibility	10
5(d) Collection Schedule	10
6. Estimating the Burden and Cost of the Collection	11
6(a) Estimating Respondent Burden	11
6(b) Estimating Respondent Costs	11
6(b)(i) Estimating Labor Costs	11
6(b)(ii) Operating and Maintenance (O&M) Costs	11
6(b)(iii) Capital/Start-up Costs	12
6(c) Estimating Agency Burden and Cost	12
6(d) Estimating the Respondent Universe and Total Burden and Costs	12
6(e) Bottom Line Burden Hours and Cost Tables	13
6(e)(i) Respondent Tally	13
6(e)(ii) The Agency Tally	13
6(f) Burden Statement	13

Appendices

  A. Respondents and Agency Activities Tables

Tables

Table 6.1 Respondent tally	13
Table 6.2 Agency tally	13

1. Identification of the Information Collection
1(a) Title of the Information Collection
Title: Diesel Emissions Reduction Act (DERA) Rebate Program
OMB Control Number: 2060-NEW
EPA ICR Number: 2461.01
1(b) Short Characterization/Abstract
This is a new Information Collection Request (ICR) for the Diesel Emission Reduction Act program (DERA) authorized by Title VII, Subtitle G (Sections 791 to 797) of the Energy Policy Act of 2005 (Public Law 109-58), as amended by the Diesel Emissions Reduction Act of 2010 (Public Law 111-364), codified at 42 U.S.C. 16131 et seq.  DERA provides the Environmental Protection Agency (EPA) with the authority to award grants, rebates or low-cost revolving loans on a competitive basis to eligible entities to fund the costs of a retrofit technology that significantly reduces diesel emissions from mobile sources through implementation of a certified engine configuration, verified technology, or emerging technology.  Eligible mobile sources include buses (including school buses), medium heavy-duty or heavy heavy-duty diesel trucks, marine engines, locomotives, or nonroad engines or diesel vehicles or equipment used in construction, handling of cargo (including at port or airport), agriculture, mining, or energy production.  In addition, eligible entities may also use funds awarded for programs or projects to reduce long-duration idling using verified technology involving a vehicle or equipment described above. The objective of the assistance under this program is to achieve significant reductions in diesel emissions in terms of tons of pollution produced and reductions in diesel emissions exposure, particularly from fleets operating in areas designated by the Administrator as poor air quality areas.

EPA uses approved procedures and forms to collect necessary information to operate a grant program, and has been providing grants under DERA since Fiscal Year 2008.  EPA is requesting approval through this ICR for forms needed to collect necessary information to operate a rebate program as authorized by Congress under the DERA program.

EPA will collect information from applicants who wish to apply for a rebate under the DERA rebate program.  Information collected from applicants will ensure that they are eligible to receive funds under DERA, that funds are provided for eligible activities, and to calculate estimated and actual emissions benefits that result from activities funded with rebates as required in DERA's authorizing legislation.
2. Need For and Use of the Collection
2(a) Need/Authority for the Collection
This ICR is necessary to ensure that only eligible entities will receive funds under this program, and that funds are only provided for eligible activities per the DERA legislation (42 U.S.C. 16131 et seq.).  The information requested on the rebate application form is also needed to ensure the activities are completed in accordance with program guidance.  In addition, the information is necessary to ensure minimum fiscal control and accountability for EPA funds and to deter waste, fraud, and abuse.

Congress requires EPA to calculate and report on the estimated and actual air quality and diesel fuel conservation benefits resulting from DERA funding, as well as cost-effectiveness and cost-benefits of the grant, rebate and loan programs.  In order to accurately provide this required information to Congress, EPA must collect specific information about the vehicles and technologies funded through the DERA program.

2(b) Practical Utility/Users of the Data
There are several sections of the Application Form.  All applicants will fill out Table 1 of the form, that asks for information about the applicant including DUNS number, address, and number of vehicles to be retrofitted or replace.  This information is required to ensure the applicant is eligible, and to have contact information on file.  All applicants will also fill out Table 2, providing information on the current vehicle to be replaced or retrofitted.  Information requested includes the fleet type, vehicle identification number, engine model year, and average annual vehicle miles traveled.  This information is collected to ensure the vehicle or equipment being replaced is eligible under the DERA rebate program.

Applicants applying for a vehicle or engine replacement rebate must fill out Table 3,  and applicants applying for a retrofit rebate must fill out Table 4.  Information in Tables 3 and 4 include specifics about the proposed new vehicle or equipment, and will be used to ensure that the vehicle or technology that is planned for purchase by the applicant meets all eligibility requirements under the DERA rebate program.  In addition, the information will be used to calculate the estimated emissions reductions that will be achieved through the rebate, and to meet the statutory requirements to report to Congress the estimated air quality and diesel fuel conservation benefits, cost-effectiveness, and cost-benefits of that activity prior to the activity occurring.

After the applicant has been approved, the applicant may purchase the vehicle or equipment specified in the rebate program guidance.  After purchase and installation of the new vehicle or equipment, the applicant will re-submit the completed application form, correcting and confirming all information that was estimated on the initial form submittal.  The applicant will also submit a copy of all invoices to be reimbursed for eligible expenses.  This information is necessary to meet the statutory requirements to report to Congress the actual air quality and diesel fuel conservation benefits, cost-effectiveness, and cost-benefits of that activity.  In addition the information collected will ensure minimum fiscal control and accountability for EPA funds and to deter waste, fraud, and abuse.

3. Non-duplication, Consultations, and Other Collection Criteria
3(a) Non-duplication
Information requested from respondents under this ICR is not available from other sources. There are no existing rebate programs at EPA where this information may have been previously collected. Some rebate applicants may have applied for and received grants from EPA; however, information currently held in EPA's Integrated Grants Management System that could pertain to the rebate program would likely only consist of applicant names, addresses, and other identifying information that would not be burdensome for a rebate applicant to reproduce. Other information related to the specific vehicle(s) applying for rebates would not be readily available from other sources.
3(b) Public Notice Required Prior to ICR Submissions to OMB
In compliance with the 1995 Paperwork Reduction Act (PRA), any agency developing a non-rule-related ICR must solicit public comments for a 60-day period before submitting the ICR to OMB.  These comments, which are used partly to determine realistic burden estimates for respondents, must be considered when completing the Supporting Statement that is submitted to OMB.
3(c) Consultations
EPA headquarters and regional staff responsible for DERA program oversight and implementation were contacted to provide information, data, and review for this ICR.

EPA solicited information on rebate program structure, management, and information collection from other Federal, state and local rebate programs, including:

   * USDOT CARS Program ("Cash for Clunkers")
      Contact: Terry Anderson, National Highway Traffic Safety Administration

   * California Air Resources Board (CARB) Hybrid Truck and Bus Voucher Incentive Project
      Contact: Joe Calavita, CARB

   * Pittsburgh Healthy School Bus Initiative
      Contact: Brooke Suter, Clean Air Task Force

Additionally, EPA consulted with representatives from industries potentially affected by a rebate program to determine availability of the information we are requesting on the rebate forms and the typical process and time required to procure a new vehicle or retrofit an existing vehicle. As EPA anticipates initially conducting pilot program offering rebates for the replacement of school buses, we consulted with the following representatives of public and private school bus fleets:

   * Shenendahowa Central School District, Clifton Park, NY
      Contact: David Christopher

   * National Association for Pupil Transportation
      Contact: Alexandra Robinson, President

   * Stafford County Public Schools, Fredericksburg, VA
      Contact: Barry Sudduth

   * Farmington Public Schools, Farmington, MI
      Contact: William Tousley

   * Adams 12 Five Star Schools, Broomfield, CO
      Contact: David Anderson

   * Midland School District, Midland, TX
      Contact: Willie Tarleton

All of the representatives contacted generally supported the idea of offering rebates to incentivize the replacement of older, more polluting school buses with new, cleaner or alternative fuel models.

3(d) Effects of Less Frequent Collection
EPA recognizes the importance of balancing the need for data collection efforts against respondent burden and costs.  The information needed for EPA to assess whether a rebate applicant is eligible to receive a rebate is expected to be submitted one time for each rebate requested. Individual applicants can initially apply for up to 5 rebates at one time; however, as the rebate application form is specific to each vehicle, the applicant would be expected to submit one form per vehicle. EPA needs current information about the vehicle(s) to be replaced and the proposed replacement vehicle(s) to properly evaluate rebate eligibility. The burden described in this ICR identifies the burden that EPA has determined as necessary.  EPA strives to minimize burden.  EPA has determined that the information currently required is the minimum that is necessary to adequately evaluate applicant eligibility.
3(e) General Guidelines
This information collection is consistent with OMB guidelines contained in 5 CFR 1320.5(d)(2). Requests for supplemental information for the purposes of emergency response or enforcement activities are exempt from the Paperwork Reduction Act requirements.
3(f) Confidentiality
Applicants will not be required to submit confidential business information. If an applicant feels that any information requested would be confidential business information, the applicant may request that such information be treated as confidential.  All confidential data will be handled in accordance with 40 CFR 122.7, 40 CFR Part 2, and EPA's Security Manual Part III, Chapter 9, dated August 9, 1976.  Any claim of confidentiality must be asserted at the time of submission.
3(g) Sensitive Questions
Sensitive questions are defined in EPA's ICR Handbook, Guide to Writing Information Collection Requests Under the Paperwork Reduction Act of 1995 as "questions concerning sexual behavior or attitudes, religious beliefs, or other matters usually considered private."  The requirements addressed in this ICR do not include sensitive questions.

4. The Respondents and the Information Requested
4(a) Respondents/Standard Industrial Classification (SIC) Codes

The primary recipients of EPA rebates are State and local governments, Indian Tribes, educational institutions, not-for-profit institutions, and certain private organizations.  The information requested is used to determine rebate eligibility, pay recipients, and collect information on how Federal funds are being spent.

Standard Industrial Classification Codes for respondents include:

4151		 -  School Buses
8211 		 -  Elementary and Secondary Schools
8221 		 -  Colleges, Universities, and Professional Schools
8399		 -  Social Services, Not Elsewhere Classified
9199		 -  General Government, Not Elsewhere Classified

The corresponding North American Industry Classification System (NAICS) Codes for respondents include:

48541 		 -  School and Employee Bus Transportation
61111 		 -  Elementary and Secondary Schools
61131 		 -  Colleges, Universities, and Professional Schools
813212	 -  Voluntary Health Organizations
813219 	 -  Other Grantmaking and Giving Services
813312 	 -  Environment, Conservation, and Wildlife Organizations
813910 	 -  Business Associations
813920 	 -  Professional Organizations
9211 		 -  Executive, Legislative, and Other Government Support
9221		 -  Justice, Public Order, and Safety Activities

4(b) Information Requested
This section presents the data items, including recordkeeping requirements, and required respondent activities involved in preparing and submitting those data items.

4(b)(i) Data Items

The following data items are expected to be collected as part of a rebate application and receipt process:

   * Applicant name, address, and other identifying information, such as Employer Identification Number or Dun and Bradstreet Number
   * Characteristics of the vehicle(s) for which the rebate(s) is requested, including information to allow for the calculation of potential emissions reduced
   * Information on the proposed replacement vehicle(s) or retrofit technology(ies), to ensure that DERA program objectives will be met
   * If a private applicant, documentation of a contract, license, or lease with an eligible public entity
   * If a vehicle replacement rebate, price quote for the replacement vehicle proposed method of old vehicle scrappage
   * If a retrofit rebate, documentation of vehicle data logging (if applicable to the chosen retrofit make and model)
4(b)(ii) Respondent Activities

DERA Rebate Program applicants must perform the following:

   * Submit a completed application form signed by an Authorized Representative and any necessary supporting documentation
   * Submit evidence of completion of the rebate-eligible activity (e.g., vehicle replacement and scrappage of old vehicle or retrofit of existing vehicle) to obtain a rebate payment
   * Retain all records related to the rebate application and payment for a period of 3 years

5. The Information Collected -- Agency Activities, Collection Methodology, and Information Management
5(a) Agency Activities
This ICR includes all of the application and reimbursement forms related to EPA's Diesel Emissions Reduction Act Rebate Program. EPA will accept, evaluate, and approve applications from eligible applicants for eligible rebate activities. EPA will subsequently review each applicant's claim form to determine if payment is warranted. EPA will enter information on applicants, vehicles, and rebate payments into a database to manage the rebate program.

Agency activities associated with the review and approval of a rebate consist of the following:

   * Determine and notify within 30 days of initial application submission whether submission is eligible
   * Determine and notify within 30 days of rebate request submission whether submission is complete and rebate can be issued
5(b) Collection Methodology and Management
EPA will collect and store data from applicants, such as applicant, vehicle, and payment information in a database to manage the rebate program. Data supplied by rebate applicants on paper or electronic forms (via email) will be entered into the database by EPA. EPA will ensure the accuracy and completeness of collected information by reviewing each submittal. EPA will use data collected on processed rebate requests to estimate the emission reductions and cost-effectiveness of the rebate program for its required annual report to Congress.
5(c) Small Entity Flexibility
For many reasons, EPA believes the reporting requirements discussed in this ICR do not place an unreasonable burden on small businesses. The application form requests minimal information used to identify an applicant, verify eligibility, and evaluate the proposed action for rebate eligibility. An application form is submitted once for each eligible vehicle or piece of equipment. The burden represented by the application form cannot be further reduced for small businesses.  EPA needs certain basic information to make decisions regarding rebate payments.  This basic information is not dependent on an operator's size.

Minimizing the burden on small entities also comes in the form of guidance materials.  For example, to assist applicants of all sizes, but potentially most useful for small entities, EPA will develop guidance on applying for a rebate.
5(d) Collection Schedule
Applying for a rebate is a voluntary activity. Information collection would begin once EPA announces the availability of rebate funds and makes the program guidance available on the internet (www.epa.gov/cleandiesel). Applicants may submit Part I of the rebate application form to apply for rebate funds at any time while funds are available. If approved, applicants will have 60 days from receipt of the notice of approval from EPA to submit evidence of an order being placed for a new vehicle or retrofit, such as a copy of a purchase order.  Finally, applicants will have nine months from the initial notice of approval to submit Part II of the rebate application form with supporting documentation to obtain a rebate.

6. Estimating the Burden and Cost of the Collection
6(a) Estimating Respondent Burden
 This section presents the estimated respondent burden for each information request.  Data are tabulated in the "Respondents and Agency Activities Table" provided as Appendix A.  That table presents all assumptions, calculations, and results discussed in this ICR. The breakdown of cost and burden by labor category is provided in Section 6(b).

6(b) Estimating Respondent Costs
With burden hour estimates in place from Section 6(a), the next step is to estimate the labor cost per respondent and the capital costs required to complete each activity.  The total cost for each respondent activity is composed of the following:
Labor Cost;
Operating and Maintenance (O&M) Cost; and
Capital/Start-up Cost.

The results of the respondents' costs analysis are presented in the Respondents and Agency Activities Table in Appendix A. Note that there are no O&M or capital costs associated with the DERA Rebate Program.

6(b)(i) Estimating Labor Costs
To estimate the potential costs, EPA identified labor categories associated with performing each activity.  Labor categories include managerial, technical, and clerical.  Mean hourly wage data was obtained from the Bureau of Labor Statistics (BLS) publication, National Compensation Survey: Occupational Earnings in the United States, 2010 (May 2011).  Estimates of benefits as a percentage of mean hourly wage were obtained from the BLS news release, Employer Costs for Employee Compensation - September 2011. Table A1 in Appendix A shows the assumptions made by EPA when determining the cost of labor for various types of applicants.
6(b)(ii) Operating and Maintenance (O&M) Costs
This ICR account for labor costs only. The DERA rebate program does not require respondents to perform activities outside the normal operation practices.
6(b)(iii) Capital/Start-up Costs
This ICR account for labor costs only. The DERA rebate program does not require respondents to perform activities outside the normal operation practices.
6(c) Estimating Agency Burden and Cost
EPA's estimate of its burden and costs are from the activities described in Section 5(a).  When calculating the Agency cost, EPA makes the following assumption:

EPA determined the hourly employment cost of federal employees using methodology established in previous ICRs.  According to the U.S. Office of Personnel Management, 2012 General Schedule (2012-GS), the average annual salary of a government employee at the GS-9, Step 10 level is $54,028.  At 2,080 hours per year, the hourly wage is $25.98.  Assuming overhead costs of 60 percent, or $15.59 per hour, the fully loaded cost of employment for a federal employee is $41.57.

Burden and costs incurred by EPA are presented in Table A7 in Appendix A.
6(d) Estimating the Respondent Universe and Total Burden and Costs
Detailed information describing the universe and basis for burden and costs is provided in Section 6(a).  Results are presented in Tables A2 through A6 in Appendix A.  Those tables provide the respondent universe and the source of information for all respondent categories used throughout this ICR.
6(e) Bottom Line Burden Hours and Cost Tables
6(e)(i) Respondent Tally
The bottom line burden hours and costs for rebate applicants are the average annual hours and costs collectively incurred for all activities during the 3-year period covered by this ICR.  Table 6.1 provides a summary of the average annual number of applicants, burden hours, and costs. A more detailed summary is provided in Tables A2 through A6 in Appendix A.

                          Table 6.1 Respondent tally
Respondents (number)
                                                                            120
Responses (number)
                                                                            220
Burden (hours)
                                                                            894
Costs (labor)
                                                                        $44,547
Costs (capital)
                                                                             $0
Costs (O&M)
                                                                             $0
Total costs
                                                                        $44,547
Average annual burden per respondent
                                                                           $371
6(e)(ii) The Agency Tally
The bottom line burden hours and costs for the Agency are the total annual hours and costs collectively incurred for all activities during the period covered by this ICR. Table 6.2 provides a summary of the average annual Agency burden hours and costs. A more detailed summary is provided in Table A7 in Appendix A.

                            Table 6.2 Agency tally
Responses (number)
                                                                            220
Burden (hours)
                                                                            270
Costs (labor)
                                                                        $11,224
Costs (capital)
                                                                             $0
Costs (O&M)
                                                                             $0
Total costs
                                                                        $11,224

6(f) Burden Statement
The calculations made for this ICR cover the burden and costs for EPA and eligible applicants to the DERA Rebate Program. This ICR estimates an annual burden of 894 hours for 120 applicants at a labor cost of $44,547. Agency burden is 270 hours annually at a labor cost of $11,057.  The annual respondent reporting and recordkeeping burden for this collection of information is estimated to average 7.925 hours per response.

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, or disclose or provide information to or for a federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

To comment on EPA's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, the Agency has established a public docket for this ICR under Docket ID No. EPA - HQ - OAR - 2012 - 0103, which is available for public viewing at the Air and Radiation Docket in the EPA Docket Center (EPA/DC), 1200 Pennsylvania Avenue NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Air Docket is<PHONE_NUMBER>.  An electronic version of the public docket is available through the Federal Docket Management System (FDMS) at http://www.regulations.gov/. Use FDMS to submit or view public comments, to access the index listing of the contents of the public docket, and to access documents in the public docket that are available electronically. Once in the system, key in the docket ID number identified above. You can also send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA.  Please include the EPA Docket ID No. EPA - HQ - OAR - 2012 - 0103 and OMB Control No. 2060-NEW in any correspondence.


[Federal Register Volume 87, Number 61 (Wednesday, March 30, 2022)]
[Notices]
[Page 18362]
[FR Doc No: 2022-06694]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD06-6-000]

Notice of Joint Meeting of the Federal Energy Regulatory
Commission and the Nuclear Regulatory Commission

    The Federal Energy Regulatory Commission (FERC) and the Nuclear
Regulatory Commission (NRC) will hold a joint meeting on Thursday,
March 31, 2022. The open meeting will be held virtually and is expected
to begin at 9:00 a.m. and conclude at approximately 11:30 a.m. Eastern
Time. Members of the public may attend the open session. Commissioners
from both agencies are expected to participate.
    The format for the joint meeting will consist of discussions
between the two sets of Commissioners following presentations by their
respective staffs. In addition, a representative of the North American
Electric Reliability Corporation (NERC) will attend and participate in
this meeting. Attached is an agenda of the meeting.
    A free webcast of this event will be made available for viewing
through the NRC's Webcast portal at https://video.nrc.gov/. In
addition, the event will be transcribed, and the transcription will be
made available through the NRC website at https://www.nrc.gov/reading-rm/doc-collections/commission/tr/2022/index.html approximately a week
after the meeting.
    All interested persons are invited to the open meeting. Pre-
registration is not required and there is no fee to attend this joint
meeting. Questions about the meeting should be directed to Lodie White
at [email protected] or by phone at<PHONE_NUMBER>.

    Dated: March 24, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-06694 Filed 3-29-22; 8:45 am]
BILLING CODE 6717-01-P