7931 Federal Register / Vol. 68, No. 33 / Wednesday, February 19, 2003 / Rules and Regulations Dated: February 4, 2003. Craig E. Bone, Captain, Coast Guard Captain of the Port, New York. [ FR Doc. 03   3980 Filed 2   18   03; 8: 45 am]

BILLING CODE 4910   15   P ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2002   0273; FRL   7278   7]

Pelargonic Acid ( Nonanoic Acid); Exemption from the Requirement of a Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of the pelargonic acid in or on all foods when applied used as a component of a food contact surface sanitizing solution in food handling establishments. Eco Lab Inc. 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 February 19, 2003. Objections and requests for hearings, identified by docket ID number OPP   2002   0273, must be received on or before April 21, 2003. ADDRESSES: Written objections and hearing requests may be submitted by mail, electronically, or in person. Please follow the detailed instructions for each method as provided in Unit VI. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Adam Heyward, Antimicrobials Division ( 7510C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   6422; e mail address: heyward. adam@ 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:   Crop production ( NAIC code 111)   Animal production ( NAIC code 112)   Food manufacturing ( NAIC code 311)   Pesticide manufacturing ( NAIC code 32532)

B. How Can I Get Copies of this Document and Other Related Information? 1. Docket. EPA has established an official public docket for this action under docket identification ( ID) number OPP   2002   0273. The official public docket consists of the documents specifically referenced in this action, any public comments received, and other information related to this action. Although a part of the official docket, the public docket does not include Confidential Business Information ( CBI) or other information whose disclosure is restricted by statute. The official public docket is the collection of materials that is available for public viewing at the Public Information and Records Integrity Branch ( PIRIB), Rm. 119, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. This docket facility is open from 8: 30 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The docket telephone number is ( 703) 305   5805. 2. Electronic access. You may access this Federal Register document electronically through the EPA Internet under the `` Federal Register'' listings at http:// www. epa. gov/ fedrgstr/. A frequently updated electronic version of 40 CFR part 180 is available at http:// www. access. gpo. gov/ nara/ cfr/ cfrhtml_ 00/ Title_ 40/ 40cfr180_ 00. html, a beta site currently under development. An electronic version of the public docket is available through EPA's electronic public docket and comment system, EPA Dockets. You may use EPA Dockets at http:// www. epa. gov/ edocket/ to submit or view public comments, access the index listing of the contents of the official public docket, and to access those documents in the public docket that are available electronically. Although not all docket materials may be available electronically, you may still access any of the publicly available docket materials through the docket facility identified in Unit I. B. 1. Once in the system, select `` search,'' then key in the appropriate docket ID number.

II. Background and Statutory Findings In the Federal Register of December 7, 2001 ( 66 FR 63534) ( FRL   6737   9), EPA issued a notice pursuant to section 408 of FFDCA, 21 U. S. C. 346a, as amended by FQPA ( Public Law 104   170), announcing the filing of a pesticide petition ( PP 0F6193) by Eco Lab Inc., 370 N. Wabasha Street, St. Paul MN 55102. That notice included a summary of the petition prepared by Eco Lab, Inc., the registrant. There were no comments received in response to the notice of filing. The petition requested that 40 CFR 180.1159 be amended by establishing an exemption from the requirement of a tolerance for residues of nonanoic acid. Nonanoic acid is a component of a proposed product KX 6116 in which this active ingredient is present at 6.49% in the formulation. The proposed sanitizer formulation is applied to food contact surfaces such as equipment, pipelines, tanks, vats, fillers, evaporators, pasteurizers and aseptic equipment in restaurants, food service operations, dairies, breweries, wineries, and beverage and food processing plants. The sanitizer is applied by immersion, coarse spray, or circulation technique as appropriate to the equipment. The solution, once applied, is allowed to drain and dry and there is no potable water rinse. Section 408( b)( 2)( A)( i) of the FFDCA allows EPA to establish an exemption from the requirement for 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) 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) 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. First, EPA determines the toxicity of pesticides. Second, EPA examines exposure to the pesticide through food, drinking water, and through other exposures that occur as a result of pesticide use in residential settings.

III. Toxicological Profile 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 and considered its validity, completeness and reliability and the relationship of this information to human risk. EPA has also considered available information concerning the VerDate Dec< 13> 2002 15: 02 Feb 18, 2003 Jkt 200001 PO 00000 Frm 00035 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19FER1. SGM 19FER1 7932 Federal Register / Vol. 68, No. 33 / Wednesday, February 19, 2003 / Rules and Regulations variability of the sensitivities of major identifiable subgroups of consumers, including infants and children. The nature of the toxic effects caused by pelargonic acid ( nonanoic acid) are discussed in this unit.

A. Acute Toxicity As a result of a number of acute toxicity studies, technical pelargonic acid is placed in the following Toxicity Categories: Primary eye irritation ( Toxicity Category II), primary eye irritation ( Toxicity Category II), acute oral toxicity ( Toxicity Category IV), acute dermal and inhalation toxicity ( Toxicity Category III). Sensitization test results showed that pelargonic acid cannot be considered a dermal sensitizer.

B. Subchronic and Chronic Toxicity In an oral toxicity study ( conducted for 14 days), no systemic toxicity was observed with either sex even at the highest dose tested, 20,000 parts per million ( ppm) ( 1,834 milligrams/ kilogram/ day ( mg/ kg/ day)). In addition, pelargonic acid showed no adverse effects on survival, clinical signs, body weight gain, food consumption, hematology, clinical chemistry or gross pathology. For each dose, three animals per sex were tested. However, the study did not report organ weights and histopathology. This was considered a deficiency in this study. Nevertheless, the Agency determined that because no toxic effects were observed at a very high level of   2,000 mg/ kg, a 90   day oral study was not necessary. A 28   day dermal toxicity study conducted on rabbits was submitted to the Agency under TSCA section 8( e). Five male and five female New Zealand white rabbits were dermally treated with pelargonic acid present in mineral oil. In all, 10 applications were made ( 5 per week) at a dose level of 500 mg/ kg/ day. A 2   week recovery period was allowed for selected rabbits. During the first and second week of treatment, slight body weight loss and decreased food consumption were observed. One female rabbit showed ocular discharge and hypoactivity during the second week of treatment. All rabbits dermally treated with pelargonic acid by day 14 showed signs of severe erythema and moderate edema. Dermal reactions consisting of moderate desquamation, moderate fissuring, eschar, exfoliation and necrosis were also observed at day 14. By day 29, all dermal reactions had reversed. It was evident that at the treatment level of 500 mg/ kg/ day of pelargonic acid, significant dermal signs of toxicity were observed but no significant systemic reaction. A supplemental study on chronic toxicity/ carcinogenicity in mice was conducted for 80 weeks. A dose of 50 mg of pelargonic acid was dermally applied to each mouse twice/ day for 80 weeks. Histopathology showed no nonneoplastic or neoplastic lesions on skins and internal organs of mice. The Agency concluded that this study although not exactly conducted according to guideline, adequately assesses the chronic toxicity and the carcinogenic potential of pelargonic acid via the dermal route.

C. Developmental Toxicity A development toxicity was conducted on a group of 22 pregnant Crl: COBS CD( SD) BR rats. These rats were treated with pelargonic acid in corn oil at a dose of 1,500 mg/ kg on gestation days 6 through 15 ( both days inclusive). Maternal body weight was not significantly affected during the treatment. Only 1 out of 22 animals showed signs of clinical toxicity. No significant histopathology signs were observed in the maternal animals. Pelargonic acid treatment did not have any significant effect on cesarean section observations. Four fetuses in one litter showed a higher incidence of cleft palate compared to the control mean. For maternal toxicity, the Agency has determined the no observed adverse effect level ( NOAEL) to be greater than 1,500 mg/ kg/ day. Because fetal effects were observed at 1,500 mg/ kg/ day, the NOAEL for developmental toxicity was not determined. The Agency has determined that this dose is in excess of the Agency's limit dose for toxic effects. The type and level of exposure expected from the use of this chemical is much lower than the dose level shown in the study.

D. Mutagenicity/ Carcinogenicity Ames Test ( Salmonella/ reverse mutation assay) showed pelargonic acid to be non mutgenic. Similarly, in vivo cytogenetics study using micronucleus assay gave a negative result. In a mouse lymphoma forward mutation study, pelargonic acid appears to induce a weak mutagenic response at or higher than 50 milligrams/ milliliter ( mg/ mL) level. This was observed in the presence of increasing toxicity, and may be an indication of gross chromosomal changes or damage and not actual mutational changes within the thymidine kinese gene locus. As described above, a summary of the results of a dermal carcinogenicity study in mice with pelargonic acid was submitted. Fifty mice were treated twice weekly with 50 mg doses of undiluted pelargonic acid for 80 weeks. No evidence of severe dermal or systemic toxicity was seen. Histopathology revealed no tumors of the skin or the internal organs E. Exposure Assessment In examining aggregate exposure, FFDCA section 408 directs EPA to consider available information concerning exposures from the pesticide residue in food and all other nonoccupational exposures, including drinking water from ground water or surface water and exposure through pesticide use in gardens, lawns, or buildings ( residential and other indoor uses). The Agency has considered available information on the aggregate exposure levels of consumers ( and major identifiable subgroups of consumers) to the pesticide chemical residue of pelargonic acid ( nonanoic acid) and to other related substances. In these considerations, the Agency has included dietary exposure under the tolerance exemption and all other tolerances or exemptions in effect for pelargonic acid's chemical residue and exposure from non occupational sources. The Food and Drug Administration has cleared pelargonic acid as a synthetic food flavoring agent ( 21 CFR 172.515), as an adjuvant, production aid and sanitizer to be used in contact with food ( 21 CFR 178.1010( b)) and in washing or to assist in lye peeling of fruits and vegetables ( up to 1%) ( 21 CFR 173.315). Pelargonic acid is also exempt from the requirement of a tolerance when used in or on all food commodities, as a plant regulator on plants, seeds, or cuttings after harvest in accordance with GAP. It is also exempt from a tolerance when used as a herbicide on all plant food commodities provided that allocations are not made directly to the food commodity except when used as a harvest aid or dessicant to any root or tuber vegetable, bulb, or cotton ( 40 CFR 180.1159). Applications of the proposed end use products containing pelargonic acid will not directly contact edible portions of food commodities. 1. Food. For the proposed sanitizer uses, a worst case dietary exposure estimate has been calculated, assuming that all food consumed by an adult or child has contacted a sanitized surface using pelargonic acid, that a 1 mg/ cm2 sanitizer residue remains on the surface, and that 100% of the residue ( 170 ppm) is transferred to the food from the surface. Using these assumptions, in which all food contacts 4,000 cm2 of sanitized non porous food contact surfaces a worst case dietary exposure of 680 µ g/ day is calculated. For a 70 kg adult this becomes 9.7 µ g/ kg/ day and for VerDate Dec< 13> 2002 15: 02 Feb 18, 2003 Jkt 200001 PO 00000 Frm 00036 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19FER1. SGM 19FER1 7933 Federal Register / Vol. 68, No. 33 / Wednesday, February 19, 2003 / Rules and Regulations a 15 kg child, exposure is calculated as 45 µ g/ kg/ day. 2. Drinking water exposure. KX 6116 as a sanitizer contains pelargonic acid as its active component and low concentrations of pelargonic acid could be expected to be introduced into drinking water. However, exposure through drinking water is expected to be low and not of significance. 3. Other non occupational exposure. Based on the intended use of pelargonic acid in food handling establishments, exposure to pelargonic acid as a component of KX 6116 sanitizer through non occupational, non dietary sources is not likely to occur. 4. Cumulative effects. Section 408( b)( 2)( D)( v) 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. Based on the information discussed in Unit VII. EPA concluded that pelargonic acid is sufficiently non toxic that EPA can determine that it does not share a common mechanism of toxicity with other substances.

F. Safety Factor for Infants and Children 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. Based on the considerations discussed in Unit III. G., EPA concluded that pelargonic acid was sufficiently nontoxic that a margin of safety analysis was not appropriate. For the same reason, EPA has not applied an additional margin of safety for the protection of infants and children.

G. Determination of Safety Based on the following considerations, EPA concludes that pelargonic acid is unlikely to pose a risk under all reasonable exposure scenarios: 1. Fatty acids such as pelargonic acid are processed by known metabolic pathways within the body and contribute to normal physiological function. 2. Pelargonic acid is naturally present at levels up to 224 parts per billion ( ppb) in apples, 385 ppm in the skin of grapes, and 143 ppm in grape pulp. It is present in a number of other foods as well. An average serving of grapes containing 385 ppm of pelargonic acid in the grape skins would result in exposure to pelargonic acid to an average consumer of 164 µ g/ kg/ day. In comparison, a worst case estimate of dietary exposure to pelargonic acid as a result of its use as sanitizer is 9.7 µ g/ kg/ day for a 70 kg adult and 45 µ g/ kg/ day for a 15 kg child. 3. The Food and Drug Administration has cleared pelargonic acid as a synthetic food flavoring agent ( 21 CFR 172.515), as an adjuvant, production aid and sanitizer to be used in contact with food ( 21 CFR 178.1010( b)) and in washing or to assist in lye peeling of fruits and vegetables ( up to 1%) ( 21 CFR 173.315). Pelargonic acid is also exempt from the requirement of a tolerance when used in or on all food commodities, as a plant regulator on plants, seeds, or cuttings after harvest in accordance with Good Agricultural Practices ( GAP). It is also exempt from a tolerance when used as a herbicide on all plant food commodities provided that allocations are not made directly to the food commodity except when used as a harvest aid or dessicant to any root or tuber vegetable, bulb, or cotton ( 40 CFR 180.1159). 4. Dietary toxicity testing evidenced adverse reactions only at doses that were at or above limit doses. Dermal toxicity testing showed no significant systemic reaction. 5. The estimated exposures to pelargonic acid and other fatty acids from direct or indirect addition to food as well as sanitizer uses are well below the doses administered in animal studies that are required to elicit an adverse effect. Accordingly, EPA concludes that there is a reasonable certainty of no harm to the general population, including infants and children, from aggregate exposure to pelargonic acid.

IV. Other Considerations A. Analytical Method( s)

Because an exemption from the requirement of a tolerance without numerical limitation for residues in food is being granted for pelargonic acid, an enforcement analytical method is not needed. However, an analytical method is available in cases of gross misuse. The analytical method is being made available to anyone interested in pesticide enforcement when requested, from Norm Cook, Antimicrobials Division ( 7510C), Office of Pesticide Programs, U. S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. Office location and telephone number: 1921 Jefferson Davis Highway, 3rd Floor, Arlington, VA 22202, ( 703) 308   8253.

B. Existing Tolerances 1. 40 CFR 180.1159. Pelargonic acid is exempted from the requirement of a tolerance on all food commodities when used as a plant regulator on plants, seeds, or cuttings and all food commodities after harvest in accordance with GAP or as a herbicide when applications are not made directly to the food commodity except when used as a harvest aid or dessicant to: any root and tuber vegetables, bulb vegetable or cotton. When pelargonic acid is used as a harvest aid or dessicant, application must be made no later than 24 hours prior to harvest. 2. 21 CFR 178.1010( c)( 37). Pelargonic acid is permitted in food contact sanitizing solutions at a level up to 90 ppm. 3. 21 CFR 172.515. Pelargonic acid may be safely used as synthetic food flavoring substances and adjuvants in food in the minimum quantity required to reproduce the intended effect. 4. 21 CFR 173.315. Pelargonic acid may be used in an aliphatic acid mixture for washing or to assist in the peeling of fruits and vegetables. The aliphatic acid mixture may be used at a level not to exceed 1% in the lye peeling solution.

C. International Tolerances No codex maximum residue levels have been established for the pelargonic acid.

V. Conclusion An exemption from the requirement of a tolerance is established for residues of pelargonic acid in or on all raw agricultural commodities and in processed commodities, when such residues result from the use of pelargonic acid as an antimicrobial treatment in solutions containing a diluted end use concentration of pelargonic acid up to 170 ppm per application on food contact surfaces such as equipment, pipelines, tanks, vats, fillers, evaporators, pasteurizers and aseptic equipment in restaurants, food service operations, dairies, breweries, wineries, beverage and food processing plants. The sanitizer shall be applied by immersion, coarse spay, or circulation technique as appropriate to the equipment or utensil. No potable VerDate Dec< 13> 2002 15: 02 Feb 18, 2003 Jkt 200001 PO 00000 Frm 00037 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19FER1. SGM 19FER1 7934 Federal Register / Vol. 68, No. 33 / Wednesday, February 19, 2003 / Rules and Regulations water rinse is required following the use of the sanitizer.

VI. Objections and Hearing Requests Under section 408( g) of the FFDCA, as amended by the FQPA, any person may file an objection to any aspect of this regulation and may also request a hearing on those objections. The EPA procedural regulations which govern the submission of objections and requests for hearings appear in 40 CFR part 178. Although the procedures in those regulations require some modification to reflect the amendments made to the FFDCA by the FQPA, EPA will continue to use those procedures, with appropriate adjustments, until the necessary modifications can be made. The new section 408( g) of the FFDCA provides essentially the same process for persons to `` object'' to a regulation for an exemption from the requirement of a tolerance issued by EPA under new section 408( d) of FFDCA, as was provided in the old sections 408 and 409 of the FFDCA. However, the period for filing objections is now 60 days, rather than 30 days.

A. What Do I Need to Do to File an Objection or Request a Hearing? You must file your objection or request a hearing on this regulation in accordance with the instructions provided in this unit and in 40 CFR part 178. To ensure proper receipt by EPA, you must identify docket ID number OPP   2002   0273 in the subject line on the first page of your submission. All requests must be in writing, and must be mailed or delivered to the Hearing Clerk on or before April 21, 2003. 1. Filing the request. Your objection must specify the specific provisions in the regulation that you object to, and the grounds for the objections ( 40 CFR 178.25). If a hearing is requested, the objections must include a statement of the factual issues( s) on which a hearing is requested, the requestor's contentions on such issues, and a summary of any evidence relied upon by the objector ( 40 CFR 178.27). Information submitted in connection with an objection or hearing request may be claimed confidential by marking any part or all of that information as CBI. Information so marked will not be disclosed except in accordance with procedures set forth in 40 CFR part 2. A copy of the information that does not contain CBI must be submitted for inclusion in the public record. Information not marked confidential may be disclosed publicly by EPA without prior notice. Mail your written request to: Office of the Hearing Clerk ( 1900C), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. You may also deliver your request to the Office of the Hearing Clerk in Rm. 104, Crystal Mall # 2, 1921 Jefferson Davis Hwy., Arlington, VA. The Office of the Hearing Clerk is open from 8 a. m. to 4 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Office of the Hearing Clerk is ( 703) 603   0061. 2. Tolerance fee payment. If you file an objection or request a hearing, you must also pay the fee prescribed by 40 CFR 180.33( i) or request a waiver of that fee pursuant to 40 CFR 180.33( m). You must mail the fee to: EPA Headquarters Accounting Operations Branch, Office of Pesticide Programs, P. O. Box 360277M, Pittsburgh, PA 15251. Please identify the fee submission by labeling it `` Tolerance Petition Fees.'' EPA is authorized to waive any fee requirement `` when in the judgement of the Administrator such a waiver or refund is equitable and not contrary to the purpose of this subsection.'' For additional information regarding the waiver of these fees, you may contact James Tompkins by phone at ( 703) 305   5697, by e mail at tompkins. jim@ epa. gov, or by mailing a request for information to Mr. Tompkins at Registration Division ( 7505C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. If you would like to request a waiver of the tolerance objection fees, you must mail your request for such a waiver to: James Hollins, Information Resources and Services Division ( 7502C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001. 3. Copies for the Docket. In addition to filing an objection or hearing request with the Hearing Clerk as described in Unit VI. A., you should also send a copy of your request to the PIRIB for its inclusion in the official record that is described in Unit I. B. 1. Mail your copies, identified by docket ID number OPP   2002   0273, 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 an exemption from the tolerance requirement 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 VerDate Dec< 13> 2002 15: 02 Feb 18, 2003 Jkt 200001 PO 00000 Frm 00038 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19FER1. SGM 19FER1 7935 Federal Register / Vol. 68, No. 33 / Wednesday, February 19, 2003 / Rules and Regulations 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 exemption in this final rule, do not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act ( RFA) ( 5 U. S. C. 601 et seq.) do not apply. In addition, the Agency has determined that this action will not have a substantial direct effect on States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government, as specified in Executive Order 13132, entitled Federalism ( 64 FR 43255, August 10, 1999). Executive Order 13132 requires EPA to develop an accountable process to ensure `` meaningful and timely input by State and local officials in the development of regulatory policies that have federalism implications.'' `` Policies that have federalism implications'' is defined in the Executive Order to include regulations that have `` substantial direct effects on the States, on the relationship between the national government and the States, or on the distribution of power and responsibilities among the various levels of government.'' This final rule directly regulates growers, food processors, food handlers and food retailers, not States. This action does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of 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: January 21, 2003. James Jones, Acting 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 374.

2. Section 180.1159 is amended by adding paragraph ( c) to read as follows:

§ 180.1159 Pelargonic acid; exemption from the requirement of a tolerance.

* * * * * ( c) An exemption from the requirement of a tolerance is established for residues of pelargonic acid in or on all raw agricultural commodities and in processed commodities, when such residues result from the use of pelargonic acid as an antimicrobial treatment in solutions containing a diluted end use concentration of pelargonic acid up to 170 ppm per application on food contact surfaces such as equipment, pipelines, tanks, vats, fillers, evaporators, pasteurizers and aseptic equipment in restaurants, food service operations, dairies, breweries, wineries, beverage and food processing plants.

[ FR Doc. 03   3842 Filed 2   18   03; 8: 45 am]

BILLING CODE 6560   50   S ENVIRONMENTAL PROTECTION AGENCY 40 CFR Part 180 [ OPP   2002   0272; FRL   7278   6]

Decanoic Acid; Exemption from the Requirement of a Pesticide Tolerance AGENCY: Environmental Protection Agency ( EPA). ACTION: Final rule.

SUMMARY: This regulation establishes an exemption from the requirement of a tolerance for residues of decanoic acid ( capric acid) in or on all foods when applied/ used as a component of a food contact surface sanitizing solution in food handling establishments. Eco Lab Inc. submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act ( FFDCA), as amended by the Food Quality Protection Act of 1996 ( FQPA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of decanoic acid. DATES: This regulation is effective February 19, 2003. Objections and requests for hearings, identified by docket ID number OPP   2002   0272, must be received on or before April 21, 2003. ADDRESSES: Written objections and hearing requests may be submitted electronically, by mail, or through hand delivery/ courier. Follow the detailed instructions as provided in Unit X. of the SUPPLEMENTARY INFORMATION. FOR FURTHER INFORMATION CONTACT: Adam Heyward, Antimicrobials Division ( 7510C), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460   0001; telephone number: ( 703) 308   6422; email address: heyward. adam@ 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:   Crop production ( NAIC code 111)   Animal production ( NAIC code 112)

VerDate Dec< 13> 2002 15: 02 Feb 18, 2003 Jkt 200001 PO 00000 Frm 00039 Fmt 4700 Sfmt 4700 E:\ FR\ FM\ 19FER1. SGM 19FER1


[Federal Register Volume 82, Number 67 (Monday, April 10, 2017)]
[Rules and Regulations]
[Pages 17134-17136]
[FR Doc No: 2017-07029]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2016-0705; FRL-9960-81-Region 5]

Air Plan Approval; Michigan; Transportation Conformity Procedures

AGENCY: Environmental Protection Agency (EPA).

ACTION: Direct final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is approving a State
Implementation Plan (SIP) revision for carbon monoxide (CO) and
particulate matter (PM2.5), submitted by the State of
Michigan on October 3, 2016. The purpose of this revision is to
establish transportation conformity criteria and procedures related to
interagency consultation, and enforceability of certain transportation
related control and mitigation measures.

DATES: This direct final rule is effective June 9, 2017, unless EPA
receives adverse comments by May 10, 2017. If adverse comments are
received, EPA will publish a timely withdrawal of the direct final rule
in the Federal Register informing the public that the rule will not
take effect.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2016-0705 at http://www.regulations.gov or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Michael Leslie, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR 18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document whenever ``we,''
``us,'' or ``our'' is used, we mean EPA. This supplementary information
section is arranged as follows:

I. What is the background for this action?
II. What is EPA's analysis of Michigan's SIP revision?
III. What action is EPA taking?
IV. Statutory and Executive Order Reviews

I. What is the background for this action?

    Transportation conformity is required under section 176(c) of the
Clean Air Act (Act) to ensure that transportation planning activities
are consistent with (``conform to'') air quality planning goals in
nonattainment/maintenance areas. The transportation conformity
regulation is found in 40 CFR part 93 and provisions related to
transportation conformity SIPs are found in 40 CFR 51.390.
Transportation conformity applies to areas that are designated
nonattainment or maintenance for the transportation related criteria
pollutants listed in 40 CFR 93.102(b)(1). Michigan currently has
maintenance areas for CO and PM2.5.
    EPA originally promulgated the Federal transportation conformity
criteria and procedures (``Transportation Conformity Rule'') on
November 24, 1993 (58 FR 62188). On August 10, 2005, the ``Safe,
Accountable, Flexible, Efficient Transportation Equity Act: A Legacy
for Users'' (SAFETEA-LU) was signed into law. SAFETEA-LU revised
section 176(c) of the Act transportation conformity provisions.
SAFETEA-LU streamlined the requirements for conformity SIPs. Under
SAFETEA-LU, States are required to address and tailor only three
sections of the rules in their conformity SIPs: 40 CFR 93.105, 40 CFR
93.122(a)(4)(ii), and 40 CFR 93.125(c). 40 CFR 93.105 addresses
consultation procedures for conformity. 40 CFR 93.122(a)(4)(ii) and 40
CFR 93.125(c), addresses written commitments from project implementers
of transportation control measures. In general, states are no longer
required to submit conformity SIP revisions that address the other
sections of the conformity rule.

II. What is EPA's analysis of Michigan's SIP revision?

    A conformity SIP can be adopted as a state rule, as a memorandum of
understanding, or a memorandum of agreement (MOA). The appropriate form
of the state conformity procedures depends upon the requirements of
local or State law, as long as the selected form complies with all
requirements used by the Act for adoption, submission to EPA, and
implementation of SIPs. EPA will accept state conformity SIPs in any
form provided the state can demonstrate to EPA's satisfaction that, as
a matter of state law, the state has adequate authority to compel
compliance with the requirements of the conformity SIP.
    Michigan concluded that this SIP revision in the form of a MOA will
be enforceable through a number of Michigan statutes. These statutes
authorize state agencies to enter into legally binding cooperative
contracts for the receipt or furnishing of services. In this case,
these services relate to the transportation/air quality planning
process in Michigan. Michigan collaborated with the Michigan Department
of Transportation (MDOT), the EPA, the Federal Highway Administration
(FHWA), the Federal Transit Administration (FTA), and the Southeast
Michigan Council of Governments, to develop the Transportation
Conformity MOA. This MOA was agreed upon and signed by all of the above
consultation parties.
    EPA has evaluated this SIP submission and finds that the state has
addressed the requirements of the Federal transportation conformity
rule as described in 40 CFR 51.390 and 40 CFR part 93, subpart A. The
transportation conformity rule requires the states to develop their own
processes and procedures for interagency consultation and resolution of
conflicts meeting the criteria in 40 CFR 93.105. The SIP revision
includes processes and procedures to be followed by the Metropolitan
Planning Organization (MPO), MDOT, the FHWA and the FTA, in
consultation with the state and local air quality agencies and EPA
before making transportation conformity determinations. Michigan's
transportation conformity SIP also included processes and procedures
for the state and local air quality agencies and EPA to coordinate the
development of applicable SIPs with the MPOs, the state Department of
Transportation (DOT), and the U.S. DOT, and requires written
commitments to control measures and mitigation measures (40 CFR
93.122(a)(4)(ii) and 93.125(c)).

    EPA's review of the Michigan SIP revision indicates that it is
consistent with the Act as amended by SAFETEA-LU and EPA regulations
(40 CFR part 93, subpart A, and 40 CFR 51.390) governing state
procedures for transportation conformity and interagency consultation
and therefore EPA has concluded that the submittal is approvable.

III. What action is EPA taking?

    EPA is approving a SIP revision submitted by the State of Michigan,
for the purpose of establishing transportation conformity criteria and
procedures related to interagency consultation, and enforceable
commitments to implement transportation related control and mitigation
measures.
    We are publishing this action without prior proposal because we
view this as a noncontroversial amendment and anticipate no adverse
comments. However, in the proposed rules section of this Federal
Register publication, we are publishing a separate document that will
serve as the proposal to approve the state plan if relevant adverse
written comments are filed. This rule will be effective June 9, 2017
without further notice unless we receive relevant adverse written
comments by May 10, 2017. If we receive such comments, we will withdraw
this action before the effective date by publishing a subsequent
document that will withdraw the final action. All public comments
received will then be addressed in a subsequent final rule based on the
proposed action. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. If we do
not receive any comments, this action will be effective June 9, 2017.

IV. Statutory and Executive Order Reviews

    Under the Act, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, EPA's role is to approve state choices,
provided that they meet the criteria of the Act. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond those imposed by state
law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Public Law 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    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 action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Act, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by June 9, 2017. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. Parties with objections to this direct final rule are
encouraged to file a comment in response to the parallel notice of
proposed rulemaking for this action published in the proposed rules
section of this Federal Register, rather than file an immediate
petition for judicial review of this direct final rule, so that EPA can
withdraw this direct final rule and address the comment in the proposed
rulemaking. This action may not be challenged later in proceedings to
enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Particulate matter, Intergovernmental
relations.

    Dated: March 17, 2017.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

0
2. Section 52.1173 is amended by adding paragraph (l) to read as
follows:

Sec.  52.1173  Control strategy: Particulates.

* * * * *
    (l) Approval--On October 3, 2016, the State of Michigan submitted a
revision to their Particulate Matter State Implementation Plan. The
submittal established transportation conformity ``Conformity'' criteria
and procedures related to interagency consultation, and enforceability
of certain transportation related control and mitigation measures.

0
3. Section 52.1179 is amended by adding paragraph (c) to read as
follows:

Sec.  52.1179  Control strategy: Carbon monoxide.

* * * * *
    (c) Approval--On October 3, 2016, the State of Michigan submitted a
revision to their Carbon Monoxide State Implementation Plan. The
submittal established transportation conformity ``Conformity'' criteria
and procedures related to interagency consultation, and enforceability
of certain transportation related control and mitigation measures.

[FR Doc. 2017-07029 Filed 4-7-17; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: August 10, 2007 (Volume 72, Number 154)]
[Notices]
[Page 45030-45031]
[DOCID:fr10au07-66]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP07-541-000]

Southwest Gas Storage Company; Notice of Proposed Changes in FERC
Gas Tariff

August 6, 2007.
    Take notice that on August 1, 2007, Southwest Gas Storage Company,

(Southwest Gas Storage) tendered for filing as part of its FERC Gas
Tariff, First Revised Volume No. 1, Twentieth Revised Sheet No. 5, to
become effective September 1, 2007.
    Southwest Gas Storage states that the primary reason for the filing
of the revised tariff sheet is a general rate increase to adjust
Southwest Gas Storage's rates for storage services. Projected storage
revenues, excluding surcharges, are $50.6 million based on the 12-month
period ending April 30, 2007, as adjusted, resulting in a $4.7 million
increase when compared with actual revenues.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
 [FR Doc. E7-15651 Filed 8-9-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Notices]
[Pages 15665-15666]
[FR Doc No: 2021-06097]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2011-0465; FRL 10021-17-OW]

Proposed Information Collection Request for Water Quality
Standards Regulation (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The U.S. Environmental Protection Agency (EPA) is planning to
submit an information collection request (ICR), ``Water Quality
Standards Regulation (Renewal)'' (EPA ICR No. 0988.14, OMB Control No.
2040-0049) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. Before doing
so, EPA is soliciting public comments on specific aspects of the
proposed information collection as described below. This ICR renews the
Water Quality Standards Regulation ICR, which is currently approved
through December 31, 2021. 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.

DATES: Comments must be submitted on or before May 24, 2021.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OW-
2011-0465, online using www.regulations.gov (our preferred method), by
email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Menchu Martinez, Office of Water,
Office of Science and Technology, Standards and Health Protection
Division, (4305T), Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460; telephone number:<PHONE_NUMBER>; email
address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that EPA would be collecting are available in the
public docket for this ICR (Docket ID No. EPA-HQ-OW-2011-0465). The
docket can be viewed online at www.regulations.gov or in person at the
EPA Docket Center, WJC West, Room 3334, 1301 Constitution Ave. NW,
Washington, DC. The telephone number for the Docket Center is 202-566-
1744. For additional information about EPA's public docket, visit
http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act
(PRA), EPA is soliciting comments and information to enable it to: (i)
Evaluate whether the proposed collection of information is necessary
for the proper performance of the functions of the Agency, including
whether the information will have practical utility; (ii) evaluate the
accuracy of the Agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (iii) enhance the quality, utility, and clarity
of the information to be collected; and, (iv) minimize the burden of
the collection of information on those who are to respond, including
through the use of appropriate automated electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses. EPA
will consider the comments received and amend the proposed ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval. At that time, EPA will issue another Federal
Register notice to announce the submission of the ICR to OMB and the
opportunity to submit additional comments to OMB.
    Abstract: Water quality standards (WQS) under the Clean Water Act
(hereafter referred to as ``the Act'') are provisions of state,\1\
tribal,\2\ or federal law which consist of designated uses for waters
of the United States, water quality criteria to protect those uses, and
antidegradation requirements. WQS are established to protect public
health or welfare, protect and enhance the quality of water, and serve
the purposes of the Act. Such standards serve the dual purposes of
establishing the water quality goals for water bodies and serving as
the regulatory basis for the establishment of water quality-based
treatment controls and strategies beyond technology-based levels of
treatment required by sections 301(b) and 306 of the Act. The WQS
regulation, consisting of 40 CFR part 131, establishes the framework
for states and authorized tribes to adopt standards, and for EPA to
review and approve or disapprove them. This ICR is for information
collections needed to implement the WQS regulation, required to obtain
or retain benefits (e.g., relaxed regulatory requirements) under the
WQS regulation, and requested on a voluntary basis to gather technical
program information.
---------------------------------------------------------------------------

    \1\ ``States'' in EPA's WQS Regulation and in this document
includes the 50 states, the District of Columbia, Guam, the
Commonwealth of Puerto Rico, the Virgin Islands, American Samoa, and
the Commonwealth of the Northern Mariana Islands.
    \2\ ``Tribes'' in this document refers to federally recognized
tribes and ``authorized tribes'' refers to those federally
recognized Indian tribes with authority to administer a CWA WQS
program.
---------------------------------------------------------------------------

    This ICR renews the WQS Regulation ICR, OMB control no. 2040-0049,
expiration date 12/31/2021. This ICR renewal describes the estimated
burden for states and authorized tribes associated with the information
collections related to implementation of the requirements of 40 CFR
part 131 (Water Quality Standards). This ICR also covers periodic
requests for voluntary WQS information from states and tribes to ensure
efficient and effective administration of the WQS program and further
cooperative federalism.
    Form Numbers: None.
    Respondents/affected entities: Potential respondents to this ICR

include: The 50 states, the District of Columbia, five territories,
authorized tribes with EPA-approved water quality standards (45 tribes
as of February 2021), and a total of 18 additional tribal respondents
over the three-year duration of the ICR. The total number of potential
respondents is thus 119.
    Respondent's obligation to respond: Some collections in this ICR
are mandatory, some are required to obtain or retain benefits pursuant
to the WQS Regulation, and some are voluntary.
    Estimated number of respondents: 119.
    Frequency of response: Variable (once every three years, on
occasion or as necessary, or only once) depending on type of
information collected.
    Total estimated burden: 466,242 hours per year. Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $21,409,833 in labor costs and $263,520 in
operations and maintenance costs per year. There are no annualized
capital costs.
    Change in estimates: A decrease of 41,645 hours in estimated
respondent burden compared with the currently approved ICR. The
decrease reflects removal of one completed collection and transfer and
consolidation of two collections with the ICR of another program, and
adjustments to reflect changes in the estimated number of respondents.
    See Supporting Statement in the docket for more information.

Deborah Nagle,
Director, Office of Science and Technology, Office of Water.
[FR Doc. 2021-06097 Filed 3-23-21; 8:45 am]
BILLING CODE 6560-50-P


To: Nhan Nguyen, RAD Branch Chief From: Joe Avcin, RAD Staff

Date: 1/30/2015 Re: Close-Out of Technical Matters associated with the ECA Incineration Testing Program: Laboratory-Scale Incineration Testing of Fluoropolymers

The ECA Incineration Testing Program: Laboratory-Scale Incineration Testing of Fluoropolymers was completed on October 30, 2009.  The final study report associated with this effort consisted of about 3,900 pages of main report body pages and the associated supporting appendices.  The central conclusion of this study was that Phase II combustion testing of Fluoropolymer Composites 1, 2, 3, and 4 in the laboratory-scale thermal reactor system determined that waste incineration of fluoropolymers does not emit detectable levels of PFOA under conditions representative of typical municipal waste combustor operations in the U.S.  Based on this testing, waste incineration of fluoropolymers is not expected to be a source of PFOA in the environment.

Both Phase I and Phase II testing described in the Final Study Report were performed in accordance with the requirements of the Enforcable Consent Agreement (ECA) and the TSCA GLPs as embodied in the EPA-approved Quality Assurance Project Plans (QAPPs).  Upon review of the report and appendices, EPA did find eight areas that required additional technical clarification from the test sponsors.  These areas have been discussed with Philip Taylor, the Study Director, and Robert Giraud, the Technical Project Manager/Facility Management.

Satisfactory responses to Area #1, 2, 5, 7, and 8 have been obtained.  These topics and their responses are detailed in the file "Responses to EPA Review of Fluoropolymers Final Study Report.pdf."

The following areas remain open at the time of the writing of this memo pending a response from Robert Giraud:

      Area #3  -  O-ring a soure of F?       Area #4  -  CGA Concerns       Area #6  -  Other Perfluorinated Compounds        The closure of these issues while important in providing technical completeness are not necessary in order to close-out the study itself.  Any potential outcome of these issues would not alter the conclusions of the study.  Reponses to these open matters are expected within the first half of 2015.  These responses will be documented as appropriate when they are received.


[Federal Register Volume 84, Number 120 (Friday, June 21, 2019)]
[Notices]
[Pages 29211-29212]
[FR Doc No: 2019-13221]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-1536]

Opioid Analgesic Drugs: Considerations for Benefit-Risk
Assessment Framework; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Opioid
Analgesic Drugs: Considerations for Benefit-Risk Assessment
Framework.'' The purpose of this guidance is to describe the benefit-
risk framework the Agency uses in evaluating applications for opioid
analgesic drugs. This guidance summarizes the information that should
be included in a new drug application (NDA) for an opioid analgesic
drug to facilitate the Agency's benefit-risk assessment.

DATES: Submit either electronic or written comments on the draft
guidance by August 20, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-D-1536 for ``Opioid Analgesic Drugs: Considerations for
Benefit-Risk Assessment Framework.'' Received comments will be placed
in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly

viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Sharon Hertz, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3170, Silver Spring, MD 20993-0002, 301-
796-1225.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Opioid Analgesic Drugs: Considerations for Benefit-Risk
Assessment Framework.'' The purpose of this guidance is to describe the
benefit-risk framework the Agency uses in evaluating applications for
opioid analgesic drugs. This guidance summarizes the information that
should be included in an NDA for an opioid analgesic drug to facilitate
the Agency's benefit-risk assessment.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Opioid
Analgesic Drugs: Considerations for Benefit-Risk Assessment
Framework.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.
This guidance is not subject to Executive Order 12866.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR parts 312 and 314 have been
approved under OMB control numbers 0910-0014 and 0910-0001,
respectively.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: June 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-13221 Filed 6-20-19; 8:45 am]
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[Federal Register Volume 85, Number 225 (Friday, November 20, 2020)]
[Rules and Regulations]
[Pages 74259-74260]
[FR Doc No: 2020-25549]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0803; Airspace Docket No. 20-AGL-30]
RIN 2120-AA66

Amendment of Class E Airspace; Charlevoix, MI

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends the Class E airspace extending upward from
700 feet above the surface at Charlevoix Municipal Airport, Charlevoix,
MI. This action is the result of an airspace review caused by the
decommissioning of the Charlevoix non-directional beacon (NDB). The
geographic coordinates of the airport are also being updated to
coincide with the FAA's aeronautical database.

DATES: Effective 0901 UTC, February 25, 2021. The Director of the
Federal Register approves this incorporation by reference action under
Title 1 Code of Federal Regulations part 51, subject to the annual
revision of FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11E, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed online at https://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11E at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: Jeffrey Claypool, Federal Aviation
Administration, Operations Support Group, Central Service Center, 10101
Hillwood Parkway, Fort Worth, TX 76177; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends the Class E airspace extending upward from 700 feet above
the surface at Charlevoix Municipal Airport, Charlevoix, MI, to support
instrument flight rule operations at this airport.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (85 FR 55395; September 8, 2020) for Docket No. FAA-2020-0803
to amend the Class E airspace extending upward from 700 feet above the
surface at Charlevoix Municipal Airport, Charlevoix, MI. Interested
parties were invited to participate in this rulemaking effort by
submitting written comments on the proposal to the FAA. One comment was
received; however, the comment did not pertain to the proposed action
so no response is provided.
    Class E airspace designations are published in paragraph 6005 of
FAA Order 7400.11E, dated July 21, 2020, and effective September 15,
2020, which is incorporated by reference in 14 CFR 71.1. The Class E
airspace designations listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11E, Airspace Designations and
Reporting Points, dated July 21, 2020, and effective September 15,
2020. FAA Order 7400.11E is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11E lists Class A,
B, C, D, and E airspace areas,

air traffic service routes, and reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71 amends the Class E airspace extending upward from 700 feet
above the surface to within a 6.5-mile (reduced from a 7-mile) radius
of Charlevoix Municipal Airport, Charlevoix, MI; and updates the
geographic coordinates of the airport to coincide with the FAA's
aeronautical database.
    This action is the result of an airspace review caused by the
decommissioning of the Charlevoix NDB.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current, is
non-controversial and unlikely to result in adverse or negative
comments. It, therefore: (1) Is not a ``significant regulatory action''
under Executive Order 12866; (2) is not a ``significant rule'' under
DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that only affects air traffic procedures and air navigation, it is
certified that this rule, when promulgated, does not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5.a. This airspace action is not expected
to cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

    In consideration of the foregoing, the Federal Aviation
Administration amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11E,
Airspace Designations and Reporting Points, dated July 21, 2020, and
effective September 15, 2020, is amended as follows:

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

AGL MI E5 Charlevoix, MI [Amended]

Charlevoix Municipal Airport, MI
    (Lat. 45[deg]18'18'' N, long. 85[deg]16'31'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.5-mile radius of Charlevoix Municipal Airport.

    Issued in Fort Worth, Texas, on November 16, 2020.
Martin A. Skinner,
Acting Manager, Operations Support Group, ATO Central Service Center.
[FR Doc. 2020-25549 Filed 11-19-20; 8:45 am]
BILLING CODE 4910-13-P